Medical Device Testing Services Global Market Report 2024

The medical device testing services market size has grown rapidly in recent years. It will grow from $8.35 billion in 2023 to $9.25 billion in 2024 at a compound annual growth rate (CAGR) of 10.6%. The growth observed in the historical period can be attributed to several factors, including industry consolidation, heightened quality assurance requirements, a focus on patient safety, the globalization of the medical device industry, and the increasing complexity of medical devices. These factors collectively contributed to the demand for comprehensive and rigorous testing services to ensure the effectiveness, safety, and compliance 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 $13.12 billion in 2028 at a compound annual growth rate (CAGR) of 9.1%. The anticipated growth in the forecast period is expected to be driven by factors such as the rapid expansion of the medical device industry, emerging markets and regulatory changes, an increased focus on personalized medicine, growing concerns related to cybersecurity, and a shift towards value-based healthcare. Key trends in the forecast period encompass the adoption of sustainable testing practices, the integration of regulatory consulting services, the emphasis on personalized medicine and testing, advancements in testing equipment and technologies, and the expansion of in vitro diagnostic (IVD) testing services.

The anticipated increase in the prevalence of chronic diseases is poised to drive the growth of the medical device testing services market. Chronic diseases, characterized by long-term health conditions lasting a year or more, are on the rise due to factors such as an aging population, unhealthy lifestyle choices, and environmental influences. Medical device testing services play a crucial role in managing chronic diseases, facilitating remote patient monitoring (RPM) and real-time detection of health changes. These services ensure the safety, efficacy, reliability, and quality of devices, ultimately enhancing patient outcomes and quality of life. According to the National Library of Medicine, 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. The escalating prevalence of chronic diseases is a key driver propelling the growth of the medical device testing services market.

Prominent companies in the medical device testing services market are strategically focusing on adopting technological advancements to offer comprehensive testing solutions. These services encompass a range of tests conducted by specialized companies to ensure the effectiveness, safety, and compliance of medical devices with national and international regulations. In October 2023, UL Solutions, a US-based provider of medical testing, inspection, and certification services, introduced new medical device testing services at its Rochester Hills laboratory. These services include compliance training for medical device makers, usability testing, and third-party verification and validation. The initiative contributes to the growth of the state's medical device sector, aiding manufacturers in enhancing the safety, security, usability, and interoperability of their devices. Additionally, it offers cybersecurity services, auditing, and compliance training to address potential risks such as quality, safety, and cybersecurity issues, all while fostering innovation and safeguarding users.

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

Major companies operating in the medical device testing services market report 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 2023. 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.

Medical device testing services involve the systematic processes and procedures conducted to assess the safety, efficacy, reliability, and quality of medical devices. These services play a critical role in ensuring that medical devices adhere to regulatory standards and requirements, establishing their suitability for marketing and use in clinical settings.

The primary types of products in medical device testing services include 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 specific type designed to be implanted in the body for therapeutic or monitoring purposes. These devices undergo various testing services such as biocompatibility tests, chemistry tests, microbiology and sterility tests, and package validation. The testing process typically encompasses both preclinical and clinical phases to ensure the safety, efficacy, and compliance of the device.

The medical device testing services market research report is one of a series of new reports that provides medical device testing services market statistics, including medical device testing services industry global market size, regional shares, competitors with a medical device testing services market share, detailed medical device testing services market segments, market trends and opportunities, and any further data you may need to thrive in the medical device testing services industry. This medical device testing services market research report delivers a complete perspective of everything you need, with an in-depth analysis of the current and future scenario of the industry.

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 goods and/or services sold within the specified market and geography through sales, grants, or donations in terms of currency (in USD unless otherwise specified).

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


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