List of Contents

Regulatory Affairs Market Size, Share, and Trends 2024 to 2034

Regulatory Affairs Market (By Services: Regulatory Consulting, Legal Representation, Regulatory Writing & Publishing, Product Registration & Clinical Trial Applications, Other Services; By Category: Drugs, Biologics, Medical Devices; By Indication; By Stage; By Service Provider; By Company; By End User) - Global Industry Analysis, Size, Share, Growth, Trends, Regional Outlook, and Forecast 2023-2032

  • Last Updated : February 2024
  • Report Code : 1986
  • Category : Healthcare

Chapter 1. Introduction

1.1. Research Objective

1.2. Scope of the Study

1.3. Definition

Chapter 2. Research Methodology

2.1. Research Approach

2.2. Data Sources

2.3. Assumptions & Limitations

Chapter 3. Executive Summary

3.1. Market Snapshot

Chapter 4. Market Variables and Scope 

4.1. Introduction

4.2. Market Classification and Scope

4.3. Industry Value Chain Analysis

4.3.1. Raw Material Procurement Analysis 

4.3.2. Sales and Distribution Channel Analysis

4.3.3. Downstream Buyer Analysis

Chapter 5. Market Dynamics Analysis and Trends

5.1. Market Dynamics

5.1.1. Market Drivers

5.1.2. Market Restraints

5.1.3. Market Opportunities

5.2. Porter’s Five Forces Analysis

5.2.1. Bargaining power of suppliers

5.2.2. Bargaining power of buyers

5.2.3. Threat of substitute

5.2.4. Threat of new entrants

5.2.5. Degree of competition

Chapter 6. Competitive Landscape

6.1.1. Company Market Share/Positioning Analysis

6.1.2. Key Strategies Adopted by Players

6.1.3. Vendor Landscape

6.1.3.1. List of Suppliers

6.1.3.2. List of Buyers

Chapter 7. Global Regulatory Affairs Market, By Services

7.1. Regulatory Affairs Market, by Services, 2023-2032

7.1.1. Regulatory Consulting

7.1.1.1. Market Revenue and Forecast (2021-2032)

7.1.2. Legal Representation

7.1.2.1. Market Revenue and Forecast (2021-2032)

7.1.3. Regulatory Writing & Publishing

7.1.3.1. Market Revenue and Forecast (2021-2032)

7.1.4. Product Registration & Clinical Trial Applications

7.1.4.1. Market Revenue and Forecast (2021-2032)

7.1.5. Other Services

7.1.5.1. Market Revenue and Forecast (2021-2032)

Chapter 8. Global Regulatory Affairs Market, By Category

8.1. Regulatory Affairs Market, by Category, 2023-2032

8.1.1. Drugs

8.1.1.1. Market Revenue and Forecast (2021-2032)

8.1.2. Biologics

8.1.2.1. Market Revenue and Forecast (2021-2032)

8.1.3. Medical Devices

8.1.3.1. Market Revenue and Forecast (2021-2032)

Chapter 9. Global Regulatory Affairs Market, By Indication

9.1. Regulatory Affairs Market, by Indication, 2023-2032

9.1.1. Oncology

9.1.1.1. Market Revenue and Forecast (2021-2032)

9.1.2. Neurology

9.1.2.1. Market Revenue and Forecast (2021-2032)

9.1.3. Cardiology

9.1.3.1. Market Revenue and Forecast (2021-2032)

9.1.4. Immunology

9.1.4.1. Market Revenue and Forecast (2021-2032)

9.1.5. Others

9.1.5.1. Market Revenue and Forecast (2021-2032)

Chapter 10. Global Regulatory Affairs Market, By Stage

10.1. Regulatory Affairs Market, by Stage, 2023-2032

10.1.1. Preclinical

10.1.1.1. Market Revenue and Forecast (2021-2032)

10.1.2. Clinical studies

10.1.2.1. Market Revenue and Forecast (2021-2032)

10.1.3. PMA

10.1.3.1. Market Revenue and Forecast (2021-2032)

Chapter 11. Global Regulatory Affairs Market, By Service Provider

11.1. Regulatory Affairs Market, by Service Provider, 2023-2032

11.1.1. In-house

11.1.1.1. Market Revenue and Forecast (2021-2032)

11.1.2. Outsourced

11.1.2.1. Market Revenue and Forecast (2021-2032)

Chapter 12. Global Regulatory Affairs Market, By Company

12.1. Regulatory Affairs Market, by Company, 2023-2032

12.1.1. Small

12.1.1.1. Market Revenue and Forecast (2021-2032)

12.1.2. Medium

12.1.2.1. Market Revenue and Forecast (2021-2032)

12.1.3. Large

12.1.3.1. Market Revenue and Forecast (2021-2032)

Chapter 13. Global Regulatory Affairs Market, By End User

13.1. Regulatory Affairs Market, by End User, 2023-2032

13.1.1. Medical Device Companies

13.1.1.1. Market Revenue and Forecast (2021-2032)

13.1.2. Pharmaceutical Companies

13.1.2.1. Market Revenue and Forecast (2021-2032)

13.1.3. Biotechnology Companies

13.1.3.1. Market Revenue and Forecast (2021-2032)

Chapter 14. Global Regulatory Affairs Market, Regional Estimates and Trend Forecast

