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

Medical Device Testing Services Market Size, Share & Trends Analysis Report By Service (Biocompatibility Tests, Chemistry Test, Microbiology & Sterility Test, Package Validation), By Phase, By Region, And Segment Forecasts, 2021 - 2028

  • Published Date: May, 2021
  • Base Year for Estimate: 2020
  • Report ID: GVR-2-68038-115-3
  • Format: Electronic (PDF)
  • Historical Data: 2016 - 2019
  • Number of Pages: 100

Report Overview

The global medical device testing services market size was estimated at USD 7.8 billion in 2020 and is expected to expand at a compound annual growth rate (CAGR) of 11.6% from 2021 to 2028. 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.

U.S. medical device testing services market size, by service, 2016 - 2028 (USD Billion)

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 facemasks were intended as single-use products. However, owing to their global shortage, numerous manufacturers are working on options to test these masks for multiple uses. The test includes fitment tests, adherence to original filtration specifications, and sterilization tests.

Additionally, technological advancements such as Artificial Intelligence (AI), and wearables, combined with a special emphasis on real-time monitoring of patients, have led to a complex medical device ecosystem. These devices should undergo rigorous testing under accelerated conditions in order 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, these different regulations in different countries make it challenging to launch a product on a global scale.

Service Insights

The microbiology and sterility testing segment dominated the medical device testing services market and accounted for the largest revenue share of 34.1% in 2020. The segment is further divided into bioburden determination, pyrogen, and endotoxin testing, sterility test and validation, and anti-microbial activity testing. Microbiology and sterility testing is performed to eliminate or reduce the risk of contamination in the production process, which may cause infections in patients or users of products. Failure to perform such tests might delay the regulatory process for devices.

The package validation segment ensures product integrity and protects against damage throughout the supply chain. Though the market is less monopolized and accounted for 14.0% of the revenue share in 2020. The manufacturers of the companies are now considering environmental and economic factors to revalidate their packaging. Also, regulatory authorities such as FDA have increased their focus on medical device packaging which is acting as a driving force behind the market growth.

Phase Insights

The preclinical phase led the market for medical device testing services and accounted for the largest revenue share of more than 60.0% in 2020. The segment is also anticipated to dominate the market over the forecast period, as a major portion of biocompatibility, microbiology, and chemistry tests are performed in this phase.

Global medical device testing services market share, by phase, 2020 (%)

Medical device testing services during the clinical trial phase are expected to grow significantly in the coming years. As medical devices are critical they have a direct impact on human lives. Hence, the medical device manufacturers are required to follow the testing along with verification & validation practices to ensure the quality & reliability of medical devices. This is anticipated to contribute towards the growth of the market for medical device testing services.

Regional Insights

Asia Pacific led the market for medical device testing services and accounted for the largest revenue share of 41.8% in 2020. The region is also expected to grow at a significant rate during the forecast period due to growing global interest in the China and India markets, stringent product approval in countries such as China, and advancements in healthcare infrastructure. China is the leading exporter for many companies around the world, which has resulted in an increase in medical device testing services in the country to maintain compliance with international standards.

In North America, the market for medical device testing services accounted for the second-largest revenue share in 2020 and is expected to grow rapidly during the forecast period. The major factors driving this regional market are expected to be increasing complexity in product design and growing efforts toward cost-cutting. Besides, the presence of stringent regulatory bodies such as the FDA is fueling the growth of the market for medical device testing services.

Key Companies & Market Share Insights

Market players are undertaking various strategic initiatives such as the launch of new services, partnerships, collaborations, mergers and acquisitions, geographic expansion, aiming to strengthen their product portfolio and provide a competitive advantage.

For example, in June 2020, Intertek Plc has announced the addition of N95 respirator precertification testing to the National Institute for Occupational Safety and Health standards to its personal protective equipment services. Eurofins Medical Device Testing is also determined to provide professional support in evaluating the safety and efficacy of devices used in the fight against COVID-19. Some of the prominent players in the medical device testing services market include:

  • SGS SA

  • Toxikon, Inc.

  • Eurofins Scientific

  • Pace Analytical Services LLC

  • Intertek Group Plc

  • Wuxi AppTec

  • North American Science Associates, Inc.

  • TÜV SÜD AG

  • American Preclinical Services

  • Sterigenics International LLC

  • Charles River Laboratories International, Inc.

  • Medical Device Testing Services

Medical Device Testing Services Market Report Scope

Report Attribute

Details

Market Size value in 2021

USD 8.7 billion

Revenue forecast in 2028

USD 18.6 billion

Growth Rate

CAGR of 11.6% from 2021 to 2028

Base year for estimation

2020

Historical data

2016 - 2019

Forecast period

2021 - 2028

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, phase, region

Regional scope

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

Country scope

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

Key companies profiled

SGS SA; Toxikon, Inc.; Eurofins Scientific; Pace Analytical Services LLC; Intertek Group Plc; Wuxi AppTec; North American Science Associates, Inc.; TÜV SÜD AG; American Preclinical Services; Sterigenics International LLC; Charles River Laboratories International, Inc.; Medical Device Testing Services

Customization scope

Free report customization (equivalent up to 8 analyst’s working days) with purchase. Addition or alteration to country, regional & segment scope.

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Segments Covered in the Report

This report forecasts revenue growth at global, regional, and country levels and provides an analysis of the latest industry trends in each of the sub-segments from 2016 to 2028. For the purpose of this study, Grand View Research has segmented the medical device testing services market report on the basis of service, phase, and region:

  • Service 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

  • Phase Outlook (Revenue, USD Million, 2016 - 2028)

    • Preclinical

    • Clinical

  • 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

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