Global Medical Device Testing Services Market to Reach USD 16.63 Billion by 2032 with 11% CAGR: Report and Data

Reports And Data

The global medical device testing services market size is expected to reach USD 16.63 billion in 2032 and register a revenue CAGR of 11%.

NEW YORK, NEW YORK, UNITED STATES, April 23, 2023 /EINPresswire.com/ — According to a recent report, the global Medical Device Testing Services Market size was USD 6.5 billion in 2022, and it is expected to increase to USD 16.63 billion by 2032 with a CAGR of 11% during the forecast period. The demand for high-quality medical devices has increased due to an aging population and an increase in chronic diseases, leading to a need for comprehensive testing services. Regulatory bodies like the FDA require manufacturers to adhere to strict norms and regulations, leading to a surge in demand for medical device testing services, including preclinical and clinical testing, biocompatibility testing, sterility testing, and package testing. The market is also expected to grow due to advancements in medical device technology and the need for personalized medicine development. However, the high cost of testing services, a shortage of qualified personnel, and a lengthy regulatory approval process are expected to hinder market revenue growth throughout the forecast period. Additionally, increasing demand for outsourcing medical device testing services is expected to drive revenue growth for the market.

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Segments Covered in the Report –
The global medical device testing services market is segmented by Service Type Outlook, Device Type Outlook, End-Use Outlook, and Regional Outlook. Under Service Type Outlook, the market is categorized into Biocompatibility Testing, Sterility Testing, Performance Testing, Validation Testing, and Others. Biocompatibility Testing ensures that the medical device is safe for use by the human body. Sterility Testing is conducted to determine the level of bacterial contamination in medical devices. Performance Testing ensures that the medical device is working according to its intended use, while Validation Testing ensures that the medical device is consistently producing accurate results.

Under Device Type Outlook, the market is categorized into In Vitro Diagnostic Devices, Cardiovascular Devices, Orthopedic Devices, Ophthalmic Devices, and Others. In Vitro Diagnostic Devices are used to diagnose diseases and conditions, while Cardiovascular Devices are used to treat heart and blood vessel diseases. Orthopedic Devices are used to treat musculoskeletal injuries, and Ophthalmic Devices are used to diagnose and treat eye conditions.
Under End-Use Outlook, the market is categorized into Hospitals, Ambulatory Surgical Centers, and Others. Hospitals are the major end-users of medical device testing services as they offer a wide range of medical procedures and require high-quality and reliable medical devices. Ambulatory Surgical Centers provide surgical procedures on an outpatient basis and require medical devices that are safe and efficient.

The market has been geographically segmented into North America, Europe, Asia Pacific, Latin America, and the Middle East & Africa. The countries covered under the regional scope are the U.S., Canada, U.K., Germany, France, BENELUX, China, India, Japan, South Korea, Brazil, Saudi Arabia, UAE, and Turkey. North America and Europe are the major markets for medical device testing services due to the presence of established medical device manufacturers and stringent regulations regarding medical devices. Asia Pacific is expected to be the fastest-growing market for medical device testing services due to the rising demand for medical devices and increasing government initiatives to improve healthcare infrastructure.

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Strategic development:
• Eurofins Scientific SE expanded its testing services in the United States and enhanced its food and water testing capabilities by acquiring the food and water testing business of IEH Laboratories & Consulting Group in 2021. Similarly, SGS SA launched its SGS Digicomply platform in 2020, which is an AI-powered regulatory compliance platform that enables companies to manage compliance risks by providing real-time alerts on regulatory changes and monitoring their compliance status.
• Intertek Group plc launched its Protek service in 2020, which is a health, safety, and well-being assurance program that includes testing, inspection, and certification services. The program is aimed at helping companies maintain a safe working environment during the COVID-19 pandemic. Bureau Veritas S.A. acquired the testing and inspection business of Shenzhen Dianfeng Testing Services Co., Ltd in 2019 to expand its testing services in China and enhance its capabilities in the electrical and electronics sector.
• In 2018, TÜV SÜD AG acquired Advanced Compliance Solutions, a U.S.-based provider of medical device testing and certification services, to expand its medical device testing services in North America and enhance its capabilities in the medical device sector. UL LLC acquired CLEB Laboratories, a Canadian testing and certification company specializing in the wireless and Electromagnetic Compatibility (EMC) sectors in 2018. The acquisition aimed to expand UL’s testing and certification services in Canada and enhance its capabilities in the wireless and EMC sectors.
• DEKRA SE acquired E3 Compliance, a U.S.-based testing and certification company specializing in the medical device sector, in 2017 to expand its medical device testing services in North America and enhance its capabilities in the medical device sector. In 2016, Element Materials Technology Ltd. acquired Exova Group plc, a U.K.-based testing and certification company specializing in the aerospace, defense, and transportation sectors. The acquisition aimed to expand Element’s testing and certification services in the aerospace, defense, and transportation sectors.
• In terms of new services, Eurofins Medical Device Testing launched Eurofins Medical Device Online Academy in 2021, which provides online training courses for medical device manufacturers, regulatory affairs professionals, and quality assurance personnel. Similarly, Charles River Laboratories International, Inc. launched its Endotoxin Testing Services for Medical Devices in 2020, which provides medical device manufacturers with endotoxin testing services to ensure the safety and effectiveness of their products.
• NAMSA launched NAMSA Network in 2020, which is a global network of medical device testing facilities and experts that provides medical device manufacturers with a streamlined approach to testing and regulatory compliance. TÜV SÜD launched Medical Device Connectivity Testing in 2019, which provides medical device manufacturers with testing services to ensure the interoperability and security of connected medical devices.
• Furthermore, Intertek Group plc launched Bioanalytical Services for Medical Devices in 2019, which provides medical device manufacturers with bioanalytical testing services to ensure the safety and effectiveness of their products. SGS SA launched Medical Device Single Audit Program (MDSAP) in 2018, which provides medical device manufacturers with a standardized approach to regulatory compliance across multiple countries.
• Lastly, WuXi AppTec Co., Ltd. launched WuXi AppTec Medical Device Testing Services in 2018, which provides medical device manufacturers with testing and certification services to ensure the safety and efficacy of their products. Toxikon Corporation launched Extractables and Leachables Testing for Medical Devices in 2017, which provides medical device manufacturers with testing services to identify and quantify the chemical compounds that can leach from medical devices.

Competitive Landscape:
The global medical device testing services market is witnessing intense competition, driven by the presence of large and medium-sized players that account for a significant portion of the market revenue. To stay ahead of the competition, major companies in the market are adopting various strategies such as mergers and acquisitions, partnerships, product launches, and collaborations to expand their presence in the market.
Eurofins Scientific SE, SGS SA, Intertek Group plc, Bureau Veritas S.A., TÜV SÜD AG, UL LLC, DEKRA SE, Element Materials Technology Ltd., Pace Analytical Services, LLC, and Charles River Laboratories International, Inc. are some of the major players operating in the global medical device testing services market.

The increasing demand for medical devices, the growing emphasis on quality and safety, and the rising regulatory scrutiny are the primary factors driving the growth of the medical device testing services market. Moreover, the COVID-19 pandemic has further accelerated the demand for medical device testing services, particularly in the areas of testing, inspection, and certification.

North America, Europe, Asia Pacific, Latin America, and the Middle East & Africa are the major regions covered in the global medical device testing services market report. North America is the dominant region in the market, owing to the presence of several key players and a robust healthcare infrastructure. The Asia Pacific region is expected to witness significant growth in the coming years, driven by the increasing demand for medical devices and the growing focus on quality and safety in the region.

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