New Zealand Clinical Trials Support Service Market Analysis Sample Report 2022 to 2030

salonishah296132 23 views 66 slides Aug 07, 2024
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About This Presentation

This report presents a strategic analysis of the New Zealand Clinical Trials Support Service Market and a forecast for its development in the medium and long term. It provides a broad overview of the market dynamics, trends and insights, growth drivers and restraints, segmentation, competitive lands...


Slide Content

New Zealand Clinical Trials
Support Service Market
Analysis
Sample Report
June 2024

This report presents a strategic analysis of the New Zealand Clinical
Trials Support Service Market and a forecast for its development in
the medium and long term. It provides a comprehensive overview of the
market value, dynamics, segmentation, main players, growth and
demand drivers, challenges & future outlook, etc. This is one of the
most comprehensive reports about the New Zealand Clinical Trials
Support Service Market, and offers unmatched value, accuracy, and
expert insights.

3 A Sample Report on New Zealand Clinical Trials Support Service Market Analysis I Confidential
Report Attribute Details
Number of Pages 70-80
Base Year for Estimation 2023
Forecast Period 2024-2030
Report Coverage
Market Overview, Size & Forecasting, Market Segmentation, Growth Factors and Trends, Competitive
Landscape, Key Company Profiles, Government Policies, Regulatory Landscape, Reimbursement
Scenario
Quantitative Units Revenue in USD Million/Billion (Mn/Bn)
Currency Conversion 1 NZD = 0.61 USD
Research Approach Secondary Research (90%), Primary Research (10%)
Report Scope

4 A Sample Report on New Zealand Clinical Trials Support Service Market Analysis I Confidential
CONTENT PG. NO.
1. Market Overview 07-15
1.1 New Zealand Clinical Trials Support Service Market Overview
1.2 Clinical Trials Support Service Market Overview: Global
1.3 Economic Overview: New Zealand
1.4 Clinical Trials Support Service Market Overview: New Zealand
1.5 Healthcare Overview: New Zealand
1.6 Budget of New Zealand Government for Public Insurance
1.7 Top Developments in New Zealand
2. Services Provided in Clinical Trial Site Support 16-19
2.1 Operational Assistance
2.2 Data Management Support
2.3 Regulatory Support
2.4 Patient Recruitment and Retention
Table of Content

5 A Sample Report on New Zealand Clinical Trials Support Service Market Analysis I Confidential
CONTENT PG. NO.
2.5 SOP Development and Staff Training
3. Market Size and Forecasting 20-25
3.1 New Zealand Clinical Trials Support Service Market Size and Forecasts
3.2 Snapshot of Clinical Trials Support Service Market Segmentation
3.2.1 Market Segmentation: By Service
3.2.2 Market Segmentation: By Phase
3.2.3 Market Segmentation: By Sponsor
4. Market Dynamics 26-31
4.1 Market Growth Drivers
4.2 Market Restraints
5. Competitive Landscape 32-39
5.1 Key Players in New Zealand Clinical Trials Support Service Market
6. Regulatory and Reimbursement Landscape 40-45
Table of Content

6 A Sample Report on New Zealand Clinical Trials Support Service Market Analysis I Confidential
CONTENT PG. NO.
6.1 Regulatory Landscape in New Zealand
6.2 Reimbursement Scenario in New Zealand
6.3 Reimbursement Process
Table of Content

New Zealand Clinical Trials Support Service Market Analysis
1. Market Overview

▪Clinical Trials Support Service Market encompasses a
range of services provided to support the planning,
execution, and management of clinical trials
▪These services are essential for ensuring that clinical trials
are conducted efficiently, ethically, and in compliance with
regulatory requirements
Here are the five specific services provided in clinical trial site support:
▪Operational Assistance
▪Data Management Support
▪Regulatory Support
▪Patient Recruitment and Retention
▪SOP Development and Staff Training
1.1 Clinical Trials Support Service Market Overview

