Product Code: GVR-4-68040-769-4
AI In Regulatory Affairs Market Summary
The global AI in regulatory affairs market size was estimated at USD 1.31 billion in 2024 and is projected to reach USD 6.65 billion by 2033, growing at a CAGR of 18.60% from 2025 to 2033. The growing complexity of regulatory submissions and rising cost pressures in drug development and regulatory operations are significant factors contributing to market growth.
In addition, the rising cost pressures in drug development and regulatory operations, and technological advancements are some other factors fueling market growth further. The increasing complexity and volume of global regulatory requirements across the pharmaceutical, biotechnology, and medical device sectors drive the AI in regulatory affairs industry. AI platforms reduce time and labor costs by automating routine tasks such as data extraction, document validation, and submission formatting. Predictive analytics allow regulatory teams to forecast submission timelines and optimize resource allocation. Artificial intelligence (AI) also supports regulatory strategy planning, enabling faster approvals and market entry. For instance, in March 2025, ArisGlobal launched LifeSphere Unify, an R&D compliance platform harmonizing safety, medical affairs, regulatory, and quality data for efficiency and compliance.
Another key driver is the rising demand for real-time regulatory intelligence and decision support as the industry faces rapid innovation in drug development, including advanced therapies, biologics, and personalized medicine. AI-powered platforms gather actionable insights from large and diverse datasets, helping regulatory professionals anticipate trends and respond more efficiently. In addition, outsourcing regulatory affairs functions to AI-enabled service providers is growing, offering cost-effective and scalable compliance solutions. For instance, in September 2025, Parexel partnered with Weave Bio to accelerate regulatory submission processes and speed time to market for new therapies. Parexel is Weave's CRO design partner, leveraging regulatory expertise to enhance Weave's AI platform.
Global AI In Regulatory Affairs Market Report Segmentation
This report forecasts revenue growth at the global, regional, and country levels and provides an analysis of the latest industry trends in each of the sub-segments from 2021 to 2033. For this study, Grand View Research has segmented the global AI in regulatory affairs market report based on component, deployment mode, application, end-use, and region:
- Component Outlook (Revenue, USD Million, 2021 - 2033)
- Software/Platforms
- Services
- Deployment Mode Outlook (Revenue, USD Million, 2021 - 2033)
- Cloud-based
- On-Premises
- Application Outlook (Revenue, USD Million, 2021 - 2033)
- Regulatory Intelligence
- Data Migration & Integration
- Dossier Management
- Document Management
- Product Registration & Approvals
- Pharmacovigilance & Safety Reporting
- Regulatory Submissions & Publishing
- Others
- End-use Outlook (Revenue, USD Million, 2021 - 2033)
- Pharmaceutical Companies
- Biotechnology Companies
- Medical Device Companies
- CRO/CDMO
- Others
- Regional Outlook (Revenue, USD Million, 2021 - 2033)
- North America
- Europe
- Germany
- UK
- France
- Italy
- Spain
- Denmark
- Sweden
- Norway
- Asia Pacific
- China
- Japan
- India
- South Korea
- Australia
- Thailand
- Latin America
- MEA
- South Africa
- Saudi Arabia
- UAE
- Kuwait
Table of Contents
Chapter 1. Methodology and Scope
- 1.1. Market Segmentation & Scope
- 1.2. Market Definitions
- 1.2.1. Component Segment
- 1.2.2. Deployment Mode Segment
- 1.2.3. Application Segment
- 1.2.4. End Use
- 1.3. Information analysis
- 1.3.1. Market formulation & data visualization
- 1.4. Data validation & publishing
- 1.5. Information Procurement
- 1.6. Information or Data Analysis
- 1.7. Market Formulation & Validation
- 1.8. Market Model
- 1.9. Total Market: CAGR Calculation
