Precision Medicine Healthcare Research Report
shraddhabandalkar
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Sep 24, 2024
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About This Presentation
The SG Analytics report on precision medicine provides a comprehensive overview of this transformative approach to healthcare. Precision medicine customizes treatments to individual patients based on their genetic, environmental, and lifestyle factors, moving away from the traditional one-size-fits-...
Slide Content
2Healthcare Industry Report
Executive Summary
Introduction
Precision Medicine Landscape
Recent Trends and Innovations
Key Legislation and Policies
Access and Reimbursement
How SGA Can Help
References
Methodology
CONTENTS
01
02
03
04
05
06
07
08
09
Executive Summary
Introduction
Precision Medicine Landscape
Recent Trends and Innovations
Key Legislation and Policies
Access and Reimbursement
How SGA Can Help
References
Methodology
CONTENTS
01
02
03
04
05
06
07
08
09
3Healthcare Industry Report
The world of Precision Medicine is truly transformative and a ground-
breaking approach to healthcare that tailors’ treatments to individual
patients’ genetic, environmental, and lifestyle variations. New devel-
opments such as mutation specific therapies, immunotherapies, and
chimeric antigen receptor – T (CAR–T) cell therapy can increase life
expectancy as well as quality of life
The journey of precision medicine, from the elucidation of Deoxyribo-
nucleic acid (DNA) structure in 1953 to the approval of 26 personal-
ized medicines by the US Food and Drug Administration (USFDA) in
2023, has been full of key milestones and innovations.
Pharmacogenomics is a key tool in precision medicine, which aims to
improve patient care by matching medications to individual genet-
ics. Recent enhancements in computing power and developments in
quantum computing have given a boost to the development of preci-
sion medicines. This has now led to more than 40% of all approvals in
2023 being precision medicine.
Other innovations such as Clustered Regularly Interspaced Short
Palindromic Repeats (CRISPR), biomarkers, and Next Generation Se-
quencing (NGS) have helped precision medicine to be more effective.
The advent of Artificial Intelligence (AI) has helped uncover hidden
associations in genomic datasets helping clinicians to devise person-
alized treatment plans for their patients.
Key legislation and policies are highlighted. Various countries, includ-
ing the US, the UK, Australia, Canada, India, and Israel are reviewed,
providing a global perspective on the regulatory environment.
Applications of precision medicine in areas such as cancer treatment,
infectious disease control, and chronic disease management leading
to benefits such as increased treatment efficacy, reduced side effects,
and early detection and prevention, are also important.
As precision medicine is generally highly priced, payers are looking at
paying for outcomes and working on value-based agreements. They
are also using machine learning (ML) techniques to identify high-val-
ue patients.
Executive Summary
01
Precision Medicine: A
New Era in Personalized
Healthcare
Doctors have always
recognized that every
patient is unique and
have tried to tailor their
treatments as best they
can as per the individuals.
You can match a blood
transfusion to a blood type
— that was an important
discovery. What if matching
a cancer cure to our genetic
code was just as easy,
just as standard? What if
figuring out the right dose of
medicine was as simple as
taking our temperature?”
- President Obama,
January 30, 2015
The world of Precision Medicine is truly transformative and a ground-
breaking approach to healthcare that tailors’ treatments to individual
patients’ genetic, environmental, and lifestyle variations. New devel-
opments such as mutation specific therapies, immunotherapies, and
chimeric antigen receptor – T (CAR–T) cell therapy can increase life
expectancy as well as quality of life
The journey of precision medicine, from the elucidation of Deoxyribo-
nucleic acid (DNA) structure in 1953 to the approval of 26 personal-
ized medicines by the US Food and Drug Administration (USFDA) in
2023, has been full of key milestones and innovations.
Pharmacogenomics is a key tool in precision medicine, which aims to
improve patient care by matching medications to individual genet-
ics. Recent enhancements in computing power and developments in
quantum computing have given a boost to the development of preci-
sion medicines. This has now led to more than 40% of all approvals in
2023 being precision medicine.
Other innovations such as Clustered Regularly Interspaced Short
Palindromic Repeats (CRISPR), biomarkers, and Next Generation Se-
quencing (NGS) have helped precision medicine to be more effective.
The advent of Artificial Intelligence (AI) has helped uncover hidden
associations in genomic datasets helping clinicians to devise person-
alized treatment plans for their patients.
Key legislation and policies are highlighted. Various countries, includ-
ing the US, the UK, Australia, Canada, India, and Israel are reviewed,
providing a global perspective on the regulatory environment.
Applications of precision medicine in areas such as cancer treatment,
infectious disease control, and chronic disease management leading
to benefits such as increased treatment efficacy, reduced side effects,
and early detection and prevention, are also important.
As precision medicine is generally highly priced, payers are looking at
paying for outcomes and working on value-based agreements. They
are also using machine learning (ML) techniques to identify high-val-
ue patients.
Executive Summary
01
Precision Medicine: A
New Era in Personalized
Healthcare
Doctors have always
recognized that every
patient is unique and
have tried to tailor their
treatments as best they
can as per the individuals.
You can match a blood
transfusion to a blood type
— that was an important
discovery. What if matching
a cancer cure to our genetic
code was just as easy,
just as standard? What if
figuring out the right dose of
medicine was as simple as
taking our temperature?”
- President Obama,
January 30, 2015
4Healthcare Industry Report
Introduction
02
Importance and Significance in Life Sciences
and Healthcare
Study found conventional/legacy drug therapies were
ineffective in 38% of patients on antidepressants, 40% on
asthma drugs, 43% on diabetes drugs, 50% taking arthritis
medication, 70% of patients with Alzheimer’s disease, and
75% taking cancer drugs. An increasing number of current
examples of personalized medicines include mutation
specific therapies,
immunotherapies, and CAR-T cell therapy.
Overview of Precision Medicines
Precision medicine is a cutting-edge approach in
healthcare that customizes medical treatment to the
individual characteristics of each patient. This approach
takes into account variations in genetics, environment, and
lifestyle for each person, which allows for more accurate
diagnosis, prevention, and treatment of diseases.
Precision medicine, also
known as personalized
medicine, is an innovative
approach to disease
prevention and treatment
that considers individual
differences in genes,
environments, and lifestyles.
The goal of precision
medicine is to target the
right treatments to the right
patients at the right time.
This paradigm shift promises
more effective interventions
and reduced adverse effects,
as treatments are tailored
to individual patients rather
than taking a one-size-fits-all
approach.
Overview of Precision Medicine
Introduction
02
Importance and Significance in Life Sciences
and Healthcare
Study found conventional/legacy drug therapies were
ineffective in 38% of patients on antidepressants, 40% on
asthma drugs, 43% on diabetes drugs, 50% taking arthritis
medication, 70% of patients with Alzheimer’s disease, and
75% taking cancer drugs. An increasing number of current
examples of personalized medicines include mutation
specific therapies,
immunotherapies, and CAR-T cell therapy.
Overview of Precision Medicines
Precision medicine is a cutting-edge approach in
healthcare that customizes medical treatment to the
individual characteristics of each patient. This approach
takes into account variations in genetics, environment, and
lifestyle for each person, which allows for more accurate
diagnosis, prevention, and treatment of diseases.
Precision medicine, also
known as personalized
medicine, is an innovative
approach to disease
prevention and treatment
that considers individual
differences in genes,
environments, and lifestyles.
The goal of precision
medicine is to target the
right treatments to the right
patients at the right time.
This paradigm shift promises
more effective interventions
and reduced adverse effects,
as treatments are tailored
to individual patients rather
than taking a one-size-fits-all
approach.
Overview of Precision Medicine
5Healthcare Industry Report
Key Components
Genomic Sequencing:
By analyzing a patient’s genetic makeup,
healthcare providers can identify genetic
mutations and variations that may
contribute to disease. This is particularly
useful in oncology, where targeted
therapies can be developed to treat
specific types of cancer based on their
genetic profiles.
Personalized Treatment Plans:
Precision medicine aims to tailor
treatments to individual patients rather
than using a one-size-fits-all approach.
This can involve selecting the most
effective medications and dosages based
on genetic information, reducing the
likelihood of adverse drug reactions and
improving outcomes.
Advanced Technologies:
The integration of artificial intelligence
(AI) and ML along with Big Data in
precision medicine helps analyze large
datasets to uncover patterns and make
predictions about treatment responses.
These technologies enhance the ability
to provide precise and effective medical
care.
Biomarker Identification:
Biomarkers are measurable indicators
of a biological condition or state. In
precision medicine, biomarkers are
used to predict disease risk, diagnose
conditions early, and monitor treatment
effectiveness. Accurate biomarker
measurement is crucial for developing
targeted therapies and monitoring
disease progression.
Individualization: Personalized medicine
advocates for treatments based on a
person’s genetic makeup, considering
the unique variations in their genome.
This personalized method acknowledges
that while most genetic variations do
not influence well-being, they can
greatly affect an individual’s health when
combined with environmental factors and
lifestyle behaviors.
The two key principles of personalized medicine are as follows:
Precision: Utilizing advanced technologies,
such as genome sequencing, personalized
medicine can identify specific DNA
mutations that are linked to diseases.
This enables more precise diagnosis
and treatment targeted at these specific
mutations.
These principles combined greatly
reduce the trial-and-error inefficiencies,
allowing healthcare professionals to better
understand disease and address it.
Key Components
Genomic Sequencing:
By analyzing a patient’s genetic makeup,
healthcare providers can identify genetic
mutations and variations that may
contribute to disease. This is particularly
useful in oncology, where targeted
therapies can be developed to treat
specific types of cancer based on their
genetic profiles.
Personalized Treatment Plans:
Precision medicine aims to tailor
treatments to individual patients rather
than using a one-size-fits-all approach.
This can involve selecting the most
effective medications and dosages based
on genetic information, reducing the
likelihood of adverse drug reactions and
improving outcomes.
Advanced Technologies:
The integration of artificial intelligence
(AI) and ML along with Big Data in
precision medicine helps analyze large
datasets to uncover patterns and make
predictions about treatment responses.
These technologies enhance the ability
to provide precise and effective medical
care.
Biomarker Identification:
Biomarkers are measurable indicators
of a biological condition or state. In
precision medicine, biomarkers are
used to predict disease risk, diagnose
conditions early, and monitor treatment
effectiveness. Accurate biomarker
measurement is crucial for developing
targeted therapies and monitoring
disease progression.
Individualization: Personalized medicine
advocates for treatments based on a
person’s genetic makeup, considering
the unique variations in their genome.
This personalized method acknowledges
that while most genetic variations do
not influence well-being, they can
greatly affect an individual’s health when
combined with environmental factors and
lifestyle behaviors.
The two key principles of personalized medicine are as follows:
Precision: Utilizing advanced technologies,
such as genome sequencing, personalized
medicine can identify specific DNA
mutations that are linked to diseases.
This enables more precise diagnosis
and treatment targeted at these specific
mutations.
These principles combined greatly
reduce the trial-and-error inefficiencies,
allowing healthcare professionals to better
understand disease and address it.
6Healthcare Industry Report
Pharmacogenomics is the
study of the relationship
between genetic variations
and how our body responds
to medications. Under this,
genomic information is used
to study individual responses
to drugs. When a gene
variant is associated with
a particular drug response
in a patient, there is the
potential for making clinical
decisions based on genetics
by adjusting the dosage or
choosing a different drug. For
example, scientists assess
gene variants affecting an
individual’s drug response
the same way they assess
gene variants associated
with diseases: by identifying
genetic loci associated with
known drug responses and
then testing individuals
whose response is unknown.
Overview of
Precision Medicine
Cancer Treatment
Precision oncology uses genetic information to identify
specific mutations in cancer cells, allowing for the
development of targeted therapies that are more effective
and have fewer side effects compared to traditional
treatments.
Infectious Disease Control
Genome sequencing helps in identifying and tracking
pathogens dauring outbreaks, leading to faster and more
accurate public health responses.
Chronic Disease Management
Personalized treatment plans based on genetic, lifestyle,
and environmental factors improve the management of
chronic conditions such as cardiovascular diseases.
Applications
Benefits
• Increased Treatment Efficacy: Tailoring treatments to individual genetic profiles increase
the likelihood of successful outcomes. For example, CAR-T cell therapy, developed by ImmunoAct
in collaboration with IIT Bombay and Tata Memorial Hospital, has been administered to 15 patients
in India, with three achieving successful cancer remission.
• Reduced Side Effects: Precision medicine minimizes adverse reactions by selecting the most
appropriate medications and dosages. For example, in CAR-T cell therapy side-effects depends,
with about 30% to 60% of patients experiences some degree of cytokine release syndrome. This
condition can vary in severity: from mild cases, where patients may only experience a fever for a
day, to severe cases that can lead to significant illness and require intensive care unit admission.
