Healthcare Regulatory Affairs Outsourcing Market Size & Share Analysis - Growth Trends & Forecasts (2024 - 2029)

The Report Covers Global Healthcare Regulatory Outsourcing Services Market Trends and Outlook. The Market is Segmented by Services, (Regulatory Consulting, Legal Representation, Regulatory Writing & Publishing, Product Registration & Clinical Trial Applications, Other Services), End Users (Pharmaceutical and Biotechnology Companies, Medical Device Companies), and Geography (North America, Europe, Asia-Pacific, Middle East, and Africa, and South America). The value is provided in (USD million) for the above segments.

Healthcare Regulatory Affairs Outsourcing Market Size

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Healthcare Regulatory Affairs Outsourcing Market Summary
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Study Period 2019 - 2029
Market Size (2024) USD 8.35 Billion
Market Size (2029) USD 12.71 Billion
CAGR (2024 - 2029) 8.74 %
Fastest Growing Market Asia Pacific
Largest Market North America

Major Players

Healthcare Regulatory Affairs Outsourcing Market Major Players

*Disclaimer: Major Players sorted in no particular order

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Healthcare Regulatory Affairs Outsourcing Market Analysis

The Global Healthcare Regulatory Affairs Outsourcing Market size is estimated at USD 8.35 billion in 2024, and is expected to reach USD 12.71 billion by 2029, growing at a CAGR of 8.74% during the forecast period (2024-2029).

During the pandemic, the massive influx of COVID-19 patients resulted in mass lockdowns, which disrupted clinical studies of various chronic diseases such as cancer. The reduction in the number of clinical trials amid the pandemic resulted in a decrease in the demand for healthcare regulatory affairs outsourcing services. For instance, a study published in the Frontiers in Medicine1 in December 2021 highlighted that clinical trial activities decreased during the pandemic as the number of COVID-19 patients increased. The source also stated that new drug submissions dropped in non-COVID-19 clinical developments amid the pandemic.

Therefore, disruptions in the global supply chain affected the manufacturing and distribution of pharmaceutical products during the pandemic's initial phase, significantly impacting the market growth. Regulatory affairs teams had to navigate challenges related to ensuring the availability and safety of essential drugs, necessitating regulatory adaptations.

Moreover, growing R&D expenditure, the increasing number of clinical trials, and the cost-effectiveness of outsourcing are expected to drive market growth. For instance, according to Global Observatory on Health R&D analysis published on February 2022, there was a constant rise in the number of newly recruiting trials registered on the WHO International Clinical Trials Registry Platform (ICTRP) for most WHO regions. Moreover, the number of trials registered in WHO's Europe, Americas, and Western Pacific regions increased at a higher rate than in other regions. For instance, in 2021, Western Pacific registered 16,860 clinical trials, around 20 times higher than that in Africa, which accounted for 851 clinical trials. Thus, an increasing number of clinical trial studies are expected to increase regulatory affairs outsourcing over the forecast period.

Furthermore, increasing research and development investment by pharmaceutical and biotechnology firms is anticipated to drive market growth. As per the PhRMA, the members of PhRMA invested about USD 102.3 billion in R&D activities in 2021. As per the data published by the European Federation of Pharmaceutical Industries and Associations in 2022, the research-based European pharmaceutical industry has increased from the past years and reached the value of EUR 300 billion (USD 323.7 billion) in 2021. The same source also stated that this industry received a significant R&D investment of EUR 41.5 billion (USD 44.77 billion) in 2021.

Additionally, various strategic activities by key market players, such as mergers and acquisitions, are anticipated to drive market growth. For instance, in July 2021, Covance acquired GlobalCare, a global leader in patient-centric decentralized clinical trials (DCTs), to expand Covance's DCT offerings into international markets and meet the growing demand for patient-centric trial designs.

Thus, the factors mentioned above are expected to increase the demand for healthcare regulatory services in the industry, thereby driving market growth over the forecast period. However, the risk associated with data security and lack of standardization is the major restraining factor for the studied market.

Healthcare Regulatory Affairs Outsourcing Market Trends

Product Registration & Clinical Trial Application Segment is Expected to Hold Significant Market Share Over the Forecast Period

Product Registration refers to the application for regulatory approval granted by the applicable authority in a given country or territory to allow a product to be marketed, distributed, sold, or imported into the country or region. The Clinical Trial Application refers to submission to the competent national regulatory authorities for getting authorization to conduct a clinical trial in the country. The clinical trial application contains detailed information about the investigational medicinal product and planned trial, allowing regulatory authorities to assess the study's feasibility.

