세계의 규제업무 아웃소싱 시장(2025-2035년) : 산업 분석, 시장 규모, 점유율, 성장, 동향, 예측

Regulatory Affairs Outsourcing Market - Scope of Report

TMR's report on the global regulatory affairs outsourcing market studies the past as well as the current growth trends and opportunities to gain valuable insights of the indicators of the market during the forecast period from 2025 to 2035. The report provides revenue of the global regulatory affairs outsourcing market for the period 2019-2035, considering 2025 as the base year and 2035 as the forecast year. The report also provides the compound annual growth rate (CAGR %) of the global regulatory affairs outsourcing market from 2025 to 2035.

The report has been prepared after an extensive research. Primary research involved bulk of the research efforts, wherein analysts carried out interviews with key opinion leaders, industry leaders, and opinion makers. Secondary research involved referring to key players' product literature, annual reports, press releases, and relevant documents to understand the regulatory affairs outsourcing market.

Secondary research also included Internet sources, statistical data from government agencies, websites, and trade associations. Analysts employed a combination of top-down and bottom-up approaches to study various attributes of the global regulatory affairs outsourcing market.

The report includes an elaborate executive summary, along with a snapshot of the growth behavior of various segments included in the scope of the study. Moreover, the report throws light on the changing competitive dynamics in the global regulatory affairs outsourcing market. These serve as valuable tools for existing market players as well as for entities interested in participating in the global regulatory affairs outsourcing market.

The report delves into the competitive landscape of the global regulatory affairs outsourcing market. Key players operating in the global regulatory affairs outsourcing market have been identified and each one of these has been profiled in terms of various attributes. Company overview, financial standings, recent developments, and SWOT are the attributes of players in the global regulatory affairs outsourcing market profiled in this report.

Key Questions Answered in Global regulatory affairs outsourcing Market Report:

• What is the sales/revenue generated by regulatory affairs outsourcing across all regions during the forecast period?
• What are the opportunities in the global regulatory affairs outsourcing market?
• What are the major drivers, restraints, opportunities, and threats in the market?
• Which regional market is set to expand at the fastest CAGR during the forecast period?
• Which segment is expected to generate the highest revenue globally in 2035?
• Which segment is projected to expand at the highest CAGR during the forecast period?
• What are the market positions of different companies operating in the global market?

Regulatory Affairs Outsourcing Market - Research Objectives and Research Approach

The comprehensive report on the global regulatory affairs outsourcing market begins with an overview, followed by the scope and objectives of the study. The report provides detailed explanation of the objectives behind this study and key vendors and distributors operating in the market and regulatory scenario for approval of products.

For reading comprehensibility, the report has been compiled in a chapter-wise layout, with each section divided into smaller ones. The report comprises an exhaustive collection of graphs and tables that are appropriately interspersed. Pictorial representation of actual and projected values of key segments is visually appealing to readers. This also allows comparison of the market shares of key segments in the past and at the end of the forecast period.

The report analyzes the global regulatory affairs outsourcing market in terms of product, end-user, and region. Key segments under each criterion have been studied at length, and the market share for each of these at the end of 2035 has been provided. Such valuable insights enable market stakeholders in making informed business decisions for investment in the global regulatory affairs outsourcing market.

Table of Contents

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. Segment Definition
• 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 Forecasts, 2020 to 2035
  • 4.4.1. Market Revenue Projections (US$ Mn)

5. Key Insights

• 5.1. Overview on Current Trends
• 5.2. PORTER's Five Forces Analysis
• 5.3. PESTEL Analysis
• 5.4. Regulatory Scenario across Key Regions/Country
• 5.5. Service Launches/Approvals by the Major Players/Regulatory Authority
• 5.6. Mergers and Acquisition Scenario for Regulatory Affairs Outsourcing Market
• 5.7. Benchmarking of the Services Offered by the Competitors
• 5.8. Investment Trends in Regulatory Affairs Outsourcing Services
• 5.9. Go-to-Market Strategy for New Market Entrants

