The medical device testing market was valued at USD 9.3 billion in 2020 and is projected to reach USD 11.8 billion by 2025; growing at a CAGR of 4.8% from 2020 to 2025.
The medical device testing market is growing due to the increasing need of verification and validation for medical devices. The in-vitro diagnostic (IVD) medical device segment held the largest share of the medical device testing market in 2019, owing to the increasing demand for rapid testing kits and other diagnostics devices across regions. The active implant medical device segment is projected to witness the highest CAGR during the forecast period, owing to the implementation of stringent regulations to ensure that the implantable medical devices are fit for the human body.
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Testing Services, by service type held the largest share in the global medical device testing market in 2019
There is an increasing demand for TIC services in medical devices, owing to the rising demand for good quality and standard products across the industry. In the market, testing services ensure the products have met the required quality, safety, and performance regulatory standards. A few of the major examples of testing services are electromedical device testing, biocompatibility testing, clinical research services assessing the final product to investigate the faulty material, and testing the performance of medical devices and the electrical safety of devices. Testing services are carried out in laboratories and research sites. Testing services assist manufacturers in improving the marketability of their medical devices and in lowering costs in the pre-production phase (e.g. R&D, the selection of suppliers, etc. However, the Certification services tend to grow at a higher CAGR during the forecast period as certifications ensure that the manufacturers of the medical products have followed the standards and quality and safety norms during the production process.
Outsourcing, by sourcing type will grow at a higher CAGR during the forecast period
Many large firms are increasingly outsourcing medical device testing services as the increased regulations make it costly to conduct in-house tests, thereby helping firms reduce the overall cost of testing.
The demand for outsourcing TIC services to third-party vendors is increasing for technologies, such as active implant medical devices, owing to the capital-intensive nature of in-house TIC activities. However, the in-house sourcing type held the major share of the global medical device testing market in 2019.
The demand for class III medical device is high due to the associated risk factor involved in these devices
The class III medical device testing market is projected to grow at the highest CAGR from 2020 to 2025. There is an increasing need for classifying medical devices due to the presence of potential risks associated with medical devices and concerned patients. Class III medical devices are used to sustain or support human life. Class III devices are generally the high-risk devices and are therefore subject to the highest level of regulatory control. Class III devices must typically be approved by the FDA before they are marketed. Class III devices include replacement heart valves, implantable pacemakers, and pulse generators. However, Class II devices held the largest share of the global market in 2019.
Asia Pacific is projected to grow at the highest CAGR during the forecast period
The medical device testing market in APAC is growing rapidly because of the rising per capita income among the middle class. Moreover, there is growing consumer awareness regarding the importance of certification. The medical device testing market in India is projected to growing at the highest CAGR during the forecast period. North America, however, holds the largest share in the global medical device testing market as Strict regulations have been established by the governments to maintain quality and safety standards in the industry, which drives the need for medical device testing services in North America.
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SGS (Switzerland), Eurofins Scientific (UK), Bureau Veritas (UK), Intertek (UK), TÜV SÜD (UK), and DEKRA (UK), Source Bioscience (UK), NSF International (US), BDC laboratories (US) and Surpass (US) are the key players in the global medical device testing market.
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