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.
| Industry Worth | Details |
| Market Size in 2025 | USD 17,370 Million |
| Market Size by 2034 | USD 36,490 Million |
| Market Growth Rate from 2025 to 2034 | CAGR of 8.6% |
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.
"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."
“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.
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.
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.
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.
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.
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$)
| Year | Genpact Limited | Medicus Limited | Medpace Holdings, Inc. |
| 2024 | 4,767,139 | 161,429 | 2,109,054 |
| 2023 | 4,476,888 | 124,787 | 2,109,054 |
| 2022 | 4,371,172 | 93,401 | 1,459,996 |
Published by Laxmi Narayan
For any questions about this dataset or to discuss customization options, please write to us at sales@statifacts.com
| Stats ID: | 8245 |
| Format: | Databook |
| Published: | April 2025 |
| Delivery: | Immediate |
| Stats ID: | 8245 |
| Format: | Databook |
| Published: | April 2025 |
| Delivery: | Immediate |
Unlock unlimited access to all exclusive market research reports, empowering your business.
Get industry insights at the most affordable plan
Stay ahead of the competition with comprehensive, actionable intelligence at your fingertips!
Learn More
Download
Actionable Solutions
