Medical Device Testing Services Market Size, Share & Trends Report

Medical Device Testing Services Market Size, Share & Trends Analysis Report By Phase (Preclinical, Clinical), By Service (Chemistry, Biocompatibility, Microbiology & Sterility Testing), By Region, And Segment Forecasts, 2018 - 2025

  • Published Date: Dec, 2018
  • Base Year for Estimate: 2016
  • Report ID: GVR-2-68038-115-3
  • Format: Electronic (PDF)
  • Historical Data: 2014 - 2016
  • Number of Pages: 106

Industry Insights

The medical device testing services market size was valued at USD 5.6 billion in 2017 and is expected to grow at a CAGR of 11.5% over the forecast period. Increasing complexity in product design coupled with stringent regulatory norms is anticipated to drive the market growth during the forecast period.

Emergence of personalized medication, drug device combination, Artificial Intelligence (AI), wearables and focus on real-time patient monitoring resulted in complex medical devices ecosystem. To match these parameters, devices now have to undergo shear testing in accelerated conditions to obtain marketing approval. Conducting these tests in-house requires a lot of time, cost, and labor; this is projected to augment the demand for outsourcing of these services thereby boosting the market growth.

U.S. medical device testing services market

Increasing demand for in-vitro tests is also expected to drive the market, as a lot of CROs are developing novel methods to replace the traditional in-vivo tests, which require animal testing. Advancement in the development and standardization of novel in vitro test methods; particularly for sensitization, cytotoxicity, and irritation, which are the basic test required for all the medical device is also likely to support market growth.

In addition, rising number of companies in this industry is contributing to the market development. Structurally, global medical device industry is bifurcated amongst few major players and a huge number of Small- and Medium-sized Enterprises (SMEs). Thus, escalating demand from SMEs, which lack in-house capabilities, will support the market.

The stringent regulatory standards pertaining to user safety have also contributed to the market. Increasing demand for high-quality products is also expected to propel the demand for testing services.

Service Insights

The service segment includes biocompatibility test, microbiology and sterility test, and package validation. Microbiology and sterility testing led the market as of 2017. The biocompatibility test segment is also expected to witness significant growth during the forecast period. Development of novel in-vitro methods is expected to replace some of the current in-vivo test, thereby reducing the overall costs of biocompatibility test. The chemistry test is expected to witness the fastest growth during the forecast period. It is a great tool in identifying which biocompatibility tests are needed. .

Phase Insights

By services phase, the market is segmented into preclinical and clinical phase. The preclinical phase is further analyzed for antimicrobial wound dressings, medical coatings, and others. The preclinical segment accounted for the largest share in 2017.

Global preclinical medical device testing services market

The clinical phase also accounted for a significant share in 2017. This phase of device development process includes cleaning validation, sterilization testing and validation, package and shipping testing, and shelf life and accelerated aging test.

Regional Insights

Asia Pacific held the largest share in the medical device testing services market owing to increased outsourcing in countries, such as India and China. Contract Research Organizations (CROs) are investing heavily in developing countries of APAC owing to lower cost and easy availability of skilled labor. North America accounted for the second-largest share in 2017 and is expected to witness significant growth during the forecast period.

This growth can be attributed to the fact that it is one of the top manufacturing hubs of complex, high-end, and reliable medical devices. Many CROs have an established business in the region, which provides complete range of testing services for companies. The Europe region is led by EU5 nations (France, Italy, Spain, U.K., and Germany). Rising need for cost cutting and increasing complexity in product designing are expected to be the major market drivers.

Medical Device Testing Services Market Share Insights

Toxikon, Inc.; SGS S.A.; Eurofins Scientific, LLC; Intertek Group plc; WuXi AppTec Group; Pace Analytical Services, North American Science Associates, Inc.; Sterigenics International LLC; Charles River Laboratories International, Inc.; and American Preclinical Services LLC are the key companies in this market.

Service portfolio expansion along with regional penetration is anticipated to be the key market strategy. There has been significant consolidation in CRO space in recent years. For instance, in October 2017, Sterigenics International LLC acquired Toxikon Europe N.V., the European division of Toxikon Corporation, to strengthen its preclinical service portfolio for pharmaceutical and medical device companies.

Report Scope



Base year for estimation


Actual estimates/Historical data

2014 - 2016

Forecast period

2018 - 2025

Market representation

Revenue in USD Million, Volume in Units and CAGR from 2018 to 2025

Regional scope

North America, Europe, Asia Pacific, Latin America, and MEA

Report coverage

Revenue forecast, company share, competitive landscape, growth factors and trends

Country Scope

U.S., Canada, France, Germany, Japan, China, India, Mexico, Brazil, and South Africa

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Segments Covered in the Report

This report forecasts revenue and volume growth at global, regional, and country levels and provides an analysis of industry trends in each of the sub-segments from 2014 to 2025. For the purpose of this study, Grand View Research, Inc. has segmented the global medical device testing services market report on the basis of service, phase, and region:

  • Service Outlook (Volume, Units; Revenue, USD Million, 2014 - 2025)

    • Biocompatibility Tests

    • Chemistry Test

    • Microbiology & Sterility Testing

      • Bio-Burden Determination

      • Pyrogen and Endotoxin Testing

      • Sterility Test and Validation

      • Anti-microbial Activity Testing

      • Other Services

    • Package Validation

  • Phase Outlook (Volume, Units; Revenue, USD Million, 2014 - 2025)

    • Preclinical

      • Antimicrobial Wound Dressings

      • Medical Coatings

      • Others

    • Clinical

  • Regional Outlook (Volume, Units; Revenue, USD Million, 2014 - 2025)

    • North America

      • U.S.

      • Canada

    • Europe

      • France

      • Germany

    • Asia Pacific

      • Japan

      • China

      • India

    • Latin America

      • Brazil

      • Mexico

    • MEA

      • South Africa

Key questions answered by the report
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