세계의 의료기기 임상시험 시장 규모, 점유율, 동향 분석 보고서 : 연구 유형별, 연구 디자인별, 적응증별, 지역별, 부문 예측(2025-2030년)

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

Table of Contents

Chapter 1. Methodology and Scope

• 1.1. Market Segmentation & Scope
  • 1.1.1. Regional Scope
  • 1.1.2. Estimates and Forecast Timeline
• 1.2. Market Definitions
• 1.3. Research Methodology
  • 1.3.1. Information Procurement
  • 1.3.2. Purchased Database
  • 1.3.3. GVR's Internal Database
  • 1.3.4. Secondary Sources
  • 1.3.5. Primary Research
• 1.4. Information or Data Analysis
  • 1.4.1. Data Analysis Models
• 1.5. Market Formulation & Validation
  • 1.5.1. Region Wise Market: Base Estimates
  • 1.5.2. Global Market: CAGR Calculation
• 1.6. Model Details
  • 1.6.1. Commodity Flow Analysis (Model 1)
  • 1.6.2. Value-Chain-Based Sizing & Forecasting (Model 2)
  • 1.6.3. QFD Model Sizing & Forecasting (Model 3)
  • 1.6.4. Bottom-Up Approach (Model 4)
• 1.7. List of Secondary Sources
• 1.8. List of Abbreviations
• 1.9. Objectives

Chapter 2. Executive Summary

• 2.1. Market Outlook
• 2.2. Segment Snapshot
• 2.3. Competitive Landscape Snapshot

Chapter 3. Market Variables, Trends, & Scope

• 3.1. Market Lineage Outlook
  • 3.1.1. Parent Market Outlook
  • 3.1.2. Related/Ancillary Market Outlook
• 3.2. Market Trends and Outlook
• 3.3. Market Dynamics
  • 3.3.1. Market Driver Analysis
  • 3.3.2. Market Restraint Analysis
• 3.4. Technological Advancements
  • 3.4.1. Integration of AI and Digital Technologies
• 3.5. Pricing Model Analysis
• 3.6. Clinical Trials Volume Analysis, 2024
  • 3.6.1. Total Number of Clinical Trials, by Region (2024)
  • 3.6.2. Total Number of Clinical Trials, by Phase (2024)
  • 3.6.3. Total Number of Clinical Trials, by Study Design (2024)
  • 3.6.4. Total Number of Clinical Trials, by Key Therapeutic Area (2024)
• 3.7. Industry Analysis Tools
  • 3.7.1. Porter's Five Forces Analysis
  • 3.7.2. PESTEL Analysis
  • 3.7.3. COVID-19 Impact Analysis

Chapter 4. Medical Device Clinical Trials Market: Study Type Estimates & Trend Analysis

• 4.1. Segment Dashboard
• 4.2. Medical Device Clinical Trials Market; Study Type Movement Analysis
• 4.3. Medical Device Clinical Trials Size & Trend Analysis, by Study Type, 2018 to 2030 (USD Million)
• 4.4. Feasibility and Pilot Study
  • 4.4.1. Feasibility and pilot study market estimates and forecasts 2018 to 2030 (USD Million)
• 4.5. Pivotal Study
  • 4.5.1. Pivotal study market estimates and forecasts 2018 to 2030 (USD Million)
• 4.6. FDA PMA Application
  • 4.6.1. FDA PMA application market estimates and forecasts 2018 to 2030 (USD Million)
• 4.7. Post-Approval Study
  • 4.7.1. Post-Approval study market estimates and forecasts 2018 to 2030 (USD Million)

Chapter 5. Medical Device Clinical Trials Market: Study Design Estimates & Trend Analysis

• 5.1. Segment Dashboard
• 5.2. Medical Device Clinical Trials Market; Study Design Movement Analysis
• 5.3. Medical Device Clinical Trials Size & Trend Analysis, by Phase, 2018 to 2030 (USD Million)
• 5.4. Interventional
  • 5.4.1. Interventional market estimates and forecasts 2018 to 2030 (USD Million)
• 5.5. Observational
  • 5.5.1. Observational market estimates and forecasts 2018 to 2030 (USD Million)
• 5.6. Expanded Access
  • 5.6.1. Expanded Access market estimates and forecasts 2018 to 2030 (USD Million)