• Early Detection and Prevention: Genetic screening and biomarker analysis enable early
detection of diseases, allowing for timely intervention and prevention strategies.
Pharmacogenomics is the
study of the relationship
between genetic variations
and how our body responds
to medications. Under this,
genomic information is used
to study individual responses
to drugs. When a gene
variant is associated with
a particular drug response
in a patient, there is the
potential for making clinical
decisions based on genetics
by adjusting the dosage or
choosing a different drug. For
example, scientists assess
gene variants affecting an
individual’s drug response
the same way they assess
gene variants associated
with diseases: by identifying
genetic loci associated with
known drug responses and
then testing individuals
whose response is unknown.
Overview of
Precision Medicine
Cancer Treatment
Precision oncology uses genetic information to identify
specific mutations in cancer cells, allowing for the
development of targeted therapies that are more effective
and have fewer side effects compared to traditional
treatments.
Infectious Disease Control
Genome sequencing helps in identifying and tracking
pathogens dauring outbreaks, leading to faster and more
accurate public health responses.
Chronic Disease Management
Personalized treatment plans based on genetic, lifestyle,
and environmental factors improve the management of
chronic conditions such as cardiovascular diseases.
Applications
Benefits
• Increased Treatment Efficacy: Tailoring treatments to individual genetic profiles increase
the likelihood of successful outcomes. For example, CAR-T cell therapy, developed by ImmunoAct
in collaboration with IIT Bombay and Tata Memorial Hospital, has been administered to 15 patients
in India, with three achieving successful cancer remission.
• Reduced Side Effects: Precision medicine minimizes adverse reactions by selecting the most
appropriate medications and dosages. For example, in CAR-T cell therapy side-effects depends,
with about 30% to 60% of patients experiences some degree of cytokine release syndrome. This
condition can vary in severity: from mild cases, where patients may only experience a fever for a
day, to severe cases that can lead to significant illness and require intensive care unit admission.
• Early Detection and Prevention: Genetic screening and biomarker analysis enable early
detection of diseases, allowing for timely intervention and prevention strategies.
7Healthcare Industry Report
Evolution of Precision Medicine
The elucidation of the structure
of DNA by James Watson, Francis
Crick, and Rosalind Franklin
1953
Human Genome Project initiat-
ed to create genetic blueprint of
humans
1990
Human Genome project com-
pleted with generating the first
sequence of the human genome
(Approximately 92% of the entire
human genome sequence has
been mapped)
2003
The Precision Medicine Coalition
(PMC) was founded by 20 insti-
tutions from various sectors of
the healthcare system
2004
USFDA brings out guidance to
facilitate scientific progress in
the field of pharmacogenom-
ics and to facilitate the use of
pharmacogenomic data in drug
development
2005
The European Alliance for Per-
sonalized Medicine (EAPM) was
Launched
2012
The USFDA approved 26 person-
alized medicines, accounting
for 47% of all approvals. With 19
additional indications of existing
personalized medicines and 17
significant new or expanded uses
for 12 diagnostic testing prod-
ucts.
2023
Researchers successfully pro-
duced the first complete, seam-
less sequence of a human
genome
2022
Emmanuelle Charpentier and
Jennifer A. Doudna were award-
ed the Nobel Prize in Chemistry
for their discovery of CRISPR/
Cas9
2020
The USFDA approved 25 person-
alized medicines, making up 42%
of all approvals granted
2018
The White House introduced
the “Precision Medicine Initia-
tive Cohort Program,” which has
since evolved into the “All of Us
Research Program”
2015
Global Alliance for Genomics
and Health (GA4GH) formed to
expand genomic data use within
a human rights framework
2013
The first CAR T-cell therapies tar-
geting the B-lymphocyte antigen
CD19 approved by the USFDA
and the EMA
2017 &
2018
Evolution of Precision Medicine
The elucidation of the structure
of DNA by James Watson, Francis
Crick, and Rosalind Franklin
1953
Human Genome Project initiat-
ed to create genetic blueprint of
humans
1990
Human Genome project com-
pleted with generating the first
sequence of the human genome
(Approximately 92% of the entire
human genome sequence has
been mapped)
2003
The Precision Medicine Coalition
(PMC) was founded by 20 insti-
tutions from various sectors of
the healthcare system
2004
USFDA brings out guidance to
facilitate scientific progress in
the field of pharmacogenom-
ics and to facilitate the use of
pharmacogenomic data in drug
development
2005
The European Alliance for Per-
sonalized Medicine (EAPM) was
Launched
2012
The USFDA approved 26 person-
alized medicines, accounting
for 47% of all approvals. With 19
additional indications of existing
personalized medicines and 17
significant new or expanded uses
for 12 diagnostic testing prod-
ucts.
2023
Researchers successfully pro-
duced the first complete, seam-
less sequence of a human
genome
2022
Emmanuelle Charpentier and
Jennifer A. Doudna were award-
ed the Nobel Prize in Chemistry
for their discovery of CRISPR/
Cas9
2020
The USFDA approved 25 person-
alized medicines, making up 42%
of all approvals granted
2018
The White House introduced
the “Precision Medicine Initia-
tive Cohort Program,” which has
since evolved into the “All of Us
Research Program”
2015
Global Alliance for Genomics
and Health (GA4GH) formed to
expand genomic data use within
a human rights framework
2013
The first CAR T-cell therapies tar-
geting the B-lymphocyte antigen
CD19 approved by the USFDA
and the EMA
2017 &
2018
8Healthcare Industry Report
Market Overview
Clinical Trials
Marketed Products
Representative List for Clinical Trial Data of Precision Medicine in Phase III:
Therapeutic Molecular Personalized Medicines Approved by the FDA
Title Disease/Indication Sponsor Name
Clinical Trial
Phase
Completion
Date
Liquid Biopsy (ctDNA) Guided
Treatment in Localized Pancreatic
Cancer
Pancreatic Cancer
Elisabethinen
Hospital
Phase III 31-Dec-26
Personalized Medicine for Advanced
Biliary Cancer Patients
Biliary Tract
Neoplasms
UNICANCER Phase III Jun-28
Patient-derived Organoid-guided
Personalized Treatment vs.
Physician's Choice Treatment in
Breast Cancer
Breast Cancer
Sun Yat-sen
University
Phase III 15-Jan-28
Precision Medicine Approach for
Early Dementia & Mild Cognitive
Impairment
Mild Cognitive
Impairment
Alzheimer's
Prevention and
Reversal Project Inc.
Phase III Sep-25
Sr. No.Product Name Indication Class of agent Manufacturer
1
Casgevy (Exagamglogene
Autotemcel )
Sickle Cell Disease Biologic Vertex Pharmaceuticals
2
Elevidys (Delandistrogene
Moxeparvovec)
Duchenne Muscular
Dystrophy
Biosimilar Sarepta Therapeutics
3
Elfabrio (Pegunigalsidase
Alfa)
Fabry Disease
Biosimilar (Enzyme
Replacement Therapy)
CHIESI FARMACEUTICI
4 Fabhalta (Iptacopan)
Paroxysmal Nocturnal
Hemoglobinuria
Small Molecule Novartis
Recent advancements in precision medicine have led to the approval of several molecular personal-
ized medicines by the FDA, targeting a variety of diseases.
A few notable approvals in 2023 include:
Market Overview
Clinical Trials
Marketed Products
Representative List for Clinical Trial Data of Precision Medicine in Phase III:
Therapeutic Molecular Personalized Medicines Approved by the FDA
Title Disease/Indication Sponsor Name
Clinical Trial
Phase
Completion
Date
Liquid Biopsy (ctDNA) Guided
Treatment in Localized Pancreatic
Cancer
Pancreatic Cancer
Elisabethinen
Hospital
Phase III 31-Dec-26
Personalized Medicine for Advanced
Biliary Cancer Patients
Biliary Tract
Neoplasms
UNICANCER Phase III Jun-28
Patient-derived Organoid-guided
Personalized Treatment vs.
Physician's Choice Treatment in
Breast Cancer
Breast Cancer
Sun Yat-sen
University
Phase III 15-Jan-28
Precision Medicine Approach for
Early Dementia & Mild Cognitive
Impairment
Mild Cognitive
Impairment
Alzheimer's
Prevention and
Reversal Project Inc.
Phase III Sep-25
Sr. No.Product Name Indication Class of agent Manufacturer
1
Casgevy (Exagamglogene
Autotemcel )
Sickle Cell Disease Biologic Vertex Pharmaceuticals
2
Elevidys (Delandistrogene
Moxeparvovec)
Duchenne Muscular
Dystrophy
Biosimilar Sarepta Therapeutics
3
Elfabrio (Pegunigalsidase
Alfa)
Fabry Disease
Biosimilar (Enzyme
Replacement Therapy)
CHIESI FARMACEUTICI
4 Fabhalta (Iptacopan)
Paroxysmal Nocturnal
Hemoglobinuria
Small Molecule Novartis
Recent advancements in precision medicine have led to the approval of several molecular personal-
ized medicines by the FDA, targeting a variety of diseases.
A few notable approvals in 2023 include:
9Healthcare Industry Report
Sr. No.Product Name Indication Class of agent Manufacturer
5 Filspari (Sparsentan) Proteinuria Small Molecule Travere Therapeutics
6 Joenja (Leniolisib)
Activated
Phosphoinositide
3-Kinase Delta
Syndrome
Small Molecule Pharming Group
7
Lamzede (Velmanase
Alfa)
Alpha-Mannosidosis Biosimilar CHIESI FARMACEUTICI
8
Lyfgenia (Lovotibeglogene
Autotemcel)
Sickle Cell Disease Biologic bluebird bio
9
Pombiliti (Cipaglucosidase
Alfa)
Pompe Disease Biosimilar Amicus Therapeutics
10 Qalsody (Tofersen)
Amyotrophic Lateral
Sclerosis
Biologic Biogen
11Rivfloza (Nedosiran)
Primary Hyperoxaluria
Type 1
Small Molecule Novo Nordisk
12
Roctavian (Valoctocogene
Roxaparvovec)
Hemophilia A Biosimilar
BioMarin
Pharmaceutical
13 Sohonos (Palovarotene)
Fibrodysplasia
Ossificans Progressiva
Small Molecule
Ipsen
Biopharmaceuticals
14 Veopoz (Pozelimab) CHAPLE Disease Biosimilar
Regeneron
Pharmaceuticals
15
Vyjuvek (Beremagene
Geperpavec)
Dystrophic
Epidermolysis Bullosa
Biosimilar Krystal Biotech
16 Wainua (Eplontersen)
Hereditary
Transthyretin-Mediated
Amyloidosis
Small Molecule AstraZeneca
17 Augtyro (Repotrectinib)
Non-small Cell Lung
Cancer
Small Molecule BMS
18 Loqtorzi (Toripalimab)
Nasopharyngeal
Carcinoma
Biosimilar Coherus BioSciences
19 Omisirge (Omidubicel)
Hematologic
Malignancies
Biosimilar Gamida Cell
20 Orserdu (Elacestrant)
Metastatic Breast
Cancer
Small Molecule Stemline Therapeutics
21 Truqap (Capivasertib)
Metastatic Breast
Cancer
Small Molecule AstraZeneca
Sr. No.Product Name Indication Class of agent Manufacturer
5 Filspari (Sparsentan) Proteinuria Small Molecule Travere Therapeutics
6 Joenja (Leniolisib)
Activated
Phosphoinositide
3-Kinase Delta
Syndrome
Small Molecule Pharming Group
7
Lamzede (Velmanase
Alfa)
Alpha-Mannosidosis Biosimilar CHIESI FARMACEUTICI
8
Lyfgenia (Lovotibeglogene
Autotemcel)
Sickle Cell Disease Biologic bluebird bio
9
Pombiliti (Cipaglucosidase
Alfa)
Pompe Disease Biosimilar Amicus Therapeutics
10 Qalsody (Tofersen)
Amyotrophic Lateral
Sclerosis
Biologic Biogen
11Rivfloza (Nedosiran)
Primary Hyperoxaluria
Type 1
Small Molecule Novo Nordisk
12
Roctavian (Valoctocogene
Roxaparvovec)
Hemophilia A Biosimilar
BioMarin
Pharmaceutical
13 Sohonos (Palovarotene)
Fibrodysplasia
Ossificans Progressiva
Small Molecule
Ipsen
Biopharmaceuticals
14 Veopoz (Pozelimab) CHAPLE Disease Biosimilar
Regeneron
Pharmaceuticals
15
Vyjuvek (Beremagene
Geperpavec)
Dystrophic
Epidermolysis Bullosa
Biosimilar Krystal Biotech
16 Wainua (Eplontersen)
Hereditary
Transthyretin-Mediated
Amyloidosis
Small Molecule AstraZeneca
17 Augtyro (Repotrectinib)
Non-small Cell Lung
Cancer
Small Molecule BMS
18 Loqtorzi (Toripalimab)
Nasopharyngeal
Carcinoma
Biosimilar Coherus BioSciences
19 Omisirge (Omidubicel)
Hematologic
Malignancies
Biosimilar Gamida Cell
20 Orserdu (Elacestrant)
Metastatic Breast
Cancer
Small Molecule Stemline Therapeutics
21 Truqap (Capivasertib)
Metastatic Breast
Cancer
Small Molecule AstraZeneca
10Healthcare Industry Report
Sr. No.Product Name Indication Class of agent Manufacturer
22 Vanflyta (Quizartinib) Acute Myeloid LeukemiaSmall Molecule Daiichi Sankyo
23 Zynyz (Retifanlimab) Merkel Cell Carcinoma Biosimilar Incyte Corporation
24 Leqembi (Lecanemab) Alzheimer’s Disease Biosimilar Eisai Co.
25
Rystiggio
(Rozanolixizumab)
Generalized Myasthenia
gravis
Biosimilar UCB
26 Zilbrysq (Zilucoplan)
Generalized Myasthenia
gravis
Small Molecule UCB
Year of Drug’s First
FDA- approval
FDA-approved
Drug
FDA Drug Label Listed
Biomarker
Class of Agent
Mechanism of Action
or Drug Target
2021 Amivantamab EGFR Exon 20 InsertionsMonoclonal Antibody
EGFR-MET Bispecific
Antibody
2021 Asciminib Ph+ (BCR-ABL1 Fusion)Biosimilar Incyte Corporation
or ABL1 T315I
Small Molecule
Kinase Inhibitor
ABL/BCR-ABL1 Tyrosine
Kinase Inhibitor
Biosimilar Eisai Co.
