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Regulatory Affairs Outsourcing Market

Regulatory Affairs Outsourcing Market (Service: Regulatory Affairs, Clinical Trial Applications & Product Registrations, Regulatory Writing & Publishing, Regulatory Consulting & Legal Representation, and Others) - Global Industry Analysis, Size, Share, Growth, Trends, and Forecast, 2021-2028

Regulatory Affairs Outsourcing Market Outlook 2028

  • The global market was valued at US$ 4.5 Bn in 2020
  • It is estimated to expand at a CAGR of 19% from 2021 to 2028
  • The global market for regulatory affairs outsourcing is expected to reach the value of US$ 17.3 Bn by the end of 2028

Regulatory Affairs Outsourcing Industry: Overview

  • According to Transparency Market Research’s latest report on the global regulatory affairs outsourcing market for the historical period 2017–2028 and forecast period 2021–2028, an increase in research & development activities in the life science industry across the world is projected to drive the global market during the forecast period

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Rise in Number of Clinical Trials and Growth of Life Science Industry: Key Drivers

  • The global regulatory affairs outsourcing market is driven by an increase in the number of clinical trials, growth of the life sciences industry, and advancements in biosimilars, personalized medicine, orphan pharmaceuticals
  • Rise in investment in R&D activities to develop biosimilar, orphan, and generic drugs, the increase in investment in clinical research, the surge in focus on product development to expand supply, strict government regulation, and the rise in the number of FDA-approved manufacturing plants boost the growth of the global market for regulatory affairs outsourcing
  • The global regulatory affairs outsourcing market presents significant opportunities to global and mid-sized market players such as the delivery of low-cost regulatory services and boosting marketing activities
  • The COVID-19 pandemic has placed many regulatory and outsourcing teams under pressure; however, it has also had a positive effect on the bio/pharmaceutical outsourcing industry, wherein the demand for R&D activity is growing, leading to surging in regulatory affairs assistance

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Increase in Investments by Key Players in Research & Development for Regulatory Affairs Outsourcing

  • As new therapies and medicines are introduced to the market, the field of medicine continues to evolve. Several public-private institutes and businesses focus on research in order to discover novel medicines.
  • Bayer AG's pharmaceutical division unveiled a cell and gene therapy platform in December 2020. Moreover, expanding the pharmaceutical and biotechnology product pipeline is expected to drive the market during the forecast period.

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Risk Associated with Regulatory Affairs Outsourcing

  • Risks associated with outsourcing and data sharing are expected to hamper the growth of the global regulatory outsourcing market during the forecast period. Several outsourcing partners have access to pharmaceutical and other industries' sensitive data, which is likely to pose a threat to data sharing and security for the companies.

Regulatory Affairs Outsourcing Market: Competition Landscape

  • This report profiles major players in the global regulatory affairs outsourcing market based on various attributes such as company overview, financial overview, product portfolio, business strategies, and recent developments
  • The global regulatory affairs outsourcing business is highly fragmented, with the presence of a number of international as well as regional players
  • Leading players operating in the global regulatory affairs outsourcing industry are
    • Accell Clinical Research, LLC
    • Charles River Laboratories International, Inc.
    • Clinilabs, Inc.
    • Covance, Inc.
    • Criterium, Inc.
    • ICON plc
    • Medpace, Inc.
    • PAREXEL International Corporation
    • Pharmaceutical Product Development, (PPD) LLC
    • Promedica International
    • Quintiles Transnational Corporation
    • WuXi App Tec, among others

Regulatory Affairs Outsourcing Market: Key Developments

  • Key players in the global regulatory affairs outsourcing market are engaged in regulatory approvals, technologically advanced products, the launch of new products, and acquisition & collaborative agreements with other companies. These strategies are likely to fuel the growth of the global regulatory affairs outsourcing business. A few expansion strategies adopted by players operating in the global market are:
    • In 2019, Freyer developed new regulatory affair outsourcing software RIM and Freyer rDMS, which provide end-to-end regulatory document management solutions including creating, capturing, managing, organizing, and delivering data in a timely manner
    • In March 2018, Parexel International Corporation offered PAREXEL's medical writing to offer regulatory services
    • In April 2019, Charles River Laboratories International, Inc. purchased Citoxlab, a non-clinical contract research business. This purchase was undertaken to broaden the company's product offering and boost its market position.
  • The report on the global regulatory affairs outsourcing market discussed individual strategies, followed by company profiles of manufacturers of regulatory affairs outsourcing devices. The competition landscape section has been included in the report to provide readers with a dashboard view and a company market share analysis of key players operating in the global market for regulatory affairs outsourcing.

