Medical Device Testing Market Report 2025

The medical device testing market size has grown strongly in recent years. It will grow from $9.89 billion in 2024 to $10.49 billion in 2025 at a compound annual growth rate (CAGR) of 6%. The growth in the historic period can be attributed to stringent regulatory requirements, increasing complexity of medical devices, globalization of medical device industry, rise in chronic diseases, focus on patient safety.

The medical device testing market size is expected to see strong growth in the next few years. It will grow to $13.39 billion in 2029 at a compound annual growth rate (CAGR) of 6.3%. The growth in the forecast period can be attributed to advancements in medical technology, increased outsourcing of testing services, rapid growth of personalized medicine, expanding regulatory landscape, focus on cybersecurity for medical devices. Major trends in the forecast period include enhanced regulatory compliance testing, expansion of biocompatibility testing methods, application of simulation and modeling techniques, and increased demand for sterility testing, introduction of testing services for connected devices.

The medical device testing market is being propelled forward by an increase in medical device recalls. Device recalls involve corrective actions taken by manufacturers or distributors to address issues with medical devices. Medical device testing is utilized by manufacturers to identify potential safety concerns associated with devices. It helps determine the necessity of medical recalls to ensure patient safety, device effectiveness, and product quality improvement to avoid recalls. For instance, Sedgwick reported a 11% increase in medical recalls in Q2 2022 compared to Q1 2022, with a total of 719 recalls. Therefore, the growing number of medical device recalls is a key driver for the medical device testing market.

The expansion of the medical device testing market in the future is expected to be driven by the rising healthcare expenditure. Healthcare expenditure encompasses spending on healthcare-related goods and services within a healthcare system or economy. It plays a crucial role in supporting the development and accessibility of medical device testing. In November 2022, the Canadian Institute for Health Information reported a 0.8% rise in healthcare expenditure to $331 billion in 2022, following a 7.6% increase in 2021. Thus, the increasing healthcare expenditure is fueling the growth of the medical device testing market.

A prominent trend in the medical device testing market is the introduction of product innovations by major companies to maintain their market position. For instance, Nelson Labs launched the Nelson Labs Mark in February 2022, a product testing verification program that provides authentication of test reports and reliable data on product performance. This program, initially intended for masks and respirator devices, includes two-factor authentication for consumers to confirm the legitimacy of tests.

Major companies in the medical device testing market are focusing on developing innovative services to drive revenues. UL Solutions, a safety science company, launched new medical device testing services in October 2023 at its laboratory in Michigan, USA. These services aim to help manufacturers address potential risks such as quality, safety, and cybersecurity issues while supporting innovation and protecting medical device users.

In November 2022, Millstone Medical Outsourcing LLC acquired MycoScience Inc. for an undisclosed amount. This strategic acquisition is geared towards expanding Millstone Medical Outsourcing LLC's laboratory and environmental testing services in the medical device testing market. MycoScience Inc. is a provider of medical device and pharmaceutical laboratory testing services.

Major companies operating in the medical device testing market include Intertek Group plc., SGS SA, Bureau Veritas Group, TUV SUD AG, TUV Rheinland Group, Pace Analytical Services LLC., Charles River Laboratories Inc., UL Solutions, North American Science Associates LLC, Medistri SA, WuXi AppTec Inc., Cordant Health Solutions, GE Healthcare Technologies Inc., Thermo Fisher Scientific Inc., Biomedical Device Labs, NSF International, Analytical Lab Group LLC, Boston Analytical, DDL Inc., Element Materials Technology, Empirical Testing Corp., Eurofins Scientific, Gateway Analytical LLC, iuvo BioScience, Laboratory Corporation of America Holdings, Microtest Laboratories Inc., Nelson Laboratories LLC, National Technical Systems Inc., Pacific Biolabs Inc., Sterigenics International LLC, Toxikon Corporation, WCG Imaging, Westpak Inc.

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

Medical device testing is the process of assessing and validating the safety, effectiveness, and quality of medical devices. This crucial evaluation ensures that these products are safe for use in patient care and comply with the standards and regulations established by relevant authorities.

The primary types of medical device testing include physical testing, chemical or biological testing, cybersecurity testing, microbiology and sterility testing, and other related evaluations. Physical testing involves subjecting medical devices to a series of tests to assess their performance, durability, and safety, aiding manufacturers in ensuring the safety, effectiveness, and reliability of their products. The device classes include class I, class II, and class III, and testing services can be conducted both in-house and outsourced. Services offered encompass testing, inspection, and certification. Medical device testing is utilized by various end-users, including hospitals, research centers, homecare clinics, and others.

The medical device testing market research report is one of a series of new reports that provides medical device testing market statistics, including the medical device testing industry global market size, regional shares, competitors with a medical device testing market share, detailed medical device testing market segments, market trends and opportunities, and any further data you may need to thrive in the medical device testing industry. This medical device testing 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 devices testing market includes revenues earned by entities by providing services such as biocompatibility testing services, bio-burden determination services, and quality assurance testing services. The market value includes the value of related goods sold by the service provider or included within the service offering. Only goods and services traded between entities or sold to end consumers are included.

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).

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.

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