PUBLISHER: The Business Research Company | PRODUCT CODE: 1760610
PUBLISHER: The Business Research Company | PRODUCT CODE: 1760610
Medical device safety testing involves evaluating a medical device to ensure its safety for use by patients, healthcare professionals, and others in its intended environment. This process identifies and mitigates potential risks related to electrical, mechanical, thermal, biological, and radiation hazards. Medical device safety testing ensures compliance with regulatory standards and verifies that the device performs as intended without causing harm.
The primary services in medical device safety testing include testing, inspection, and certification. Testing is a systematic process used to evaluate medical devices to ensure they meet safety requirements. This testing is applied to various types of medical devices, including active medical devices, passive medical devices, in vitro diagnostic devices, implantable devices, and surgical instruments. The technologies involved include active implantable devices, in vitro diagnostic devices, diagnostic imaging devices, and ophthalmic devices. Key application areas include cardiovascular devices, orthopedic devices, neurological devices, ophthalmic devices, and dental devices. These services are used by various end users such as hospitals, clinics, research laboratories, medical device manufacturers, and regulatory bodies.
The medical device safety testing market research report is one of a series of new reports from The Business Research Company that provides medical device safety testing market statistics, including medical device safety testing industry global market size, regional shares, competitors with a medical device safety testing market share, detailed medical device safety testing market segments, market trends and opportunities, and any further data you may need to thrive in the medical device safety testing industry. This medical device safety 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 device safety testing market size has grown strongly in recent years. It will grow from $8.55 billion in 2024 to $9.31 billion in 2025 at a compound annual growth rate (CAGR) of 8.9%. The growth during the historic period can be attributed to the increasing complexity of medical devices, a rise in product recalls, more stringent regulatory requirements, the globalization of medical device manufacturing, and a higher frequency of regulatory inspections.
The medical device safety testing market size is expected to see strong growth in the next few years. It will grow to $13.04 billion in 2029 at a compound annual growth rate (CAGR) of 8.8%. The growth during the forecast period can be attributed to the rise of wearable and implantable devices, stricter international regulatory harmonization, sustainability and environmental regulations, an increase in remote testing and virtual simulations, and the growth of regulatory consulting services. Major trends expected during this period include AI-powered predictive testing, digital twin technology, cybersecurity and embedded software testing, wearable device testing frameworks, and testing for fifth generation (5G) and wireless signal interference.
The growing prevalence of lifestyle-related diseases is expected to fuel the growth of the medical device safety testing market in the coming years. Lifestyle-related diseases include health conditions primarily caused by an individual's daily habits and choices, such as heart disease, type 2 diabetes, obesity, hypertension, certain cancers, and mental health issues. The rise in these diseases is largely attributed to physical inactivity, leading to weight gain, poor cardiovascular health, and decreased insulin sensitivity, all of which increase the risk of chronic conditions. Medical device safety testing plays a crucial role in managing these diseases by ensuring the reliability and performance of diagnostic and therapeutic devices. By verifying that devices meet regulatory standards, it enhances patient safety, improves treatment outcomes, and fosters greater trust and efficiency in healthcare systems. For example, in June 2024, the National Health Service (NHS), a UK-based government department, reported that 3,615,330 individuals registered with a general practitioner (GP) were diagnosed with non-diabetic hyperglycemia or pre-diabetes in 2023, marking an 18% increase from 3,065,825 cases in 2022. This rise in lifestyle-related diseases underscores the growing demand for medical device safety testing.
Leading companies in the medical device safety testing market are focusing on expanding their capabilities with advanced testing facilities to improve device accuracy, reduce time-to-market, and ensure compliance with evolving global regulatory standards. These state-of-the-art testing facilities leverage cutting-edge technology to conduct comprehensive evaluations of medical devices. For instance, in December 2023, Impelsys, an India-based technology company, launched an advanced medical device testing laboratory in Mangalore, India. The facility uses AI-driven analytics and cloud-based platforms to accelerate the development of diagnostic and therapeutic devices by offering advanced testing, simulations, and regulatory support. This move highlights the company's commitment to data-driven innovation in healthcare.
In January 2025, Applus+ Laboratories, a Spain-based provider of testing, inspection, and certification services, acquired De.Testing for an undisclosed amount. This acquisition enables Applus+ to enhance its position in the rapidly growing Chinese medical device market, expand its global testing capabilities, and provide more comprehensive and innovative solutions in the healthcare sector. De.Testing, based in China, specializes in medical device safety testing, making it a strategic addition to Applus+ Laboratories' portfolio.
Major players in the medical device safety testing market are Thermo Fisher Scientific, Medtronic plc, Baxter International, SGS SA, Eurofins Scientific SE, Bureau Veritas SA, Bausch & Lomb, Intertek Group plc, TUV SUD AG, Underwriters Laboratories LLC, Applus+ Group, BSI Group, NSF International, NEMKO AS, Smithers Group Inc., Laboratory Testing Inc., JPen Medical Inc., ArchiMed, F2 Labs Inc., Medistri SA.
North America was the largest region in the medical device safety testing market in 2024. Asia-Pacific is expected to be the highest-growing region in the forecast period. The regions covered in medical device safety testing report are Asia-Pacific, Western Europe, Eastern Europe, North America, South America, Middle East and Africa.
The countries covered in the medical device safety testing market report are Australia, Brazil, China, France, Germany, India, Indonesia, Japan, Russia, South Korea, UK, USA, Canada, Italy, Spain.
The medical device safety testing market consists of revenues earned by entities by providing services such as product safety assessments, regulatory compliance testing, risk management analysis, performance validation, clinical trials support, environmental stress testing, material characterization, and software performance evaluations. 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 and 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.
Medical Device Safety Testing Global Market Report 2025 from The Business Research Company provides strategists, marketers and senior management with the critical information they need to assess the market.
This report focuses on medical device safety testing market which is experiencing strong growth. The report gives a guide to the trends which will be shaping the market over the next ten years and beyond.
Where is the largest and fastest growing market for medical device safety testing ? How does the market relate to the overall economy, demography and other similar markets? What forces will shape the market going forward? The medical device safety testing market global report from the Business Research Company answers all these questions and many more.
The 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 forecasts are made after considering the major factors currently impacting the market. These include the Russia-Ukraine war, rising inflation, higher interest rates, and the legacy of the COVID-19 pandemic.