Regulatory Affairs Outsourcing Global Market Report 2025

Regulatory Affairs Outsourcing Global Market Report 2025 from The Business Research Company provides strategists, marketers and senior management with the critical information they need to assess the market.

This report focuses on regulatory affairs outsourcing market which is experiencing strong growth. The report gives a guide to the trends which will be shaping the market over the next ten years and beyond.

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Description:

Where is the largest and fastest growing market for regulatory affairs outsourcing ? How does the market relate to the overall economy, demography and other similar markets? What forces will shape the market going forward? The regulatory affairs outsourcing market global report from the Business Research Company answers all these questions and many more.

The report covers market characteristics, size and growth, segmentation, regional and country breakdowns, competitive landscape, market shares, trends and strategies for this market. It traces the market’s historic and forecast market growth by geography.
  • The market characteristics section of the report defines and explains the market.
  • The market size section gives the market size ($b) covering both the historic growth of the market, and forecasting its development.
  • The forecasts are made after considering the major factors currently impacting the market. These include:
  • The forecasts are made after considering the major factors currently impacting the market. These include the Russia-Ukraine war, rising inflation, higher interest rates, and the legacy of the COVID-19 pandemic.
  • Market segmentations break down the market into sub markets.
  • The regional and country breakdowns section gives an analysis of the market in each geography and the size of the market by geography and compares their historic and forecast growth. It covers the growth trajectory of COVID-19 for all regions, key developed countries and major emerging markets.
  • The competitive landscape chapter gives a description of the competitive nature of the market, market shares, and a description of the leading companies. Key financial deals which have shaped the market in recent years are identified.
  • The trends and strategies section analyses the shape of the market as it emerges from the crisis and suggests how companies can grow as the market recovers.
Scope

Markets Covered:1) By Service: Legal Representation; Regulatory Consulting; Product Registration & Clinical Trial Application; Regulatory Writing & Publication; Other Services

2) By Indication: Neurology; Oncology; Immunology; Cardiology; Other Indications

3) By Category: Biologics; Drugs; Medical Devices; By Company Size: Small; Medium; Large

4) By End User: Medical Device Company; Biotechnology Company; Pharmaceutical Company

Subsegments:

1) By Legal Representation: Compliance Support; Litigation Support; Intellectual Property Services

2) By Regulatory Consulting: Strategy Development; Risk Assessment; Regulatory Intelligence

3) By Product Registration And Clinical Trial Application: Dossier Preparation; Application Submission; Liaison With Regulatory Authorities

4) By Regulatory Writing And Publication: Clinical Study Reports; Regulatory Submission Documents; Scientific Publications

5) By Other Services: Training And Development; Pharmacovigilance; Quality Assurance And Auditing

Companies Mentioned: Thermo Fisher Scientific Inc. (PPD); IQVIA; ICON plc; WuXi App Tec; Syneos Health

Countries: Australia; Brazil; China; France; Germany; India; Indonesia; Japan; Russia; South Korea; UK; USA; Canada; Italy; Spain

Regions: Asia-Pacific; Western Europe; Eastern Europe; North America; South America; Middle East; Africa

Time series: Five years historic and ten years forecast.

Data: Ratios of market size and growth to related markets, GDP proportions, expenditure per capita,

Data segmentations: country and regional historic and forecast data, market share of competitors, market segments.

Sourcing and Referencing: Data and analysis throughout the report is sourced using end notes.

Delivery format: PDF, Word and Excel Data Dashboard.