9 A Sample Report on New Zealand Clinical Trials Support Service Market Analysis I Confidential
197
211
249
244
262
272
281
289
296
302
2019 2020 2021 2022 2023 2024 2025 2026 2027 2028
Total Global Spending on Pharmaceutical Research and Development ($ Bn)
Sources:
1.2 Clinical Trials Support Service Market Overview: Global (1/2)
50%
of clinical trials
incorporated some form
of AI or big data in 2023
40%
Of clinical trials in 2023 were
multinational, involving sites
in multiple countries​
55
Novel Drugs FDA has
approved in 2023
$200 Bn
Global pharmaceutical
R&D expenditure in 2022

10 A Sample Report on New Zealand Clinical Trials Support Service Market Analysis I Confidential
New Zealand Market
~$xx Bn Market
Illustrative
1.2 New Zealand Clinical Trials Support Service Market Overview: Global (2/2)

11 A Sample Report on New Zealand Clinical Trials Support Service Market Analysis I Confidential
22%
62%
16%
4.44
4.52
4.61
4.71
4.81
4.90
4.98
5.095.115.12
2013201420152016201720182019202020212022
Population of New Zealand, (In Mn)
2.76%
3.81%
3.74%
3.80%
3.52%
3.53% 2.45%
-0.65%
5.17%
2.85%
2013201420152016201720182019202020212022
GDP Growth (Annual %) - New Zealand
Population Split (2023)
0-14
15-64
65+
MaleFemale
By Age GroupBy Gender
▪New Zealand is an aging country, as its median age is 37 years
which is higher than the global median age
▪Country's population’s global share is 0.06% and it is increasing
at a rate of 0.8%
▪Life expectancy of the female is 84.8 years and for males it is
81.4 years
▪Currently 82.4% of the population is urban in New Zealand
▪Top 3 largest cities in New Zealand are Auckland, Wellington
and Christchurch
Illustrative
1.3 Economic Overview: New Zealand

12 A Sample Report on New Zealand Clinical Trials Support Service Market Analysis I Confidential
Illustrative
1.4 New Zealand Clinical Trials Support Service Market Overview: New Zealand
835,658
Population of people
aged 65 years and
older in 2022
61.8 K
Noncommunicable diseases
are the Top causes of death
in New Zealand
10.5%
Is a health expenditure (%
of GDP) in 2019
$3.06 Bn
New Zealand’s
pharmaceutical R&D
expenditure in 2021
106.5
63.4
49.7
39.2
37.9
31.3
19.2
16.1
15.4
15.4
Ischaemic heart disease
Alzheimer disease and other dementias
Stroke
Trachea, bronchus, lung cancers
Chronic obstructive pulmonary disease
Colon and rectum cancers
Lower respiratory infections
Diabetes mellitus
Prostate cancer
Breast cancer
Top Causes of Death in New Zealand, (Per 100 000 Population)

13 A Sample Report on New Zealand Clinical Trials Support Service Market Analysis I Confidential
1.5 Healthcare Overview: New Zealand
Public Healthcare
Structure
›Funding: Predominantly funded through general taxation
›Administration: The Ministry of Health oversees the
system, with District Health Boards (DHBs) managing
services in different regions
›Services: Public healthcare covers a wide range of
services, including hospital care, emergency services,
maternity care, and specialist care
Access
›Eligibility: All citizens, permanent residents, and some
work visa holders have access to public healthcare
›Cost: Many services are free or subsidized, including
hospital stays and emergency care. Primary care (e.g., GP
visits) often requires a co-payment
Private Healthcare
Structure
›Providers: Includes private hospitals, clinics, and
specialists
›Funding: Primarily funded through private health
insurance and out-of-pocket payments by patients
›Services: Public healthcare covers a wide range of
services, including hospital care, emergency services,
maternity care, and specialist care
Access
›Insurance: Private health insurance is common, covering
services that are either not fully funded or not available in
the public system
›Cost: Patients often face higher out-of-pocket expenses,
but insurance can offset these costs

