臨床試験におけるAI活用の世界市場は、2024年に約14億8000万米ドルに達すると評価され、2025〜2035年の予測期間中は14.00%を超える堅調な年平均成長率（CAGR）で拡大すると見込まれています。臨床研究エコシステムがデータ主導の意思決定にますます依存するようになるにつれ、人工知能（AI）は、創薬と試験実施における従来のパラダイムを再定義できる変革の触媒として浮上しています。AIツールを活用することで、関係者はプロトコル設計を強化し、患者の転帰を予測し、リクルートメントを加速し、施設選択を最適化することができます。これらはすべて、規制遵守を維持し、データの完全性を確保しながら実現できます。臨床開発の複雑さが増し、研究開発費削減のプレッシャーが高まる中、製薬スポンサーと開発業務受託機関（CRO）は、タイムラインを短縮し、成功率を高めるために、AI主導のプラットフォームを積極的に統合しています。
臨床データの急激な増加と、治療法の市場投入までの期間短縮の必要性が相まって、治験におけるAI活用ソリューションの需要が高まっています。機械学習（ML）、自然言語処理（NLP）、コンピュータービジョンといった技術は、臨床試験開始前のデータ収集の効率化、異常値の特定、患者行動のシミュレーションモデル化に活用されています。例えば、コンテキストボットはリアルタイムの患者エンゲージメントを促進し、治験ロジスティクスを自動化することで、人的ミスや事務負担を最小限に抑えています。最近の業界分析によると、AIの導入により、特に腫瘍学や希少疾患の研究において、治験実施計画書（プロトコル）の開発期間が著しく短縮され、治験継続率が向上しています。さらに、サービスプロバイダーはエンドツーエンドのAI主導型臨床ソリューションを提供しており、治験依頼者は複雑な規制環境をより効率的に乗り越えることができます。
地域別では、北アメリカが2025年の臨床試験におけるAI市場を牽引しました。これは、広範な臨床研究インフラ、先進技術の早期導入、デジタル治療に対する好ましい規制環境などが要因です。大手製薬会社とAIイノベーターの存在が、そのリーダーシップをさらに強化しています。ヨーロッパは、ライフサイエンス分野におけるAI統合の促進を目的とした、ヘルステック企業と公衆衛生機関の共同イニシアチブに牽引され、これに追随しています。一方、アジア太平洋地域は、中国、インド、日本などの国々におけるヘルスケアAIへの投資の増加、患者プールの拡大、臨床診療のデジタル変革に支えられ、予測期間中に最も急速な成長が見込まれています。政府支援のイノベーションハブと国際的なパートナーシップは、この地域が世界的な臨床試験大国へと進化するのを加速させています。
本調査の目的は、近年における様々なセグメントおよび国における市場規模を定義し、今後数年間の価値を予測することです。本レポートは、調査対象国における業界の定性的および定量的側面の両方を網羅するように設計されており、市場の将来の成長を決定づける推進要因や課題といった重要な側面についても詳細な情報を提供しています。さらに、利害関係者が投資できるマイクロ市場における潜在的な機会、そして主要プレーヤーの競争環境と製品提供の詳細な分析も盛り込んでいます。
目次
Table of Contents
Chapter 1. Global AI in Clinical Trials Market Report Scope & Methodology
1.1. Research Objective
1.2. Research Methodology
1.2.1. Forecast Model
1.2.2. Desk Research
1.2.3. Top-Down and Bottom-Up Approach
1.3. Research Attributes
1.4. Scope of the Study
1.4.1. Market Definition
1.4.2. Market Segmentation
1.5. Research Assumption
1.5.1. Inclusion & Exclusion
1.5.2. Limitations
1.5.3. Years Considered for the Study
Chapter 2. Executive Summary
2.1. CEO/CXO Standpoint
2.2. Strategic Insights
2.3. ESG Analysis
2.4. Key Findings
Chapter 3. Global AI in Clinical Trials Market Forces Analysis
3.1. Market Forces Shaping The Global AI in Clinical Trials Market (2024-2035)
3.2. Drivers
3.2.1. Increasing Complexity and Escalating R&D Costs
3.2.2. Exponential Growth of Clinical Data
3.3. Restraints
3.3.1. Regulatory Compliance Complexity
3.3.2. Data Privacy and Security Concerns
3.4. Opportunities
3.4.1. Expansion in Emerging Markets
3.4.2. Integration with Real-World Evidence and Digital Health Platforms
Chapter 4. Global AI in Clinical Trials Industry Analysis
4.1. Porter’s Five Forces Model
4.1.1. Bargaining Power of Buyer
4.1.2. Bargaining Power of Supplier
4.1.3. Threat of New Entrants
4.1.4. Threat of Substitutes
4.1.5. Competitive Rivalry
4.2. Porter’s Five Forces Forecast Model (2024-2035)
4.3. PESTEL Analysis
4.3.1. Political
4.3.2. Economic
4.3.3. Social
4.3.4. Technological
4.3.5. Environmental