1. Executive Summary
2. Regulatory Affairs Outsourcing Market Characteristics
3. Regulatory Affairs Outsourcing Market Trends And Strategies
4. Regulatory Affairs Outsourcing Market - Macro Economic Scenario Macro Economic Scenario Including The Impact Of Interest Rates, Inflation, Geopolitics And Covid And Recovery On The Market
5. Global Regulatory Affairs Outsourcing Growth Analysis And Strategic Analysis Framework
5.1. Global Regulatory Affairs Outsourcing PESTEL Analysis (Political, Social, Technological, Environmental and Legal Factors, Drivers and Restraints)
5.2. Analysis Of End Use Industries
5.3. Global Regulatory Affairs Outsourcing Market Growth Rate Analysis
5.4. Global Regulatory Affairs Outsourcing Historic Market Size and Growth, 2019 - 2024, Value ($ Billion)
5.5. Global Regulatory Affairs Outsourcing Forecast Market Size and Growth, 2024 - 2029, 2034F, Value ($ Billion)
5.6. Global Regulatory Affairs Outsourcing Total Addressable Market (TAM)
6. Regulatory Affairs Outsourcing Market Segmentation
6.1. Global Regulatory Affairs Outsourcing Market, Segmentation By Service, Historic and Forecast, 2019-2024, 2024-2029F, 2034F, $ Billion
Legal Representation
Regulatory Consulting
Product Registration & Clinical Trial Application
Regulatory Writing & Publication
Other Services
6.2. Global Regulatory Affairs Outsourcing Market, Segmentation By Indication, Historic and Forecast, 2019-2024, 2024-2029F, 2034F, $ Billion
Neurology
Oncology
Immunology
Cardiology
Other Indications
6.3. Global Regulatory Affairs Outsourcing Market, Segmentation By Category, Historic and Forecast, 2019-2024, 2024-2029F, 2034F, $ Billion
Biologics
Drugs
Medical Devices
Other Categories
6.4. Global Regulatory Affairs Outsourcing Market, Segmentation By Company Size, Historic and Forecast, 2019-2024, 2024-2029F, 2034F, $ Billion
Small
Medium
Large
6.5. Global Regulatory Affairs Outsourcing Market, Segmentation By End User, Historic and Forecast, 2019-2024, 2024-2029F, 2034F, $ Billion
Medical Device Company
Biotechnology Company
Pharmaceutical Company
6.6. Global Regulatory Affairs Outsourcing Market, Sub-Segmentation Of Legal Representation, By Type, Historic and Forecast, 2019-2024, 2024-2029F, 2034F, $ Billion
Compliance Support
Litigation Support
Intellectual Property Services
6.7. Global Regulatory Affairs Outsourcing Market, Sub-Segmentation Of Regulatory Consulting, By Type, Historic and Forecast, 2019-2024, 2024-2029F, 2034F, $ Billion
Strategy Development
Risk Assessment
Regulatory Intelligence
6.8. Global Regulatory Affairs Outsourcing Market, Sub-Segmentation Of Product Registration And Clinical Trial Application, By Type, Historic and Forecast, 2019-2024, 2024-2029F, 2034F, $ Billion
Dossier Preparation
Application Submission
Liaison With Regulatory Authorities
6.9. Global Regulatory Affairs Outsourcing Market, Sub-Segmentation Of Regulatory Writing And Publication, By Type, Historic and Forecast, 2019-2024, 2024-2029F, 2034F, $ Billion
Clinical Study Reports
Regulatory Submission Documents
Scientific Publications
6.10. Global Regulatory Affairs Outsourcing Market, Sub-Segmentation Of Other Services, By Type, Historic and Forecast, 2019-2024, 2024-2029F, 2034F, $ Billion
Training And Development
Pharmacovigilance
Quality Assurance And Auditing
7. Regulatory Affairs Outsourcing Market Regional And Country Analysis
7.1. Global Regulatory Affairs Outsourcing Market, Split By Region, Historic and Forecast, 2019-2024, 2024-2029F, 2034F, $ Billion