14 A Sample Report on New Zealand Clinical Trials Support Service Market Analysis I Confidential
Proposed Budget By Category
Outlays 2020 2021 2022 2023 2024 2025 2026 2027 2028 2029 2030 2031 2022-31
In Billions Of Dollars
Medicare
$769 $709 $766 $841 $840 $947 $1,014 $1,085 $1,227 $1,178 $1,325 $1,412 $10,633
As % Of GDP 3.7% 3.2% 3.3% 3.4% 3.3% 3.6% 3.7% 3.8% 4.1% 3.8% 4.1% 4.2% 3.7%
▪National Health Expenditures (NHE) grew 2.7% to $4.3 Tn in 2021, or $12,914 per person, and accounted for 18.3% of Gross Domestic Product (GDP)
▪Medicare spending grew 8.4% to $900.8 Bn in 2021, or 21% of total NHE
▪Private health insurance spending grew 5.8% to $1,211.4 Bn in 2021, or 28% of total NHE
▪Out of pocket spending grew 10.4% to $433.2 Bn in 2021, or 10% of total NHE
▪Other Third Party Payers and Programs and Public Health Activity spending declined 20.7% in 2021 to $596.6 Bn, or 14% of total NHE
▪Hospital expenditures grew 4.4% to $1,323.9 Bn in 2021, slower than the 6.2% growth in 2020
▪Physician and clinical services expenditures grew 5.6% to $864.6 Bn in 2021, slower growth than the 6.6% in 2020
▪Prescription drug spending increased 7.8% to $378.0 Bn in 2021, faster than the 3.7% growth in 2020
▪Largest shares of total health spending were sponsored by the federal government (34%) and the households (27%). The private business share of health spending
accounted for 17% of total health care spending, state and local governments accounted for 15%, and other private revenues accounted for 7%
Illustrative
1.6 Budget of New Zealand Government for Public Insurance

15 A Sample Report on New Zealand Clinical Trials Support Service Market Analysis I Confidential
Company Name Type Year Key Pointers
Acquisition Jan, 2024
▪Novotech, a prominent Asia-Pacific CRO, acquired Acrostar's SMO
Division to strengthen its clinical trial capabilities, particularly in site
management and patient recruitment
▪This acquisition aligns with Novotech's strategy to enhance its service
offerings and expand its geographic footprint in the region
Acquisition Dec, 2023
▪Forsyth Barr, a leading New Zealand investment firm, acquired Hobson
Wealth to expand its financial services and investment management
capabilities
▪This acquisition is part of Forsyth Barr's growth strategy to increase its
market share and enhance its service offerings in the financial sector
Acquisition Oct, 2023
▪Altus Group, an Australian traffic management company, acquired Traffic
Management NZ to expand its operations in New Zealand and strengthen
its presence in the traffic management industry
▪This acquisition aims to leverage Traffic Management NZ's local expertise
and operational capabilities to enhance Altus Group's service offerings
Latest Deals in New Zealand
Illustrative
1.7 Top Developments in New Zealand

New Zealand Clinical Trials Support Service Market Analysis
2. Services Provided in Clinical Trial Site Support

17 A Sample Report on New Zealand Clinical Trials Support Service Market Analysis I Confidential
Illustrative
2. Services Provided in Clinical Trial Site Support
2.1 Operational Assistance
▪Operational assistance can encompass nearly anything related
to the day-to-day tasks involved in conducting the clinical trial
▪Sites may be obligated to follow practices, protocols, or routines
that are unfamiliar, and since each trial is unique, operational
assistance could take many forms
▪It could even be provided on a site-by-site basis, where the
sponsor or a support team is available for a given amount of time
to help with whatever aspects the site needs help with
▪Operational tasks can include activities like scheduling patient
visits, recording patient data as per protocol and CRFs,
managing study supplies, reporting to the sponsor, etc.
2.2 Data Management Support
▪Clinical trial results can inform decisions on drug approvals and
inform patient care guidelines and healthcare policy
▪With such important implications, it’s essential that clinical trial
data be reliable and accurate
▪While most research centers and medical facilities will have
experience handling data, the nature of clinical trial data
management is somewhat different
▪Of particular (unique) relevance to clinical trials are data privacy
and confidentiality considerations, such as HIPAA in the US or
the GDPR in the EU, dealing with blinded data, and the use of
integrated data systems as imposed by the sponsor
▪Depending on the data collection method(s) used, the site may
need particular training on tools or software systems employed,
data collection and reporting procedures, data security, etc.

