Medical Device Clinical Trials Market Growth & Trends
The global medical device clinical trials market size is expected to reach USD 23.53 billion by 2030, and is anticipated to grow at a CAGR of 6.18% from 2025 to 2030, according to a new report by Grand View Research, Inc. The market is driven by a rising number of clinical trials, growing R&D investments, and regulatory requirements for device validation. In addition, constant technological advancements, such as AI-driven analytics, automation, and digital platforms, are revolutionizing trial efficiency by optimizing patient recruitment, real-time monitoring, and data analysis. The integration of machine learning, decentralized trial models, and wearable technology is further enhancing trial accuracy and reducing costs.
Moreover, the increasing integration of wearable devices and digital biomarkers in clinical trials has significantly transformed patient monitoring and data collection by enabling continuous, real-world health tracking. Devices such as smartwatches, biosensors, and remote health trackers provided real-time physiological data, allowing researchers to monitor patients outside of clinical settings, which enhanced trial accuracy and reduced the need for frequent site visits. This advancement has driven the widespread adoption of decentralized and hybrid clinical trials, enabling greater patient participation, particularly among those in remote or underserved areas.
Furthermore, the shift toward personalized medicine and patient-specific treatment approaches has significantly driven the demand for customized medical devices, particularly in fields such as orthopedics, cardiology, and oncology. The growing emphasis on tailored therapies had necessitated the development of medical devices designed to meet individual patient needs, leading to increased clinical trials focused on adaptive study designs. These trials allowed for real-time modifications based on patient-specific responses, ensuring more precise, effective, and safer outcomes. With advancements in 3D printing, AI-driven diagnostics, and biomaterial engineering, medical device manufacturers have expanded their capabilities to create highly personalized implants, prosthetics, and drug-device combinations.
Key market players are implementing strategic partnerships, product innovations, regulatory approvals, geographic expansions, and AI-driven trial solutions to strengthen their position in the Medical Device Clinical Trials market. Companies like Medtronic and Siemens Healthineers have expanded their AI-driven clinical trial ecosystems, while Abbott secured FDA approval for a label update on its HeartMate 3 LVAD to enhance patient management.
Medical Device Clinical Trials Market Report Highlights
Based on study type, pivotal study dominated the market due to its critical role in securing regulatory approvals. Pivotal studies provide comprehensive safety and efficacy data, serving as the final step before a device reaches commercialization.
Based on study design, the interventional segment held the largest revenue share in 2024. Interventional studies are essential for obtaining regulatory approvals for high-risk devices, especially in areas like cardiology, orthopedics, and neurology.
Based on Indication, cardiovascular devices held the largest revenue share in 2024due to due to the high global burden of cardiovascular diseases (CVDs) and the continuous innovation in implantable cardiac devices, stents, and valve replacement technologies.
Based on region, North America held the dominant position in 2024 due to its strong clinical research infrastructure, high R&D investments, and the presence of leading pharmaceutical and biotechnology companies
Medical Device Clinical Trials Market Segmentation
Grand View Research has segmented the global medical device clinical trials market based on study type, study design, indication, and region:
Medical Device Clinical Trials Study Type Outlook (Revenue, USD Million, 2018 - 2030)
Feasibility and Pilot Study
Pivotal Study
FDA PMA Application
Post-Approval Study
Medical Device Clinical Trials Study Design Outlook (Revenue, USD Million, 2018 - 2030)
Interventional
Observational
Expanded Access
Medical Device Clinical Trials Indication Outlook (Revenue, USD Million, 2018 - 2030)
Cardiovascular devices
Neurology devices
Orthopedic devices
Diagnostic imaging
Anesthesia and Respiratory devices
Others
