Medical Device Testing Market Opportunities and Challenges


According to the new research report "Medical Device Testing Market by Services (Testing, Inspection, Certification), Sourcing (In-house, Outsourced), Class (Class I, Class II, Class III), Technology (Active Implant, IVD, Orthopedic & Dental, Ophthalmic, Vascular) - Global Forecast to 2023", the medical device testing market size is expected to be USD 12.26 Billion by 2023, growing at a CAGR of 6.18% from USD 8.56 Billion in 2017. The market growth is mainly driven by an increasing need of validation and verification (V&V) for medical device, and imposition of rigorous government regulations and standards across medical devices.


Medical device testing market for testing services held the largest market share in 2016

Increasing regulatory focus on quality control for manufacturing operations, on additional safety, testing, and reporting measures requires advanced test equipment and instrumentation on-site in manufacturing facilities and laboratories. The accuracy of test results depend largely on the accuracy of test and measurement instruments, used for a particular test process. There is an increasing demand for TIC services in medical devices, owing to the growing demand for good quality and standard products across the industry.

Medical device testing market for outsourced services is expected to grow at the highest CAGR during the forecast period

Many large firms are increasingly outsourcing medical device testing, inspection, and certification services, as stringent regulations drive the cost to conduct test in-house. As a result, outsourcing TIC services helps manufacturers reduce the overall cost of testing. Demand for outsourcing TIC services to third-party vendors is increasing for applications, such as consumer goods and manufacturing owing to the capital-intensive nature of in-house TIC activities.

Medical device testing market for IVD medical devices held the largest share in 2016

The marketplace witnesses rapid growth, driven by technological advancements, better diagnostic tools, improved treatment monitoring, and increased availability of over-the-counter tests. IVD adds significant value to the treatment process and medical diagnosis, which simultaneously increases the well-being of the public health.

North America accounted for the largest share of the medical device testing market in 2016

In North America, the US is the leading country in medical devices in terms of awareness among the users about the safety and security of medical devices. The federal government established medical devices regulating agencies, such as FDA.


SGS (Switzerland), Bureau Veritas (France), Intertek (UK), and DEKRA (Germany), and TÜV SÜD (Germany) are the major players covered in the report with market share analysis. The report also covers various innovators, such as Avomeen Analytical Services (US), Medistri (Switzerland), and Envigo (UK).

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