Regulatory Affairs Outsourcing Market Size, Share, Opportunities, And Trends By Services (Regulatory Affairs, Clinical Trial Applications, Product Registrations, Regulatory Writing and Publishing, Regulatory Consulting, Legal Representation Others), And Geography - Forecasts From 2025 To 2030

Description

Regulatory Affairs Outsourcing Market Size:

The regulatory affairs outsourcing market, at a 8.34% CAGR, is expected to grow from USD 8.369 billion in 2025 to USD 12.493 billion in 2030.

Regulatory affairs outsourcing is becoming a common practice in the Pharma and Biotech industry. Outsourcing is also practised in pharmacovigilance as well and most companies are looking for partnerships in order to manage the operational tasks which include report publishing and submission as well. Incidences of rising disease prevalence especially in the regions of Asia Pacific and MEA are driving the growth of the global regulatory affairs outsourcing market in the forecast period. Also, with the advent of new and rare diseases, the number of clinical trials is also increasing, thus leading to an increase in the demand of these services. Furthermore, the growing trend of biosimilars is expected to create a demand for regulatory expertise which will lead to the growth of the regulatory affairs outsourcing market in the forecast period and beyond.

Regulatory Affairs Outsourcing Market Trends:

This research study examines the current market trends related to demand, supply, and sales, in addition to the recent developments. Major drivers, restraints, and opportunities have been covered to provide an exhaustive picture of the market. The analysis presents in-depth information regarding the development, trends, and industry policies and regulations implemented in each of the geographical regions. Further, the overall regulatory framework of the market has been exhaustively covered to offer stakeholders a better understanding of the key factors affecting the overall market environment.

Identification of key industry players in the industry and their revenue contribution to the overall business or relevant segment aligned to the study have been covered as a part of competitive intelligence done through extensive secondary research. Various studies and data published by industry associations, analyst reports, investor presentations, press releases and journals among others have been taken into consideration while conducting the secondary research. Both bottom-up and top down approaches have been utilized to determine the market size of the overall market and key segments. The values obtained are correlated with the primary inputs of the key stakeholders in the regulatory affairs outsourcing value chain. The last step involves complete market engineering which includes analyzing the data from different sources and existing proprietary datasets while using various data triangulation methods for market breakdown and forecasting.

Market intelligence is presented in the form of analysis, charts, and graphics to help the clients in gaining a faster and more efficient understanding of the regulatory affairs outsourcing market.

Regulatory Affairs Outsourcing Market Players:

Major industry players profiled as part of the report are Syneos Health, Genpact, CRITERIUM, INC., PRAHEALTHSCIENCES and PMI among others.

Segmentation

• REGULATORY AFFAIRS OUTSOURCING MARKET BY SERVICES
  • Regulatory Affairs
  • Clinical Trial Applications
  • Product Registrations
  • Regulatory Writing and Publishing
  • Regulatory Consulting
  • Legal Representation
  • Others
• REGULATORY AFFAIRS OUTSOURCING MARKET BY GEOGRAPHY
  • North America
    • USA
    • Canada
    • Mexico
  • South America
    • Brazil
    • Argentina
    • Others
  • Europe
    • Germany
    • France
    • United Kingdom
    • Spain
    • Others
  • Middle East and Africa
    • Saudi Arabia
    • UAE
    • Others
  • Asia Pacific
    • China
    • India
    • Japan
    • South Korea
    • Indonesia
    • Thailand
    • Others

