Northbrook, IL -- (SBWIRE) -- 06/27/2021 -- The global medical device testing market is expected to grow from USD 9.3 billion in 2020 to USD 11.8 billion by 2025, at a CAGR of 4.8% during the forecast period. The harmonization of standards, growing consumption of medical devices in emerging countries, increasing need of validation and verification for medical devices, the imposition of rigorous government regulations, the growing trend of outsourcing medical device testing services and standards across medical devices are a few of the driving factors for the medical device testing market. The COVID-19 outbreak in 2019 further accentuated the development of advanced low-cost medical devices. These devices need to comply with stringent regulations regarding medical devices, hence, manufacturers are investing heavily in testing their devices.

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 medical device testing 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.

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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 medical device testing market in 2019.

IVD adds significant value to the treatment process and medical diagnosis, and is projected to hold the largest share in the by technology, medical device testing market during the forecast period

IVD adds significant value to the treatment process and medical diagnosis, which simultaneously increases the well-being of public health. These devices help detect infections, diagnose medical conditions, and monitor drug therapies. IVD medical devices include various devices, but not limited to HIV hepatitis detection devices, infectious disease detection devices, blood glucose monitors, human leukocyte antigen detection devices, cancer markers, clinical chemistry devices, COVID-19 test kits, pregnancy test kits, coagulation test systems, urine test strips, and receptacles manufactured specifically for medical specimens. However, the active implant medical device technology tend to grow at a higher CAGR during the forecast period because of there direct impact on safety and health of personnel.

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 TIC services in North America.

Key Market Players
The medical device testing market is dominated by a few globally established players such as SGS (Switzerland), Eurofins Scientific (UK), Bureau Veritas (UK), Intertek (UK), TÜV SÜD (UK), and DEKRA (UK).