Emerging Trends to Drive Medical Device Clinical Trials Market Growth at 7.1% CAGR Through 2029

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Medical Device Clinical Trials Market Size Growth Forecast: What to Expect by 2025?
The market size for medical device clinical trials has seen robust growth in the previous years. It is projected to expand from $16.87 billion in 2024 to $18.07 billion in 2025, with a compound annual growth rate (CAGR) of 7.1%. The growth during this historical period can be associated with a rising incidence of chronic illnesses, a growing demand for groundbreaking medical technologies, supportive regulations for clinical research, an increasing elderly population, an enlargement of healthcare infrastructure, and enhanced investments from both public and private sectors.

How Will the Medical Device Clinical Trials Market Size Evolve and Grow by 2029?
The market for clinical trials in the medical device sector is projected to witness considerable expansion in the coming years, ballooning to an estimated value of $23.75 billion by 2029, registering a compound annual growth rate (CAGR) of 7.1%. This predicted growth can be traced back to several factors including the heightened demand for bespoke medical devices, a surge in emphasis on real-world evidence, the prevalent use of AI in both designing and monitoring trials, the extension of decentralised and virtual trials, the backing of regulations for quick approvals, and a rise in financial investment towards digital health innovations. The forecast period also expects seeing trends such as the rising adoption of decentralised trials, the merging of AI and big data analytics, an increase in the use of wearable devices for monitoring, advancement in regulatory harmonisation, and progress in both trial designing and data analytics.

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What Drivers Are Propelling the Growth of Medical Device Clinical Trials Market Forward?
The increasing occurrence of chronic illnesses is anticipated to stimulate the expansion of the medical device clinical trials market in the future. These are prolonged health disorders that evolve gradually and necessitate continuous medical supervision. Sedentary lifestyles, involving lengthy durations spent at workstations or utilizing electronic gadgets, diminishes calorie burn and impairs heart health, ensuing in conditions such as obesity, diabetes, and hypertension. This growth in chronic ailments enforces the requirement for medical device clinical trials, to devise and corroborate novel devices for effective detection, therapy, and control. For instance, the Institute for Health Metrics and Evaluation, a US-based public health research institute, disclosed that more than 500 million individuals worldwide had diabetes in June 2023. This figure is projected to more than double, touching 1.3 billion individuals by 2050. Consequently, the increasing prevalence of chronic illnesses is fueling the expansion of the medical device clinical trials market.

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Which Emerging Trends Are Transforming the Medical Device Clinical Trials Market in 2025?
Leading businesses in the medical device clinical trials market are directing their efforts towards the creation of AI-powered medical device software. This aims to refine clinical trial procedures and resource allocation, improving trial outcomes and decreasing expenses. By definition, AI-powered medical device software applies artificial intelligence (AI) algorithms, such as machine learning or deep learning, to supplement or automate healthcare tasks. An example of this occurred in January 2025 when Risklick, a Swiss pharmaceutical company, introduced Protocol AI, an artificial intelligence-supported software intended to expedite and streamline clinical trials for medical devices. Protocol AI employs Natural Language Processing (NLP) and Machine Learning (ML) to dissect clinical data, research publications, and regulatory documents, consequently producing clinical trial protocols swiftly. This innovative approach markedly diminishes the duration and financial resources required for protocol creation, a process that generally takes approximately six months. It has been shown to cut document development time for pharmaceutical products by up to 50%.

What Are the Key Segments in the Medical Device Clinical Trials Market?
The medical device clinical trials market covered in this report is segmented -

1) By Study Type: Feasibility And Pilot Study, Pivotal Study, FDA Premarket Approval (PMA) Application, Post-Approval Study
2) By Indication: Cardiovascular Devices, Neurology Devices, Orthopedic Devices, Diagnostic Imaging, Anesthesia And Respiratory Devices, Other Indications
3) By Study Design: Interventional, Observational, Expanded Access

Subsegments:
1) By Feasibility And Pilot Study: First-in-Human (FIH) Trials, Device Safety Assessment, Procedural Feasibility Studies, Prototype Testing
2) By Pivotal Study: Comparative Effectiveness Studies, Randomized Controlled Trials (RCTs), Non-Inferiority Trials, Superiority Trials
3) By FDA PMA (Pre-Market Approval) Application: Clinical Data Submission, Device Risk Analysis, Effectiveness Evidence Studies, Manufacturing Process Validation
4) By Post-Approval Study: Long-Term Safety Monitoring, Real-World Evidence Collection, Registry Studies, Comparative Outcome Studies

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Who Are the Key Players Shaping the Medical Device Clinical Trials Market's Competitive Landscape?
Major companies operating 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, ISS AG

What Geographic Markets Are Powering Growth in the Medical Device Clinical Trials Market?
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 the medical device clinical trials market report are Asia-Pacific, Western Europe, Eastern Europe, North America, South America, Middle East, Africa.

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