Regulatory Affairs Outsourcing Services Market Insights, Global Outlook and Forecast 2022-2028
Regulatory Affairs Outsourcing Services Market Insights, Global Outlook and Forecast 2022-2028
Discover the latest insights into the booming Regulatory Affairs Outsourcing Services Market. This report analyzes market size, growth trends (CAGR ), key players, and regional performance, offering valuable data for investors and industry professionals. Explore market drivers, restraints, and future projections for -.
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Regulatory affairs (RA), also called government affairs, is a profession within regulated industries, such as pharmaceuticals, medical devices, agrochemicals (plant protection products and fertilizers), energy, banking, telecom etc.
The latest research study released by Market IntelliX evaluates market size and forecasts of Regulatory Affairs Outsourcing Services in Global, including the following market information:
Global Regulatory Affairs Outsourcing Services Market Revenue, 2017-2022, 2023-2028, ($ millions)
Global top five companies in 2021 (%)
The global Regulatory Affairs Outsourcing Services market was valued at 4397.3 million in 2021 and is projected to reach US$ 7156.9 million by 2028, at a CAGR of 7.2% during the forecast period.
The U.S. Market is Estimated at $ Million in 2021, While China is Forecast to Reach $ Million by 2028.
Regulatory Writing & Publishing Segment to Reach $ Million by 2028, with a % CAGR in next six years.
The global key manufacturers of Regulatory Affairs Outsourcing Services include Medpace Inc., Accell Clinical Research, PRA International, Criterium Inc., PAREXEL International Corporation, Clinilabs Inc., Quintiles Transnational Holdings and Charles River Laboratories International Inc., etc. In 2021, the global top five players have a share approximately % in terms of revenue.
MI has surveyed the Regulatory Affairs Outsourcing Services companies, and industry experts on this industry, involving the revenue, demand, product type, recent developments and plans, industry trends, drivers, challenges, obstacles, and potential risks.
Market Segmentations:
Global Regulatory Affairs Outsourcing Services Market, by Type, 2017-2022, 2023-2028 ($ millions)
Global Regulatory Affairs Outsourcing Services Market Segment Percentages, by Type, 2021 (%)
Regulatory Writing & Publishing
Regulatory Consulting
Clinical Trial and Product Registration
Legal Representation
Other Services
Global Regulatory Affairs Outsourcing Services Market, by Application, 2017-2022, 2023-2028 ($ millions)
Global Regulatory Affairs Outsourcing Services Market Segment Percentages, by Application, 2021 (%)
Pharma Industry
Biotech Industry
Global Regulatory Affairs Outsourcing Services Market, By Region and Country, 2017-2022, 2023-2028 ($ Millions)
Global Regulatory Affairs Outsourcing Services Market Segment Percentages, By Region and Country, 2021 (%)
North America
US
Canada
Mexico
Europe
Germany
France
U.K.
Italy
Russia
Nordic Countries
Benelux
Rest of Europe
Asia
China
Japan
South Korea
Southeast Asia
India
Rest of Asia
South America
Brazil
Argentina
Rest of South America
Middle East & Africa
Turkey
Israel
Saudi Arabia
UAE
Rest of Middle East & Africa
Competitor Analysis
The report also provides analysis of leading market participants including:
Key companies Regulatory Affairs Outsourcing Services revenues in global market, 2017-2022 (estimated), ($ millions)
Key companies Regulatory Affairs Outsourcing Services revenues share in global market, 2021 (%)
The report presents profiles of competitors in the market, Some of the prominent key players covered:
Medpace Inc.
Accell Clinical Research
PRA International
Criterium Inc.
PAREXEL International Corporation
Clinilabs Inc.
Quintiles Transnational Holdings
Charles River Laboratories International Inc.
Key Takeaways from this Report
Evaluate market potential through analyzing growth rates (CAGR %), Volume (Units) and Value ($M) data given at country level – for product types, end use applications and by different industry verticals.
Understand the different dynamics influencing the market – key driving factors, challenges and hidden opportunities.
Get in-depth insights on your competitor performance – market shares, strategies, financial benchmarking, product benchmarking, SWOT and more.