7.2. Global Regulatory Affairs Outsourcing Market, Split By Country, Historic and Forecast, 2019-2024, 2024-2029F, 2034F, $ Billion
8. Asia-Pacific Regulatory Affairs Outsourcing Market
8.1. Asia-Pacific Regulatory Affairs Outsourcing Market Overview
Region Information, Market Information, Background Information, Government Initiatives, Regulations, Regulatory Bodies, Major Associations, Taxes Levied, Corporate Tax Structure, Investments, Major Companies
8.2. Asia-Pacific Regulatory Affairs Outsourcing Market, Segmentation By Service, Historic and Forecast, 2019-2024, 2024-2029F, 2034F, $ Billion
8.3. Asia-Pacific Regulatory Affairs Outsourcing Market, Segmentation By Indication, Historic and Forecast, 2019-2024, 2024-2029F, 2034F, $ Billion
8.4. Asia-Pacific Regulatory Affairs Outsourcing Market, Segmentation By Category, Historic and Forecast, 2019-2024, 2024-2029F, 2034F, $ Billion
9. China Regulatory Affairs Outsourcing Market
9.1. China Regulatory Affairs Outsourcing Market Overview
9.2. China Regulatory Affairs Outsourcing Market, Segmentation By Service, Historic and Forecast, 2019-2024, 2024-2029F, 2034F,$ Billion
9.3. China Regulatory Affairs Outsourcing Market, Segmentation By Indication, Historic and Forecast, 2019-2024, 2024-2029F, 2034F,$ Billion
9.4. China Regulatory Affairs Outsourcing Market, Segmentation By Category, Historic and Forecast, 2019-2024, 2024-2029F, 2034F,$ Billion
10. India Regulatory Affairs Outsourcing Market
10.1. India Regulatory Affairs Outsourcing Market, Segmentation By Service, Historic and Forecast, 2019-2024, 2024-2029F, 2034F, $ Billion
10.2. India Regulatory Affairs Outsourcing Market, Segmentation By Indication, Historic and Forecast, 2019-2024, 2024-2029F, 2034F, $ Billion
10.3. India Regulatory Affairs Outsourcing Market, Segmentation By Category, Historic and Forecast, 2019-2024, 2024-2029F, 2034F, $ Billion
11. Japan Regulatory Affairs Outsourcing Market
11.1. Japan Regulatory Affairs Outsourcing Market Overview
11.2. Japan Regulatory Affairs Outsourcing Market, Segmentation By Service, Historic and Forecast, 2019-2024, 2024-2029F, 2034F, $ Billion
11.3. Japan Regulatory Affairs Outsourcing Market, Segmentation By Indication, Historic and Forecast, 2019-2024, 2024-2029F, 2034F, $ Billion
11.4. Japan Regulatory Affairs Outsourcing Market, Segmentation By Category, Historic and Forecast, 2019-2024, 2024-2029F, 2034F, $ Billion
12. Australia Regulatory Affairs Outsourcing Market
12.1. Australia Regulatory Affairs Outsourcing Market, Segmentation By Service, Historic and Forecast, 2019-2024, 2024-2029F, 2034F, $ Billion
12.2. Australia Regulatory Affairs Outsourcing Market, Segmentation By Indication, Historic and Forecast, 2019-2024, 2024-2029F, 2034F, $ Billion
12.3. Australia Regulatory Affairs Outsourcing Market, Segmentation By Category, Historic and Forecast, 2019-2024, 2024-2029F, 2034F, $ Billion
13. Indonesia Regulatory Affairs Outsourcing Market
13.1. Indonesia Regulatory Affairs Outsourcing Market, Segmentation By Service, Historic and Forecast, 2019-2024, 2024-2029F, 2034F, $ Billion
13.2. Indonesia Regulatory Affairs Outsourcing Market, Segmentation By Indication, Historic and Forecast, 2019-2024, 2024-2029F, 2034F, $ Billion
13.3. Indonesia Regulatory Affairs Outsourcing Market, Segmentation By Category, Historic and Forecast, 2019-2024, 2024-2029F, 2034F, $ Billion