2021 Belzutifan
VHL Oncogenic
Mutations
Small Molecule
Inhibitor
HIF-2a Inhibitor
2021 Dostarlimab
*dMMR
*dMMR or MSI-H
Immune Checkpoint
Inhibitor
Anti PD-1 Antibody
2021 Infigratinib FGFR2 Fusions
Small Molecule Kinase
Inhibitor
FGFR1/2/3 Inhibitor
2021 Mobocertinib EGFR Exon 20 Insertions
Small Molecule Kinase
Inhibitor
EGFR Exon 20 Inhibitor
2021 Sotorasib KRAS G12C
Small Molecule
Inhibitor
KRAS G12C Inhibitor
2021 Tepotinib
MET Exon 14 Skipping
Mutations
Small Molecule Kinase
Inhibitor
MET Inhibitor
FDA-approved Precision Oncology Therapy: 198 new oncology drugs approved by the USFDA between
1998 and 2022. Approximately 43% were precision oncology therapies, the use of which is guided by
biomarker testing.
Sr. No.Product Name Indication Class of agent Manufacturer
22 Vanflyta (Quizartinib) Acute Myeloid LeukemiaSmall Molecule Daiichi Sankyo
23 Zynyz (Retifanlimab) Merkel Cell Carcinoma Biosimilar Incyte Corporation
24 Leqembi (Lecanemab) Alzheimer’s Disease Biosimilar Eisai Co.
25
Rystiggio
(Rozanolixizumab)
Generalized Myasthenia
gravis
Biosimilar UCB
26 Zilbrysq (Zilucoplan)
Generalized Myasthenia
gravis
Small Molecule UCB
Year of Drug’s First
FDA- approval
FDA-approved
Drug
FDA Drug Label Listed
Biomarker
Class of Agent
Mechanism of Action
or Drug Target
2021 Amivantamab EGFR Exon 20 InsertionsMonoclonal Antibody
EGFR-MET Bispecific
Antibody
2021 Asciminib Ph+ (BCR-ABL1 Fusion)Biosimilar Incyte Corporation
or ABL1 T315I
Small Molecule
Kinase Inhibitor
ABL/BCR-ABL1 Tyrosine
Kinase Inhibitor
Biosimilar Eisai Co.
2021 Belzutifan
VHL Oncogenic
Mutations
Small Molecule
Inhibitor
HIF-2a Inhibitor
2021 Dostarlimab
*dMMR
*dMMR or MSI-H
Immune Checkpoint
Inhibitor
Anti PD-1 Antibody
2021 Infigratinib FGFR2 Fusions
Small Molecule Kinase
Inhibitor
FGFR1/2/3 Inhibitor
2021 Mobocertinib EGFR Exon 20 Insertions
Small Molecule Kinase
Inhibitor
EGFR Exon 20 Inhibitor
2021 Sotorasib KRAS G12C
Small Molecule
Inhibitor
KRAS G12C Inhibitor
2021 Tepotinib
MET Exon 14 Skipping
Mutations
Small Molecule Kinase
Inhibitor
MET Inhibitor
FDA-approved Precision Oncology Therapy: 198 new oncology drugs approved by the USFDA between
1998 and 2022. Approximately 43% were precision oncology therapies, the use of which is guided by
biomarker testing.
11Healthcare Industry Report
Year of Drug’s First
FDA- approval
FDA-approved
Drug
FDA Drug Label Listed
Biomarker
Class of Agent
Mechanism of Action
or Drug Target
2021
Trastuzumab +
Pembrolizumab
HER2+ (ERBB2
Amplification)
Monoclonal Antibody
and Immune
Checkpoint Inhibitor
Combination
Anti-HER2 (ERBB2)
Antibody + Anti-PD-1
Antibody
2022 Adagrasib KRAS G12C
Small Molecule
Inhibitor
KRAS G12C Inhibitor
2022 Futibatinib FGFR2 Fusions
Small Molecule Kinase
Inhibitor
FGFR1/2/3 Inhibitor
2022
Mirvetuximab
soravtansine
FRa
Antibody Drug
Conjugate
Folate Receptor Alpha-
directed Antibody
Microtubule Inhibitor
Conjugate
2022 Olutasidenib IDH1 R132C/G/H/L/S
Small Molecule
Inhibitor
IDH1 Inhibitor
2022 Pluvicto PSMA+ Radiotherapy
Radioligand
Therapeutic Agent
2022 Tebentafusp HLA-A*02:01-Positivity
Bispecific T-cell
Engager
Bispecific gp100
Peptide-HLA-A*02:01-
directed T-cell
Receptor CD3 T cell
Engager
2023 Capivasertib
PIK3CA, AKT1, or PTEN
Oncogenic Mutations
and HR+/HER2-
Small Molecule Kinase
Inhibitor
AKT1/2/3 Inhibitor
2023 Elacestrant
ESR1 Ligand-binding
Domain Missense
Mutations and
Small Molecule Kinase
Inhibitor
MET Inhibitor
ER+/HER2-
Hormone
Therapy
Selective Estrogen
Receptor Degrader
(SERD)
2023 Quizartinib FLT3 ITD Mutations
Small Molecule
Inhibitor
FLT3 Inhibitor
2023 Repotrectinib ROS1 Fusions
Small Molecule Kinase
Inhibitor
Multi-targeted Kinase
Inhibitor (targets
include ROS1 and
NTRK1/2/3)
2024 Tovorafenib
BRAF Fusions, BRAF
Rearrangement, and
BRAF V600
Small Molecule Kinase
Inhibitor
RAF Inhibitor
Year of Drug’s First
FDA- approval
FDA-approved
Drug
FDA Drug Label Listed
Biomarker
Class of Agent
Mechanism of Action
or Drug Target
2021
Trastuzumab +
Pembrolizumab
HER2+ (ERBB2
Amplification)
Monoclonal Antibody
and Immune
Checkpoint Inhibitor
Combination
Anti-HER2 (ERBB2)
Antibody + Anti-PD-1
Antibody
2022 Adagrasib KRAS G12C
Small Molecule
Inhibitor
KRAS G12C Inhibitor
2022 Futibatinib FGFR2 Fusions
Small Molecule Kinase
Inhibitor
FGFR1/2/3 Inhibitor
2022
Mirvetuximab
soravtansine
FRa
Antibody Drug
Conjugate
Folate Receptor Alpha-
directed Antibody
Microtubule Inhibitor
Conjugate
2022 Olutasidenib IDH1 R132C/G/H/L/S
Small Molecule
Inhibitor
IDH1 Inhibitor
2022 Pluvicto PSMA+ Radiotherapy
Radioligand
Therapeutic Agent
2022 Tebentafusp HLA-A*02:01-Positivity
Bispecific T-cell
Engager
Bispecific gp100
Peptide-HLA-A*02:01-
directed T-cell
Receptor CD3 T cell
Engager
2023 Capivasertib
PIK3CA, AKT1, or PTEN
Oncogenic Mutations
and HR+/HER2-
Small Molecule Kinase
Inhibitor
AKT1/2/3 Inhibitor
2023 Elacestrant
ESR1 Ligand-binding
Domain Missense
Mutations and
Small Molecule Kinase
Inhibitor
MET Inhibitor
ER+/HER2-
Hormone
Therapy
Selective Estrogen
Receptor Degrader
(SERD)
2023 Quizartinib FLT3 ITD Mutations
Small Molecule
Inhibitor
FLT3 Inhibitor
2023 Repotrectinib ROS1 Fusions
Small Molecule Kinase
Inhibitor
Multi-targeted Kinase
Inhibitor (targets
include ROS1 and
NTRK1/2/3)
2024 Tovorafenib
BRAF Fusions, BRAF
Rearrangement, and
BRAF V600
Small Molecule Kinase
Inhibitor
RAF Inhibitor
12Healthcare Industry Report
• Liquid Biopsy: This method uses biomarkers in blood for non-
invasive, real-time prognostic, and predictive purposes. By
analyzing blood or urine samples, liquid biopsies can diagnose
diseases, monitor treatment progress, and detect recurrence with
minimal discomfort to patients. This is particularly useful in cancer
management, where early detection and ongoing monitoring are
crucial.
• Microfluids (Lab on a Chip): Microfluidic technologies enable
extremely precise fluid control and manipulation, facilitating
rapid and high-throughput sample processing in integrated
micro-scale medical systems. This technology allows for the
miniaturization of laboratory processes, leading to faster and
more accurate diagnostic results.
• 4D Sonography: This advanced imaging technique creates
detailed images of tissues, organs, and fluid flow within the body.
It enhances diagnostic ability, precision in treatment selection,
and prognosis evaluation, especially in fields like obstetrics,
cardiology, and oncology.
• iKnife: The intelligent knife (iKnife) combines an electrosurgical
scalpel with a mass spectrometer to distinguish tissues during
surgery. It can detect and diagnose cancer in real-time, enabling
surgeons to make more informed decisions and improving
surgical outcomes.
• Companion Diagnostic (CDx): A companion diagnostic is a
medical device, often an IVD, which provides information that is
essential for the safe and effective use of a corresponding drug or
biological product.
Recent Trends and Innovations
02
Cutting Edge Technologies
In Vitro Diagnostics
In vitro diagnostics (IVD)
involve testing samples taken
from the human body to
detect, diagnose, and monitor
diseases. This field has seen
significant innovations that
enhance precision medicine.
5-6%
compounded ed annual
growth rate of Global IVD
market from 2023 – 2029
Contribution of top 7 players in
the IVD market by revenue for
2024 5
• Liquid Biopsy: This method uses biomarkers in blood for non-
invasive, real-time prognostic, and predictive purposes. By
analyzing blood or urine samples, liquid biopsies can diagnose
diseases, monitor treatment progress, and detect recurrence with
minimal discomfort to patients. This is particularly useful in cancer
management, where early detection and ongoing monitoring are
crucial.
• Microfluids (Lab on a Chip): Microfluidic technologies enable
extremely precise fluid control and manipulation, facilitating
rapid and high-throughput sample processing in integrated
micro-scale medical systems. This technology allows for the
miniaturization of laboratory processes, leading to faster and
more accurate diagnostic results.
• 4D Sonography: This advanced imaging technique creates
detailed images of tissues, organs, and fluid flow within the body.
It enhances diagnostic ability, precision in treatment selection,
and prognosis evaluation, especially in fields like obstetrics,
cardiology, and oncology.
• iKnife: The intelligent knife (iKnife) combines an electrosurgical
scalpel with a mass spectrometer to distinguish tissues during
surgery. It can detect and diagnose cancer in real-time, enabling
surgeons to make more informed decisions and improving
surgical outcomes.
• Companion Diagnostic (CDx): A companion diagnostic is a
medical device, often an IVD, which provides information that is
essential for the safe and effective use of a corresponding drug or
biological product.
Recent Trends and Innovations
02
Cutting Edge Technologies
In Vitro Diagnostics
In vitro diagnostics (IVD)
involve testing samples taken
from the human body to
detect, diagnose, and monitor
diseases. This field has seen
significant innovations that
enhance precision medicine.
