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Global Medical Device Testing Market Size, Share, Trends, COVID-19 Impact & Growth Research Report – Segmented By Services, Sourcing Type, Device Class & Region (North America, Europe, APAC, Latin America, Middle East and Africa), Industry Forecast (2022 to 2027)

Published: March, 2022
ID: 12866
Pages: 190
Formats: report pdf report excel report power bi report ppt

Global Medical Device Testing Market Size (2022 to 2027)

The size of the global medical device testing market is forecasted to be growing at a CAGR of 5.12% from 2022 to 2027 and worth USD 13.64 billion by 2027 from USD 10.63 billion in 2022.

COVID-19 pandemic has affected almost every industry in the world, closing their factories and stopping most of their activities. Due to the increase in the number of coronavirus cases, the government has taken several measures to prevent the spread of the virus. As a result, healthcare systems are overburdened in delivering medical care systems to the most affected regions.  Less importance has been given to surgeries, primarily cosmetic surgeries such as breast implantation, lipoplasty, and non-essential dental procedures due to COVID-19, which acted as a restraining factor for medical devices adoption at the beginning of the pandemic.

On the other hand, the COVID-19 pandemic has positively impacted the medical devices market as more and more medical devices have been required to treat patients infected with COVID-19. Since medical devices are in short supply during the pandemic, personal protective equipment (PPE) is the most testing medical device. PPE testing includes validating its reusability and forming single-use masks. During the pandemic, some of the masks were intended as single-use products. In addition, the COVID-19 outbreak has increased the demand for automated quality even more because there has been less human interaction in the process. As a result, machine vision is now recognized as an essential step in the long-term development of automation.


Increasing technical advancements, the growing need for verification and validation of medical devices, and the rise in in-vitro tests are primarily accelerating the growth of the global medical device testing market.

The verification and validation methods are essential methods in the healthcare sector. Verification is one of the important phases in developing a product. It is used to verify whether the product has been developed based on given requirements and validation checks whether the intended use has been met. Thus, usability specifics are fulfilled. Design, process, and software verification and validation are the methods of verification and validation for medical devices. Medical devices use smaller, more significant, and advanced designs. This makes the validation and verification process more critical. The importance of this test is better repeatability, less rework and redesign, faster market time, fewer mistakes, improved competitiveness, and lower production costs.

Medical device testing is the most used in vitro diagnostics (IVD). It tests on samples such as blood or tissue taken from the human body. It can detect various diseases and monitor a person's overall health to help cure, treat, or prevent diseases. In-vitro tests are used in various disease detections, such as HIV infections, malaria, and hepatitis. The increasing prevalence of such diseases rapidly results in the growing demand for in-vitro tests and various medical devices.

Technological advancements such as IoT and AI in various devices are a key growth factor for the global medical device testing market. Key companies are focusing on manufacturing these advanced products. Innovation and advanced medical devices help for the accurate result of disease diagnosing invention in medical devices also provide cost-effectiveness of technology-based therapeutic tools during disease treatment. Various governmental bodies and healthcare providers also support the medical research centers. In 2021, PaxeraHealth announced that it had launched an AI-based imagining platform in the U.S.

Increasing need for verification and validation for medical devices, increased adaption of various portable medical devices and wearable medical devices, increasing healthcare expenditure, wearable devices, developments in the field of drug-device combination, integration of mobile and medical devices, personalized medicine, stringent government rules and standards across medical devices and medical device technologies are the major driving factors for the growth of medical device testing market in coming years.


Increasing the cost, long time for manufacturing of products, and high competition in medical devices are the restraining factors for medical device testing market growth. In addition, lack of testing facilities, changing regulations and standard rules, and lack of skilled professionals for testing medical devices are challenging the growth of the medical device testing market.