Chapter 6. Medical Device Clinical Trials Market: Indication Estimates & Trend Analysis

• 6.1. Segment Dashboard
• 6.2. Medical Device Clinical Trials Market; Indication Movement Analysis
• 6.3. Medical Device Clinical Trials Size & Trend Analysis, by Indication, 2018 to 2030 (USD Million)
• 6.4. Cardiovascular devices
  • 6.4.1. Cardiovascular devices market estimates and forecasts 2018 to 2030 (USD Million)
• 6.5. Neurology devices
  • 6.5.1. Neurology devices market estimates and forecasts 2018 to 2030 (USD Million)
• 6.6. Orthopedic devices
  • 6.6.1. Orthopedic devices market estimates and forecasts 2018 to 2030 (USD Million)
• 6.7. Diagnostic imaging
  • 6.7.1. Diagnostic imaging market estimates and forecasts 2018 to 2030 (USD Million)
• 6.8. Anesthesia and Respiratory devices
  • 6.8.1. Anesthesia and respiratory devices market estimates and forecasts 2018 to 2030 (USD Million)
• 6.9. Others
  • 6.9.1. Others market estimates and forecasts 2018 to 2030 (USD Million)

Chapter 7. Medical Device Clinical Trials Market: Regional Estimates & Trend Analysis

