Medical Device Testing and Certification Market Size
| Study Period | 2019 - 2029 |
| Market Size (2024) | USD 10.16 Billion |
| Market Size (2029) | USD 12.73 Billion |
| CAGR (2024 - 2029) | 3.80 % |
| Fastest Growing Market | Asia Pacific |
| Largest Market | North America |
| Market Concentration | Medium |
Major Players
*Disclaimer: Major Players sorted in no particular order |
Medical Device Testing and Certification Market Analysis
The Global Medical Device Testing And Certification Market size is estimated at USD 10.16 billion in 2024, and is expected to reach USD 12.73 billion by 2029, at a CAGR of 3.80% during the forecast period (2024-2029).
Various factors drive the medical device testing and certification market, including the rising demand for Validation and Verification (V&V) of medical devices and the significant influence of stringent government regulations. For example, a September 2024 article by VertMarkets, Inc. highlights the transformative impact of robotic automation in medical device testing. Robotic systems, adept at executing repetitive and precise tasks, are versatile for various testing scenarios. In the medical realm, these systems can simulate conditions, from power levels and environmental factors to patient scenarios, enabling manufacturers to validate device performance in diverse situations.
In April 2023, the International Medical Device Regulators Forum (IMDRF) introduced detailed guidelines focusing on verification and validation for personalized medical devices. These guidelines seek to unify requirements across different regulatory frameworks, a move vital for reducing costs and resource use for both manufacturers and regulatory bodies. As regulatory demands tighten, the corresponding rise in the need for efficient and reliable V&V methods propels the medical device testing and certification market in the coming years.
Technological innovations, notably the integration of artificial intelligence (AI) and machine learning (ML) in medical devices, are transforming the compliance landscape. For instance, in June 2024, Element Materials Technology launched Element RegNav, an AI-centric regulatory intelligence platform. Aimed at simplifying the FDA regulatory pathway for medical devices, RegNav signifies a significant evolution in manufacturers’ navigation of the complex regulatory landscape, promoting safer and more efficient market entries for medical innovations.
In August 2024, Sonova Holding AG introduced two groundbreaking platforms under its flagship brand, Phonak: Audéo Infinio and Audéo Sphere Infinio. These platforms represent a new era of hearing aids, harnessing real-time AI-driven technology. Audéo Sphere Infinio features Sonova’s proprietary dual-chip technology, with one-chip processing sound through real-time AI. This leap forward sets new standards in sound quality, connectivity, and power management, crucial for those with hearing loss, enhancing both speech comprehension and conversational quality. Consequently, the demand for medical device testing and certification services is projected to rise during the forecast period, driven by the necessity to meet regulatory standards and ensure the safety, efficacy, and reliability of healthcare innovations.
Given these factors, including the growing demand for V&V, the weight of stringent regulations, and technological strides in medical devices, the market is set for growth in the forecast period.
Yet, varying regulatory landscapes globally could hinder medical device development, testing, inspection, and certification, potentially curtailing the market’s growth during the study period.
Medical Device Testing and Certification Market Trends
Testing Services Segment is Expected to Witness Rapid Growth During the Forecast Period
Medical device testing evaluates medical devices' safety, efficacy, and performance. This thorough process encompasses a series of tests, experiments, and evaluations, ensuring that medical devices meet regulatory standards and function as intended. The medical device testing services segment is on the brink of substantial growth, fueled by the rising adoption of these services, the rollout of advanced testing options by industry leaders, and the enforcement of stringent regulatory mandates.
Various laboratories and key players are at the forefront of providing these testing services. For example, in December 2023, Impelsys, a leading global technology firm, launched a state-of-the-art medical device testing laboratory in Mangalore. This facility, dedicated to medical device testing, complements Impelsys's extensive healthcare offerings, which span data analytics, AI-driven platforms, cloud services, and educational solutions. Similarly, UL Solutions, a global leader in applied safety science, rolled out new medical device testing services at its Rochester Hills laboratory in Michigan, United States, in October 2023. These newly introduced services are poised to bolster the rapidly expanding medical device sector in the U.S., assisting manufacturers in elevating the safety, security, usability, and interoperability of their essential healthcare products.
Moreover, the surging demand for testing services, driven by stringent regulatory mandates, is anticipated to accelerate the market's growth in the foreseeable future. For instance, a June 2023 article in the Annals of Internal Medicine highlighted the European Union's revamped Medical Device Regulation (MDR), which has tightened oversight on medical devices. This regulation broadens the spectrum of devices subjected to intensified clinical trial testing before market approval. Additionally, the MDR enforces rigorous clinical surveillance on these devices, monitoring their benefits and potential risks throughout their lifecycle. Given these intensified regulations, the appetite for testing services is poised to escalate, propelling segment growth in the years ahead.
