Global Medical Device Testing Market Segmentation, By Service Type (Testing Services, Inspection Service and Certification Services), Testing Type (Physical Testing, Chemical/Biological Testing, Cybersecurity Testing, Microbiology and Sterility Testing and Others), Phase (Preclinical and Clinical), Sourcing Type (In-House and Outsourced), Device Class (Class I, Class II and Class III), Product (Active Implant Medical Device, Active Medical Device, Non-Active Medical Device, In-vitro Diagnostics Medical Device, Ophthalmic Medical Device, Orthopedic and Dental Medical Device, Vascular Medical Device and Others) Industry Trends and Forecast to 2031
Medical Device Testing Market Insights
Medical device testing is the process of demonstrating that the device is reliably and safely perform in use. In new product development, extensive design validation testing is applied. This includes performance testing, toxicity and chemical analysis, and sometimes human factors or even clinical testing. Ongoing quality assurance testing is generally more limited. This usually include dimensional checks, some functional tests, and packaging verification. Various types of medical testing services are available there in the market such as inspection services, certification services among others.
Medical Device Testing Market Size
Global medical device testing market size was valued at USD 4.70 billion in 2023 and is projected to reach USD 10.68 billion by 2031, with a CAGR of 10.8% during the forecast period of 2024 to 2031.
Report Scope and Market Segmentation
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Attributes
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Medical Device Testing Key Market Insights
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Segmentation
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Countries Covered
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U.S., Canada, Mexico, Germany, France, U.K., Italy, Spain, Netherlands, Russia, Switzerland, Turkey, Belgium, Rest of Europe, China, Japan, India, South Korea, Australia, Singapore, Thailand, Malaysia, Indonesia, Philippines, Rest of Asia-Pacific, Brazil, Argentina,, Rest of South America, South Africa, Saudi Arabia, U.A.E, Egypt, Israel, Rest of Middle East and Africa
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Key Market Players
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Intertek Group plc, SGS SA, Bureau Veritas, TUV SUD, TUV Rheinland, Pace, Charles River Laboratories, Biomedical Device Labs, UL LLC, North American Science Associates, LLC, Medistri SA, WuXi AppTec, NSF, Labcorp, Eurofins Scientific, Nelson Laboratories, LLC- A Sotera Health company, Gateway Analytical, ITC ZLIN, Element Materials Technology, EndoLab Mechanical Engineering GmbH, Hohenstein, Medical Engineering Technologies Ltd., Bioneeds, Cigniti, Arbro Pharmaceuticals Private Limited & Auriga Research Private Limited, Q Laboratories, IMR Test Labs and among others.
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Medical Device Testing Market Definition
Medical device testing is the process of demonstrating that the device is reliably and safely perform in use. In new product development, extensive design validation testing is applied. This includes performance testing, toxicity and chemical analysis, and sometimes human factors or even clinical testing. Ongoing quality assurance testing is generally more limited. This usually include dimensional checks, some functional tests, and packaging verification. Various types of medical testing services are available there in the market such as inspection services, certification services and among others.
Medical Device Testing Market Dynamics
Drivers
- Rise Need for the Verification and Validation Of Medical Devices
The verification and validation methods are widespread and extensively used in the healthcare industry. In general, verification is the developmental phase of a product if it complies with the specified requirements, whereas validation checks if the intended use has been met and thus, usability specifics are fulfilled. The most common types of verification and validation for medical devices are design, process, and software verification and validation. Medical devices are also becoming smaller and more complex in design, sometimes using advanced, engineered plastics. This makes validation and verification (V&V) all the more important. The result is better repeatability, fewer mistakes, less rework and redesign, faster market-time, improved competitiveness, and lower production costs.
- Increase in the Demand of In-Vitro Tests
In vitro diagnostics (IVD) are tests on samples such as blood or tissue taken from the human body. '-vitro diagnostics can detect diseases or other conditions, and can be used to monitor a person's overall health to help cure, treat, or prevent diseases. In-vitro tests are used in various disease detections such as HIV infections, malaria, and hepatitis, among others. The prevalence of such diseases is rapidly increasing globally, leading to the increasing demand for in-vitro tests and various medical devices.
- Escalation in Innovation & Technologies
Acceleration in technology development in the healthcare sector has tremendously increased in the last few years. Advancement in technology of medical devices supports painless and uncomplicated treatment during disease management. Moreover, innovation and up gradation in medical devices assist for the precise and rapid result of disease diagnosing invention in medical devices also provides cost-effectiveness of technology-based therapeutic tools during disease treatment. Moreover, many government bodies and healthcare organizations are supporting the medical research centers. The primary purpose of this support is to enhance health care innovations worldwide. Henceforth, growing innovation and technological advancement bolster the growth of medical device testing in the forecasted period.
