Regulatory Affairs Market - Databook 2025 to 2034

The global regulatory affairs market size surpassed USD 15,990 million in 2024 and is predicted to reach around USD 36,490 million by 2034, registering a CAGR of 8.6% from 2025 to 2034.

Highlights of the Regulatory Affairs Market

• Asia Pacific dominated the global regulatory affairs market in 2024.
• North America is anticipated to grow at the fastest rate in the market during the forecast period.
• By services, the regulatory writing and publishing segment holds a dominant presence in the regulatory affairs market in 2024.
• By services, the legal representation segment is expected to grow at the fastest rate in the market during the forecast period.
• By category, the medical devices segment holds a dominant presence in the regulatory affairs market in 2024.
• By category, the drugs segment is expected to grow at the fastest rate in the market during the forecast period.
• By indication, the oncology segment holds a dominant presence in the regulatory affairs market in 2024.
• By indication, the neurology segment is expected to grow at the fastest rate in the market during the forecast period.
• By stage, the clinical studies segment holds a dominant presence in the regulatory affairs market in 2024.
• By stage, the PMA segment is expected to grow at the fastest rate in the market during the forecast period.
• By service provider, the outsource segment holds a dominant presence in the regulatory affairs market in 2024.
• By service provider, the in-house segment is expected to grow at the fastest rate in the market during the forecast period.
• By company, the medium segment holds a dominant presence in the regulatory affairs market in 2024.
• By end-user, the pharmaceutical companies segment holds a dominant presence in the regulatory affairs market in 2024.
• By end-user, the biotechnology companies segment is expected to grow at the fastest rate in the market during the forecast period.

Industry Valuation and Growth Rate Projection

Regulatory affairs cover a wider scope rotating around the scientifically grounded and legal framework that controls product approvals, ranging from medical devices and pharmaceuticals to beverages and food. The fundamental of regulatory affairs appears from the imperative to guarantee product efficacy, safety, and compliance with the changing regulatory landscapes worldwide. Its usages are evident in industries included in goods production and distribution, assuring that they encounter both international and national regulations.

Regulatory Affairs Market: Stats and Figures

• In 2023, 55 new molecular entities were accepted by the FDA, which is the second-highest count in the last 30 years. This cohort was almost double what it was in 2022, which is nearly to be because issues like bandwidth problems and workflow disruptions caused by the COVID-19 pandemic globally have improved.
• In December 2023, AstraZeneca agreed to accept Icosavax, Inc. (Icosavax). The acquisition tightens AstraZeneca’s late-stage pipeline. Later, embellishing their portfolio, at the end of 2023, the firm entered into a definitive agreement to accept Gracell Biotechnologies Inc., enriching the firm’s growing pipeline of cell therapies.

Industry Leader Announcements

• Samarth Kulkarni, PhD, Chief Executive Officer of CRISPR Therapeutics

"Steve's extensive experience in regulatory strategy and operations across multiple therapeutic areas and geographies will be a tremendous addition to the CRISPR team," said Samarth Kulkarni, PhD, Chief Executive Officer of CRISPR Therapeutics. "We are thrilled to have Steve join us at such an important time for our company as we advance multiple programs to the clinic."

• Mr. Wei Fu, Chairman of Everest Medicines and Chief Executive Officer of CBC Group

“As Everest Medicines continues to evolve our business strategy and expand our novel product pipeline at a rapid pace, we are thrilled to have Rogers join the Company to lead Everest through its next phase of growth in becoming a fully integrated biopharma company in China,” said Mr. Wei Fu, Chairman of Everest Medicines and Chief Executive Officer of CBC Group.

How AI Has Benefitted the Regulatory Affairs Market

• AI can transform via thousands of scientific articles, case studies, and clinical trial data, automatically flagging the most related data for the submission.
• AI algorithms compare the dossier over regulatory guidelines to point inconsistencies or omissions.
• AI can compile real-world evidence (RWE), clinical trial data, and economic information into concise, committee-ready presentations.

Geographical Insights

The regulatory affairs market is experiencing significant growth, with Asia Pacific maintaining its position as the dominant region while Europe emerges as the rapidly growing market. In the North America region is projected to be the fastest growing in the market during the forecast period.

APAC

Asia Pacific (APAC) dominated the global regulatory affairs market in 2024. The market growth is imputed to the enhanced regulatory landscape, expense savings, increasing number of clinical trials managed in the area, and growing number of biopharmaceutical firms in the region. Moreover, the presence of a skilled staff at a lower expense than in the U.S. is another reason anticipated to propel expansion. Thus, the growth of well-known biopharmaceutical firms may raise the requirement for regulatory service providers.

Europe

Europe is experiencing rapid growth in the regulatory affairs market during the forecast period. This is due to the existence of many pharmaceutical firms, ongoing drug discoveries, and the growing need for CROs in the area. Several CROs focusing on drug discovery have established centers in countries such as the UK, leveraging the solid research infrastructure and skilled staff in these countries.

North America

North America is projected to be the fastest growing in the market during the forecast period. It is owing to continuous research and development by the key players in the area and increasing goods pipelines and their subsequent acceptance that would lead to the region’s market expansion. Further, stringent processes and increasing R&D expenses in North America are expected to raise the requirement for outsourcing regulatory affairs methods by large biopharmaceuticals.

Recent Developments

• In February 2025, Newleos Therapeutics generate new treatments for numerous mental health conditions. The biotechnology firm’s pipeline, which it licensed from Swiss pharmaceutical giant Roche, that has four drugs in human testing for conditions such as generalized anxiety disorder, cognitive impairment, and substance use disorder.
• In July 2024, Third Arc Bio Inc. disclosed a $165 million oversubscribed Series A financing that will develop the firm through clinical studies to understand significant unmet demands in oncology and autoimmunity.

Competitive Landscape

The competitive landscape of the global regulatory affairs market is categorized by a dynamic interplay of well-known industry leaders and the latest innovative emerging players. Companies hold excellent positions due to their global reach, extensive experience, and numerous service portfolios. These industries have leveraged their technological capabilities, deep regulatory expertise, and strong client relationships to provide comprehensive regulatory solutions.

• Company Name: Genpact Limited
• Year of Incorporation: 2007
• Headquarters: New York, New York, United States

Genpact Ltd is a manufacturer of business procedure management services. The firm provides services like artificial intelligence, sales and commercial, intelligent automation, sourcing and procurement, cloud services, supply chain management, risk and compliance, data and analytics. It helps clients in capital markets, automotive, aerospace, consumer goods, healthcare, media and entertainment, high-technology, manufacturing, hospitality, life sciences, financial services, banking, chemicals, and energy sectors.

• Company Name: Pro Medicus Limited
• Year of Incorporation: 1983
• Headquarters: Richmond VIC, Victoria

Pro Medicus Limited is a healthcare IT firm primarily aimed at radiology imaging software. They tackle competition from numerous players in the radiology imaging software market, which includes both large well-known companies and emerging players.

• Company Name: Medpace Holdings, Inc.
• Year of Incorporation: 2016
• Headquarters: Cincinnati, Ohio, United States

Medpace is a public firm and functions as a clinical research organization providing a range of services. The firm has 38 active competitors, which includes 3 funded and 5 that have existed. Its top competitors are companies such as Lambda Therapeutic, Icon, and Dhiti Life Sciences.

Annual Revenue: Genpact Limited vs Pro Medicus Limited vs Medpace Holdings, Inc. 2022-24 (Millions of US$)