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

Medical Device Analytical Testing Outsourcing Market Size, Share & Trends Analysis Report By Services, By Therapeutic Area (Cardiology, Diagnostic Imaging, Orthopedic), By End-use, By Device Type, By Region, And Segment Forecasts, 2021 - 2028

  • Published Date: Feb 2021
  • Report ID: GVR-1-68038-366-9
  • Number of Pages: 142
  • Format: Electronic (PDF)
  • Historical Data: 2016 - 2019

Report Overview

The global medical device analytical testing outsourcing market size was estimated at USD 4.8 billion in 2020 and is expected to expand at a compound annual growth rate (CAGR) of 7.6% from 2021 to 2028. Complexity in product design, intensifying competition, increase in the number of small size medical devices manufacturers, and strict approval norms are the key factors driving the market.

U.S. medical device analytical testing outsourcing market size, by services, 2016 – 2028 (USD Million)

The regulatory authorities also perform routine post-market surveillance by levying a fee from the manufacturer. Receipt of any complaints about the drawbacks of the product entails its withdrawal from the market, thereby proving the stringent nature of these procedures. The emergence of personalized medicine, drug-device combination, artificial intelligence, wearables, and increased focus on real-time patient monitoring resulted in a complex medical devices ecosystem. Real-time patient monitoring, remote patient monitoring, and continuous patient monitoring are the focal areas of interest when it comes to chronic disease management, such as diabetes and cardiovascular diseases.

The development of advanced devices such as surgical robots, surgical microscopes, ophthalmic surgical devices, and neurosurgery devices has reduced direct human interference in surgical procedures. In addition, increasing demand for minimally invasive surgeries bolstered the lucrative growth of this market. To maintain precision and accuracy, periodic maintenance and quality checks are required to meet the desired performance. Outsourcing quality checks of such devices is a wise option where a high level of experience and expertise is required.

Medical device companies today are operating in different worlds. In developed countries, such as the U.S., there is pricing pressure, hence, operators are exploring every possible way to reduce costs throughout the value chain. On the other hand, it is in the developing economies where the actual potential lies. However, developing regions are likely to be price sensitive. Hence, market players today are striving hard to reduce the overall cost of devices. Outsourcing analytical testing operations helps companies focus on product development and enhance marketing efforts.

COVID19 impact: Asia Pacific region to register a lucrative growth of 8.1%

Pandemic Impact

Post COVID Outlook

During the first half of 2020, much of the R&D and investigation work conducted by Medical Device Manufacturers (MDMs) was ceased; however, it later started to regain normalcy as the industry learned to operate amid the pandemic.

The pandemic has resulted in unprecedented levels of demand for device testing with requests for rapid turnaround times.

MDMs want to catch up on their delayed testing needs and be ready for the rollout of the new EU MDR. This requires plenty of testing and support from their lab partners, especially in-depth discussions regarding the General Safety and Performance Requirement (GSPR) 10.4.1 regarding carcinogens, mutagens, and reproductive toxins.

Advisory services with testing firms are completely booked, as medical device manufacturers rush to be ready for the new EU-MDR, which was supposed to be effective as of May 2021. Device firms are undertaking efforts to conduct the necessary testing to be compliant with the new EU-MDR to avoid products being withdrawn after May 2021

Most laboratories have reduced the presence of office staff in their facilities to the absolute minimum. This includes management, project managers, study directors and supporting staff.

Over the past year, there has been a major spike in demand for testing services, with timelines being extended in many cases. Numerous postponed projects have resumed and the industry is trying to accelerate processes.


The COVID-19 outbreak has emphasized the development of innovative low-cost medical devices. This crisis has led to economic and health pandemic globally. Due to this reason, various businesses have shut down their manufacturing plants and have halted most of the manufacturing process. The medical device TIC services have always been on the rise as its service plays an important role globally in protecting consumers from unsafe and poor quality medical device products. For example, due to COVID 19, the demand for masks has increased, and various countries have published relevant specifications such as UNE 0064-1, UNE 0065, and UNE 0064-2.

Service Insights

Material characterization services held a substantial share of 18.3% in 2020 and are anticipated to grow at a rate of 7.4% over the forecast period. Other tests are inclusive of cleaning, reprocessing, method development and validation, accelerated stability testing, biocompatibility, validation testing for packaging materials (container closure permeation), and transport stability. Medical devices are also subjected to extractable and leaching tests along with pharmaceutical formulations. This is undertaken to identify if any solutes and/or chemicals are present on the surface of the medical devices, which may be removed or leached out into the surrounding when used with the intended liquids.

Based on services, the market is segmented into extractable and leachable, material characterization, physical testing, bioburden testing, sterility testing, and other testing services.

Therapeutic Areas Insights

Cardiology medical device testing outsourcing held the largest revenue share of 20.9% in 2020 and it is also expected to witness remunerative growth over the forecast period. The rising demand for cardiovascular devices as a result of the increasing prevalence of associated conditions is attributed to the growth of outsourcing of these devices. As per the World Health Organization (WHO) statistics in 2015, 17.3 million people died due to cardiovascular diseases, and this number is expected to reach 23.6 million in 2030.

