Global Healthcare Regulatory Affairs Outsourcing Market Size (2024 - 2029)

The healthcare regulatory affairs outsourcing market is projected to experience significant growth over the forecast period, driven by increasing research and development investments, a rise in clinical trials, and the cost-effectiveness of outsourcing. Despite disruptions caused by the pandemic, which temporarily decreased demand due to reduced clinical trials, the market is expected to expand as regulatory affairs services become more essential. Strategic activities by key players, such as mergers and acquisitions, further contribute to market expansion. However, challenges related to data security and standardization pose potential risks to market growth.

Market Size of Global Healthcare Regulatory Affairs Outsourcing Industry

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Healthcare Regulatory Affairs Outsourcing Market Summary
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 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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Global Healthcare Regulatory Affairs Outsourcing Market Size Summary

The Healthcare Regulatory Affairs Outsourcing Market is poised for significant growth, driven by increasing research and development investments and the rising number of clinical trials. The market is expected to expand substantially over the forecast period, fueled by the cost-effectiveness of outsourcing and the need for regulatory compliance in the pharmaceutical and biotechnology sectors. The pandemic initially disrupted clinical trials and reduced demand for outsourcing services, but the subsequent recovery and increase in trial registrations have revitalized the market. Strategic activities such as mergers and acquisitions by key players are further propelling market expansion, as companies seek to enhance their service offerings and meet the growing demand for regulatory support.

In North America, the market is experiencing robust growth due to the high volume of clinical trials and the presence of major industry players. The region's growth is supported by strategic collaborations and technological innovations aimed at streamlining clinical trial processes. The outsourcing of regulatory affairs activities is driven by the need to navigate complex regulatory environments and the pressures of pricing and reimbursement changes. Despite the fragmented nature of the market, with several companies holding significant shares, the competitive landscape is characterized by strategic partnerships and acquisitions that aim to strengthen market positions and expand service capabilities.

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Global Healthcare Regulatory Affairs Outsourcing Market Size - Table of Contents

  1. 1. MARKET DYNAMICS

    1. 1.1 Market Overview

    2. 1.2 Market Drivers

      1. 1.2.1 Increasing Number of Clinical Trials

      2. 1.2.2 Life Science Companies Focusing on Their Core Competencies

    3. 1.3 Market Restraints

      1. 1.3.1 Risk Associated with the Data Security

      2. 1.3.2 Lack of Standardization

    4. 1.4 Porter's Five Force Analysis

      1. 1.4.1 Threat of New Entrants

      2. 1.4.2 Bargaining Power of Buyers/Consumers

      3. 1.4.3 Bargaining Power of Suppliers

      4. 1.4.4 Threat of Substitute Products

      5. 1.4.5 Intensity of Competitive Rivalry

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

    1. 2.1 By Services

      1. 2.1.1 Regulatory Consulting

      2. 2.1.2 Legal Representation

      3. 2.1.3 Regulatory Writing & Publishing

      4. 2.1.4 Product Registration & Clinical Trial Application

      5. 2.1.5 Other Services

    2. 2.2 By End User

      1. 2.2.1 Pharmaceutical and Biotechnology Companies

      2. 2.2.2 Medical Device Companies

    3. 2.3 Geography

      1. 2.3.1 North America

        1. 2.3.1.1 United States

        2. 2.3.1.2 Canada

        3. 2.3.1.3 Mexico

      2. 2.3.2 Europe

        1. 2.3.2.1 Germany

        2. 2.3.2.2 United Kingdom

        3. 2.3.2.3 France

        4. 2.3.2.4 Italy

        5. 2.3.2.5 Spain

        6. 2.3.2.6 Rest of Europe

      3. 2.3.3 Asia-Pacific

        1. 2.3.3.1 China

        2. 2.3.3.2 Japan

        3. 2.3.3.3 India

        4. 2.3.3.4 Australia

        5. 2.3.3.5 South Korea

        6. 2.3.3.6 Rest of Asia-Pacific

      4. 2.3.4 Middle-East and Africa

        1. 2.3.4.1 GCC

        2. 2.3.4.2 South Africa

        3. 2.3.4.3 Rest of Middle-East and Africa

      5. 2.3.5 South America

        1. 2.3.5.1 Brazil

        2. 2.3.5.2 Argentina

        3. 2.3.5.3 Rest of South America

Global Healthcare Regulatory Affairs Outsourcing Market Size 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.

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