Medical Devices Testing Services Market Expansion is $19.65 Billion with 9.40% CAGR by 2032

Medical Device Testing Services Market Size Worth $19.65 Billion By 2032 | CAGR: 9.40%

The global medical device testing services market size is expected to reach USD 19.65 billion by 2032, according to a new study by Polaris Market Research. The report Medical Device Testing Services Market Share, Size, Trends, Industry Analysis Report, By Service (Microbiology and Sterility Testing, Chemistry Test, Biocompatibility Test, Package Validation); By Phase; By Region; Segment Forecast, 2024 - 2032” gives a detailed insight into current market dynamics and provides analysis on future market growth.

Medical device testing is an essential process that guarantees the reliability and safety of a device when in use. In the course of new product development, comprehensive design validation testing is carried out, which includes toxicity tests, performance testing, chemical analysis, and sometimes even human factors or clinical testing.

The increasing popularity of wearable and portable medical devices is anticipated to be a key driving force behind this expansion. Furthermore, government programs dedicated to enhancing healthcare infrastructure and boosting healthcare resources are bolstering the demand for testing services within this industry.

Rigorous regulatory guidelines, represented by the FDA and EMA directive, in-depth medical device assessments to guarantee their safety and effectiveness. The imperative for ongoing advancements necessitates thorough testing protocols to mitigate emerging risks and amplify patient well-being. An increasing need for medical devices, propelled by the aging demographic and soaring healthcare expenses, has precipitated substantial expansion within the testing sector. Consequently, numerous medical device enterprises are now subcontracting their testing requirements to specialized organizations.

COVID-19 has impacted medical device testing. The healthcare system prioritized testing and validating COVID-19 medical devices, causing a rise in demand for rapid diagnostic tests, ventilators, PPE, and other essential devices. Telehealth and remote monitoring devices were also developed, requiring new testing protocols. However, traditional supply chains were disrupted, causing delays in testing non-COVID-19 devices. The pandemic is expected to lead to a more streamlined and technologically advanced approach to testing, with a focus on remote and virtual methods, as well as shaping the regulatory landscape for future health crises.

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Additionally, a study published in the National Library of Medicine in June 2021 highlighted the significant impact of coronary artery disease (CAD) on global health. CAD alone is responsible for approximately 610,000 deaths annually, accounting for an estimated one in four deaths and making it the foremost cause of mortality in the United States. With the incidence of CAD rising, there is a growing demand for effective coronary stent devices to address this pressing medical need. Consequently, this factor is projected to drive the demand for coronary stents throughout the forecast period.

Medical Devices Testing Services Market Report Highlights

  • The microbiology and sterility test segment held the largest revenue share in the medical devices testing services market. Microbiology and sterility testing are essential in reducing contamination risks and preventing infections. These tests are necessary to avoid regulatory delays. The field includes Pyrogen and Endotoxin testing, sterility test validation, bioburden determination, and antimicrobial activity testing.
  • The clinical segment accounted for the highest market share during the forecast period. The clinical phase is crucial for medical device development. It involves testing the device on humans to evaluate its safety and effectiveness. Clinical trials gather data to support regulatory approval and commercialization. Precise data collection, management, and analysis are essential, and testing services play a pivotal role in maintaining data quality.
  • Asia Pacific dominated the largest market in the medical devices testing services market The area will see growth due to global interest in Chinese and Indian markets, driven by China's strict product approval standards and better healthcare infrastructure. There is also an increase in medical device testing services availability due to China's significant global exportation.
  • The North America region accounted for the fastest growth in the medical devices testing services market. The region's demand for TIC services is increasing, which will significantly boost regional market expansion. The sub-continent is well-positioned to penetrate the market due to increasing product design complexity and cost reduction pressure. The thriving pharmaceutical sector and substantial medical device manufacturing companies' presence will drive significant growth in the medical device testing industry across the region.
  • The global key market players include American Preclinical Services, Charles River Laboratories, Element Minnetonka, Eurofins Scientific, Intertek Group Plc., Labcorp (Toxikon, Inc), North America Science Associates Inc., Pace Analytical Services LLC, SGS S.A., and Sterigenics International LLC.

Polaris Market Research has segmented the medical devices testing services market report based on service, phase and region:

Medical Devices Testing Services, Service Outlook (Revenue - USD Billion, 2019 - 2032)

  • Microbiology and Sterility Testing
    • Bioburden Determination
    • Pyrogen & Endotoxin Testing
    • Sterility Test & validation
    • Antimicrobial testing
    • Others
  • Chemistry Test
  • Biocompatibility Test
  • Package validation

Medical Devices Testing Services, Phase Outlook (Revenue - USD Billion, 2019 - 2032)

  • Clinical
  • Pre-Clinical

Medical Devices Testing Services, Regional Outlook (Revenue - USD Billion, 2019 - 2032)

  • North America
  • U.S.
  • Canada
  • Europe
  • Germany
  • UK
  • France
  • Italy
  • Spain
  • Russia
  • Netherlands
  • Asia Pacific
  • China
  • India
  • Japan
  • South Korea
  • Indonesia
  • Malaysia
  • Latin America
  • Argentina
  • Brazil
  • Mexico
  • Middle East & Africa
  • UAE
  • Saudi Arabia
  • Israel
  • South Africa

Medical Device Testing Services Market Report Scope

Report Attributes


Market size value in 2024

USD 8.80 billion

Revenue forecast in 2032

USD 19.65 billion


9.40% from 2024 – 2032

Base year


Historical data

2019 – 2022

Forecast period

2024 – 2032

Quantitative units

Revenue in USD billion and CAGR from 2024 to 2032

Segments Covered

By Service, By Phase, By Region

Regional scope

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


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