세계의 RA(Regulatory Affairs) 아웃소싱 시장 규모 - 서비스, 카테고리, 적응증, 제품 단계, 최종 사용자별 - 지역별 전망, 경쟁 전략, 부문 예측(-2033년)

Regulatory Affairs Outsourcing Market Introduction and Overview

According to SPER market research, 'Regulatory Affairs Outsourcing Market Size- By Service, By Category, By Indication, By Product Stage, By End User- Regional Outlook, Competitive Strategies and Segment Forecast to 2033' state that the Regulatory Affairs Outsourcing Market is predicted to reach 20896.18 million by 2033 with a CAGR of 10.92%.

In order to safeguard the general public's health, government affairs, also known as regulatory affairs, is the study and examination of goods from a variety of industries, including agrochemicals, cosmetics, pesticides, medical devices, pharmaceuticals, veterinary medications, and complementary and alternative medicine. Outsourcing regulatory issues may be advantageous for companies that produce pharmaceuticals, biomedical equipment, and medical supplies.

The pandemic's widespread lockdowns caused by the high number of COVID-19 cases it included disrupted clinical trials for several chronic diseases, including cancer. The pandemic's reduction in clinical study numbers resulted in a downturn in the market for healthcare regulatory affairs outsourcing services. As a result, early pandemic disruptions in the global supply chain affected pharmaceutical product manufacturing and distribution, which significantly hindered market expansion.

Scope of the Report:

Report Metric Details

Market size available for years 2020-2033

Base year considered 2023

Forecast period 2024-2033

Segments covered By Service, By Category, By Indication, By Product Stage, By End User

Regions covered North America, Asia-Pacific, Latin America, Middle East & Africa and Europe

Companies Covered Accell Clinical Research, LLC, Genpact, CRITERIUM, INC, Promedica International, WuXi AppTec, Medpace, Charles River Laboratories, Pharmexon, Qvigilance, BlueReg, Cambridge Regulatory Services, APCER Life Sciences, Inc, Real Regulatory Ltd, ProPharma Group MIS Limited.

Regulatory Affairs Outsourcing Market Segmentation

By Service: Based on the Service, Global Regulatory Affairs Outsourcing Market is segmented as; Regulatory Consulting, Legal Representation, Regulatory Writing & Publishing, Product Registration & Clinical Trial Applications, Regulatory Operations, Regulatory Submissions, Others.

By Category: Based on the Category, Global Regulatory Affairs Outsourcing Market is segmented as; Pharmaceuticals, Medical Device, Others.

By Indication: Based on the Indication, Global Regulatory Affairs Outsourcing Market is segmented as; Oncology, Neurology, Cardiology, Immunology, Others.

By Product Stage: Based on the Product Stage, Global Regulatory Affairs Outsourcing Market is segmented as; Preclinical, Clinical, PMA, Others.

Table of Contents

1. Introduction

• 1.1. Scope of the report
• 1.2. Market segment analysis

2. Research Methodology

• 2.1. Research data source
  • 2.1.1. Secondary Data
  • 2.1.2. Primary Data
  • 2.1.3. SPER's internal database
  • 2.1.4. Premium insight from KOL's
• 2.2. Market size estimation
  • 2.2.1. Top-down and Bottom-up approach
• 2.3. Data triangulation

3. Executive Summary

4. Market Dynamics

• 4.1. Driver, Restraint, Opportunity and Challenges analysis
  • 4.1.1. Drivers
  • 4.1.2. Restraints
  • 4.1.3. Opportunities
  • 4.1.4. Challenges
• 4.2. COVID-19 Impacts of the Global Regulatory Affairs Outsourcing Market

5. Market variable and outlook

• 5.1. SWOT Analysis
  • 5.1.1. Strengths
  • 5.1.2. Weaknesses
  • 5.1.3. Opportunities
  • 5.1.4. Threats
• 5.2. PESTEL Analysis
  • 5.2.1. Political Landscape
  • 5.2.2. Economic Landscape
  • 5.2.3. Social Landscape
  • 5.2.4. Technological Landscape
  • 5.2.5. Environmental Landscape
  • 5.2.6. Legal Landscape
• 5.3. PORTER's Five Forces
  • 5.3.1. Bargaining power of suppliers
  • 5.3.2. Bargaining power of buyers
  • 5.3.3. Threat of Substitute
  • 5.3.4. Threat of new entrant
  • 5.3.5. Competitive rivalry
• 5.4. Heat Map Analysis

6. Competitive Landscape

• 6.1. Global Regulatory Affairs Outsourcing Market Manufacturing Base Distribution, Sales Area, Ingredients
• 6.2. Mergers & Acquisitions, Partnerships, Product Launch, and Collaboration in Global Regulatory Affairs Outsourcing Market