14. South Korea Regulatory Affairs Outsourcing Market
14.1. South Korea Regulatory Affairs Outsourcing Market Overview
14.2. South Korea Regulatory Affairs Outsourcing Market, Segmentation By Service, Historic and Forecast, 2019-2024, 2024-2029F, 2034F, $ Billion
14.3. South Korea Regulatory Affairs Outsourcing Market, Segmentation By Indication, Historic and Forecast, 2019-2024, 2024-2029F, 2034F, $ Billion
14.4. South Korea Regulatory Affairs Outsourcing Market, Segmentation By Category, Historic and Forecast, 2019-2024, 2024-2029F, 2034F, $ Billion
15. Western Europe Regulatory Affairs Outsourcing Market
15.1. Western Europe Regulatory Affairs Outsourcing Market Overview
15.2. Western Europe Regulatory Affairs Outsourcing Market, Segmentation By Service, Historic and Forecast, 2019-2024, 2024-2029F, 2034F, $ Billion
15.3. Western Europe Regulatory Affairs Outsourcing Market, Segmentation By Indication, Historic and Forecast, 2019-2024, 2024-2029F, 2034F, $ Billion
15.4. Western Europe Regulatory Affairs Outsourcing Market, Segmentation By Category, Historic and Forecast, 2019-2024, 2024-2029F, 2034F, $ Billion
16. UK Regulatory Affairs Outsourcing Market
16.1. UK Regulatory Affairs Outsourcing Market, Segmentation By Service, Historic and Forecast, 2019-2024, 2024-2029F, 2034F, $ Billion
16.2. UK Regulatory Affairs Outsourcing Market, Segmentation By Indication, Historic and Forecast, 2019-2024, 2024-2029F, 2034F, $ Billion
16.3. UK Regulatory Affairs Outsourcing Market, Segmentation By Category, Historic and Forecast, 2019-2024, 2024-2029F, 2034F, $ Billion
17. Germany Regulatory Affairs Outsourcing Market
17.1. Germany Regulatory Affairs Outsourcing Market, Segmentation By Service, Historic and Forecast, 2019-2024, 2024-2029F, 2034F, $ Billion
17.2. Germany Regulatory Affairs Outsourcing Market, Segmentation By Indication, Historic and Forecast, 2019-2024, 2024-2029F, 2034F, $ Billion
17.3. Germany Regulatory Affairs Outsourcing Market, Segmentation By Category, Historic and Forecast, 2019-2024, 2024-2029F, 2034F, $ Billion
18. France Regulatory Affairs Outsourcing Market
18.1. France Regulatory Affairs Outsourcing Market, Segmentation By Service, Historic and Forecast, 2019-2024, 2024-2029F, 2034F, $ Billion
18.2. France Regulatory Affairs Outsourcing Market, Segmentation By Indication, Historic and Forecast, 2019-2024, 2024-2029F, 2034F, $ Billion
18.3. France Regulatory Affairs Outsourcing Market, Segmentation By Category, Historic and Forecast, 2019-2024, 2024-2029F, 2034F, $ Billion
19. Italy Regulatory Affairs Outsourcing Market
19.1. Italy Regulatory Affairs Outsourcing Market, Segmentation By Service, Historic and Forecast, 2019-2024, 2024-2029F, 2034F, $ Billion
19.2. Italy Regulatory Affairs Outsourcing Market, Segmentation By Indication, Historic and Forecast, 2019-2024, 2024-2029F, 2034F, $ Billion
19.3. Italy Regulatory Affairs Outsourcing Market, Segmentation By Category, Historic and Forecast, 2019-2024, 2024-2029F, 2034F, $ Billion
20. Spain Regulatory Affairs Outsourcing Market
20.1. Spain Regulatory Affairs Outsourcing Market, Segmentation By Service, Historic and Forecast, 2019-2024, 2024-2029F, 2034F, $ Billion
20.2. Spain Regulatory Affairs Outsourcing Market, Segmentation By Indication, Historic and Forecast, 2019-2024, 2024-2029F, 2034F, $ Billion
20.3. Spain Regulatory Affairs Outsourcing Market, Segmentation By Category, Historic and Forecast, 2019-2024, 2024-2029F, 2034F, $ Billion
