Regulatory Affairs Market Size to Hit Around USD 31 Bn by 2030


Ottawa, Aug. 04, 2022 (GLOBE NEWSWIRE) — The global regulatory affairs market size was valued at USD 15.2 billion in 2022. This market contacts under the government domain for the regulation of the industries of the medical devices, pharmaceuticals and agrochemicals.

Key Insights:

  • The regulatory writing & publishing services segment dominated the market with revenue share of 37% in 2021.
  • By product stage, the clinical studies segment garnered 46.5% market share in 2021.
  • In 2021, the outsourcing service segment accounted market share 57%.
  • In 2021, the medium-sized segment contributed 48% market share.
  • In 2021, the oncology indication segment has reached market share of around 33.5%.
  • In 2021, the pharmaceutical companies segment hit 39% market share.
  • The Asia Pacific region accounted largest revenue share of 38% in 2021.

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Why Asia Pacific region dominated the regulatory affairs market?

  • On the basis of the region, the Asia Pacific region is expected to dominate the market in the coming years. This region is expected to have a larger market share as compared to the other regions. This region has dominated the market in the past with a share of about 37% in terms of revenue. It is also expected to have the highest compound annual growth rate during the forecast period.
  • Due to an increase in the clinical trials that are performed in this region the market is expected to grow well. The presence of various biopharmaceutical companies in the Asia Pacific region will also help in the growth of the market during the forecast period.
  • As the workforce in the Asia Pacific region is skilled and available at a lower cost as compared two other regions of the world these factors are also expected to help in the growth of the market during the forecast period.
  • Increased geriatric population of the Asia Pacific region and the increased cases of chronic diseases will create a greater demand for this market. Various initiatives taken by the government are supportive of the healthcare sector and constant research and development procedures will help in introducing new medicines which shall be cost effective. The need for the regulatory services will grow during the forecast period.

Why North America region growing faster?

  • The North American region is also expected to witness a good mount of growth during the forecast period. The regulatory system of the North American region is extremely outstanding as compared to any other systems across the globe.
  • Due to the increased cases of outsourcing for the regulatory affairs this market is expected to grow well in the coming years.

Report Highlights

  • On the basis of service, the regulatory publishing and writing segment proves to be the fastest growing market as a result of the high revenue returns generated by it. The increasing trend of outsourcing done by the key market players helps the market to record a significant growth.
  • On the basis of category, the segment of medical device has proved to be the fastest growing market as a result of the huge demand and supply. The increasing use of medical devices for diagnostic purposes has helped the market to record a significant growth.
  • On the basis of product, the segment of clinical studies has recorded the fastest growth as a result of the rapid how to search and development which is carried out in the form of clinical trials.
  • On the basis of service provider, the market has been dominated by the outsourcing segment which is a major trend followed by the major companies globally. It helps the company to focus on the core instead of making huge investments on training the staff.
  • On the basis of company size, the medium sized companies proved to be the market leaders in this sector.
  • On the basis of indication, the segment of oncology has proved to be the fastest growing market as a result of the huge number of patients that are increasing worldwide.
  • On the basis of end user, the segment of pharmaceutical companies has topped the list as a result of the huge demand and supply.

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Scope of the Report

Report Attributes Details
Market Size in 2021 USD 13.9 Billion
Revenue Forecast by 2030 USD 31 Billion
CAGR 9.32% from 2022 to 2030
Largest Market North America
Fastest Growing Region Asia Pacific
Base Year 2021
Forecast Year 2022 to 2030
Key Players Accell Clinical Research, LLC, WuXi AppTec, Inc., Genpact, Promedica International, Medpace, Criterium, Inc., Charles River Laboratories International, PRA Health Sciences, PAREXEL International Corp., Inc., Freyr, ICON plc, Covance, Inc.

Market Dynamics


With the increasing competition among the key market players multiple restraining factors are arising which has forced the modifications regarding the strategies of the company. The alterations which need to be made in the regulatory landscape of the business proves to be a major restraining factor for the growth of the regulatory affairs market during the forecast period. major market players are making a rapid shift towards artificial intelligence which has hampered the skilled workforce. a complete makeover is expected in the regulatory environment to produce better outputs in order to make it acceptable before the regulators.


The increasing requirement for advanced medicines and medical devices which are involved with the core functioning and also comply to the standards prove to be a major opportunity for the growth and development of the regulatory affairs market. The huge demand which has experienced in the market for better regulatory services has helped the market to record a tremendous revenue return during the forecast period. These multiple factors prove to be great opportunities for the growth of the market during the future period.


The number of complexities that has to be dealt with in the production of drugs proves to be a major challenge for the growth of the market. With the rapid advancements made by the key market players it is a competition among them two increase the production in a limited period of time. The high cost which is associated with the production process also hampers the growth of the market tremendously. The higher demand of regulatory norms proves to be a great challenge for the growth of the market during the forecast period.

The rapid decline in the sales and demand which has been experienced over the period of time has also challenged the growth of the market. The shift made by key market players towards the emerging technologies proves to be a deciding factor for the future of the market.

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Recent Development

  • In 2019, a collaboration was made between Syntax and Accell in order to increase the client base in the region of Europe.

Market Segmentation

By Services

  • Regulatory Consulting
  • Legal Representation
  • Regulatory Writing & Publishing
    • Writing
    • Publishing
  • Product Registration & Clinical Trial Applications
  • Other Services

By Category

  • Drugs
    • Innovator
    • Preclinical
    • Clinical
    • Post Market
    • Generics
    • Preclinical
    • Clinical
    • Post Market
  • Biologics
    • Biotech
    • Preclinical
    • Clinical
    • Post Market
    • ATMP
    • Preclinical
    • Clinical
    • Post Market
    • Biosimilars
    • Preclinical
    • Clinical
    • Post Market
  • Medical Devices
    • Diagnostics
    • Preclinical
    • Clinical
    • Post Market
    • Therapeutics
    • Preclinical
    • Clinical
    • Post Market

By Indication

  • Oncology
  • Neurology
  • Cardiology
  • Immunology
  • Others

By Stage

  • Preclinical
  • Clinical studies
  • PMA

By Service Provider

  • In-house
  • Outsourced

By Company

  • Small
  • Medium
  • Large

By End User

  • Medical Device Companies
  • Pharmaceutical Companies
  • Biotechnology Companies

By Geography

  • North America
  • Europe
  • Asia-Pacific
  • Latin America
  • Middle East & Africa (MEA)

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