Medical Device Testing Market
Medical Device Testing Market Forecasts to 2030 - Global Analysis By Product (Active Implant Medical Devices, Non-active Medical Devices, In Vitro Diagnostic (IVD) Medical Devices, Ophthalmic Medical Devices, Orthopedic Medical Devices, Vascular Medical Devices and Other Products), By Service Type (Testing Services, Inspection Services, Certification Services and Other Service Types), By Sourcing Type (In-house and Outsourced), By Device Class, By End User and By Geography
|
Years Covered |
2021-2030 |
|
Estimated Year Value (2023) |
US $10.9 BN |
|
Projected Year Value (2030) |
US $17.3 BN |
|
CAGR (2023 - 2030) |
6.9% |
|
Regions Covered |
North America, Europe, Asia Pacific, South America, and Middle East & Africa |
|
Countries Covered |
US, Canada, Mexico, Germany, UK, Italy, France, Spain, Japan, China, India, Australia, New Zealand, South Korea, Rest of Asia Pacific, South America, Argentina, Brazil, Chile, Middle East & Africa, Saudi Arabia, UAE, Qatar, and South Africa |
|
Largest Market |
North America |
|
Highest Growing Market |
Asia Pacific |
According to Stratistics MRC, the Global Medical Device Testing Market is accounted for $10.9 billion in 2023 and is expected to reach $17.3 billion by 2030 growing at a CAGR of 6.9% during the forecast period. Medical device testing refers to the rigorous evaluation and assessment of medical devices to ensure their safety, efficacy and compliance with regulatory standards. It involves a series of tests, inspections and trials conducted during product development and manufacturing, as well as post-market surveillance. Medical device testing is essential to verify that devices meet quality standards, perform as intended and pose minimal risk to patients.
According to the Center for Medicare & Medicaid Services, the United States healthcare spending grew by 4.6% in 2018, reaching USD 3.6 trillion or USD 11,172 per person.
Market Dynamics:
Driver:
Growing aging population
As the global demographic landscape skews older, there is a parallel increase in healthcare needs. Elderly individuals often require a wide range of medical devices, from orthopedic implants to cardiac devices and mobility aids. To ensure the safety and efficacy of these devices, rigorous testing is essential. Moreover, older patients may be more vulnerable to potential device-related complications, making thorough testing even more critical. The rising demand for medical devices tailored to this demographic underscores the importance of robust testing processes to meet the unique healthcare challenges posed by an aging population.
Restraint:
Increasing complexity of medical devices
As medical technology advances, devices are becoming more intricate, incorporating cutting-edge materials, electronics, and software. Testing these sophisticated devices demands specialized expertise, sophisticated equipment, and advanced methodologies, which can substantially drive up testing costs and duration. Furthermore, the intricacy of these devices poses challenges in ensuring their safety and efficacy, making it critical to develop and apply equally complex testing procedures. This complexity adds to the regulatory burden and can hinder innovation and market entry, impacting the overall efficiency and competitiveness of the medical device testing process.
Opportunity:
Rising healthcare expenditure
Increased healthcare budgets result in higher investments in medical device research, development, and manufacturing. This, in turn, fuels the demand for comprehensive testing services to ensure that these devices meet stringent quality and safety standards. As healthcare systems allocate more resources to technological advancements and device innovation, the need for rigorous testing to verify the functionality and safety of these devices becomes paramount. This growing financial commitment to healthcare infrastructure and medical technology offers a promising landscape for companies specializing in medical device testing, creating opportunities for expansion and innovation in the market.
Threat:
Limited access to skilled personnel
The industry demands a highly specialized workforce with expertise in various scientific and technical disciplines, including clinical research, quality assurance, data analysis, and regulatory affairs. The shortage of qualified professionals can hinder the efficient and accurate execution of tests and trials, potentially leading to delays in product development and market entry. Furthermore, it can result in increased operational costs and quality control challenges, ultimately affecting the competitiveness and credibility of medical device testing companies.
Covid-19 Impact:
The COVID-19 pandemic has had a positive impact on the medical device testing market. With a heightened focus on healthcare and the urgent need for diagnostic and therapeutic devices, the demand for efficient and reliable testing solutions surged. Medical device testing played a crucial role in ensuring the safety and effectiveness of products like ventilators, diagnostic kits, and PPE. Additionally, the pandemic accelerated the development and regulatory approval of new medical devices, leading to increased demand for testing services. This unforeseen global health crisis underscored the importance of rigorous testing and quality assurance, resulting in a growing market for medical device testing.
