Regulatory Affairs Outsourcing Market, 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

Regulatory Affairs Outsourcing Market, 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), By Therapeutic Area (Oncology, Neurology, Cardiology, Immunology, Others), By Geography (North America, Latin America, Europe, Asia Pacific, Middle East & Africa)


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.


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
About us and Sales Contact
*Browse 32 market data tables and 28 figures on Regulatory Affairs Outsourcing Market” - Global forecast to 2031

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