14.1. North America

14.1.1. Market Revenue and Forecast, by Services (2021-2032)

14.1.2. Market Revenue and Forecast, by Category (2021-2032)

14.1.3. Market Revenue and Forecast, by Indication (2021-2032)

14.1.4. Market Revenue and Forecast, by Stage (2021-2032)

14.1.5. Market Revenue and Forecast, by Service Provider (2021-2032)

14.1.6. Market Revenue and Forecast, by End User (2021-2032)

14.1.7. Market Revenue and Forecast, by Company (2021-2032)

14.1.8. U.S.

14.1.8.1. Market Revenue and Forecast, by Services (2021-2032)

14.1.8.2. Market Revenue and Forecast, by Category (2021-2032)

14.1.8.3. Market Revenue and Forecast, by Indication (2021-2032)

14.1.8.4. Market Revenue and Forecast, by Stage (2021-2032)

14.1.8.5. Market Revenue and Forecast, by Service Provider (2021-2032)

14.1.8.6. Market Revenue and Forecast, by End User (2021-2032)

14.1.8.7. Market Revenue and Forecast, by Company (2021-2032)

14.1.9. Rest of North America

14.1.9.1. Market Revenue and Forecast, by Services (2021-2032)

14.1.9.2. Market Revenue and Forecast, by Category (2021-2032)

14.1.9.3. Market Revenue and Forecast, by Indication (2021-2032)

14.1.9.4. Market Revenue and Forecast, by Stage (2021-2032)

14.1.9.5. Market Revenue and Forecast, by Service Provider (2021-2032)

14.1.9.6. Market Revenue and Forecast, by End User (2021-2032)

14.1.9.7. Market Revenue and Forecast, by Company (2021-2032)

14.2. Europe

14.2.1. Market Revenue and Forecast, by Services (2021-2032)

14.2.2. Market Revenue and Forecast, by Category (2021-2032)

14.2.3. Market Revenue and Forecast, by Indication (2021-2032)

14.2.4. Market Revenue and Forecast, by Stage (2021-2032)

14.2.5. Market Revenue and Forecast, by Service Provider (2021-2032)

14.2.6. Market Revenue and Forecast, by End User (2021-2032)

14.2.7. Market Revenue and Forecast, by Company (2021-2032)

14.2.8. UK

14.2.8.1. Market Revenue and Forecast, by Services (2021-2032)

14.2.8.2. Market Revenue and Forecast, by Category (2021-2032)

14.2.8.3. Market Revenue and Forecast, by Indication (2021-2032)

14.2.8.4. Market Revenue and Forecast, by Stage (2021-2032)

14.2.8.5. Market Revenue and Forecast, by Service Provider (2021-2032)

14.2.8.6. Market Revenue and Forecast, by End User (2021-2032)

14.2.8.7. Market Revenue and Forecast, by Company (2021-2032)

14.2.9. Germany

14.2.9.1. Market Revenue and Forecast, by Services (2021-2032)

14.2.9.2. Market Revenue and Forecast, by Category (2021-2032)

14.2.9.3. Market Revenue and Forecast, by Indication (2021-2032)

14.2.9.4. Market Revenue and Forecast, by Stage (2021-2032)

14.2.9.5. Market Revenue and Forecast, by Service Provider (2021-2032)

14.2.9.6. Market Revenue and Forecast, by End User (2021-2032)

14.2.9.7. Market Revenue and Forecast, by Company (2021-2032)

14.2.10. France

14.2.10.1. Market Revenue and Forecast, by Services (2021-2032)

14.2.10.2. Market Revenue and Forecast, by Category (2021-2032)

14.2.10.3. Market Revenue and Forecast, by Indication (2021-2032)

14.2.10.4. Market Revenue and Forecast, by Stage (2021-2032)

14.2.10.5. Market Revenue and Forecast, by Service Provider (2021-2032)