The active implant medical devices segment is expected to be the largest during the forecast period
The active implant medical devices segment is expected to have lucrative growth. These devices, such as cardiac pacemakers, neurostimulators, and implantable defibrillators, require meticulous testing to validate their safety, functionality, and compatibility with the human body. Testing encompasses assessments of electronic systems, battery performance, biocompatibility, and electromagnetic compatibility. Ensuring the reliability and long-term safety of these implantable devices is paramount as they directly affect patient well-being.
The consumers and patients segment is expected to have the highest CAGR during the forecast period
The consumers and patients segment is anticipated to witness the fastest CAGR growth during the forecast period. With the growing focus on patient safety, consumers, and patients are becoming more informed and discerning about the medical devices they use. This increased awareness is driving demand for stringent testing to ensure the safety and efficacy of devices. Additionally, the rise in direct-to-consumer medical devices and home healthcare equipment further emphasizes the need for robust testing to build trust among end-users. As the empowered healthcare consumer trend continues to gain momentum, the Consumers and Patients segment is poised for substantial growth.
Region with largest share:
North America holds a significant share in the market over the forecast period. The region boasts a well-established healthcare industry, advanced research infrastructure, and stringent regulatory frameworks. North American countries, particularly the United States, host a plethora of medical device manufacturers and research organizations, fueling the demand for testing services to ensure product compliance with regulatory standards. The market benefits from a robust ecosystem of accredited testing laboratories, clinical trial facilities, and regulatory experts, making it an attractive destination for both domestic and international medical device companies seeking rigorous and reliable testing, certification, and validation services.
Region with highest CAGR:
Asia Pacific is projected to have the highest CAGR over the forecast period. The region's expanding healthcare sector, increasing investments in research and development, and growing demand for medical devices have fuelled the need for comprehensive testing services. With the rising awareness of healthcare quality and safety, Asia Pacific countries are enhancing their regulatory and quality standards, driving the demand for testing to ensure product compliance and safety. Additionally, the availability of a skilled workforce, cost-effective clinical trials, and a diverse patient population make Asia Pacific an attractive destination for medical device manufacturers looking to conduct clinical studies and tests.
Key players in the market
Some of the key players in Medical Device Testing market include Avomeen, BSI Group, Bureau Veritas, Dekra Testing and Certification GmbH, Element Materials Technology, Eurofins Scientific, Gateway Analytical LLC, Intertek Group PLC, Medistri SA, Pace Analytical Services LLC, SGS SA, TUV Rheinland and WuXi AppTec.
Key Developments:
In June 2023, TÜV SÜD has opened a laboratory in New Brighton, Minnesota, accredited to ISO 17025 for biological and chemical testing of medical devices. Staffed by experienced scientists and technicians, the lab will cater to both domestic and international medical device companies, aiding in research and development through microbiology, reusable device testing, chemistry, biocompatibility, and packaging testing services.
In September 2022, Bureau Veritas has acquired Galbraith Laboratories Inc., known for advanced analytical solutions in healthcare. This acquisition amplifies Bureau Veritas' presence in Consumer Healthcare and Industrial Chemicals supply chains, bolstering support for research, development, and product testing. Galbraith Laboratories' expertise will enhance Bureau Veritas' service portfolio, particularly in medical device testing, expanding its reach and influence in the US.
Products Covered:
• Active Implant Medical Devices
• Non-active Medical Devices
• In Vitro Diagnostic (IVD) Medical Devices
• Ophthalmic Medical Devices
• Orthopedic Medical Devices
• Vascular Medical Devices
• Other Products
Service Types Covered:
• Testing Services
• Inspection Services
• Certification Services
• Other Service Types
Sourcing Types Covered:
• In-house
• Outsourced
Device Classes Covered:
• Class I
• Class II
• Class III
• Other Device Classes
End Users Covered:
• Academic and Research Institutions
• Consumers and Patients
• Healthcare Professionals
• Other End Users
Regions Covered:
• North America
o US
o Canada
o Mexico
• Europe
o Germany
o UK
o Italy
o France
o Spain
o Rest of Europe
• Asia Pacific
o Japan
o China
o India
o Australia
o New Zealand
o South Korea
o Rest of Asia Pacific
• South America
o Argentina
o Brazil
o Chile