5-6%
compounded ed annual
growth rate of Global IVD
market from 2023 – 2029
Contribution of top 7 players in
the IVD market by revenue for
2024 5
13Healthcare Industry Report
identify patients who are most likely to benefit from
a particular therapeutic product,
identify patients likely to be at increased risk for
serious side effects as a result of treatment with a
particular therapeutic product; or
monitor response to treatment with a particular
therapeutic product for the purpose of adjusting
treatment to achieve improved safety or
effectiveness.
Companion Diagnostics can
1
2
3
The inception of CDx can be traced back to 1998, when the FDA granted
concurrent approval for trastuzumab, a targeted cancer drug and
HercepTest™, a HER2 immunohistochemical assay. This milestone
marked the birth of the drug-diagnostic co-development model, a
transformative approach that has since witnessed consistent and
substantial adoption.
The evolution of CDx was gradual, with significant progress seen only in
the last decade. From 1998 to 2012, around 20 new CDx were approved.
However, this number drastically increased to 134 from 2013 to 2023,
indicating a substantial acceleration in CDx development.
From 2021 to 2023, the use of companion diagnostic and biomarkers in
oncology decreased as compared to the targeted therapies, i.e., 52%,
50%, and 28% in 2021, 2022, and 2023, respectively.
About 170 CDx
have been approved by the
USFDA till now
identify patients who are most likely to benefit from
a particular therapeutic product,
identify patients likely to be at increased risk for
serious side effects as a result of treatment with a
particular therapeutic product; or
monitor response to treatment with a particular
therapeutic product for the purpose of adjusting
treatment to achieve improved safety or
effectiveness.
Companion Diagnostics can
1
2
3
The inception of CDx can be traced back to 1998, when the FDA granted
concurrent approval for trastuzumab, a targeted cancer drug and
HercepTest™, a HER2 immunohistochemical assay. This milestone
marked the birth of the drug-diagnostic co-development model, a
transformative approach that has since witnessed consistent and
substantial adoption.
The evolution of CDx was gradual, with significant progress seen only in
the last decade. From 1998 to 2012, around 20 new CDx were approved.
However, this number drastically increased to 134 from 2013 to 2023,
indicating a substantial acceleration in CDx development.
From 2021 to 2023, the use of companion diagnostic and biomarkers in
oncology decreased as compared to the targeted therapies, i.e., 52%,
50%, and 28% in 2021, 2022, and 2023, respectively.
About 170 CDx
have been approved by the
USFDA till now
14Healthcare Industry Report
Biomarkers
Next Generation Sequencing
Biomarkers are measurable indicators used to evaluate biological
processes, disease states, and responses to treatments. They are
integral to precision medicine across various medical fields.
• Role in Precision Medicine : Biomarkers are used to identify
specific diseases, monitor disease progression, and evaluate
treatment efficacy. They are vital in oncology, where they can help
distinguish between different types of cancer and guide targeted
therapy.
• Epigenetic Biomarkers : These biomarkers provide insights
into gene expression influenced by environmental and social
factors. They are crucial for understanding disease prediction and
progression, offering a more comprehensive view of an individual’s
health.
Next-generation sequencing (NGS) has revolutionized genomic
research and clinical practice. It allows for comprehensive analysis of
genetic information, which is pivotal in precision medicine.
• Applications : NGS can sequence entire genomes or specific
targeted regions, analyze epigenetic factors, and study microbial
populations. This technology is essential for identifying genetic
mutations, understanding disease mechanisms, and developing
targeted therapies.
• Wearable and Implantable Biosensors : Advancements in
microelectronics and electrochemical sensing have led to the
development of biosensors that generate signals proportional to
the concentration of analytes. For instance, glucose is an ‘analyte’ in
a biosensor designed to detect glucose. These devices are used for
disease detection, chronic disease management, drug discovery,
and health monitoring.
Naeiry highlighted the
importance of genomic
data, stating that you
must be “Able to build
causality for relation
rather than predictive for
relation. Without genomic
component it is hard to
establish causality. It is like
a car with no wheels.”
- Naiery Vetraven,
Vice President: R&D Business
Development (BASE life science)
Biomarkers
Next Generation Sequencing
Biomarkers are measurable indicators used to evaluate biological
processes, disease states, and responses to treatments. They are
integral to precision medicine across various medical fields.
• Role in Precision Medicine : Biomarkers are used to identify
specific diseases, monitor disease progression, and evaluate
treatment efficacy. They are vital in oncology, where they can help
distinguish between different types of cancer and guide targeted
therapy.
• Epigenetic Biomarkers : These biomarkers provide insights
into gene expression influenced by environmental and social
factors. They are crucial for understanding disease prediction and
progression, offering a more comprehensive view of an individual’s
health.
Next-generation sequencing (NGS) has revolutionized genomic
research and clinical practice. It allows for comprehensive analysis of
genetic information, which is pivotal in precision medicine.
• Applications : NGS can sequence entire genomes or specific
targeted regions, analyze epigenetic factors, and study microbial
populations. This technology is essential for identifying genetic
mutations, understanding disease mechanisms, and developing
targeted therapies.
• Wearable and Implantable Biosensors : Advancements in
microelectronics and electrochemical sensing have led to the
development of biosensors that generate signals proportional to
the concentration of analytes. For instance, glucose is an ‘analyte’ in
a biosensor designed to detect glucose. These devices are used for
disease detection, chronic disease management, drug discovery,
and health monitoring.
Naeiry highlighted the
importance of genomic
data, stating that you
must be “Able to build
causality for relation
rather than predictive for
relation. Without genomic
component it is hard to
establish causality. It is like
a car with no wheels.”
- Naiery Vetraven,
Vice President: R&D Business
Development (BASE life science)
15Healthcare Industry Report
Genetic Therapy
Genetic therapy encompasses techniques designed to correct
defective genes and explore the use of genes to treat diseases.
CRISPR Technology
Clustered Regularly Interspaced Short Palindromic Repeats
(CRISPR) technology uses guided RNA to cleave DNA at
specific locations in a genome. This technology has the
potential to address a wide range of diseases, including
cancers, genetic disorders, diabetes, inflammatory diseases,
cardiovascular disease, HIV/AIDS, and muscular dystrophy.
During the COVID-19 pandemic, CRISPR was used to develop
diagnostic tests, demonstrating its versatility.
Genomic Surveillance
This field involves the large-scale monitoring of viruses to
detect, track, and control outbreaks. Genomic surveillance
has expanded due to recent infectious disease outbreaks,
improving our ability to understand pathogen transmission
and evolution. For example, public health bodies have begun
using wastewater monitoring systems to detect signs of
infectious diseases. This approach allows for early detection
and planning of vaccination campaigns.
RNA and mRNA Diagnostics and Therapeutics
RNA-based technologies can stimulate immune responses
and deliver therapeutic proteins. They are used to uncover
the roles of RNA in brain development and understand
the root causes of neurodegenerative diseases. Besides
the most notable mRNA vaccines discovered during the
pandemic, Evrysdi (Roche) and Spinraza (Biogen) are
two FDA-approved mRNA drugs that treat spinal muscular
atrophy (SMA) by altering the way SMN2 mRNA is created
About 600 plus
patent applications by top
10 organizations on mRNA
vaccines or therapeutics
Genetic Therapy
Genetic therapy encompasses techniques designed to correct
defective genes and explore the use of genes to treat diseases.
CRISPR Technology
Clustered Regularly Interspaced Short Palindromic Repeats
(CRISPR) technology uses guided RNA to cleave DNA at
specific locations in a genome. This technology has the
potential to address a wide range of diseases, including
cancers, genetic disorders, diabetes, inflammatory diseases,
cardiovascular disease, HIV/AIDS, and muscular dystrophy.
During the COVID-19 pandemic, CRISPR was used to develop
diagnostic tests, demonstrating its versatility.
Genomic Surveillance
This field involves the large-scale monitoring of viruses to
detect, track, and control outbreaks. Genomic surveillance
has expanded due to recent infectious disease outbreaks,
improving our ability to understand pathogen transmission
and evolution. For example, public health bodies have begun
using wastewater monitoring systems to detect signs of
infectious diseases. This approach allows for early detection
and planning of vaccination campaigns.
RNA and mRNA Diagnostics and Therapeutics
RNA-based technologies can stimulate immune responses
and deliver therapeutic proteins. They are used to uncover
the roles of RNA in brain development and understand
the root causes of neurodegenerative diseases. Besides
the most notable mRNA vaccines discovered during the
pandemic, Evrysdi (Roche) and Spinraza (Biogen) are
two FDA-approved mRNA drugs that treat spinal muscular
atrophy (SMA) by altering the way SMN2 mRNA is created
About 600 plus
patent applications by top
10 organizations on mRNA
vaccines or therapeutics
16Healthcare Industry Report
Impact of AI and ML
Big Data and AI in Precision Medicine
In the early 2000s, the rise of big data technologies enabled the stor-
age and processing of massive amounts of healthcare data from di-
verse sources. This paved the way for the application of AI techniques,
like ML, to extract insights and patterns from these large datasets. The
convergence of AI and precision medicine is revolutionizing health-
care. Precision medicine methods identify unique patient phenotypes
and characteristics to enable more personalized diagnosis, risk pre-
diction, and treatment planning.
AI and big data analytics are playing a crucial role in this transfor-
mation. By leveraging sophisticated computational techniques, AI can
extract insights from diverse data sources including genomics, clini-
cal history, medical imaging, and digital health indicators. This allows
for the integration of multimodal data to generate a comprehensive
understanding of individual patient profiles.
• Big Data: The first step involves the collection and preparation of
big data. This term refers to datasets that are so large and com-
plex that they require advanced analytics tools and technologies
for processing. These datasets, which may include genetic pro-
files, lifestyle information, and medical histories, are often gener-
ated at high speeds and require prompt processing. The ability to
handle and analyze such data is crucial in precision medicine, as
it enables the selection of more effective treatments tailored to
individual patients.
• Leveraging AI: The second step is where AI takes center stage.
AI has the capability to process vast amounts of real-time data,
identify patterns, and generate valuable insights. In the context of
precision medicine, AI can interpret extensive genomic datasets.
Utilizing ML and deep learning techniques, AI can uncover hidden
associations within these datasets. Consequently, clinicians are
empowered to devise genome-informed treatment plans for their
patients, enhancing the effectiveness of medical interventions.
Immuneel Therapeutics used AI to ensure closed automated GMP
production in deciding the best kind of starting material, the best
process, and using AI and blockchain (as transportation is under
-115°C under liquid nitrogen).
Health and disease states
result from many-to-
many interactions between
genes and their products
in a spatiotemporal
orchestrated manner.
AI-ML models built using
multi-modal and multi-
omics data are helping
us connect data dots
and decipher hidden
correlations.
- Dr. Urmila Kulkarni Kale,
Senior Vice President,
Citadel Precision Medicine
Impact of AI and ML
Big Data and AI in Precision Medicine
In the early 2000s, the rise of big data technologies enabled the stor-
age and processing of massive amounts of healthcare data from di-
verse sources. This paved the way for the application of AI techniques,
like ML, to extract insights and patterns from these large datasets. The
convergence of AI and precision medicine is revolutionizing health-
care. Precision medicine methods identify unique patient phenotypes
and characteristics to enable more personalized diagnosis, risk pre-
diction, and treatment planning.
AI and big data analytics are playing a crucial role in this transfor-
mation. By leveraging sophisticated computational techniques, AI can
extract insights from diverse data sources including genomics, clini-
cal history, medical imaging, and digital health indicators. This allows
for the integration of multimodal data to generate a comprehensive
understanding of individual patient profiles.
• Big Data: The first step involves the collection and preparation of
big data. This term refers to datasets that are so large and com-
plex that they require advanced analytics tools and technologies
for processing. These datasets, which may include genetic pro-
files, lifestyle information, and medical histories, are often gener-
ated at high speeds and require prompt processing. The ability to
handle and analyze such data is crucial in precision medicine, as
it enables the selection of more effective treatments tailored to
individual patients.
• Leveraging AI: The second step is where AI takes center stage.
AI has the capability to process vast amounts of real-time data,
identify patterns, and generate valuable insights. In the context of
precision medicine, AI can interpret extensive genomic datasets.
Utilizing ML and deep learning techniques, AI can uncover hidden
associations within these datasets. Consequently, clinicians are
empowered to devise genome-informed treatment plans for their
patients, enhancing the effectiveness of medical interventions.
Immuneel Therapeutics used AI to ensure closed automated GMP
production in deciding the best kind of starting material, the best
process, and using AI and blockchain (as transportation is under
-115°C under liquid nitrogen).
