The Rising Adoption Of Digital Healthcare Creates New Opportunities To Transform The Medical Device Testing And Certification Market
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 devices are used for diagnosis, treatment, monitoring and rehabilitation of patients. Medical devices range from simple tongue depressors and bedpans to complex programmable pacemakers with micro-chip technology and robot-assisted surgical systems. Medical device testing and certification is necessary to establish the safety and effectiveness of medical devices before they reach the market. It ensures that medical devices meet appropriate standards for safety and performance. The testing process includes electrical safety testing, EMC/EMI testing, biocompatibility testing, sterilization validation, package integrity testing, shelf-life studies and more.
Market Dynamics:
One of the major drivers for the medical device testing and certification market is the increasing incidence of chronic and lifestyle diseases globally. Chronic diseases like cardiovascular diseases, cancer, diabetes etc. contribute significantly to the healthcare expenditure and mortality rates. This has increased the demand for advanced medical technologies for diagnosis and treatment of such diseases. Moreover, growing geriatric populationwhich is more prone to chronic diseases will further drive the need for medical devices and subsequent testing. Another key driver is the rising adoption of digital healthcare technologies. Technological advancementsare allowing integration ofArtificial Intelligence, Augmented Reality, IoT and predictive analytics in medical devices. This is increasing the complexity of devices and underscores the need for rigorous testing and certification of new digital health solutions entering the market.
Segment Analysis
The medical device testing and certification market can be segmented into laboratory services, auditing & inspection services and certification services. Among these, laboratory services dominate the market owing to the increasing need for testing services across various phases of product development and certification. Laboratories provide a wide range of testing services including biocompatibility testing, electrical safety testing, and sterilization validation testing to ensure medical devices meet regulatory standards before marketing.
PEST Analysis
Political: Stringent regulations regarding medical device testing and certification across major markets like the US, EU and China are driving market growth. Economic: Rising healthcare spending globally is increasing investments in new medical technology development, boosting demand for testing and certification services. Social: Growing elderly population and focus on patient safety are key factors raising quality standards for medical devices. Technological: Advancements in simulation testing methods and digitization of compliance processes are supporting efficiency and market expansion.
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 regulatory stringency.
The North American region dominates the market currently due to the presence of major players and stringent FDA norms. Rapid growth is expected in the Asia Pacific region supported by rising medical device production 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