The Largest Segment Driving The Growth Of Medical Device Testing And Certification Market
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| Medical Device Testing And Certification Market |
The global 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 ensures devices meet safety, efficacy and quality standards to prevent harm to patients. Testing covers areas such as biocompatibility, sterility validation, safety and performance. This protects patients and health systems from faulty devices.
Market key trends:
One of the key trends in the medical device testing and certification market is the growing demand for third-party laboratory testing services. With stringent regulations around the world, medical device manufacturers are increasingly outsourcing testing requirements to third party laboratories to ensure their products meet all regulatory standards before commercialization. These laboratories provide a range of analytical testing, extractable and leachable testing, sterility validation, biocompatibility testing, packaging testing, microbial identification, and other services aimed at evaluating product safety and performance. This trend is expected to continue driving market growth over the forecast period.
Market key trends:
The medical device testing and certification market has been witnessing growing demand for third-party testing and certification services owing to stringent regulations. Manufacturers are outsourcing testing and certification to achieve regulatory approvals and ensure the quality and safety of medical devices. Rising medical device recalls due to quality issues have further propelled the need for thorough testing and certification. Additionally, the market is driven by the increasing complexity of medical devices which requires rigorous testing procedures to validate their performance.
SWOT Analysis
Strength: Third-party certification helps manufacturers comply with regulations and gain user trust. It also simplifies the approval process.
Weakness: High costs associated with certification processes especially for new and small manufacturers.
Opportunity: Growing medical technologies in developing nations have opened up new markets for testing service providers. Continued regulatory reforms also create more opportunities.
Threats: Uncertified products from less compliant regions increase compliance risks. Delays in certification can impact new product launches.
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, 2023 to 2030, due to increasing regulatory requirements.
North America dominates the market currently owing to stringent MDR and FDA norms for approval. Asia Pacific is expected to grow at the fastest pace during the forecast period with the liberalizing regulatory environment in countries like India, China 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.
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