6. Global Regulatory Affairs Outsourcing Market Analysis and Forecasts, By Service Type

• 6.1. Introduction & Definition
• 6.2. Key Findings / Developments
• 6.3. Market Value Forecast By Service Type, 2020 to 2035
  • 6.3.1. Regulatory Consulting and Legal Representation
  • 6.3.2. Product Registration and Clinical Trial Applications
  • 6.3.3. Regulatory Writing and Publishing
  • 6.3.4. Regulatory Submission
  • 6.3.5. Regulatory Operations
  • 6.3.6. Others
• 6.4. Market Attractiveness By Service Type

7. Global Regulatory Affairs Outsourcing Market Analysis and Forecasts, By Product Development Stage

• 7.1. Introduction & Definition
• 7.2. Key Findings / Developments
• 7.3. Market Value Forecast By Product Development Stage, 2020 to 2035
  • 7.3.1. Preclinical
  • 7.3.2. Clinical
  • 7.3.3. PMA (Post Market Authorization)
• 7.4. Market Attractiveness By Product Development Stage

8. Global Regulatory Affairs Outsourcing Market Analysis and Forecasts, By Enterprise Size

• 8.1. Introduction & Definition
• 8.2. Key Findings / Developments
• 8.3. Market Value Forecast By Enterprise Size, 2020 to 2035
  • 8.3.1. Small/Medium Enterprises
  • 8.3.2. Large Enterprises
• 8.4. Market Attractiveness By Enterprise Size

9. Global Regulatory Affairs Outsourcing Market Analysis and Forecasts, By Therapeutic Area

• 9.1. Introduction & Definition
• 9.2. Key Findings / Developments
• 9.3. Market Value Forecast By Therapeutic Area, 2020 to 2035
  • 9.3.1. Oncology
  • 9.3.2. Neurology
  • 9.3.3. Cardiology
  • 9.3.4. Immunology
  • 9.3.5. Dermatology
  • 9.3.6. Others
• 9.4. Market Attractiveness By Therapeutic Area

10. Global Regulatory Affairs Outsourcing Market Analysis and Forecasts, By End-user

• 10.1. Introduction & Definition
• 10.2. Key Findings / Developments
• 10.3. Market Value Forecast By End-user, 2020 to 2035
  • 10.3.1. Medical Device Companies
  • 10.3.2. Biopharma & Pharmaceutical Companies
  • 10.3.3. Others
• 10.4. Market Attractiveness By End-user

11. Global Regulatory Affairs Outsourcing Market Analysis and Forecasts, By Region

• 11.1. Key Findings
• 11.2. Market Value Forecast By Region
  • 11.2.1. North America
  • 11.2.2. Europe
  • 11.2.3. Asia Pacific
  • 11.2.4. Latin America
  • 11.2.5. Middle East & Africa
• 11.3. Market Attractiveness By Region

12. North America Regulatory Affairs Outsourcing Market Analysis and Forecast

• 12.1. Introduction
  • 12.1.1. Key Findings
• 12.2. Market Value Forecast By Service Type, 2020 to 2035
  • 12.2.1. Regulatory Consulting and Legal Representation
  • 12.2.2. Product Registration and Clinical Trial Applications
  • 12.2.3. Regulatory Writing and Publishing
  • 12.2.4. Regulatory Submission
  • 12.2.5. Regulatory Operations
  • 12.2.6. Others
• 12.3. Market Value Forecast By Product Development Stage, 2020 to 2035
  • 12.3.1. Preclinical
  • 12.3.2. Clinical
  • 12.3.3. PMA (Post Market Authorization)
• 12.4. Market Value Forecast By Enterprise Size, 2020 to 2035
  • 12.4.1. Small/Medium Enterprises
  • 12.4.2. Large Enterprises
• 12.5. Market Value Forecast By Therapeutic Area, 2020 to 2035
  • 12.5.1. Oncology
  • 12.5.2. Neurology
  • 12.5.3. Cardiology
  • 12.5.4. Immunology
  • 12.5.5. Dermatology
  • 12.5.6. Others
• 12.6. Market Value Forecast By End-user, 2020 to 2035
  • 12.6.1. Medical Device Companies
  • 12.6.2. Biopharma & Pharmaceutical Companies
  • 12.6.3. Others
• 12.7. Market Value Forecast By Country, 2020 to 2035
  • 12.7.1. U.S.
  • 12.7.2. Canada
• 12.8. Market Attractiveness Analysis
  • 12.8.1. By Service Type
  • 12.8.2. By Product Development Stage
  • 12.8.3. By Enterprise Size
  • 12.8.4. By Therapeutic Area
  • 12.8.5. By End-user
  • 12.8.6. By Country

