Sweden Medical Device Market Sample Report 2022 to 2030
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About This Presentation
This report presents a strategic analysis of the Sweden Medical Devices 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 landscape, healthcare poli...
This report presents a strategic analysis of the Sweden Medical Devices 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 landscape, healthcare policies and regulatory framework, reimbursement scenario, challenges and future outlook. This is one of the most comprehensive reports about the Sweden Medical Devices Market, offering unmatched value, accuracy and expert insights.
Size: 3.77 MB
Language: en
Added: Sep 06, 2024
Slides: 63 pages
Slide Content
Sweden Medical Devices
Market Analysis
Sample Report
July 2024
This report presents a strategic analysis of the Sweden Medical
Devices Market Analysis 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 Sweden Medical Devices
Market Analysis, and offers unmatched value, accuracy, and expert
insights
3 A Sample Report on Sweden Medical Devices 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 SEK Kr = 0.095 USD
Research Approach Secondary Research (90%), Primary Research (10%)
Report Scope
4 A Sample Report on Sweden Medical Devices Market Analysis I Confidential
CONTENT PG. NO.
1. Market Overview 07-15
1.1 Sweden Medical Devices Market Analysis Overview
1.2 Medical Devices Market Analysis Overview: Global
1.3 Economic Overview: Sweden
1.4 Medical Devices Market Analysis Overview: Sweden
1.5 Healthcare Overview: Sweden
1.6 Budget of Sweden Government for Public Insurance
1.7 Top Developments in Sweden
2. Medical Devices Landscape 16-18
2.1 Types and Future of Medical Devices
2.2 Patient Flow
3. Market Size and Forecasting 19-24
3.1 Sweden Medical Devices Market Analysis Size and Forecasts
Table of Content
5 A Sample Report on Sweden Medical Devices Market Analysis I Confidential
CONTENT PG. NO.
3.2 Snapshot of Sweden Medical Devices Market Analysis Segmentation
3.2.1 Market Segmentation: By Product Type
3.2.2 Market Segmentation: By Application
3.2.3 Market Segmentation: By End-User
4. Market Dynamics 25-30
4.1 Market Growth Drivers
4.2 Market Restraints
5. Competitive Landscape 31-35
5.1 Key Players in Sweden Medical Device Market Analysis
6. Regulatory and Reimbursement Landscape
6.1 Regulatory Landscape in Sweden 36-41
6.2 Reimbursement Scenario in Sweden
6.3 Reimbursement Process
Table of Content
Sweden Medical Devices Market Analysis
1. Market Overview
▪Medical devices are instruments, apparatus, implements, machines, contrivances, implants, or
other similar or related articles intended for use in the diagnosis, prevention, and treatment of
diseases or conditions of human beings or animals
▪They can be used for various purposes, from monitoring a patient's health to replacing a body part
▪There is a vast range of medical devices, from simple bandages and tongue depressors to complex
pacemakers and artificial limbs
Benefits of Medical Devices:
▪Medical devices enable accurate diagnoses and minimally invasive procedures
▪Devices empower patients to manage chronic conditions and allow for remote monitoring
▪Devices restore mobility and independence through prosthetics and implants
▪Early detection via devices can reduce overall healthcare costs
▪Advanced surgical devices enhance precision, reduce tissue damage, and speed up healing
▪Improved prosthetics offer better functionality, mobility, and a natural appearance
Illustrative
1.1 Medical Devices Market Analysis Overview
8 A Sample Report on Sweden Medical Devices Market Analysis I Confidential
596.98
617.50
639.40
662.72
687.02
712.13
737.24
758.73
779.74
805.17
2014 2015 2016 2017 2018 2019 2020 2021 2022 2023
Population Aged 65 and above (Mn)
1.2 Medical Devices Market Analysis Overview: Global (1/2)
805.17 Mn
Population of people
aged 60 years and
above in 2023
18.3%
Mortality from CVD, Cancer,
and Diabetes between 30 to
70 year of age in 2019
10.35%
Of GDP for Global Current
healthcare expenditure in
2021
25
New medical devices
approved by USFDA in
2023
Illustrative
9 A Sample Report on Sweden Medical Devices Market Analysis I Confidential
Sweden Market
~$xx Bn Market
Illustrative
1.2 Medical Devices Market Analysis Overview: Global (2/2)
10 A Sample Report on Sweden Medical Devices Market Analysis I Confidential
18%
62%
20%
2014201520162017201820192020202120222023
Population of Sweden, (Bn)
2014201520162017201820192020202120222023
GDP Growth of Sweden, (%)
Population Split (2023)
0-14
15-64
65+
50.4%
49.6%
By Age GroupBy Gender
▪Sweden is an aging country, as its median age is 39.7 years
which is higher than the global median age
▪Country’s population’s global share is 0.13% and it is
increasing at a rate of 0.59%
