임상시험용 AI 시장 규모, 점유율, 성장, 세계 산업 분석 : 유형별, 용도별, 지역별 인사이트, 예측(2026-2034년)

Growth Factors of AI in clinical trials Market

The global AI in clinical trials market is witnessing exponential growth due to the increasing complexity of drug development, rising clinical trial costs, and the adoption of AI technologies to optimize trial processes. The market was valued at USD 3.8 billion in 2025, expected to grow to USD 5.5 billion in 2026, and projected to reach USD 120.91 billion by 2034, reflecting a remarkable CAGR of 47.14% during the forecast period.

Artificial intelligence is being increasingly integrated across clinical trial design, execution, monitoring, and data analysis. These AI technologies help pharmaceutical companies and contract research organizations (CROs) reduce timelines, streamline patient recruitment, automate data cleaning, and enable adaptive trial designs. For example, in September 2022, IQVIA Inc. reported that decentralized clinical trials delivered measurable reductions in both time and cost compared to traditional trial workflows.

The market is dominated by companies such as IQVIA Inc., Dassault Systemes, and AiCure, with strong geographic presence, broad product portfolios, and innovative AI solutions supporting their leadership positions.

Market Dynamics

Market Drivers

Rising adoption of AI-based solutions to tackle high costs and complexity in clinical trials is a primary driver. AI allows faster patient recruitment, real-time monitoring, and predictive outcome modeling, resulting in reduced trial durations and lower failure risks. The increasing volume of clinical trials worldwide further accelerates AI adoption.

Market Restraints

Data privacy and regulatory compliance remain key restraints. Regulations like HIPAA in the U.S. and GDPR in Europe limit cross-border data exchange and multi-site collaborations, increasing operational costs and time. These factors slow adoption of AI in multinational clinical trials.

Market Opportunities

The expansion of clinical trials in emerging markets offers significant growth potential. Regions like Asia Pacific, Latin America, and Middle East & Africa provide cost advantages and untapped patient populations. AI can optimize fragmented healthcare data and trial logistics in these regions, enabling faster and efficient trial execution.

Market Challenges

Integration of AI solutions with traditional IT systems poses challenges. Legacy electronic data capture (EDC) systems, paper-based records, and fragmented IT infrastructure hinder seamless AI deployment. Even when AI tools are implemented, inefficiencies in integration can limit their potential.

Market Trends

A major trend is the shift toward decentralized and hybrid clinical trials, which include remote patient monitoring, telemedicine, and distributed investigational-product logistics. Adoption of decentralized clinical trial (DCT) models rose from 28% pre-pandemic to 87% post-pandemic, with 95% of sponsors planning increased use, showcasing the strong role of AI in supporting these models.

Segmentation Analysis

By Offering:

• Services segment dominated in 2026 with 52.74% share, driven by outsourcing to CROs and specialized service providers.
• Software/platforms complement services for data analytics, patient monitoring, and trial management.

By Technology:

• Machine learning (ML) accounted for 55.90% share in 2026, widely applied for predictive analytics and trial optimization.
• Natural language processing (NLP) is expected to grow at 44.74% CAGR during the forecast period.

By Application:

• Patient recruitment & retention led in 2026 with 31.45% share, optimizing enrollment and reducing trial delays.
• Predictive analytics & outcome modeling is projected to witness 52.05% growth.

By Specialty:

• Oncology dominated in 2026 with 39.25% share, driven by complex drug molecules and use of AI for biomarkers.
• Neurology is projected to grow at 48.98% CAGR during the forecast period.

By End-User:

• Pharmaceutical companies dominated in 2025 with 59.9% share, leveraging large clinical datasets and partnerships for AI deployment.
• CROs are projected to grow at 48.56% CAGR.

Regional Outlook

• North America: Dominated with USD 1.98 billion in 2025, growing to USD 2.87 billion in 2026, driven by U.S. clinical trial investments. The U.S. market is expected to reach USD 2.64 billion in 2026.
• Europe: Valued at USD 0.75 billion in 2025, with strong growth due to AI adoption in oncology and rare disease trials. UK, Germany, and France markets are projected to reach USD 0.23B, 0.26B, 0.14B respectively in 2026.
• Asia Pacific: Estimated at USD 0.83 billion in 2025, with Japan, China, and India projected at USD 0.27B, 0.31B, 0.24B in 2026.
• Latin America: USD 0.15 billion in 2025, moderate growth expected.
• Middle East & Africa: GCC valued at USD 0.04 billion in 2025, growing steadily with modernization of trial infrastructure.

