Regulatory Affairs Outsourcing Market, By Service Type, By End User, By Stage, By Therapeutic Area, By Geography

Description

Global regulatory affairs outsourcing market is estimated to be valued at USD 8.41 Bn 2024 and is expected to reach USD 17.10 Bn by 2031, exhibiting a compound annual growth rate (CAGR) of 10.7% from 2024 to 2031.

Report Coverage		Report Details
Base Year:	2023	Market Size in 2024:	US$ 8.41 Bn
Historical Data for:	2019 to 2023	Forecast Period:	2024 to 2031
Forecast Period 2024 to 2031 CAGR:	10.70%	2031 Value Projection:	US$ 17.10 Bn

Figure. Regulatory Affairs Outsourcing Market Share (%), By Region 2024

Regulatory Affairs Outsourcing Market - IMG1

Global regulatory affairs outsourcing market growth is driven by increasing complexity of regulatory frameworks. Regulatory requirements have become more stringent across regions necessitating specialized expertise and resources for compliance. Furthermore, drug development process has become highly regulated requiring close monitoring and management of compliance at various stages from clinical development to approvals. This has prompted pharmaceutical and biotech companies including medical device manufacturers to rely on third-party service providers with domain expertise to outsource regulatory functions. Regulatory outsourcing helps firms streamline processes, reduce costs, and focus resources on core competencies.

Market Dynamics:

Global regulatory affairs outsourcing market growth is driven by factors such as increasing R&D expenditure of pharmaceutical and biotechnology firms, stringent regulatory environment, and cost pressures. However, data privacy & security concerns and quality control issues can hamper the market growth. Emerging markets can offer significant opportunities due to outsourcing and clinical trial activities shifting to low-cost destinations in Asia Pacific and Latin America. Increased mergers and acquisitions and partnership strategies adopted by regulatory service providers can also expand their capabilities and global footprint, thus, offering new growth opportunities.

Key Features of the Study:

This report provides in-depth analysis of the global regulatory affairs outsourcing market, and provides market size (USD Billion) and compound annual growth rate (CAGR%) for the forecast period (2024-2031), considering 2023 as the base year
It elucidates potential revenue opportunities across different segments and explains attractive investment proposition matrices for this market
This study also provides key insights about market drivers, restraints, opportunities, new product launches or approval, market trends, regional outlook, and competitive strategies adopted by key players
It profiles key players in the global regulatory affairs outsourcing market based on the following parameters - company highlights, products portfolio, key highlights, financial performance, and strategies
Key companies covered as a part of this study include Prophecy, PAREXEL, Clinitec, ICON, Accell, and Covance
Insights from this report would allow marketers and the management authorities of the companies to make informed decisions regarding their future product launches, type up-gradation, market expansion, and marketing tactics
Global regulatory affairs outsourcing market report caters to various stakeholders in this industry including investors, suppliers, product manufacturers, distributors, new entrants, and financial analysts
Stakeholders would have ease in decision-making through various strategy matrices used in analyzing the global regulatory affairs outsourcing market

Detailed Segmentation-

By Service Type
- Regulatory Consulting and Legal Representation
- Product Registration and Clinical Trial Applications
- Regulatory Writing and Publishing
- Regulatory Submission
- Regulatory Operations
- Others
By End User
- Medical Device Companies
- Pharmaceutical Companies
- Biotechnology Companies
By Stage
- Preclinical
- Clinical
- PMA (Post Market Authorization)
By Therapeutic Area
- Oncology
- Neurology
- Cardiology
- Immunology
- Others
By Region
- North America
- Europe
- Asia Pacific
- Latin America
- Middle East
- Africa
Company Profiles:
- Accell Clinical Research, LLC
- Genpact
- CRITERIUM, INC.
- PRA Health Sciences
- Promedica International
- WuXiAppTec
- Medpace
- PPD Inc.
- Charles River Laboratories
- ICON plc
- Covance
- Parexel International Corporation
- Freyr
- Navitas Clinical Research, Inc.
- Medelis, Inc.
- Sciformix
- Tech Tammina
- Acorn Regulatory Consultancy Services Ltd.
- BIOMAPAS
- REGULATORY PROFESSIONALS
- CompareNetworks, Inc.

