GVR Report cover Preclinical Medical Device Testing Services Market Size, Share & Trends Report

Preclinical Medical Device Testing Services Market Size, Share & Trends Analysis Report By Service (Biocompatibility Tests, Chemistry Test, Microbiology & Sterility Testing), By Region, And Segment Forecasts, 2022 - 2030

  • Report ID: GVR-4-68039-943-4
  • Number of Pages: 275
  • Format: Electronic (PDF)
  • Historical Range: 2018 - 2020
  • Industry: Healthcare

Report Overview

The global preclinical medical device testing services market size was valued at USD 5.7 billion in 2021 and is anticipated to exhibit a CAGR of 11.3% during the forecast period. The growing demand for technologically advanced medical devices is one of the key reasons driving the market. Apart from this, the strict regulations by the regulatory authorities to develop high-quality devices are further promoting the market. The COVID-19 pandemic had created an urgent need for medical devices owing to which several medical device companies around the globe developed new devices for testing COVID-19. This is likely to have a positive impact on the market.

U.S. preclinical medical device testing services market size, by service, 2020-2030 (USD Billion)

The high prevalence of diseases is creating an interest among the manufacturers to develop new medical devices. Product design and development of medical devices is a complex procedure. The high complexities associated with medical device design and the growing prevalence of diseases are likely to increase the demand for preclinical medical device testing services.

Over the years, the technological advancements in medical devices have improved. Medical devices now are equipped with IoT and AI. Moreover, the market players are also keen on launching advanced medical devices to stay competitive in the market. For instance, in August 2021, PaxeraHealth, a provider of imagining heath announced that it is launching an AI-based imagining platform in the U.S. Such initiatives are further expected to enhance the demand for preclinical medical device testing services.

During the advent of the COVID-19 pandemic, the preclinical medical device trials were not focused on treating and diagnosing diseases like cancer, cardiovascular diseases, and other diseases owing to the widespread of COVID-19 globally. This had slowed down the market to some extent. The pandemic, however, had created an urgent demand for PPE kits, masks, IVD kits, and other devices so as to curb the spread of disease. The public organizations were also keen to support the development of medical devices for diagnosing and treating COVID-19. For instance, in April 2021 the NIH provided USD 443,000 funding to the Rutgers researchers to develop the COVID-19 Breathalyzer Test. Such initiatives are expected to have a positive impact on the market.

Service Insights

The microbiology & sterility testing segment accounted for the maximum revenue share of 34.2% in 2021. Microbiology & sterility testing is one of the major tests included in pre-clinical medical device testing. These tests help in detecting the presence of microorganisms in the device. The FDA and other regulatory bodies require these tests for validation purposes. These tests are also performed as a part of regular quality control. The growing demand for medical devices globally is driving the segment growth.

The chemistry test segment is expected to rise with the fastest CAGR of 11.7% over the forecast period. Chemical testing is done for characterizing, identifying, and comprehending the chemicals used for manufacturing medical devices. Chemical testing complies with the ISO 10993-17 and 10993-18T regulations. The complexities associated with the designing of medical devices are driving the segment growth.

Regional Insights

North America held a substantial revenue share of 25.6% in 2021. The rise in the demand for advanced medical devices and the presence of sophisticated infrastructure for developing complex, highly reliable, and high-end medical devices is driving the preclinical medical device testing services market in the region. Moreover, the presence of key players operating in the market is further contributing to the growth of the North American market.

Global preclinical medical device testing services market share, by region, 2021 (%)

The Asia Pacific market is expected to rise with the fastest growth of 12.2% over the forecast period. The low cost associated with outsourcing medical device testing services in the Asia Pacific is one of the major factors driving the regional market. The growing demand for advanced medical devices in the region owing to the growing disease burden is further contributing to the regional market growth.

Key Companies and Market Share Insights

Expansions, acquisitions, and partnerships among others were the key strategies adopted by key players to maintain their market share. For instance, in December 2021, life sciences company LabCorp acquired Toxikon Corporation a preclinical contract research organization. This acquisition was intended to expand Labcorp’s nonclinical development testing capabilities for medical device, biotech, and pharmaceutical clients. Similarly, in November 2019, WuXiAppTec lab testing division expanded its toxicology facility in Suzhou China to provide full-service preclinical and clinical-stage toxicology. Some prominent players in the global preclinical medical device testing services market include:

  • SGS SA

  • Labcorp

  • Eurofins Scientific

  • Pace Analytical Services LLC

  • Intertek Group Plc



  • Sterigenics International LLC

  • Nelson Labs

  • North American Science Associates, Inc.

  • Charles River Laboratories International, Inc.

Preclinical Medical Device Testing Services Market Report Scope

Report Attribute


Market Size value in 2022

USD 6.3 billion

Revenue forecast in 2030

USD 14.9 billion

Growth Rate

CAGR 11.3% from 2022 to 2030

Base year for estimation


Historical data

2018 - 2020

Forecast period

2022 - 2030

Quantitative units

Revenue in USD Million and CAGR from 2021 to 2028

Report coverage

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

Segments covered

Service, region

Regional scope

North America; Europe; Asia Pacific; Latin America; Middle East & Africa

Country scope

U.S.; Canada; U.K.; Germany; France; Italy; Spain; Netherland; Belgium; Switzerland; Russia; Sweden India; Japan; China; Thailand; South Korea; Australia; Malaysia; Indonesia; Singapore; Philippines; Brazil; Mexico; Argentina; Colombia; Chile;  South Africa; Saudi Arabia; UAE; Israel; Egypt

Report coverage

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

Key companies profiled

SGS SA; Eurofins Scientific; Pace Analytical Services LLC; Intertek Group Plc; WUXI APPTEC; TÜV SÜD AG; Sterigenics International LLC; Nelson Labs; North American Science Associates, Inc.; Charles River Laboratories International, Inc

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Segments Covered in the Report

This report forecasts revenue growth at global, regional & country levels and provides an analysis of the latest industry trends in each of the sub-segments from 2018 to 2030. For the purpose of this study, Grand View Research has segmented the global preclinical medical device testing services market report on the basis of service and region

  • Service Outlook (Revenue, USD Million, 2018 - 2030)

    • Biocompatibility Tests

    • Chemistry Test

    • Microbiology & Sterility Testing

      • Bioburden Determination

      • Pyrogen & Endotoxin Testing

      • Sterility Test And Validation

      • Antimicrobial Activity Testing

      • Others

    • Package Validation

  • Regional Outlook (Revenue, USD Million, 2018 - 2030) 

    • North America

      • U.S.

      • Canada

    • Europe

      • France

      • Germany

      • U.K.

      • 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

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