Medical Device Testing Market Size, Share, by Services (Testing, Inspection, Certification); Technology (Active Implant Medical Device, Active Device, Non-Active Device, In Vitro Diagnostic); Application (Active Implant, In-vitro Diagnosis, Orthopedic & Dental, Ophthalmic, Vascular); End-user (Hospital, Research Center, Homecare Clinics) - Global Supply & Demand Analysis, Growth Forecasts, Statistics Report 2023-2035

  • Report ID: 3866
  • Published Date: Aug 07, 2023
  • Report Format: PDF, PPT

Global Market Size, Forecast, and Trend Highlights Over 2023 - 2035

Medical Device Testing Market size is set to reach USD 25 Billion by the end of 2035, growing at a CAGR of 5% during the forecast period, i.e., 2023-2035. In the year 2022, the industry size of medical device testing was over USD 9 Billion. Consumers repeatedly are demanding effectiveness, outstanding performance, and security from medical devices. This factor has raised the demand for the verification and validation of medical devices. Therefore, it is compulsory for manufacturers to properly define and test medical devices for confirmation of quality. The government authorities of various regions have mandated the medical testing procedure for medical devices before their use.  

Advancement in technology such as the adoption 0f AI or IoT in multiple medical devices is expected to create lucrative growth opportunities for the sector. Various companies are now incorporating these technologies into their devices. Innovative and advanced medical devices aid in accurate results of disease diagnosing invention in medical devices and also offers cost-friendly technology-based therapeutic tools for disease treatment. Various government authorities and companies do promote medical research centers. In 2021, PaxeraHealth declared that it had established an AI-based imagining platform in the United States

Medical Device Testing
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Medical Device Testing Landscape: Key Insights

Base Year


Forecast Year

2023 – 2035



Base Year Market Size (2022)

~USD 9 billion

Forecast Year Market Size (2035)

~USD 25 billion

Regional Scope

  • North America (U.S., and Canada)
  • Latin America (Mexico, Argentina, Rest of Latin America)
  • Asia-Pacific (Japan, China, India, Indonesia, Malaysia, Australia, Rest of Asia-Pacific)
  • Europe (U.K., Germany, France, Italy, Spain, Russia, NORDIC, Rest of Europe)
  • Middle East and Africa (Israel, GCC North Africa, South Africa, Rest of the Middle East and Africa)
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Medical Device Testing Sector: Growth Drivers and Challenges


Growth Drivers

  • Increasing Demand for Medical Devices – As the utilization of medical devices grows, consumers start demanding devices that ensure safe, and effectiveness and meet regulatory requirements. This attribute has boosted the growth in the medical device testing market, as market players now offering testing services and equipment to ensure the quality of medical devices. As per the statistics, the revenue in the Medical Devices segment reached a value of ~USD 480 billion in 2021.
  • Growing Geriatric Population Globally – As the geriatric population increases, the demand for various medical devices also seems to grow owing to the demand for treatment of aged people suffering from various health conditions and diseases. This has increased the invention of innovative and advanced medical devices as well as raised the focus on ensuring that these devices are effective and safe with the help of rigorous testing methods. By 2030, 1 in 6 people is estimated to be over the age of 60 years old. An estimated 2.1 billion people are anticipated to be above the age of 60 or under the geriatric population by 2050 globally. 
  • Growing Complexity in Medical Devices – The complexities in medical devices are growing day by day, which is expected to drive the need for specialized testing services and devices. As medical devices become complex the testing needed for the medical equipment to check their safety and effectiveness becomes complex which raises the demand for medical device testing.  
  • A surge in Demand for In-Vitro Tests – Medical device testing is used in In-vitro diagnostics to detect various harmful health conditions such as HIV, malaria, hepatitis, and others. It is tested on human body samples such as on blood or tissue. 