Analyze the sales and distribution channels across key geographies to improve top-line revenues.
Understand the industry supply chain with a deep-dive on the value augmentation at each step, in order to optimize value and bring efficiencies in your processes.
Get a quick outlook on the market entropy – M&A’s, deals, partnerships, product launches of all key players for the past 4 years.
Evaluate the supply-demand gaps, import-export statistics and regulatory landscape for more than top 20 countries globally for the market.
1 Introduction to Research & Analysis Reports
1.1 Regulatory Affairs Outsourcing Services Market Definition
1.2 Market Segments
1.2.1 Market by Type
1.2.2 Market by Application
1.3 Global Regulatory Affairs Outsourcing Services Market Overview
1.4 Features & Benefits of This Report
1.5 Methodology & Sources of Information
1.5.1 Research Methodology
1.5.2 Research Process
1.5.3 Base Year
1.5.4 Report Assumptions & Caveats
2 Global Regulatory Affairs Outsourcing Services Overall Market Size
2.1 Global Regulatory Affairs Outsourcing Services Market Size: 2021 VS 2028
2.2 Global Regulatory Affairs Outsourcing Services Market Size, Prospects & Forecasts: 2017-2028
2.3 Key Market Trends, Opportunity, Drivers and Restraints
2.3.1 Market Opportunities & Trends
2.3.2 Market Drivers
2.3.3 Market Restraints
3 Company Landscape
3.1 Top Regulatory Affairs Outsourcing Services Players in Global Market
3.2 Top Global Regulatory Affairs Outsourcing Services Companies Ranked by Revenue
3.3 Global Regulatory Affairs Outsourcing Services Revenue by Companies
3.4 Top 3 and Top 5 Regulatory Affairs Outsourcing Services Companies in Global Market, by Revenue in 2021
3.5 Global Companies Regulatory Affairs Outsourcing Services Product Type
3.6 Tier 1, Tier 2 and Tier 3 Regulatory Affairs Outsourcing Services Players in Global Market
3.6.1 List of Global Tier 1 Regulatory Affairs Outsourcing Services Companies
3.6.2 List of Global Tier 2 and Tier 3 Regulatory Affairs Outsourcing Services Companies
4 Market Sights by Product
4.1 Overview
4.1.1 by Type - Global Regulatory Affairs Outsourcing Services Market Size Markets, 2021 & 2028
