Overview


According to FutureWise analysis the market for regulatory affairs outsourcing in 2023 is US$ 7.58 billion, and is expected to reach US$ 14.25 billion by 2031 at a CAGR of 8.2%.

FutureWise Market Research has instantiated a report that provides an intricate analysis of Regulatory Affairs Outsourcing Market trends that shall affect the overall market growth. Furthermore, it includes detailed information on the graph of profitability, SWOT analysis, market share and regional proliferation of this business. Moreover, the report offers insights on the current stature of prominent market players in the competitive landscape analysis of this market.

According to the research study conducted by FutureWise research analysts, the Regulatory Affairs Outsourcing Market is anticipated to attain substantial growth by the end of the forecast period. The report explains that this business is predicted to register a noteworthy growth rate over the forecast period. This report provides crucial information pertaining to the total valuation that is presently held by this industry and it also lists the segmentation of the market along with the growth opportunities present across this business Indication.

  • Accell Clinical Research, LLC
  • GenPact Ltd
  • Criterium
  • PRA Health Sciences
  • Promedica International
  • WuXiAppTec, Inc
  • Medpace
  • Pharmaceutical Product Development, LLC (PPD)
  • Charles River Laboratories International, Inc.
  • ICON plc
  • Covance
  • Parexel International Corporation; Inc
  • Freyr
  • Clinilabs Inc.
  • IQVIA Holdings Inc.
  • Certara, L.P.

(Note: The list of the major players will be updated with the latest market scenario and trends)

By Services

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

By Company Size

  • Small
  • Medium
  • Large

By Category

  • Drugs
    • Generics
    • Innovators
  • Biologics
    • Biotech
    • ATMPs
  • Medical devices
    • Therapeutic
    • Diagnostic

By Indication

  • Oncology
  • Neurology
  • Cardiology
  • Immunology
  • Others

By Stage

  • Preclinical
  • Clinical
  • PMA (Post Market Authorization)

By End-user

  • Medical Device Companies
  • Pharmaceutical Companies
  • Biotechnology Companies

By Region

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

  • Tier 1 players- established companies in the market with a major market share
  • Tier 2 players
  • Emerging players which are growing rapidly
  • New Entrants

  • Growth prospects
  • SWOT analysis
  • Key trends
  • Key data-points affecting market growth

  • To provide with an exhaustive analysis on the Regulatory Affairs Outsourcing Market By Services, By Company Size, By Category, By Indication, By Stage, By End-user and By Region.
  • To cater comprehensive information on factors impacting market growth (drivers, restraints, opportunities, and industry-specific restraints)
  • To evaluate and forecast micro-markets and the overall market
  • To predict the market size, in key regions— North America, Europe, Asia Pacific, Latin America and Middle East and Africa.
  • To record and evaluate competitive landscape mapping- Services launches, technological advancements, mergers and expansions

  • We have a flexible delivery model and you can suggest changes in the scope/table of content as per your requirement
  • The customization Mobility Care offered are free of charge with purchase of any license of the report
  • You can directly share your requirements/changes to the current table of content to: sales@futurewiseresearch.com

Table of Contents


  • 1.   Market Introduction
    •   1. Objectives of the Study
        2. Market Definition
        3. Market Scope
         3.1 . Years Considered for the Study
         3.2 . Market Covered
        4. Currency
        5. Limitations
        6. Stakeholders
  • 2.   Research Company Sizeology
    •   1. Research Data
         1.1 . Secondary Data
          1.1.1 . Key Data from Secondary Sources
         1.2 . Primary Data
          1.2.1. Key Data from Primary Sources
        2. Market Size Estimation
        3. Market Breakdown and Data Triangulation
        4. Assumptions for the Study
  • 3.   Executive Summary
    •   1. Market Outlook
        2. Segment Outlook
        3. Competitive Insights
  • 4.   Regulatory Affairs Outsourcing Market Variables, Trends and Scope

    •   1. Market Lineage Outlook
        2. Penetration and Growth Prospect Mapping
        3. Industry Value Chain Analysis
        4. Cost Analysis Breakdown
        5. Technology Overview
        6. Regulatory Framework
         6.1. Reimbursement Framework
         6.2. Standards and Compliances