13. Europe Regulatory Affairs Outsourcing Market Analysis and Forecast

• 13.1. Introduction
  • 13.1.1. Key Findings
• 13.2. Market Value Forecast By Service Type, 2020 to 2035
  • 13.2.1. Regulatory Consulting and Legal Representation
  • 13.2.2. Product Registration and Clinical Trial Applications
  • 13.2.3. Regulatory Writing and Publishing
  • 13.2.4. Regulatory Submission
  • 13.2.5. Regulatory Operations
  • 13.2.6. Others
• 13.3. Market Value Forecast By Product Development Stage, 2020 to 2035
  • 13.3.1. Preclinical
  • 13.3.2. Clinical
  • 13.3.3. PMA (Post Market Authorization)
• 13.4. Market Value Forecast By Enterprise Size, 2020 to 2035
  • 13.4.1. Small/Medium Enterprises
  • 13.4.2. Large Enterprises
• 13.5. Market Value Forecast By Therapeutic Area, 2020 to 2035
  • 13.5.1. Oncology
  • 13.5.2. Neurology
  • 13.5.3. Cardiology
  • 13.5.4. Immunology
  • 13.5.5. Dermatology
  • 13.5.6. Others
• 13.6. Market Value Forecast By End-user, 2020 to 2035
  • 13.6.1. Medical Device Companies
  • 13.6.2. Biopharma & Pharmaceutical Companies
  • 13.6.3. Others
• 13.7. Market Value Forecast By Country/Sub-region, 2020 to 2035
  • 13.7.1. Germany
  • 13.7.2. UK
  • 13.7.3. France
  • 13.7.4. Italy
  • 13.7.5. Spain
  • 13.7.6. Switzerland
  • 13.7.7. The Netherlands
  • 13.7.8. Rest of Europe
• 13.8. Market Attractiveness Analysis
  • 13.8.1. By Service Type
  • 13.8.2. By Product Development Stage
  • 13.8.3. By Enterprise Size
  • 13.8.4. By Therapeutic Area
  • 13.8.5. By End-user
  • 13.8.6. By Country/Sub-region

14. Asia Pacific Regulatory Affairs Outsourcing Market Analysis and Forecast

• 14.1. Introduction
  • 14.1.1. Key Findings
• 14.2. Market Value Forecast By Service Type, 2020 to 2035
  • 14.2.1. Regulatory Consulting and Legal Representation
  • 14.2.2. Product Registration and Clinical Trial Applications
  • 14.2.3. Regulatory Writing and Publishing
  • 14.2.4. Regulatory Submission
  • 14.2.5. Regulatory Operations
  • 14.2.6. Others
• 14.3. Market Value Forecast By Product Development Stage, 2020 to 2035
  • 14.3.1. Preclinical
  • 14.3.2. Clinical
  • 14.3.3. PMA (Post Market Authorization)
• 14.4. Market Value Forecast By Enterprise Size, 2020 to 2035
  • 14.4.1. Small/Medium Enterprises
  • 14.4.2. Large Enterprises
• 14.5. Market Value Forecast By Therapeutic Area, 2020 to 2035
  • 14.5.1. Oncology
  • 14.5.2. Neurology
  • 14.5.3. Cardiology
  • 14.5.4. Immunology
  • 14.5.5. Dermatology
  • 14.5.6. Others
• 14.6. Market Value Forecast By End-user, 2020 to 2035
  • 14.6.1. Medical Device Companies
  • 14.6.2. Biopharma & Pharmaceutical Companies
  • 14.6.3. Others
• 14.7. Market Value Forecast By Country/Sub-region, 2020 to 2035
  • 14.7.1. China
  • 14.7.2. Japan
  • 14.7.3. India
  • 14.7.4. Australia & New Zealand
  • 14.7.5. South Korea
  • 14.7.6. Rest of Asia Pacific
• 14.8. Market Attractiveness Analysis
  • 14.8.1. By Service Type
  • 14.8.2. By Product Development Stage
  • 14.8.3. By Enterprise Size
  • 14.8.4. By Therapeutic Area
  • 14.8.5. By End-user
  • 14.8.6. By Country/Sub-region

