Medical Device Testing Services Market Size - By Services (Biocompatibility Tests, Chemistry Test, Microbiology & Sterility Testing, Package Validation), By Phase (Preclinical, Clinical), Global Forecast, 2023 – 2032

Medical Device Testing Services Market Size

Medical Device Testing Services Market size was valued at around USD 7.5 billion in 2022 and it is anticipated to reach over 16.7 billion by 2032 at a CAGR of 8.5%. Rising complexity of medical devices, advancements in testing technologies, stringent regulatory requirements and focus on patient safety among others are key trends shaping the market growth.
 

As medical devices become more advanced and complex, their testing requirements also become more intricate. Manufacturers often lack the resources and expertise to perform these specialized tests in-house, leading them to rely on third-party testing services. Additionally, healthcare professionals, including doctors and surgeons, are becoming more conscious of the importance of using approved and tested medical devices. As a result, they are more likely to recommend and use devices that have undergone thorough testing and certification.
 

Patient safety is of utmost importance in the healthcare industry. Thorough testing of medical devices helps identify potential risks and ensures that only safe and effective products reach the market, benefiting patients and healthcare providers. As the medical industry continues to evolve, the need for reliable and comprehensive testing will remain a critical factor for ensuring patient safety and market success for manufacturers.
 

Medical device testing services refer to the comprehensive range of tests and evaluations conducted on medical devices to ensure their safety, efficacy, and compliance with regulatory standards before they are approved for use in the market. These services are crucial in the medical industry as they help identify potential risks associated with the devices and confirm their performance and reliability.

However, while stringent regulations can drive demand for testing services, they can also create obstacles for some manufacturers. Meeting complex regulatory requirements can be time-consuming and costly, particularly for companies operating in multiple countries with varying regulatory frameworks. Comprehensive testing of medical devices can be expensive, especially when using advanced technologies and specialized equipment. This cost burden may deter some manufacturers, particularly smaller ones, from seeking professional testing services and could lead to delays in bringing products to market.
 

Further, some medical device manufacturers, particularly smaller or newer companies, may not fully understand the importance of comprehensive testing or the regulatory requirements. This lack of awareness can hinder the growth of the market.
 

COVID-19 Impact

The COVID-19 pandemic negatively impacted the medical device testing services market revenue in 2020. The pandemic caused disruptions in global supply chains, affecting the availability of testing equipment, reagents, and other essential resources. This led to delays in testing processes and impacted service providers' ability to meet testing demands promptly. The economic impact of the pandemic led to financial constraints for many medical device manufacturers. Some companies had to cut costs, leading them to postpone or reduce their spending on testing services. Further, the focus of regulatory bodies shifted towards addressing the public health crisis, which led to delays in the approval process for some medical devices. This affected the timelines for testing service providers, as well as manufacturers trying to launch new products.
 

However, the pandemic increased the demand for specific medical devices such as ventilators, personal protective equipment (PPE), diagnostic tests, and remote patient monitoring devices. This surge in demand drove the need for testing services related to these critical products. It also prompted the adoption of remote and virtual testing methods where possible, allowing some testing service providers to continue operations despite physical restrictions. While the initial disruptions were challenging, the increased focus on healthcare preparedness and the accelerated innovation in the medical device industry have opened new avenues for growth in the testing services sector.
 

Medical Device Testing Services Market Trends

Stricter approval norms and regulations imposed by regulatory authorities serve several essential purposes, and their emphasis has a direct impact on the demand for testing services. The primary objective of strict approval norms is to ensure the safety of patients and users of medical devices. By mandating comprehensive testing and evaluation of devices, regulatory bodies aim to identify and mitigate potential risks associated with these products. The focus on patient safety increases the demand for testing services to thoroughly assess the devices before they reach the market.
 

Additionally, adherence to stringent approval norms helps reduce the likelihood of product recalls and legal liabilities for manufacturers. By ensuring that medical devices have undergone thorough testing, potential issues and risks are identified and addressed early in the development process, minimizing the chances of defects and failures after the devices are on the market.
 

Further, stricter approval norms push manufacturers to invest in research and innovation to meet regulatory requirements. This, in turn, stimulates the development of novel and more advanced medical devices. As manufacturers innovate, they seek specialized testing services to validate the safety and performance of these cutting-edge products. Thus, the growing focus on strict approval norms is instrumental in driving the market progress for medical device testing services.
 