Moreover, the high complexity of cardiovascular devices and the need for technical expertise results in higher outsourcing of these devices. On the other hand, general and plastic surgery devices outsourcing is anticipated to exhibit lucrative growth over the forecast period. The availability of competent outsourcing firms that comply with the regulatory requirements, & rising demand for cosmetic surgeries are expected to be responsible for the growth of this segment.

Device Type Insights

Analytical testing outsourcing for other devices, which include single-use and expensive therapeutic and monitoring devices, held around 80.1% revenue share in 2020. Reprocessed devices are likely to grow at a lucrative rate over the forecast period.

End-use Insights

Hospitals dominated the end-use segment and accounted for the largest revenue share of around 86.7% in 2020. This can be attributed to greater patient volume and greater budget allocation for these operations by hospital management. Other healthcare settings such as diagnostic centers, ambulatory centers, and specialty care centers are also likely to gain lucrative share over the forecast period.

Global medical device analytical testing outsourcing market size, by end-use, 2020 (%)

The hospital segment is further sub-segmented into equipment and consumables. Equipment held around 39.7% share in hospital-based medical device analytical testing services market in 2020. These devices include imaging equipment, cardiology equipment, surgical devices, surgical microscopes, and therapeutic and monitoring devices. These devices are purchased for long-term use and outsourced for calibration tests, preventive maintenance tests, and performance tests.

Regional Insights

Asia Pacific dominated the medical device analytical testing outsourcing market and accounted for the largest revenue share of 41.8% in 2020. This is owing to improving healthcare infrastructure with government initiatives. Moreover, economic developments in countries such as India and China are expected to help market growth. A huge population base with low per capita income in the Asia Pacific led to high demand for affordable treatment options. Multinational companies are looking forward to investing in developing countries such as India and China.

North America held commanding shares in 2020. This can be attributed to the fact that it is one of the top manufacturing hubs of highly reliable, complex, and high-end medical devices. Consequently, original equipment manufacturers are increasingly moving toward electronics manufacturing service providers to efficiently handle the increasing volume of electronic components in the current medical devices. The rapid increase in the manufacture of medical devices to meet the rising demand for efficient healthcare in the region is expected to be one of the major factors propelling the development of the market.

Key Companies & Market Share Insights

Key players are focusing on adopting various growth strategies, such as partnership, mergers & acquisitions, and expansion of product portfolio to retain their market position. Service portfolio expansion along with regional penetration is anticipated to positively affect the market players. Some of the prominent players in the medical device analytical testing outsourcing market include:

  • SGS SA

  • Toxikon, Inc.

  • Eurofins Scientific

  • Pace Analytical Services, LLC

  • Intertek Group plc

  • WuXi AppTec.


  • Envigo

  • Charles River Laboratories International Inc.

  • Medical Device Testing Services

Medical Device Analytical Testing Outsourcing Market Report Scope

Report Attribute


Market size value in 2021

USD 5.4 billion

Revenue Forecast in 2028

USD 9.7 billion

Growth Rate

CAGR of 7.6% from 2021 to 2028

Base year for estimation


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 share, competitive landscape, growth factors, and trends

Segments covered

Service, therapeutic areas, device type, end-use, region

Regional scope

North America; Europe; Asia Pacific; Latin America; MEA

Country scope

U.S.; Canada; U.K.; Germany; China; Japan; Brazil; Mexico; South Africa; Saudi Arabia

Key companies profiled

SGS SA; Toxikon, Inc.; Eurofins Scientific; Pace Analytical Services, LLC; Intertek Group plc; WuXi AppTec.; NORTH AMERICAN SCIENCE ASSOCIATES INC.; Envigo; Charles River Laboratories International Inc.; Medical Device Testing Services

Customization scope

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

Pricing and purchase options

Avail customized purchase options to meet your exact research needs. Explore purchase options

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 global medical device analytical testing outsourcing market report based on service, therapeutic areas, device type, end-use, and region:

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

    • Extractable and leachable

    • Material characterization

    • Physical testing

    • Bioburden testing

    • Sterility testing

    • Other tests

  • Therapeutic Areas Outlook (Revenue, USD Million, 2016 - 2028)

    • Cardiology

    • Diagnostic Imaging

    • Orthopedic

    • IVD

    • Ophthalmic

    • General & Plastic Surgery

    • Drug Delivery

    • Endoscopy

    • Dental

    • Diabetes Care

    • Others

  • Device Type Outlook (Revenue, USD Million, 2016 - 2028)

    • Reprocessed Devices

      • Hospital

      • Others

    • Others

  • End-use Outlook (Revenue, USD Million, 2016 - 2028)

    • Hospital

      • Equipment

      • Consumables

    • Others

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

    • North America

      • U.S.

      • Canada

    • Europe

      • U.K.

      • Germany

    • Asia Pacific

      • Japan

      • China

    • Latin America

      • Brazil

      • Mexico

    • Middle East & Africa

      • South Africa

      • Saudi Arabia

Frequently Asked Questions About This Report

gvr icn


gvr icn

This FREE sample includes market data points, ranging from trend analyses to market estimates & forecasts. See for yourself.

gvr icn


We can customize every report - free of charge - including purchasing stand-alone sections or country-level reports, as well as offer affordable discounts for start-ups & universities.

Contact us now to get our best pricing.

BBB icon D&B icon

We are GDPR and CCPA compliant! Your transaction & personal information is safe and secure.