  • 5.   Market Overview
    •   1. Market Dynamics
         1.1. Market Driver Analysis
          1.1.1. Increasing focus of Regulatory Affairs Outsourcing Companies on Brand Protection
          1.1.2. Untapped Opportunities in Emerging Regions
         1.2. Market Restraint Analysis
          1.2.1. High Cost Associated with Implementation of Predictive Analysis
         1.3. Industry Challenges
          1.3.1. Presence of Ambiguous Regulatory Framework
  • 6.   Regulatory Affairs Outsourcing Market Analysis Tools
    •   1. Industry Analysis - Porter’s
         1.1. Supplier Power
         1.2. Buyer Power
         1.3. Substitution Threat
         1.4. Threat from New Entrants
         1.5. Competitive Rivalry
        2. Pestel Analysis
         2.1. Political Landscape
         2.2. Environmental Landscape
         2.3. Social Landscape
         2.4. Technology Landscape
         2.5. Legal Landscape
        3. Major Deals And Strategic Alliances Analysis
         3.1. Joint Ventures
         3.2. Mergers and Acquisitions
         3.3. Licensing and Partnership
         3.4. Technology Collaborations
         3.5. Strategic Divestments
        4. Market Entry Strategies
        5. Case Studies
  • 7.   Regulatory Affairs Outsourcing Market, By Services Historical Analysis and Forecast 2025-2033 (USD Million)

    •   1. Regulatory Consulting
        2. Legal Representation
        3. Regulatory Writing and Publishing
        4. Product Registration and Clinical Trial Applications
        5. Other Services

  • 8.   Regulatory Affairs Outsourcing Market, By Company Size Historical Analysis and Forecast 2025-2033 (USD Million)

    •   1. Small
        2. Medium
        3. Large

  • 9.   Regulatory Affairs Outsourcing Market, By Category Historical Analysis and Forecast 2025-2033 (USD Million)

    •   1. Drugs
         1.1. Generics
         1.2. Innovators
        2. Biologics
         2.1. Biotech
         2.2. ATMPs
        3. Medical devices
         3.1. Therapeutic
         3.2. Diagnostic

  • 10.   Regulatory Affairs Outsourcing Market, By Indication Historical Analysis and Forecast 2025-2033 (USD Million)

    •   1. Oncology
        2. Neurology
        3. Cardiology
        4. Immunology
        5. Others

  • 11.   Regulatory Affairs Outsourcing Market, By Stage Historical Analysis and Forecast 2025-2033 (USD Million)

    •   1. Preclinical
        2. Clinical
        3. PMA (Post Market Authorization)

  • 12.   Regulatory Affairs Outsourcing Market, By End-user Historical Analysis and Forecast 2025-2033 (USD Million)

    •   1. Medical Device Companies
        2. Pharmaceutical Companies
        3. Biotechnology Companies

  • 13.   North America Regulatory Affairs Outsourcing Market Analysis 2018-2024 and Forecast 2025-2033 (USD Million)

    •   1. Introduction
        2. Historical Market Size (USD Million) Analysis By Country, 2018-2024
         2.1. U.S.A
         2.2. Canada
         2.3. Mexico
        3. Market Size (USD Million) Forecast for North America 2025-2033

  • 14.   Latin America Regulatory Affairs Outsourcing Market Analysis 2018-2024 and Forecast 2025-2033 (USD Million)

    •   1. Introduction
        2. Historical Market Size (USD Million) Analysis By Country, 2018-2024
         2.1. Brazil
         2.2. Venezuela
         2.3. Argentina
         2.4. Rest of Latin America
        3. Market Size (USD Million) Forecast for Latin America 2025-2033

  • 15.   Europe Regulatory Affairs Outsourcing Market Analysis 2018-2024 and Forecast 2025-2033 (USD Million)

    •   1. Introduction
        2. Historical Market Size (USD Million) Analysis By Country, 2018-2024
         2.1. Germany
         2.2. U.K
         2.3. France
         2.4. Italy
         2.5. Spain
         2.6. Russia
         2.7. Poland
         2.8. Rest of Europe
        3. Market Size (USD Million) Forecast for Europe 2025-2033

  • 16.   Asia Pacific Regulatory Affairs Outsourcing Market Analysis 2018-2024 and Forecast 2025-2033 (USD Million)

    •   1. Introduction
        2. Historical Market Size (USD Million) Analysis By Country, 2018-2024
         2.1. Japan
         2.2. China
         2.3. India
         2.4. Australia and New Zealand
         2.5. ASEAN
         2.6. Rest of Asia Pacific
        3. Market Size (USD Million) Forecast for Asia Pacific 2025-2033

