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Press release content from Business Wire. The AP news staff was not involved in its creation.

Worldwide Regulatory Affairs Outsourcing Industry to 2026 - Featuring Covance, Freyr and Medpace Holdings Among Others -

December 15, 2021 GMT

DUBLIN--(BUSINESS WIRE)--Dec 15, 2021--

The “Regulatory Affairs Outsourcing Market: Global Industry Trends, Share, Size, Growth, Opportunity and Forecast 2021-2026” report has been added to’s offering.

The global regulatory affairs outsourcing market grew at a CAGR of around 10% during 2015-2020. Looking forward, the publisher expects the market to exhibit strong growth during 2021-2026.

Companies Mentioned

  • Charles River Laboratories International Inc.
  • Covance Inc (Laboratory Corporation of America Holdings)
  • Freyr
  • ICON Plc
  • Medpace Holdings Inc.
  • Parexel International Corporation
  • Pharmaceutical Product Development LLC
  • Promedica International- A California Corporation
  • Wuxi AppTec Co. Ltd.


Keeping in mind the uncertainties of COVID-19, we are continuously tracking and evaluating the direct as well as the indirect influence of the pandemic on different end use sectors. These insights are included in the report as a major market contributor.

Regulatory affairs outsourcing refers to the hiring of third-party services by the government bodies and private organizations to ensure public health and safety. The services include managing regulatory requirements for generic drugs, innovator drugs, biologics, biosimilars, etc. The outsourcing organizations control the safety and efficacy of the products and ensure that they are safe for consumption. These services are required for clinical trial and patent application, regulatory writing and publishing, product registration and legal representation. Pharmaceutical organizations also opt for these services to seek speedy government approvals in various regions.

Significant growth in the pharmaceutical and biotechnological industries across the globe represents one of the key factors creating a positive outlook for the market. Furthermore, the increasing emphasis of pharmaceutical organizations to expand their operations and supplies in the emerging economies is also driving the market growth. Outsourcing regulatory affairs also aid in minimizing the costs associated with managing in-house resources, such as facilities, training, technology, specialized knowledge and geographic regulations.


Additionally, regulatory affairs outsourcing services are also widely used for the development of biosimilar, orphan and generic drugs, which is acting as another major growth-inducing factor. Life science organizations are increasingly outsourcing non-core functions and regulatory services and increase their overall operational efficiencies, which, in turn, is contributing to the market growth. Other factors, including significant improvements in the healthcare infrastructure, along with extensive research and development (R&D) activities, are anticipated to drive the market further.

Key Questions Answered in This Report:

  • How has the global regulatory affairs outsourcing market performed so far and how will it perform in the coming years?
  • What has been the impact of COVID-19 on the global regulatory affairs outsourcing market?
  • What are the key regional markets?
  • What is the breakup of the market based on the services?
  • What is the breakup of the market based on the company size?
  • What is the breakup of the market based on the category?
  • What is the breakup of the market based on the indication?
  • What is the breakup of the market based on the stage?
  • What is the breakup of the market based on the end user?
  • What are the various stages in the value chain of the industry?
  • What are the key driving factors and challenges in the industry?
  • What is the structure of the global regulatory affairs outsourcing market and who are the key players?
  • What is the degree of competition in the industry?

Key Topics Covered:

1 Preface

2 Scope and Methodology

3 Executive Summary

4 Introduction

4.1 Overview

4.2 Key Industry Trends

5 Global Regulatory Affairs Outsourcing Market

5.1 Market Overview

5.2 Market Performance

5.3 Impact of COVID-19

5.4 Market Forecast

6 Market Breakup by Services

7 Market Breakup by Company Size

8 Market Breakup by Category

9 Market Breakup by Indication

10 Market Breakup by Stage

11 Market Breakup by End User

12 Market Breakup by Region

13 SWOT Analysis

14 Value Chain Analysis

15 Porters Five Forces Analysis

16 Price Analysis

17 Competitive Landscape

17.1 Market Structure

17.2 Key Players

17.3 Profiles of Key Players

For more information about this report visit

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SOURCE: Research and Markets

Copyright Business Wire 2021.

PUB: 12/15/2021 01:13 PM/DISC: 12/15/2021 01:13 PM