The medical device testing and certification market involves services for testing and certification of medical devices to ensure their safety and efficacy. Medical devices range from simple thermometers to complex programmable mechanical devices. All medical devices sold commercially in countries must meet the safety and performance standards set by the respective regulatory bodies. Medical device testing helps in verifying that a device and its manufacturing process meet various regulatory standards and requirements before approval and market launch. Certification confirms that medical devices have passed all the required testing protocols. With increasing penetration of advanced medical technologies, the demand for medical device testing and certification is growing steadily to ensure public health.
The global Medical Device Testing and Certification Market is estimated to be valued at US$ 916.9 Mn in 2023 and is expected to exhibit a CAGR of 5.3% over the forecast period 2023 to 2030, as highlighted in a new report published by Coherent Market Insights.
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Market key trends:
Rising healthcare expenditure globally is a major driver for market growth. Increasing incidence of chronic diseases and growing geriatric population are key factors driving healthcare spending worldwide. This results in higher demand for advanced medical technologies and devices. Regulatory mandates regarding product quality and safety also propel the need for medical device testing and certification. Growing complexity of medical devices in terms of design and functions require thorough testing and approval procedures. Outsourcing of testing services is a developing trend among small and mid-sized medical device manufacturers due to associated cost benefits. Adoption of new medical technologies remains central to improving patient outcomes, thereby augmenting the requirement for testing across various devices.
Threat of new entrants: The high initial capital investments and the stringent regulatory requirements pose significant barriers for new players to enter this market.
Bargaining power of buyers: The large number of players operating in this market reduces the bargaining power of buyers.
Bargaining power of suppliers: The presence of a large number of component suppliers reduces the bargaining power of individual suppliers in this market.
Threat of new substitutes: There is a low threat from substitutes due to lack of suitable alternatives for medical devices and equipment.
Competitive rivalry: The medical device testing and certification market witnesses strong competitive rivalry among the top players.
The global medical device testing and certification market is expected to witness high growth, exhibiting CAGR of 5.3% over the forecast period, due to increasing regulatory requirements for medical devices.
Regional analysis: North America is expected to dominate the global medical device testing and certification market during the forecast period, owing to stringent regulatory standards for medical devices in the region. Asia Pacific is anticipated to exhibit the fastest growth during the forecast period, driven by growth in medical device industry and rising safety concerns.
Key players: Key players operating in the medical device testing and certification market are PerSys Medical, Aero Healthcare AU Pty Ltd, Teleflex Incorporated, PAVmed Inc., BIOPSYBELL S.R.L., Becton Dickinson Company, Cook Group, SAM Medical, Argon Medical Devices, Inc., Cardinal Health, Inc., StarFish Product Engineering Inc., and Medax SRL unipersonle. These players are focusing on new product launches and mergers & acquisitions to strengthen their market position.
- Source: Coherent Market Insights, Public sources, Desk research
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