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Global Regulatory Affairs Outsourcing Markets, 2021-2028 - Demand for the Faster Approval Process for Breakthrough Drugs and Devices -

DUBLIN--(BUSINESS WIRE)--The "Global Regulatory Affairs Outsourcing Market Size, Share & Trends Analysis Report by Service, by Company Size, by Category, by Indication, by Stage, by End-user, by Region, and Segment Forecasts, 2021-2028" report has been added to's offering.

The global regulatory affairs outsourcing market size is expected to reach USD 14.9 billion by 2028. It is expected to expand at a CAGR of 11.9% from 2021 to 2028.

A significant increase in the fixed costs of in-house resources for regulatory affairs and operation activities, like training, technology, specialized knowledge, and facilities, is driving the outsourcing of regulatory affairs functions.

Addressing local regulatory challenges and constant changes in the regulations of the major markets, such as the U.S., Europe, and Asia, are creating demand for the services. Compliance with the current regulations has become an immense chore, leave alone trying to stay up to date with developments around the world.

Amendments to current regulations are likely to simplify the regulatory pathway for the industry but, in turn, complicate the operation for healthcare product manufacturing companies. Thus, leading to the regulatory affairs outsourcing to service providers.

Moreover, due to the COVID-19, various healthcare companies are likely to opt for more regulatory advice in the recovery phase - on remote monitoring, telemedicine, data privacy, and more.

Furthermore, as companies push to speed up the product development and approvals in therapies, vaccines, and devices for COVID-19, they are likely to engage even more intensively with the regulatory agencies.

Regulatory Affairs Outsourcing Market Report Highlights

  • The regulatory writing and publishing services dominated the market with a share of 36.7% in 2020 as they are offered from the early stages of development to the post-marketing authorization phase and are vital for the success of a product
  • In terms of company size, the large size companies are projected to expand at the fastest CAGR of 12.3% during the forecast period. Goodwill and resource abundance are the two key factors promoting their selection by end users
  • By stage, the clinical segment accounted for the largest share of 46.7% in 2020 due to the increasing demand for clinical trials in developing countries
  • Based on end user, the pharmaceutical companies are anticipated to register the fastest growth rate over the forecast period. This may be due to evolving areas such as orphan drugs and adaptive trial designs
  • The Asia Pacific held the largest share of 37.9% in 2020 owing to higher offshoring of such services into regions of economic benefits and the expansion of life sciences companies in countries, such as India and China

Market Dynamics

Market Driver Analysis

  • Changing regulatory landscape
  • Entry of companies in the global market
  • Life science companies focusing on their core competencies
  • Economic and competitive pressures
  • Demand for the faster approval process for breakthrough drugs and devices
  • Growth in emerging areas such as personalized medicine, biosimilars, and orphan drugs

Market Restraint Analysis

  • Risk associated with data security
  • Monitoring issues and lack of standardization

Companies Mentioned

  • 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, Inc.
  • Freyr
  • Pharmalex GmbH
  • NDA Group AB
  • Pharmexon Consulting s.r.o
  • Qvigilance
  • BlueReg Group
  • Cambridge Regulatory Services
  • APCER Life Sciences, Inc.
  • Real Regulatory Ltd.
  • Voisin Consulting Life Sciences
  • PrimeVigilance
  • ProPharma Group MIS Limited
  • Regulatory Pharma Net srl
  • Zeincro Group
  • BioMapas
  • Dr. Regenold GmbH

For more information about this report visit

Laura Wood, Senior Press Manager

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Editor Details

  • Company:
    • Businesswire
Last Updated: 14-Oct-2021