Regulatory Affairs Outsourcing Market Snapshot

Attribute

Detail

Market Size Value in 2020

US$ 4.5 Bn

Market Forecast Value in 2028

US$ 17.3 Bn

Growth Rate (CAGR)

19%

Forecast Period

2021–2028

Quantitative Units

US$ Mn for Value

Market Analysis

It includes cross segment analysis at global as well as regional level. Moreover, qualitative analysis includes drivers, restraints, opportunities, key trends, and parent industry overview.

Competition Landscape
  • Market share analysis by company (2020)
  • Company profiles section includes overview, product portfolio, sales footprint, key subsidiaries or distributors, strategy & recent developments, and key financials

Format

Electronic (PDF) + Excel

Market Segmentation
  • By Service
    • Regulatory Affairs
    • Clinical Trial Applications and Product Registrations
    • Regulatory Writing and Publishing
    • Regulatory Consulting and Legal Representation
    • Others

Regions Covered
  • North America
  • Latin America
  • Europe
  • Latin America
  • Middle East & Africa

Countries Covered
  • U.S.
  • Canada
  • Germany
  • U.K.
  • France
  • Italy
  • Spain
  • China
  • India
  • Japan
  • Australia & New Zealand
  • Brazil
  • Mexico
  • GCC Countries
  • South Africa

Companies Profiled
  • Accell Clinical Research LLC
  • Charles River Laboratories International, Inc.
  • Clinilabs, Inc.
  • Covance, Inc.
  • Criterium, Inc.
  • ICON plc
  • Medpace, Inc.
  • PAREXEL International Corporation
  • Pharmaceutical Product Development, (PPD) LLC
  • Promedica International
  • Quintiles Transnational Corporation
  • WuXi App Tec.
  • Other Prominent Players.

Customization Scope

Available upon request

Pricing

Available upon request

Regulatory Affairs Outsourcing Market – Segmentation

Service
  • Regulatory Affairs
  • Clinical Trial Applications and Product Registrations
  • Regulatory Writing and Publishing
  • Regulatory Consulting and Legal Representation
  • Others
Region
  • North America
  • Europe
  • Asia Pacific
  • Latin America
  • Middle East & Africa

Frequently Asked Questions

What is the total market worth of regulatory affairs outsourcing market?

The global market for regulatory affairs outsourcing was worth US$ 4.5 Bn and is projected to reach a value of US$ 17.3 Bn by the end of 2028

What is the anticipated CAGR of the global market for regulatory affairs outsourcing in the forecast period?

The market for regulatory affairs outsourcing is anticipated to grow at a CAGR of 19% during the forecast period

Which region is expected to project the highest market share in the global market?

North America accounted for a major share of the global market

What are the key driving factors for the growth of the regulatory affairs outsourcing business?

Regulatory affairs outsourcing market is driven by increase in the number of clinical trials, growth of the life sciences industry, and advancements in biosimilars, personalized medicine, orphan pharmaceuticals

Who are the key players in the global regulatory affairs outsourcing industry?

Key players in the global market for regulatory affairs outsourcing include Accell Clinical Research, LLC, Charles River Laboratories International, Inc., Clinilabs, Inc., Covance, Inc., Criterium, Inc., ICON plc, Medpace, Inc., PAREXEL International Corporation, Pharmaceutical Product Development, (PPD) LLC, Promedica International, Quintiles Transnational Corporation, and WuXi App Tec.