Health and disease states
result from many-to-
many interactions between
genes and their products
in a spatiotemporal
orchestrated manner.
AI-ML models built using
multi-modal and multi-
omics data are helping
us connect data dots
and decipher hidden
correlations.
- Dr. Urmila Kulkarni Kale,
Senior Vice President,
Citadel Precision Medicine
17Healthcare Industry Report
Company in Focus
Tempus: AI-driven Precision Medicine
Revenue in 2023 - US$ 531.8 Million
Overview
Google-backed Tempus AI combines clinical and molecular data
with advanced analytics to provide personalized treatment options for
patients. Their platform, based on clinical records of millions of patients
clinical records, collects and organizes data from various sources,
including electronic health records (EHRs), genomic sequencing,
imaging, and lab results.
July 2024 - Tempus launched its multimodal immune profile score
(IPS) algorithmic test for research use only (RUO). IPS is the flagship
of Tempus’ new immunotherapy-based portfolio, leveraging clinical,
genomic, and transcriptomic data to identify potential responders
to immunotherapy. Tempus is also collaborating with partners like
Cleveland Clinic to expand this portfolio with additional algorithmic
tests tailored for immuno-oncology.
Tempus AI, Inc. announced that its PurISTSM algorithmic test has been
granted a proprietary laboratory analysis (PLA) code by the American
Medical Association (AMA), effective October 1, 2024. This marks
the first CPT code for an algorithm-only analysis using previously
sequenced RNA data from a laboratory developed test (LDT). PurISTSM
identifies molecular subtypes in unresectable stage III or IV pancreatic
ductal adenocarcinoma (PDAC), aiding in therapy management
decisions. Clinical validation shows PurISTSM can stratify overall
survival among PDAC patients for first-line therapies FOLFIRINOX and
gemcitabine nab-paclitaxel.
AI Applications
Genomic Sequencing: Tempus sequences the DNA and RNA
of patients’ tumors to identify mutations and other genetic
abnormalities, helping understand the specific characteristics of
a patient’s cancer.
Data Integration and Analysis: Tempus integrates clinical data
with molecular data to identify patterns and predict how patients
will respond to different treatments.
Predictive Modeling: The AI models developed by Tempus
predict which treatments are most likely to be effective for
individual patients based on their unique genetic makeup and
clinical history.
Impact
Personalized Treatment Plans:
Tempus provides oncologists
with detailed reports that
include actionable insights,
helping them choose the most
effective treatment options
tailored to each patient.
Improved Outcomes: By
personalizing treatment plans,
Tempus aims to improve
patient outcomes, reducing
the trial-and-error approach
often associated with cancer
treatment.
Clinical Trials: Tempus helps
match patients with relevant
clinical trials, providing access
to cutting-edge therapies
suitable for their specific cancer
type and genetic profile.
Company in Focus
Tempus: AI-driven Precision Medicine
Revenue in 2023 - US$ 531.8 Million
Overview
Google-backed Tempus AI combines clinical and molecular data
with advanced analytics to provide personalized treatment options for
patients. Their platform, based on clinical records of millions of patients
clinical records, collects and organizes data from various sources,
including electronic health records (EHRs), genomic sequencing,
imaging, and lab results.
July 2024 - Tempus launched its multimodal immune profile score
(IPS) algorithmic test for research use only (RUO). IPS is the flagship
of Tempus’ new immunotherapy-based portfolio, leveraging clinical,
genomic, and transcriptomic data to identify potential responders
to immunotherapy. Tempus is also collaborating with partners like
Cleveland Clinic to expand this portfolio with additional algorithmic
tests tailored for immuno-oncology.
Tempus AI, Inc. announced that its PurISTSM algorithmic test has been
granted a proprietary laboratory analysis (PLA) code by the American
Medical Association (AMA), effective October 1, 2024. This marks
the first CPT code for an algorithm-only analysis using previously
sequenced RNA data from a laboratory developed test (LDT). PurISTSM
identifies molecular subtypes in unresectable stage III or IV pancreatic
ductal adenocarcinoma (PDAC), aiding in therapy management
decisions. Clinical validation shows PurISTSM can stratify overall
survival among PDAC patients for first-line therapies FOLFIRINOX and
gemcitabine nab-paclitaxel.
AI Applications
Genomic Sequencing: Tempus sequences the DNA and RNA
of patients’ tumors to identify mutations and other genetic
abnormalities, helping understand the specific characteristics of
a patient’s cancer.
Data Integration and Analysis: Tempus integrates clinical data
with molecular data to identify patterns and predict how patients
will respond to different treatments.
Predictive Modeling: The AI models developed by Tempus
predict which treatments are most likely to be effective for
individual patients based on their unique genetic makeup and
clinical history.
Impact
Personalized Treatment Plans:
Tempus provides oncologists
with detailed reports that
include actionable insights,
helping them choose the most
effective treatment options
tailored to each patient.
Improved Outcomes: By
personalizing treatment plans,
Tempus aims to improve
patient outcomes, reducing
the trial-and-error approach
often associated with cancer
treatment.
Clinical Trials: Tempus helps
match patients with relevant
clinical trials, providing access
to cutting-edge therapies
suitable for their specific cancer
type and genetic profile.
18Healthcare Industry Report
Blockchain
Quantum Computing’s Role in
Revolutionizing Personalized Medicine
Improved Data Management: The technology offers a secure and
transparent system for handling large volumes of patient data, such
as genetic and medical information. This enhances the integrity and
accessibility of critical health data.
• Automated Patient Care : Through smart contracts, blockchain
can automate various aspects of patient care, including
medication dosages and treatment plans. This not only improves
operational efficiency but also reduces the potential for errors.
• Fostering Collaboration and Innovation : By providing
secure data sharing and maintaining transparency, blockchain
encourages collaboration among researchers and accelerates
innovation in personalized medicine.
Enhanced Data Analysis: Quantum computers could vastly accelerate
the analysis of pangenomes – new representations of DNA sequences
that capture population diversityata, enabling more precise and
individualized genetic insights.
• Improved Personalization : By moving beyond traditional
reference genomes, quantum computing can offer more tailored
and accurate genetic information, leading to better-personalized
medical treatments.
• Pathogen Tracking : The same technologies can improve the
tracking and management of pathogens, aiding in more effective
outbreak responses and public health strategies.
For example - Researchers are pioneering a project that combines
quantum computing with genomics to address one of the most
complex problems in genomic science: analyzing datasets of
pangenomes for large populations. This collaboration, involving the
University of Cambridge, the Wellcome Sanger Institute, and EMBL-EBI,
has received up to US$ 3.5 million in funding through the Wellcome
Leap Q4Bio Challenge Program.
Key Points
Project Goal: Develop quantum
computing algorithms to
enhance the creation and
analysis of pangenomes,
which are comprehensive
representations of genetic
diversity in populations.
Methodology: The project aims
to use quantum computing to
speed up processes related
to mapping genetic data
onto sequence graphs and
navigating these graphs
efficiently.
Impact: This advancement
could significantly benefit
personalized medicine by
providing more accurate
insights into individual genetic
makeups compared to the
traditional reference genome. It
also has potential applications
in tracking and managing
pathogen outbreaks.
Blockchain
Quantum Computing’s Role in
Revolutionizing Personalized Medicine
Improved Data Management: The technology offers a secure and
transparent system for handling large volumes of patient data, such
as genetic and medical information. This enhances the integrity and
accessibility of critical health data.
• Automated Patient Care : Through smart contracts, blockchain
can automate various aspects of patient care, including
medication dosages and treatment plans. This not only improves
operational efficiency but also reduces the potential for errors.
• Fostering Collaboration and Innovation : By providing
secure data sharing and maintaining transparency, blockchain
encourages collaboration among researchers and accelerates
innovation in personalized medicine.
Enhanced Data Analysis: Quantum computers could vastly accelerate
the analysis of pangenomes – new representations of DNA sequences
that capture population diversityata, enabling more precise and
individualized genetic insights.
• Improved Personalization : By moving beyond traditional
reference genomes, quantum computing can offer more tailored
and accurate genetic information, leading to better-personalized
medical treatments.
• Pathogen Tracking : The same technologies can improve the
tracking and management of pathogens, aiding in more effective
outbreak responses and public health strategies.
For example - Researchers are pioneering a project that combines
quantum computing with genomics to address one of the most
complex problems in genomic science: analyzing datasets of
pangenomes for large populations. This collaboration, involving the
University of Cambridge, the Wellcome Sanger Institute, and EMBL-EBI,
has received up to US$ 3.5 million in funding through the Wellcome
Leap Q4Bio Challenge Program.
Key Points
Project Goal: Develop quantum
computing algorithms to
enhance the creation and
analysis of pangenomes,
which are comprehensive
representations of genetic
diversity in populations.
Methodology: The project aims
to use quantum computing to
speed up processes related
to mapping genetic data
onto sequence graphs and
navigating these graphs
efficiently.
Impact: This advancement
could significantly benefit
personalized medicine by
providing more accurate
insights into individual genetic
makeups compared to the
traditional reference genome. It
also has potential applications
in tracking and managing
pathogen outbreaks.
19Healthcare Industry Report
Key Legislation and Policies
Precision medicine has garnered significant legislative support globally, reducing
roadblocks to patient-centered drug development.
04
US UK
• Precision Medicine Institute (2015): In
2015 President Obama Launched PMI to
support precision medicine research and
patient engagement.
• Mission: To enable a new era of medicine
through research, technology, and poli-
cies that empower patients, researchers,
and providers to work together toward
development of individualized care.
• 21st Century Cures Act (2016): Provided
the FDA with tools to accelerate precision
medicine therapies by reducing regula-
tory requirements, recognizing new trial
designs, and facilitating the use of re-
al-world evidence.
In 2013, Genomics England (GeL), a national
genomics initiative under the Department of
Health and Social Care in the UK, was tasked
with collecting 100,000 genomes as part of
the well-known 100,000 Genomes Project.
• Impact: The 100,000 Genomes Project
was a British initiative to sequence and
study the role genes play in health and
disease. Recruitment was completed in
December 2018, although research and
analysis are still ongoing.
• 18.5% of data from the Project turned into
actionable findings
• 85K+ participants genomes sequenced
for the Project
• 100K+ genomes sequenced by December
2018
Key Legislation and Policies
Precision medicine has garnered significant legislative support globally, reducing
roadblocks to patient-centered drug development.
04
US UK
• Precision Medicine Institute (2015): In
2015 President Obama Launched PMI to
support precision medicine research and
patient engagement.
• Mission: To enable a new era of medicine
through research, technology, and poli-
cies that empower patients, researchers,
and providers to work together toward
development of individualized care.
• 21st Century Cures Act (2016): Provided
the FDA with tools to accelerate precision
medicine therapies by reducing regula-
tory requirements, recognizing new trial
designs, and facilitating the use of re-
al-world evidence.
In 2013, Genomics England (GeL), a national
genomics initiative under the Department of
Health and Social Care in the UK, was tasked
with collecting 100,000 genomes as part of
the well-known 100,000 Genomes Project.
• Impact: The 100,000 Genomes Project
was a British initiative to sequence and
study the role genes play in health and
disease. Recruitment was completed in
December 2018, although research and
analysis are still ongoing.
• 18.5% of data from the Project turned into
actionable findings
• 85K+ participants genomes sequenced
for the Project
• 100K+ genomes sequenced by December
2018
20Healthcare Industry Report
Australia
Canada
Israel
• The National Health Genomics Policy
Framework outlines steps to integrate ge-
nomics into the Australian health system,
demonstrating bold steps toward preci-
sion medicine adoption.
• The Australian Genomics Health Alliance
(Australian Genomics) was created in
2016 from a National Health and Medi-
cal Research Council grant in Australia.
Australian Genomics manages AUS$ 55
million of funding allocated to genomics
research through the National Health and
Medical Research Council and the Ge-
nomics Health Futures Mission. Australian
Genomics is composed of more than 100
organizations across Australia and has
the aim of building a national infrastruc-
ture for genomic data storage and ac-
cess. The objective is to create national
policies and processes to ethically access
genomic data for research purposes, and
to establish a system for diagnostic labs
to share variant classifications. Also plan
is to build a first-of-its kind national gen-
otype-phenotype database.
• The Canadian Institute of Health Research
included precision medicine within its
2015–2019 strategic plans, indicating a
commitment to advancing personalized
healthcare.
• The Israel Precision Medicine Partner-
ship (IPMP) is a collaborative initiative
supported by Yad Hanadiv, the Klarman
Family Foundation, and other key partners
including Israeli universities and health-
care institutions. With a focus on genomic
research, advanced biomedical studies,
and computational technologies, IPMP
aims to develop personalized diagnostics
and therapies. Funded by a US$ 60 million
grant over seven years through the Israel
Science Foundation, it fosters a culture of
data sharing and collaboration between
clinical and research sectors to advance
precision medicine for public benefit.