Medical Device Testing Services Market Analysis

Based on services, the medical device testing services market is bifurcated into biocompatibility tests, microbiology & sterility testing, chemistry test and package validation. The microbiology & sterility testing segment accounted for leading revenue share and was valued at over USD 2.7 billion in 2022. Microbiology and sterility testing are essential to ensure that medical devices, particularly those intended for direct or indirect contact with patients, are free from harmful microorganisms. Ensuring sterility and microbial control is crucial in preventing infections and complications, thereby safeguarding patient safety. Regulatory bodies, such as the FDA and EMA, mandate microbiology and sterility testing for medical devices to obtain market approval.
 

Moreover, factors such as advancements in implantable medical devices, rise in point-of-care testing devices, infection prevention in healthcare settings and quality control are further propelling the segmental progression.
 

Based on phase, the medical device testing services market is segmented into preclinical and clinical. The clinical segment held a majority revenue share in 2022 and is anticipated to reach around USD 11.0 billion by 2032. The clinical phase is a crucial stage in the development process where the medical device is tested on human subjects to evaluate its safety and efficacy under real-world conditions. During this phase, the device is tested in clinical trials, and the data collected is used to support the device's regulatory approval and commercialization. Clinical trials generate a vast amount of data that requires accurate collection, management, and analysis. Testing services assist in ensuring data quality and integrity during the clinical phase.
 

Additionally, clinical testing may uncover areas for device improvement and optimization. Testing services help manufacturers iterate and refine the device design based on clinical trial outcomes.
 

The North America medical device testing services market was valued at over USD 2.1 billion in 2022. The significant regional share is attributed to the fact that North America is at the forefront of technological advancements in the medical device industry. The region is a hub for innovation and research, leading to the development of cutting-edge medical devices that require extensive testing services to support their regulatory approval and commercialization. Stringent regulatory environment in the U.S. overseen by the Food and Drug Administration (FDA), necessitate thorough testing and evaluation before medical devices can be approved for market entry.
 

Further, the region boasts a large and diverse medical device market, serving a wide range of healthcare needs. This diversity spans from diagnostic equipment and surgical instruments to implantable devices and remote patient monitoring solutions, all of which require testing services.
 

Medical Device Testing Services Market Share

Some of the leading players operating in the medical device testing services market include:

• Charles River Laboratories
• American Preclinical Services
• North America Science Associates Inc
• Element Materials Technology
• WuXiAppTec Group
• Eurofins Scientific
• Labcorp (Toxikon, Inc),
• TÜV SÜD AG
   

These major market players are involved in strategic developments including mergers and acquisition, product launches, and collaborations, to expand and strengthen their business reach.
 

Medical Device Testing Services Industry News:

• In March 2023, ARCHIMED, a leading investment firm focused on healthcare industries funded North America Science Associates Inc. (NAMSA) to acquire SUAZIO, a marketing consultancy firm specializing in the commercialization of new medical devices. This development will provide NAMSA with immediate cross selling opportunities in the industry, thereby enhancing its business reach.
   
• In May 2022,  Eurofins BioPharma Product Testing has acquired Human Factors MD, LLC, a testing company for pharmaceutical and medical device firms. This development will allow the company to expand its service portfolio and better serve its customers at the same time improving its sales prospectus.
   

Medical device testing services market research report includes an in-depth coverage of the industry with estimates & forecast in terms of revenue (USD Million) from 2018 to 2032, for the following segments:

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By Services, 2018 - 2032 (USD Million)

• Biocompatibility Tests
• Chemistry Test
• Microbiology & Sterility Testing
• Package Validation

By Phase, 2018 - 2032 (USD Million)

• Preclinical
• Clinical

The above information is provided for the following regions and countries:

• North America
  • U.S.
  • Canada
• Europe
  • Germany
  • UK
  • France
  • Spain
  • Italy
  • Poland
  • Sweden
  • The Netherlands
• Asia Pacific
  • China
  • Japan
  • India
  • Australia
  • South Korea
  • Indonesia
  • Philippines
  • Vietnam
• Latin America
  • Brazil
  • Mexico
  • Argentina
  • Columbia
  • Peru
  • Chile
• Middle East & Africa
  • South Africa
  • Saudi Arabia
  • UAE
  • Turkey
  • Israel
  • Iran