The increase in outsourcing of clinical trial applications and product registrations in both developed and developing countries is driving the product registration and clinical trial application segment over the forecast period. Due to the complexity of the product registration process, lack of professionals in the industry, and lack of internal capability, most pharmaceutical and medical device companies outsource their product registration activities to third-party service providers. Furthermore, constant changes and updation in regulatory affairs also drive the outsourcing of such services. For instance, on 31 January 2022, the European Medicines Agency announced the regulatory harmonization of clinical trials in the EU. It also launched a new Clinical Trials Information System (CTIS). This is anticipated to propel the segment growth over the forecast period.

Thus, all factors mentioned above are expected to boost segment growth over the forecast period.

Healthcare Regulatory Affairs Outsourcing Market:  Number of Clinical Trials by WHO Region, 2021

North America is Expected to Hold Major Market Share Over the Forecast Period

Pricing pressure due to the changing reimbursement scenario and generic competition is causing major pharmaceutical firms to outsource regulatory affairs activities expected to drive the growth of healthcare regulatory outsourcing services in North America. Additionally, growing research and development activity and rising clinical trials are anticipated to drive regional market growth. For instance, according to the Global Observatory on Health R&D, the United States registered 10,870 clinical trials in 2021, accounting for 18.1% of the total. According to the same source, Canada registered 2,099 clinical trials in 2021, accounting for 3.5% of the total. Thus, many clinical trials in the region are likely to drive the regulatory affairs outsourcing market.

Moreover, the presence of key regional players and strategic collaborations in the industry are driving the market's growth. For instance, in April 2021, Parexel and Veeva Systems announced a strategic partnership to speed up clinical trials by leveraging technology and process innovation. Both businesses will benefit from each other's regulatory consulting services.

Thus, all factors above are expected to boost the market growth in the North America region over the forecast period.

: Healthcare Regulatory Affairs Outsourcing Market - Growth Rate By Region

Healthcare Regulatory Affairs Outsourcing Industry Overview

The Healthcare Regulatory Affairs Outsourcing Market is a slightly fragmented market owing to the presence of various market players. The competitive landscape includes an analysis of a few companies which hold significant market shares, including Charles River Laboratories, Syneos Health, Laboratory Corporation of America Holdings, ICON Plc., IQVIA, PAREXEL International Corporation, and Thermo Fisher Scientific Inc. (PPD), among others.

Healthcare Regulatory Affairs Outsourcing Market Leaders

  1. IQVIA

  2. Parexel International Corporation

  3. ICON PLC

  4. Charles River Laboratories

  5. Laboratory Corporation of America Holdings

*Disclaimer: Major Players sorted in no particular order

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Healthcare Regulatory Affairs Outsourcing Market News

  • In August 2022, PharmaLex Group, announced a merger with DRA Consulting, a consulting firm based in Finland. DRA Consulting offers intelligent solutions in the areas of pharmacovigilance, market access and reimbursement, quality and manufacturing, regulatory services, and end-to-end services to a wide range of more than 300 clients.
  • In September 2022, AmerisourceBergen Corporation announced that it had signed a definitive agreement to acquire PharmaLex Holding GmbH, a leading provider of specialized services for the life sciences industry, from AUCTUS Capital Partners AG.

Healthcare Regulatory Affairs Outsourcing Market Report - Table of Contents

  1. 1. INTRODUCTION

    1. 1.1 Study Assumptions and Market Definition

    2. 1.2 Scope of the Study

  2. 2. RESEARCH METHODOLOGY

  3. 3. EXECUTIVE SUMMARY

  4. 4. MARKET DYNAMICS

    1. 4.1 Market Overview

    2. 4.2 Market Drivers

      1. 4.2.1 Increasing Number of Clinical Trials

      2. 4.2.2 Life Science Companies Focusing on Their Core Competencies

    3. 4.3 Market Restraints

      1. 4.3.1 Risk Associated with the Data Security

      2. 4.3.2 Lack of Standardization

    4. 4.4 Porter's Five Force Analysis

      1. 4.4.1 Threat of New Entrants

      2. 4.4.2 Bargaining Power of Buyers/Consumers

      3. 4.4.3 Bargaining Power of Suppliers

      4. 4.4.4 Threat of Substitute Products

      5. 4.4.5 Intensity of Competitive Rivalry

  5. 5. MARKET SEGMENTATION (Market Size by Value - USD million)