Table Of Contents

1. EXECUTIVE SUMMARY
2. MARKET SNAPSHOT
    2.1. Market Overview
    2.2. Market Definition
    2.3. Scope of the Study
    2.4. Market Segmentation
3. BUSINESS LANDSCAPE
    3.1. Market Drivers
    3.2. Market Restraints
    3.3. Market Opportunities
    3.4. Porter’s Five Forces Analysis
    3.5. Industry Value Chain Analysis
    3.6. Policies and Regulations
    3.7. Strategic Recommendations
4. TECHNOLOGICAL OUTLOOK
5. REGULATORY AFFAIRS OUTSOURCING MARKET BY SERVICES
    5.1. Introduction
    5.2. Regulatory Affairs
    5.3. Clinical Trial Applications
    5.4. Product Registrations
    5.5. Regulatory Writing and Publishing
    5.6. Regulatory Consulting
    5.7. Legal Representation
    5.8. Others
6. REGULATORY AFFAIRS OUTSOURCING MARKET BY GEOGRAPHY
    6.1. Introduction
    6.2. North America
        6.2.1. USA
        6.2.2. Canada
        6.2.3. Mexico
    6.3. South America
        6.3.1. Brazil
        6.3.2. Argentina
        6.3.3. Others
    6.4. Europe
        6.4.1. Germany
        6.4.2. France
        6.4.3. United Kingdom
        6.4.4. Spain
        6.4.5. Others
    6.5. Middle East and Africa
        6.5.1. Saudi Arabia
        6.5.2. UAE
        6.5.3. Others
    6.6. Asia Pacific
        6.6.1. China
        6.6.2. India
        6.6.3. Japan
        6.6.4. South Korea
        6.6.5. Indonesia
        6.6.6. Thailand
        6.6.7. Others
7. COMPETITIVE ENVIRONMENT AND ANALYSIS
    7.1. Major Players and Strategy Analysis
    7.2. Market Share Analysis
    7.3. Mergers, Acquisitions, Agreements, and Collaborations
    7.4. Competitive Dashboard
8. COMPANY PROFILES
    8.1. Syneos Health
    8.2. Genpact
    8.3. CRITERIUM, INC.
    8.4. PRAHEALTHSCIENCES
    8.5. PMI
    8.6. WuXi AppTec
    8.7. Medpace, Inc.
    8.8. Pharmaceutical Product Development, LLC
    8.9. PAREXEL International Corporation
    8.10. IQVIA
9. APPENDIX
    9.1. Currency
    9.2. Assumptions
    9.3. Base and Forecast Years Timeline
    9.4. Key benefits for the stakeholders
    9.5. Research Methodology
    9.6. Abbreviations
LIST OF FIGURES
LIST OF TABLES
1. EXECUTIVE SUMMARY
2. MARKET SNAPSHOT
    2.1. Market Overview
    2.2. Market Definition
    2.3. Scope of the Study
    2.4. Market Segmentation
3. BUSINESS LANDSCAPE
    3.1. Market Drivers
    3.2. Market Restraints
    3.3. Market Opportunities
    3.4. Porter’s Five Forces Analysis
    3.5. Industry Value Chain Analysis
    3.6. Policies and Regulations
    3.7. Strategic Recommendations
4. TECHNOLOGICAL OUTLOOK
5. REGULATORY AFFAIRS OUTSOURCING MARKET BY SERVICES
    5.1. Introduction
    5.2. Regulatory Affairs
    5.3. Clinical Trial Applications
    5.4. Product Registrations
    5.5. Regulatory Writing and Publishing
    5.6. Regulatory Consulting
    5.7. Legal Representation
    5.8. Others
6. REGULATORY AFFAIRS OUTSOURCING MARKET BY GEOGRAPHY
    6.1. Introduction
    6.2. North America
        6.2.1. USA
        6.2.2. Canada
        6.2.3. Mexico
    6.3. South America
        6.3.1. Brazil
        6.3.2. Argentina
        6.3.3. Others
    6.4. Europe
        6.4.1. Germany
        6.4.2. France
        6.4.3. United Kingdom
        6.4.4. Spain
        6.4.5. Others
    6.5. Middle East and Africa
        6.5.1. Saudi Arabia
        6.5.2. UAE
        6.5.3. Others
    6.6. Asia Pacific
        6.6.1. China
        6.6.2. India
        6.6.3. Japan
        6.6.4. South Korea
        6.6.5. Indonesia
        6.6.6. Thailand
        6.6.7. Others
7. COMPETITIVE ENVIRONMENT AND ANALYSIS
    7.1. Major Players and Strategy Analysis
    7.2. Market Share Analysis
    7.3. Mergers, Acquisitions, Agreements, and Collaborations
    7.4. Competitive Dashboard
8. COMPANY PROFILES
    8.1. Syneos Health
    8.2. Genpact
    8.3. CRITERIUM, INC.
    8.4. PRAHEALTHSCIENCES
    8.5. PMI
    8.6. WuXi AppTec
    8.7. Medpace, Inc.
    8.8. Pharmaceutical Product Development, LLC
    8.9. PAREXEL International Corporation
    8.10. IQVIA
9. APPENDIX
    9.1. Currency
    9.2. Assumptions
    9.3. Base and Forecast Years Timeline
    9.4. Key benefits for the stakeholders
    9.5. Research Methodology
    9.6. Abbreviations
LIST OF FIGURES
LIST OF TABLES

Companies Profiled

Syneos Health

Genpact

CRITERIUM, INC

PRAHEALTHSCIENCES

PMI

WuXi AppTec

Medpace, Inc

Pharmaceutical Product Development, LLC

PAREXEL International Corporation

IQVIA

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