U.S. Regulatory Affairs - Industry Report, 2034

The U.S. regulatory affairs market size was exhibited at USD 5,585 million in 2025 and is projected to hit around USD 12,230 million by 2034, growing at a CAGR of 9.1% during the forecast period 2024 to 2034.

U.S. Regulatory Affairs Market Report Highlights

• By service, the regulatory writing and publishing segment dominated the U.S. regulatory affairs market share of over 19.5% in 2025.
• By service, the legal representation segment is expected to grow the fastest during the forecast period.
• By category, the medical devices segment accounted for the largest market revenue share in 2025 and is anticipated to grow at the fastest CAGR over the forecast period.
• By category, the biology segment is anticipated to grow the fastest during the forecast period.
• By indication, the oncology segment accounted for the largest market revenue share in 2025.  
• By indication, the immunology segment is expected to be the fastest-growing during the forecast period.
• By product stage, the clinical studies segment accounted for the largest U.S. regulatory affairs market revenue share in 2025.
• By product stage, the preclinical segment is expected to grow fastest during the forecast period.
• By service provider, the outsourced segment accounted for the largest market revenue share in 2025 and is anticipated to grow at the fastest CAGR over the forecast period.
• By company size, the medium-sized segment accounted for the largest market share revenue share in 2025.
• By company size, the large-size companies segment is projected to register the fastest CAGR during the forecast period.
• By end-use, the pharmaceutical companies segment dominated the U.S. regulatory affairs market in 2025 and is anticipated to grow at the fastest CAGR over the forecast period.

The U.S. regulatory affairs market refers to the production, distribution, and application of these regulatory affairs, which is a profession developed from the desire of governments to protect public health by controlling the safety and efficacy of products in areas including complementary medicines, cosmetics, agrochemicals, pesticides, medical devices, veterinary medicines, and pharmaceuticals. Regulatory affairs (RA) are a profession that deals with an organization’s adherence to regulatory adherence. The benefits of regulatory affairs include providing the basis for the assurance of high-quality food products, which can increase consumers' interest in ensuring safety, efficacy, and quality. It also provides opportunities for growth and advancement. Regulatory affairs play a crucial role in ensuring the efficacy, safety, and quality of medical devices and pharmaceutical products in clinical research.

Digital health and innovation initiatives driving the growth of the U.S. regulatory affairs market. The government’s support for research & development (R&D), digital health, and innovation initiatives underlines its commitment to a more robust pharmaceutical ecosystem. To keep up with advancements and global standards, the regulatory framework will need to evolve, creating more roles in DRA to handle policy development, innovation, and digital compliance. Digitalization in pharmaceutical regulatory affairs improves internal processes through decision-making, collaboration, data quality, and efficiency. Drug regulatory affairs also play an important role in the drug development processes, helping to ensure that new drugs are thoroughly tested and evaluated before they are approved for use. Without regulatory oversight, ineffective or unsafe products can be marketed, potentially putting patients at risk. Regulatory affairs play an important role throughout the lifecycle of a medical device. It allows medical device manufacturers to devise premarket strategies, ensure post-market compliance, and draft regulatory submissions. These regulatory affairs in the medical device industry aim to protect the patient and ensure health benefits.

Artificial intelligence (AI) can be used to simplify and automate pharmaceutical regulatory processes that drive the growth of the U.S. regulatory affairs market. AI reduces complexity, resulting in a more effective management system. AI reduces the time spent on quality management and identifies vulnerabilities. AI tools can be applied to automate regulatory processes like quality management, the implementation of regulations, auditing, data extraction, dossier filling, and administrative work. AI reduces complexity and creates process links, resulting in a more efficient management system. Generative AI can also used to update the policies, standards, and procedures to comply with new regulatory requirements. It also supports training and communication on new requirements by providing users with intuitive chat interfaces to explore internal documents.

Competitive pricing and government initiatives driving the growth of the U.S. regulatory affairs market. Supportive policies and incentives from governments, mainly in developed regions, help the growth of the market. The affordability of regulatory affairs outsourcing products, coupled with enhanced production methods, has made it accessible to a larger population. Federal regulatory bodies issue rules and regulations that govern the development, manufacturing, testing, and marketing of pharmaceuticals and medical devices. These regulations ensure products meet high standards of safety, quality, and efficacy. The competitive pricing benefits include helping businesses understand their market position and boost profits.