4.3.6. Legal
4.4. Top Investment Opportunities
4.5. Top Winning Strategies (2025)
4.6. Market Share Analysis (2024-2025)
4.7. Global Pricing Analysis and Trends 2025
4.8. Analyst Recommendation & Conclusion
Chapter 5. Global AI in Clinical Trials Market Size & Forecasts by Component 2025-2035
5.1. Market Overview
5.2. Global AI in Clinical Trials Market Performance - Potential Analysis (2025)
5.3. Software
5.3.1. Top Countries Breakdown Estimates & Forecasts, 2024-2035
5.3.2. Market Size Analysis, by Region, 2025-2035
5.4. Service
5.4.1. Top Countries Breakdown Estimates & Forecasts, 2024-2035
5.4.2. Market Size Analysis, by Region, 2025-2035
Chapter 6. Global AI in Clinical Trials Market Size & Forecasts by Technology 2025-2035
6.1. Market Overview
6.2. Global AI in Clinical Trials Market Performance - Potential Analysis (2025)
6.3. Machine Learning (ML)
6.3.1. Top Countries Breakdown Estimates & Forecasts, 2024-2035
6.3.2. Market Size Analysis, by Region, 2025-2035
6.4. Natural Language Processing (NLP)
6.4.1. Top Countries Breakdown Estimates & Forecasts, 2024-2035
6.4.2. Market Size Analysis, by Region, 2025-2035
6.5. Computer Vision
6.5.1. Top Countries Breakdown Estimates & Forecasts, 2024-2035
6.5.2. Market Size Analysis, by Region, 2025-2035
6.6. Contextual Bots
6.6.1. Top Countries Breakdown Estimates & Forecasts, 2024-2035
6.6.2. Market Size Analysis, by Region, 2025-2035
Chapter 7. Global AI in Clinical Trials Market Size & Forecasts by Region 2025-2035
7.1. AI in Clinical Trials Market, Regional Market Snapshot
7.2. Top Leading & Emerging Countries
7.3. North America AI in Clinical Trials Market
7.3.1. U.S. AI in Clinical Trials Market
7.3.1.1. Component Breakdown Size & Forecasts, 2025-2035
7.3.1.2. Technology Breakdown Size & Forecasts, 2025-2035
7.3.2. Canada AI in Clinical Trials Market
7.3.2.1. Component Breakdown Size & Forecasts, 2025-2035
7.3.2.2. Technology Breakdown Size & Forecasts, 2025-2035
7.4. Europe AI in Clinical Trials Market
7.4.1. UK AI in Clinical Trials Market
7.4.1.1. Component Breakdown Size & Forecasts, 2025-2035
7.4.1.2. Technology Breakdown Size & Forecasts, 2025-2035
7.4.2. Germany AI in Clinical Trials Market
7.4.2.1. Component Breakdown Size & Forecasts, 2025-2035
7.4.2.2. Technology Breakdown Size & Forecasts, 2025-2035
7.4.3. France AI in Clinical Trials Market
7.4.3.1. Component Breakdown Size & Forecasts, 2025-2035
7.4.3.2. Technology Breakdown Size & Forecasts, 2025-2035
7.4.4. Spain AI in Clinical Trials Market
7.4.4.1. Component Breakdown Size & Forecasts, 2025-2035
7.4.4.2. Technology Breakdown Size & Forecasts, 2025-2035
7.4.5. Italy AI in Clinical Trials Market
7.4.5.1. Component Breakdown Size & Forecasts, 2025-2035
7.4.5.2. Technology Breakdown Size & Forecasts, 2025-2035
7.4.6. Rest of Europe AI in Clinical Trials Market
