The Artificial Intelligence (AI) in Regulatory Affairs Market is Expected to Expand at a 22.8% CAGR Until 2029

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The Business Research Company’s Artificial Intelligence (AI) in Regulatory Affairs Global Market Report 2025 – Market Size, Trends, And Forecast 2025-2034

LONDON, GREATER LONDON, UNITED KINGDOM, December 11, 2025 /EINPresswire.com/ -- The use of artificial intelligence (AI) in regulatory affairs is becoming increasingly important as industries seek faster, more accurate, and efficient ways to manage complex regulatory requirements. This emerging market is witnessing rapid growth driven by technological advancements and rising demand for automation in compliance processes. Let’s explore the current market size, key growth factors, leading regions, and future trends shaping the AI in regulatory affairs sector.

Artificial Intelligence in Regulatory Affairs Market Size and Growth Forecast
The artificial intelligence (AI) in regulatory affairs market has experienced significant growth in recent years. It is projected to increase from $1.39 billion in 2024 to $1.71 billion in 2025, representing a compound annual growth rate (CAGR) of 23.2%. This growth reflects the rising complexity of global regulatory frameworks, greater adoption of AI solutions in life sciences, the need to accelerate drug approval timelines, the expanding volume of regulatory data, and the growing demand for automation in compliance management.

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Looking ahead, the market is expected to surge further, reaching $3.90 billion by 2029 at a CAGR of 22.8%. Factors driving this forecast include efforts to reduce human error in regulatory submissions, enhanced collaboration between regulatory agencies and technology firms, pressures to cut costs through digital transformation, increased use of data analytics in regulatory decision-making, and a stronger focus on transparency and precision in regulatory reporting. Key innovation trends likely to influence the market are improvements in natural language processing for handling regulatory documents, AI-powered compliance monitoring tools, machine learning for predictive regulatory insights, automation of submission and approval workflows, and advanced data analytics for regulatory intelligence.

Understanding AI Applications in Regulatory Affairs
Artificial intelligence in regulatory affairs involves applying technologies such as machine learning, natural language processing, and automation to optimize and streamline regulatory activities within pharmaceuticals, biotechnology, and medical device sectors. AI supports the management of vast regulatory data volumes, speeds up document review processes, ensures compliance with changing regulations, and enhances decision-making accuracy. By automating routine tasks and analyzing complex datasets, AI enables faster regulatory submissions, lowers the risk of errors, and improves communication efficiency between companies and regulatory authorities.

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Key Factors Propelling the Growth of AI in Regulatory Affairs
The increasing integration of AI-powered platforms is a major factor fueling the expansion of the artificial intelligence in regulatory affairs market. These AI-enabled systems combine machine learning, natural language processing, and predictive analytics to automate complex regulatory workflows, enhance decision-making capabilities, and boost operational efficiency across industries. The rising demand for automation and streamlined handling of regulatory challenges supports faster data processing and more accurate regulatory decisions. AI applications in regulatory affairs facilitate smoother compliance procedures, speed up approval processes, and improve data quality, which collectively accelerate innovation and market access. For example, a report released in October 2024 by the UK’s Department for Science, Innovation and Technology (DSIT) highlighted that the UK’s AI sector generated $16.32 billion (£14.2 billion) in revenue in 2023, marking a 34% increase from the previous year, while employment in AI-related roles reached approximately 64,500. This illustrates how the wider adoption of AI-enabled platforms is driving growth within regulatory affairs.

Regional Leaders in the AI in Regulatory Affairs Market
In 2024, North America held the largest share of the artificial intelligence in regulatory affairs market. However, the Asia-Pacific region is expected to exhibit the fastest growth during the forecast period. The market analysis includes key regions such as Asia-Pacific, Western Europe, Eastern Europe, North America, South America, and the Middle East and Africa, providing a comprehensive global perspective on market dynamics.

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