14.2.10.6. Market Revenue and Forecast, by End User (2021-2032)

14.2.10.7. Market Revenue and Forecast, by Company (2021-2032)

14.2.11. Rest of Europe

14.2.11.1. Market Revenue and Forecast, by Services (2021-2032)

14.2.11.2. Market Revenue and Forecast, by Category (2021-2032)

14.2.11.3. Market Revenue and Forecast, by Indication (2021-2032)

14.2.11.4. Market Revenue and Forecast, by Stage (2021-2032)

14.2.11.5. Market Revenue and Forecast, by Service Provider (2021-2032)

14.2.11.6. Market Revenue and Forecast, by End User (2021-2032)

14.2.11.7. Market Revenue and Forecast, by Company (2021-2032)

14.3. APAC

14.3.1. Market Revenue and Forecast, by Services (2021-2032)

14.3.2. Market Revenue and Forecast, by Category (2021-2032)

14.3.3. Market Revenue and Forecast, by Indication (2021-2032)

14.3.4. Market Revenue and Forecast, by Stage (2021-2032)

14.3.5. Market Revenue and Forecast, by Service Provider (2021-2032)

14.3.6. Market Revenue and Forecast, by End User (2021-2032)

14.3.7. Market Revenue and Forecast, by Company (2021-2032)

14.3.8. India

14.3.8.1. Market Revenue and Forecast, by Services (2021-2032)

14.3.8.2. Market Revenue and Forecast, by Category (2021-2032)

14.3.8.3. Market Revenue and Forecast, by Indication (2021-2032)

14.3.8.4. Market Revenue and Forecast, by Stage (2021-2032)

14.3.8.5. Market Revenue and Forecast, by Service Provider (2021-2032)

14.3.8.6. Market Revenue and Forecast, by End User (2021-2032)

14.3.8.7. Market Revenue and Forecast, by Company (2021-2032)

14.3.9. China

14.3.9.1. Market Revenue and Forecast, by Services (2021-2032)

14.3.9.2. Market Revenue and Forecast, by Category (2021-2032)

14.3.9.3. Market Revenue and Forecast, by Indication (2021-2032)

14.3.9.4. Market Revenue and Forecast, by Stage (2021-2032)

14.3.9.5. Market Revenue and Forecast, by Service Provider (2021-2032)

14.3.9.6. Market Revenue and Forecast, by End User (2021-2032)

14.3.9.7. Market Revenue and Forecast, by Company (2021-2032)

14.3.10. Japan

14.3.10.1. Market Revenue and Forecast, by Services (2021-2032)

14.3.10.2. Market Revenue and Forecast, by Category (2021-2032)

14.3.10.3. Market Revenue and Forecast, by Indication (2021-2032)

14.3.10.4. Market Revenue and Forecast, by Stage (2021-2032)

14.3.10.5. Market Revenue and Forecast, by Service Provider (2021-2032)

14.3.10.6. Market Revenue and Forecast, by End User (2021-2032)

14.3.10.7. Market Revenue and Forecast, by Company (2021-2032)

14.3.11. Rest of APAC

14.3.11.1. Market Revenue and Forecast, by Services (2021-2032)

14.3.11.2. Market Revenue and Forecast, by Category (2021-2032)

14.3.11.3. Market Revenue and Forecast, by Indication (2021-2032)

14.3.11.4. Market Revenue and Forecast, by Stage (2021-2032)

14.3.11.5. Market Revenue and Forecast, by Service Provider (2021-2032)

14.3.11.6. Market Revenue and Forecast, by End User (2021-2032)

14.3.11.7. Market Revenue and Forecast, by Company (2021-2032)

14.4. MEA

14.4.1. Market Revenue and Forecast, by Services (2021-2032)

14.4.2. Market Revenue and Forecast, by Category (2021-2032)