▪Life expectancy of females is 85.2 years and for males it is
82.1 years
▪Currently 86.3 % of population is urban in Sweden
▪Top 3 largest cities of Sweden are Stockholm, Goeteborg,
Malmoe
Illustrative
1.3 Economic Overview: Sweden
Male
Female
11 A Sample Report on Sweden Medical Devices Market Analysis I Confidential
2014 2015 2016 2017 2018 2019 2020 2021 2022 2023
65+ Population in the Sweden (Mn)
1.4 Medical Devices Market Analysis Overview: Sweden (1/2)
6.8%
Prevalence of diabetes
in Sweden was 6.8%,
affecting 496,200 adults
in 2021
8.4%
Mortality from CVD, Cancer,
and Diabetes between 30 to
70 age group in 2019
2.15 Mn
Population of people aged
60 years and older in
2023
13.5%
Government expenditure
on education in 2021
Illustrative
12 A Sample Report on Sweden Medical Devices Market Analysis I Confidential
1.5 Healthcare Overview: Sweden
Public Healthcare
Overview: Sweden's universal healthcare system ensures all
residents have access to medical care, funded mainly through
taxes by county councils and municipalities
Universal Coverage: All Swedish residents receive
necessary medical care regardless of income or employment
status, highlighting the country's commitment to equitable
healthcare
Tax-Funded Model: Healthcare system is funded through
taxes collected by county councils and municipalities,
ensuring a stable flow of resources for high-quality care
Decentralized Administration: Healthcare administration is
decentralized across 21 regional councils, allowing tailored
services that meet the specific needs of different regions
Patient Fees: Patients pay small fees for certain services like
doctor visits and prescriptions, with caps and exemptions for
low-income residents to maintain affordability
Private Healthcare
Overview: Private healthcare is relatively uncommon due to
the strength of the public healthcare system. Only about 10%
of the population opts for private health insurance
Limited Use: With the robust public system, private
healthcare usage is low, with only a small portion of the
population choosing private insurance for their medical needs
Reasons for Choosing Private Healthcare: People seek
private healthcare primarily for faster access to specialists
and elective procedures, as well as for more comfort and
privacy during their treatment
Types of Private Care: Private healthcare in Sweden is
divided into contracted providers, who work under
agreements with the public system and offer subsidized care,
and fully private providers, who operate independently and
charge the full cost of treatment
Illustrative
13 A Sample Report on Sweden Medical Devices 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 Sweden Government for Public Insurance
14 A Sample Report on Sweden Medical Devices Market Analysis I Confidential
Company Name Type Year Key Pointers
Acquisition
October
2023
▪Thermo Fisher's subsidiary acquired Olink Holding for $3.1 Bn in October
2023
▪Deal combines Thermo Fisher's mass spectrometry with Olink's
proteomics expertise
▪This aims to accelerate proteomics solutions, broaden Olink's reach, and
improve workflow integration
▪Olink announced receipt of cma clearance for the proposed acquisition by
thermo fisher on July 8
th
2024
Acquisition September
2023
▪Repligen Corporation, a bioprocessing technology leader, acquired
Metenova AB, a magnetic mixing technology innovator, for $170 Mn USD
▪Acquisition was announced on September 26, 2023, it enhances
Repligen's Fluid Management portfolio by integrating Metenova's
solutions with their existing products
▪Expected benefits include a projected revenue increase of $5Mn in Q4
2023 and $25-27Mn in 2024, improved margins, and a stronger presence
in the single-use mixing market
Latest Deals in Sweden
Illustrative
1.7 Top Developments in Sweden
Sweden Medical Devices Market Analysis
2. Medical Devices Landscape
16 A Sample Report on Sweden Medical Devices Market Analysis I Confidential
Illustrative
2.1 Types and Future of Medical Devices
Types of Medical Devices
▪Class I (Low-Risk): Simple devices with minimal risk,
like tongue depressors, thermometers, bandages, Non-
electric heating pads, Manual stethoscopes
▪Class II (Moderate-Risk): Devices with a moderate risk
profile, like contact lenses, blood glucose monitors,
catheters, powered wheelchairs, and dental filling
▪Class III (High-Risk): Complex devices with a high risk
to the patient, like pacemakers, artificial heart valves,
breast implant and implantable defibrillators
▪In Vitro Diagnostic Devices (IVDs): Devices used for
analyzing samples outside the body for diagnosis, like
pregnancy tests, blood tests, and tissue analysis
equipment
Future of Medical Devices
▪Personalized Medicine: AI-driven devices create
personalized treatment plans based on genetic profiles,
improving outcomes and reducing side effects