  • High Initial Investment – Medical device testing involves high initial investment, especially in terms of complex devices that need extensive testing. This can emerge as a barrier in front of this market in the upcoming times. 
  • Strict Regulations on Medical Device Standards
  • Rapidly Changing Technology 

Medical Device Testing Segmentation

Services (Testing, Inspection, Certification)

The testing segment is anticipated to observe the largest market value throughout the forecast period in terms of service segment. The testing segment is high in demand in the medical device testing market owing to increased demand for advanced products, awareness among consumers, and high-quality products. The testing service aids in reducing the cost of the pre-production phase along with this it enhances the marketability of medical devices.

Moreover, in response to the urgent demands of patients and healthcare systems around the world dealing with COVID-19. Medtronic PLC announced in March 2020 that it had increased production by more than 40% to date and was on track to more than double its capacity to manufacture and supply ventilators. ​


End-User (Hospitals, Research Centers, Homecare Clinics)

Based on end-user segmentation, the hospital segment is predicted to hold 38% share of the global medical device testing market in the projected period. Hospitals use all types of medical devices from simple diagnostic devices to complex ones, and these devices must be checked and verified before use to ensure their safety and effectiveness. 

Our in-depth analysis of the global market includes the following segments:


  • Testing
  • Inspection
  • Certification


  • Active Implant Medical Device
  • Active Device
  • Non-Active Device
  • In Vitro Diagnostic


  • Active Implant
  • In-vitro Diagnosis (IVD)
  • Orthopedic & Dental
  • Ophthalmic
  • Vascular

End User

  • Hospital
  • Research Center
  • Homecare Clinics

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Medical Device Testing Industry - Regional Synopsis

APAC Market Forecast

The medical device testing market in the Asia Pacific region is estimated to witness noteworthy growth of over 35% in the estimated period. The regional growth is attributed to the large geriatric population in countries, such as India and China.  As the old population rises in the region prevalence of chronic and other kinds of diseases grows leading to the major demand for medical devices and medical device testing.

Moreover, improving healthcare facilities, along with rising health awareness amongst the people, are projected to boost the market growth in this region over the upcoming decades.  

North American Market Statistics

The North American medical device testing market is poised to gain the largest market share throughout the projected period. The regional growth is ascribed to the high investment in testing activities, along with increasing investment in R&D activities in the region. The American Medical Association estimates that the United States spent USD 4.3 trillion, or USD 12.914 per person, on healthcare in 2021.

Additionally, as more medical devices are approved in the area, rising demand for medical device testing services may promote market expansion over the forecast timeframe.

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Medical Device Testing Market
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Companies Dominating the Medical Device Testing Landscape

    • Intertek Group PLC
      • Company Overview
      • Business Strategy
      • Key Product Offerings
      • Financial Performance
      • Key Performance Indicators
      • Risk Analysis
      • Recent Development
      • Regional Presence
      • SWOT Analysis 
    • SGS S.A.
    • TUV Rheinland Group
    • Eurofins Scientific
    • Cordant Health Solutions
    • Legacy Medical Services, LLC
    • Omega Laboratories, Inc.
    • GE Healthcare
    • Thermo Fisher Scientific, Inc.
    • Siemens AG


In The News

  • Eurofins Scientific and Transgenic Inc. Acquired Genetic Lab Co., Ltd. To establish a network of clinical diagnostics laboratories in Asia. 
  • Intertek expanded its business to personal protective equipment services, including respirator precertification testing after COVID-19.

Author Credits:  Radhika Gupta, Shivam Bhutani

  • Report ID: 3866
  • Published Date: Aug 07, 2023
  • Report Format: PDF, PPT

Frequently Asked Questions (FAQ)

The growing geriatric population is estimated to boost the market growth.

The market is anticipated to attain a CAGR of 5% over the forecast period, i.e., 2023 – 2035.

The major players in the market are SGS S.A., TUV Rheinland Group, Eurofins Scientific, Cordant Health Solutions, Legacy Medical Services, LLC, Omega Laboratories, Inc., GE Healthcare, and others.

The IVD segment is anticipated to garner the largest market size by the end of 2035 and display significant growth opportunities.

The market in North America is projected to hold the largest market share by the end of 2035 and provide more business opportunities in the future.
Medical Device Testing Market Report Scope

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