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Regulatory Affairs Outsourcing Market

Regulatory Affairs Outsourcing Market

Regulatory Affairs Outsourcing Market by Services (Regulatory Consulting Outsourcing, Legal Representation Outsourcing), by Category (Drugs, Biologics), by Indication (Oncology, Neurology, Radiology), by Stage, by Company Size, by End Use & Regional Forecast 2022-2032

Regulatory Affairs Outsourcing Market
  • Feb-2022
  • List of Tables : 84
  • List of Figures : 138
  • 170 Pages
  • Healthcare

Global Regulatory Affairs Outsourcing Market Outlook

The global regulatory affairs outsourcing market is estimated to secure a market value of US$ 15.11 Bn by 2032. The worth of the market is anticipated to be US$ 7 Bn in 2022, and the projected growth rate is 8% during the forecast period from 2022 to 2032.

Report Attributes


Estimated Market Value in 2022

US$ 7 Bn

Estimated Market Value in 2032

US$ 15.11 Bn

Projected CAGR from 2022 to 2032


Key Players of the Global Cloud Computing Market

  • Accell Clinical Research LLC
  • GenPact Ltd.
  • Criterium Inc.
  • PRA Health Sciences
  • Promedica International
  • WuxI AppTec Inc.
  • Medspace
  • Charles River Laboratories International Inc.
  • ICON Plc.
  • Labcorp

The increasing number of clinical trial applications and growing product registration are key factors boosting the expansion of the industry. The rapid growth of the pharmaceutical and biotechnology sectors is likely to offer significant growth opportunities to the market.

Revenue Analysis of Regulatory Affairs Outsourcing Market 2017 to 2021 vs. Future Outlook 2022 to 2032

According to Fact. MR- a market research and competitive intelligence provider- demand for regulatory affairs outsourcing expanded at a value CAGR of 6.5% from 2015 to 2021, reaching a value of US$ 6 Bn. Regulatory affairs outsourcing services are widely used to develop generic and orphan drugs, which acts as a catalyst to market growth.

During the COVID-19 pandemic, the need for regulatory affairs outsourcing acquired even more importance. Given the highly contagious and debilitating nature of the disease, pharmaceutical research organizations and medical companies came together to develop anti-COVID drugs and vaccines. This required governments at a pan-global level to permit outsourcing of critical medical and pharmaceutical technology to global parties.

With the aggressive geographical expansion initiatives by companies that aim for fast approvals in local markets, the industry is expected to expand to show significant growth by 2032. The observations at Fact. MR shows that the market is projected to garner a value of US$ 15.11 Bn by 2032.

What are the factors boosting the Global Regulatory Affairs Outsourcing Market?

Increasing out-of-pocket expenses to strengthen the global regulatory affairs services market

The increasing pressure on personal pockets and the growing measures taken by the governments of various countries are expected to boost the market growth during the forecast period. The ongoing developments in the healthcare sectors along with extensive research and development (R&D) are other salient factors propelling the market growth.

In addition, the rising demand to reduce costs in the life-sciences industry is enhancing the demand for third-party services for regulatory affairs. In addition, the advent of efficient software that keeps the record of regulatory affairs is projected to provide a significant boost to the market growth in the forecast period.

The outbreak of COVID-19 created an urgency for the regulatory authorities such as FDA and EU to authorize the emergency usage of various COVID-19 testing equipment, which provided a significant thrust to the market growth during the lockdown.

What are the restraining factors of the Global Regulatory Affairs Outsourcing Market?

Risks associated with Healthcare Regulatory Affairs Outsourcing to Hamper the Market Growth

The risks associated with healthcare regulatory affairs outsourcing are expected to hamper the market growth during the forecast period. Threats related to outsourcing and data sharing are likely to inhibit the industry’s growth. Various outsourcing partners have access to the sensitive data of pharmaceutical industries which is a threat to the security of companies and hampers market growth.

Also, the outbreak of COVID-19 brought a negative impact on the market. The imposition of lockdown across the globe resulted in the closure of clinical trials. The regulatory bodies had also temporarily suspended their activities and focused on keeping a track of the supply chain. However, as per the observations at Fact.MR, the market regained its momentum in 2021 since various players made a significant investment in R&D activities for new vaccines and medical devices.

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Country-Wise Analysis

Why is APAC anticipated to be a Lucrative Market for Regulatory Affairs Services?

Presence of Developing Countries to Boost the Healthcare Regulatory Affairs Outsourcing Market

The analysis at Fact.MR reveals that the APAC region garnered the maximum market share of 37% in 2022. The presence of developing countries such as; India and China is expected to act as a significant asset to the region. Such emerging nations are making aggressive investments in their healthcare sector, thereby pushing the market expansion.

The analysis disclosed that the region is anticipated to be the fastest-growing market. The availability of a workforce at a cheaper cost as compared to the other developed nations is likely to propel the market in the APAC region. In addition, the rapid development of the life sciences sector and the increasing cost of pocket-friendly outsourcing are other crucial factors expanding the market size in the forecast period.

What is the Contribution of North America and Europe in Boosting the Regulatory Affairs Service Market?

Presence of Key Players in the region to bolster the Regulatory Affairs Service Market

Europe and North America are anticipated to record a significant contribution in boosting the regulatory affairs service market during the forecast period. The presence of established pharmaceutical and medical devices players is one of the key factors driving the market growth.

