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Healthcare Regulatory Affairs Outsourcing Market

Global Healthcare Regulatory Affairs Outsourcing Market Size: By Services: Regulatory Consulting, Legal Representation, Regulatory Writing and Publishing, Product Registration and Clinical Trial Applications; By Categories: Drugs, Biologics, Medical Devices; Regional Analysis; Market Dynamics; Supplier Landscape; 2024-2032

Global Healthcare Regulatory Affairs Outsourcing Market Outlook

The global healthcare regulatory affairs outsourcing market size was valued at USD 8.10 billion in 2023, driven by the increasing research and development activities across the globe. The market size is anticipated to grow at a CAGR of 9.5% during the forecast period of 2024-2032 to achieve a value of USD 18.34 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.

 

*At Expert Market Research, we strive to always give you current and accurate information. The numbers depicted in the description are indicative and may differ from the actual numbers in the final EMR report.

1    Preface
    1.1    Objectives of the Study
    1.2    Key Assumptions
    1.3    Report Coverage – Key Segmentation and Scope 
    1.4    Research Methodology
2    Executive Summary
3    Global Healthcare Regulatory Affairs Outsourcing Market Overview 

    3.1    Global Healthcare Regulatory Affairs Outsourcing Market Historical Value (2017-2023) 
    3.2    Global Healthcare Regulatory Affairs Outsourcing Market Forecast Value (2024-2032)
4    Global Healthcare Regulatory Affairs Outsourcing Market Landscape
    4.1    Lentiviral Vectors: Developers Landscape
        4.1.1    Analysis by Year of Establishment
        4.1.2    Analysis by Company Size
        4.1.3    Analysis by Region
    4.2    Lentiviral Vectors: Product Landscape
        4.2.1    Analysis by Type
        4.2.2    Analysis by Products
        4.2.3    Analysis by Applications
5    Global Healthcare Regulatory Affairs Outsourcing Market Dynamics
    5.1    Market Drivers and Constraints
    5.2    SWOT Analysis
    5.3    Porter’s Five Forces Model
    5.4    Key Demand Indicators 
    5.5    Key Price Indicators
    5.6    Industry Events, Initiatives, and Trends  
    5.7    Value Chain Analysis
6    Global Healthcare Regulatory Affairs Outsourcing Market Segmentation
    6.1    Global Healthcare Regulatory Affairs Outsourcing Market by Services
        6.1.1    Market Overview
        6.1.2    Regulatory Consulting
        6.1.3    Legal Representation
        6.1.4    Regulatory Writing and Publishing
        6.1.5    Product Registration and Clinical Trial Applications
    6.2    Global Healthcare Regulatory Affairs Outsourcing Market by Categories
        6.2.1    Market Overview
        6.2.2    Drugs
        6.2.3    Biologics
        6.2.4    Medical Devices
    6.3    Global Healthcare Regulatory Affairs Outsourcing Market by Region
        6.3.1    Market Overview
        6.3.2    North America
        6.3.3    Europe 
        6.3.4    Asia Pacific
        6.3.5    Latin America
        6.3.6    Middle East and Africa
7    North America Healthcare Regulatory Affairs Outsourcing Market
    7.1    Market Share by Country
    7.2    United States of America
    7.3    Canada
8    Europe Healthcare Regulatory Affairs Outsourcing Market
    8.1    Market Share by Country
    8.2    United Kingdom
    8.3    Germany
    8.4    France
    8.5    Italy
    8.6    Others
9    Asia Pacific Healthcare Regulatory Affairs Outsourcing Market
    9.1    Market Share by Country
    9.2    China
    9.3    Japan
    9.4    India
    9.5    ASEAN
    9.6    Australia
    9.7    Others
10    Latin America Healthcare Regulatory Affairs Outsourcing Market
    10.1    Market Share by Country
    10.2    Brazil
    10.3    Argentina
    10.4    Mexico
    10.5    Others
11    Middle East and Africa Healthcare Regulatory Affairs Outsourcing Market
