Report Overview

2023

Base Year

2017-2023

Historical Year

2024-2032

Forecast Year

Global Healthcare Regulatory Affairs Outsourcing Market Outlook

The global healthcare regulatory affairs outsourcing market size attained a value of 8.05 billion in 2023. The market is expected to grow at a CAGR of 8.96% between 2024 and 2032, reaching almost 17.42 billion by 2032.

healthcare-regulatory-affairs-outsourcing-market

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Healthcare Regulatory Affairs Outsourcing: Introduction

Healthcare regulatory affairs outsourcing refers to the practice of engaging external service providers or consulting firms to handle regulatory affairs tasks and responsibilities on behalf of healthcare organizations. Regulatory affairs in the healthcare sector involve navigating and complying with the complex and evolving regulatory landscape that governs the development, manufacturing, and marketing of pharmaceuticals, medical devices, biotechnology products, and other healthcare-related items.

Global Healthcare Regulatory Affairs Outsourcing Market Analysis

Life sciences companies are increasingly turning to digitization, which has led to changes in the way regulatory publishing and information are managed. These companies face significant constraints in terms of time and the volume of data that needs to be processed. The integration of artificial intelligence is expected to drive growth in this sector. Additionally, increased awareness of the benefits of outsourcing healthcare regulatory affairs is also driving the global healthcare regulatory affairs outsourcing market growth.

The rising number of clinical trials is a major contributor to market growth. This increase is due to the growing demand for research and development in various domains, including the development of new medicines requiring approval from the U.S. Food and Drug Administration. The demand for new treatment therapies and drugs to address various medical conditions is also driving market growth.

Healthcare Regulatory Affairs Outsourcing Market

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Global Healthcare Regulatory Affairs Outsourcing Market Segmentations

Market Breakup by Services

  • Regulatory Consulting
  • Legal Representation
  • Regulatory Writing and Publishing
  • Product Registration and Clinical Trial Applications

Market Breakup by Categories

  • Drugs
  • Biologics
  • Medical Devices

Market Breakup by Region

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

healthcare-regulatory-affairs-outsourcing-market-by-region

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Global Healthcare Regulatory Affairs Outsourcing Market Overview

The market growth is expected to be driven by a surge in research and development expenditure due to a rising number of clinical trials, and the cost-effectiveness associated with outsourcing. The increasing investments in research and development by pharmaceutical and biotechnology companies are expected to be a key driver, stimulating the demand for regulatory services in the healthcare industry.

The market is further expected to be driven by the escalating outsourcing of clinical trial applications and product registrations. This trend expands across both developed and developing countries, particularly influencing the product registration and clinical trial application segment throughout the forecast period. The increased complexity in the product registration process, coupled with a shortage of industry professionals and internal capabilities, has led pharmaceutical and medical device companies to increasingly opt for third-party service providers for their product registration activities, propelling the global healthcare regulatory affairs outsourcing market growth.

Additionally, the market is characterized by several factors, including heightened R&D investments, a growing number of clinical trials, and the compelling cost advantages associated with outsourcing.

Global Healthcare Regulatory Affairs Outsourcing Market: Competitor Landscape

The key features of the market report include patent analysis, grants analysis, clinical trials analysis, funding and investment analysis, partnerships, and collaborations analysis by the leading key players. The major companies in the market are as follows:

  • Accell Clinical Research
  • Takeda Pharmaceutical Company Limited
  • Genpact
  • Promedica International
  • WuXi AppTec, Inc.
  • PRA Health Sciences
  • Medpace
  • Charles River Laboratories International
  • PAREXEL International Corp.
  • Covance, Inc.

Please note that this only represents a partial list of companies, and the complete list has been provided in the report.

Key Highlights of the Report

REPORT FEATURES DETAILS
Base Year 2023
Historical Period 2017-2023
Forecast Period 2024-2032
Scope of the Report

Historical and Forecast Trends, Industry Drivers and Constraints, Historical and Forecast Market Analysis by Segment:

  • Services
  • Categories
  • Region
Breakup by Services
  • Regulatory Consulting
  • Legal Representation
  • Regulatory Writing and Publishing
  • Product Registration and Clinical Trial Applications
Breakup by Categories
  • Drugs
  • Biologics
  • Medical Devices
Breakup by Region
  • North America
  • Europe
  • Asia Pacific
  • Latin America
  • Middle East and Africa
Market Dynamics
  • Market Drivers and Constraints
  • SWOT Analysis
  • Porter’s Five Forces Model 
  • Key Demand Indicators
  • Key Price Indicators
  • Industry Events, Initiatives, and Trends 
  • Value Chain Analysis
Competitive Landscape
  • Market Structure
  • Company Profiles
    • Financial Analysis
    • Product Portfolio
    • Demographic Reach and Achievements
    • Mergers and Acquisitions
    • Certifications
Companies Covered
  • Accell Clinical Research
  • Takeda Pharmaceutical Company Limited
  • Genpact
  • Promedica International
  • WuXi AppTec, Inc.
  • PRA Health Sciences
  • Medpace
  • Charles River Laboratories International
  • PAREXEL International Corp.
  • Covance, Inc.

*While we strive to always give you current and accurate information, the numbers depicted on the website are indicative and may differ from the actual numbers in the main report. At Expert Market Research, we aim to bring you the latest insights and trends in the market. Using our analyses and forecasts, stakeholders can understand the market dynamics, navigate challenges, and capitalize on opportunities to make data-driven strategic decisions.*

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Key Questions Answered in the Report

The market attained a value of about USD 8.05 billion in 2023, driven by the increased FDA approvals.

The market is anticipated to grow at a CAGR of 8.96% during the forecast period of 2024-2032 and is likely to reach a market value of USD 17.42 billion by 2032.

The market growth is driven by the increased integration of advanced technologies in the procedure to process a huge amount of data.

The increasing number of research activities and the rapid development of the healthcare sector are the major factors driving the market growth.

The major regions of the market include North America, Europe, Asia Pacific, Latin America, Middle East, and Africa. North America is currently leading the global market.

Services such as regulatory consulting, legal representation, regulatory writing & publishing, product registration, and clinical trial applications are covered in healthcare regulatory affairs outsourcing. 

The categories in the market include includes drugs, biologics, and medical devices.

Key players involved in the market are Accell Clinical Research, Takeda Pharmaceutical Company Limited, Genpact, Promedica International, WuXi AppTec, Inc., Covance, Inc., Medpace, Charles River Laboratories International, PAREXEL International Corp., and PRA Health Sciences.

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