Product Code: CMI2751

1. Research Objectives and Assumptions

Research Objectives
Assumptions
Abbreviations

2. Market Purview

Report Description
- Market Definition and Scope
Executive Summary
- Market Snapshot, By Service Type
- Market Snapshot, By End User
- Market Snapshot, By Stage
- Market Snapshot, By Therapeutic Area
- Market Snapshot, By Region
Coherent Opportunity Map (COM)

3. Market Dynamics, Regulations, and Trends Analysis

Market Dynamics
- Drivers
- Restraints
- Opportunities
Impact Analysis
Market Trends
Key Developments
Regulatory Scenario
Acquisitions and Partnerships Scenario
Funding and Investments
PEST Analysis
Porter's Analysis

4. Global Regulatory Affairs Outsourcing Market - Impact of Coronavirus (COVID-19) Pandemic

Overall Impact
Government Initiatives
COVID-19 Impact on the Market

5. Global Regulatory Affairs Outsourcing Market, By Service Type, 2019 - 2031, (USD Bn)

Overview
- Market Share Analysis, 2024 and 2031 (%)
- Y-o-Y Growth Analysis, 2019 - 2031
- Segment Trends
Regulatory Consulting and Legal Representation
- Overview
- Market Size and Forecast, and Y-o-Y Growth, 2019-2031, (USD Bn)
Product Registration and Clinical Trial Applications
- Overview
- Market Size and Forecast, and Y-o-Y Growth, 2019-2031, (USD Bn)
Regulatory Writing and Publishing
- Overview
- Market Size and Forecast, and Y-o-Y Growth, 2019-2031, (USD Bn)
Regulatory Submission
- Overview
- Market Size and Forecast, and Y-o-Y Growth, 2019-2031, (USD Bn)
Regulatory Operations
- Overview
- Market Size and Forecast, and Y-o-Y Growth, 2019-2031, (USD Bn)
Others
- Overview
- Market Size and Forecast, and Y-o-Y Growth, 2019-2031, (USD Bn)

6. Global Regulatory Affairs Outsourcing Market, By End User, 2019 - 2031, (USD Bn)

Overview
- Market Share Analysis, 2024 and 2031 (%)
- Y-o-Y Growth Analysis, 2019 - 2031
- Segment Trends
Medical Device Companies
- Overview
- Market Size and Forecast, and Y-o-Y Growth, 2019-2031, (USD Bn)
Pharmaceutical Companies
- Overview
- Market Size and Forecast, and Y-o-Y Growth, 2019-2031, (USD Bn)
Biotechnology Companies
- Overview
- Market Size and Forecast, and Y-o-Y Growth, 2019-2031, (USD Bn)

7. Global Regulatory Affairs Outsourcing Market, By Stage, 2019 - 2031, (USD Bn)

Overview
- Market Share Analysis, 2024 and 2031 (%)
- Y-o-Y Growth Analysis, 2019 - 2031
- Segment Trends
Preclinical
- Overview
- Market Size and Forecast, and Y-o-Y Growth, 2019-2031, (USD Bn)
Clinical
- Overview
- Market Size and Forecast, and Y-o-Y Growth, 2019-2031, (USD Bn)
PMA (Post Market Authorization)
- Overview
- Market Size and Forecast, and Y-o-Y Growth, 2019-2031, (USD Bn)

8. Global Regulatory Affairs Outsourcing Market, By Therapeutic Area, 2019 - 2031, (USD Bn)

Overview
- Market Share Analysis, 2024 and 2031 (%)
- Y-o-Y Growth Analysis, 2019 - 2031
- Segment Trends
Oncology
- Overview
- Market Size and Forecast, and Y-o-Y Growth, 2019-2031, (USD Bn)
Neurology
- Overview
- Market Size and Forecast, and Y-o-Y Growth, 2019-2031, (USD Bn)
Cardiology
- Overview
- Market Size and Forecast, and Y-o-Y Growth, 2019-2031, (USD Bn)
Immunology
- Overview
- Market Size and Forecast, and Y-o-Y Growth, 2019-2031, (USD Bn)
Others
- Overview
- Market Size and Forecast, and Y-o-Y Growth, 2019-2031, (USD Bn)

