PUBLISHER: The Business Research Company | PRODUCT CODE: 1889302
PUBLISHER: The Business Research Company | PRODUCT CODE: 1889302
Artificial intelligence (AI) in regulatory affairs refers to the application of AI technologies such as machine learning, natural language processing, and automation to streamline and enhance regulatory processes in pharmaceuticals, biotechnology, and medical devices. It assists in managing large volumes of regulatory data, accelerating document review, ensuring compliance with evolving regulations, and improving decision-making accuracy. By automating repetitive tasks and analyzing complex datasets, AI enables faster submissions, reduces errors, and facilitates more efficient communication with regulatory authorities.
The key components of artificial intelligence (AI) in regulatory affairs are software or platforms and services. AI in regulatory affairs software refers to tools that leverage artificial intelligence to automate, streamline, and enhance compliance processes, including document management, submission tracking, and data analysis, ensuring faster and more accurate regulatory decision-making. The deployment modes include cloud-based and on-premises. These solutions are used for applications such as regulatory intelligence, data migration and integration, dossier management, product registration and approvals, pharmacovigilance and safety reporting, regulatory submissions and publishing, and others, and are utilized by various end users such as pharmaceutical companies, biotechnology companies, and others.
Note that the outlook for this market is being affected by rapid changes in trade relations and tariffs globally. The report will be updated prior to delivery to reflect the latest status, including revised forecasts and quantified impact analysis. The report's Recommendations and Conclusions sections will be updated to give strategies for entities dealing with the fast-moving international environment.
The sudden escalation of U.S. tariffs and the consequent trade frictions in spring 2025 are severely impacting the healthcare sector, particularly in the supply of critical medical devices, diagnostic equipment, and pharmaceuticals. Hospitals and healthcare providers are facing higher costs for imported surgical instruments, imaging equipment, and consumables such as syringes and catheters, many of which have limited domestic alternatives. These increased costs are straining healthcare budgets, leading some providers to delay equipment upgrades or pass on expenses to patients. Additionally, tariffs on raw materials and components are disrupting the production of essential drugs and devices, causing supply chain bottlenecks. In response, the industry is diversifying sourcing strategies, boosting local manufacturing where possible, and advocating for tariff exemptions on life-saving medical products.
The artificial intelligence (AI) in regulatory affairs market research report is one of a series of new reports from The Business Research Company that provides artificial intelligence (AI) in regulatory affairs market statistics, including artificial intelligence (AI) in regulatory affairs industry global market size, regional shares, competitors with the artificial intelligence (AI) in regulatory affairs market share, artificial intelligence (AI) in regulatory affairs market segments, market trends, and opportunities, and any further data you may need to thrive in the artificial intelligence (AI) in regulatory affairs industry. This artificial intelligence (AI) in regulatory affairs market research report delivers a complete perspective of everything you need, with an in-depth analysis of the current and future scenario of the industry.
The artificial intelligence (AI) in regulatory affairs market size has grown exponentially in recent years. It will grow from $1.39 billion in 2024 to $1.71 billion in 2025 at a compound annual growth rate (CAGR) of 23.2%. The growth in the historic period can be attributed to the increasing complexity of global regulatory requirements, rising adoption of AI technologies in life sciences, growing need for faster drug approval processes, increasing volume of regulatory data and documentation, and the rising demand for automation in compliance management.
The artificial intelligence (AI) in regulatory affairs market size is expected to see exponential growth in the next few years. It will grow to $3.90 billion in 2029 at a compound annual growth rate (CAGR) of 22.8%. The growth in the forecast period can be attributed to the growing focus on reducing human error in regulatory submissions, increasing collaboration between regulatory bodies and tech firms, rising cost pressures driving digital transformation, growing use of data analytics for regulatory decision-making, and increasing emphasis on transparency and accuracy in regulatory reporting. Key trends in the forecast period include advancement in natural language processing for regulatory documentation, innovation in AI-driven compliance monitoring tools, integration of machine learning for predictive regulatory insights, advancement in automation of submission and approval processes, and innovation in data analytics for regulatory intelligence.
The increasing integration of AI-enabled platforms is expected to drive the growth of the artificial intelligence (AI) in regulatory affairs market in the coming years. AI-enabled platforms are digital systems or solutions that incorporate artificial intelligence technologies such as machine learning, natural language processing, and predictive analytics to automate tasks, improve decision-making, and enhance operational efficiency across various industries. The adoption of AI-enabled platforms is rising due to the growing demand for automation and efficiency in handling complex regulatory tasks, enabling faster data processing and more accurate decision-making. AI in regulatory affairs supports AI-enabled platforms by streamlining compliance processes, facilitating faster regulatory approvals, and improving data accuracy, which accelerates innovation and market readiness. For example, in October 2024, a report published by the Department for Science, Innovation and Technology (DSIT), a UK-based government organization, indicated that the UK's AI sector generated USD 16.32 billion (£14.2 billion) in revenue in 2023, representing a 34% year-on-year increase, while employment in AI-related roles rose to approximately 64,500. Therefore, the growing integration of AI-enabled platforms is propelling the growth of the AI in regulatory affairs market.
