Medical Device Testing Services Market Segmentation, Industry Survey and Business Development Analysis till 2030

 Medical Device Testing Services Industry Overview

The global medical device testing services market size was estimated at USD 8.7 billion in 2021 and is expected to expand at a compound annual growth rate (CAGR) of 11.3% from 2022 to 2030.

The COVID-19 pandemic has accelerated the demand for testing services around the globe in the short term. The market is majorly driven by the increasing influence of strict regulations by the government that led to the increasing demand for verification and validation for medical devices. Besides, the rise in the number of small medical device companies that lack in-house expertise is also boosting the market growth.

COVID-19 provoked a surge in demand for medical device testing. But, since medical devices are in short supply, the vast majority of medical equipment being tested is personal protective equipment (PPE). PPE testing comprises validating their reuse, including single-use masks. Until the onset of the pandemic, most face masks were intended as single-use products. However, owing to their global shortage, numerous manufacturers are working on the options to test these masks for multiple uses. The test includes fitment tests, adherence to original filtration specifications, and sterilization tests.

Gather more insights about the market drivers, restrains and growth of the Global Medical Device Testing Services market

Additionally, technological advancements such as artificial intelligence (AI), and wearable, combined with a special emphasis on real-time monitoring of the patients, have led to a complex medical device ecosystem. These devices should undergo rigorous testing under accelerated conditions to obtain marketing authorization. Conducting these tests in-house requires a lot of time, cost, and labor and this is projected to augment the demand for outsourcing medical device testing services.

Ongoing technological development in the medical industry is also likely to have a positive impact on the demand for testing services during the forecast period. Advancement in the development and standardization of novel in-vitro test methods, particularly for sensitization, cytotoxicity, and irritation, is also likely to propel market growth. These are some of the most basic tests required for all medical devices.

Medical device guidelines differ by country, and it is mandatory for every manufacturing company to follow these guidelines when marketing their products in a particular country. The U.S., for example, follows FDA guidelines, Canada requires Health Canada Registration, Europe considers CE approval and India requires CDSCO approval. Hence, such varied regulations in different countries make it challenging to launch a product on a global scale.

Browse through Grand View Research's Medical Devices Industry Research Reports.

  • Wearable Brain Devices Market - The global wearable brain devices market size was valued at USD 247.8 million in 2021 and is expected to expand at a compound annual growth rate (CAGR) of 12.33% from 2022 to 2030.
  • Medical Device Outsourcing Market - The global medical device outsourcing market size was valued at USD 107.92 billion in 2021 and is anticipated to exhibit a compound annual growth rate (CAGR) of 12.1% over the forecast period.

Medical Device Testing Services Market Segmentation

Grand View Research has segmented the global medical device testing services market based on Service, Phase, and region:

  • Medical Device Testing Services by Services Outlook (Revenue, USD Million, 2017 - 2030)
    • Biocompatibility Tests
    • Chemistry Test
    • Microbiology & Sterility Testing
      • Bioburden Determination
      • Pyrogen & Endotoxin testing
      • Sterility Test & Validation
      • Antimicrobial Testing
      • Others
    • Package Validation
  • Medical Device Testing Services by Phase Outlook (Revenue, USD Million, 2017 - 2030)
    • Preclinical
    • Clinical
  • Medical Device Testing Services by Regional Outlook (Revenue, USD Million, 2017 - 2030)
  • North America
  • Europe
  • Asia Pacific
  • Latin America
  • Middle East & Africa (MEA)

Market Share Insights

  • 2021: TÜV SÜD announced that it would present itself at Medtec LIVE, to exhibit its ability to be a one-stop-shop for medical device testing.
  • June 2020: Intertek Plc announced the addition of N95 respirator precertification testing to the National Institute for Occupational Safety and Health standards to its personal protective equipment services.

Key Companies profiled:

Some prominent players in the global medical device testing services market include

  • SGS SA
  • Toxikon, Inc
  • American Preclinical Services
  • Sterigenics International LLC
  • River Laboratories International Inc
  • Medical Device Testing Services
  • North America Science Associates Inc
  • Euro fins Scientific
  • Pace Analytical Services LLC
  • Intertek Group Plc

Order a free sample PDF of the Medical Device Testing Services Market Intelligence Study, published by Grand View Research.

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