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Regulatory Affairs Outsourcing Market Size 2022 In-Depth Analysis, Industry Revenue and Forecast till 2030

Quadintel published a new report on the Regulatory Affairs Outsourcing Market. The research report consists of thorough information about demand, growth, opportunities, challenges, and restraints. In addition, it delivers an in-depth analysis of the structure and possibility of global and regional industries.

Global Regulatory Affairs Outsourcing Market is valued approximately USD 5.72 billion in 2021 and is anticipated to grow with a healthy growth rate of more than 8.90 % over the forecast period 2022-2028.

Regulatory affairs outsourcing is becoming more common in the healthcare industry. The adoption of regulatory outsourcing models is projected to be aided by an increase in geographical expansion activities by corporations seeking quick approvals in local markets. The regulatory affairs outsourcing market is quickly growing as a result of increased R&D activity, which is increasing the number of clinical trial applications and product registrations. Outsourcing of regulatory affairs duties is being driven by a significant increase in the fixed expenses of in-house resources for regulatory affairs and operations activities such as training, technology, specialist knowledge, and facilities.

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For example, ProPharma Group bought iSafety Systems, an Indian pharmacovigilance service provider, in August 2021 to boost its pharmacovigilance market position. Similarly, in July 2021, ICON plc purchased PRA Health Sciences, contract research organization that specializes in medication development and regulatory consultation. The goal of this acquisition was to expand ICON plc’s service portfolio. The demand for these services is being driven by local legal challenges and frequent changes in the rules of major markets such as the United States, Europe, and Asia.. Amendments to current regulations are likely to make the regulatory process easier for the business, but they will also make it more difficult for healthcare product manufacturers to operate. As a result, regulatory affairs are being outsourced to service providers. This is due to an increase in the number of clinical trial registrations in recent years. reports that about 401,716 studies were registered in January 2022, up from around 325,834 by the end of 2019. Furthermore, an increase in the number of biologics, a high demand for innovative technologies, and a need for individualized orphan pharmaceuticals and medicine are all expected to drive segment growth throughout the projection period. However, over the projection period of 2022-2028, rigorous government regulations governing various medical items would stifle market growth.

The key regions considered for the global Regulatory Affairs Outsourcing Market study includes Asia Pacific, North America, Europe, Latin America, and Rest of the World. The Asia Pacific area had the largest share. Over the forecast period, the area is also expected to have the quickest CAGR. This can be linked to an increase in clinical trials as well as a rise in the number of enterprises attempting to penetrate developing markets such as India and China. Another element projected to drive regional market expansion is the availability of a competent labour in the region at cheaper costs than in the United States.

Major market player included in this report are:

Accell Clinical Research, LLC

GenPact Ltd.

Criterium, Inc.

PRA Health Sciences

Promedica International

Dr. Regenold GmbH


Zeincro Group

Parexel International Corp.

Charles River Laboratories International, Inc.


The objective of the study is to define market sizes of different segments & countries in recent years and to forecast the values to the coming eight years. The report is designed to incorporate both qualitative and quantitative aspects of the industry within each of the regions and countries involved in the study. Furthermore, the report also caters the detailed information about the crucial aspects such as driving factors & challenges which will define the future growth of the market. Additionally, the report shall also incorporate available opportunities in micro markets for stakeholders to invest along with the detailed analysis of competitive landscape and product offerings of key players. The detailed segments and sub-segment of the market are explained below:

By Services

Regulatory Consulting

Legal Representation

Regulatory Writing & Publishing

Product Registration & Clinical Trial Applications

Other Services

By Company Size




By Category








Medical devices



By Indication






By Stage



PMA (Post Market Authorization)

By End-use

Medical Device Companies

Pharmaceutical Companies

Biotechnology Companies

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By Region:

North America










Asia Pacific





South Korea


Latin America



Rest of the World

Furthermore, years considered for the study are as follows:

Historical year – 2018, 2019, 2020

Base year – 2021

Forecast period – 2022 to 2028

Target Audience of the Global Regulatory Affairs Outsourcing Market in Market Study:

Key Consulting Companies & Advisors

Large, medium-sized, and small enterprises

Venture capitalists

Value-Added Resellers (VARs)

Third-party knowledge providers

Investment bankers


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Table of Contents:

  • Market Overview
  • Market Definition and Scope
  • Market Dynamics
  • Market Industry Analysis
  • Market, Regional Analysis
  • Analysis of Leading Companies
  • Competitive Intelligence
  • Research Process
  • Market Analysis and Forecast, By Product Types

Factors Influencing

The global market is forecast to witness a rapid growth, owing to increasing demand for technological advancements from end-users. Moreover, increasing investments in research and development activities, launches, partnerships, and other strategic initiatives will benefit the market. Furthermore, the growing focus of authorities towards increasing urbanization and industrialization is forecast to drive the market growth.

What aspects regarding the regional analysis Market are included in this report?

  • Geographical regions covered in the report include North America, Europe, Asia Pacific, Latin America and Middle East and Africa region.
  • The report consists of detailed region-wise analysis of current and future market trends, providing information on product usage and consumption.
  • The growth rate of the market in every region, including their countries over the forecast period is included in the market report.
  • Based on what factors are the key market players assessed in this report?
  • The report offers detailed analysis of leading companies in the market across the globe.
  • It provides details of the major vendors involved in the Market including Key Players
  • A comprehensive overview of each company including the company profile, generated revenue, pricing of goods and
  • the manufactured products is incorporated in the report.
  • The facts and figures about market competitors along with standpoints of leading market players are presented in the report.
  • The recent developments, mergers and acquisitions related to mentioned key players are provided in the market report.

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