• 7.1. Regional Dashboard
• 7.2. Market Size & Forecasts and Trend Analysis, 2018 to 2030
• 7.3. North America
  • 7.3.1. North America medical device clinical trials market estimates and forecasts, 2018 - 2030 (USD Million)
  • 7.3.2. U.S.
    • 7.3.2.1. Key Country Dynamics
    • 7.3.2.2. Competitive Scenario
    • 7.3.2.3. Regulatory Framework
    • 7.3.2.4. U.S. medical device clinical trials market estimates and forecasts, 2018 - 2030 (USD Million)
  • 7.3.3. Canada
    • 7.3.3.1. Key Country Dynamics
    • 7.3.3.2. Competitive Scenario
    • 7.3.3.3. Regulatory Framework
    • 7.3.3.4. Canada medical device clinical trials market estimates and forecasts, 2018 - 2030 (USD Million)
  • 7.3.4. Mexico
    • 7.3.4.1. Key Country Dynamics
    • 7.3.4.2. Competitive Scenario
    • 7.3.4.3. Regulatory Framework
    • 7.3.4.4. Mexico medical device clinical trials market estimates and forecasts, 2018 - 2030 (USD Million)
• 7.4. Europe
  • 7.4.1. Europe medical device clinical trials market estimates and forecasts, 2018 - 2030 (USD Million)
  • 7.4.2. Germany
    • 7.4.2.1. Key Country Dynamics
    • 7.4.2.2. Competitive Scenario
    • 7.4.2.3. Regulatory Framework
    • 7.4.2.4. Germany medical device clinical trials market estimates and forecasts, 2018 - 2030 (USD Million)
  • 7.4.3. UK
    • 7.4.3.1. Key Country Dynamics
    • 7.4.3.2. Competitive Scenario
    • 7.4.3.3. Regulatory Framework
    • 7.4.3.4. UK medical device clinical trials market estimates and forecasts, 2018 - 2030 (USD Million)
  • 7.4.4. France
    • 7.4.4.1. Key Country Dynamics
    • 7.4.4.2. Competitive Scenario
    • 7.4.4.3. Regulatory Framework
    • 7.4.4.4. France medical device clinical trials market estimates and forecasts, 2018 - 2030 (USD Million)
  • 7.4.5. Italy
    • 7.4.5.1. Key Country Dynamics
    • 7.4.5.2. Competitive Scenario
    • 7.4.5.3. Regulatory Framework
    • 7.4.5.4. Italy medical device clinical trials market estimates and forecasts, 2018 - 2030 (USD Million)
  • 7.4.6. Spain
    • 7.4.6.1. Key Country Dynamics
    • 7.4.6.2. Competitive Scenario
    • 7.4.6.3. Regulatory Framework
    • 7.4.6.4. Spain medical device clinical trials market estimates and forecasts, 2018 - 2030 (USD Million)
  • 7.4.7. Denmark
    • 7.4.7.1. Key Country Dynamics
    • 7.4.7.2. Competitive Scenario
    • 7.4.7.3. Regulatory Framework
    • 7.4.7.4. Denmark medical device clinical trials market estimates and forecasts, 2018 - 2030 (USD Million)
  • 7.4.8. Sweden
    • 7.4.8.1. Key Country Dynamics
    • 7.4.8.2. Competitive Scenario
    • 7.4.8.3. Regulatory Framework
    • 7.4.8.4. Sweden medical device clinical trials market estimates and forecasts, 2018 - 2030 (USD Million)
  • 7.4.9. Norway
    • 7.4.9.1. Key Country Dynamics
    • 7.4.9.2. Competitive Scenario
    • 7.4.9.3. Regulatory Framework
    • 7.4.9.4. Norway medical device clinical trials market estimates and forecasts, 2018 - 2030 (USD Million)
• 7.5. Asia Pacific
  • 7.5.1. Asia Pacific medical device clinical trials market estimates and forecasts, 2018 - 2030 (USD Million)
  • 7.5.2. Japan
    • 7.5.2.1. Key Country Dynamics
    • 7.5.2.2. Competitive Scenario
    • 7.5.2.3. Regulatory Framework
    • 7.5.2.4. Japan medical device clinical trials market estimates and forecasts, 2018 - 2030 (USD Million)
  • 7.5.3. China
    • 7.5.3.1. Key Country Dynamics
    • 7.5.3.2. Competitive Scenario
    • 7.5.3.3. Regulatory Framework
    • 7.5.3.4. China medical device clinical trials market estimates and forecasts, 2018 - 2030 (USD Million)
  • 7.5.4. India
    • 7.5.4.1. Key Country Dynamics
    • 7.5.4.2. Competitive Scenario
    • 7.5.4.3. Regulatory Framework
    • 7.5.4.4. India medical device clinical trials market estimates and forecasts, 2018 - 2030 (USD Million)
  • 7.5.5. South Korea
    • 7.5.5.1. Key Country Dynamics
    • 7.5.5.2. Competitive Scenario
    • 7.5.5.3. Regulatory Framework
    • 7.5.5.4. South Korea medical device clinical trials market estimates and forecasts, 2018 - 2030 (USD Million)
  • 7.5.6. Australia
    • 7.5.6.1. Key Country Dynamics
    • 7.5.6.2. Competitive Scenario
    • 7.5.6.3. Regulatory Framework
    • 7.5.6.4. Australia medical device clinical trials market estimates and forecasts, 2018 - 2030 (USD Million)
  • 7.5.7. Thailand
    • 7.5.7.1. Key Country Dynamics
    • 7.5.7.2. Competitive Scenario
    • 7.5.7.3. Regulatory Framework
    • 7.5.7.4. Thailand medical device clinical trials market estimates and forecasts, 2018 - 2030 (USD Million)
• 7.6. Latin America
  • 7.6.1. Latin America medical device clinical trials market estimates and forecasts, 2018 - 2030 (USD Million)
  • 7.6.2. Brazil
    • 7.6.2.1. Key Country Dynamics
    • 7.6.2.2. Competitive Scenario
    • 7.6.2.3. Regulatory Framework
    • 7.6.2.4. Brazil medical device clinical trials market estimates and forecasts, 2018 - 2030 (USD Million)
  • 7.6.3. Argentina
    • 7.6.3.1. Key Country Dynamics
    • 7.6.3.2. Competitive Scenario
    • 7.6.3.3. Regulatory Framework
    • 7.6.3.4. Argentina medical device clinical trials market estimates and forecasts, 2018 - 2030 (USD Million)
• 7.7. MEA
  • 7.7.1. MEA medical device clinical trials market estimates and forecasts, 2018 - 2030 (USD Million)
  • 7.7.2. South Africa
    • 7.7.2.1. Key Country Dynamics
    • 7.7.2.2. Competitive Scenario
    • 7.7.2.3. Regulatory Framework
    • 7.7.2.4. South Africa medical device clinical trials market estimates and forecasts, 2018 - 2030 (USD Million)
  • 7.7.3. Saudi Arabia
    • 7.7.3.1. Key Country Dynamics
    • 7.7.3.2. Competitive Scenario
    • 7.7.3.3. Regulatory Framework
    • 7.7.3.4. Saudi Arabia medical device clinical trials market estimates and forecasts, 2018 - 2030 (USD Million)
  • 7.7.4. UAE
    • 7.7.4.1. Key Country Dynamics
    • 7.7.4.2. Competitive Scenario
    • 7.7.4.3. Regulatory Framework
    • 7.7.4.4. UAE medical device clinical trials market estimates and forecasts, 2018 - 2030 (USD Million)
  • 7.7.5. Kuwait
    • 7.7.5.1. Key Country Dynamics
    • 7.7.5.2. Competitive Scenario
    • 7.7.5.3. Regulatory Framework
    • 7.7.5.4. Kuwait medical device clinical trials market estimates and forecasts, 2018 - 2030 (USD Million)