4.1.2 Regulatory Writing & Publishing
4.1.3 Regulatory Consulting
4.1.4 Clinical Trial and Product Registration
4.1.5 Legal Representation
4.1.6 Other Services
4.2 By Type - Global Regulatory Affairs Outsourcing Services Revenue & Forecasts
4.2.1 By Type - Global Regulatory Affairs Outsourcing Services Revenue, 2017-2022
4.2.2 By Type - Global Regulatory Affairs Outsourcing Services Revenue, 2023-2028
4.2.3 By Type - Global Regulatory Affairs Outsourcing Services Revenue Market Share, 2017-2028
5 Sights by Application
5.1 Overview
5.1.1 By Application - Global Regulatory Affairs Outsourcing Services Market Size, 2021 & 2028
5.1.2 Pharma Industry
5.1.3 Biotech Industry
5.2 By Application - Global Regulatory Affairs Outsourcing Services Revenue & Forecasts
5.2.1 By Application - Global Regulatory Affairs Outsourcing Services Revenue, 2017-2022
5.2.2 By Application - Global Regulatory Affairs Outsourcing Services Revenue, 2023-2028
5.2.3 By Application - Global Regulatory Affairs Outsourcing Services Revenue Market Share, 2017-2028
6 Sights by Region
6.1 By Region - Global Regulatory Affairs Outsourcing Services Market Size, 2021 & 2028
6.2 By Region - Global Regulatory Affairs Outsourcing Services Revenue & Forecasts
6.2.1 By Region - Global Regulatory Affairs Outsourcing Services Revenue, 2017-2022
6.2.2 By Region - Global Regulatory Affairs Outsourcing Services Revenue, 2023-2028
6.2.3 By Region - Global Regulatory Affairs Outsourcing Services Revenue Market Share, 2017-2028
6.3 North America
6.3.1 By Country - North America Regulatory Affairs Outsourcing Services Revenue, 2017-2028
6.3.2 US Regulatory Affairs Outsourcing Services Market Size, 2017-2028
6.3.3 Canada Regulatory Affairs Outsourcing Services Market Size, 2017-2028
6.3.4 Mexico Regulatory Affairs Outsourcing Services Market Size, 2017-2028
6.4 Europe
6.4.1 By Country - Europe Regulatory Affairs Outsourcing Services Revenue, 2017-2028
6.4.2 Germany Regulatory Affairs Outsourcing Services Market Size, 2017-2028
6.4.3 France Regulatory Affairs Outsourcing Services Market Size, 2017-2028
6.4.4 U.K. Regulatory Affairs Outsourcing Services Market Size, 2017-2028
6.4.5 Italy Regulatory Affairs Outsourcing Services Market Size, 2017-2028
6.4.6 Russia Regulatory Affairs Outsourcing Services Market Size, 2017-2028
6.4.7 Nordic Countries Regulatory Affairs Outsourcing Services Market Size, 2017-2028
6.4.8 Benelux Regulatory Affairs Outsourcing Services Market Size, 2017-2028
6.5 Asia
6.5.1 By Region - Asia Regulatory Affairs Outsourcing Services Revenue, 2017-2028
6.5.2 China Regulatory Affairs Outsourcing Services Market Size, 2017-2028
6.5.3 Japan Regulatory Affairs Outsourcing Services Market Size, 2017-2028
6.5.4 South Korea Regulatory Affairs Outsourcing Services Market Size, 2017-2028
6.5.5 Southeast Asia Regulatory Affairs Outsourcing Services Market Size, 2017-2028
6.5.6 India Regulatory Affairs Outsourcing Services Market Size, 2017-2028
6.6 South America
6.6.1 By Country - South America Regulatory Affairs Outsourcing Services Revenue, 2017-2028
6.6.2 Brazil Regulatory Affairs Outsourcing Services Market Size, 2017-2028
6.6.3 Argentina Regulatory Affairs Outsourcing Services Market Size, 2017-2028
6.7 Middle East & Africa
6.7.1 By Country - Middle East & Africa Regulatory Affairs Outsourcing Services Revenue, 2017-2028
6.7.2 Turkey Regulatory Affairs Outsourcing Services Market Size, 2017-2028
6.7.3 Israel Regulatory Affairs Outsourcing Services Market Size, 2017-2028
6.7.4 Saudi Arabia Regulatory Affairs Outsourcing Services Market Size, 2017-2028
6.7.5 UAE Regulatory Affairs Outsourcing Services Market Size, 2017-2028
7 Players Profiles
7.1 Medpace Inc.
7.1.1 Medpace Inc. Corporate Summary
7.1.2 Medpace Inc. Business Overview
7.1.3 Medpace Inc. Regulatory Affairs Outsourcing Services Major Product Offerings
7.1.4 Medpace Inc. Regulatory Affairs Outsourcing Services Revenue in Global Market (2017-2022)
7.1.5 Medpace Inc. Key News
7.2 Accell Clinical Research
7.2.1 Accell Clinical Research Corporate Summary
7.2.2 Accell Clinical Research Business Overview
7.2.3 Accell Clinical Research Regulatory Affairs Outsourcing Services Major Product Offerings
7.2.4 Accell Clinical Research Regulatory Affairs Outsourcing Services Revenue in Global Market (2017-2022)
7.2.5 Accell Clinical Research Key News
7.3 PRA International
7.3.1 PRA International Corporate Summary
7.3.2 PRA International Business Overview
7.3.3 PRA International Regulatory Affairs Outsourcing Services Major Product Offerings
7.3.4 PRA International Regulatory Affairs Outsourcing Services Revenue in Global Market (2017-2022)
7.3.5 PRA International Key News
7.4 Criterium Inc.
7.4.1 Criterium Inc. Corporate Summary
7.4.2 Criterium Inc. Business Overview