• The Mosaic Initiative for Personalized
Medicine is leveraging Israel’s National
Digital Health Plan to integrate 20 years
of medical records for nine million resi-
dents into a unified database. This ini-
tiative aims to attract global researchers
and industry leaders by providing access
to comprehensive health data, covering
over 98% of the population with individual
consent. Supported by a US$ 287 million
funding commitment, Mosaic also estab-
lishes innovation labs to foster collabo-
ration between multinational firms and
Israeli digital health startups, promoting
joint ventures and educational programs
to advance the sector.
Australia
Canada
Israel
• The National Health Genomics Policy
Framework outlines steps to integrate ge-
nomics into the Australian health system,
demonstrating bold steps toward preci-
sion medicine adoption.
• The Australian Genomics Health Alliance
(Australian Genomics) was created in
2016 from a National Health and Medi-
cal Research Council grant in Australia.
Australian Genomics manages AUS$ 55
million of funding allocated to genomics
research through the National Health and
Medical Research Council and the Ge-
nomics Health Futures Mission. Australian
Genomics is composed of more than 100
organizations across Australia and has
the aim of building a national infrastruc-
ture for genomic data storage and ac-
cess. The objective is to create national
policies and processes to ethically access
genomic data for research purposes, and
to establish a system for diagnostic labs
to share variant classifications. Also plan
is to build a first-of-its kind national gen-
otype-phenotype database.
• The Canadian Institute of Health Research
included precision medicine within its
2015–2019 strategic plans, indicating a
commitment to advancing personalized
healthcare.
• The Israel Precision Medicine Partner-
ship (IPMP) is a collaborative initiative
supported by Yad Hanadiv, the Klarman
Family Foundation, and other key partners
including Israeli universities and health-
care institutions. With a focus on genomic
research, advanced biomedical studies,
and computational technologies, IPMP
aims to develop personalized diagnostics
and therapies. Funded by a US$ 60 million
grant over seven years through the Israel
Science Foundation, it fosters a culture of
data sharing and collaboration between
clinical and research sectors to advance
precision medicine for public benefit.
• The Mosaic Initiative for Personalized
Medicine is leveraging Israel’s National
Digital Health Plan to integrate 20 years
of medical records for nine million resi-
dents into a unified database. This ini-
tiative aims to attract global researchers
and industry leaders by providing access
to comprehensive health data, covering
over 98% of the population with individual
consent. Supported by a US$ 287 million
funding commitment, Mosaic also estab-
lishes innovation labs to foster collabo-
ration between multinational firms and
Israeli digital health startups, promoting
joint ventures and educational programs
to advance the sector.
21Healthcare Industry Report
India
pharmaceutical sector, with a focus on gene therapy and
precision medicine. The policy, being fine-tuned with input
from various ministries, aims to establish centers of excellence
and encourage industry-driven research. Key areas include
drug discovery, innovative drug delivery systems, advanced
medical devices, and gene therapy. The initiative has been
well-received by the industry, with hopes that it will stimulate
increased investment in research and development. The policy
is part of the 2023 Union Budget’s broader aim to increase
healthcare expenditure.
AI is revolutionizing precision medicine in India, with leading
health institutions establishing specialty facilities that leverage
AI for advanced care. For example: The Apollo Cancer Centre
(ACC) in Bengaluru has inaugurated the country’s first AI-pow-
ered Precision Oncology Centre. This center provides individu-
alized care, utilizing AI for various applications:
• Identifying patients suitable for targeted therapy and im-
munotherapy.
• Alerting care teams about patient deterioration.
• Educating patients and their families about diagnosis,
treatment, and support groups through conversational AI.
• Monitoring adherence to standard care.
• Managing patients based on genomic, clinical, and patho-
logical data.
• Recommending diagnostic tests and enrollment to val-
ue-based care and other patient benefit programs.
In another significant development, Immuneel Therapeutics,
a Bangalore-based start-up that is focused on cell and gene
therapy is on the verge of commercializing a CD-19 CAR-T cell
therapy in July 2024. Immuneel was started with the intention
of providing quality personalized cancer care at a fraction of
the cost in developed markets.
Rebu highlighted
the importance of
reimbursement, stating
that “We are working
with NBFCs to provide
full or bridge funding
for the treatment, which
the patient can pay off
in the remainder of their
healthy life; and we are
also targeting key central
and state government
accounts, that provide
reimbursement for cancer
care”
- Rebu Ninan,
Head - Commercial and Market
Access, Cell and Gene Therapies
(Immuneel Therapeutics)
India
pharmaceutical sector, with a focus on gene therapy and
precision medicine. The policy, being fine-tuned with input
from various ministries, aims to establish centers of excellence
and encourage industry-driven research. Key areas include
drug discovery, innovative drug delivery systems, advanced
medical devices, and gene therapy. The initiative has been
well-received by the industry, with hopes that it will stimulate
increased investment in research and development. The policy
is part of the 2023 Union Budget’s broader aim to increase
healthcare expenditure.
AI is revolutionizing precision medicine in India, with leading
health institutions establishing specialty facilities that leverage
AI for advanced care. For example: The Apollo Cancer Centre
(ACC) in Bengaluru has inaugurated the country’s first AI-pow-
ered Precision Oncology Centre. This center provides individu-
alized care, utilizing AI for various applications:
• Identifying patients suitable for targeted therapy and im-
munotherapy.
• Alerting care teams about patient deterioration.
• Educating patients and their families about diagnosis,
treatment, and support groups through conversational AI.
• Monitoring adherence to standard care.
• Managing patients based on genomic, clinical, and patho-
logical data.
• Recommending diagnostic tests and enrollment to val-
ue-based care and other patient benefit programs.
In another significant development, Immuneel Therapeutics,
a Bangalore-based start-up that is focused on cell and gene
therapy is on the verge of commercializing a CD-19 CAR-T cell
therapy in July 2024. Immuneel was started with the intention
of providing quality personalized cancer care at a fraction of
the cost in developed markets.
Rebu highlighted
the importance of
reimbursement, stating
that “We are working
with NBFCs to provide
full or bridge funding
for the treatment, which
the patient can pay off
in the remainder of their
healthy life; and we are
also targeting key central
and state government
accounts, that provide
reimbursement for cancer
care”
- Rebu Ninan,
Head - Commercial and Market
Access, Cell and Gene Therapies
(Immuneel Therapeutics)
22Healthcare Industry Report
Access and Reimbursement in
Precision Medicine
05
While CAR-T cells have proven to be successful and useful, there are
still some obstacles to overcome. These include issues related to the
patient, such as the scarcity of treatment facilities and additional
expenses like travel, accommodation, and food. On the other hand,
providers face challenges related to logistics, allocation of staff time,
resource limitations, and uncertainties around reimbursement.
One way that is being explored to overcome this issue is through the
use of on-site manufacture of CAR-T cells. This may reduce the costs
of genetic engineering and expansion. However, there are still many
challenges and other costs, including patient evaluation, selection,
conditioning, and post-treatment recovery. There are also many other
hidden costs in setting up and maintaining a CAR-T cell manufacturing
facility, including facility costs, hidden staffing costs, and release
testing.
However, countries with lower GDP per capita have difficulty accessing
conventional commercial products; therefore, various strategies have
been adopted to overcome this barrier.
Focus on Payment for Outcomes Countries are looking at
innovative agreements
including keeping prices
confidential
Access and Reimbursement in
Precision Medicine
05
While CAR-T cells have proven to be successful and useful, there are
still some obstacles to overcome. These include issues related to the
patient, such as the scarcity of treatment facilities and additional
expenses like travel, accommodation, and food. On the other hand,
providers face challenges related to logistics, allocation of staff time,
resource limitations, and uncertainties around reimbursement.
One way that is being explored to overcome this issue is through the
use of on-site manufacture of CAR-T cells. This may reduce the costs
of genetic engineering and expansion. However, there are still many
challenges and other costs, including patient evaluation, selection,
conditioning, and post-treatment recovery. There are also many other
hidden costs in setting up and maintaining a CAR-T cell manufacturing
facility, including facility costs, hidden staffing costs, and release
testing.
However, countries with lower GDP per capita have difficulty accessing
conventional commercial products; therefore, various strategies have
been adopted to overcome this barrier.
Focus on Payment for Outcomes Countries are looking at
innovative agreements
including keeping prices
confidential
23Healthcare Industry Report
A review of the progress in Asian countries
India
Iran
Japan
There are two commercial CAR-T cell
products available (NexCAR19 from Im-
munoACT and QARTEMI from Immuneel
Therapeutics). Indigenous CAR-T cell
technology is being developed by the
Indian Institute of Technology and the
Advanced Centre for Treatment, Research,
and Education in Cancer. Two investiga-
tional products are in clinical trials.
One local CAR-T cell clinical trial for pe-
diatric patients, financed by the Council
for Development Stem Cell Sciences and
Technology of Iran and an investor.
High-cost medical care reimbursement
system. Five commercial CAR-T cells are
available, all priced at approximately
US$242,000.
Malaysia
Singapore
Thailand
Korea
A CAR-T cell product sold through Auxi
Therapeutics for approximately US$ 40,000
to US$ 50,000.
Two commercial CAR-T cell products sold
at approximately US$ 375,000. Several clin-
ical trials are ongoing.
Two studies have been conducted, both
funded by the Thai government and phil-
anthropic organizations.
Many approved cell therapies, mostly in
regenerative medicine. One commercial
CAR-T cell product for cancer immunother-
apy, priced at approximately US$ 300,000.
A review of the progress in Asian countries
India
Iran
Japan
There are two commercial CAR-T cell
products available (NexCAR19 from Im-
munoACT and QARTEMI from Immuneel
Therapeutics). Indigenous CAR-T cell
technology is being developed by the
Indian Institute of Technology and the
Advanced Centre for Treatment, Research,
and Education in Cancer. Two investiga-
tional products are in clinical trials.
One local CAR-T cell clinical trial for pe-
diatric patients, financed by the Council
for Development Stem Cell Sciences and
Technology of Iran and an investor.
High-cost medical care reimbursement
system. Five commercial CAR-T cells are
available, all priced at approximately
US$242,000.
Malaysia
Singapore
Thailand
Korea
A CAR-T cell product sold through Auxi
Therapeutics for approximately US$ 40,000
to US$ 50,000.
Two commercial CAR-T cell products sold
at approximately US$ 375,000. Several clin-
ical trials are ongoing.
Two studies have been conducted, both
funded by the Thai government and phil-
anthropic organizations.
Many approved cell therapies, mostly in
regenerative medicine. One commercial
CAR-T cell product for cancer immunother-
apy, priced at approximately US$ 300,000.
24Healthcare Industry Report
Tempus: AI-driven Precision Medicine
Key Features
Benefits
Solutions
• Uses ML to identify high-value patients and enhance clini-
cal decision-making.
• Aligns reimbursement levels with data-driven predictions.
• Incentivize clinical use of therapies based on real-world
evidence (RWE).
• Encourages scalable models adaptable to stakeholder
needs.
• Improved patient outcomes through personalized care.
• Increased affordability for payers, providers, and patients.
• Sustained innovation by manufacturers.
• Generation of valuable real-world data to further refine
precision medicine approaches.
• Several approaches have been suggested to overcome the obstacles to CAR-T therapy. These encom-
pass enhancing CAR-T production, involving community oncologists, increasing the number of centers
providing CAR-T treatment, and addressing financial matters such as the pricing of CAR-T cells, reim-
bursement, and personal expenses. However, extending academic CAR-T cell production to all locations
and hospitals may not necessarily resolve these issues due to hidden costs and quality variability.
• Regarding financial reimbursement, it’s crucial to persuade funders to conduct a thorough long-term
cost-effectiveness analysis. This is because the efficacy of CAR-T cells is best illustrated by the pro-
longed remission observed in long-term survivors.
• Despite these efforts, the cost of CAR-T cell therapies remains high. Therefore, cost-sharing among
various payers is essential for affording CAR-T treatments. Governments can support patients through
hospital subsidies, product cost coverage, and grants. Insurance companies can help with hospi-
tal stays, critical illness, and cell therapy product coverage. Pharmaceutical companies that produce
CAR-T cells can contribute through patient assistance programs and subsidies. Additionally, philan-
thropic organizations can offer support through program funding and crowdfunding for individual pa-
tients.
• In terms of access to precision medicine, it’s important to note that these therapies are becoming
increasingly available as our understanding of diseases at the molecular level improves. This allows
for more targeted and effective treatments. However, access to these therapies can be limited owing
to factors such as cost, availability of technology, and the need for specialized care. Efforts are being
made to increase access to precision medicine through policy changes, technological advancements,
and initiatives aimed at reducing costs. For example, telemedicine is being used to reach patients in
remote areas and new payment models are being explored to make these therapies more affordable.