- 1.10. Objectives
- 1.10.1. Objective 1
- 1.10.2. Objective 2
Chapter 2. Executive Summary
- 2.1. Market Outlook
- 2.2. Segment Snapshot
- 2.3. Competitive Insights Landscape
Chapter 3. AI in Regulatory Affairs 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 Dynamics
- 3.2.1. Market driver analysis
- 3.2.2. Market restraint analysis
- 3.2.3. Market opportunity analysis
- 3.2.4. Market challenges analysis
- 3.3. AI in Regulatory Affairs Market Analysis Tools
- 3.3.1. Industry Analysis - Porter's
- 3.3.1.1. Supplier power
- 3.3.1.2. Buyer power
- 3.3.1.3. Substitution threat
- 3.3.1.4. Threat of new entrant
- 3.3.1.5. Competitive rivalry
- 3.3.2. PESTEL Analysis
- 3.3.2.1. Political landscape
- 3.3.2.2. Technological landscape
- 3.3.2.3. Economic landscape
- 3.3.2.4. Environmental Landscape
- 3.3.2.5. Legal Landscape
- 3.3.2.6. Social Landscape
- 3.4. Case Studies
- 3.5. Technology Overview
Chapter 4. AI in Regulatory Affairs Market: Component Estimates & Trend Analysis
- 4.1. Segment Dashboard
- 4.2. Global AI in Regulatory Affairs Market Component Movement Analysis
- 4.3. Global AI in Regulatory Affairs Market Size & Trend Analysis, by Component, 2021 to 2033 (USD Million)
- 4.4. Software/Platforms
- 4.4.1. Market estimates and forecasts, 2021 to 2033 (USD Million)
- 4.5. Services
- 4.5.1. Market estimates and forecasts, 2021 to 2033 (USD Million)
Chapter 5. AI in Regulatory Affairs Market: Deployment Mode Estimates & Trend Analysis
- 5.1. Segment Dashboard
- 5.2. Global AI in Regulatory Affairs Market Deployment Mode Movement Analysis
- 5.3. Global AI in Regulatory Affairs Market Size & Trend Analysis, by Deployment Mode, 2021 to 2033 (USD Million)
- 5.4. Cloud-based
- 5.4.1. Market estimates and forecasts, 2021 to 2033 (USD Million)
- 5.5. On-Premises
- 5.5.1. Market estimates and forecasts, 2021 to 2033 (USD Million)
Chapter 6. AI in Regulatory Affairs Market: Application Estimates & Trend Analysis
- 6.1. Segment Dashboard
- 6.2. Global AI in Regulatory Affairs Market Application Movement Analysis
- 6.3. Global AI in Regulatory Affairs Market Size & Trend Analysis, by Application, 2021 to 2033 (USD Million)
- 6.4. Regulatory Intelligence
- 6.4.1. Market estimates and forecasts, 2021 to 2033 (USD Million)
- 6.5. Data Migration & Integration
- 6.5.1. Market estimates and forecasts, 2021 to 2033 (USD Million)
- 6.6. Dossier Management
- 6.6.1. Market estimates and forecasts, 2021 to 2033 (USD Million)
- 6.7. Document Management
- 6.7.1. Market estimates and forecasts, 2021 to 2033 (USD Million)
- 6.8. Product Registration & Approvals
- 6.8.1. Market estimates and forecasts, 2021 to 2033 (USD Million)
- 6.9. Pharmacovigilance & Safety Reporting
- 6.9.1. Market estimates and forecasts, 2021 to 2033 (USD Million)
- 6.10. Regulatory Submissions & Publishing
- 6.10.1. Market estimates and forecasts, 2021 to 2033 (USD Million)
- 6.11. Others
- 6.11.1. Market estimates and forecasts, 2021 to 2033 (USD Million)
Chapter 7. AI in Regulatory Affairs Market: End Use Estimates & Trend Analysis
- 7.1. Segment Dashboard
- 7.2. Global AI in Regulatory Affairs Market End Use Movement Analysis
- 7.3. Global AI in Regulatory Affairs Market Size & Trend Analysis, by End Use, 2021 to 2033 (USD Million)
- 7.4. Pharmaceutical Companies
- 7.4.1. Market estimates and forecasts, 2021 to 2033 (USD Million)
- 7.5. Biotechnology Companies
- 7.5.1. Market estimates and forecasts, 2021 to 2033 (USD Million)
- 7.6. Medical Device Companies
- 7.6.1. Market estimates and forecasts, 2021 to 2033 (USD Million)
- 7.7. CRO/CDMO
- 7.7.1. Market estimates and forecasts, 2021 to 2033 (USD Million)
- 7.8. Others
- 7.8.1. Market estimates and forecasts, 2021 to 2033 (USD Million)
Chapter 8. AI in Regulatory Affairs Market: Regional Estimates & Trend Analysis
- 8.1. Regional Market Share Analysis, 2024 & 2033
- 8.2. Regional Market Dashboard
- 8.3. Market Size & Forecasts Trend Analysis, 2021 to 2033:
- 8.4. North America
- 8.4.1. U.S.
