의약품용 에이전트형 인공지능(AI) : 시장 점유율 분석, 업계 동향 및 통계, 성장 예측(2026-2031년)

According to Mordor Intelligence, the agentic AI in pharmaceuticals market size is expected to grow from USD 0.18 billion in 2025 to USD 0.25 billion in 2026 and is forecasted to reach USD 1.23 billion by 2031, registering a 37.68% CAGR over 2026-2031.

This report is Segmented by Application (Drug Discovery and Lead Identification, Lead Optimization, and Others), Deployment Mode (On-Premise, Cloud-Based, Hybrid), End User (Large Pharmaceutical Companies, and Others), and Geography (North America, Europe, Asia-Pacific, Middle East and Africa, South America). The Market Forecasts are Provided in Terms of Value (USD).

Global Agentic AI In Pharmaceuticals Market Trends and Insights

Escalating R&D Cost Pressures Driving AI-Led Discovery

The out-of-pocket cost of bringing a single molecule from target nomination to approval averaged USD 2.6 billion in 2024, with Phase II failure rates near 60%. AI-first platforms can trim preclinical timelines by 30-50% by predicting ADMET liabilities in silico, letting teams cull weak candidates before synthesis. Partnerships such as Recursion-Bayer (USD 50 million upfront) and Schrodinger-Eli Lilly (USD 50 million) demonstrate that sponsors perceive enough economic upside to fund external AI capabilities.Each month removed from preclinical work extends patent exclusivity by the same duration, translating into USD 50-100 million in peak-year sales for blockbuster assets. Firms slow to deploy AI risk forfeiting first-mover advantage in therapeutic areas where even a six-month delay can shift market leadership.

Rising Availability of High-Quality Biological Data Sets

Public data stores surpassed 200,000 experimentally solved protein structures in 2025, while AlphaFold 3 predicted coordinates for 200 million more, providing the corpus that foundation models require to generalize across targets. Real-world evidence platforms now aggregate anonymized health records for 150 million patients across North America and Europe, allowing AI models to surface biomarker-response links invisible in traditional Phase III trials. Federated-learning networks connect 20+ academic medical centers without moving raw data, ensuring compliance with privacy laws yet preserving statistical power, and Asia-Pacific adds scale through a 25% surge in 2025 trial volume.

Data-Privacy and Cybersecurity Concerns Limit Data Sharing

A 2024 cloud misconfiguration exposed anonymized European patient genotypes, drew EUR 20 million in GDPR fines, and pushed 30% of EU sponsors back to on-premise storage. HIPAA's breach-notification mandates elevate reputational risk; the average U.S. healthcare data breach cost USD 10.9 million in 2024. Sponsors increasingly require vendors to carry at least USD 50 million in cyber-insurance, barring many early-stage AI startups from procurement lists. Differential privacy can mitigate exposure but erodes model accuracy by up to 10 percentage points, an efficiency hit acceptable only when regulatory penalties outweigh performance loss.

Other drivers and restraints analyzed in the detailed report include:

1. Regulatory Encouragement for AI-Driven Trial Design
2. Integration of Agentic AI With Self-Driving Laboratories
3. Skill Gap in Validating and Deploying Complex AI Agents

For complete list of drivers and restraints, kindly check the Table Of Contents.

Segment Analysis

Clinical-trial design and recruitment is expected to grow at 39.34% CAGR through 2031, eclipsing drug discovery, which held 38.44% of 2025 revenues. AI-based patient stratification lowers screen-failure rates by 20-30 percentage points, directly trimming per-protocol costs. Adaptive designs embracing interim biomarker reads cut Phase III enrollment by one-quarter, preserving statistical power while accelerating timelines. The agentic AI in pharmaceuticals market size for clinical-trial applications is projected to reach USD 0.52 billion by 2031, underscoring sponsors' pivot toward data-driven enrollment systems.

Manufacturing-process optimization and pharmacovigilance together represented <15% of 2025 outlays. Explainability remains the chief barrier, because GMP auditors insist upon causal chains for every automated bioreactor tweak. Uptake should rise after regulators formalize acceptance criteria for reinforcement-learning controllers, but current penetration still lags discovery and clinical segments.

Geography Analysis

North America generated 50.76% of 2025 revenue on the strength of AI-native players like Recursion, Schrodinger, and Relay Therapeutics plus regulatory first-mover advantage after the January 2026 FDA-EMA principles. U.S. venture funding for pharmaceutical AI hit USD 4.2 billion in 2024, enabling startups to scale without early licensing deals. Canada benefits from generous R&D tax credits but lacks the domestic customer base to match U.S. scale, and Mexico remains nascent pending regulatory modernization.

Asia-Pacific is expected to grow at a 40.12% CAGR through 2031, driven by China's subsidies for quantum-computing infrastructure and India's significantly lower clinical trial costs, averaging about USD 2,000 per patient compared to approximately USD 15,000 in the United States. Japan's PMDA draft guidance allows AI-guided stratification for rare diseases, unlocking previously unviable studies, while South Korea's KRW 500 billion (USD 375 million) initiative underwrites public-private AI-pharma projects. Australia trails but may catch up after regulatory harmonization with the FDA in February 2026.

