DUBLIN, Jan. 6, 2026 (Globe Newswire) — The “Artificial Intelligence (AI) in Regulatory Affairs Global Market Report 2025'' has been added. ResearchAndMarkets.com Offerings.
The artificial intelligence (AI) market for regulatory affairs is experiencing significant growth and is expected to expand from $1.39 billion in 2024 to $1.71 billion by 2025, reflecting a compound annual growth rate (CAGR) of 23.2%. This momentum is being driven by increasing global regulatory complexity, widespread adoption of AI technologies in life sciences, and the pressing need to speed up drug approval processes.
According to forecasts, the market value is expected to reach $3.9 billion in 2029, maintaining a CAGR of 22.8%. Factors contributing to this growth include a focus on minimizing human error in regulatory filings, increased collaboration between regulatory agencies and technology companies, and an increased emphasis on data-driven regulatory decision-making.
AI-enabled platforms are essential to this growth as they automate complex regulatory tasks, accelerate data processing, and ensure accurate decision-making. These solutions support faster regulatory approvals and improve data accuracy, driving innovation and market readiness. Notably, the UK's AI sector generated US$16.32 billion in 2023, up 34% year-on-year, highlighting significant employment growth in AI-related occupations.
Leading companies are investing in advanced innovations such as regulatory information management (RIM) systems. A prime example is the July 2024 launch of ArisGlobal LLC's upgraded LifeSphere Regulatory Platform, a comprehensive cloud-based system that integrates next-generation GenAI capabilities to enhance regulatory management.
Strategic acquisitions are also being made in this area to strengthen capabilities, as evidenced by Ernst & Young Global Limited's acquisition of Acrance AE in October 2025. The move strengthens EY's offering in life sciences consulting and enables the company to leverage AI to improve regulatory solutions.
Prominent players dominating AI in the regulated market include Freyr Software Services, Celegence LLC, Wipro Limited, Indegene Limited, IBM, and others. Asia Pacific is projected to witness the fastest growth over the forecast period while North America leads the market.
However, the industry faces challenges from global trade trends. U.S. tariff hikes in 2025 will have a major impact on healthcare, disrupting supply chains for medical devices and pharmaceuticals and increasing costs for healthcare providers. The industry response has been to adapt sourcing strategies and promote local manufacturing to mitigate these impacts.
The market research report on AI in Regulatory Affairs offers an in-depth analysis covering regional shares, market trends, and potential opportunities to provide stakeholders with comprehensive insights for strategic decision-making in this rapidly evolving field.
Key attributes:
| report attributes | detail |
| Number of pages | 250 |
| Forecast period | 2025 – 2029 |
| Estimated market value in 2025 (USD) | $1.71 billion |
| Projected market value to 2029 (USD) | $3.9 billion |
| compound annual growth rate | 22.8% |
| Target area | global |
Report scope:
Target market:
- By component: software or platform. service
- By deployment mode: Cloud based. on-premises
- By application: Regulatory intelligence; data migration and integration; Document management; product registration and approval. Pharmacovigilance and safety reporting. Regulatory Submissions and Publications. Other uses
- By end user: Pharmaceutical company. Biotechnology companies; other end users
Subsegment:
- By software or platform: regulatory information management; document management; data analysis and insights. Natural language processing tools. Cloud-based compliance solution. Workflow automation system; AI-powered decision support
- By service: Implementation and integration. training and consulting. Support and maintenance. Outsourcing of regulatory processes. Data migration and validation. Compliance monitoring service; managed service
Featured companies
- Freyr Software Services Private Limited
- Selegence LLC
- Wipro Limited
- Indegene Limited
- Clarivate
- Zenobel Pharma Services LLP
- Regdesk Co., Ltd.
- Compliance i Co., Ltd.
- Ioni Eye Co., Ltd.
- Interface Technologies Co., Ltd.
- One Trust LLC
- Zapien Co., Ltd.
- SpringsApps Technologies Pvt Ltd.
- Fairnow Co., Ltd.
- Navitas Life Sciences Private Limited
- S&P Global Co., Ltd.
- International Business Machines Corporation
- ZS Associates International Co., Ltd.
- Vistar Technologies Co., Ltd.
- Lexim AI Co., Ltd.
For more information on this report, please visit https://www.researchandmarkets.com/r/8rix4r.
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Artificial intelligence (AI) in regulated markets