▪Implantable Devices: Devices like glucose monitors and
pacemakers treat chronic conditions in real-time and may
adjust medications automatically
▪Smart Medical Devices: Wearable devices like
smartwatches enable remote monitoring and timely
interventions, with data analysed in the cloud
▪Non-invasive Surgery: Robotic-assisted systems like
the da Vinci Surgical System perform minimally invasive
procedures with greater precision
▪Biocompatible Materials: Materials that integrate
seamlessly with the body minimize rejection and
complications
17 A Sample Report on Sweden Medical Devices Market Analysis I Confidential
Illustrative
2.2 Patient Flow
Pre-Treatment Phase
1.Consultation: The patient visits a doctor or specialist for an
initial consultation. During this visit, the doctor will discuss the
patient's condition, medical history, and suitability for the
medical device treatment
2.Diagnosis & Tests: Depending on the specific device and
condition, the doctor may order additional tests (X-rays, blood
tests) to confirm the diagnosis and ensure the device is
appropriate
3.Insurance Pre-authorization: For some procedures, the
patient may need to obtain pre-authorization from their
insurance company to ensure coverage for the device and
treatment
4.Informed Consent: The doctor will explain the treatment
process, potential risks and benefits of the device, and
alternative treatment options. The patient will then be asked to
sign an informed consent form if they agree to proceed
Treatment Phase
5.Device Implantation/Placement: This involves the actual
surgical or non-surgical procedure to implant or place the
medical device in the patient's body. The specific details will vary
depending on the device and its purpose
6.Recovery and Monitoring: Following the procedure, the patient
will be monitored in a recovery area or hospital room for a certain
period. This allows medical staff to assess any immediate
reactions or complications
7.Discharge and Follow-up: Once the patient is stable and
recovering well, they will be discharged with instructions on
wound care, medication (if needed), and rehabilitation exercises
(if applicable). Follow-up appointments will be scheduled to
monitor progress and adjust the treatment plan as necessary
Treatment Phase
Sweden Medical Devices Market Analysis
3. Market Size and Forecasting
19 A Sample Report on Sweden Medical Devices Market Analysis I Confidential
2023 2024F 2025F 2026F 2027F 2028F 2029F 2030F
Sweden Medical Devices Market Analysis 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
Sweden 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
Sweden Market Size ($Bn) 61 74 84 87 91 95 99 106
Illustrative
3.1 Sweden Medical Devices Market Analysis Size and Forecasts
20 A Sample Report on Sweden Medical Devices Market Analysis I Confidential
▪In this section you will get an understanding of the segmentations which will cover the Sweden Medical Devices Market Analysis
▪In order to obtain access to all of the information that you are seeking, you will need to purchase the final report
Product Type
Diagnostics Imaging
Therapeutics
Monitoring Devices
Assistive Technologies
Application
Cardiology
Oncology
Neurology
Ophthalmology
Orthopedics
End-User
Hospitals
Ambulatory Surgical Centers
Clinics
Home Healthcare
Illustrative
3.2 Snapshot of Sweden Medical Devices Market Analysis Segmentation
21 A Sample Report on Sweden Medical Devices 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
Sweden Medical Devices Market Analysis Share, By Product Type
(2023)
Diagnostics
Imaging
Therapeutics
Monitoring
Devices
Assistive
Technologies
Illustrative
3.2.1 Market Segmentation: By Product Type
22 A Sample Report on Sweden Medical Devices 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
Sweden Medical Devices Market Analysis Share, By Application
(2023)
Illustrative
3.2.2 Market Segmentation: By Application
Orthopedics
Ophthalmology
Neurology
Oncology
Cardiology
23 A Sample Report on Sweden Medical Devices 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
Sweden Medical Devices Market Analysis Share, By End-User
(2023)
Home
Healthcare
Clinics
Ambulatory
Surgical
Centers
Hospitals
Illustrative
3.2.3 Market Segmentation: By End-User
Sweden Medical Devices Market Analysis
4. Market Dynamics
25 A Sample Report on Sweden Medical Devices Market Analysis I Confidential
Illustrative
4.1.1
In Sweden over
20% of people aged
65 or older in 2023
from 8% in 2010
4.1.2
All Swedish
residents receive
necessary medical
care regardless of
income or
employment status
4.1.3
Sweden has a strong
focus on medical
technology research
and development
4.2.1
Swedish medical
device market is
highly competitive, led
by the Netherlands
Germany, and US
4.2.2
Regulatory
Challenges
4. Snapshot Of Market Growth Drivers And Restraints
