Medical Device Clinical Trials Global Market Report 2025

The medical device clinical trials market size has grown strongly in recent years. It will grow from $16.87 billion in 2024 to $18.12 billion in 2025 at a compound annual growth rate (CAGR) of 7.4%. The growth in the historic period can be attributed to the rising prevalence of chronic diseases, increasing demand for innovative medical technologies, regulatory support for clinical research, growing aging population, expansion of healthcare infrastructure, and increased investment from public and private sectors.

The medical device clinical trials market size is expected to see strong growth in the next few years. It will grow to $23.91 billion in 2029 at a compound annual growth rate (CAGR) of 7.2%. The growth in the forecast period can be attributed to the increasing demand for personalized medical devices, rising focus on real-world evidence, growing use of AI in trial design and monitoring, expansion of decentralized and virtual trials, regulatory support for faster approvals, and increasing investments in digital health innovations. Major trends in the forecast period include the adoption of decentralized trials, integration of AI and big data analytics, use of wearable monitoring devices, enhanced regulatory harmonization, and advancements in trial design and data analytics.

The increasing prevalence of chronic diseases is expected to drive the growth of the medical device clinical trials market. Chronic diseases are long-term health conditions that progress slowly and require continuous management. These diseases are on the rise due to sedentary lifestyles, where individuals spend extended hours sitting at desks or using electronic devices, reducing calorie expenditure and weakening cardiovascular health. This leads to conditions such as obesity, diabetes, and hypertension. As chronic diseases become more prevalent, there is a greater need for medical device clinical trials to develop and validate innovative devices for diagnosis, treatment, and management. For example, in June 2023, the Institute for Health Metrics and Evaluation, a U.S.-based public health research institute, reported that over half a billion people worldwide were living with diabetes, and this number is projected to more than double, reaching 1.3 billion people by 2050. Consequently, the rising prevalence of chronic diseases is driving the growth of the medical device clinical trials market.

Companies in the medical device clinical trials market are focusing on AI-powered medical device software to optimize clinical trial protocols and resource allocation, improving trial efficiency and reducing costs. AI-powered medical device software uses artificial intelligence (AI) algorithms, such as machine learning or deep learning, to support or automate medical tasks. For instance, in January 2025, Risklick, a Switzerland-based pharmaceutical company, launched Protocol AI, an AI-based software designed to accelerate and optimize clinical trials for medical devices. Protocol AI uses Natural Language Processing (NLP) and Machine Learning (ML) to analyze clinical data, publications, and regulatory documents, automatically drafting clinical trial protocols in minutes. This innovation significantly reduces the time and cost required for protocol development, which traditionally takes around six months, and has already demonstrated up to a 50% reduction in document development time for medicinal products.

In January 2024, eMed, a U.S.-based health services company, acquired Science 37 for \$38 million. This acquisition strengthens eMed's clinical research capabilities by combining telehealth and diagnostic services with decentralized trial technology to improve patient enrollment and reach underrepresented groups. Science 37 is a U.S.-based research company specializing in decentralized clinical trials, including those for medical devices.

Major players in the medical device clinical trials market are Abbott Laboratories, Siemens Healthineers, Stryker Corporation, Philips Healthcare, Baxter International, Roche Diagnostics, ICON, Intuitive Surgical, Edwards Lifesciences, Fortrea, Medidata, NAMSA, Veranex, TFS HealthScience, Avania, Parexel, Meditrial, Syneos Health, Qserve CRO, Clinius Ltd, Eclevar Medtech, 1med Sa, and ISS AG.

North America was the largest region in the medical device clinical trials market in 2024. Asia-Pacific is expected to be the fastest-growing region in the forecast period. The regions covered in medical device clinical trials report are Asia-Pacific, Western Europe, Eastern Europe, North America, South America, Middle East and Africa.

The countries covered in the medical device clinical trials market report are Australia, Brazil, China, France, Germany, India, Indonesia, Japan, Russia, South Korea, UK, USA, Canada, Italy, Spain.

Medical device clinical trials are research studies conducted to evaluate the safety and effectiveness of medical devices in humans. The process includes phases such as feasibility, pivotal, and post-approval studies, which are essential for regulatory approval. These trials generate critical data for device market authorization and continued safety monitoring.

The main study types in medical device clinical trials include feasibility and pilot studies, pivotal studies, FDA premarket approval (PMA) applications, and post-approval studies. Feasibility and pilot studies are early-phase trials with a small group of participants to assess the practicality, safety, and potential challenges of a new device before progressing to larger-scale trials. These studies span various indications such as cardiovascular, neurology, orthopedic, diagnostic imaging, anesthesia and respiratory devices, and others. Study designs typically include interventional, observational, and expanded access categories.

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

The medical device clinical trials market includes revenues earned by entities by providing services such as clinical trial design and management, regulatory consulting, site selection and monitoring, patient recruitment, data management, and statistical analysis. The market value includes the value of related goods sold by the service provider or included within the service offering. The medical device clinical trials market also includes sales of diagnostic devices, therapeutic devices, surgical instruments, monitoring equipment, implantable devices, wearable health technologies, and medical imaging systems. 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).

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.

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