15. Latin America Regulatory Affairs Outsourcing Market Analysis and Forecast

• 15.1. Introduction
  • 15.1.1. Key Findings
• 15.2. Market Value Forecast By Service Type, 2020 to 2035
  • 15.2.1. Regulatory Consulting and Legal Representation
  • 15.2.2. Product Registration and Clinical Trial Applications
  • 15.2.3. Regulatory Writing and Publishing
  • 15.2.4. Regulatory Submission
  • 15.2.5. Regulatory Operations
  • 15.2.6. Others
• 15.3. Market Value Forecast By Product Development Stage, 2020 to 2035
  • 15.3.1. Preclinical
  • 15.3.2. Clinical
  • 15.3.3. PMA (Post Market Authorization)
• 15.4. Market Value Forecast By Enterprise Size, 2020 to 2035
  • 15.4.1. Small/Medium Enterprises
  • 15.4.2. Large Enterprises
• 15.5. Market Value Forecast By Therapeutic Area, 2020 to 2035
  • 15.5.1. Oncology
  • 15.5.2. Neurology
  • 15.5.3. Cardiology
  • 15.5.4. Immunology
  • 15.5.5. Dermatology
  • 15.5.6. Others
• 15.6. Market Value Forecast By End-user, 2020 to 2035
  • 15.6.1. Medical Device Companies
  • 15.6.2. Biopharma & Pharmaceutical Companies
  • 15.6.3. Others
• 15.7. Market Value Forecast By Country/Sub-region, 2020 to 2035
  • 15.7.1. Brazil
  • 15.7.2. Mexico
  • 15.7.3. Argentina
  • 15.7.4. Rest of Latin America
• 15.8. Market Attractiveness Analysis
  • 15.8.1. By Service Type
  • 15.8.2. By Product Development Stage
  • 15.8.3. By Enterprise Size
  • 15.8.4. By Therapeutic Area
  • 15.8.5. By End-user
  • 15.8.6. By Country/Sub-region

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

• 16.1. Introduction
  • 16.1.1. Key Findings
• 16.2. Market Value Forecast By Service Type, 2020 to 2035
  • 16.2.1. Regulatory Consulting and Legal Representation
  • 16.2.2. Product Registration and Clinical Trial Applications
  • 16.2.3. Regulatory Writing and Publishing
  • 16.2.4. Regulatory Submission
  • 16.2.5. Regulatory Operations
  • 16.2.6. Others
• 16.3. Market Value Forecast By Product Development Stage, 2020 to 2035
  • 16.3.1. Preclinical
  • 16.3.2. Clinical
  • 16.3.3. PMA (Post Market Authorization)
• 16.4. Market Value Forecast By Enterprise Size, 2020 to 2035
  • 16.4.1. Small/Medium Enterprises
  • 16.4.2. Large Enterprises
• 16.5. Market Value Forecast By Therapeutic Area, 2020 to 2035
  • 16.5.1. Oncology
  • 16.5.2. Neurology
  • 16.5.3. Cardiology
  • 16.5.4. Immunology
  • 16.5.5. Dermatology
  • 16.5.6. Others
• 16.6. Market Value Forecast By End-user, 2020 to 2035
  • 16.6.1. Medical Device Companies
  • 16.6.2. Biopharma & Pharmaceutical Companies
  • 16.6.3. Others
• 16.7. Market Value Forecast By Country/Sub-region, 2020 to 2035
  • 16.7.1. GCC Countries
  • 16.7.2. South Africa
  • 16.7.3. Rest of Middle East & Africa
• 16.8. Market Attractiveness Analysis
  • 16.8.1. By Service Type
  • 16.8.2. By Product Development Stage
  • 16.8.3. By Enterprise Size
  • 16.8.4. By Therapeutic Area
  • 16.8.5. By End-user
  • 16.8.6. By Country/Sub-region