    1. Preface

        1.1. Market Definition and Scope

        1.2. Market Segmentation

        1.3. Key Research Objectives

        1.4. Research Highlights

    2. Assumptions and Research Methodology

    3. Executive Summary: Global Regulatory Affairs Outsourcing Market

    4. Market Overview

        4.1. Introduction

            4.1.1. Definition

            4.1.2. Industry Evolution / Developments

        4.2. Overview

        4.3. Market Dynamics

            4.3.1. Drivers

            4.3.2. Restraints

            4.3.3. Opportunities

        4.4. Global Regulatory Affairs Outsourcing Market Analysis and Forecast, 2017–2028

    5. Key Insights

        5.1. Top 3 players operating in the market space

        5.2. Regulatory Scenario by Region/globally

        5.3. Key Mergers & Acquisitions

        5.4. COVID-19 Pandemics Impact on Industry

    6. Global Regulatory Affairs Outsourcing Market Analysis and Forecast, by Services

        6.1. Introduction & Definition

        6.2. Key Findings / Developments

        6.3. Market Value Forecast, by Services, 2017–2028

            6.3.1. Regulatory Affairs

            6.3.2. Clinical Trial Applications & Product Registrations

            6.3.3. Regulatory Writing & Publishing

            6.3.4. Regulatory Consulting & Legal Representation

            6.3.5. Others

        6.4. Market Attractiveness By Services

    7. Global Regulatory Affairs Outsourcing Market Analysis and Forecast, by Region

        7.1. Key Findings

        7.2. Market Value Forecast, by Region

            7.2.1. North America

            7.2.2. Europe

            7.2.3. Asia Pacific

            7.2.4. Latin America

            7.2.5. Middle East & Africa

        7.3. Market Attractiveness Analysis, by Region

    8. North America Regulatory Affairs Outsourcing Market Analysis and Forecast

        8.1. Introduction

            8.1.1. Key Findings

        8.2. Market Value Forecast, by Services, 2017–2028

            8.2.1. Regulatory Affairs

            8.2.2. Clinical Trial Applications & Product Registrations

            8.2.3. Regulatory Writing & Publishing

            8.2.4. Regulatory Consulting & Legal Representation

            8.2.5. Others

        8.3. Market Value Forecast, by Country, 2017–2028

            8.3.1. U.S.

            8.3.2. Canada

        8.4. Market Attractiveness Analysis

            8.4.1. By Services

            8.4.2. By Country

    9. Europe Regulatory Affairs Outsourcing Market Analysis and Forecast

        9.1. Introduction

            9.1.1. Key Findings

        9.2. Market Value Forecast, by Services, 2017–2028

            9.2.1. Regulatory Affairs

            9.2.2. Clinical Trial Applications & Product Registrations

            9.2.3. Regulatory Writing & Publishing

            9.2.4. Regulatory Consulting & Legal Representation

            9.2.5. Others

        9.3. Market Value Forecast, by Country/Sub-region, 2017–2028

            9.3.1. Germany

            9.3.2. U.K.

            9.3.3. France

            9.3.4. Italy

            9.3.5. Spain

            9.3.6. Rest of Europe

        9.4. Market Attractiveness Analysis

            9.4.1. By Services

            9.4.2. By Country/Sub-region

    10. Asia Pacific Regulatory Affairs Outsourcing Market Analysis and Forecast

        10.1. Introduction

            10.1.1. Key Findings

        10.2. Market Value Forecast, by Services, 2017–2028

            10.2.1. Regulatory Affairs

            10.2.2. Clinical Trial Applications & Product Registrations

            10.2.3. Regulatory Writing & Publishing

            10.2.4. Regulatory Consulting & Legal Representation

            10.2.5. Others

        10.3. Market Value Forecast, by Country/Sub-region, 2017–2028

            10.3.1. China

            10.3.2. Japan

            10.3.3. India

            10.3.4. Australia & New Zealand

            10.3.5. Rest of Asia Pacific

        10.4. Market Attractiveness Analysis

            10.4.1. By Services

            10.4.2. By Country/Sub-region

    11. Latin America Regulatory Affairs Outsourcing Market Analysis and Forecast

        11.1. Introduction

            11.1.1. Key Findings

        11.2. Market Value Forecast, by Services, 2017–2028

            11.2.1. Regulatory Affairs

            11.2.2. Clinical Trial Applications & Product Registrations

            11.2.3. Regulatory Writing & Publishing

            11.2.4. Regulatory Consulting & Legal Representation

            11.2.5. Others

        11.3. Market Value Forecast, by Country/Sub-region, 2017–2028

            11.3.1. Brazil

            11.3.2. Mexico

            11.3.3. Rest of Latin America

        11.4. Market Attractiveness Analysis

            11.4.1. By Services

            11.4.2. By Country/Sub-region

    12. Middle East & Africa Regulatory Affairs Outsourcing Market Analysis and Forecast

        12.1. Introduction

            12.1.1. Key Findings

        12.2. Market Value Forecast, by Services, 2017–2028

            12.2.1. Regulatory Affairs

            12.2.2. Clinical Trial Applications & Product Registrations

            12.2.3. Regulatory Writing & Publishing

            12.2.4. Regulatory Consulting & Legal Representation

            12.2.5. Others

        12.3. Market Value Forecast, by Country/Sub-region, 2017–2028

            12.3.1. GCC Countries

            12.3.2. South Africa

            12.3.3. Rest of Middle East & Africa