7. Global Regulatory Affairs Outsourcing Market, By Service (USD Million)

• 7.1. Global Regulatory Affairs Outsourcing Market Value Share and Forecast, By Service 2024-2033
• 7.2. Regulatory Consulting
  • 7.2.1. Strategy & Development Planning
  • 7.2.2. QA Consulting
  • 7.2.3. Others
• 7.3. Legal Representation
• 7.4. Regulatory Writing & Publishing
• 7.5. Product Registration & Clinical Trial Applications
• 7.6. Regulatory Operations
• 7.7. Regulatory Submission
• 7.8. Others

8. Global Regulatory Affairs Outsourcing Market, By Category (USD Million)

• 8.1. Global Regulatory Affairs Outsourcing Market Value Share and Forecast, By Category 2024-2033
• 8.2. Pharmaceuticals
  • 8.2.1. Regulatory Consulting
  • 8.2.2. Legal Representation
  • 8.2.3. Regulatory Writing & Publishing
  • 8.2.4. Product Registration & Clinical Trial Applications
  • 8.2.5. Regulatory Submissions
  • 8.2.6. Regulatory Operations
  • 8.2.7. Others
• 8.3. Medical Device
  • 8.3.1. Regulatory Consulting
  • 8.3.2. Legal Representation
  • 8.3.3. Regulatory Writing & Publishing
  • 8.3.4. Product Registration & Clinical Trial Applications
  • 8.3.5. Regulatory Submissions
  • 8.3.6. Regulatory Operations
• 8.4. Others

9. Global Regulatory Affairs Outsourcing Market, By Indication (USD Million)

• 9.1. Global Regulatory Affairs Outsourcing Market Size Value Share and Forecast, By Indication 2024-2033
• 9.2. Oncology
• 9.3. Neurology
• 9.4. Cardiology
• 9.5. Immunology
• 9.6. Others

10. Global Regulatory Affairs Outsourcing Market, By Product Stage (USD Million)

• 10.1. Global Regulatory Affairs Outsourcing Market Size Value Share and Forecast, By Product Stage 2024-2033
• 10.2. Preclinical
• 10.3. Clinical
• 10.4. PMA (Post Market Authorization

11. Global Regulatory Affairs Outsourcing Market, By End User (USD Million)

• 11.1. Global Regulatory Affairs Outsourcing Market Size Value Share and Forecast, By End User 2024-2033
• 11.2. Medical Device Companies
• 11.3. Pharmaceutical Companies
• 11.4. Biotechnology Companies
• 11.5. Others

12. Global Regulatory Affairs Outsourcing Market, Forecast, 2020-2033 (USD Million)

• 12.1. Global Regulatory Affairs Outsourcing Market Size and Market Share

13. Global Regulatory Affairs Outsourcing Market, By Service 2020-2033 (USD Million)

• 13.1. Global Regulatory Affairs Outsourcing Market Size and Market Share, By Service (2020-2026)
• 13.2. Global Regulatory Affairs Outsourcing Market Size and Market Share, By Service (2027-2033)

14. Global Regulatory Affairs Outsourcing Market, By Category 2020-2033 (USD Million)

• 14.1. Global Regulatory Affairs Outsourcing Market Size and Market Share, By Category (2020-2026)
• 14.2. Global Regulatory Affairs Outsourcing Market Size and Market Share, By Category (2027-2033)

15. Global Regulatory Affairs Outsourcing Market, By Indication 2020-2033 (USD Million)

• 15.1. Global Regulatory Affairs Outsourcing Market Size and Market Share, By Indication (2020-2026)
• 15.2. Global Regulatory Affairs Outsourcing Market Size and Market Share, By Indication (2027-2033)

16. Global Regulatory Affairs Outsourcing Market, By Product Stage 2020-2033 (USD Million)

• 16.1. Global Regulatory Affairs Outsourcing Market Size and Market Share, By Product Stage (2020-2026)
• 16.2. Global Regulatory Affairs Outsourcing Market Size and Market Share, By Product Stage (2027-2033)

17. Global Regulatory Affairs Outsourcing Market, By End User 2020-2033 (USD Million)

• 17.1. Global Regulatory Affairs Outsourcing Market Size and Market Share, By End User (2020-2026)
• 17.2. Global Regulatory Affairs Outsourcing Market Size and Market Share, By End User (2027-2033)