17. Competition Landscape

• 17.1. Market Player - Competition Matrix (By Tier and Size of companies)
• 17.2. Market Share Analysis By Company (2024)
• 17.3. Company Profiles
  • 17.3.1. Accell Clinical Research, LLC
    • 17.3.1.1. Company Overview
    • 17.3.1.2. Financial Overview
    • 17.3.1.3. Financial Overview
    • 17.3.1.4. Business Strategies
    • 17.3.1.5. Recent Developments
  • 17.3.2. Genpact
    • 17.3.2.1. Company Overview
    • 17.3.2.2. Financial Overview
    • 17.3.2.3. Financial Overview
    • 17.3.2.4. Business Strategies
    • 17.3.2.5. Recent Developments
  • 17.3.3. CRITERIUM, INC
    • 17.3.3.1. Company Overview
    • 17.3.3.2. Financial Overview
    • 17.3.3.3. Financial Overview
    • 17.3.3.4. Business Strategies
    • 17.3.3.5. Recent Developments
  • 17.3.4. Promedica International
    • 17.3.4.1. Company Overview
    • 17.3.4.2. Financial Overview
    • 17.3.4.3. Financial Overview
    • 17.3.4.4. Business Strategies
    • 17.3.4.5. Recent Developments
  • 17.3.5. WuXi AppTec
    • 17.3.5.1. Company Overview
    • 17.3.5.2. Financial Overview
    • 17.3.5.3. Financial Overview
    • 17.3.5.4. Business Strategies
    • 17.3.5.5. Recent Developments
  • 17.3.6. Medpace
    • 17.3.6.1. Company Overview
    • 17.3.6.2. Financial Overview
    • 17.3.6.3. Financial Overview
    • 17.3.6.4. Business Strategies
    • 17.3.6.5. Recent Developments
  • 17.3.7. Charles River Laboratories
    • 17.3.7.1. Company Overview
    • 17.3.7.2. Financial Overview
    • 17.3.7.3. Financial Overview
    • 17.3.7.4. Business Strategies
    • 17.3.7.5. Recent Developments
  • 17.3.8. ICON plc
    • 17.3.8.1. Company Overview
    • 17.3.8.2. Financial Overview
    • 17.3.8.3. Financial Overview
    • 17.3.8.4. Business Strategies
    • 17.3.8.5. Recent Developments
  • 17.3.9. Parexel International Corporation
    • 17.3.9.1. Company Overview
    • 17.3.9.2. Financial Overview
    • 17.3.9.3. Financial Overview
    • 17.3.9.4. Business Strategies
    • 17.3.9.5. Recent Developments
  • 17.3.10. Freyr
    • 17.3.10.1. Company Overview
    • 17.3.10.2. Financial Overview
    • 17.3.10.3. Financial Overview
    • 17.3.10.4. Business Strategies
    • 17.3.10.5. Recent Developments
  • 17.3.11. PHARMALEX GMBH
    • 17.3.11.1. Company Overview
    • 17.3.11.2. Financial Overview
    • 17.3.11.3. Financial Overview
    • 17.3.11.4. Business Strategies
    • 17.3.11.5. Recent Developments
  • 17.3.12. Labcorp Drug Development
    • 17.3.12.1. Company Overview
    • 17.3.12.2. Financial Overview
    • 17.3.12.3. Financial Overview
    • 17.3.12.4. Business Strategies
    • 17.3.12.5. Recent Developments
  • 17.3.13. Other Prominent Players
    • 17.3.13.1. Company Overview
    • 17.3.13.2. Financial Overview
    • 17.3.13.3. Financial Overview
    • 17.3.13.4. Business Strategies
    • 17.3.13.5. Recent Developments