        12.4. Market Attractiveness Analysis

            12.4.1. By Services

            12.4.2. By Country/Sub-region

    13. Competition Landscape

        13.1. Market Player - Competition Matrix (by tier and size of companies)

        13.2. Market Share Analysis, by Company, 2020

        13.3. Company Profiles

            13.3.1. Accell Clinical Research, LLC

                13.3.1.1. Company Overview (HQ, Business Segments, Employee Strength)

                13.3.1.2. Financial Analysis

                13.3.1.3. Growth Strategies

                13.3.1.4. SWOT Analysis

            13.3.2. Charles River Laboratories International, Inc.

                13.3.2.1. Company Overview (HQ, Business Segments, Employee Strength)

                13.3.2.2. Financial Analysis

                13.3.2.3. Growth Strategies

                13.3.2.4. SWOT Analysis

            13.3.3. Clinilabs, Inc.

                13.3.3.1. Company Overview (HQ, Business Segments, Employee Strength)

                13.3.3.2. Financial Analysis

                13.3.3.3. Growth Strategies

                13.3.3.4. SWOT Analysis

            13.3.4. Covance, Inc.

                13.3.4.1. Company Overview (HQ, Business Segments, Employee Strength)

                13.3.4.2. Financial Analysis

                13.3.4.3. Growth Strategies

                13.3.4.4. SWOT Analysis

            13.3.5. Criterium, Inc.

                13.3.5.1. Company Overview (HQ, Business Segments, Employee Strength)

                13.3.5.2. Financial Analysis

                13.3.5.3. Growth Strategies

                13.3.5.4. SWOT Analysis

            13.3.6. ICON plc.

                13.3.6.1. Company Overview (HQ, Business Segments, Employee Strength)

                13.3.6.2. Financial Analysis

                13.3.6.3. Growth Strategies

                13.3.6.4. SWOT Analysis

            13.3.7. Medpace, Inc.

                13.3.7.1. Company Overview (HQ, Business Segments, Employee Strength)

                13.3.7.2. Financial Analysis

                13.3.7.3. Growth Strategies

                13.3.7.4. SWOT Analysis

            13.3.8. PAREXEL International Corporation

                13.3.8.1. Company Overview (HQ, Business Segments, Employee Strength)

                13.3.8.2. Financial Analysis

                13.3.8.3. Growth Strategies

                13.3.8.4. SWOT Analysis

            13.3.9. Pharmaceutical Product Development, (PPD) LLC

                13.3.9.1. Company Overview (HQ, Business Segments, Employee Strength)

                13.3.9.2. Financial Analysis

                13.3.9.3. Growth Strategies

                13.3.9.4. SWOT Analysis

            13.3.10. Quintiles Transnational Corporation

                13.3.10.1. Company Overview (HQ, Business Segments, Employee Strength)

                13.3.10.2. Financial Analysis

                13.3.10.3. Growth Strategies

                13.3.10.4. SWOT Analysis

            13.3.11. WuXi App Tec

                13.3.11.1. Company Overview (HQ, Business Segments, Employee Strength)

                13.3.11.2. Financial Analysis

                13.3.11.3. Growth Strategies

                13.3.11.4. SWOT Analysis

    List of Tables

    Table 1: Market Snapshot: Global Regulatory Affairs Outsourcing Market, 2017 and 2028

    Table 2: Percentage of Registered Studies by Location

    Table 3: Share of Total Global R&D Spending

    Table 4: Global Regulatory Affairs Outsourcing Market Revenue (US$ Mn), by Services, 2021–2028

    Table 5: Global Regulatory Affairs Outsourcing Market Revenue (US$ Mn), by Region, 2021–2028

    Table 6: North America Regulatory Affairs Outsourcing Market Revenue (US$ Mn), by Country, 2021–2028

    Table 7: Europe Regulatory Affairs Outsourcing Market Revenue (US$ Mn), by Country/Sub-region, 2021–2028

    Table 8: Asia Pacific Regulatory Affairs Outsourcing Market Revenue (US$ Mn), by Country/Sub-region, 2021–2028

    Table 9: Latin America Regulatory Affairs Outsourcing Market Revenue (US$ Mn), by Country/Sub-region, 2021–2028

    Table 10: Middle East and Africa Regulatory Affairs Outsourcing Market Revenue (US$ Mn), by Country/Sub-region, 2021–2028

    List of Figures

    Figure 1: Market Segmentation: Regulatory Affairs Outsourcing Market

    Figure 2: Global Regulatory Affairs Outsourcing Market Share, by Region, 2017 and 2028 (Value %)

    Figure 3: Global Regulatory Affairs Outsourcing Market (US$ Mn), by Services, 2017 and 2028 (Value %)

    Figure 4: Porter’s Five Forces Analysis: Regulatory Affairs Outsourcing Market

    Figure 5: Value Chain Analysis: Regulatory Affairs Outsourcing Market

    Figure 6: Market Attractiveness Analysis: Regulatory Affairs Outsourcing Market

    Figure 7: Competitive Landscape: Regulatory Affairs Outsourcing Market

    Figure 8: Global Outsourcing of Regulatory Submissions Market Revenue (US$ Mn), 2021–2028

    Figure 9: Global Outsourcing of Clinical Trial Application & Product Registration Market Revenue (US$ Mn), 2021–2028

    Figure 10: Global Outsourcing of Regulatory Writing and Publishing Market Revenue (US$ Mn), 2021–2028

    Figure 11: Global Outsourcing of Regulatory Consulting & Legal Representation Market Revenue (US$ Mn), 2021–2028

    Figure 12: Global Outsourcing of Other Regulatory Affairs Services Market Revenue (US$ Mn), 2021–2028

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Regulatory Affairs Outsourcing Market

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