by 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:
The medical device testing and certification market comprises services for testing and certifying medical equipment for commercialization. This includes testing the safety, efficacy, biocompatibility and performance of devices. Common devices tested include surgical instruments, implants, orthopedic devices and other medical equipment. Certification ensures that devices meet regulatory standards before marketing.
Market Dynamics:
The medical device testing and certification market is driven by increasing number of regulatory mandates for ensuring safety and efficacy of medical equipment before use. Stringent rules by agencies like the US FDA and European CE regulate design, testing and certification of devices. This has increased the demand for third-party testing and certification services from medical device manufacturers. Additionally, rapid technological advancements have led to introduction of newer and more complex devices. Thorough testing and validation is required to commercialize such innovative products, further boosting market growth.
While regulatory compliance and innovation are major drivers, a highly fragmented supply chain increases outsourcing of testing and certification needs. This decentralized approach streamlines compliance while reducing costs for OEMs.
SWOT Analysis
Strength: Medical device testing and certification provides quality assurance. Regulatory approval is must which drives demand for testing. Testing helps identify errors early and reduce healthcare risks.
Weakness: Testing process is complex and lengthy. High compliance costs especially for small companies can be prohibitive. Lack of global harmonization increases cost burden.
Opportunity: Emerging economies demand will fuel growth due to increase in healthcare expenditure. New technologies in digital health, IVD will create new opportunities. Streamlining regulations can boost efficiency.
Threats: Trade restrictions can disrupt supply chains. Economic slowdowns may reduce spending on testing. Stringent regulations increase compliance challenges.
Key Takeaways
The Global Medical Device Testing And Certification Market Growth is expected to witness high, exhibiting CAGR of 4.3% over the forecast period, due to increasing regulatory stringency for quality and safety.
North America dominates currently with over 35% share due stringent regulatory environment. Asia Pacific is fastest growing region due to healthcare infrastructure expansion and favorable policies in China, India and Japan.
Key players operating in the medical device testing and certification market are Medistri SA, BSI Group, Ente Certificazione Macchine, GMED, IMQ Group SRL, TOXIKON, TÃœV SÃœD, 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
*Note:
1. Source: Coherent Market Insights, Public sources, Desk research
2. We have leveraged AI tools to mine information and compile it
