Regulatory Affairs Market Size, Share & Trends Analysis Report By Service, By Categories (Biologics, Drugs), By Indication, By Product Stage, By End Use, By Service Providers, By Company Size- Global Industry Analysis, Share, Growth, Regional Outlook And Forecasts, 2021-2027

The global Regulatory Affairs market gathered revenue around USD 11.45 Billion in 2020 and market is set to grow USD 21.9 Billion by the end of 2027 and is estimated to expand at a modest CAGR of 8.0% during the prediction period 2021 to 2027.

Growth Factors:        

This growth can be attributed to the increasing demand for the faster approval process, changing regulatory landscape, growth in emerging fields such as specialty therapies, orphan drugs, personalized medicines, and companion diagnostics. The market for regulatory affairs is also driven by the emergence of new diseases triggering the need for effective vaccines and therapies.

The growing pace of innovation in digital health and the rapid technological advancements in data collection, analysis, and management is anticipated to create a need for digital transformation in one or more regulatory processes in order to improve the access and analysis of the continuously growing volume of information due to connected health products and programs. Furthermore, even several pharma/biotech companies are anticipated to upgrade their existing technologies to meet the growing healthcare needs.

Furthermore, the changes in the Central Administration for Pharmaceutical Affairs (CAPA) scope in Egypt is anticipated to change the medical device registration process in the country. Such changes in local regulations are anticipated to favor market growth. Furthermore, several regulatory changes related to clinical trials, vaccine development, and product approvals, initiated by the global and local regulatory authorities to expedite patient access to Covid-19 treatments and vaccines, are anticipated to positively affect the market growth. Market players are actively involved in the adoption of advanced technologies, strategic collaborations, and mergers & acquisition, to strengthen their market positions and outperform the competition. For instance, in 2020, ICON acquired MedPass, a medical device CRO, reimbursement, and regulatory consultancy firm. This acquisition is aimed at strengthening the medical device and diagnostic research services portfolio of ICON through the addition of new clinical and regulatory capabilities in Europe.

This research report purposes at stressing the most lucrative growth prospects. The aim of the research report is to provide an inclusive valuation of the Regulatory Affairs market and it encompasses thoughtful visions, actualities, industry-validated market findings, historic data, and prognoses by means of appropriate set of assumptions and practice. Global Regulatory Affairs market report aids in comprehending market structure and dynamics by recognizing and scrutinizing the market sectors and predicted the global market outlook.

Report Coverage

Report Scope Details
Market Size USD 21.9 Billion by 2027
Growth Rate CAGR of 8.0% From 2021 to 2027
Base Year 2020
Forecast Period 2021 to 2027
Historic Data 2017 to 2020
Report coverage Growth Factors, Revenue Status, Competitive Landscape,  and Future Trends
Segments Covered Service, service provider, categories, indication, end use, product stage, company size and Region
Regional Scope North America, Europe, Asia Pacific, Latin America, Middle East & Africa (MEA)
Companies Mentioned   Accell Clinical Research, LLC.; GenPact Ltd.; Criterium, Inc.; PRA Health Sciences; Promedica International; WuXi AppTec, Inc.; Medpace; Pharmaceutical Product Development, LLC (PPD); Charles River Laboratories International, Inc.; ICON plc; Covance; Parexel International Corporation, Inc.; Freyr.

COVID-19 Impact Assessment on Market Landscape

The report comprises the scrutiny of COVID-19 lock-down impact on the income of market leaders, disrupters and followers. Since lock down was instigated differently in diverse regions and nations, influence of same is also dissimilar across various industry verticals. The research report offers present short-term and long-term influence on the market to assist market participants across value chain makers to formulate the framework for short term and long-lasting tactics for recovery and by region.

Regulatory Affairs market Report empowers readers with all-inclusive market intelligence and offers a granular outline of the market they are operational in. Further this research study delivers exceptional combination of tangible perceptions and qualitative scrutiny to aid companies accomplishes sustainable growth. This report employs industry-leading research practices and tools to assemble all-inclusive market studies, intermingled with pertinent data. Additionally, this report also emphases on the competitive examination of crucial players by analyzing their product portfolio, pricing, gross margins, financial position, growth approaches, and regional occurrence.

Regional analysis:

Asia Pacific dominated the regulatory affairs market and accounted for the largest revenue share of more than 37.0% in 2020. It is also anticipated to be the fastest-growing region owing to relatively lower cost for outsourcing, skilled workforce with technical expertise, tax benefits, and expansion of healthcare companies in countries such as India and China. Supportive regulations are thus increasing the demand for local regulatory services. 

A supportive regulatory landscape is also anticipated to favor the growth of the market in the region. As of August 2016, nearly 60 biosimilars were approved in India. This can be attributed to a less rigorous approval pathway for biosimilars in the country and other similar emerging markets as compared to highly regulated markets. 

The implementation of In-vitro Diagnostics Regulation (IVDR) and new Medical Device Regulation (MDR) is anticipated to increase the time and cost required for entering a European market, thereby increasing the regulatory complications in the region.