Competitive Landscape

The market is semi-consolidated, led by IQVIA, Dassault Systemes, AiCure, Insilico Medicine, TEMPUS, Median Technologies, Saama, IBM, NVIDIA, and Phesi. These players focus on AI-powered solutions for patient recruitment, protocol optimization, and clinical trial analytics.

Key Developments:

• Sept 2025: PhaseV & Bioforum partnership for AI/ML-based clinical trials efficiency.
• June 2025: Advarra introduced Council for Responsible AI in Clinical Trials.
• April 2025: ConcertAI & Bayer AG multi-year agreement for AI-driven precision oncology trials.
• March 2025: EMA cleared AIM-NASH AI tool for fatty liver disease severity identification.

Conclusion

The global AI in clinical trials market is projected to grow from USD 3.8 billion in 2025 to USD 120.91 billion by 2034, at a CAGR of 47.14%. Growth is driven by increasing clinical trial complexity, adoption of AI technologies in patient recruitment, predictive analytics, and decentralized trials. Despite challenges in data privacy, regulatory compliance, and legacy system integration, opportunities in emerging markets, oncology, and neurology clinical trials will continue to propel the market globally.

Segmentation By Offering

• Software / Platforms
• Services

By Technology

• Machine Learning
• Natural Language Processing
• Others

By Application

• Patient Recruitment & Retention
• Trial Design & Protocol Optimization
• Data Collection & Management
• Predictive Analytics & Outcome Modeling
• Others

By Specialty

• Oncology
• Neurology
• Cardiovascular
• Others

By End User

• Pharmaceutical Companies
• Contract Research Organizations (CROs)
• Others

By Geography

• North America (By Offering, Technology, Application, Specialty, End User, and Country)
  • U.S.
  • Canada
• Europe (By Offering, Technology, Application, Specialty, End User, and Country/Sub-region)
  • Germany
  • U.K.
  • France
  • Spain
  • Italy
  • Scandinavia
  • Rest of Europe
• Asia Pacific (By Offering, Technology, Application, Specialty, End User, and Country/Sub-region)
  • China
  • Japan
  • India
  • Australia
  • Southeast Asia
  • Rest of Asia Pacific
• Latin America (By Offering, Technology, Application, Specialty, End User, and Country/Sub-region)
  • Brazil
  • Mexico
  • Rest of Latin America
• Middle East & Africa (By Offering, Technology, Application, Specialty, End User, and Country/Sub-region)
  • GCC
  • South Africa
  • Rest of the Middle East & Africa

Table of Content

1. Introduction

• 1.1. Research Scope
• 1.2. Market Segmentation
• 1.3. Research Methodology
• 1.4. Definitions and Assumptions

2. Executive Summary

3. Market Dynamics

• 3.1. Market Drivers
• 3.2. Market Restraints
• 3.3. Market Opportunities
• 3.4. Market Trends

4. Key Insights

• 4.1. Technological Advancements Pertaining to the Artificial Intelligence in Clinical Trials
• 4.2. Regulatory Scenario for Key Countries
• 4.3. Challenges Faced During Adoption and Implementation of AI-based Solutions in Clinical Trials
• 4.4. Key Performance Indicators for Artificial Intelligence in the Clinical Trials Market
• 4.5. Key Industry Developments - Mergers, Acquisitions, Partnerships, etc.