7.4.3 Criterium Inc. Regulatory Affairs Outsourcing Services Major Product Offerings
7.4.4 Criterium Inc. Regulatory Affairs Outsourcing Services Revenue in Global Market (2017-2022)
7.4.5 Criterium Inc. Key News
7.5 PAREXEL International Corporation
7.5.1 PAREXEL International Corporation Corporate Summary
7.5.2 PAREXEL International Corporation Business Overview
7.5.3 PAREXEL International Corporation Regulatory Affairs Outsourcing Services Major Product Offerings
7.5.4 PAREXEL International Corporation Regulatory Affairs Outsourcing Services Revenue in Global Market (2017-2022)
7.5.5 PAREXEL International Corporation Key News
7.6 Clinilabs Inc.
7.6.1 Clinilabs Inc. Corporate Summary
7.6.2 Clinilabs Inc. Business Overview
7.6.3 Clinilabs Inc. Regulatory Affairs Outsourcing Services Major Product Offerings
7.6.4 Clinilabs Inc. Regulatory Affairs Outsourcing Services Revenue in Global Market (2017-2022)
7.6.5 Clinilabs Inc. Key News
7.7 Quintiles Transnational Holdings
7.7.1 Quintiles Transnational Holdings Corporate Summary
7.7.2 Quintiles Transnational Holdings Business Overview
7.7.3 Quintiles Transnational Holdings Regulatory Affairs Outsourcing Services Major Product Offerings
7.7.4 Quintiles Transnational Holdings Regulatory Affairs Outsourcing Services Revenue in Global Market (2017-2022)
7.7.5 Quintiles Transnational Holdings Key News
7.8 Charles River Laboratories International Inc.
7.8.1 Charles River Laboratories International Inc. Corporate Summary
7.8.2 Charles River Laboratories International Inc. Business Overview
7.8.3 Charles River Laboratories International Inc. Regulatory Affairs Outsourcing Services Major Product Offerings
7.8.4 Charles River Laboratories International Inc. Regulatory Affairs Outsourcing Services Revenue in Global Market (2017-2022)
7.8.5 Charles River Laboratories International Inc. Key News
8 Conclusion
9 Appendix
9.1 Note
9.2 Examples of Clients
9.3 Disclaimer
Research Methodology:
Regulatory Affairs Outsourcing Services Market Size Estimation
To estimate market size and trends, we use a combination of top-down and bottom-up methods. This allows us to evaluate the market from various perspectives—by company, region, product type, and end users.
Our estimates are based on actual sales data, excluding any discounts. Segment breakdowns and market shares are calculated using weighted averages based on usage rates and average prices. Regional insights are determined by how widely a product or service is adopted in each area.
Key companies are identified through secondary sources like industry reports and company filings. We then verify revenue estimates and other key data points through primary research, including interviews with industry experts, company executives, and decision-makers.
We take into account all relevant factors that could influence the market and validate our findings with real-world input. Our final insights combine both qualitative and quantitative data to provide a well-rounded view. Please note, these estimates do not account for unexpected changes such as inflation, economic downturns, or policy shifts.
Data Source
Secondary Sources
This study draws on a wide range of secondary sources, including press releases, annual reports, non-profit organizations, industry associations, government agencies, and customs data. We also referred to reputable databases and directories such as Bloomberg, Wind Info, Hoovers, Factiva, Trading Economics, Statista, and others. Additional references include investor presentations, company filings (e.g., SEC), economic data, and documents from regulatory and industry bodies.
These sources were used to gather technical and market-focused insights, identify key players, analyze market segmentation and classification, and track major trends and developments across industries.
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Primary Sources
As part of our primary research, we interviewed a variety of stakeholders from both the supply and demand sides to gather valuable qualitative and quantitative insights.
On the supply side, we spoke with product manufacturers, competitors, industry experts, research institutions, distributors, traders, and raw material suppliers. On the demand side, we engaged with business leaders, marketing and sales heads, technology and innovation directors, supply chain executives, and end users across key organizations.
These conversations helped us better understand market segmentation, pricing, applications, leading players, supply chains, demand trends, industry outlook, and key market dynamics—including risks, opportunities, barriers, and strategic developments.
Key Data Information from Primary Sources
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