Opportunity
- Rise in the Healthcare Expenditure
Healthcare expenditure has increased worldwide as people's disposable income in various countries is increasing. Moreover, to accomplish the population requirements, the government bodies and healthcare organizations are taking the initiative by accelerating healthcare expenditure. The rise in healthcare expenditure simultaneously helps healthcare settings to improve their medical device testing services over the recent years
Also, the strategic initiatives key market players take will provide structural integrity and future opportunities for the medical device testing market in the forecast period of 2024-2031.
Restraint/Challenge
- High Cost of Medical Devices
However, the barriers to the local development of medical devices and the high cost of medical devices in some of the regions may impede the less production of medical devices, hampering the market's growth. Additionally, high competition in medical technology industries and long lead time for the overseas qualification can be the challenging factors for the development of the market
This medical device testing market report provides details of new recent developments, trade regulations, import-export analysis, production analysis, value chain optimization, market share, the impact of domestic and localized market players, analyses opportunities in terms of emerging revenue pockets, changes in market regulations, strategic market growth analysis, market size, category market growths, application niches and dominance, product approvals, product launches, geographic expansions, technological innovations in the market. To gain more info contact Data Bridge Market Research for an Analyst Brief, our team will help you take an informed market decision to achieve market growth.
Post COVID-19 Impact on Medical Device Testing Market
COVID-19 has positively affected the market. The use of medical devices has increased in those years such as MRI scanners, ventilators and others. Hence the use of various devices has widely increased in the 'world's population. Thus, the pandemic has effected positively on this testing market
Medical Device Testing Market Scope
Global medical device testing market is segmented into service type, testing type, phase, sourcing type, device class and product. The growth amongst these segments will help you analyse meagre growth segments in the industries and provide the users with a valuable market overview and market insights to make strategic decisions to identify core market applications.
Service Type
- Testing services
- Inspection services
- Certification services
Testing Type
- Physical testing
- Chemical/biological testing
- Cybersecurity testing
- Microbiology and sterility testing
- Others
Phase
- Preclinical
- Clinical
Sourcing Type
- Outsourced
- In-house
Device Class
- Class I
- Class II
- Class III
Product
- Active implant medical device
- Active medical device
- Non-active medical device
- In-vitro diagnostics medical device
- Opthalmic medical device
- Orthopedic and dental medical device
- Vascular medical device
- Others
Medical Device Testing Market Regional Analysis
The medical device testing market is analysed and market size insights and trends are provided by country, service type, testing type, phase, sourcing type, device class and product as referenced above.
The countries covered for this market are U.S., Canada, Mexico, Germany, France, U.K., Italy, Spain, Netherlands, Russia, Switzerland, Turkey, Belgium, Rest of Europe, China, Japan, India, South Korea, Australia, Singapore, Thailand, Malaysia, Indonesia, Philippines, Rest of Asia-Pacific, Brazil, Argentina, Rest of South America, South Africa, Saudi Arabia, UAE, Egypt, Israel, Rest of Middle East and Africa.
North America dominates the medical device testing market in terms of market share and market revenue and will continue to flourish its dominance during the forecast period. This is due to the rising need for the verification and validation of medical devices in the region, and rapid research development is boosting the market.
The country section of the report also provides individual market impacting factors and changes in regulations in the market that affect the current and future trends of the market. Data points, such as new and replacement sales, country demographics, disease epidemiology, and import-export tariffs, are some of the major pointers used to forecast the market scenario for individual countries. In addition, the presence and availability of global brands and their challenges faced due to high competition from local and domestic brands, and impact of sales channels are considered while providing forecast analysis of the country data.
Medical Device Testing Market Share
The medical device testing market competitive landscape provides details by the competitors. Details include company overview, company financials, revenue generated, market potential, investment in research and development, new market initiatives, global presence, production sites and facilities, production capacities, company strengths and weaknesses, product launch, product width and breadth, and application dominance. The above data points provided are only related to the companies' focus on medical device testing market.
Medical Device Testing Market Leaders Operating in the Market Are:
- Intertek Group plc, SGS SA
- Bureau Veritas, TUV SUD
- TUV Rheinland, Pace
- Charles River Laboratories
- Biomedical Device Labs, UL LLC
- North American Science Associates, LLC
- Medistri SA
- WuXi AppTec, NSF
- Labcorp
- Eurofins Scientific
- Nelson Laboratories, LLC- A Sotera Health company, Gateway Analytical
- ITC ZLIN, Element Materials Technology
- EndoLab Mechanical Engineering GmbH
- Hohenstein
- Medical Engineering Technologies Ltd.
- Bioneeds
- Cigniti
- Arbro Pharmaceuticals Private Limited & Auriga Research Private Limited
- Q Laboratories
- IMR Test Labs
Latest Developments in Medical Device Testing Market
- In April 2021, TÜV SÜD announced that it had presented itself at Medtec LIVE to exhibit its ability to be a one-stop-shop for medical device testing. The 'company's services covered testing in the areas of electrical and functional safety, cyber security and software, EMC, and biocompatibility. The experts from TÜV SÜD featured in the online trade show and congress program with various talks, a live hack and an elevator pitch
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