- 8.4.1.1. Key country dynamics
- 8.4.1.2. Regulatory framework
- 8.4.1.3. Competitive scenario
- 8.4.1.4. U.S. market estimates and forecasts, 2021 to 2033 (USD Million)
- 8.4.2. Canada
- 8.4.2.1. Key country dynamics
- 8.4.2.2. Regulatory framework
- 8.4.2.3. Competitive scenario
- 8.4.2.4. Canada market estimates and forecasts, 2021 to 2033 (USD Million)
- 8.4.3. Mexico
- 8.4.3.1. Key country dynamics
- 8.4.3.2. Regulatory framework
- 8.4.3.3. Competitive scenario
- 8.4.3.4. Mexico market estimates and forecasts, 2021 to 2033 (USD Million)
- 8.5. Europe
- 8.5.1. UK
- 8.5.1.1. Key country dynamics
- 8.5.1.2. Regulatory framework
- 8.5.1.3. Competitive scenario
- 8.5.1.4. UK market estimates and forecasts, 2021 to 2033 (USD Million)
- 8.5.2. Germany
- 8.5.2.1. Key country dynamics
- 8.5.2.2. Regulatory framework
- 8.5.2.3. Competitive scenario
- 8.5.2.4. Germany market estimates and forecasts, 2021 to 2033 (USD Million)
- 8.5.3. France
- 8.5.3.1. Key country dynamics
- 8.5.3.2. Regulatory framework
- 8.5.3.3. Competitive scenario
- 8.5.3.4. France market estimates and forecasts, 2021 to 2033 (USD Million)
- 8.5.4. Italy
- 8.5.4.1. Key country dynamics
- 8.5.4.2. Regulatory framework
- 8.5.4.3. Competitive scenario
- 8.5.4.4. Italy market estimates and forecasts, 2021 to 2033 (USD Million)
- 8.5.5. Spain
- 8.5.5.1. Key country dynamics
- 8.5.5.2. Regulatory framework
- 8.5.5.3. Competitive scenario
- 8.5.5.4. Spain market estimates and forecasts, 2021 to 2033 (USD Million)
- 8.5.6. Norway
- 8.5.6.1. Key country dynamics
- 8.5.6.2. Regulatory framework
- 8.5.6.3. Competitive scenario
- 8.5.6.4. Norway market estimates and forecasts, 2021 to 2033 (USD Million)
- 8.5.7. Sweden
- 8.5.7.1. Key country dynamics
- 8.5.7.2. Regulatory framework
- 8.5.7.3. Competitive scenario
- 8.5.7.4. Sweden market estimates and forecasts, 2021 to 2033 (USD Million)
- 8.5.8. Denmark
- 8.5.8.1. Key country dynamics
- 8.5.8.2. Regulatory framework
- 8.5.8.3. Competitive scenario
- 8.5.8.4. Denmark market estimates and forecasts, 2021 to 2033 (USD Million)
- 8.6. Asia Pacific
- 8.6.1. Japan
- 8.6.1.1. Key country dynamics
- 8.6.1.2. Regulatory framework
- 8.6.1.3. Competitive scenario
- 8.6.1.4. Japan market estimates and forecasts, 2021 to 2033 (USD Million)
- 8.6.2. China
- 8.6.2.1. Key country dynamics
- 8.6.2.2. Regulatory framework
- 8.6.2.3. Competitive scenario
- 8.6.2.4. China market estimates and forecasts, 2021 to 2033 (USD Million)
- 8.6.3. India
- 8.6.3.1. Key country dynamics
- 8.6.3.2. Regulatory framework
- 8.6.3.3. Competitive scenario
- 8.6.3.4. India market estimates and forecasts, 2021 to 2033 (USD Million)
- 8.6.4. Australia
- 8.6.4.1. Key country dynamics
- 8.6.4.2. Regulatory framework
- 8.6.4.3. Competitive scenario
- 8.6.4.4. Australia market estimates and forecasts, 2021 to 2033 (USD Million)
