Medical Device Testing Services Market Size - Global Industry, Share, Analysis, Trends and Forecast 2022 - 2030

The Global Medical Device Testing Services Market Size accounted for USD 7.1 Billion in 2021 and is projected to achieve a market size of USD 19.5 Billion by 2030 rising at a CAGR of 12.1% from 2022 to 2030. The medical device testing service market is driven by growing spending in preclinical phase of medical devices. Medical device testing is the process of ensuring the quality of medical devices such as MRI machines and defibrillators. Medical device testing includes both hardware and software components. Certificate testing, factory testing, and research & development testing are all part of medical device testing. Testing includes both hardware and software verification and validation.

Medical Device Testing Services Market Report Statistics

• Global medical device testing services market revenue is estimated to reach USD 19.5 Billion by 2030 with a CAGR of 12.1% from 2022 to 2030
• Asia-Pacific medical device testing services market share accounted for over 41% shares in 2021
• According to the a recent statistics, unsafe medical devices have caused 1.7 million injuries worldwide and roughly 83,000 deaths in the last 12 years
• Asia-Pacific medical device testing services market growth will record substantial CAGR from 2022 to 2030
• Based on service, microbiology & sterility testing captured over 35% of the overall market share in 2021
• Among phases, clinical occupied more than 69% of the market share from 2022 to 2030
• Surging technological advancements in device testing is a popular medical device testing services market trend that is fueling the industry demand

Global Medical Device Testing Services Market Dynamics

Market Drivers

• Rising number of stringent government regulations
• Increasing number of chronic and elderly patients
• Growing demand for verification and validation of medical devices
• Rapid advancements in medical technologies

Market Restraints

• Dynamic rules and regulations across different regions
• Lack of skilled professionals and testing facilities

Market Opportunities

• Robust growth of medical devices industries in emerging nations
• Advent of AI and IoT in medical device testing service industry

Medical Device Testing Services Market Report Coverage

Medical Device Testing Services Market Growth Factors

Rise of drug device combination, personalized medication, artificial intelligence (AI), wearables and focus on real-time patient monitoring resulted in complex medical devices ecosystem. To match these factors, gadgets now have to undergo shear testing in augmented conditions to obtain marketing approval. Conducting these tests in-house needs a lot of time, cost, and labour; this is anticipated to increase the need for outsourcing of these services thereby increasing the market development.

Medical Device Testing Services Market Insights

Growing need for in-vitro tests are also anticipated to boost the industry, as a lot of CROs are emerging novel methods to replace the traditional in-vivo tests that require animal testing. Development in the growth and standardization of novel in vitro test approaches; particularly for sensitization, cytotoxicity, and irritation that are the basic test required for all the medical device is also expected to support industry development.

Medical Device Testing Services Market Segmentation

The global medical device testing services market is segmented based on service, phase, and geography.

Medical Device Testing Services Market By Service

• Biocompatibility Tests
• Chemistry Test
• Microbiology & Sterility Testing
  • Bio-Burden Determination
  • Pyrogen and Endotoxin Testing
  • Sterility Test and Validation
  • Anti-microbial Activity Testing
  • Other Services
• Package Validation

According to the medical device testing services industry analysis, microbiology & sterility testing sub-segment grabbed the maximum revenue in 2021 and is expected to do so in the coming years. Microbiology and sterility testing are performed to eliminate or reduce the risk of contamination in the manufacturing process, which could lead to infections in patients or product users. On the other hand, chemistry test is one of the sub-segments that is anticipated to witness fastest growth rate during the projected timeframe from 2022 to 2030.

Medical Device Testing Services Market By Phase

• Preclinical
  • Antimicrobial Wound Dressings
  • Medical Coatings
  • Others
• Clinical

As per medical device testing services market forecast, the clinical sub-segment accounted for over 2/3^rd of the total market shares in 2021 and is likely to maintain this trend over the estimated timeframe of 2022 to 2030. Additionally, it is projected that during the forecast period this segment will expand the fastest. The cost of medical device testing services for the clinical stage is significantly greater than for the preclinical stage, which is a crucial element in deciding the clinical stage's greatest market.

Medical Device Testing Services Market Regional Outlook

North America

• U.S.
• Canada

Europe

• U.K.
• Germany
• France
• Spain
• Rest of Europe

Asia-Pacific

• India
• Japan
• China
• Australia
• South Korea
• Rest of Asia-Pacific

Latin America

• Brazil
• Mexico
• Rest of Latin America

The Middle East & Africa

• South Africa
• GCC Countries
• Rest of the Middle East & Africa (ME&A)

Medical Device Testing Services Market Regional Analysis

Asia-Pacific captures the largest market share in the medical device testing services market due to augmented outsourcing in nations, for instance, as India and China. Contract Research Organizations (CROs) are spending heavily in emerging nations of APAC due to lower cost and easy accessibility of trained labor. North America captures the second-largest share in 2021 and is anticipated to observer important development during the forecast timeframe.

This development can be credited to the fact that it is one of the top industrial hubs of complex, high-end, and reliable medical gadgets. Many CROs have a developed business in the region that delivers complete range of testing services for businesses. The Europe region is led by nations (Germany Spain, U.K., France, and Italy) EU5. Increasing demand for cost cutting and growing difficulty in product designing is anticipated to be the major industry drivers.

Medical Device Testing Services Market Players

Market companies are concentrating on implementing new strategies for instance regional expansion, partnerships, mergers and acquisitions, new product launches, and distribution agreements to surge their revenue share. The major players associated with the medical device testing servicesmarket are Medical Device Testing Services, Toxikon, Inc., American Preclinical Services LLC, SGS SA, Charles River Laboratories International, Inc., Eurofins Scientific, LLC, Sterigenics International LLC, Intertek Group PLC, North American Science Associates, Inc., WuXiAppTec Group, and Pace Analytical Services, LLC.