18 A Sample Report on New Zealand Clinical Trials Support Service Market Analysis I Confidential
Illustrative
2. Services Provided in Clinical Trial Site Support (Continued)
2.3 Regulatory Support
▪Clinical site support teams can assist individual sites with
institutional review board (IRB) submissions and approvals by
helping sites prepare essential trial documents in accordance
with relevant regulations
▪Clinical trial documentation can differ significantly from the type
of documentation that research sites or medical facilities may be
used to, so for inexperienced sites, receiving assistance in this
area can be of great help
▪Sponsors can also provide oversight and assistance to ensure
ongoing compliance with protocols and regulatory requirements
set forth by local/national authorities or international guidelines
such as Good Clinical Practice (GCP)
2.4 Patient Recruitment and Retention
▪Patient recruitment and retention play a critical role in the
success of clinical trials, and recruitment is a common source of
delays
▪This is thus another area wherein the sponsor can provide
assistance
▪While some sites might have well-established patient databases
or networks and efficient recruitment practices, others may need
more assistance from the sponsor (although this factor is almost
always considered during site selection)
▪Site support services could help sites identify and leverage
community groups or patient advocacy groups to raise
awareness about the trial and reach potential participants, or
could launch centralized recruitment advertising campaigns on
digital platforms that direct patients to the nearest site

19 A Sample Report on New Zealand Clinical Trials Support Service Market Analysis I Confidential
Illustrative
2. Services Provided in Clinical Trial Site Support (Continued)
2.5 SOP Development and Staff Training
▪Standard operating procedures (SOPs) play a crucial role in ensuring that sites understand exactly what is required of them, as per the trial
protocol
▪SOPs can be thought of as step-by-step instructions for the daily tasks required in order for the trial to be executed in line with protocol,
regulations, and timelines
▪If any staff member is unsure about how to proceed with anything trial-related, for example in collecting a specific type of patient data or
reporting to the sponsor, they should be able to consult a clear and detailed SOP
▪Site support teams could help sites develop comprehensive SOPs tailored to the requirements of each specific trial. For sites with SOPs
already in place, site support services might review SOP documentation or verify that they are being followed
▪Moreover, site support teams might be tasked with conducting staff training, either on understanding and following these SOPs, or on other
aspects of trial-specific operations in general, such as operating specific medical devices or reporting data according to certain constraints

New Zealand Clinical Trials Support Service Market Analysis
3. Market Size and Forecasting

21 A Sample Report on New Zealand Clinical Trials Support Service Market Analysis I Confidential
2023 2024F 2025F 2026F 2027F 2028F 2029F 2030F
New Zealand Clinical Trials Support Service Market Forecast, 2023-2030
2023 2024 2025 2026 2027 2028 2029 2030
Major Markets Patient ($Mn) 2.74 2.82 2.90 2.94 2.98 3.02 3.07 3.12
New Zealand Patient Size ($Bn) 0.51 0.61 0.68 0.69 0.70 0.71 0.72 0.73
% of Patients 18.75% 21.70% 23.56% 23.45% 23.42% 23.39% 23.34% 23.45%
Global Market Size ($Bn) 3,620 3,780 3,950 4,128 4,314 4,508 4,711 4,937
New Zealand Market Size ($Bn) 61 74 84 87 91 95 99 106
Illustrative
3.1 New Zealand Clinical Trials Support Service Market Size and Forecasts

22 A Sample Report on New Zealand Clinical Trials Support Service Market Analysis I Confidential
▪In this section you will get an understanding of the segmentations which will cover the New Zealand Clinical Trials Support Service Market
▪In order to obtain access to all of the information that you are seeking, you will need to purchase the final report
By Service
Clinical Trial Site Management
Patient Recruitment Management
Data Management
Administrative staff
IRB
Others
By Phase
Phase I
Phase II
Phase III
Phase IV
By Sponsor
Pharmaceutical &
Biopharmaceutical
Medical Devices
Others
Illustrative
3.2 Snapshot of Clinical Trials Support Service Market Segmentation