o Rest of South America
• Middle East & Africa
o Saudi Arabia
o UAE
o Qatar
o South Africa
o Rest of Middle East & Africa
What our report offers:
- Market share assessments for the regional and country-level segments
- Strategic recommendations for the new entrants
- Covers Market data for the years 2021, 2022, 2023, 2026, and 2030
- Market Trends (Drivers, Constraints, Opportunities, Threats, Challenges, Investment Opportunities, and recommendations)
- Strategic recommendations in key business segments based on the market estimations
- Competitive landscaping mapping the key common trends
- Company profiling with detailed strategies, financials, and recent developments
- Supply chain trends mapping the latest technological advancements
Free Customization Offerings:
All the customers of this report will be entitled to receive one of the following free customization options:
• Company Profiling
o Comprehensive profiling of additional market players (up to 3)
o SWOT Analysis of key players (up to 3)
• Regional Segmentation
o Market estimations, Forecasts and CAGR of any prominent country as per the client's interest (Note: Depends on feasibility check)
• Competitive Benchmarking
Benchmarking of key players based on product portfolio, geographical presence, and strategic alliances
Table of Contents
1 Executive Summary
2 Preface
2.1 Abstract
2.2 Stake Holders
2.3 Research Scope
2.4 Research Methodology
2.4.1 Data Mining
2.4.2 Data Analysis
2.4.3 Data Validation
2.4.4 Research Approach
2.5 Research Sources
2.5.1 Primary Research Sources
2.5.2 Secondary Research Sources
2.5.3 Assumptions
3 Market Trend Analysis
3.1 Introduction
3.2 Drivers
3.3 Restraints
3.4 Opportunities
3.5 Threats
3.6 Product Analysis
3.7 End User Analysis
3.8 Emerging Markets
3.9 Impact of Covid-19
4 Porters Five Force Analysis
4.1 Bargaining power of suppliers
4.2 Bargaining power of buyers
4.3 Threat of substitutes
4.4 Threat of new entrants
4.5 Competitive rivalry
5 Global Medical Device Testing Market, By Product
5.1 Introduction
5.2 Active Implant Medical Devices
5.3 Non-active Medical Devices
5.4 In Vitro Diagnostic (IVD) Medical Devices
5.5 Ophthalmic Medical Devices
5.6 Orthopedic Medical Devices
5.7 Vascular Medical Devices
5.8 Other Products
6 Global Medical Device Testing Market, By Service Type
6.1 Introduction
6.2 Testing Services
6.3 Inspection Services
6.4 Certification Services
6.5 Other Service Types
7 Global Medical Device Testing Market, By Sourcing Type
7.1 Introduction
7.2 In-house
7.3 Outsourced
8 Global Medical Device Testing Market, By Device Class
8.1 Introduction
8.2 Class I
8.3 Class II
8.4 Class III
8.5 Other Device Classes
9 Global Medical Device Testing Market, By End User
9.1 Introduction
9.2 Academic and Research Institutions
9.3 Consumers and Patients
9.4 Healthcare Professionals
9.5 Other End Users
10 Global Medical Device Testing Market, By Geography
10.1 Introduction
10.2 North America
10.2.1 US
10.2.2 Canada
10.2.3 Mexico
10.3 Europe
10.3.1 Germany
10.3.2 UK
10.3.3 Italy
10.3.4 France
10.3.5 Spain
10.3.6 Rest of Europe
10.4 Asia Pacific
10.4.1 Japan
10.4.2 China
10.4.3 India
10.4.4 Australia
10.4.5 New Zealand
10.4.6 South Korea
10.4.7 Rest of Asia Pacific
10.5 South America
10.5.1 Argentina
10.5.2 Brazil
10.5.3 Chile
10.5.4 Rest of South America
10.6 Middle East & Africa
10.6.1 Saudi Arabia
10.6.2 UAE
10.6.3 Qatar
10.6.4 South Africa
10.6.5 Rest of Middle East & Africa
11 Key Developments
11.1 Agreements, Partnerships, Collaborations and Joint Ventures
11.2 Acquisitions & Mergers
11.3 New Product Launch
11.4 Expansions
11.5 Other Key Strategies
12 Company Profiling
12.1 Avomeen
12.2 BSI Group
12.3 Bureau Veritas
12.4 Dekra Testing and Certification GmbH
12.5 Element Materials Technology
12.6 Eurofins Scientific
12.7 Gateway Analytical LLC
12.8 Intertek Group PLC
12.9 Medistri SA
12.10 Pace Analytical Services LLC
12.11 SGS SA
12.12 TUV Rheinland
12.13 WuXi AppTec
List of Tables
1 Global Medical Device Testing Market Outlook, By Region (2021-2030) ($MN)
2 Global Medical Device Testing Market Outlook, By Product (2021-2030) ($MN)
3 Global Medical Device Testing Market Outlook, By Active Implant Medical Devices (2021-2030) ($MN)
4 Global Medical Device Testing Market Outlook, By Non-active Medical Devices (2021-2030) ($MN)
5 Global Medical Device Testing Market Outlook, By In Vitro Diagnostic (IVD) Medical Devices (2021-2030) ($MN)
6 Global Medical Device Testing Market Outlook, By Ophthalmic Medical Devices (2021-2030) ($MN)
7 Global Medical Device Testing Market Outlook, By Orthopedic Medical Devices (2021-2030) ($MN)
8 Global Medical Device Testing Market Outlook, By Vascular Medical Devices (2021-2030) ($MN)
9 Global Medical Device Testing Market Outlook, By Other Products (2021-2030) ($MN)
10 Global Medical Device Testing Market Outlook, By Service Type (2021-2030) ($MN)
11 Global Medical Device Testing Market Outlook, By Testing Services (2021-2030) ($MN)
12 Global Medical Device Testing Market Outlook, By Inspection Services (2021-2030) ($MN)