In conclusion, the surge in testing services, combined with stringent regulatory oversight on medical devices, is set to catalyze the segment's growth in the forecast period.
North America Dominates the Market and is Expected to do the Same over the Forecast Period
The geographical analysis of the medical device testing and certification market shows that North America holds a significant market share in the global market. The major factors attributing to the substantial market growth in the region are the increased focus on the quality of medical devices, the presence of many companies that serve the medical device industry, well-developed healthcare, and top multinational medical device companies.
For instance, an article published by UpCert in March 2023 stated that medical electrical devices in Canada must comply with safety standards, such as the CSA C22.2 No. 60601-1, which focuses on general safety requirements for medical electrical equipment. This standard, along with others like IEC 60601-1-2 (which deals with electromagnetic compatibility) and IEC 62366 (concerning usability engineering), ensures that devices function safely in medical environments without posing risks from electrical malfunctions or interference with other equipment. Therefore, this highlights the need for manufacturers to take responsibility for their testing processes and ensure compliance with safety standards like IEC 60601-1.
Furthermore, the United States Food and Drug Administration (FDA) has steadily increased its annual authorization of novel medical devices, fostering innovation and advancing healthcare solutions that will impact the medical testing and certification market. For instance, in 2023, the FDA rebounded from the challenges posed by the pandemic, approving 84 novel medical devices despite a heavy regulatory workload in 2022. A notable highlight of 2023 includes the rapid authorization of the first over-the-counter test for the detection of fentanyl in urine, which received clearance within 16 days. Similarly, the FDA granted marketing authorization to Owlet’s medical pulse oximeter, an innovative device designed to monitor infants’ oxygen levels. This demonstrates the agency’s commitment to bringing critical technologies to market swiftly and efficiently.
Thus, all the factors mentioned above, such as increasing demand for compliant and safe medical devices coupled with the continuous launch of new devices, are anticipated to drive the application of rigorous testing conducted by manufacturers to meet stringent safety and performance standards before marketing. It is envisioned to drive market growth in the North American region over the forecast period.
Medical Device Testing and Certification Industry Overview
The medical device testing and certification market is highly consolidated, and few companies provide testing and certification services. Some prominent market players include the British Standards Institution, Eurofins Scientific, Intertek Group, SGS SA, and TÜV SÜD. These market players are focused on making strategic acquisitions and expanding their production capabilities to strengthen their regional and international presence further.
Medical Device Testing and Certification Market Leaders
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Eurofins Scientific
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SGS SA
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TÜV SÜD
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British Standards Institution
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Intertek Group
*Disclaimer: Major Players sorted in no particular order
Medical Device Testing and Certification Market News
- May 2024: Eurofins Scientific acquired ENCO Pharmaceutical Development to expand its presence in the Southeast United States and strengthen its capabilities in ophthalmic, medical device, and animal health which is renamed as Eurofins BioPharma Product Testing ENCO.
- March 2024: DEKRA was authorized by the Saudi Standards, Metrology, and Quality Organization (SASO) to facilitate the Saudi Quality Mark (SQM) in the Kingdom of Saudi Arabia (KSA). The certification mark ensures that products entering the Saudi market meet certain quality and safety requirements.
Medical Device Testing Market Report - Table of Contents
1. INTRODUCTION
1.1 Study Assumptions and Market Definition
1.2 Scope of the Study
2. RESEARCH METHODOLOGY
3. EXECUTIVE SUMMARY
4. MARKET DYNAMICS
4.1 Market Overview
4.2 Market Drivers
4.2.1 Increasing Need of Validation and Verification (V&V) for Medical Devices
4.2.2 Compliance of Standards
4.3 Market Restraints
4.3.1 Diversity in Regulation
4.4 Industry Attractiveness - Porter's Five Forces Analysis
4.4.1 Bargaining Power of Buyers/Consumers
4.4.2 Bargaining Power of Suppliers
4.4.3 Threat of New Entrants
4.4.4 Threat of Substitute Products
4.4.5 Intensity of Competitive Rivalry
5. MARKET SEGMENTATION (Market Value in USD Million)
5.1 By Service Type
5.1.1 Testing Services
5.1.2 Inspection Services
