Medical Device Testing Services Market Report 2025

This report covers market characteristics, size and growth, segmentation, regional and country breakdowns, competitive landscape, market shares, trends and strategies for this market. It traces the market’s historic and forecast market growth by geography.

The medical device testing services market size has grown rapidly in recent years. It will grow from $9.25 billion in 2024 to $10.21 billion in 2025 at a compound annual growth rate (CAGR) of 10.4%. The growth in the historic period can be attributed to industry consolidation, quality assurance requirements, focus on patient safety, globalization of medical device, increasing complexity of medical devices.

The medical device testing services market size is expected to see strong growth in the next few years. It will grow to $14.22 billion in 2029 at a compound annual growth rate (CAGR) of 8.6%. The growth in the forecast period can be attributed to rapid growth in the medical device industry, emerging markets and regulatory changes, focus on personalized medicine, cybersecurity concerns, shift towards value-based healthcare. Major trends in the forecast period include sustainable testing practices, integration of regulatory consulting services, personalized medicine and testing, advancements in testing equipment and technologies, expansion of in vitro diagnostic (IVD) testing services.

The rising prevalence of chronic diseases is expected to propel the growth of the medical device testing services market going forward. Chronic diseases refer to long-term health conditions that persist over an extended period, typically lasting for a year or more. This disease arises due to an aging population, unhealthy lifestyle choices, and environmental factors. Medical device testing services are used in the management of chronic diseases to support remote patient monitoring (RPM) and real-time detection of health changes, and these services ensures the safety, efficacy, reliability, and quality of devices, ultimately improving patient outcomes and quality of life. For instance, in January 2023, according to the National Library of Medicine, a US-based medical library, the estimated number of individuals affected by at least one chronic disease is projected to nearly double, increasing by 99.5% from 71.522 million in 2020 to 142.66 million by the year 2050. Therefore, the rising prevalence of chronic diseases is driving the growth of the medical device testing services market.

Major companies operating in the medical device testing services market are concentrating on the adoption of technological advancements, such as new medical device testing services, to provide comprehensive testing solutions. These services refer to a range of tests conducted by specialized companies to ensure the effectiveness, safety, and compliance of medical devices with national and international regulations. For instance, in October 2023, UL Solutions, a US-based provider of medical testing, inspection, and certification services, launched new medical device testing services at its laboratory in Rochester Hills. These services include medical device makers' compliance training, usability testing, and third-party verification and validation. It contributes to the state's developing medical device sector and helps manufacturers improve the safety, security, usability, and interoperability of their devices. Additionally, it also provides third-party verification and validation, cybersecurity services, auditing, usability testing, and compliance training to medical device manufacturers, as well as addressing potential risks such as quality, safety, and cybersecurity issues, all while maintaining the pace of innovation and protecting users.

In December 2022, Millstone Medical Outsourcing, a US-based provider of outsourcing solutions to the medical device industry, acquired Ethide Laboratories for an undisclosed amount. This acquisition aims to expand Millstone's internal capabilities, reinforcing its end-to-end expert sourcing, and bolstering support for medical device services. This move underscores Millstone's dedication to upholding quality standards, ensuring compliance, and driving business success within the industry. Ethide Laboratories is a US-based provider of contract medical testing services intended for the pharmaceutical industry.

Major companies operating in the medical device testing services market are Laboratory Corporation of America Holdings, Eurofins Scientific SE, SGS SA, Bureau Veritas SA, WuXiAppTec Group, Steris plc, Sartorius AG, Charles River Laboratories International Inc., Altran Corporation, TUV SUD AG, Element Minnetonka, Underwriters Laboratories LLC, Intertek Group Plc., QTS Analytical Limited, Pace Analytical Services LLC., Sterigenics International LLC, Nelson Laboratories LLC, Exova Group Limited, Mérieux NutriSciences Corporation, American Preclinical Services LLC, Toxikon Corporation, North American Science Associates Inc., Avomeen Analytical Services LLC, Element Materials Technology Group Limited, Sionic Advisors LLC, Medical Engineering Technologies Ltd.

Asia-Pacific was the largest region in the medical device testing services market in 2024. North America is expected to be the fastest-growing region in the forecast period. The regions covered in the medical device testing services market report are Asia-Pacific, Western Europe, Eastern Europe, North America, South America, Middle East, Africa. The countries covered in the medical device testing services market report are Australia, Brazil, China, France, Germany, India, Indonesia, Japan, Russia, South Korea, UK, USA, Canada, Italy, Spain.

The medical device testing services market includes revenues earned by entities through services such as sterility testing, packaging testing, electrical safety testing, performance testing, usability testing, and post-market surveillance testing services. The market value includes the value of related goods sold by the service provider or included within the service offering. The medical device testing services market also includes sales of testing instruments and equipment, consumables and reagents, mechanical testing machines, electrical safety testers and sterilizers, and autoclaves. Values in this market are ‘factory gate’ values, that is, the value of goods sold by the manufacturers or creators of the goods, whether to other entities (including downstream manufacturers, wholesalers, distributors, and retailers) or directly to end customers. The value of goods in this market includes related services sold by the creators of the goods.

The market value is defined as the revenues that enterprises gain from the sale of goods and/or services within the specified market and geography through sales, grants, or donations in terms of the currency (in USD, unless otherwise specified).

Medical device testing services refer to the processes and procedures conducted to evaluate the safety, efficacy, reliability, and quality of medical devices. These services are crucial in ensuring that medical devices meet regulatory standards and requirements before they can be marketed and used for clinical purposes.

The main types of products in medical device testing services are active implant medical devices, active medical devices, non-active medical devices, in-vitro diagnostic medical devices, ophthalmic medical devices, orthopedic and dental medical devices, vascular medical devices, and others. An active implantable medical device (AIMD) is a type of medical device that is designed to be implanted into the body to provide therapy or monitoring. It provides various services, such as biocompatibility tests, chemistry tests, microbiology and sterility tests, and package validation and it included both preclinical and clinical phases.

The main types of products in medical device testing services are active implant medical devices, active medical devices, non-active medical devices, in-vitro diagnostic medical devices, ophthalmic medical devices, orthopedic and dental medical devices, vascular medical devices, and others. An active implantable medical device (AIMD) is a type of medical device that is designed to be implanted into the body to provide therapy or monitoring. It provides various services, such as biocompatibility tests, chemistry tests, microbiology and sterility tests, and package validation and it included both preclinical and clinical phases.

The revenues for a specified geography are consumption values that are revenues generated by organizations in the specified geography within the market, irrespective of where they are produced. It does not include revenues from resales along the supply chain, either further along the supply chain or as part of other products.

This product will be delivered within 3-5 business days.