26 A Sample Report on Sweden Medical Devices 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 Demographic shift in Sweden, where the proportion of people aged 65 or older surged from 8% in 2010 to
exceed 20% by 2023, serves as a significant market driver for medical devices
Aging Population
2010 2023 2030
27 A Sample Report on Sweden Medical Devices 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 2022 2030
Illustrative
4.1 Market Growth Drivers
4.1.2 In Sweden, universal government-funded healthcare ensures equal access to medical services, minimizing
unmet healthcare needs, which supports a increase market demand for medical devices
Increase In Demand
28 A Sample Report on Sweden Medical Devices 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 Consumer demand for advanced medical devices, integration of digital health technologies, sustainability
trends, a supportive healthcare system, and robust macroeconomic factors collectively drive growth and innovation
in Sweden's medical technology market
Technology Advancement
Advance Medical Devices Digital Health
Robust Macroeconomics Sustainability and supportive
29 A Sample Report on Sweden Medical Devices Market Analysis I Confidential
4.2.1 Foreign competition from the Netherlands,
Germany, and the US challenges Swedish medical device
firms, impacting market growth and imposing pricing and
regulatory pressures
▪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
4.2.2 Regulatory challenges makes a delay in getting
approval within the country
▪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
Our analysis will thoroughly investigate the key restraints that may significantly impact business
operations and growth.
Illustrative
4.2 Market Growth Restraints
Sweden Medical Devices Market Analysis
5. Competitive Landscape
31 A Sample Report on Sweden Medical Devices 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
Siemens Healthineers1 Getinge 6
Stryker 2 Sectra 7
Johnson & Johnson3 Arjo 8
Medtronic 4 DiaLab9
F. Hoffman-La Roche5 Molndal10
Illustrative
Global Player Local Player
5.1 Key Players in Sweden Medical Devices Market Analysis
32 A Sample Report onSweden Medical Devices Market Analysis I Confidential
Founded In: 1847
HQ: Erlangen, Germany
Type: Private
Revenue: $19.44 Bn (Global)
Website: siemens
▪Siemens Healthineers is a leading medical technology company
that provides innovative technologies and services in diagnostic
and therapeutic imaging, laboratory diagnostics and molecular
medicine, as well as digital health and enterprise services
▪It has a global presence, with operations in over 150 countries,
employs over 50,000 people, and has a research and
development network with over 100 sites worldwide
▪Siemens Healthineers Sweden is a leading provider of
healthcare technology in Sweden
Offerings
➢Medical Imaging
➢Laboratory Diagnostics
➢Point-of-Care Testing
➢Digital Health
Recent Activity / Press Coverage
▪September 28, 2023 — Siemens Healthineers presents mammography system with groundbreaking new imaging technology
▪Mammomat B.brilliant delivers high-quality 3D images in just five seconds, a Unique combination of speed with high depth resolution and area resolution
▪Fast acquisition time makes scanning more comfortable for patients
▪August 25, 2023 — Siemens Healthineers has unveiled Acuson Origin, a new cardiovascular ultrasound system with robust artificial intelligence (AI)
capabilities that allow it to identify the anatomy being imaged and anticipate the next steps needed to advance patient care
▪New system includes AI algorithms to automate approximately 500 different measurements
▪March 03, 2023 — Siemens Healthineers has announced the evolution of the Acuson Sequoia Flagship series at this year’s European Congress of
Radiology (ECR) in Vienna
▪Ultrasound Derived Fat Fraction (UDFF) features are expanded to offer innovative technology on three abdominal transducers, the 5C1, 9C2 and DAX,
to aid clinicians in the early detection of NAFLD for nearly any patient body habitus
5.1.1 Siemens Healthineers (Continued)
33 A Sample Report onSweden Medical Devices Market Analysis I Confidential
Company Name Type Year Key Pointers
Partnership June, 2024
▪Siemens Healthineers and the World Stroke Organization (WSO)
announced a two-year partnership to develop the acute stroke workforce
and improve treatment and care for stroke
▪Stroke kills over 6.5 Mn people every year and leaves Mn more with
disabilities and a diminished quality of life
▪By providing healthcare professionals with valuable skills to make timely
and informed diagnoses, and equipping healthcare systems with the
latest imaging and therapy technologies
Acquisition April, 2021
▪Siemens Healthineers completes acquisition of Varian, strengthening its
position as a holistic partner in healthcare