    11.1    Market Share by Country
    11.2    Saudi Arabia
    11.3    United Arab Emirates
    11.4    Nigeria
    11.5    South Africa
    11.6    Others
12    Funding and Investment Analysis
    12.1    Analysis by Funding Instances
    12.2    Analysis by Type of Funding
    12.3    Analysis by Funding Amount
    12.4    Analysis by Leading Players
    12.5    Analysis by Leading Investors
    12.6    Analysis by Geography
13    Partnership and Collaborations Analysis
    13.1    Analysis by Partnership Instances
    13.2    Analysis by Type of Partnership
    13.3    Analysis by Leading Players
    13.4    Analysis by Geography
14    Supplier Landscape
    14.1    Accell Clinical Research
        14.1.1    Financial Analysis
        14.1.2    Product Portfolio
        14.1.3    Demographic Reach and Achievements
        14.1.4    Mergers and Acquisitions
        14.1.5    Certifications 
    14.2    Takeda Pharmaceutical Company Limited
        14.2.1    Financial Analysis
        14.2.2    Product Portfolio
        14.2.3    Demographic Reach and Achievements
        14.2.4    Mergers and Acquisitions
        14.2.5    Certifications
    14.3    Genpact
        14.3.1    Financial Analysis
        14.3.2    Product Portfolio
        14.3.3    Demographic Reach and Achievements
        14.3.4    Mergers and Acquisitions
        14.3.5    Certifications
    14.4    Promedica International
        14.4.1    Financial Analysis
        14.4.2    Product Portfolio
        14.4.3    Demographic Reach and Achievements
        14.4.4    Mergers and Acquisitions
        14.4.5    Certifications
    14.5    WuXi AppTec, Inc.
        14.5.1    Financial Analysis
        14.5.2    Product Portfolio
        14.5.3    Demographic Reach and Achievements
        14.5.4    Mergers and Acquisitions
        14.5.5    Certifications
    14.6    PRA Health Sciences
        14.6.1    Financial Analysis
        14.6.2    Product Portfolio
        14.6.3    Demographic Reach and Achievements
        14.6.4    Mergers and Acquisitions
        14.6.5    Certifications
    14.7    Medpace    
        14.7.1    Financial Analysis
        14.7.2    Product Portfolio
        14.7.3    Demographic Reach and Achievements
        14.7.4    Mergers and Acquisitions
        14.7.5    Certifications
    14.8    Charles River Laboratories International
        14.8.1    Financial Analysis
        14.8.2    Product Portfolio
        14.8.3    Demographic Reach and Achievements
        14.8.4    Mergers and Acquisitions
        14.8.5    Certifications
    14.9    PAREXEL International Corp.
        14.9.1    Financial Analysis
        14.9.2    Product Portfolio
        14.9.3    Demographic Reach and Achievements
        14.9.4    Mergers and Acquisitions
        14.9.5    Certifications
    14.10    Covance, Inc.
        14.10.1    Financial Analysis
        14.10.2    Product Portfolio
        14.10.3    Demographic Reach and Achievements
        14.10.4    Mergers and Acquisitions
        14.10.5    Certifications
15    Key Opinion Leaders (KOL) Insights (Additional Insight)
16    Company Competitiveness Analysis (Additional Insight)

    16.1    Very Small Companies
    16.2    Small Companies
    16.3    Mid-Sized Companies
    16.4    Large Companies
    16.5    Very Large Companies
17    Payment Methods (Additional Insight)
    17.1    Government Funded
    17.2    Private Insurance
    17.3    Out-of-Pocket


*Additional insights provided are customisable as per client requirements.

Key Questions Answered in the Report

The market attained a value of about USD 8.10 billion in 2023, driven by the increased FDA approvals.

The market is anticipated to grow at a CAGR of 9.5% during the forecast period of 2024-2032 and is likely to reach a market value of USD 18.34 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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