Additionally, research and development in the field of precision medicine is ongoing, with the aim of
discovering new therapies and improving existing ones.
Tempus raised
about
$410
million
in its IPO in June 2024
Tempus: AI-driven Precision Medicine
Key Features
Benefits
Solutions
• Uses ML to identify high-value patients and enhance clini-
cal decision-making.
• Aligns reimbursement levels with data-driven predictions.
• Incentivize clinical use of therapies based on real-world
evidence (RWE).
• Encourages scalable models adaptable to stakeholder
needs.
• Improved patient outcomes through personalized care.
• Increased affordability for payers, providers, and patients.
• Sustained innovation by manufacturers.
• Generation of valuable real-world data to further refine
precision medicine approaches.
• Several approaches have been suggested to overcome the obstacles to CAR-T therapy. These encom-
pass enhancing CAR-T production, involving community oncologists, increasing the number of centers
providing CAR-T treatment, and addressing financial matters such as the pricing of CAR-T cells, reim-
bursement, and personal expenses. However, extending academic CAR-T cell production to all locations
and hospitals may not necessarily resolve these issues due to hidden costs and quality variability.
• Regarding financial reimbursement, it’s crucial to persuade funders to conduct a thorough long-term
cost-effectiveness analysis. This is because the efficacy of CAR-T cells is best illustrated by the pro-
longed remission observed in long-term survivors.
• Despite these efforts, the cost of CAR-T cell therapies remains high. Therefore, cost-sharing among
various payers is essential for affording CAR-T treatments. Governments can support patients through
hospital subsidies, product cost coverage, and grants. Insurance companies can help with hospi-
tal stays, critical illness, and cell therapy product coverage. Pharmaceutical companies that produce
CAR-T cells can contribute through patient assistance programs and subsidies. Additionally, philan-
thropic organizations can offer support through program funding and crowdfunding for individual pa-
tients.
• In terms of access to precision medicine, it’s important to note that these therapies are becoming
increasingly available as our understanding of diseases at the molecular level improves. This allows
for more targeted and effective treatments. However, access to these therapies can be limited owing
to factors such as cost, availability of technology, and the need for specialized care. Efforts are being
made to increase access to precision medicine through policy changes, technological advancements,
and initiatives aimed at reducing costs. For example, telemedicine is being used to reach patients in
remote areas and new payment models are being explored to make these therapies more affordable.
Additionally, research and development in the field of precision medicine is ongoing, with the aim of
discovering new therapies and improving existing ones.
Tempus raised
about
$410
million
in its IPO in June 2024
25Healthcare Industry Report
How SGA can Help in End-to-end Support
for Companies in Precision Medicine?
Epidemiology Analysis
Using SGA’s proprietary
methodologies help companies
identify the eligible and potential
patient cohorts
Demand Analysis
Estimated expected product demand
using quantitative and qualitative
market research for HCPs, patients,
and caregivers
Forecasting
Deploy SGA’s REAL forecast
methodology to estimate future
potential of products for next 5–10
years and support with executive
friendly visualization through dynamic
dashboards
Pricing Benchmark Analysis
Identify the overall/annual cost
of therapy for competitors as well
as analogs; supports strategy for
penetration in emerging and non-
innovator friendly markets
Affordability Analysis
Understand socio-economic data as
well as private and public insurance
coverage to understand level of
insurance coverage and out-of-
pocket expenses (OOP)
Supply Chain Research and
Analytics
Research to find right fit vendors for
supply chain logistics and analytics
to optimize supply chain
1
2
3
4
5
6
How SGA can Help in End-to-end Support
for Companies in Precision Medicine?
Epidemiology Analysis
Using SGA’s proprietary
methodologies help companies
identify the eligible and potential
patient cohorts
Demand Analysis
Estimated expected product demand
using quantitative and qualitative
market research for HCPs, patients,
and caregivers
Forecasting
Deploy SGA’s REAL forecast
methodology to estimate future
potential of products for next 5–10
years and support with executive
friendly visualization through dynamic
dashboards
Pricing Benchmark Analysis
Identify the overall/annual cost
of therapy for competitors as well
as analogs; supports strategy for
penetration in emerging and non-
innovator friendly markets
Affordability Analysis
Understand socio-economic data as
well as private and public insurance
coverage to understand level of
insurance coverage and out-of-
pocket expenses (OOP)
Supply Chain Research and
Analytics
Research to find right fit vendors for
supply chain logistics and analytics
to optimize supply chain
1
2
3
4
5
6
26Healthcare Industry Report
References
• Precision Medicine US Food and Drug Administration. Medical Devices. In Vitro Diagnostics. Accessed July 23, 2024.
Available at: https://www.fda.gov/medical-devices/in-vitro-diagnostics/precision-medicine.
• SDG 3 Precision Health Overview. UNICEF Innovation. Accessed July 23, 2024. Available at: https://www.unicef.org/
innovation/media/20391/file/SDG%203%20Precision%20Health%20Overview.pdf.pdf.
• SDG 3 Precision Health Technologies and Innovations. UNICEF Innovation. Accessed July 23, 2024. Available at:
https://www.unicef.org/innovation/media/20396/file/SDG%203%20Precision%20Health%20Technologies%20And%20
Innovations.pdf.pdf.
• Technology Meets Precision Medicine. AstraZeneca. What Science Can Do. Accessed July 23, 2024. Available at:
https://www.astrazeneca.com/what-science-can-do/topics/technologies/technology-meets-precision-medicine.
html.
• Precision Medicine: The Future of Tailored Treatment. PubMed Central. Published 2020. Accessed July 23, 2024. Avail-
able at: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10975777/.
• Personalized Medicine Coalition. Personalized Medicine Coalition. Accessed July 23, 2024. Available at: https://www.
personalizedmedicinecoalition.org/.
• Feature - Precision Medicine. ISPOR. Accessed July 23, 2024. Available at: https://www.ispor.org/docs/de-
fault-source/publications/value-in-health-journal/vih-feature---precision-medicine.pdf.
• Personalized Medicine at FDA: The Scope & Significance of Progress in 2021. Personalized Medicine Coalition.
Published 2021. Accessed July 23, 2024. Available at: https://www.personalizedmedicinecoalition.org/Userfiles/
PMC-Corporate/file/Personalized_Medicine_at_FDA_The_Scope_Significance_of_Progress_in_2021.pdf.
• Precision reimbursement benefits all stakeholders. PubMed Central. Published 2023. Accessed July 23, 2024. Avail-
able at: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8651321/#:~:text=Precision%20reimbursement%20bene-
fits%20all%20stakeholders&text=Value%2Dbased%20pricing%20is%20part,highly%20efficacious%20drugs%20for%20
patients.
• Precision medicine and COVID-19: from the individual to the population. PubMed Central. Published 2021. Accessed
July 23, 2024. Available at: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9299639/.
• Precision Medicine and Its Role in Oncology: A Glance at the Current State of Affairs. PubMed Central. Published 2021.
Accessed July 23, 2024. Available at: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7877825/.
• OncoKB - Precision Oncology Knowledge Base. OncoKB. Accessed July 23, 2024. Available at: https://www.oncokb.
org/oncology-therapies.
• WEF Global Precision Medicine Council Vision Statement 2020. World Economic Forum. Published 2020. Accessed
July 23, 2024. Available at: https://www3.weforum.org/docs/WEF_Global_Precision_Medicine_Council_Vision_
Statement_2020.pdf.
• 100,000 Genomes Project. Genomics England. Accessed July 23, 2024. Available at: https://www.genomicsengland.
co.uk/initiatives/100000-genomes-project.
• Clemson Researchers Pave the Way for Precision Medicine with AI. Clemson University. Accessed July 23, 2024.
Available at: https://news.clemson.edu/clemson-researchers-pave-the-way-for-precision-medicine-with-ai/.
• PMC Report Shows Number of Personalized Medicines Doubled in 4 Years. AJMC. Published 2023. Accessed July 23,
2024. Available at: https://www.ajmc.com/view/pmc-report-shows-number-of-personalized-medicines-doubled-
in-4-years.
• Payment Models for High-cost Therapies. ASCO. Published 2021. Accessed July 23, 2024. Available at: https://asco-
pubs.org/doi/10.1200/EDBK_397912#:~:text=Payment%20Models%20for%20High%2Dcost%20Therapies,-Even%20if%20
many&text=For%20example%2C%20a%20payer%20may,a%20certain%20period%20of%20time.
• Nearly Half of Oncology Drugs Approved Since 1998 Are Precision Therapies. American Association for Cancer Re-
search. Published February 18, 2020. Accessed July 23, 2024. Available at: https://www.aacr.org/about-the-aacr/
newsroom/news-releases/nearly-half-of-oncology-drugs-approved-since-1998-are-precision-therapies/.
• Precision Medicine Initiative. The White House, Office of the Press Secretary. Published January 30, 2015. Accessed
July 23, 2024. Available at: https://obamawhitehouse.archives.gov/precision-medicine#:~:text=NIH%20is%20build-
ing%20the%20Precision,understanding%20of%20health%20and%20disease.
References
• Precision Medicine US Food and Drug Administration. Medical Devices. In Vitro Diagnostics. Accessed July 23, 2024.
Available at: https://www.fda.gov/medical-devices/in-vitro-diagnostics/precision-medicine.
• SDG 3 Precision Health Overview. UNICEF Innovation. Accessed July 23, 2024. Available at: https://www.unicef.org/
innovation/media/20391/file/SDG%203%20Precision%20Health%20Overview.pdf.pdf.
• SDG 3 Precision Health Technologies and Innovations. UNICEF Innovation. Accessed July 23, 2024. Available at:
https://www.unicef.org/innovation/media/20396/file/SDG%203%20Precision%20Health%20Technologies%20And%20
Innovations.pdf.pdf.
• Technology Meets Precision Medicine. AstraZeneca. What Science Can Do. Accessed July 23, 2024. Available at:
https://www.astrazeneca.com/what-science-can-do/topics/technologies/technology-meets-precision-medicine.
html.
• Precision Medicine: The Future of Tailored Treatment. PubMed Central. Published 2020. Accessed July 23, 2024. Avail-
able at: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10975777/.
• Personalized Medicine Coalition. Personalized Medicine Coalition. Accessed July 23, 2024. Available at: https://www.
personalizedmedicinecoalition.org/.
• Feature - Precision Medicine. ISPOR. Accessed July 23, 2024. Available at: https://www.ispor.org/docs/de-
fault-source/publications/value-in-health-journal/vih-feature---precision-medicine.pdf.
• Personalized Medicine at FDA: The Scope & Significance of Progress in 2021. Personalized Medicine Coalition.
Published 2021. Accessed July 23, 2024. Available at: https://www.personalizedmedicinecoalition.org/Userfiles/
PMC-Corporate/file/Personalized_Medicine_at_FDA_The_Scope_Significance_of_Progress_in_2021.pdf.
• Precision reimbursement benefits all stakeholders. PubMed Central. Published 2023. Accessed July 23, 2024. Avail-
able at: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8651321/#:~:text=Precision%20reimbursement%20bene-
fits%20all%20stakeholders&text=Value%2Dbased%20pricing%20is%20part,highly%20efficacious%20drugs%20for%20
patients.
• Precision medicine and COVID-19: from the individual to the population. PubMed Central. Published 2021. Accessed
July 23, 2024. Available at: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9299639/.
• Precision Medicine and Its Role in Oncology: A Glance at the Current State of Affairs. PubMed Central. Published 2021.
Accessed July 23, 2024. Available at: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7877825/.
• OncoKB - Precision Oncology Knowledge Base. OncoKB. Accessed July 23, 2024. Available at: https://www.oncokb.
org/oncology-therapies.
• WEF Global Precision Medicine Council Vision Statement 2020. World Economic Forum. Published 2020. Accessed
July 23, 2024. Available at: https://www3.weforum.org/docs/WEF_Global_Precision_Medicine_Council_Vision_
Statement_2020.pdf.
• 100,000 Genomes Project. Genomics England. Accessed July 23, 2024. Available at: https://www.genomicsengland.
co.uk/initiatives/100000-genomes-project.
• Clemson Researchers Pave the Way for Precision Medicine with AI. Clemson University. Accessed July 23, 2024.
Available at: https://news.clemson.edu/clemson-researchers-pave-the-way-for-precision-medicine-with-ai/.
• PMC Report Shows Number of Personalized Medicines Doubled in 4 Years. AJMC. Published 2023. Accessed July 23,
2024. Available at: https://www.ajmc.com/view/pmc-report-shows-number-of-personalized-medicines-doubled-
in-4-years.
