Global AI in Regulatory Affairs Market Driven by Rising Regulatory Complexity in Pharmaceuticals and Expanding Submission Volumes

Insights into Market Size, Trends, Market Dynamics, Key Segments, and Emerging Players

Straits Research, a leading market research organization, announced the release of the report titled “AI in Regulatory Affairs Market Size and Outlook Forecasts till 2034”. The report provides an in-depth analysis of the market size, trends, opportunities, and market mechanisms. The report also covers a regional analysis of several market factors.

According to the report, the market is valued at USD 1.83 billion in 2026, which is expected to grow to USD 7.20 billion by 2034. The projected CAGR for this period is 18.66%.

The AI in regulatory affairs market is segmented based on component, deployment mode, application, end use, and region. Some of the insights provided in the report are highlighted below:

• The services segment is expected to be the fastest-growing segment with a CAGR of 19.83% during the forecast period.
• North America is expected to lead the market during the forecast period, owing to early adoption of AI-enabled regulatory affairs solutions, strong regulatory digitalization, and widespread use of electronic submission standards (eCTD).
• Life sciences companies worldwide are shifting toward AI-driven regulatory affairs solutions to improve compliance efficiency, reduce submission timelines, and manage growing regulatory complexity.
• India is expected to lead the Asia Pacific market, supported by favorable government initiatives for digital health and regulatory modernization and rising adoption of AI-enabled compliance for submission platforms.

Straits Research adopts a rigorous 360° research approach that integrates both primary and secondary research methodologies. The report data is triangulated with a mix of market indicators, macroeconomic outlook, industry sources, and strategic briefings.

The report is designed to enable decision makers, such as CXOs, policymakers, investors, startups, and other related stakeholders, to understand the current and future scenario of the market.  

Market Segments

The contents of the report are as follows:

By Component

• Software/Platform
• Services

By Deployment Mode

• Cloud-based
• On-Premises

By Application

• Regulatory Intelligence
• Data Migration & Integration
• Dossier Management
• Document Management
• Product Registration & Approvals
• Pharmacovigilance & Safety Reporting
• Regulatory Submissions & Publishing
• Others

By End Use

• Pharmaceutical Companies
• Biotechnology Companies
• Medical Device Companies
• CRO/CDMO
• Others

By Region

• North America
• Europe
• Asia Pacific
• Middle East and Africa
• Latin America