Chapter 8. Competitive Landscape

• 8.1. Company Categorization
• 8.2. Company Market Position Analysis, 2024
• 8.3. Company Profiles
  • 8.3.1. Abbott
    • 8.3.1.1. Company overview
    • 8.3.1.2. Financial performance
    • 8.3.1.3. Service benchmarking
    • 8.3.1.4. Strategic initiatives
  • 8.3.2. Medtronic
    • 8.3.2.1. Company overview
    • 8.3.2.2. Financial performance
    • 8.3.2.3. Service benchmarking
    • 8.3.2.4. Strategic initiatives
  • 8.3.3. Siemens Healthineers AG
    • 8.3.3.1. Company overview
    • 8.3.3.2. Financial performance
    • 8.3.3.3. Service benchmarking
    • 8.3.3.4. Strategic initiatives
  • 8.3.4. Fresenius Medical Care AG
    • 8.3.4.1. Company overview
    • 8.3.4.2. Financial performance
    • 8.3.4.3. Service benchmarking
    • 8.3.4.4. Strategic initiatives
  • 8.3.5. GE Healthcare
    • 8.3.5.1. Company overview
    • 8.3.5.2. Financial performance
    • 8.3.5.3. Service benchmarking
    • 8.3.5.4. Strategic initiatives
  • 8.3.6. Koninklijke Philips N.V.
    • 8.3.6.1. Company overview
    • 8.3.6.2. Financial performance
    • 8.3.6.3. Service benchmarking
    • 8.3.6.4. Strategic initiatives
  • 8.3.7. Danaher Corporation
    • 8.3.7.1. Company overview
    • 8.3.7.2. Financial performance
    • 8.3.7.3. Service benchmarking
    • 8.3.7.4. Strategic initiatives
  • 8.3.8. Baxter
    • 8.3.8.1. Company overview
    • 8.3.8.2. Financial performance
    • 8.3.8.3. Service benchmarking
    • 8.3.8.4. Strategic initiatives
  • 8.3.9. Boston Scientific Corporation
    • 8.3.9.1. Company overview
    • 8.3.9.2. Financial performance
    • 8.3.9.3. Service benchmarking
    • 8.3.9.4. Strategic initiatives
  • 8.3.10. F. Hoffmann La Roche
    • 8.3.10.1. Company overview
    • 8.3.10.2. Financial performance
    • 8.3.10.3. Service benchmarking
    • 8.3.10.4. Strategic initiatives