• Payment Models for High-cost Therapies. ASCO. Published 2021. Accessed July 23, 2024. Available at: https://asco-
pubs.org/doi/10.1200/EDBK_397912#:~:text=Payment%20Models%20for%20High%2Dcost%20Therapies,-Even%20if%20
many&text=For%20example%2C%20a%20payer%20may,a%20certain%20period%20of%20time.
• Nearly Half of Oncology Drugs Approved Since 1998 Are Precision Therapies. American Association for Cancer Re-
search. Published February 18, 2020. Accessed July 23, 2024. Available at: https://www.aacr.org/about-the-aacr/
newsroom/news-releases/nearly-half-of-oncology-drugs-approved-since-1998-are-precision-therapies/.
• Precision Medicine Initiative. The White House, Office of the Press Secretary. Published January 30, 2015. Accessed
July 23, 2024. Available at: https://obamawhitehouse.archives.gov/precision-medicine#:~:text=NIH%20is%20build-
ing%20the%20Precision,understanding%20of%20health%20and%20disease.
27Healthcare Industry Report
• Primary Focus Areas - Precision Medicine. National Institute of Standards and Technology. Accessed July 23, 2024.
Available at: https://www.nist.gov/mml/bbd/primary-focus-areas/precision-medicine.
• Precision Health: Predict and Prevent Disease. Centers for Disease Control and Prevention. Accessed July 23, 2024.
Available at: https://www.cdc.gov/genomics-and-health/about/precision-health-predict-and-prevent-disease.
html.
• Mosaic - Precision Medicine in Israel: Brief Overview. Israeli Ministry of Health. Published November 12, 2018. Accessed
July 23, 2024. Available at: https://health.gov.il/services/tenders/doclib/121118-mosaic-brief.pdf.
• GEM Israel - Precision Medicine. Innovate UK Knowledge Transfer Network. Published December 2020. Accessed July
23, 2024. Available at: https://iuk.ktn-uk.org/wp-content/uploads/2020/12/B1_1__KTN_GEM_Israel-PrecisionMedi-
cine.pdf.
• Israeli Precision Medicine Partnership (IPMP) Roadmap. Yad Hanadiv. Published March 2019. Accessed July 23, 2024.
Available at: https://www.yadhanadiv.org.il/sites/default/files/media/document/2019-03/IPMP%20Roadmap.pdf.
• Tempus Expands Immuno-Oncology Portfolio with Launch of AI-enabled Multimodal Immune Profile Algorithmic
Tests. Tempus. Published March 16, 2023. Accessed July 23, 2024. Available at: https://www.tempus.com/news/
tempus-expands-immuno-oncology-portfolio-with-launch-of-ai-enabled-multimodal-immune-profile-algorith-
mic-tests/.
• American Medical Association Grants PLA Code to Tempus Algorithmic Test Purist. Tempus. Published January
18, 2024. Accessed July 23, 2024. Available at: https://www.tempus.com/news/american-medical-associa-
tion-grants-pla-code-to-tempus-algorithmic-test-purist/.
• Novel Drug Approvals 2023. US Food and Drug Administration. Accessed July 23, 2024. Available at: https://www.fda.
gov/drugs/novel-drug-approvals-fda/novel-drug-approvals-2023.
• First Complete Sequence of the Human Genome. National Institutes of Health. Published April 24, 2003. Accessed
July 23, 2024. Available at: https://www.nih.gov/news-events/nih-research-matters/first-complete-sequence-hu-
man-genome.
• Researchers Generate First Complete, Gapless Sequence of the Human Genome. National Institutes of Health.
Published May 31, 2022. Accessed July 23, 2024. Available at: https://www.nih.gov/news-events/news-releases/re-
searchers-generate-first-complete-gapless-sequence-human-genome.
• Precision medicine: the future of tailored treatment. PubMed Central. Published 2020. Accessed July 23, 2024. Avail-
able at: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10937087/.
• Pharmacogenomics Knowledge Base (PharmGKB). PharmGKB. Accessed July 23, 2024. Available at: https://www.
pharmgkb.org/.
• Pharmacogenomics and Personalized Medicine. Nature Education. Accessed July 23, 2024. Available at: https://
www.nature.com/scitable/topicpage/pharmacogenomics-and-personalized-medicine-643/.
• Companion Diagnostics. US Food and Drug Administration. Medical Devices. In Vitro Diagnostics. Accessed July 23,
2024. Available at: https://www.fda.gov/medical-devices/in-vitro-diagnostics/companion-diagnostics#:~:tex-
t=A%20companion%20diagnostic%20is%20a,corresponding%20drug%20or%20biological%20product.
• Indigenous CAR-T cell therapy now available for commercial use. Indian Express. Published July 17, 2024. Accessed
July 28, 2024. Available at: https://indianexpress.com/article/cities/mumbai/indigenous-car-t-cell-therapy-now-
available-for-commercial-use-9147148/
• Israel Precision Medicine Program: Roadmap 2019. Yad Hanadiv. Published March 2019. Accessed July 28, 2024.
https://www.yadhanadiv.org.il/sites/default/files/media/document/2019-03/IPMP%20Roadmap.pdf
• CAR-T cell therapy update. CU Anschutz Medical Campus. Published July 26, 2024. Accessed July 28, 2024. https://
news.cuanschutz.edu/cancer-center/car-t-cell-therapy-update
• Quantum computer-powered pangenome research could lead to personalized medicine, disease outbreak
tracking. The Quantum Insider. Published April 26, 2024. Accessed July 28, 2024. https://thequantuminsider.
com/2024/04/26/quantum-computer-powered-pangenome-research-could-lead-to-personalized-medi-
cine-disease-outbreak-tracking/
• Personalized Medicine Coalition. In 2023, personalized medicines topped one-third of new drug approvals for
fourth year in a row. Personalized Medicine Coalition. Available at: https://www.personalizedmedicinecoalition.org/
in-2023-personalized-medicines-topped-one-third-of-new-drug-approvals-for-fourth-year-in-a-row/#:~:tex-
t=In%202023%2C%20FDA%20approved%2016,for%20other%20diseases%20and%20conditions.
• Primary Focus Areas - Precision Medicine. National Institute of Standards and Technology. Accessed July 23, 2024.
Available at: https://www.nist.gov/mml/bbd/primary-focus-areas/precision-medicine.
• Precision Health: Predict and Prevent Disease. Centers for Disease Control and Prevention. Accessed July 23, 2024.
Available at: https://www.cdc.gov/genomics-and-health/about/precision-health-predict-and-prevent-disease.
html.
• Mosaic - Precision Medicine in Israel: Brief Overview. Israeli Ministry of Health. Published November 12, 2018. Accessed
July 23, 2024. Available at: https://health.gov.il/services/tenders/doclib/121118-mosaic-brief.pdf.
• GEM Israel - Precision Medicine. Innovate UK Knowledge Transfer Network. Published December 2020. Accessed July
23, 2024. Available at: https://iuk.ktn-uk.org/wp-content/uploads/2020/12/B1_1__KTN_GEM_Israel-PrecisionMedi-
cine.pdf.
• Israeli Precision Medicine Partnership (IPMP) Roadmap. Yad Hanadiv. Published March 2019. Accessed July 23, 2024.
Available at: https://www.yadhanadiv.org.il/sites/default/files/media/document/2019-03/IPMP%20Roadmap.pdf.
• Tempus Expands Immuno-Oncology Portfolio with Launch of AI-enabled Multimodal Immune Profile Algorithmic
Tests. Tempus. Published March 16, 2023. Accessed July 23, 2024. Available at: https://www.tempus.com/news/
tempus-expands-immuno-oncology-portfolio-with-launch-of-ai-enabled-multimodal-immune-profile-algorith-
mic-tests/.
• American Medical Association Grants PLA Code to Tempus Algorithmic Test Purist. Tempus. Published January
18, 2024. Accessed July 23, 2024. Available at: https://www.tempus.com/news/american-medical-associa-
tion-grants-pla-code-to-tempus-algorithmic-test-purist/.
• Novel Drug Approvals 2023. US Food and Drug Administration. Accessed July 23, 2024. Available at: https://www.fda.
gov/drugs/novel-drug-approvals-fda/novel-drug-approvals-2023.
• First Complete Sequence of the Human Genome. National Institutes of Health. Published April 24, 2003. Accessed
July 23, 2024. Available at: https://www.nih.gov/news-events/nih-research-matters/first-complete-sequence-hu-
man-genome.
• Researchers Generate First Complete, Gapless Sequence of the Human Genome. National Institutes of Health.
Published May 31, 2022. Accessed July 23, 2024. Available at: https://www.nih.gov/news-events/news-releases/re-
searchers-generate-first-complete-gapless-sequence-human-genome.
• Precision medicine: the future of tailored treatment. PubMed Central. Published 2020. Accessed July 23, 2024. Avail-
able at: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10937087/.
• Pharmacogenomics Knowledge Base (PharmGKB). PharmGKB. Accessed July 23, 2024. Available at: https://www.
pharmgkb.org/.
• Pharmacogenomics and Personalized Medicine. Nature Education. Accessed July 23, 2024. Available at: https://
www.nature.com/scitable/topicpage/pharmacogenomics-and-personalized-medicine-643/.
• Companion Diagnostics. US Food and Drug Administration. Medical Devices. In Vitro Diagnostics. Accessed July 23,
2024. Available at: https://www.fda.gov/medical-devices/in-vitro-diagnostics/companion-diagnostics#:~:tex-
t=A%20companion%20diagnostic%20is%20a,corresponding%20drug%20or%20biological%20product.
• Indigenous CAR-T cell therapy now available for commercial use. Indian Express. Published July 17, 2024. Accessed
July 28, 2024. Available at: https://indianexpress.com/article/cities/mumbai/indigenous-car-t-cell-therapy-now-
available-for-commercial-use-9147148/
• Israel Precision Medicine Program: Roadmap 2019. Yad Hanadiv. Published March 2019. Accessed July 28, 2024.
https://www.yadhanadiv.org.il/sites/default/files/media/document/2019-03/IPMP%20Roadmap.pdf
• CAR-T cell therapy update. CU Anschutz Medical Campus. Published July 26, 2024. Accessed July 28, 2024. https://
news.cuanschutz.edu/cancer-center/car-t-cell-therapy-update
• Quantum computer-powered pangenome research could lead to personalized medicine, disease outbreak
tracking. The Quantum Insider. Published April 26, 2024. Accessed July 28, 2024. https://thequantuminsider.
com/2024/04/26/quantum-computer-powered-pangenome-research-could-lead-to-personalized-medi-
cine-disease-outbreak-tracking/
• Personalized Medicine Coalition. In 2023, personalized medicines topped one-third of new drug approvals for
fourth year in a row. Personalized Medicine Coalition. Available at: https://www.personalizedmedicinecoalition.org/
in-2023-personalized-medicines-topped-one-third-of-new-drug-approvals-for-fourth-year-in-a-row/#:~:tex-
t=In%202023%2C%20FDA%20approved%2016,for%20other%20diseases%20and%20conditions.
28Healthcare Industry Report
The research for the white paper on T Precision Medicine – A New Era in Personalized Medicine was con-
ducted in June and July 2024.
SG Analytics used a blended methodology for this research report encompassing both secondary research
(regulatory sites, government sites, scientific journals, industry publications, webinars, press releases, etc.)
and in-depth research conducted with industry participants.
All research compiled was analyzed and final insights and conclusions were generated.
Primary Research Participants were
Rebu Ninan
Head - Commercial and
Market Access, Cell and
Gene Therapies (Immuneel
Therapeutics)
Naiery Vetraven
Vice President: R&D
Business Development
(BASE life science)
Dr. Urmila Kulkarni
Kale
Senior Vice President,
Citadel Precision Medicine
Methodology
The research for the white paper on T Precision Medicine – A New Era in Personalized Medicine was con-
ducted in June and July 2024.
SG Analytics used a blended methodology for this research report encompassing both secondary research
(regulatory sites, government sites, scientific journals, industry publications, webinars, press releases, etc.)
and in-depth research conducted with industry participants.
All research compiled was analyzed and final insights and conclusions were generated.
Primary Research Participants were
Rebu Ninan
Head - Commercial and
Market Access, Cell and
Gene Therapies (Immuneel
Therapeutics)
Naiery Vetraven
Vice President: R&D
Business Development
(BASE life science)
Dr. Urmila Kulkarni
Kale
Senior Vice President,
Citadel Precision Medicine
Methodology
Disclaimer
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Pune | Hyderabad | Bengaluru | London | Zurich | New York | San Francisco | Amsterdam | Toronto | Wroclaw
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herein is not an assertion of ownership of such trademarks by SG Analytics (SGA) and is not intended to represent
or get commercially benefited from it or imply the existence of an association between SGA and the lawful owners of
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