Key companies operating in the artificial intelligence (AI) in regulatory affairs market are focusing on advanced innovations such as Regulatory Information Management (RIM) to centralize regulatory data, automate submission workflows, ensure compliance across global markets, and enhance visibility throughout the product lifecycle. Regulatory information management refers to the systematic process of collecting, organizing, and managing regulatory data, documents, and submissions throughout a product's lifecycle to ensure compliance with global regulatory requirements and facilitate communication with health authorities. For instance, in July 2024, ArisGlobal LLC, a US-based software company, launched the latest version of its LifeSphere Regulatory Platform, providing a unified cloud-based system for end-to-end regulatory affairs management. This platform integrates next-generation GenAI and large-language-model (LLM) capabilities through its LifeSphere NavaX engine, enabling content ingestion, generation, and deeper insights while achieving over 50% efficiency gains by unifying data, content, and processes in a single ecosystem and ensuring interoperability with ArisGlobal's safety and quality systems, establishing it as a transformative solution for life-sciences regulatory workflows.
In October 2025, Ernst & Young Global Limited, a UK-based professional services firm, acquired Aqurance A.E. for an undisclosed amount. This acquisition aims to strengthen Ernst & Young Global Limited's capabilities in regulatory affairs and life sciences consulting by integrating the expertise of Aqurance A.E., enhancing its ability to provide advanced digital and AI-driven regulatory solutions, streamline compliance processes, and support global pharmaceutical and biotechnology clients in navigating complex regulatory environments. Aqurance A.E. is a Greece-based technology company specializing in AI in regulatory affairs.
Major companies operating in the artificial intelligence (ai) in regulatory affairs market are Freyr Software Services Private Limited, Celegence LLC, Wipro Limited, Indegene Limited, Clarivate Plc, Zenovel Pharma Services LLP, RegDesk Inc, Compliance.ai Inc, IONI AI INC., Interfacing Technologies Corporation, OneTrust LLC, Xapien Ltd., SpringsApps Technologies Pvt Ltd., Fairnow Inc., Navitas Life Sciences Private Limited, S&P Global Inc., International Business Machines Corporation, ZS Associates International Inc., Vistaar Technologies Inc., Lexim AI Inc.
North America was the largest region in the artificial intelligence (AI) in regulatory affairs market in 2024. Asia Pacific is expected to be the fastest-growing region in the forecast period. The regions covered in artificial intelligence (AI) in regulatory affair report are Asia-Pacific, Western Europe, Eastern Europe, North America, South America, Middle East and Africa.
The countries covered in the artificial intelligence (AI) in regulatory affairs market report are Australia, Brazil, China, France, Germany, India, Indonesia, Japan, Russia, South Korea, UK, USA, Canada, Italy, Spain.
The artificial intelligence (AI) in regulatory affairs market consists of revenues earned by entities by providing services such as risk assessment services, change management services, audit support services, pharmacovigilance services, and regulatory submission automation services. The market value includes the value of related goods sold by the service provider or included within the service offering. The artificial intelligence (AI) in regulatory affairs market also includes sales of regulatory tools, and assessment tools. Values in this market are 'factory gate' values, that is, the value of goods sold by the manufacturers or creators of the goods, whether to other entities (including downstream manufacturers, wholesalers, distributors, and retailers) or directly to end customers. The value of goods in this market includes related services sold by the creators of the goods.
The market value is defined as the revenues that enterprises gain from the sale of goods and/or services within the specified market and geography through sales, grants, or donations in terms of the currency (in USD unless otherwise specified).
The revenues for a specified geography are consumption values that are revenues generated by organizations in the specified geography within the market, irrespective of where they are produced. It does not include revenues from resales along the supply chain, either further along the supply chain or as part of other products.
Artificial Intelligence (AI) In Regulatory Affairs Global Market Report 2025 from The Business Research Company provides strategists, marketers and senior management with the critical information they need to assess the market.
This report focuses on artificial intelligence (ai) in regulatory affairs market which is experiencing strong growth. The report gives a guide to the trends which will be shaping the market over the next ten years and beyond.
Where is the largest and fastest growing market for artificial intelligence (ai) in regulatory affairs ? How does the market relate to the overall economy, demography and other similar markets? What forces will shape the market going forward, including technological disruption, regulatory shifts, and changing consumer preferences? The artificial intelligence (ai) in regulatory affairs market global report from the Business Research Company answers all these questions and many more.
The report covers market characteristics, size and growth, segmentation, regional and country breakdowns, competitive landscape, market shares, trends and strategies for this market. It traces the market's historic and forecast market growth by geography.
The forecasts are made after considering the major factors currently impacting the market. These include the technological advancements such as AI and automation, Russia-Ukraine war, trade tariffs (government-imposed import/export duties), elevated inflation and interest rates.