23 A Sample Report on New Zealand Clinical Trials Support Service Market Analysis I Confidential
▪Please be aware that this sample report is
intended to provide you with a brief
overview of the kind of information and
analysis that will be presented in the final
report
▪In order to obtain access to all of the
information that you are seeking, you will
need to purchase the final report
▪Final report will be comprehensive and
detailed, and it will include data, analysis,
trends, and other relevant information
related to the topic or subject matter of
interest
New Zealand Clinical Trials Support Service Market Share, By Service
(2023)
Clinical Trial Site
Management
Patient Recruitment
Management
Data Management
Administrative
staff
IRB
Others
Illustrative
3.2.1 Market Segmentation: By Service

24 A Sample Report on New Zealand Clinical Trials Support Service Market Analysis I Confidential
▪Please be aware that this sample report is
intended to provide you with a brief
overview of the kind of information and
analysis that will be presented in the final
report
▪In order to obtain access to all of the
information that you are seeking, you will
need to purchase the final report
▪Final report will be comprehensive and
detailed, and it will include data, analysis,
trends, and other relevant information
related to the topic or subject matter of
interest
New Zealand Clinical Trials Support Service Market Share, By Phase
(2023)
Phase I
Phase II
Phase III
Phase IV
Illustrative
3.2.2 Market Segmentation: By Phase

25 A Sample Report on New Zealand Clinical Trials Support Service Market Analysis I Confidential
▪Please be aware that this sample report is
intended to provide you with a brief
overview of the kind of information and
analysis that will be presented in the final
report
▪In order to obtain access to all of the
information that you are seeking, you will
need to purchase the final report
▪Final report will be comprehensive and
detailed, and it will include data, analysis,
trends, and other relevant information
related to the topic or subject matter of
interest
New Zealand Clinical Trials Support Service Market Share, By Sponsor
(2023)
Pharmaceutical &
Biopharmaceutic
al
Medical Devices
Others
Illustrative
3.2.3 Market Segmentation: By Sponsor

New Zealand Clinical Trials Support Service Market Analysis
4. Market Dynamics

27 A Sample Report on New Zealand Clinical Trials Support Service Market Analysis I Confidential
4.1.1
New Zealand's
efficient and
streamlined
regulatory processes
4.1.2
There is a
growing global
demand for
clinical trials
4.1.3
Presence of
experienced local
Contract Research
Organizations
(CROs)
4.2.1
New Zealand's
geographic isolation
can be a challenge for
international sponsors
and researchers
4.2.2
Relatively small
population size of
New Zealand can limit
the availability of
eligible participants
4.2.3
New Zealand
faces strong
competition from
Australia
Illustrative
4. Snapshot Of Market Growth Drivers And Restraints

28 A Sample Report on New Zealand Clinical Trials Support Service Market Analysis I Confidential
Illustrative
▪Please be aware that this sample report is intended to provide you with a
brief overview of the kind of information and analysis that will be
presented in the final report
▪In order to obtain access to all of the information that you are seeking,
you will need to purchase the final report
▪Final report will be comprehensive and detailed, and it will include data,
analysis, trends, and other relevant information related to the topic or
subject matter of interest
4.1 Market Growth Drivers
4.1.1 New Zealand's efficient and streamlined regulatory processes make it an attractive location for clinical trials
Approvals in Therapeutic Areas (%)

29 A Sample Report on New Zealand Clinical Trials Support Service Market Analysis I Confidential
▪Please be aware that this sample report is intended to provide you with a
brief overview of the kind of information and analysis that will be
presented in the final report
▪In order to obtain access to all of the information that you are seeking,
you will need to purchase the final report
▪Final report will be comprehensive and detailed, and it will include data,
analysis, trends, and other relevant information related to the topic or
subject matter of interest
2010 2020 2023
Illustrative
4.1 Market Growth Drivers
4.1.2 There is a growing global demand for clinical trials, particularly in therapeutic areas such as oncology,
neurology, and infectious diseases
Approved Drugs in New Zealand (2010-2023)

30 A Sample Report on New Zealand Clinical Trials Support Service Market Analysis I Confidential
▪Please be aware that this sample report is intended to provide you with a
brief overview of the kind of information and analysis that will be
presented in the final report
▪In order to obtain access to all of the information that you are seeking,
you will need to purchase the final report
▪Final report will be comprehensive and detailed, and it will include data,
analysis, trends, and other relevant information related to the topic or
subject matter of interest
Illustrative
4.1 Market Growth Drivers
4.1.3 Presence of experienced local Contract Research Organizations (CROs) such as PharmaSols and NZCR
enhances the attractiveness of New Zealand for clinical trials
Market Share (%)

