Regulatory Affairs Market Summary

The global regulatory affairs market size was estimated at USD 16.43 billion in 2024 and is projected to reach USD 27.18 billion by 2030, growing at a CAGR of 8.8% from 2025 to 2030. The industry’s expansion is largely driven by rapid progress in immunotherapies, orphan drugs, specialty therapies, and personalized medicines. These advancements require continuous monitoring and interpretation of evolving regulatory frameworks. As regulations become more complex to keep pace with scientific innovations, companies increasingly rely on regulatory affairs expertise to ensure timely approvals, compliance with new guidelines, and smooth progression through product development cycles.

Moreover, the rising prevalence of chronic diseases that require effective therapies and preventive vaccines is creating a stronger need for robust regulatory guidelines to ensure product safety, quality, and therapeutic accuracy. This increased demand is further supported by the strategic steps taken by market participants, including collaborations, partnerships, and mergers and acquisitions, to enhance their regulatory capabilities. For example, in March 2023, PROMETRIKA, LLC. expanded its strategic regulatory consulting services to offer comprehensive guidance for clinical development plans and improve overall efficiency and quality, reflecting the industry’s growing emphasis on specialized regulatory expertise.

Key Market Trends & Insights

  • The regulatory affairs market in Asia Pacific dominated the global industry and accounted for a 38.03% share in 2024. The region’s leadership is supported by expanding pharmaceutical manufacturing, an increasing number of clinical trials, and evolving healthcare regulations that drive demand for expert compliance services.
  • North America regulatory affairs market is anticipated to witness lucrative growth from 2025 to 2030 as companies strengthen their regulatory strategies to keep up with rising biologics and novel drug submissions.
  • Based on categories, the drugs segment dominated the regulatory affairs market in 2024 due to the high volume of drug development activities and stringent approval processes.
  • In terms of company size, the medium company size segment dominated the market in 2024, supported by growing outsourcing needs and expansion of mid-sized pharmaceutical and biotech firms.
  • Based on end-use, the pharmaceutical companies segment dominated the market in 2024, reflecting their large regulatory workloads and continuous product innovation.

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Market Size & Forecast

  • 2024 Market Size: USD 16.43 Billion
  • 2030 Projected Market Size: USD 27.18 Billion
  • CAGR (2025-2030): 8.8%
  • Asia Pacific: Largest market in 2024
  • North America: Fastest growing market

Key Companies & Market Share Insights

Key players operating in the regulatory affairs market are undertaking various initiatives to strengthen their market presence and increase the reach of their products and services. Key strategies include geographic expansions, strategic partnerships, service innovation, and acquisitions aimed at strengthening regulatory expertise and global reach. These efforts support the compliance needs of pharmaceutical, biotechnology, and medical device companies and drive overall market growth by improving service delivery across diverse regulatory environments.

Key Players

  • Accell Clinical Research, LLC
  • Genpact
  • Criterium, Inc.
  • ICON plc
  • iuvo BioScience, LLC.
  • WuXi AppTec
  • Medpace
  • Charles River Laboratories.
  • Laboratory Corporation of America Holdings
  • Parexel International (MA) Corporation
  • Freyr
  • AmerisourceBergen
  • NDA Group AB
  • Pharmexon
  • Qvigilance
  • BlueReg
  • Cambridge Regulatory Services
  • VCLS

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Conclusion

The regulatory affairs market is expected to experience sustained growth as pharmaceutical, biotechnology, and medical device companies increasingly depend on specialized regulatory expertise to navigate evolving global guidelines. The rise of advanced therapies, including personalized medicine and immunotherapies, demands efficient regulatory planning to ensure timely approvals and compliance with safety and quality standards. With Asia Pacific leading and North America poised for strong growth, the market will benefit from expanding research activities, increasing clinical trials, and strategic collaborations. As regulatory expectations become more complex, organizations will continue prioritizing robust regulatory processes to support innovation, streamline development, and meet global compliance requirements effectively.