Europe remains constrained by GDPR consent hurdles that stretch multi-site approval times to 18 months. Nonetheless, hubs in the United Kingdom, France, and Germany anchor federated-learning pilots by BenevolentAI and Owkin. Middle Eastern Gulf states fund AI research as part of economic diversification but lack sufficient patient volumes for robust model training. South Africa offers genetically diverse trial cohorts yet hosts few AI vendors, and Latin American growth is stymied by currency volatility and shifting regulatory stances.

1. Atomwise Inc.
2. Benevolent AI
3. BioAge Labs
4. Cloud Pharmaceuticals
5. Cyclica Inc.
6. DeepCure
7. Envisagenics
8. Evaxion Biotech
9. Healx
10. Iktos
11. Insilico Medicine
12. Owkin
13. Peptone
14. Relay Therapeutics
15. Schrodinger Inc.
16. Valo Health
17. Verge Genomics
18. XtalPi

Additional Benefits:

• The market estimate (ME) sheet in Excel format
• 3 months of analyst support

TABLE OF CONTENTS

1 Introduction

• 1.1 Study Assumptions and Market Definition
• 1.2 Scope of the Study

2 Research Methodology

3 Executive Summary

4 Market Landscape

• 4.1 Market Overview
• 4.2 Market Drivers
  • 4.2.1 Escalating R&D Cost Pressures Driving AI-Led Discovery
  • 4.2.2 Rising Availability of High-Quality Biological Data Sets
  • 4.2.3 Regulatory Encouragement for AI-Driven Trial Design
  • 4.2.4 Integration of Agentic AI With Self-Driving Laboratories
  • 4.2.5 Foundation Models Targeting Rare-Disease Biology
  • 4.2.6 Blockchain-Secured Data Marketplaces for Federated Learning
• 4.3 Market Restraints
  • 4.3.1 Data-Privacy and Cybersecurity Concerns Limit Data Sharing
  • 4.3.2 Skill Gap in Validating and Deploying Complex AI Agents
  • 4.3.3 Synthetic-Data Feedback Loops Risk Model Collapse
  • 4.3.4 Explainability Gaps in GMP Environments Delay Compliance
• 4.4 Value-Chain Analysis
• 4.5 Regulatory Landscape
• 4.6 Technological Outlook
• 4.7 Porter's Five Forces Analysis
  • 4.7.1 Threat of New Entrants
  • 4.7.2 Bargaining Power of Suppliers
  • 4.7.3 Bargaining Power of Buyers
  • 4.7.4 Threat of Substitutes
  • 4.7.5 Competitive Rivalry

5 Market Size & Growth Forecasts (Value, USD)

• 5.1 By Application
  • 5.1.1 Drug Discovery and Lead Identification
  • 5.1.2 Lead Optimization
  • 5.1.3 Pre-clinical Development
  • 5.1.4 Clinical-Trial Design and Recruitment
  • 5.1.5 Manufacturing-Process Optimization
  • 5.1.6 Pharmacovigilance and Safety Monitoring
  • 5.1.7 Others
• 5.2 By Deployment Mode
  • 5.2.1 On-Premise
  • 5.2.2 Cloud-Based
  • 5.2.3 Hybrid
• 5.3 By End User
  • 5.3.1 Large Pharmaceutical Companies
  • 5.3.2 Small and Mid-Size Biotech Firms
  • 5.3.3 Contract Research Organizations
  • 5.3.4 Academic and Research Institutes
• 5.4 By Geography
  • 5.4.1 North America
    • 5.4.1.1 United States
    • 5.4.1.2 Canada
    • 5.4.1.3 Mexico
  • 5.4.2 Europe
    • 5.4.2.1 Germany
    • 5.4.2.2 United Kingdom
    • 5.4.2.3 France
    • 5.4.2.4 Italy
    • 5.4.2.5 Spain
    • 5.4.2.6 Rest of Europe
  • 5.4.3 Asia-Pacific
    • 5.4.3.1 China
    • 5.4.3.2 Japan
    • 5.4.3.3 India
    • 5.4.3.4 Australia
    • 5.4.3.5 South Korea
    • 5.4.3.6 Rest of Asia-Pacific
  • 5.4.4 Middle East and Africa
    • 5.4.4.1 GCC
    • 5.4.4.2 South Africa
    • 5.4.4.3 Rest of Middle East and Africa
  • 5.4.5 South America
    • 5.4.5.1 Brazil
    • 5.4.5.2 Argentina
    • 5.4.5.3 Rest of South America

6 Competitive Landscape

• 6.1 Market Concentration
• 6.2 Market Share Analysis
• 6.3 Company Profiles (includes Global level Overview, Market level overview, Core Segments, Financials as available, Strategic Information, Market Rank/Share for key companies, Products & Services, Recent Developments)
  • 6.3.1 Atomwise Inc.
  • 6.3.2 BenevolentAI
  • 6.3.3 BioAge Labs
  • 6.3.4 Cloud Pharmaceuticals
  • 6.3.5 Cyclica Inc.
  • 6.3.6 DeepCure
  • 6.3.7 Envisagenics
  • 6.3.8 Evaxion Biotech
  • 6.3.9 Healx
  • 6.3.10 Iktos
  • 6.3.11 Insilico Medicine
  • 6.3.12 Owkin
  • 6.3.13 Peptone
  • 6.3.14 Relay Therapeutics
  • 6.3.15 Schrodinger Inc.
  • 6.3.16 Valo Health
  • 6.3.17 Verge Genomics
  • 6.3.18 XtalPi

7 Market Opportunities & Future Outlook

• 7.1 White-space & Unmet-need Assessment