31 A Sample Report on New Zealand Clinical Trials Support Service Market Analysis I Confidential
4.2.1 New Zealand's geographic
isolation can be a challenge for
international sponsors and
researchers
▪Please be aware that this sample
report is intended to provide you
with a brief overview of the kind
of information and analysis that
will be presented in the final
report
▪In order to obtain access to all of
the information that you are
seeking, you will need to
purchase the final report
4.2.2 Relatively small population
size of New Zealand can limit the
availability of eligible participants
for clinical trials
▪Please be aware that this sample
report is intended to provide you
with a brief overview of the kind
of information and analysis that
will be presented in the final
report
▪In order to obtain access to all of
the information that you are
seeking, you will need to
purchase the final report
4.2.3 New Zealand faces strong
competition from Australia, which
also offers a favorable regulatory
environment for clinical trials
▪Please be aware that this sample
report is intended to provide you
with a brief overview of the kind
of information and analysis that
will be presented in the final
report
▪In order to obtain access to all of
the information that you are
seeking, you will need to
purchase the final report
▪Final report will be
comprehensive and detailed, and
it will include data, analysis,
trends, and other relevant
information related to the topic or
subject matter of interestOur analysis will thoroughly investigate the key restraints that may significantly impact business
operations and growth.
Illustrative
4.2 Market Growth Restraints

New Zealand Clinical Trials Support Service Market Analysis
5. Competitive Landscape

33 A Sample Report on New Zealand Clinical Trials Support Service Market Analysis I Confidential
▪Here is the list of top 10 companies which
will cover in the final report
▪Each company will have slides for
oOverview
oKey details
oOfferings
oName of products
oRecent activities/ Press Coverage
oDistribution and Vendor Partners
oMergers, Acquisitions and
Collaboration
oFinancials
▪If there are specific companies that you
would like to be included in the report,
please let us know via email
▪In order to obtain access to all of the
information that you are seeking, you will
need to purchase the final report
PharmaSols (HiRO)1 PCRN6
NZCR2 Waitematā7
SCTrials Group3 Novotech8
P3 Research4 ICON plc9
Optimal Clinical Trials5 MedPharm10
Illustrative
5.1 Key Players in New Zealand Clinical Trials Support Service Market

34 A Sample Report on New Zealand Clinical Trials Support Service Market Analysis I Confidential
Founded In: 2000
HQ: Auckland, New Zealand
Type: Private
Revenue: xx
Website: pharmasols.com
▪PharmaSols, also known as HiRO (Healthcare Innovations
Research Organization), is a leading Contract Research
Organization (CRO) in New Zealand and Australia
▪Specializing in providing comprehensive clinical trial support
services, PharmaSols offers expertise in regulatory submissions,
site management, patient recruitment, data management, and
clinical trial monitoring
Offerings
➢Full Service Project Management
➢Outsourced Clinical Research
➢Regulatory Compliance
➢Quality Assurance
➢Rescue Studies
Recent Activity / Press Coverage
▪March, 2024 — PharmaSols has been instrumental in rescuing stalled global clinical trials by leveraging the diverse and willing population in the ANZ
region
▪They recently overachieved patient recruitment targets, reaching 206% of the initial target in just 26 days and achieving a 35-day start-up timeline for a
recent study
▪December, 2023 — PharmaSols and HiRO announced a new global partnership, aligning their commitment to delivering successful clinical trials
through a dedicated team of experts
▪This collaboration enhances PharmaSols' capability to operate as a global full-service CRO, benefiting clients with combined depth and breadth of
experience​
▪February, 2023 — HiRO, highlighted the importance of patient recruitment diversity in clinical trials to meet international regulatory standards
▪This partnership aims to provide tailored and cost-effective solutions for biotechs navigating complex regulatory requirements
5.1.1 PharmaSols

35 A Sample Report on New Zealand Clinical Trials Support Service Market Analysis I Confidential
Company Name Type Year Key Pointers
Latest Deals in Siemens Healthineers
Illustrative
5.1.1 PharmaSols (Continued)