  • 17.   Middle East and Africa Market Analysis 2018-2024 and Forecast 2025-2033 (USD Million)

    •   1. Introduction
        2. Historical Market Size (USD Million) Analysis By Country, 2018-2024
         2.1. GCC
         2.2. Israel
         2.3. South Africa
         2.4. Rest of MEA
        3. Market Size (USD Million) Forecast for MEA 2025-2033

  • 18.   Market Share Analysis and Competitive Landscape
    •   1. Global Landscape - Key Players, Revenue and Presence
        2. Global Share Analysis - Key Players (Tier 1, Tier 2, Tier 3)
        3. Global Emerging Companies
        4. North America - Market Share Analysis and Key Regional Players
        5. Europe - Market Share Analysis and Key Regional Players
        6. Asia Pacific - Market Share Analysis and Key Regional Players
        7. Global Key Player - Growth Matrix
  • 19.   Company Profiles (Competition Dashboard, Competitors Deep Dive, Servicess Offered and Financial Layouts)

    •   1. Accell Clinical Research, LLC
         1.1. Company Overview
         1.2. Product Portfolio
         1.3. SWOT Analysis
         1.4. Financial Overview
         1.5. Strategic Overview
        2. GenPact Ltd
         2.1. Company Overview
         2.2. Product Portfolio
         2.3. SWOT Analysis
         2.4. Financial Overview
         2.5. Strategic Overview
        3. Criterium
         3.1. Company Overview
         3.2. Product Portfolio
         3.3. SWOT Analysis
         3.4. Financial Overview
         3.5. Strategic Overview
        4. PRA Health Sciences
         4.1. Company Overview
         4.2. Product Portfolio
         4.3. SWOT Analysis
         4.4. Financial Overview
         4.5. Strategic Overview
        5. Promedica International
         5.1. Company Overview
         5.2. Product Portfolio
         5.3. SWOT Analysis
         5.4. Financial Overview
         5.5. Strategic Overview
        6. WuXiAppTec, Inc
         6.1. Company Overview
         6.2. Product Portfolio
         6.3. SWOT Analysis
         6.4. Financial Overview
         6.5. Strategic Overview
        7. Medpace
         7.1. Company Overview
         7.2. Product Portfolio
         7.3. SWOT Analysis
         7.4. Financial Overview
         7.5. Strategic Overview
        8. Pharmaceutical Product Development, LLC (PPD)
         8.1. Company Overview
         8.2. Product Portfolio
         8.3. SWOT Analysis
         8.4. Financial Overview
         8.5. Strategic Overview
        9. Charles River Laboratories International, Inc.
         9.1. Company Overview
         9.2. Product Portfolio
         9.3. SWOT Analysis
         9.4. Financial Overview
         9.5. Strategic Overview
        10. ICON plc
         10.1. Company Overview
         10.2. Product Portfolio
         10.3. SWOT Analysis
         10.4. Financial Overview
         10.5. Strategic Overview
        11. Covance
         11.1. Company Overview
         11.2. Product Portfolio
         11.3. SWOT Analysis
         11.4. Financial Overview
         11.5. Strategic Overview
        12. Parexel International Corporation; Inc
         12.1. Company Overview
         12.2. Product Portfolio
         12.3. SWOT Analysis
         12.4. Financial Overview
         12.5. Strategic Overview
        13. Freyr
         13.1. Company Overview
         13.2. Product Portfolio
         13.3. SWOT Analysis
         13.4. Financial Overview
         13.5. Strategic Overview
        14. Clinilabs Inc.
         14.1. Company Overview
         14.2. Product Portfolio
         14.3. SWOT Analysis
         14.4. Financial Overview
         14.5. Strategic Overview
        15. IQVIA Holdings Inc.
         15.1. Company Overview
         15.2. Product Portfolio
         15.3. SWOT Analysis
         15.4. Financial Overview
         15.5. Strategic Overview
        16. Certara, L.P.
         16.1. Company Overview
         16.2. Product Portfolio
         16.3. SWOT Analysis
         16.4. Financial Overview
         16.5. Strategic Overview

  • 20.  Pre and Post COVID-19 Impact

    •   1. Positive influence on the healthcare industry
        2. The financial disruption of the manufacturing sector
        3. Impact of COVID-19 on emerging companies
        4. Significant mandates in the healthcare regulations initiated by
                  administrations
        5. The overall economic slowdown of the developing and developed nations

  • 21.  FutureWise SME Key Takeaway Points for Client

    •   


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