U.S. Regulatory Affairs Market To Reach $9.65 Billion By 2033

U.S. Regulatory Affairs Market Growth & Trends

The U.S. regulatory affairs market size is expected to reach USD 9.65 billion by 2033, registering a CAGR of 8.43% from 2025 to 2033, according to a new report by Grand View Research, Inc. The regulatory landscape constantly evolves and becomes more complex, with new laws and guidelines being introduced regularly. This complexity drives the demand for regulatory affairs professionals who can navigate these intricate requirements.

As the company expands its operations globally, regulatory compliance becomes more challenging due to varying regulations across different countries. Regulatory affairs professionals help organizations navigate international regulatory frameworks and ensure market access. For instance, as per Reuters update of Jan 2024, many U.S. law corporations are expected to enter into merger agreements in 2024. Stockton & Kilpatrick Townsend recently announced a merger with smaller companies. In addition, Fennemore Craig, a Phoenix-founded medium-sized company, announced its expansion into Seattle in the current year.

Regulatory bodies prioritize patient safety and product quality, leading to stringent regulations that companies must adhere to. Regulatory affairs professionals are vital in ensuring products meet these standards while expediting the approval process. As the healthcare industry expands and competition increases, companies must stay ahead by complying with regulations efficiently. Regulatory affairs expertise becomes a competitive advantage in launching products faster while meeting regulatory requirements.

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U.S. Regulatory Affairs Market Report Highlights

• The outsourced segment dominated the U.S. regulatory affairs industry in 2024. The growth is driven by the growing number of biopharma and medtech companies seeking specialized expertise and cost-efficient compliance solutions. The product registration & clinical trial applications segment accounted for the largest share of the U.S. regulatory affairs industry in 2024

• The product registration & clinical trial applications segment accounted for the largest share of the U.S. regulatory affairs industry in 2024

• The medical devices segment accounted for the largest revenue share in 2024. The U.S. regulatory affairs market for medical devices is evolving rapidly, driven by innovation in digital health, diagnostics, and AI-enabled technologies.

• In 2024, the oncology segment dominated the U.S. regulatory affairs market due to an upsurge in innovative therapies, including immunotherapies, targeted treatments, and personalized medicine.

• The clinical studies segment accounted for the largest share of the U.S. regulatory affairs industry in 2024. The market for clinical studies plays a crucial role in ensuring compliance from the start to the end of trials

• In 2024, the medium-sized companies segment dominated the U.S. regulatory affairs market. Medium-sized companies increasingly leverage hybrid models that combine in-house expertise with selective outsourcing. With expanding pipelines and limited internal bandwidth, these companies seek cost-effective regulatory support for submissions, labeling, and U.S. FDA engagement.

• The pharmaceutical companies segment dominated the U.S. regulatory affairs industry in 2024. Pharmaceutical companies prioritize a comprehensive regulatory strategy to navigate complex U.S. FDA requirements and accelerate product approvals.

U.S. Regulatory Affairs Market Segmentation

Grand View Research has segmented the U.S. regulatory affairs market report based on type, service, product, indication, product stage, company size, and end use:

U.S. Regulatory Affairs Type Outlook (Revenue, USD Million, 2021 - 2033)

• In-house

• Outsourced

U.S. Regulatory Affairs Service Outlook (Revenue, USD Million, 2021 - 2033)

• Regulatory Consulting

• Legal Representation

• Regulatory Writing & Publishing

  • Writing

  • Publishing

• Product Registration & Clinical Trial Applications

• Other Services

U.S. Regulatory Affairs Product Outlook (Revenue, USD Million, 2021 - 2033)

• Drugs

  • Innovator

    • Preclinical

    • Clinical

    • Post Market Approval (PMA)

  • Generics

    • Preclinical

    • Clinical

    • Post Market Approval (PMA)

• Biologics

  • Biotech

    • Preclinical

    • Clinical

    • Post Market Approval (PMA)

  • ATMP

    • Preclinical

    • Clinical

    • Post Market Approval (PMA)

  • Biosimilars

    • Preclinical

    • Clinical

    • Post Market Approval (PMA)

• Medical Devices

  • Diagnostics

    • Preclinical

    • Clinical

    • Post Market Approval (PMA)

  • Therapeutics

    • Preclinical

    • Clinical

    • Post Market Approval (PMA)

U.S. Regulatory Affairs Indication Outlook (Revenue, USD Million, 2021 - 2033)

• Oncology

• Neurology

• Cardiology

• Immunology

• Others

U.S. Regulatory Affairs Product Stage Outlook (Revenue, USD Million, 2021 - 2033)

• Preclinical

• Clinical studies

• Post Market Approval (PMA)

U.S. Regulatory Affairs Company Size Outlook (Revenue, USD Million, 2021 - 2033)

• Small

• Medium

• Large

U.S. Regulatory Affairs End Use Outlook (Revenue, USD Million, 2021 - 2033)

• Medical Device Companies

• Pharmaceutical Companies

• Biotechnology Companies

List of Key Players in the U.S. Regulatory Affairs Market

• Accell Clinical Research, LLC.

• Charles River Laboratories

• Genpact

• ICON plc

• iuvo BioScience, LLC.

• WuXi AppTec

• Medpace

• IQVIA, Inc.

• Freyr

• PharmaLex (Cencora)

• ProPharma