36 A Sample Report on New Zealand Clinical Trials Support Service Market Analysis I Confidential
▪Please be aware that this sample report is
intended to provide you with a brief
overview of the kind of information and
analysis that will be presented in the final
report
▪In order to obtain access to all of the
information that you are seeking, you will
need to purchase the final report
▪Final report will be comprehensive and
detailed, and it will include data, analysis,
trends, and other relevant information
related to the topic or subject matter of
interest
2020202120222023F2024F2025F2026F2027F2028F2029F2030F
Revenues ($Bn), 2020-2030
Breakdown of Net Revenue by Segment, 2023
1 2 3 4
Illustrative
5.1.1 PharmaSols (Continued)

37 A Sample Report on New Zealand Clinical Trials Support Service Market Analysis I Confidential
Founded In:
HQ:
Type:
Revenue:
Website:
Offerings
Recent Activity / Press Coverage
5.1.2 Company 2
Illustrative

38 A Sample Report on New Zealand Clinical Trials Support Service Market Analysis I Confidential
Company Name Type Year Key Pointers
Latest Deals in CompanyName
Illustrative
5.1.2 Company 2 (Continued)

39 A Sample Report on New Zealand Clinical Trials Support Service Market Analysis I Confidential
▪Please be aware that this sample report is
intended to provide you with a brief
overview of the kind of information and
analysis that will be presented in the final
report
▪In order to obtain access to all of the
information that you are seeking, you will
need to purchase the final report
▪Final report will be comprehensive and
detailed, and it will include data, analysis,
trends, and other relevant information
related to the topic or subject matter of
interest
2020202120222023F2024F2025F2026F2027F2028F2029F2030F
Revenues ($Bn), 2020-2030
Breakdown of Net Revenue by Segment, 2023
1 2 3 4
Illustrative
5.1.2 Company 2 (Continued)

New Zealand Clinical Trials Support Service Market Analysis
6. Regulatory and Reimbursement Landscape

41 A Sample Report on New Zealand Clinical Trials Support Service Market Analysis I Confidential
Overview of the Key Regulatory Bodies and Processes Involved
6.1 Regulatory Landscape in New Zealand
Pharmac (Pharmaceutical Management Agency)
›Role: Pharmac manages the Pharmaceutical Schedule and decides which medicines and medical devices are
subsidized in New Zealand. While not directly involved in the approval of clinical trials, Pharmac's decisions can
impact the availability and funding of treatments studied in trials
Health and Disability Ethics Committees (HDECs)
›Role: HDECs are responsible for ensuring that clinical trials are conducted ethically and that the rights, safety, and
well-being of trial participants are protected
›Approval Process: All clinical trials involving human participants must receive approval from an HDEC before they
can commence
Medsafe (New Zealand Medicines and Medical Devices Safety Authority)
›Role: Medsafe is responsible for the regulation of therapeutic products in New Zealand, including medicines and
medical devices. It ensures that these products meet acceptable standards of quality, safety, and efficacy
›Clinical Trials: For clinical trials involving new medicines or medical devices, Medsafe approval is required
Illustrative

42 A Sample Report on New Zealand Clinical Trials Support Service Market Analysis I Confidential
Key Regulations and Guidelines
6.1 Regulatory Landscape in New Zealand (Continued)
Medicines Act 1981
›This Act governs the approval and
regulation of medicines and related
products in New Zealand
›It includes provisions for the
approval of clinical trials involving
new medicines
Medicines Regulations 1984
›These regulations provide detailed
requirements for the manufacture,
sale, distribution, and advertising of
medicines, including provisions
relevant to clinical trials
Guidelines on the Regulation of
Therapeutic Products in New
Zealand
›Medsafe provides comprehensive
guidelines covering the
requirements for conducting clinical
trials, including Good Clinical
Practice (GCP) standards
Approval Process for Clinical Trials
▪Ethics Approval: Researchers must submit a detailed application to an HDEC, including the study protocol, consent forms, and participant
information sheets. The HDEC reviews the application to ensure ethical standards are met
▪Regulatory Approval: For trials involving new medicines or devices, an application must be submitted to Medsafe. This includes detailed
information on the investigational product, preclinical data, and the proposed clinical trial design
▪Ongoing Monitoring and Reporting: Once a trial is approved, it is subject to ongoing monitoring. Researchers must report any adverse
events or significant changes to the trial protocol to both the HDEC and Medsafe
Illustrative