    1. 5.1 By Services

      1. 5.1.1 Regulatory Consulting

      2. 5.1.2 Legal Representation

      3. 5.1.3 Regulatory Writing & Publishing

      4. 5.1.4 Product Registration & Clinical Trial Application

      5. 5.1.5 Other Services

    2. 5.2 By End User

      1. 5.2.1 Pharmaceutical and Biotechnology Companies

      2. 5.2.2 Medical Device Companies

    3. 5.3 Geography

      1. 5.3.1 North America

        1. 5.3.1.1 United States

        2. 5.3.1.2 Canada

        3. 5.3.1.3 Mexico

      2. 5.3.2 Europe

        1. 5.3.2.1 Germany

        2. 5.3.2.2 United Kingdom

        3. 5.3.2.3 France

        4. 5.3.2.4 Italy

        5. 5.3.2.5 Spain

        6. 5.3.2.6 Rest of Europe

      3. 5.3.3 Asia-Pacific

        1. 5.3.3.1 China

        2. 5.3.3.2 Japan

        3. 5.3.3.3 India

        4. 5.3.3.4 Australia

        5. 5.3.3.5 South Korea

        6. 5.3.3.6 Rest of Asia-Pacific

      4. 5.3.4 Middle-East and Africa

        1. 5.3.4.1 GCC

        2. 5.3.4.2 South Africa

        3. 5.3.4.3 Rest of Middle-East and Africa

      5. 5.3.5 South America

        1. 5.3.5.1 Brazil

        2. 5.3.5.2 Argentina

        3. 5.3.5.3 Rest of South America

  6. 6. COMPETITIVE LANDSCAPE

    1. 6.1 Company Profiles

      1. 6.1.1 Accell Clinical Research, LLC

      2. 6.1.2 Charles River Laboratories

      3. 6.1.3 Syneos Health

      4. 6.1.4 Laboratory Corporation of America Holdings

      5. 6.1.5 ICON PLc.

      6. 6.1.6 IQVIA

      7. 6.1.7 Medpace, Inc.

      8. 6.1.8 PAREXEL International Corporation

      9. 6.1.9 Thermo Fisher Scientific Inc. (PPD)

      10. 6.1.10 Promedica International

      11. 6.1.11 WuXi App Tec

      12. 6.1.12 CTI Clinical Trial & Consulting

    2. *List Not Exhaustive
  7. 7. MARKET OPPORTUNITIES AND FUTURE TRENDS

**Subject to Availability
**Competitive Landscape covers- Business Overview, Financials, Products and Strategies and Recent Developments
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Healthcare Regulatory Affairs Outsourcing Industry Segmentation

Regulatory affairs outsourcing is the services utilized by pharmaceutical, biotech, and medical devices manufacturing companies for fast regulatory approvals from various organizations and cost-saving. Healthcare Regulatory Affairs Outsourcing market is segmented by Services (Regulatory Consulting, Legal Representation, Regulatory Writing & Publishing, Product Registration & Clinical Trial Applications, and Other Services), End User (Pharmaceutical and Biotechnology Companies and Medical Device Companies), and Geography (North America, Europe, Asia-Pacific, Middle East, and Africa, and South America). The market report also covers the estimated market sizes and trends for 17 different countries across major regions, globally. The report offers the value (in USD) for the above segments.

By Services
Regulatory Consulting
Legal Representation
Regulatory Writing & Publishing
Product Registration & Clinical Trial Application
Other Services
By End User
Pharmaceutical and Biotechnology Companies
Medical Device Companies
Geography
North America
United States
Canada
Mexico
Europe
Germany
United Kingdom
France
Italy
Spain
Rest of Europe
Asia-Pacific
China
Japan
India
Australia
South Korea
Rest of Asia-Pacific
Middle-East and Africa
GCC
South Africa
Rest of Middle-East and Africa
South America
Brazil
Argentina
Rest of South America
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Healthcare Regulatory Affairs Outsourcing Market Research FAQs

The Global Healthcare Regulatory Affairs Outsourcing Market size is expected to reach USD 8.35 billion in 2024 and grow at a CAGR of 8.74% to reach USD 12.71 billion by 2029.

In 2024, the Global Healthcare Regulatory Affairs Outsourcing Market size is expected to reach USD 8.35 billion.

IQVIA, Parexel International Corporation, ICON PLC, Charles River Laboratories and Laboratory Corporation of America Holdings are the major companies operating in the Global Healthcare Regulatory Affairs Outsourcing Market.

Asia Pacific is estimated to grow at the highest CAGR over the forecast period (2024-2029).

In 2024, the North America accounts for the largest market share in Global Healthcare Regulatory Affairs Outsourcing Market.

In 2023, the Global Healthcare Regulatory Affairs Outsourcing Market size was estimated at USD 7.68 billion. The report covers the Global Healthcare Regulatory Affairs Outsourcing Market historical market size for years: 2019, 2020, 2021, 2022 and 2023. The report also forecasts the Global Healthcare Regulatory Affairs Outsourcing Market size for years: 2024, 2025, 2026, 2027, 2028 and 2029.

Healthcare Regulatory Affairs Outsourcing Industry Report

Statistics for the 2024 Healthcare Regulatory Affairs Outsourcing market share, size and revenue growth rate, created by Mordor Intelligence™ Industry Reports. Healthcare Regulatory Affairs Outsourcing analysis includes a market forecast outlook to 2029 and historical overview. Get a sample of this industry analysis as a free report PDF download.

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Healthcare Regulatory Affairs Outsourcing Market Size & Share Analysis - Growth Trends & Forecasts (2024 - 2029)