9. Global Regulatory Affairs Outsourcing Market, By Region, 2019 - 2031, (USD Bn)

Introduction
- Market Share Analysis, By Region, 2024 and 2031 (%)
- Y-o-Y Growth Analysis, For Region, 2019-2031
- Regional Trends
  - North America
- Introduction
- Market Size and Forecast, and Y-o-Y Growth, By Service Type, 2019 - 2031, (USD Bn)
- Market Size and Forecast, and Y-o-Y Growth, By End User, 2019 - 2031, (USD Bn)
- Market Size and Forecast, and Y-o-Y Growth, By Stage, 2019 - 2031, (USD Bn)
- Market Size and Forecast, and Y-o-Y Growth, By Therapeutic Area, 2019 - 2031, (USD Bn)
- Market Size and Forecast, and Y-o-Y Growth, By Country, 2019 - 2031, (USD Bn)
  - U.S.
  - Canada
Latin America
- Introduction
- Market Size and Forecast, and Y-o-Y Growth, By Service Type, 2019 - 2031, (USD Bn)
- Market Size and Forecast, and Y-o-Y Growth, By End User, 2019 - 2031, (USD Bn)
- Market Size and Forecast, and Y-o-Y Growth, By Stage, 2019 - 2031, (USD Bn)
- Market Size and Forecast, and Y-o-Y Growth, By Therapeutic Area, 2019 - 2031, (USD Bn)
- Market Size and Forecast, and Y-o-Y Growth, By Country, 2019 - 2031, (USD Bn)
  - Brazil
  - Mexico
  - Argentina
  - Rest of Latin America
Europe
- Introduction
- Market Size and Forecast, and Y-o-Y Growth, By Service Type, 2019 - 2031, (USD Bn)
- Market Size and Forecast, and Y-o-Y Growth, By End User, 2019 - 2031, (USD Bn)
- Market Size and Forecast, and Y-o-Y Growth, By Stage, 2019 - 2031, (USD Bn)
- Market Size and Forecast, and Y-o-Y Growth, By Therapeutic Area. 2019 - 2031, (USD Bn)
- Market Size and Forecast, and Y-o-Y Growth, By Country, 2019 - 2031, (USD Bn)
  - U.K.
  - Germany
  - Italy
  - France
  - Spain
  - Russia
  - Rest of Europe
Asia Pacific
- Introduction
- Market Size and Forecast, and Y-o-Y Growth, By Service Type, 2019 - 2031, (USD Bn)
- Market Size and Forecast, and Y-o-Y Growth, By End User, 2019 - 2031, (USD Bn)
- Market Size and Forecast, and Y-o-Y Growth, By Stage, 2019 - 2031, (USD Bn)
- Market Size and Forecast, and Y-o-Y Growth, By Therapeutic Area, 2019 - 2031, (USD Bn)
- Market Size and Forecast, and Y-o-Y Growth, By Country, 2019 - 2031, (USD Bn)
  - China
  - India
  - Japan
  - ASEAN
  - Australia
  - South Korea
  - Rest of Asia Pacific
Middle East
- Introduction
- Market Size and Forecast, and Y-o-Y Growth, By Service Type, 2019 - 2031, (USD Bn)
- Market Size and Forecast, and Y-o-Y Growth, By End User, 2019 - 2031, (USD Bn)
- Market Size and Forecast, and Y-o-Y Growth, By Stage, 2019 - 2031, (USD Bn)
- Market Size and Forecast, and Y-o-Y Growth, By Therapeutic Area, 2019 - 2031, (USD Bn)
- Market Size and Forecast, and Y-o-Y Growth, By Country, 2019 - 2031, (USD Bn)
  - GCC Countries
  - Israel
  - Rest of Middle East
  - Africa
- Introduction
- Market Size and Forecast, and Y-o-Y Growth, By Service Type, 2019 - 2031, (USD Bn)
- Market Size and Forecast, and Y-o-Y Growth, By End User, 2019 - 2031, (USD Bn)
- Market Size and Forecast, and Y-o-Y Growth, By Stage, 2019 - 2031, (USD Bn)
- Market Size and Forecast, and Y-o-Y Growth, By Therapeutic Area, 2019 - 2031, (USD Bn)
- Market Size and Forecast, and Y-o-Y Growth, By Country/Sub-region, 2019 - 2031, (USD Bn)
  - North Africa
  - Central Africa
  - South Africa

10. Competitive Landscape

Company Profiles
- Accell Clinical Research, LLC
  - Company Highlights
  - Service Type Portfolio
  - Key Highlights
  - Financial Performance
  - Market Strategies
- Genpact
- CRITERIUM, INC.
- PRA Health Sciences
- Promedica International
- WuXiAppTec
- Medpace
- PPD Inc.
- Charles River Laboratories
- ICON plc
- Covance
- Parexel International Corporation
- Freyr
- Navitas Clinical Research, Inc.
- Medelis, Inc.
- Sciformix
- Tech Tammina
- Acorn Regulatory Consultancy Services Ltd.
- BIOMAPAS
- REGULATORY PROFESSIONALS
- CompareNetworks, Inc.

11. Analyst Recommendations

Wheel of Fortune
Analyst View
Coherent Opportunity Map

12. References and Research Methodology

References
Research Methodology
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