- 8.6.5. South Korea
- 8.6.5.1. Key country dynamics
- 8.6.5.2. Regulatory framework
- 8.6.5.3. Competitive scenario
- 8.6.5.4. South Korea market estimates and forecasts, 2021 to 2033 (USD Million)
- 8.6.6. Thailand
- 8.6.6.1. Key country dynamics
- 8.6.6.2. Regulatory framework
- 8.6.6.3. Competitive scenario
- 8.6.6.4. Thailand market estimates and forecasts, 2021 to 2033 (USD Million)
- 8.7. Latin America
- 8.7.1. Brazil
- 8.7.1.1. Key country dynamics
- 8.7.1.2. Regulatory framework
- 8.7.1.3. Competitive scenario
- 8.7.1.4. Brazil market estimates and forecasts, 2021 to 2033 (USD Million)
- 8.7.2. Argentina
- 8.7.2.1. Key country dynamics
- 8.7.2.2. Regulatory framework
- 8.7.2.3. Competitive scenario
- 8.7.2.4. Argentina market estimates and forecasts, 2021 to 2033 (USD Million)
- 8.8. MEA
- 8.8.1. South Africa
- 8.8.1.1. Key country dynamics
- 8.8.1.2. Regulatory framework
- 8.8.1.3. Competitive scenario
- 8.8.1.4. South Africa market estimates and forecasts, 2021 to 2033 (USD Million)
- 8.8.2. Saudi Arabia
- 8.8.2.1. Key country dynamics
- 8.8.2.2. Regulatory framework
- 8.8.2.3. Competitive scenario
- 8.8.2.4. Saudi Arabia market estimates and forecasts, 2021 to 2033 (USD Million)
- 8.8.3. UAE
- 8.8.3.1. Key country dynamics
- 8.8.3.2. Regulatory framework
- 8.8.3.3. Competitive scenario
- 8.8.3.4. UAE market estimates and forecasts, 2021 to 2033 (USD Million)
- 8.8.4. Kuwait
- 8.8.4.1. Key country dynamics
- 8.8.4.2. Regulatory framework
- 8.8.4.3. Competitive scenario
- 8.8.4.4. Kuwait market estimates and forecasts, 2021 to 2033 (USD Million)
Chapter 9. Competitive Landscape
- 9.1. Company/Competition Categorization
- 9.2. Strategy Mapping
- 9.3. Company Market Position Analysis, 2024
- 9.4. Company Profiles/Listing
- 9.4.1. Freyr
- 9.4.1.1. Company overview
- 9.4.1.2. Financial performance
- 9.4.1.3. Product benchmarking
- 9.4.1.4. Strategic initiatives
- 9.4.2. Celegence
- 9.4.2.1. Company overview
- 9.4.2.2. Financial performance
- 9.4.2.3. Product benchmarking
- 9.4.2.4. Strategic initiatives
- 9.4.3. Wipro
- 9.4.3.1. Company overview
- 9.4.3.2. Financial performance
- 9.4.3.3. Product benchmarking
- 9.4.3.4. Strategic initiatives
- 9.4.4. Indegene
- 9.4.4.1. Company overview
- 9.4.4.2. Financial performance
- 9.4.4.3. Product benchmarking
- 9.4.4.4. Strategic initiatives
- 9.4.5. Clarivate
- 9.4.5.1. Company overview
- 9.4.5.2. Financial performance
- 9.4.5.3. Product benchmarking
- 9.4.5.4. Strategic initiatives
- 9.4.6. Zenovel
- 9.4.6.1. Company overview
- 9.4.6.2. Financial performance
- 9.4.6.3. Product benchmarking
- 9.4.6.4. Strategic initiatives
- 9.4.7. RegDesk, Inc.
- 9.4.7.1. Company overview
- 9.4.7.2. Financial performance
- 9.4.7.3. Product benchmarking
- 9.4.7.4. Strategic initiatives