- Global Pharma News & Resources

Global Regulatory Affairs Outsourcing (Biologics, Medical Devices) Market Size, Share & Trends Analysis Report 2022-2030 -

DUBLIN--(BUSINESS WIRE)--The "Regulatory Affairs Outsourcing Market Size, Share & Trends Analysis Report by Category (Biologics, Medical Devices), by Company Size (Medium, Large), by Indication, by Stage, by Services, by End Use, and Segment Forecasts, 2022-2030" report has been added to's offering.

The global regulatory affairs outsourcing market size is expected to reach USD 13.9 billion by 2030, registering a CAGR of 8.9%

Significant increase in the fixed costs of in-house resources for regulatory affairs & operation activities like training, technology, specialized knowledge, and facilities are driving outsourcing of regulatory affair functions.

Addressing local regulatory challenges and constant changes in the regulations of the major markets, such as the U.S., Europe, and Asia, is creating demand for these 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. The market witnessed a significant decline in 2020 due to the outbreak of the COVID-19 pandemic, as there was a halt in clinical trial activities including regulatory updates. Disruption in the supply chain and closure of R&D sites resulted in a significant loss of revenues in 2020 across the industry.

However, due to the pandemic, various healthcare companies are opting for more regulatory advice, as companies push to speed up the product development & approvals in therapies, vaccines, & devices for COVID-19. Owing to the urgent need for medical devices and therapies for COVID-19, regulatory authorities are providing emergency use authorization for the majority of products.

Such actions have further promoted the demand for these services post 2020 and the positive rebound of sales across the industry can be witnessed from 2021.

Regulatory Affairs Outsourcing Market Report Highlights

  • The regulatory writing & publishing services segment dominated the market with the maximum revenue share in 2021 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.
  • The large companies segment is projected to witness the fastest CAGR during the forecast period. The availability of a wide variety of services and the presence of these providers in various geographies are the key factors driving the segment growth.
  • The clinical studies stage segment accounted for the largest market share in 2021 due to the increasing demand for clinical trials in developing countries.
  • The pharmaceutical companies end-use segment is anticipated to witness the fastest growth rate over the forecast period due to evolving areas, such as orphan drugs and personalized therapies.
  • Asia Pacific held the maximum revenue share of the global market in 2021 owing to higher off shoring of such services into regions of economic benefits and the expansion of life sciences companies in countries, such as India & 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 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
  • Penetration & Growth Prospect Mapping

Industry Challenges

  • Managing Relationships

Major Deals and Strategic Alliances Analysis

Regulatory Affairs: Market Analysis Tools

  • SWOT
  • Industry Analysis-Porter's
  • PESTEL Analysis

Regulatory Affairs Outsourcing Market: Service Segment Analysis

Regulatory Affairs Outsourcing Market: Service Market Share Analysis, 2020 & 2028

  • Regulatory Consulting
  • Legal Representation
  • Regulatory Writing and Publishing
  • Product Registration and Clinical Trial Application
  • Other Services

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 Corpora

For more information about this report visit

Laura Wood, Senior Press Manager

For E.S.T Office Hours Call 1-917-300-0470
For U.S./CAN Toll Free Call 1-800-526-8630
For GMT Office Hours Call +353-1-416-8900

Editor Details

  • Company:
    • Businesswire
Last Updated: 04-Mar-2022