Regulatory Affairs Market Worth $22.7 Billion By 2028 | CAGR: 8.4%

July 2021 | Report Format: Electronic (PDF)

Regulatory Affairs Market Growth & Trends

The global regulatory affairs market size is expected to reach USD 22.7 billion by 2028 registering a CAGR of 8.4%, according to a new report by Grand View Research, Inc. Rise in drug approvals, label expansions of approved products, along with the presence of Fastrack regulatory pathways are anticipated to facilitate the market growth over the forecast period. Technological advancements in regulatory software and the growing digital transformation in the healthcare industry are also expected to contribute to market growth. In addition, the introduction of Medical Devices Regulation (MDR) and In Vitro Diagnostics Regulation (IVDR) is anticipated to not only change the EU regulatory landscape and increase the stringency of regulations but also increase the number of documents required to be created and maintained by companies.

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.

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Regulatory Affairs Market Report Highlights

  • Regulatory writing and publishing was the leading service segment in 2019 and is projected to retain its dominant position throughout the forecast years

  • This growth is credited to an increase in the outsourcing of selected regulatory functions by major life sciences companies

  • The Biologics segment is anticipated to witness the fastest CAGR over the forecast period due to the increasing popularity of personalized medicines and biosimilars

  • The oncology indication segment dominated the market in 2019 and will expand further at a steady CAGR from 2020 to 2027

  • This growth can be attributed to the rising cancer cases and mortality rate along with the presence of several innovative pipeline products

Regulatory Affairs Market Segmentation

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

Regulatory Affairs Service Outlook (Revenue, USD Million, 2016 - 2028)

  • Regulatory Consulting

  • Legal Representation

  • Regulatory Writing & Publishing

  • Product Registration & Clinical Trial Application

  • Other Services

Regulatory Affairs Service Provider Outlook (Revenue, USD Million, 2016 - 2028)

  • In-house

  • Outsourcing

Regulatory Affairs Company Size Outlook (Revenue, USD Million, 2016 - 2028)

  • Small

  • Medium

  • Large

Regulatory Affairs Categories Outlook (Revenue, USD Million, 2016 - 2028)

  • Drugs

    •  Innovator

      • Preclinical

      • Clinical

      • Post Market

    •  Generic

      • Preclinical

      • Clinical

      • Post Market

  • Biologics

    • Biotech

      • Preclinical

      • Clinical

      • Post Market

    • ATMP

      • Preclinical

      • Clinical

      • Post Market

    • Biosimilar

      • Preclinical

      • Clinical

      • Post Market

  • Medical Devices

    • Diagnostic

      • Preclinical

      • Clinical

      • Post Market

    • Therapeutic

      • Preclinical

      • Clinical

      • Post Market

Regulatory Affairs Product Stage Outlook (Revenue, USD Million, 2016 - 2028)

  • Preclinical

  • Clinical

  • PMA

Regulatory Affairs Indication Outlook (Revenue, USD Million, 2016 - 2028)

  • Oncology

  • Neurology

  • Cardiology

  • Immunology

  • Others

Regulatory Affairs End-use Outlook (Revenue, USD Million, 2016 - 2028)

  • Medical Device Companies

  • Pharmaceutical Companies

  • Biotechnology Companies

Regulatory Affairs Regional Outlook (Revenue, USD Million, 2016 - 2028)

  • North America

    • U.S.

    • Canada

  • Europe

    • U.K.

    • Germany

    • France

    • Italy

    • Spain

    • Russia

    • Turkey

    • The Netherlands

    • Switzerland

    • Sweden

  • Asia Pacific

    • Japan

    • China

    • India

    • Australia

    • South Korea

    • Indonesia

    • Malaysia

    • Singapore

    • Thailand

    • Taiwan

  • Latin America

    • Brazil

    • Mexico

    • Argentina

    • Colombia

    • Chile

  • MEA

    • South Africa

    • Saudi Arabia

    • UAE

    • Egypt

    • Israel

List of Key Players of Regulatory Affairs Market

  • Accell Clinical Research, LLC.

  • GenPact Ltd.

  • Criterium, Inc.

  • PRA Health Sciences

  • Promedica International

  • WuXi AppTec, Inc.

  • Medpace

  • Charles River Laboratories International, Inc.

  • Icon plc

  • Covance

  • Parexel International Corporation

  • Freyr

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