Medical Device Testing Services Market Worth $18.6 Billion By 2028

May 2021 | Report Format: Electronic (PDF)

Medical Device Testing Services Market Growth & Trends

The global medical device testing services market size is expected to reach USD 18.6 billion by 2028, according to a new report by Grand View Research, Inc. The market is expected to expand at a CAGR of 11.6% from 2021 to 2028. Increasing complexity in product design and stringent government regulations are driving the market.

A significant rise in preclinical spending is a recent trend among pharmaceutical and medical device companies, which is expected to significantly contribute to market growth. As per a survey carried out by the International Federation of Pharmaceutical Manufacturers and Associations in 2017, around USD 149.8 billion is spent on preclinical trials every year.

With modern medical equipment offering a host of complex functions, the need for appropriate tests to check the compliance of the device with regulatory requirements is becoming vital. In order to meet the requirement of enhanced accuracy, ease of use, and durability, medical devices need to undergo extensive tests. This is expected to deliver a competitive advantage to manufacturers.

The COVID-19 pandemic has created an unprecedented demand for medical device testing services in 2020. This is largely due to the increasing demand for COVID-10 related products such as masks, PPE, and respiratory equipment. Besides, countries such as Mexico, Spain, and France have published pertinent specifications and standards, namely the UNE 0064-1, UNE 0064-2, AFNOR-SPEC-S76 and UNE 0065 which must be met until a mask can be sold.

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Medical Device Testing Services Market Report Highlights

  • The microbiology and sterility testing segment dominated the market in 2020 and accounted for the largest revenue share of 34.1%. The segment is likely to remain dominant over the forecast period

  • Producing safe and effective products is a core goal of medical equipment manufacturers and sterility assurance is a major component for achieving it

  • The preclinical phase segment dominated the market in 2020 and accounted for 65.7% of the revenue share as this stage is mostly focused on assessing the safety and biocompatibility of medical devices

  • Raw materials, packaging, and design all have an impact on a device's safety and compatibility, and preclinical testing of all of these factors is an important step in determining a device's market potential

  • Asia Pacific dominated the market and accounted for 41.8% of the revenue share in 2020. This is due to the rising demand for medical devices in developing nations such as India and China

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 Outlook (Revenue, USD Million, 2016 - 2028)

  • Biocompatibility Tests

  • Chemistry Test

  • Microbiology & Sterility Test

    • Bioburden Determination

    • Pyrogen & Endotoxin Testing

    • Sterility Test & Validation

    • Antimicrobial Activity Testing

    • Others

  • Package Validation

Medical Device Testing Services Phase Outlook (Revenue, USD Million, 2016 - 2028)

  • Preclinical

  • Clinical

Medical Device Testing Services Regional Outlook (Revenue, USD Million, 2016 - 2028)

  • North America

    • U.S.

    • Canada

  • Europe

    • U.K.

    • Germany

    • France

    • Italy

    • Spain

    • Netherlands

    • Belgium

    • Switzerland

    • Russia

    • Sweden

  • Asia Pacific

    • Japan

    • China

    • India

    • Australia

    • South Korea

    • Malaysia

    • Indonesia

    • Singapore

    • Philippines

    • Thailand

  • Latin America

    • Brazil

    • Mexico

    • Argentina

    • Colombia

    • Chile

  • Middle East & Africa

    • South Africa

    • Saudi Arabia

    • UAE

    • Israel

    • Egypt

List of Key Players of Medical Device Testing Services Market

  • SGS SA

  • Toxikon, Inc.

  • Eurofins Scientific

  • Pace Analytical Services LLC

  • Intertek Group Plc

  • Wuxi AppTec

  • North American Science Associates, Inc.


  • American Preclinical Services

  • Sterigenics International LLC

  • Charles River Laboratories International, Inc.

  • Medical Device Testing Services

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