Market Size Available

2020 to 2026

Base Year


Forecast Period

2021 to 2026

Segments Covered

By Services, Sourcing Type, Device Class & Region

Various Analyses Covered

Global, Regional & Country Level Analysis, Segment-Level Analysis, Drivers, Restraints, Opportunities, Challenges, PESTLE Analysis, Porter’s Five Forces Analysis, Competitive Landscape, Analyst Overview on Investment Opportunities

Regions Covered

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


This research report on the global medical device testing market has been segmented and sub-segmented based on services, sourcing type, device class & region.

Medical Device Testing Market – By Service Type:

  • Testing Services
  • Inspection Services
  • Certification Services

Based on the service type, the resting service segment had the largest share of the global medical device testing market in 2021. There is an increasing demand for testing services in medical devices due to increased demand for products, increasing awareness among consumers, and high-quality products.  Testing services verify the products that have met the required quality and safety. Testing services help manufacturers improve the marketability of their medical devices and lower costs in the pre-production phase. Certifications certify that the manufacturers of the medical products have followed the standards and quality and safety rules during the production process.

Medical Device Testing Market – By Sourcing Type:

  • In-house
  • Outsourced

Based on the sourcing type, the outsourced segment led the market for medical device testing worldwide in 2021. Large international companies are focusing on increasingly outsourcing medical device testing services to help reduce overall testing costs. In addition, outsourcing TIC services are growing to third-party vendors if the testing requires the implementation of complex technologies.

Medical Device Testing Market – By Device Class:

  • Class I
  • Class II
  • Class III

Based on the device class, the class III segment is forecasted to register the largest share in the global medical device testing market between 2022 to 2027. Classifying medical devices are essential due to the presence of potential risks associated with medical devices. In addition, class III medical devices are used to support human life. For example, heart valve replacements, pacemakers, and pulse generators are class III medical devices.

Medical Device Testing Market – By Region:

  • North America
  • Europe
  • Asia-Pacific
  • Latin America
  • Middle East and Africa

Geographically, the Asia-Pacific region dominated the medical device testing market in 2021 due to rising consumer awareness, increasing disposable income, and advancements in the healthcare infrastructure in China and Japan. In addition, there is growing awareness regarding healthcare devices in India after the pandemic, especially after the pandemic has forced the government to invest in research and development of new portable and accurate equipment.

On the other hand, North America was so close to the Asia-Pacific in accounting for the same amount of the share occupied by the Asia-Pacific region in the global market in 2021. The dominance of the North American region can be credited to increased awareness among the users about the safety and security of medical devices in the US and the growing adoption of advanced devices. In addition, stringent regulatory bodies such as the FDA are fuelling the market growth. According to the Centre for Medicare & Medicaid Services, the United States spent USD 3.6 trillion on healthcare in 2018.   Healthcare expenditure accounted for 17.7 percent of the GDP of the country.  Increasing demand for medical device testing services in this region and approval of many medical devices may promote market expansion. All these factors have fuelled the market in the North American region.


Toxikon, Inc., Intertek Group plc, Pace Analytical Services, Charles River Laboratories International, Inc., American Preclinical Services LLC, North American Science Associates, Inc., Sterigenics International LLC, Eurofins Scientific, WuXi AppTec Group, Bureau Veritas, TÜV SÜD, Elements Material Technology, and Envigo are a few of the notable players in the global medical device testing market profiled in this report.


  • In 2020, Intertek announced the expansion of its personal protective equipment services to include precertification testing of N95 Respirator Precertification Testing by the National Institute for Occupational Safety and Health.
  • In 2022, TUV SUD announced the expansion of its Medical & Health Services facilities in New Brighton, Minnesota.

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How big is the global medical device testing market?

By 2027, the size of the global medical device testing market is estimated to be worth USD 13.64 billion.

Which segment by service type is expected to dominated the market?

By services type, the testing segment is expected to lead the global medical device testing market in the coming years.

Which region is expected to dominate the medical device testing market?

Between 2022 to 2027, as per our research report, the APAC region is predicted to dominate the medical device testing market.

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