Competitive Rivalry

Foremost players in the market are attentive on adopting corporation strategies to enhance their market share. Some of the prominent tactics undertaken by leading market participants in order to sustain the fierce market completion include collaborations, acquisitions, substantial spending in R&D and the improvement of new-fangled products or reforms among others.

Major manufacturers & their revenues, percentage splits, market shares, growth rates and breakdowns of the product markets are determined through secondary sources and verified through the primary sources.

  • Company Overview
  • Company Market Share/Positioning Analysis
  • Product Offerings
  • Financial Performance
  • Recent Initiatives
  • Key Strategies Adopted by Players
  • Vendor Landscape
  • List of Suppliers
  • List of Buyers

Some of the prominent players in the Regulatory Affairs Market include:  Accell Clinical Research, LLC.; GenPact Ltd.; Criterium, Inc.; PRA Health Sciences; Promedica International; WuXi AppTec, Inc.; Medpace; Pharmaceutical Product Development, LLC (PPD); Charles River Laboratories International, Inc.; ICON plc; Covance; Parexel International Corporation, Inc.; Freyr.

Unravelling the Critical Segments

This research report offers market revenue, sales volume, production assessment and prognoses by classifying it on the basis of various aspects including product type, application/end-user, and region. Further, this research study investigates market size, production, consumption and its development trends at global, regional, and country level for period 2017 to 2027 and covers subsequent region in its scope:

  • By Service
    • Regulatory consulting
    • Legal representation
    • Regulatory writing & publishing
    • Product registration & clinical trial applications
    • Other services
  • By Categories
    • Drugs
      • Innovator
        • Preclinical
        • Clinical
        • Post market
      • Generic
        • 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 Product Stage
    • Preclinical
    • Clinical
    • PMA
  • By End-use
    • Medical Device Companies
    • Biotechnology Companies
    • Pharmaceutical Companies
  • By Service Provider
    • In-house
    • Outsourced
  • By Company Size
    • Small
    • Medium
    • Large

By Geography

North America

  • U.S.
  • Canada


  • Germany
  • France
  • United Kingdom
  • Rest of Europe

Asia Pacific

  • China
  • Japan
  • India
  • Southeast Asia
  • Rest of Asia Pacific

Latin America

  • Brazil
  • Rest of Latin America

Middle East & Africa (MEA)

  • GCC
  • North Africa
  • South Africa
  • Rest of Middle East & Africa

Highlights of the Report:

  • Market Penetration: Comprehensive information on the product portfolios of the top players in the market.
  • Product Development/Innovation: Detailed insights on the upcoming technologies, R&D activities, and product launches in the market
  • Competitive Assessment: In-depth assessment of the market strategies, geographic and business segments of the leading players in the market
  • Market Development: Comprehensive information about emerging markets. This report analyzes the market for various segments across geographies
  • Market Diversification: Exhaustive information about new products, untapped geographies, recent developments, and investments in the market

Research Methodology

In the study, a unique research methodology is utilized to conduct extensive research on the growth of the Regulatory Affairs market, and reach conclusions on the future growth parameters of the market. This research methodology is a combination of primary and secondary research, which helps analysts ensure the accuracy and reliability of the conclusions.

Secondary resources referred to by analysts during the production of the Regulatory Affairs market study are as follows - statistics from government organizations, trade journals, white papers, and internal and external proprietary databases. Analysts have also interviewed senior managers, product portfolio managers, CEOs, VPs, marketing/product managers, and market intelligence managers, all of whom have contributed to the development of this report as a primary resource.

Comprehensive information acquired from primary and secondary resources acts as a validation from companies in the market, and makes the projections on the growth prospects of the Regulatory Affairs markets more accurate and reliable.

Secondary Research

It involves company databases such as Hoover's: This assists us recognize financial information, structure of the market participants and industry competitive landscape.

The secondary research sources referred in the process are as follows:

  • Governmental bodies, and organizations creating economic policies
  • National and international social welfare institutions
  • Company websites, financial reports and SEC filings, broker and investor reports
  • Related patent and regulatory databases
  • Statistical databases and market reports
  • Corporate Presentations, news, press release, and specification sheet of Manufacturers

Primary Research

Primary research includes face-to face interviews, online surveys, and telephonic interviews.

  • Means of primary research: Email interactions, telephonic discussions and Questionnaire based research etc.
  • In order to validate our research findings and analysis we conduct primary interviews of key industry participants. Insights from primary respondents help in validating the secondary research findings. It also develops Research Team’s expertise and market understanding.

Industry participants involved in this research study include:

  • CEOs, VPs, market intelligence managers
  • Procuring and national sales managers technical personnel, distributors and resellers
  • Research analysts and key opinion leaders from various domains

Key Points Covered in Regulatory Affairs market Study:

  • Growth of Regulatory Affairs in 2021
  • Market Estimates and Foreca
  • <