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:
The medical device testing and certification market consists of products and services involved in the testing and certification of medical devices. These include product testing, quality management system audits, pre-assessment audits, and regulatory compliance tests. The key objective of medical device testing and certification is to ensure product and system compliance with international standards and regulatory requirements. This helps evaluate product safety and efficacy before launch. The rising demand for quality-assured and regulatory-approved medical devices is driving the need for proper testing and certification across the product lifecycle.
Market key trends:
One of the key trends in the medical device testing and certification market is the growing adoption of digital health solutions and remote patient monitoring devices. With the COVID-19 pandemic accelerating digital transformation in the healthcare industry, there is a surge in demand for connected medical devices with integrated digital capabilities. However, digital health technologies introduce new levels of complexity that require sophisticated testing methods. Regulatory standards are also evolving to address unique compliance requirements for networked and software-based medical devices. This is expected to boost demand for specialized testing services equipped to evaluate the safety, quality and performance of digital health solutions.
Porter’s Analysis
Threat of new entrants: Low capital requirement and technology advancement has lowered the barriers to entry in this market. However, stringent regulations and certification requirements from authorities acts as a barrier.
Bargaining power of buyers: Large number of buyers and suppliers in the fragmented market has increased bargaining power of buyers. Buyers can negotiate for better prices and demand value-added services.
Bargaining power of suppliers: Presence of numerous global and regional players has reduced individual supplier's influence on pricing. However, suppliers influence pricing through differentiation and provision of additional services.
Threat of new substitutes: Moderate threat as new alternative testing technologies can disrupt the existing market.
Competitive rivalry: Intense competition exists among existing players to gain higher market share through expanding service portfolios and capabilities.
Key Takeaways
The global Medical Device Testing And Certification Market is expected to witness high growth, exhibiting CAGR of 4.3% over the forecast period, due to increasing regulatory standards for product quality and safety.
North America dominated the market in 2023, accounting for over 30% share, owing to stringent quality regulations enforced by authorities like FDA. Asia Pacific is expected to witness fastest growth during the forecast period, with China and India emerging as major hubs for outsourcing medical device testing.
Key players operating in the Medical Device Testing And Certification market are 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.
