U.S. Regulatory Affairs Market To Reach $7.71 Billion By 2030

U.S. Regulatory Affairs Market Growth & Trends

The U.S. regulatory affairs market size is anticipated to reach USD 7.71 billion by 2030 and is anticipated to expand at a CAGR of 9.0% during the forecast period, 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

• Regulatory writing & publishing dominated the services segment with more than 16% share in 2023 owing to increasing outsources of these services by mid- and large size medical device and biopharmaceutical firms

• The legal representation segment is expected to grow at the fastest CAGR over the forecast period

• The medical devices segment held the largest market share in 2023. This is attributable to the rising outsource activities of medical devices by pharmaceutical firms allowing them to focus on their underlying competencies

• Oncology accounted for the largest market revenue share in 2023.This can be attributed to the growing prevalence of cancer cases, encouraging a demand for effective and safe treatment selections

• The immunology segment is expected to grow at the fastest CAGR of 10.4% during the forecast period owing to its capability to facilitate the treatment of several neurological, cardiovascular, inflammatory, and oncological diseases

• Clinical studies accounted for the largest market revenue share in 2023 owing to the growing incidences of new diseases and the increasing occurrence of chronic illnesses.

• Outsourced service provider accounted for the largest market revenue share in 2023 and is anticipated to grow at the fastest CAGR over the forecast period

• The medium size companies accounted for the largest market revenue share in 2023 owing to the existence of several mid-sized recognized providers, specifically privately held, is anticipated to promote to the segment’s growth

• The pharmaceutical companies segment dominated the market in 2023 and is anticipated to grow at the fastest CAGR over the forecast period attributing to the expansion in the number of authorized pharmaceutical products

U.S. Regulatory Affairs Market Segmentation

Grand View Research has segmented the U.S. regulatory affairs market on the basis of services; category; indication; product stage; service provider; company size; end-use, and region:

U.S. Regulatory Affairs Service Outlook (Revenue, USD Million, 2018 - 2030)

• Services Regulatory consulting

• Legal Representation

• Regulatory Writing & Publishing

• Writing

• Publishing

• Product registration & Clinical Trial Applications

• Other Services

U.S. Regulatory Affairs Category Outlook (Revenue, USD Million, 2018 - 2030)

• Drugs

  • Innovator

  • Preclinical

  • Clinical

  • Pre-Market Approval (PMA)

  • Generics

  • Preclinical

  • Clinical

  • Pre-Market Approval (PMA)

•  Biologics

  • Biotech

    • Preclinical

    • Clinical

    • Pre-Maker Approval (PMA)

  • ATMP

    • Preclinical

    • Clinical

    • Pre-Maker Approval (PMA)

• Biosimilars

• Preclinical

• Clinical

• Pre-Market Approval (PMA)

• Medical Devices

  • Diagnostics

  • Preclinical

  • Clinical

  • Pre-Market Approval (PMA)

  • Therapeutics

  • Preclinical

  • Clinical

  • Pre-Market Approval (PMA)

U.S. Regulatory Affairs Indication Outlook (Revenue, USD Million, 2018 - 2030)

• Oncology

• Neurology

• Cardiology

• Immunology

• Others

U.S. Regulatory Affairs Product Stage Outlook (Revenue, USD Million, 2018 - 2030)

• Preclinical

• Clinical Studies

• PMA

U.S. Regulatory Affairs Service Provider Outlook (Revenue, USD Million, 2018 - 2030)

• In-house

• Outsourced

U.S. Regulatory Affairs Company Size Outlook (Revenue, USD Million, 2018 - 2030)

• Small

• Medium

• Large

U.S. Regulatory Affairs End-use Outlook (Revenue, USD Million, 2018 - 2030)

• Medical Device Companies

• Pharmaceutical Companies

• Biotechnology Companies

U.S. Regulatory Affairs Regional Outlook (Revenue, USD Million, 2018 - 2030)

• West

• Midwest

• Northeast

• Southwest

• Southeast

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

• Accell Clinical Research, LLC

• Genpact

• CRITERIUM, INC.

• ICON plc

• Promedica International

• WuXi AppTec

• Medpace

• Charles River Laboratories

• Labcorp Drug Development

• Parexel International (MA) Corporation

• Freyr

• Pharmalex GmbH

• NDA Group AB

• Qvigilance

• BlueReg

• Cambridge Regulatory Services

• VCLS