7.4.6.1. Component Breakdown Size & Forecasts, 2025-2035
7.4.6.2. Technology Breakdown Size & Forecasts, 2025-2035
7.5. Asia Pacific AI in Clinical Trials Market
7.5.1. China AI in Clinical Trials Market
7.5.1.1. Component Breakdown Size & Forecasts, 2025-2035
7.5.1.2. Technology Breakdown Size & Forecasts, 2025-2035
7.5.2. India AI in Clinical Trials Market
7.5.2.1. Component Breakdown Size & Forecasts, 2025-2035
7.5.2.2. Technology Breakdown Size & Forecasts, 2025-2035
7.5.3. Japan AI in Clinical Trials Market
7.5.3.1. Component Breakdown Size & Forecasts, 2025-2035
7.5.3.2. Technology Breakdown Size & Forecasts, 2025-2035
7.5.4. Australia AI in Clinical Trials Market
7.5.4.1. Component Breakdown Size & Forecasts, 2025-2035
7.5.4.2. Technology Breakdown Size & Forecasts, 2025-2035
7.5.5. South Korea AI in Clinical Trials Market
7.5.5.1. Component Breakdown Size & Forecasts, 2025-2035
7.5.5.2. Technology Breakdown Size & Forecasts, 2025-2035
7.5.6. Rest of APAC AI in Clinical Trials Market
7.5.6.1. Component Breakdown Size & Forecasts, 2025-2035
7.5.6.2. Technology Breakdown Size & Forecasts, 2025-2035
7.6. Latin America AI in Clinical Trials Market
7.6.1. Brazil AI in Clinical Trials Market
7.6.1.1. Component Breakdown Size & Forecasts, 2025-2035
7.6.1.2. Technology Breakdown Size & Forecasts, 2025-2035
7.6.2. Mexico AI in Clinical Trials Market
7.6.2.1. Component Breakdown Size & Forecasts, 2025-2035
7.6.2.2. Technology Breakdown Size & Forecasts, 2025-2035
7.7. Middle East & Africa AI in Clinical Trials Market
7.7.1. UAE AI in Clinical Trials Market
7.7.1.1. Component Breakdown Size & Forecasts, 2025-2035
7.7.1.2. Technology Breakdown Size & Forecasts, 2025-2035
7.7.2. Saudi Arabia AI in Clinical Trials Market
7.7.2.1. Component Breakdown Size & Forecasts, 2025-2035
7.7.2.2. Technology Breakdown Size & Forecasts, 2025-2035
7.7.3. South Africa AI in Clinical Trials Market
7.7.3.1. Component Breakdown Size & Forecasts, 2025-2035
7.7.3.2. Technology Breakdown Size & Forecasts, 2025-2035
Chapter 8. Competitive Intelligence
8.1. Top Market Strategies
8.2. IBM Watson Health
8.2.1. Company Overview
8.2.2. Key Executives
8.2.3. Company Snapshot
8.2.4. Financial Performance (Subject to Data Availability)
8.2.5. Product/Services Portfolio
8.2.6. Recent Development
8.2.7. Market Strategies
8.2.8. SWOT Analysis
8.3. Google Health
8.4. IQVIA
8.5. Medidata Solutions (Dassault Systèmes)
8.6. Oracle Corporation
8.7. Microsoft Corporation
8.8. PAREXEL International Corporation
8.9. Veristat
8.10. BioXcel Therapeutics
8.11. Deep 6 AI
8.12. Saama Technologies
8.13. Trials.ai
8.14. Concerto HealthAI
8.15. Tempus
8.16. PathAI
List of Tables
Table 1. Global AI in Clinical Trials Market, Report Scope
Table 2. Global AI in Clinical Trials Market Estimates & Forecasts By Region 2024-2035
