July 18, 2024
Medical Device Testing And Certification Market

Medical Device Testing And Certification Market Is Estimated To Witness High Growth Owing To Increasing Number Of Medical Device Recalls

The Medical Device Testing And Certification Market is estimated to be valued at US$ 10,073.4 Mn in 2023 and is expected to exhibit a CAGR of 4.3% over the forecast period 2023 to 2030, as highlighted in a new report published by Coherent Market Insights.

Market Overview:

Medical device testing and certification involves performance and safety testing of medical devices as per standards set by regulatory authorities to ensure devices are safe and effective for patients. Testing covers areas such as biocompatibility, sterilization validation, electrical safety, EMC, software validation and other performance characteristics. Certification provides manufacturers a symbol that the device meets applicable regulatory standards.

Market key trends:

Increasing number of medical device recalls have augmented the need for stringent testing and certification of devices. As per the U.S. Food and Drug Administration (FDA), over 4,000 medical device corrections and removals were reported in 2021 alone. Majority of recalls were attributed to labeling or sterilization issues. Stringent regulatory norms especially in developed markets have prompted manufacturers to undertake testing early in product development cycle. Moreover, growing outsourcing of testing services by OEMs to third party testing facilities has created opportunities for standalone testing providers. Growing demand for contract testing from small and medium enterprises owing to high internal costs of testing also favors market growth over the forecast period.

Porter’s Analysis

Threat of new entrants: The threat of new entrants is medium as the medical device testing and certification market requires high investment in infrastructure, equipment and trained personnel. This poses significant barriers for new players.

Bargaining power of buyers: The bargaining power of buyers is high as there are numerous testing service providers in the market. Buyers can negotiate price and demand transparency in testing standards and timelines.

Bargaining power of suppliers: The bargaining power of suppliers is low as there are no major raw material requirements for testing services. Testing equipment and reagents availability from multiple suppliers prevent supplier dominance.

Threat of new substitutes: There is no threat from substitutes currently as medical device testing is mandated by regulators globally to ensure product quality and safety.

Competitive rivalry: The competitive rivalry is high owing to presence of numerous global and regional players providing quality and personalized testing services.

SWOT Analysis

Strengths: Presence of accredited labs, skilled workforce, adherence to international quality certifications.

Weaknesses: High capital investment requirements, dependency on regulatory policies, potential conflicts of interest in certain geographies.

Opportunities: Growth in medical device innovation, rising investments in technological advancements, expansion into emerging markets.

Threats: Price wars, changing trade policies, stringent regulatory guidelines.

Key Takeaways

The Global Medical Device Testing And Certification Market Demand is expected to witness high growth, exhibiting CAGR of 4.3% over the forecast period, due to increasing stringent regulations globally. North America dominates the market currently owing to presence of large medical devices industry and well-established regulatory framework. Europe and Asia Pacific are the fastest growing markets driven by rising healthcare spending and focus on ensuring product quality and safety.

North America will continue dominating the market holding over 35% share owing to stringent FDA regulations mandating third-party testing and certification. Asia Pacific region is poised to grow at 6.2% CAGR during the forecast period on account of increasing penetration of global players and growing medical devices industry in countries like China, India and South Korea.

Key players operating in the medical device testing and certification market include Medistri SA, BSI Group, Ente Certificazione Macchine, GMED, IMQ Group SRL, TOXIKON, TÜV SÜD, WuXi AppTec, Pace Analytical Services LLC, Gateway Analytical LLC, Boston Analytical, Bureau Veritas, UL LLC, TUV Rheinland, SGS SA, Intertek Group PLC, Eurofins Scientific, Element Materials Technology, Dekra Testing and Certification GmbH, and Institute for testing and Certification Inc., among others.


1. Source: Coherent Market Insights, Public sources, Desk research
2. We have leveraged AI tools to mine information and compile it