21. Eastern Europe Regulatory Affairs Outsourcing Market
21.1. Eastern Europe Regulatory Affairs Outsourcing Market Overview
21.2. Eastern Europe Regulatory Affairs Outsourcing Market, Segmentation By Service, Historic and Forecast, 2019-2024, 2024-2029F, 2034F, $ Billion
21.3. Eastern Europe Regulatory Affairs Outsourcing Market, Segmentation By Indication, Historic and Forecast, 2019-2024, 2024-2029F, 2034F, $ Billion
21.4. Eastern Europe Regulatory Affairs Outsourcing Market, Segmentation By Category, Historic and Forecast, 2019-2024, 2024-2029F, 2034F, $ Billion
22. Russia Regulatory Affairs Outsourcing Market
22.1. Russia Regulatory Affairs Outsourcing Market, Segmentation By Service, Historic and Forecast, 2019-2024, 2024-2029F, 2034F, $ Billion
22.2. Russia Regulatory Affairs Outsourcing Market, Segmentation By Indication, Historic and Forecast, 2019-2024, 2024-2029F, 2034F, $ Billion
22.3. Russia Regulatory Affairs Outsourcing Market, Segmentation By Category, Historic and Forecast, 2019-2024, 2024-2029F, 2034F, $ Billion
23. North America Regulatory Affairs Outsourcing Market
23.1. North America Regulatory Affairs Outsourcing Market Overview
23.2. North America Regulatory Affairs Outsourcing Market, Segmentation By Service, Historic and Forecast, 2019-2024, 2024-2029F, 2034F, $ Billion
23.3. North America Regulatory Affairs Outsourcing Market, Segmentation By Indication, Historic and Forecast, 2019-2024, 2024-2029F, 2034F, $ Billion
23.4. North America Regulatory Affairs Outsourcing Market, Segmentation By Category, Historic and Forecast, 2019-2024, 2024-2029F, 2034F, $ Billion
24. USA Regulatory Affairs Outsourcing Market
24.1. USA Regulatory Affairs Outsourcing Market Overview
24.2. USA Regulatory Affairs Outsourcing Market, Segmentation By Service, Historic and Forecast, 2019-2024, 2024-2029F, 2034F, $ Billion
24.3. USA Regulatory Affairs Outsourcing Market, Segmentation By Indication, Historic and Forecast, 2019-2024, 2024-2029F, 2034F, $ Billion
24.4. USA Regulatory Affairs Outsourcing Market, Segmentation By Category, Historic and Forecast, 2019-2024, 2024-2029F, 2034F, $ Billion
25. Canada Regulatory Affairs Outsourcing Market
25.1. Canada Regulatory Affairs Outsourcing Market Overview
25.2. Canada Regulatory Affairs Outsourcing Market, Segmentation By Service, Historic and Forecast, 2019-2024, 2024-2029F, 2034F, $ Billion
25.3. Canada Regulatory Affairs Outsourcing Market, Segmentation By Indication, Historic and Forecast, 2019-2024, 2024-2029F, 2034F, $ Billion
25.4. Canada Regulatory Affairs Outsourcing Market, Segmentation By Category, Historic and Forecast, 2019-2024, 2024-2029F, 2034F, $ Billion
26. South America Regulatory Affairs Outsourcing Market
26.1. South America Regulatory Affairs Outsourcing Market Overview
26.2. South America Regulatory Affairs Outsourcing Market, Segmentation By Service, Historic and Forecast, 2019-2024, 2024-2029F, 2034F, $ Billion
26.3. South America Regulatory Affairs Outsourcing Market, Segmentation By Indication, Historic and Forecast, 2019-2024, 2024-2029F, 2034F, $ Billion
26.4. South America Regulatory Affairs Outsourcing Market, Segmentation By Category, Historic and Forecast, 2019-2024, 2024-2029F, 2034F, $ Billion
27. Brazil Regulatory Affairs Outsourcing Market
27.1. Brazil Regulatory Affairs Outsourcing Market, Segmentation By Service, Historic and Forecast, 2019-2024, 2024-2029F, 2034F, $ Billion