5. Global AI in Clinical Trials Market Analysis, Insights and Forecast, 2021-2034

• 5.1. Market Analysis, Insights and Forecast - By Offering
  • 5.1.1. Software/Platforms
  • 5.1.2. Services
• 5.2. Market Analysis, Insights and Forecast - By Technology
  • 5.2.1. Machine Learning
  • 5.2.2. Natural Language Processing
  • 5.2.3. Others
• 5.3. Market Analysis, Insights and Forecast - By Application
  • 5.3.1. Patient Recruitment & Retention
  • 5.3.2. Trial Design & Protocol Optimization
  • 5.3.3. Data Collection & Management
  • 5.3.4. Predictive Analytics & Outcome Modelling
  • 5.3.5. Others
• 5.4. Market Analysis, Insights and Forecast - By Specialty
  • 5.4.1. Oncology
  • 5.4.2. Neurology
  • 5.4.3. Cardiovascular
  • 5.4.4. Others
• 5.5. Market Analysis, Insights and Forecast - By End User
  • 5.5.1. Pharmaceutical Companies
  • 5.5.2. Contract Research Organizations (CROs)
  • 5.5.3. Others
• 5.6. Market Analysis, Insights and Forecast - By Region
  • 5.6.1. North America
  • 5.6.2. Europe
  • 5.6.3. Asia Pacific
  • 5.6.4. Latin America
  • 5.6.5. Middle East & Africa

6. North America AI in Clinical Trials Market Analysis, Insights and Forecast, 2021-2034

• 6.1. Market Analysis, Insights and Forecast - By Offering
  • 6.1.1. Software/Platforms
  • 6.1.2. Services
• 6.2. Market Analysis, Insights and Forecast - By Technology
  • 6.2.1. Machine Learning
  • 6.2.2. Natural Language Processing
  • 6.2.3. Others
• 6.3. Market Analysis, Insights and Forecast - By Application
  • 6.3.1. Patient Recruitment & Retention
  • 6.3.2. Trial Design & Protocol Optimization
  • 6.3.3. Data Collection & Management
  • 6.3.4. Predictive Analytics & Outcome Modelling
  • 6.3.5. Others
• 6.4. Market Analysis, Insights and Forecast - By Specialty
  • 6.4.1. Oncology
  • 6.4.2. Neurology
  • 6.4.3. Cardiovascular
  • 6.4.4. Others
• 6.5. Market Analysis, Insights and Forecast - By End User
  • 6.5.1. Pharmaceutical Companies
  • 6.5.2. Contract Research Organizations (CROs)
  • 6.5.3. Others
• 6.6. Market Analysis, Insights and Forecast - By Country
  • 6.6.1. U.S.
  • 6.6.2. Canada

7. Europe AI in Clinical Trials Market Analysis, Insights and Forecast, 2021-2034

• 7.1. Market Analysis, Insights and Forecast - By Offering
  • 7.1.1. Software/Platforms
  • 7.1.2. Services
• 7.2. Market Analysis, Insights and Forecast - By Technology
  • 7.2.1. Machine Learning
  • 7.2.2. Natural Language Processing
  • 7.2.3. Others
• 7.3. Market Analysis, Insights and Forecast - By Application
  • 7.3.1. Patient Recruitment & Retention
  • 7.3.2. Trial Design & Protocol Optimization
  • 7.3.3. Data Collection & Management
  • 7.3.4. Predictive Analytics & Outcome Modelling
  • 7.3.5. Others
• 7.4. Market Analysis, Insights and Forecast - By Specialty
  • 7.4.1. Oncology
  • 7.4.2. Neurology
  • 7.4.3. Cardiovascular
  • 7.4.4. Others
• 7.5. Market Analysis, Insights and Forecast - By End User
  • 7.5.1. Pharmaceutical Companies
  • 7.5.2. Contract Research Organizations (CROs)
  • 7.5.3. Others
• 7.6. Market Analysis, Insights and Forecast - By Country/Sub-region
  • 7.6.1. U.K.
  • 7.6.2. Germany
  • 7.6.3. France
  • 7.6.4. Spain
  • 7.6.5. Italy
  • 7.6.6. Scandinavia
  • 7.6.7. Rest of Europe

