Regulatory Affairs Outsourcing Market Reach$13.69 Billion By 2032, CAGR: 8.4%

Regulatory Affairs Outsourcing Market Size Worth $13.69 Billion By 2032 | CAGR: 8.4%

The global regulatory affairs outsourcing market size is expected to reach USD 13.69 billion by 2032, according to a new study by Polaris Market Research. The report “Regulatory Affairs Outsourcing Market Share, Size, Trends, Industry Analysis Report, By Service (Regulatory Consulting, Regulatory Writing & Publishing, Regulatory Submission, Regulatory Operations, Legal Representation, Product Registration & Clinical Trial Applications, Others); By Size of Company; By Indication; By Product Stage; By End-User; By Region; Segment Forecast, 2024- 2032” gives a detailed insight into current market dynamics and provides analysis on future market growth.  

Outsourcing regulatory affairs has evolved into a crucial practice within the healthcare industry. The growing trend of companies expanding geographically to secure swift approvals in local markets is anticipated to drive the adoption of outsourcing models for regulatory services. The regulatory affairs outsourcing market is experiencing rapid expansion, attributed to the surge in research and development (R&D) activities, a growing inclination towards personalized medicine, and the increasing volume of clinical trial applications and product registrations, particularly in the realm of biologics.

The globalization of biopharmaceuticals and medical device companies stands out as a significant market driver. Emerging markets in Asia Pacific, Latin America, and the Middle East and Africa (MEA) regions present advantages such as lower product development and manufacturing costs, tax benefits, and access to skilled labor at comparatively reduced expenses, all supported by favorable regulations. These factors collectively make regional markets attractive for outsourcing and expansion among biopharmaceutical and medical device companies, thereby fueling the demand for regulatory services. Additionally, the increasing adoption of decentralized clinical trials, expedited approvals through fast-track processes, and the global harmonization of new product development contribute to the overall market demand.

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However, entrusting regulatory affairs functions to outsourcing may lead to a perceived loss of control for companies over vital aspects of their operations. Companies might be cautious about ceding control, particularly concerning sensitive processes related to regulatory compliance. Striking the right balance between reaping the benefits of outsourcing and retaining necessary control becomes imperative for fostering a successful collaboration.

Regulatory Affairs Outsourcing Market Report Highlights

  • In 2023, the legal representation segment is expected to witness highest growth during forecast period owing to rising global demand for legal representatives
  • Medium size company segment is expected to dominate the regulatory affairs outsourcing market during forecast period.
  • Immunology segment is expected to witness highest growth during forecast period. Owing to its potential in aiding the treatment of diverse diseases
  • The preclinical segment is projected to grow at a CAGR during the projected period in the regulatory affairs outsourcing market. The growth of the preclinical segment is driven by the escalating demand for novel treatments for diseases
  • Pharmaceutical companies segment is expected to dominate the regulatory affairs outsourcing market during forecast period
  • In 2023, Asia-Pacific accounted for the largest revenue share due to presence of major players, technological advancements, and presence of a skilled workforce.
  • The market is highly competitive owing to the existence of market players with a global presence, including Freyr Solutions, ICON plc, IQVIA, Medpace Holdings, Inc., PAREXEL International Corporation, PPD, Inc., among others.

Polaris Market Research has segmented the regulatory affairs outsourcing market report based on service, size of company, indication, product stage, end-user, and region:

Regulatory Affairs Outsourcing, Service Outlook (Revenue - USD Billion, 2019 - 2032)

  • Regulatory Consulting
  • Regulatory Writing & Publishing
  • Regulatory Submission
  • Regulatory Operations
  • Legal Representation
  • Product Registration & Clinical Trial Applications
  • Others      

Regulatory Affairs Outsourcing, Size of Company Outlook (Revenue - USD Billion, 2019 - 2032)

  • Small
  • Medium
  • Large

Regulatory Affairs Outsourcing, Indication Outlook (Revenue - USD Billion, 2019 - 2032)

  • Neurology
  • Oncology
  • Cardiology
  • Immunology
  • Others

Regulatory Affairs Outsourcing, Product Stage Outlook (Revenue - USD Billion, 2019 - 2032)

  • Preclinical
  • Clinical
  • Post Market Authorization

Regulatory Affairs Outsourcing, End-user Outlook (Revenue - USD Billion, 2019 - 2032)

  • Pharmaceutical Companies
  • Medical Device Companies
  • Biotechnology Companies

Regulatory Affairs Outsourcing, Regional Outlook (Revenue - USD Billion, 2019 - 2032)

  • North America
  • U.S.
  • Canada
  • Europe
  • France
  • Germany
  • UK
  • Italy
  • Netherlands
  • Spain
  • Russia
  • Asia Pacific
  • Japan
  • China
  • India
  • Malaysia
  • Indonesia
  • South Korea
  • Latin America
  • Brazil
  • Mexico
  • Argentina
  • Middle East & Africa
  • Saudi Arabia
  • UAE
  • Israel
  • South Africa

Regulatory Affairs Outsourcing Market Report Scope

Report Attributes


Market size value in 2024

USD 7.20 billion

Revenue forecast in 2032

USD 13.69 billion


8.4% from 2024 – 2032

Base year


Historical data

2019 – 2022

Forecast period

2024 – 2032

Quantitative units

Revenue in USD billion and CAGR from 2024 to 2032

Segments covered

  • By Service
  • By Size of Company
  • By Indication
  • By Product Stage
  • By End-User
  • By Region

Regional scope

  • North America
  • Europe
  • Asia Pacific
  • Latin America
  • Middle East & Africa

Competitive Landscape

  • Regulatory Affairs Outsourcing Market Share Analysis (2023)
  • Company Profiles/Industry participants profiling includes company overview, financial information, product/service benchmarking, and recent developments

Report Format

  • PDF + Excel


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