43 A Sample Report on New Zealand Clinical Trials Support Service Market Analysis I Confidential
Coverage Penetration (% Total Population) Source of Funding
Spend on Healthcare (%of Current Health Expenditure)
Reimbursement Market Trends
Public healthcare coverage is provided by the government and includes
programs like Medicare and Medicaid
Medicare is a federal program that provides healthcare coverage to individuals
who are 65 years of age or older, as well as certain younger people with
disabilities
▪Shift towards value-based care has been a significant trend in New Zealand healthcare system, with payers and providers increasingly focused on improving patient
outcomes and reducing costs
▪This has led to the development of alternative payment models such as accountable care organizations (ACOs) and bundled payment arrangements, which
incentivize providers to deliver high-quality, cost-effective care
38.9% 37.1% 35.6% 32.5% 31.5%
44.0%
46.0% 47.7%
51.0% 51.8%
2017 2018 2019 2020 2021 2022 2023
Government Expenditure
Private Health Insurance
Out of Pocket
Other
NA NA
100% 100% 100% 100% 100%
xx
xx xx
xx xx
2019 2020 2021 2022 2023
Public Healthcare
Coverage
Private Coverage
6.3% 4.08% 5.1% 3.8% 2.2% 2.4% 3.6% GDP Growth (yoy)
14.7% 11.3% 15.5% 7.5% 4.2% NA NA HC Spend Growth (yoy)
Illustrative
6.2 Reimbursement Scenario in New Zealand

44 A Sample Report on New Zealand Clinical Trials Support Service Market Analysis I Confidential
The reimbursement process in New Zealand healthcare system can be complex and can vary depending on the type of healthcare
service, the healthcare provider, and the insurance coverage. Here are the general steps involved in the reimbursement process:
▪Service or Treatment Provided: The healthcare provider performs a service or treatment for the patient
▪Billing: The healthcare provider submits a claim to the insurance company or other payer, requesting reimbursement for the
service provided
▪Adjudication: The insurance company or other payer reviews the claim to determine whether it meets the criteria for
reimbursement. This can involve verifying the patient's eligibility, reviewing the treatment provided, and checking for any potential
errors or fraud
▪Payment: If the claim is approved, the insurance company or other payer reimburses the healthcare provider for the service
provided, based on the negotiated payment rates or fee schedule
▪Patient Responsibility: Depending on the patient's insurance coverage, they may be responsible for paying a portion of the cost
of the service, such as deductibles, co-payments, or co-insurance
In order to obtain access to all of the information that you are seeking, you will need to purchase the final report
Final report will be comprehensive and detailed, and it will include data, analysis, trends, and other relevant information related to the
topic or subject matter of interest
Illustrative
6.3 Reimbursement Process

45 A Sample Report on New Zealand Clinical Trials Support Service Market Analysis I Confidential
The reimbursement process in New Zealand healthcare system can be
complex and can vary depending on the type of healthcare service, the
healthcare provider, and the insurance coverage. Here are the general
steps involved in the reimbursement process:
▪Service or Treatment Provided: The healthcare provider performs a
service or treatment for the patient
▪Billing: The healthcare provider submits a claim to the insurance
company or other payer, requesting reimbursement for the service
provided
▪Adjudication: The insurance company or other payer reviews the claim
to determine whether it meets the criteria for reimbursement. This can
involve verifying the patient's eligibility, reviewing the treatment
provided, and checking for any potential errors or fraud
▪Payment: If the claim is approved, the insurance company or other
payer reimburses the healthcare provider for the service provided,
based on the negotiated payment rates or fee schedule
MoH
Private Payers Public Payers
Health Technology Assessment
PaymentCoverageCoding
Coding depends on availability code while coverage and
payment process decisions are made through an HTA.
Market Authorization
1 32
Illustrative
6.3 Reimbursement Process (Continued)

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