Regulatory Affairs Market Size To Reach $27.18 Billion By 2030

April 2025 | Report Format: Electronic (PDF)

Regulatory Affairs Market Growth & Trends

The global regulatory affairs market size is expected to reach USD 27.18 billion by 2030, expanding at a CAGR of 8.80% from 2025 to 2030, according to a new report by Grand View Research, Inc. The factors expected to contribute to the growth of this market include changing regulatory requirements based on business activities and geographies, an increase in clinical trials & drug approvals along with accelerated regulatory approval, and technological advancement in regulatory software. Also, the evolution of personalized medicines, the increasing need for companies to focus on core business activities, and economic and competitive pressures are other factors that are contributing to the growth of the market.

The pharmaceutical and regulatory agencies joined forces to rapidly develop vaccines and medical products required to fight against the COVID-19 infection. The regulatory authorities take numerous precautions to ensure patient and personnel safety during a clinical trial, as well as data integrity and good laboratory practices are maintained. Growth in markets for biosimilars, orphan drugs, personalized medicines, companion diagnostics, and adaptive trial designs is projected to boost the demand for regulatory specialization in these areas. As companies venture into newer fields, the growing need to comply with regulations is boosting the demand for specialized service providers with expertise in regulatory affairs. Patent expiration of biologics, such as Simulect, Vectibix, Mircera, and Kineret, is increasing the demand and development of biosimilars, thereby contributing to the demand for regulatory services.

Several companies are actively involved in collaborations and new product development to gain leadership in the personalized medicine market, indicating a need for supportive regulatory affairs. For instance, in May 2020, Regeneron Pharmaceuticals, Inc. collaborated with Colorado Center for Personalized Medicine to design advancements in personalized medicine and human genetics.

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Regulatory Affairs Market Report Highlights

  • The outsourcing segment dominated the market with a share of 59.05% in 2024. The growth of the segment is mainly due to the growing focus of the pharmaceutical and medical device companies to outsource their activities as it allows access to specialized expertise and resources that they may not have in-house.

  • The regulatory writing & publishing segment held a significant share of the market in 2024. The growth of the segment is attributed to several pharmaceutical or biopharmaceutical companies reducing costs, prioritizing strategic projects, reducing staff training time, and improving overall efficiency, as well as providing greater flexibility.

  • The drugs segment dominated the regulatory affairs market in 2024. The growth of the segment can be attributed to various regulations and related regulatory submissions/documentation at each of the steps involved in the process.

  • The oncology segment dominated the market in 2024. The growth of the segment is due to the increasing prevalence of cancer, which requires effective and safe treatment options.

  • Clinical studies dominated the market in 2024. The increasing prevalence of chronic diseases coupled with the emergence of new diseases will increase the demand for better treatment options, further growing the number of clinical trials conducted globally to meet the growing needs of the patients.

  • The medium company size segment dominated the market in 2024. The growth of the market is mainly due to the strong presence of several mid-sized established firms, mainly which are privately held.

  • The pharmaceutical companies segment dominated the market in 2024. The growth of the segment is due to growing research and development activities coupled with an increase in the number of approved pharmaceutical products.

  • The regulatory affairs market in Asia Pacific dominated the global industry and accounted for a 38.03% share in 2024.

Regulatory Affairs Market Segmentation

Grand View Research has segmented the global regulatory affairs market on the basis of services, categories, indication, stage, type, company size, end-use, and region:

Regulatory Affairs Type Outlook (Revenue, USD Billion, 2018 - 2030)

  • In-house

  • Outsourced

Regulatory Affairs Services Outlook (Revenue, USD Billion, 2018 - 2030)

  • Regulatory Consulting

  • Legal Representation

  • Regulatory Writing & Publishing

    • Writing

    • Publishing

  • Product Registration & Clinical Trial Applications

  • Other Services

Regulatory Affairs Categories Outlook (Revenue, USD Billion, 2018 - 2030)

  • Drugs

    • Innovator

      • Preclinical

      • Clinical

      • Pre-Market Approval (PMA)

    • Generics

      • Preclinical

      • Clinical

      • Pre-Market Approval (PMA)

  • Biologics

    • Biotech

      • Preclinical

      • Clinical

      • Pre-Market Approval (PMA)

    • ATMP

      • Preclinical

      • Clinical

      • Pre-Market 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)

Regulatory Affairs Indication Outlook (Revenue, USD Billion, 2018 - 2030)

  • Oncology

  • Neurology

  • Cardiology

  • Immunology

  • Others

Regulatory Affairs Product Stage Outlook (Revenue, USD Billion, 2018 - 2030)

  • Preclinical

  • Clinical studies

  • Post Market Approval (Pre-Market Approval (PMA) )

Regulatory Affairs Company Size Outlook (Revenue, USD Billion, 2018 - 2030)

  • Small

  • Medium

  • Large

Regulatory Affairs End-use Outlook (Revenue, USD Billion, 2018 - 2030)

  • Medical Device Companies

  • Pharmaceutical Companies

  • Biotechnology Companies

Regulatory Affairs Regional Outlook (Revenue, USD Billion, 2018 - 2030)

  • North America

    • U.S.

    • Canada

    • Mexico

  • Europe

    • UK

    • Germany

    • France

    • Italy

    • Spain

    • Denmark

    • Norway

    • Netherlands

    • Switzerland

    • Sweden

  • Asia Pacific

    • Japan

    • China

    • India

    • Australia

    • South Korea

    • Indonesia

    • Malaysia

    • Singapore

    • Thailand

    • Taiwan

  • Latin America

    • Brazil

    • Argentina

    • Colombia

    • Chile

  • MEA

    • South Africa

    • Saudi Arabia

    • UAE

    • Egypt

    • Israel

    • Kuwait

List of Key Players of Regulatory Affairs Market

  • Accell Clinical Research, LLC

  • Genpact

  • Criterium, Inc.

  • ICON plc

  • iuvo BioScience, LLC.

  • WuXi AppTec

  • Medpace

  • Charles River Laboratories.

  • Laboratory Corporation of America Holdings

  • Parexel International (MA) Corporation

  • Freyr

  • AmerisourceBergen

  • NDA Group AB

  • Pharmexon

  • Qvigilance

  • BlueReg

  • Cambridge Regulatory Services

  • VCLS

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