13 Global Medical Device Testing Market Outlook, By Certification Services (2021-2030) ($MN)
14 Global Medical Device Testing Market Outlook, By Other Service Types (2021-2030) ($MN)
15 Global Medical Device Testing Market Outlook, By Sourcing Type (2021-2030) ($MN)
16 Global Medical Device Testing Market Outlook, By In-house (2021-2030) ($MN)
17 Global Medical Device Testing Market Outlook, By Outsourced (2021-2030) ($MN)
18 Global Medical Device Testing Market Outlook, By Device Class (2021-2030) ($MN)
19 Global Medical Device Testing Market Outlook, By Class I (2021-2030) ($MN)
20 Global Medical Device Testing Market Outlook, By Class II (2021-2030) ($MN)
21 Global Medical Device Testing Market Outlook, By Class III (2021-2030) ($MN)
22 Global Medical Device Testing Market Outlook, By Other Device Classes (2021-2030) ($MN)
23 Global Medical Device Testing Market Outlook, By End User (2021-2030) ($MN)
24 Global Medical Device Testing Market Outlook, By Academic and Research Institutions (2021-2030) ($MN)
25 Global Medical Device Testing Market Outlook, By Consumers and Patients (2021-2030) ($MN)
26 Global Medical Device Testing Market Outlook, By Healthcare Professionals (2021-2030) ($MN)
27 Global Medical Device Testing Market Outlook, By Other End Users (2021-2030) ($MN)
Note: Tables for North America, Europe, APAC, South America, and Middle East & Africa Regions are also represented in the same manner as above.
List of Figures
RESEARCH METHODOLOGY
We at ‘Stratistics’ opt for an extensive research approach which involves data mining, data validation, and data analysis. The various research sources include in-house repository, secondary research, competitor’s sources, social media research, client internal data, and primary research.
Our team of analysts prefers the most reliable and authenticated data sources in order to perform the comprehensive literature search. With access to most of the authenticated data bases our team highly considers the best mix of information through various sources to obtain extensive and accurate analysis.
Each report takes an average time of a month and a team of 4 industry analysts. The time may vary depending on the scope and data availability of the desired market report. The various parameters used in the market assessment are standardized in order to enhance the data accuracy.
Data Mining
The data is collected from several authenticated, reliable, paid and unpaid sources and is filtered depending on the scope & objective of the research. Our reports repository acts as an added advantage in this procedure. Data gathering from the raw material suppliers, distributors and the manufacturers is performed on a regular basis, this helps in the comprehensive understanding of the products value chain. Apart from the above mentioned sources the data is also collected from the industry consultants to ensure the objective of the study is in the right direction.
Market trends such as technological advancements, regulatory affairs, market dynamics (Drivers, Restraints, Opportunities and Challenges) are obtained from scientific journals, market related national & international associations and organizations.
Data Analysis
From the data that is collected depending on the scope & objective of the research the data is subjected for the analysis. The critical steps that we follow for the data analysis include:
- Product Lifecycle Analysis
- Competitor analysis
- Risk analysis
- Porters Analysis
- PESTEL Analysis
- SWOT Analysis
The data engineering is performed by the core industry experts considering both the Marketing Mix Modeling and the Demand Forecasting. The marketing mix modeling makes use of multiple-regression techniques to predict the optimal mix of marketing variables. Regression factor is based on a number of variables and how they relate to an outcome such as sales or profits.
Data Validation
The data validation is performed by the exhaustive primary research from the expert interviews. This includes telephonic interviews, focus groups, face to face interviews, and questionnaires to validate our research from all aspects. The industry experts we approach come from the leading firms, involved in the supply chain ranging from the suppliers, distributors to the manufacturers and consumers so as to ensure an unbiased analysis.
We are in touch with more than 15,000 industry experts with the right mix of consultants, CEO's, presidents, vice presidents, managers, experts from both supply side and demand side, executives and so on.
The data validation involves the primary research from the industry experts belonging to:
- Leading Companies
- Suppliers & Distributors
- Manufacturers
- Consumers
- Industry/Strategic Consultants
Apart from the data validation the primary research also helps in performing the fill gap research, i.e. providing solutions for the unmet needs of the research which helps in enhancing the reports quality.
For more details about research methodology, kindly write to us at info@strategymrc.com
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