18. Global Regulatory Affairs Outsourcing Market, By Region, 2020-2033 (USD Million)

• 18.1. Global Regulatory Affairs Outsourcing Market Size and Market Share, By Region (2020-2026)
• 18.2. Global Regulatory Affairs Outsourcing Market Size and Market Share, By Region (2027-2033)
• 18.3. Asia-Pacific
  • 18.3.1. Australia
  • 18.3.2. China
  • 18.3.3. India
  • 18.3.4. Japan
  • 18.3.5. South Korea
  • 18.3.6. Rest of Asia-Pacific
• 18.4. Europe
  • 18.4.1. France
  • 18.4.2. Germany
  • 18.4.3. Italy
  • 18.4.4. Spain
  • 18.4.5. United Kingdom
  • 18.4.6. Rest of Europe
• 18.5. Middle East and Africa
  • 18.5.1. Kingdom of Saudi Arabia
  • 18.5.2. United Arab Emirates
  • 18.5.3. Rest of Middle East & Africa
• 18.6. North America
  • 18.6.1. Canada
  • 18.6.2. Mexico
  • 18.6.3. United States
• 18.7. Latin America
  • 18.7.1. Argentina
  • 18.7.2. Brazil
  • 18.7.3. Rest of Latin America

19. Company Profile

• 19.1. Accell Clinical Research, LLC
  • 19.1.1. Company details
  • 19.1.2. Financial outlook
  • 19.1.3. Product summary
  • 19.1.4. Recent developments
• 19.2. Genpact
  • 19.2.1. Company details
  • 19.2.2. Financial outlook
  • 19.2.3. Product summary
  • 19.2.4. Recent developments
• 19.3. CRITERIUM, INC
  • 19.3.1. Company details
  • 19.3.2. Financial outlook
  • 19.3.3. Product summary
  • 19.3.4. Recent developments
• 19.4. Promedica International
  • 19.4.1. Company details
  • 19.4.2. Financial outlook
  • 19.4.3. Product summary
  • 19.4.4. Recent developments
• 19.5. WuXi AppTec
  • 19.5.1. Company details
  • 19.5.2. Financial outlook
  • 19.5.3. Product summary
  • 19.5.4. Recent developments
• 19.6. Medpace
  • 19.6.1. Company details
  • 19.6.2. Financial outlook
  • 19.6.3. Product summary
  • 19.6.4. Recent developments
• 19.7. Charles River Laboratories
  • 19.7.1. Company details
  • 19.7.2. Financial outlook
  • 19.7.3. Product summary
  • 19.7.4. Recent developments
• 19.8. ICON plc
  • 19.8.1. Company details
  • 19.8.2. Financial outlook
  • 19.8.3. Product summary
  • 19.8.4. Recent developments
• 19.9. Labcorp Drug Development
  • 19.9.1. Company details
  • 19.9.2. Financial outlook
  • 19.9.3. Product summary
  • 19.9.4. Recent developments
• 19.10. Parexel International Corporation
  • 19.10.1. Company details
  • 19.10.2. Financial outlook
  • 19.10.3. Product summary
  • 19.10.4. Recent developments
• 19.11. Freyr
  • 19.11.1. Company details
  • 19.11.2. Financial outlook
  • 19.11.3. Product summary
  • 19.11.4. Recent developments
• 19.12. PHARMALEX GMBH
  • 19.12.1. Company details
  • 19.12.2. Financial outlook
  • 19.12.3. Product summary
  • 19.12.4. Recent developments
• 19.13. NDA Group AB
  • 19.13.1. Company details
  • 19.13.2. Financial outlook
  • 19.13.3. Product summary
  • 19.13.4. Recent developments
• 19.14. Pharmexon
  • 19.14.1. Company details
  • 19.14.2. Financial outlook
  • 19.14.3. Product summary
  • 19.14.4. Recent developments
• 19.15. Qvigilance
  • 19.15.1. Company details
  • 19.15.2. Financial outlook
  • 19.15.3. Product summary
  • 19.15.4. Recent developments
• 19.16. BlueReg
  • 19.16.1. Company details
  • 19.16.2. Financial outlook
  • 19.16.3. Product summary
  • 19.16.4. Recent developments
• 19.17. Cambridge Regulatory Services
  • 19.17.1. Company details
  • 19.17.2. Financial outlook
  • 19.17.3. Product summary
  • 19.17.4. Recent developments
• 19.18. APCER Life Sciences, Inc.
  • 19.18.1. Company details
  • 19.18.2. Financial outlook
  • 19.18.3. Product summary
  • 19.18.4. Recent developments
• 19.19. Real Regulatory Ltd
  • 19.19.1. Company details
  • 19.19.2. Financial outlook
  • 19.19.3. Product summary
  • 19.19.4. Recent developments
• 19.20. VCLS
  • 19.20.1. Company details
  • 19.20.2. Financial outlook
  • 19.20.3. Product summary
  • 19.20.4. Recent developments
• 19.21. PrimeVigilance
  • 19.21.1. Company details
  • 19.21.2. Financial outlook
  • 19.21.3. Product summary
  • 19.21.4. Recent developments
• 19.22. ProPharma Group MIS Limited
  • 19.22.1. Company details
  • 19.22.2. Financial outlook
  • 19.22.3. Product summary
  • 19.22.4. Recent developments
• 19.23. Others

20. List of Abbreviations

21. Reference Links

22. Conclusion

23. Research Scope