27.2. Brazil Regulatory Affairs Outsourcing Market, Segmentation By Indication, Historic and Forecast, 2019-2024, 2024-2029F, 2034F, $ Billion
27.3. Brazil Regulatory Affairs Outsourcing Market, Segmentation By Category, Historic and Forecast, 2019-2024, 2024-2029F, 2034F, $ Billion
28. Middle East Regulatory Affairs Outsourcing Market
28.1. Middle East Regulatory Affairs Outsourcing Market Overview
28.2. Middle East Regulatory Affairs Outsourcing Market, Segmentation By Service, Historic and Forecast, 2019-2024, 2024-2029F, 2034F, $ Billion
28.3. Middle East Regulatory Affairs Outsourcing Market, Segmentation By Indication, Historic and Forecast, 2019-2024, 2024-2029F, 2034F, $ Billion
28.4. Middle East Regulatory Affairs Outsourcing Market, Segmentation By Category, Historic and Forecast, 2019-2024, 2024-2029F, 2034F, $ Billion
29. Africa Regulatory Affairs Outsourcing Market
29.1. Africa Regulatory Affairs Outsourcing Market Overview
29.2. Africa Regulatory Affairs Outsourcing Market, Segmentation By Service, Historic and Forecast, 2019-2024, 2024-2029F, 2034F, $ Billion
29.3. Africa Regulatory Affairs Outsourcing Market, Segmentation By Indication, Historic and Forecast, 2019-2024, 2024-2029F, 2034F, $ Billion
29.4. Africa Regulatory Affairs Outsourcing Market, Segmentation By Category, Historic and Forecast, 2019-2024, 2024-2029F, 2034F, $ Billion
30. Regulatory Affairs Outsourcing Market Competitive Landscape And Company Profiles
30.1. Regulatory Affairs Outsourcing Market Competitive Landscape
30.2. Regulatory Affairs Outsourcing Market Company Profiles
30.2.1. Thermo Fisher Scientific Inc. (PPD) Overview, Products and Services, Strategy and Financial Analysis
30.2.2. IQVIA Overview, Products and Services, Strategy and Financial Analysis
30.2.3. ICON plc Overview, Products and Services, Strategy and Financial Analysis
30.2.4. WuXi App Tec Overview, Products and Services, Strategy and Financial Analysis
30.2.5. Syneos Health Overview, Products and Services, Strategy and Financial Analysis
31. Regulatory Affairs Outsourcing Market Other Major And Innovative Companies
31.1. Catalent Pharma Solutions
31.2. Charles River Laboratories International. Inc.
31.3. Parexel International Corporation
31.4. Medpace
31.5. Curia
31.6. Certara L.P.
31.7. Amicus GMP
31.8. Pace Life Sciences
31.9. CTI Clinical Trial & Consulting
31.10. Accell Clinical Research LLC
31.11. Promedica International
31.12. Clinilabs Inc.
31.13. CliniExperts Pvt Ltd.
31.14. Global Regulatory Services (GRS)
31.15. Pharma Design Limited
32. Global Regulatory Affairs Outsourcing Market Competitive Benchmarking And Dashboard
33. Key Mergers And Acquisitions In The Regulatory Affairs Outsourcing Market
34. Recent Developments In The Regulatory Affairs Outsourcing Market
35. Regulatory Affairs Outsourcing Market High Potential Countries, Segments and Strategies
35.1 Regulatory Affairs Outsourcing Market In 2029 - Countries Offering Most New Opportunities
35.2 Regulatory Affairs Outsourcing Market In 2029 - Segments Offering Most New Opportunities
35.3 Regulatory Affairs Outsourcing Market In 2029 - Growth Strategies
35.3.1 Market Trend Based Strategies
35.3.2 Competitor Strategies
36. Appendix
36.1. Abbreviations
36.2. Currencies
36.3. Historic And Forecast Inflation Rates
36.4. Research Inquiries
36.5. The Business Research Company
36.6. Copyright And Disclaimer

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