▪Transformative combination accelerates the company’s impact on global
healthcare and establishes a strong partner for customers and patients
along the entire cancer care continuum and for many of the most
threatening diseases
▪Varian becomes a new business segment within Siemens Healthineers;
important step in the implementation of its Strategy 2025
Latest Deals in Siemens Healthineers
Illustrative
5.1.1 Siemens Healthineers (Continued)
34 A Sample Report onSweden Medical Devices 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 Siemens Healthineers (Continued)
35 A Sample Report on Sweden Medical Devices Market Analysis I Confidential
5.1.2 Company 2
Founded in:
HQ:
Type:
Revenue:
Website:
Solutions offered by Company
Drugs Indications
Drugs for Telemedicine Recent Activity / Press Coverage
36 A Sample Report on Sweden Medical Devices Market Analysis I Confidential
5.1.2 Company 2 (Continued)
Major Distribution Partners Major Vendor Partners
Partnerships Ecosystem
Sweden Medical Devices Market Analysis
6. Regulatory and Reimbursement Landscape
38 A Sample Report on Sweden Medical Devices Market Analysis I Confidential
European Union (EU) Regulations
▪MDR (Medical Devices Regulation): Implemented in 2017, the
MDR establishes a robust framework for ensuring the safety,
quality, and performance of medical devices across the EU. It
mandates stricter conformity assessments, post-market
surveillance, and risk management processes
▪IVDR (In Vitro Diagnostic Medical Devices Regulation):
Similar to the MDR, the IVDR (implemented in 2017) sets out
requirements for in vitro diagnostic medical devices used to
diagnose or monitor medical conditions
▪Notified Bodies: These are independent organizations
designated by the EU to assess a device's compliance with the
MDR and IVDR. Manufacturers need a Notified Body certificate to
place their device on the EU market
Illustrative
Regulatory Authorities With Jurisdiction Over Drugs, Biologicals, And Medical Devices In Sweden
6.1 Regulatory Landscape in Sweden
Swedish Medical Products Agency
▪Responsible for implementing and enforcing the EU MDR and
IVDR in Sweden, they also manage national regulations for
medical devices, such as:
▪Classification: The agency classifies medical devices based on
their risk (Class I: lowest, Class III: highest) determining the
conformity assessment route
▪Clinical Trials: They oversee clinical trials for medical devices
conducted in Sweden
▪Vigilance: The agency manages the reporting and follow-up of
adverse events associated with medical devices
▪Benefits: Manufacturers who successfully navigate the EU
regulations and obtain Swedish approval gain access to the entire
European market with a population of over 500 Mn
39 A Sample Report on Sweden Medical Devices Market Analysis I Confidential
Key Legislation
Key legislations for the drug industry in Sweden are the Swedish Healthcare Act (1982:763), Act on the Dental and Pharmaceutical Benefits
Agency (TLV) (2009:726), Medicinal Products Act (2015:315), Regulations Implementing EU MDR and IVDR (2017), and TLV Regulations and
Guidelines
Authorization
▪Swedish Healthcare Act (1982:763): Establishes universal access to healthcare, regardless of income or employment status, Emphasizes
cost-effectiveness within the healthcare system
▪Act on the Dental and Pharmaceutical Benefits Agency (TLV) (2009:726): Creates the TLV to decide on reimbursement of
pharmaceuticals and medical devices, TLV evaluates therapeutic benefit, and cost-effectiveness, and sets reimbursement levels
▪Medicinal Products Act (2015:315): Focuses on safety and quality for pharmaceuticals and some medical devices and indirectly influences
device reimbursement by ensuring safety and effectiveness
▪Regulations Implementing EU MDR and IVDR (2017): Adopts EU standards for medical devices and in vitro diagnostics, Ensures devices
meet safety and quality requirements essential for reimbursement consideration by the TLV
▪TLV Regulations and Guidelines: TLV publishes its regulations and guidelines detailing the specific criteria, processes, and documentation
manufacturers need to submit for reimbursement consideration
Illustrative
Regulatory Framework For The Authorization, Pricing, And Reimbursement Of Drugs
6.2 Reimbursement Scenario in Sweden
40 A Sample Report on Sweden Medical Devices 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 Sweden 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 Sweden (Continued)
41 A Sample Report on Sweden Medical Devices Market Analysis I Confidential
The reimbursement process in Sweden 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
42 A Sample Report on Sweden Medical Devices Market Analysis I Confidential
The reimbursement process in Sweden 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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