Table 3. Global AI in Clinical Trials Market Estimates & Forecasts By Component 2024-2035
Table 4. Global AI in Clinical Trials Market Estimates & Forecasts By Component 2024-2035
Table 5. Global AI in Clinical Trials Market Estimates & Forecasts By Technology 2024-2035
Table 6. Global AI in Clinical Trials Market Estimates & Forecasts By Technology 2024-2035
Table 7. Global AI in Clinical Trials Market Estimates & Forecasts By Application 2024-2035
Table 8. Global AI in Clinical Trials Market Estimates & Forecasts By Application 2024-2035
Table 9. Global AI in Clinical Trials Market Estimates & Forecasts By End User 2024-2035
Table 10. Global AI in Clinical Trials Market Estimates & Forecasts By End User 2024-2035
Table 11. North America AI in Clinical Trials Market Estimates & Forecasts, 2024-2035
Table 12. Canada AI in Clinical Trials Market Estimates & Forecasts, 2024-2035
Table 13. UK AI in Clinical Trials Market Estimates & Forecasts, 2024-2035
Table 14. Germany AI in Clinical Trials Market Estimates & Forecasts, 2024-2035
Table 15. France AI in Clinical Trials Market Estimates & Forecasts, 2024-2035
Table 16. Spain AI in Clinical Trials Market Estimates & Forecasts, 2024-2035
Table 17. Italy AI in Clinical Trials Market Estimates & Forecasts, 2024-2035
Table 18. Rest of Europe AI in Clinical Trials Market Estimates & Forecasts, 2024-2035
Table 19. Asia Pacific AI in Clinical Trials Market Estimates & Forecasts, 2024-2035
Table 20. Latin America & Middle East & Africa AI in Clinical Trials Market Estimates & Forecasts, 2024-2035
List of Figures
Fig 1. Global AI in Clinical Trials Market, Research Methodology
Fig 2. Global AI in Clinical Trials Market, Market Estimation Techniques
Fig 3. Global Market Size Estimates & Forecast Methods
Fig 4. Global AI in Clinical Trials Market, Key Trends 2025
Fig 5. Global AI in Clinical Trials Market, Growth Prospects 2024-2035
Fig 6. Global AI in Clinical Trials Market, Porter’s Five Forces Model
Fig 7. Global AI in Clinical Trials Market, PESTEL Analysis
Fig 8. Global AI in Clinical Trials Market, Value Chain Analysis
Fig 9. AI in Clinical Trials Market By Application, 2025 & 2035
Fig 10. AI in Clinical Trials Market By Component, 2025 & 2035
Fig 11. AI in Clinical Trials Market By Technology, 2025 & 2035
Fig 12. AI in Clinical Trials Market By End User, 2025 & 2035
Fig 13. North America AI in Clinical Trials Market, 2025 & 2035
Fig 14. Europe AI in Clinical Trials Market, 2025 & 2035
Fig 15. Asia Pacific AI in Clinical Trials Market, 2025 & 2035
Fig 16. Latin America AI in Clinical Trials Market, 2025 & 2035
Fig 17. Middle East & Africa AI in Clinical Trials Market, 2025 & 2035
Fig 18. Global AI in Clinical Trials Market, Company Market Share Analysis (2025)
Fig 19. Global AI in Clinical Trials Market, Forecast Methodology Comparison