Furthermore, the contribution of the FDA and EMA is a notable one since they regulate more than half of the medical devices globally. Collectively, both Europe and North America are expected to account for 60% of global regulatory affairs outsourcing demand.

Category-Wise Insights

What is the Role of Clinical Studies Segment in Propelling the Regulatory Affairs Service Market?

Clinical Studies Segment to Secure the Largest Share in the Regulatory Affairs services Market

According to Fact.MR, the clinical studies segment is expected to secure the largest market share of about 46% in 2022. disclosed that there were approximately 401, 716 trials registered in January 2022 against 325,834 by the 2019 end. 

The expansion of the market can be attributed to the increased demand for advanced technologies and the rising number of biologics. Further, the growing requirement for personalized orphan drugs & medicine is expected to provide a significant thrust to the market in the forecast period.

How do Pharmaceutical Companies Contribute to the Expansion of the Regulatory Affairs Service Market?

Increasing demand for Orphan Drugs to Boost the Healthcare Regulatory Affairs Outsourcing Market

The increasing number of new drugs penetrating the pharmaceutical industry is expected to boost the segmental growth during the forecast period. The analysis conducted at Fact. MR reveals that the pharmaceutical companies’ end-use segment secured the largest share of about 38% in 2022.

The segment is expected to propel at the fastest CAGR during the forecast period. The growth of the segment can be attributed to the growing demand for orphan drugs and personalized medicines which are offering lucrative opportunities for expansion to the market.

An Adaptive Approach to Modern-day Research Needs

Competitive Landscape

The players of the global regulatory affairs outsourcing market focus on expanding their global influence. Some of the adopted strategies are partnerships, collaborations, and acquisitions. Recent key developments among key players are:

  • In August 2021, ProPharma Group, a portfolio company of Odyssey Investment Partners, announced the acquisition of iSafety Systems. iSafety is an Indian pharmacovigilance outsourcing service provider.
  • In July 2021, ICON plc acquired a CRO, called PRA Health Sciences. The objective of the acquisition was to increase the services portfolio of ICON plc. The company plans to continue its original name, ICON. It aims to bring together 38,000 employees across 47 countries and create the most developed clinical research organization and healthcare intelligence.

Regulatory Affairs Outsourcing Market- Report Scope

Report Attributes


Forecast Period


Historical Data


Key Regions Covered

  • North America
  • MEA
  • Latin America
  • Europe
  • Asia-Pacific

Key Countries Covered

  • U.S
  • Canada
  • Brazil
  • Mexico
  • Germany
  • U.K
  • France
  • Italy
  • Nordics
  • China
  • Japan
  • South Korea
  • GCC
  • Turkey
  • South Africa

Key Segments Covered

  • Service
  • Category
  • Company Size
  • Indication
  • End Use
  • Stage
  • Region


Available upon Request

Key Market Segments Covered in the Global Regulatory Affairs Outsourcing Market

  • By Services

    • Regulatory Consulting Outsourcing
    • Legal Representation Outsourcing
    • Regulatory Writing & Publishing Outsourcing
    • Other Regulatory Affairs Outsourcing Services
  • By Company Size

    • Regulatory Affairs Outsourcing for Small Sized Companies
    • Regulatory Affairs Outsourcing for Medium Sized Companies
    • Regulatory Affairs Outsourcing for Large Sized Companies
  • By Category

    • Regulatory Affairs Outsourcing for Drugs
      • Generics
      • Innovators
    • Regulatory Affairs Outsourcing for Biologics
      • Biotech
      • ATMPs
      • Biosimilars
    • Regulatory Affairs Outsourcing for Medical Devices
      • Therapeutic
      • Diagnostic
  • By Indication

    • Regulatory Affairs Outsourcing for Oncology
    • Regulatory Affairs Outsourcing for Neurology
    • Regulatory Affairs Outsourcing for Radiology
    • Regulatory Affairs Outsourcing for Immunology
    • Regulatory Affairs Outsourcing for Other Indications
  • By Stage

    • Pre-Clinical Regulatory Affairs Outsourcing
    • Clinical Regulatory Affairs Outsourcing
    • Post Market Authorization Regulatory Affairs Outsourcing
  • By End Use

    • Regulatory Affairs Outsourcing for Medical Device Companies
    • Regulatory Affairs Outsourcing for Pharmaceutical Companies
    • Regulatory Affairs Outsourcing for Biotechnology Companies

- FAQs -

The global regulatory affairs outsourcing market is expected to secure a market value of US$ 7 Bn in 2022
As of 2021, the regulatory affairs outsourcing market was valued at US$ 6 Bn, as per Fact.MR
By 2032, regulatory affairs outsourcing demand is forecast to reach a value of US$ 15.11 Bn
From 2015 to 2021, demand for regulatory affairs outsourcing expanded at a CAGR of 6.5%
The market is expected to exhibit a growth of 8% during the forecast period from 2022 to 2032
According to Fact.MR, the regulatory affairs outsourcing market is expected to accumulate 37% revenue in 2022
Collectively, North America and Europe shall comprise 60% of regulatory affairs outsourcing deployment

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Yes, the report has been compiled by expert analysts of Fact.MR, through a combination of primary and secondary research. To know more about how the research was conducted, you can speak to a research analyst.

What research methodology is followed by Fact.MR?

Fact.MR follows a methodology that encompasses the demand-side assessment of the market, and triangulates the same through a supply-side analysis. This methodology is based on the use of standard market structure, methods, and definitions.

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