8. Asia Pacific AI in Clinical Trials Market Analysis, Insights and Forecast, 2021-2034

• 8.1. Market Analysis, Insights and Forecast - By Offering
  • 8.1.1. Software/Platforms
  • 8.1.2. Services
• 8.2. Market Analysis, Insights and Forecast - By Technology
  • 8.2.1. Machine Learning
  • 8.2.2. Natural Language Processing
  • 8.2.3. Others
• 8.3. Market Analysis, Insights and Forecast - By Application
  • 8.3.1. Patient Recruitment & Retention
  • 8.3.2. Trial Design & Protocol Optimization
  • 8.3.3. Data Collection & Management
  • 8.3.4. Predictive Analytics & Outcome Modelling
  • 8.3.5. Others
• 8.4. Market Analysis, Insights and Forecast - By Specialty
  • 8.4.1. Oncology
  • 8.4.2. Neurology
  • 8.4.3. Cardiovascular
  • 8.4.4. Others
• 8.5. Market Analysis, Insights and Forecast - By End User
  • 8.5.1. Pharmaceutical Companies
  • 8.5.2. Contract Research Organizations (CROs)
  • 8.5.3. Others
• 8.6. Market Analysis, Insights and Forecast - By Country/Sub-region
  • 8.6.1. Japan
  • 8.6.2. China
  • 8.6.3. India
  • 8.6.4. Australia
  • 8.6.5. Southeast Asia
  • 8.6.6. Rest of Asia Pacific

9. Latin America AI in Clinical Trials Market Analysis, Insights and Forecast, 2021-2034

• 9.1. Market Analysis, Insights and Forecast - By Offering
  • 9.1.1. Software/Platforms
  • 9.1.2. Services
• 9.2. Market Analysis, Insights and Forecast - By Technology
  • 9.2.1. Machine Learning
  • 9.2.2. Natural Language Processing
  • 9.2.3. Others
• 9.3. Market Analysis, Insights and Forecast - By Application
  • 9.3.1. Patient Recruitment & Retention
  • 9.3.2. Trial Design & Protocol Optimization
  • 9.3.3. Data Collection & Management
  • 9.3.4. Predictive Analytics & Outcome Modelling
  • 9.3.5. Others
• 9.4. Market Analysis, Insights and Forecast - By Specialty
  • 9.4.1. Oncology
  • 9.4.2. Neurology
  • 9.4.3. Cardiovascular
  • 9.4.4. Others
• 9.5. Market Analysis, Insights and Forecast - By End User
  • 9.5.1. Pharmaceutical Companies
  • 9.5.2. Contract Research Organizations (CROs)
  • 9.5.3. Others
• 9.6. Market Analysis, Insights and Forecast - By Country/Sub-region
  • 9.6.1. Brazil
  • 9.6.2. Mexico
  • 9.6.3. Rest of Latin America

10. Middle East & Africa AI in Clinical Trials Market Analysis, Insights and Forecast, 2021-2034

• 10.1. Market Analysis, Insights and Forecast - By Offering
  • 10.1.1. Software/Platforms
  • 10.1.2. Services
• 10.2. Market Analysis, Insights and Forecast - By Technology
  • 10.2.1. Machine Learning
  • 10.2.2. Natural Language Processing
  • 10.2.3. Others
• 10.3. Market Analysis, Insights and Forecast - By Application
  • 10.3.1. Patient Recruitment & Retention
  • 10.3.2. Trial Design & Protocol Optimization
  • 10.3.3. Data Collection & Management
  • 10.3.4. Predictive Analytics & Outcome Modelling
  • 10.3.5. Others
• 10.4. Market Analysis, Insights and Forecast - By Specialty
  • 10.4.1. Oncology
  • 10.4.2. Neurology
  • 10.4.3. Cardiovascular
  • 10.4.4. Others
• 10.5. Market Analysis, Insights and Forecast - By End User
  • 10.5.1. Pharmaceutical Companies
  • 10.5.2. Contract Research Organizations (CROs)
  • 10.5.3. Others
• 10.6. Market Analysis, Insights and Forecast - By Country/Sub-region
  • 10.6.1. GCC
  • 10.6.2. South Africa
  • 10.6.3. Rest of Middle East & Africa

11. Competitive Analysis

• 11.1. Global Market Share Analysis (2025)
• 11.2. Company Profiles (Overview, Products & Services, SWOT analysis, Recent developments, strategies, financials (based on availability))
  • 11.2.1. IQVIA Inc.
  • 11.2.2. Dassault Systemes
  • 11.2.3. AiCure
  • 11.2.4. Insilico Medicine
  • 11.2.5. TEMPUS
  • 11.2.6. Median Technologies
  • 11.2.7. Saama
  • 11.2.8. IBM
  • 11.2.9. NVIDIA Corporation
  • 11.2.10. Phesi