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Global Healthcare Regulatory Affairs Outsourcing Market Report (2022 to 2027) - Growth, Trends, COVID-19 Impact and Forecasts -

DUBLIN--(BUSINESS WIRE)--The "Healthcare Regulatory Affairs Outsourcing Market- Growth, Trends, COVID-19 Impact, and Forecasts (2022 - 2027)" report has been added to's offering.

The Healthcare Regulatory Affairs Outsourcing Market is expected to register a CAGR of 8.5% during the forecast period of 2022-2027.

Companies Mentioned

  • Accell Clinical Research, LLC.
  • Charles River Laboratories International, Inc.
  • Criterium Inc.
  • Covance, Inc.
  • ICON PLc.
  • Medpace, Inc.
  • PAREXEL International Corporation
  • Pharmaceutical Product Development, (PPD) LLC.
  • Promedica International
  • WuXi App Tec

Key Market Trends

Product Registration & Clinical Trial Applications Segment is Expected to Hold Large Market Share Over the Forecast Period

Product Registration refers to the application for regulatory approval granted by the applicable governmental authority in a given country or territory to allow a product to be marketed, distributed, sold, or imported in that country or territory. And a clinical trial application contains detailed information about the investigational medicinal product and planned trial, allowing regulatory authorities to assess the study's feasibility.

The increase in outsourcing of clinical trial applications and product registrations in both developed and developing countries is driving the expansion of the clinical trial applications and product registrations segment over the forecast period. Due to the complexity of the product registration process, lack of industry professions, and lack of internal capability, most pharmaceutical and medical device companies outsource their product registration activities to third-party service providers. This is anticipated to propel the segment growth over the forecast period.

Thus, all aforementioned factors are expected to boost the segment growth over the forecast period.

North America is Expected to Hold Major Market Share Over the Forecast Period

Pricing pressure due to the changing reimbursement scenario and generic competition is causing major pharmaceutical firms to outsource regulatory affairs activities which are supplementing the growth of healthcare regulatory outsourcing services in North America. Additionally, growing research and development activity rising in the number of clinical trials anticipated the market growth in the region.

Furthermore, as per November 2021 updated data by, 32% of the trials were registered in the United States where the major number of trials are related to various types of drugs which is likely to drive the regulatory affairs outsourcing thereby anticipated the market growth.

Moreover, the presence of key players in the region and strategic collaborations by these companies are driving the market's growth. For instance, in April 2021, Parexel and Veeva Systems announced a strategic partnership to speed up clinical trials by leveraging technology and process innovation. Both businesses will benefit from each other's regulatory consulting services.

Thus, all aforementioned factor expected to boost the market growth in the North America region over the forecast period.

Key Topics Covered:





4.1 Market Overview

4.2 Market Drivers

4.2.1 Increasing Number of Clinical Trials

4.2.2 Life Science Companies Focusing on Their Core Competencies

4.3 Market Restraints

4.3.1 Risk Associated with the Data Security

4.4 Porter's Five Force Analysis

5 MARKET SEGMENTATION (Market Size by Value - USD million)

5.1 by Services

5.1.1 Regulatory Consulting

5.1.2 Legal Representation

5.1.3 Regulatory Writing & Publishing

5.1.4 Product Registration & Clinical Trial Applications

5.1.5 Other Services

5.2 by End User

5.2.1 Pharmaceutical and Biotechnology Companies

5.2.2 Medical Device Companies

5.3 Geography


6.1 Company Profiles


For more information about this report visit

Laura Wood, Senior Press Manager

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Editor Details

  • Company:
    • Businesswire
Last Updated: 07-Oct-2022