5.1.3 Certification Services
5.2 By Sourcing Type
5.2.1 In-house
5.2.2 Outsourced
5.3 By Device Class
5.3.1 Class I
5.3.2 Class II
5.3.3 Class III
5.4 By Technology
5.4.1 Active Implant Medical Device
5.4.2 Active Medical Device
5.4.3 Non-active Medical Device
5.4.4 In Vitro Diagnostic Medical Device
5.4.5 Ophthalmic Medical Device
5.4.6 Orthopedic and Dental Medical Device
5.4.7 Other Technologies
5.5 By Geography
5.5.1 North America
5.5.1.1 United States
5.5.1.2 Canada
5.5.1.3 Mexico
5.5.2 Europe
5.5.2.1 Germany
5.5.2.2 United Kingdom
5.5.2.3 France
5.5.2.4 Italy
5.5.2.5 Spain
5.5.2.6 Rest of Europe
5.5.3 Asia-Pacific
5.5.3.1 China
5.5.3.2 Japan
5.5.3.3 India
5.5.3.4 Australia
5.5.3.5 South Korea
5.5.3.6 Rest of Asia-Pacific
5.5.4 Middle East & Africa
5.5.4.1 GCC
5.5.4.2 South Africa
5.5.4.3 Rest of Middle East & Africa
5.5.5 South America
5.5.5.1 Brazil
5.5.5.2 Argentina
5.5.5.3 Rest of South America
6. COMPETITIVE LANDSCAPE
6.1 Company Profiles
6.1.1 British Standards Institution
6.1.2 DEKRA
6.1.3 Eurofins Scientific
6.1.4 ITC ZLÍN
6.1.5 Intertek Group plc
6.1.6 SGS SA
6.1.7 TUV Rheinland
6.1.8 UL LLC
6.1.9 Bureau Veritas
6.1.10 Element Materials Technology
6.1.11 TÜV SÜD
6.1.12 Gateway Analytical LLC (AptarGroup, Inc.)
6.1.13 Medistri SA
6.1.14 Pace Analytical Services LLC
6.1.15 WuXi AppTec
- *List Not Exhaustive
7. MARKET OPPORTUNITIES AND FUTURE TRENDS
Medical Device Testing and Certification Industry Segmentation
As per the scope of the report, medical device testing, certification, and auditing are necessary to ensure the safety of the devices. These testing and certification can be provided by the third party under the recognized auditing organization. The global medical device testing and certification market are segmented by service type (testing services, inspection services, and certification services), sourcing type (in-house and outsourced), device class (class I, class II, and class III), technology (active implant medical device, active medical device, non-active medical device, in vitro diagnostic medical device, ophthalmic medical device, orthopedic and dental medical device, and other technologies), and geography (North America, Europe, Asia Pacific, Middle East and Africa, and South America). The report also offers the market size and forecasts for 19 countries across the regions. The report offers the value (in USD million) for the above segments.
| By Service Type | |
| Testing Services | |
| Inspection Services | |
| Certification Services |
| By Sourcing Type | |
| In-house | |
| Outsourced |
| By Device Class | |
| Class I | |
| Class II | |
| Class III |
| By Technology | |
| Active Implant Medical Device | |
| Active Medical Device | |
| Non-active Medical Device | |
| In Vitro Diagnostic Medical Device | |
| Ophthalmic Medical Device | |
| Orthopedic and Dental Medical Device | |
| Other Technologies |
| By Geography | ||||||||
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Medical Device Testing Market Research FAQs
How big is the Global Medical Device Testing And Certification Market?
The Global Medical Device Testing And Certification Market size is expected to reach USD 10.16 billion in 2024 and grow at a CAGR of 3.80% to reach USD 12.73 billion by 2029.
What is the current Global Medical Device Testing And Certification Market size?
In 2024, the Global Medical Device Testing And Certification Market size is expected to reach USD 10.16 billion.
Who are the key players in Global Medical Device Testing And Certification Market?
Eurofins Scientific, SGS SA, TÜV SÜD, British Standards Institution and Intertek Group are the major companies operating in the Global Medical Device Testing And Certification Market.
Which is the fastest growing region in Global Medical Device Testing And Certification Market?
Asia Pacific is estimated to grow at the highest CAGR over the forecast period (2024-2029).
Which region has the biggest share in Global Medical Device Testing And Certification Market?
In 2024, the North America accounts for the largest market share in Global Medical Device Testing And Certification Market.
What years does this Global Medical Device Testing And Certification Market cover, and what was the market size in 2023?
In 2023, the Global Medical Device Testing And Certification Market size was estimated at USD 9.77 billion. The report covers the Global Medical Device Testing And Certification Market historical market size for years: 2019, 2020, 2021, 2022 and 2023. The report also forecasts the Global Medical Device Testing And Certification Market size for years: 2024, 2025, 2026, 2027, 2028 and 2029.
Medical Device Testing Industry Report
Statistics for the 2024 Medical Device Testing market share, size and revenue growth rate, created by Mordor Intelligence™ Industry Reports. Medical Device Testing analysis includes a market forecast outlook to 2029 and historical overview. Get a sample of this industry analysis as a free report PDF download.
Medical Device Testing Market Report Snapshots