14.4.3. Market Revenue and Forecast, by Indication (2021-2032)

14.4.4. Market Revenue and Forecast, by Stage (2021-2032)

14.4.5. Market Revenue and Forecast, by Service Provider (2021-2032)

14.4.6. Market Revenue and Forecast, by End User (2021-2032)

14.4.7. Market Revenue and Forecast, by Company (2021-2032)

14.4.8. GCC

14.4.8.1. Market Revenue and Forecast, by Services (2021-2032)

14.4.8.2. Market Revenue and Forecast, by Category (2021-2032)

14.4.8.3. Market Revenue and Forecast, by Indication (2021-2032)

14.4.8.4. Market Revenue and Forecast, by Stage (2021-2032)

14.4.8.5. Market Revenue and Forecast, by Service Provider (2021-2032)

14.4.8.6. Market Revenue and Forecast, by End User (2021-2032)

14.4.8.7. Market Revenue and Forecast, by Company (2021-2032)

14.4.9. North Africa

14.4.9.1. Market Revenue and Forecast, by Services (2021-2032)

14.4.9.2. Market Revenue and Forecast, by Category (2021-2032)

14.4.9.3. Market Revenue and Forecast, by Indication (2021-2032)

14.4.9.4. Market Revenue and Forecast, by Stage (2021-2032)

14.4.9.5. Market Revenue and Forecast, by Service Provider (2021-2032)

14.4.9.6. Market Revenue and Forecast, by End User (2021-2032)

14.4.9.7. Market Revenue and Forecast, by Company (2021-2032)

14.4.10. South Africa

14.4.10.1. Market Revenue and Forecast, by Services (2021-2032)

14.4.10.2. Market Revenue and Forecast, by Category (2021-2032)

14.4.10.3. Market Revenue and Forecast, by Indication (2021-2032)

14.4.10.4. Market Revenue and Forecast, by Stage (2021-2032)

14.4.10.5. Market Revenue and Forecast, by Service Provider (2021-2032)

14.4.10.6. Market Revenue and Forecast, by End User (2021-2032)

14.4.10.7. Market Revenue and Forecast, by Company (2021-2032)

14.4.11. Rest of MEA

14.4.11.1. Market Revenue and Forecast, by Services (2021-2032)

14.4.11.2. Market Revenue and Forecast, by Category (2021-2032)

14.4.11.3. Market Revenue and Forecast, by Indication (2021-2032)

14.4.11.4. Market Revenue and Forecast, by Stage (2021-2032)

14.4.11.5. Market Revenue and Forecast, by Service Provider (2021-2032)

14.4.11.6. Market Revenue and Forecast, by End User (2021-2032)

14.4.11.7. Market Revenue and Forecast, by Company (2021-2032)

14.5. Latin America

14.5.1. Market Revenue and Forecast, by Services (2021-2032)

14.5.2. Market Revenue and Forecast, by Category (2021-2032)

14.5.3. Market Revenue and Forecast, by Indication (2021-2032)

14.5.4. Market Revenue and Forecast, by Stage (2021-2032)

14.5.5. Market Revenue and Forecast, by Service Provider (2021-2032)

14.5.6. Market Revenue and Forecast, by End User (2021-2032)

14.5.7. Market Revenue and Forecast, by Company (2021-2032)

14.5.8. Brazil

14.5.8.1. Market Revenue and Forecast, by Services (2021-2032)

14.5.8.2. Market Revenue and Forecast, by Category (2021-2032)

14.5.8.3. Market Revenue and Forecast, by Indication (2021-2032)

14.5.8.4. Market Revenue and Forecast, by Stage (2021-2032)

14.5.8.5. Market Revenue and Forecast, by Service Provider (2021-2032)

14.5.8.6. Market Revenue and Forecast, by End User (2021-2032)

14.5.8.7. Market Revenue and Forecast, by Company (2021-2032)

14.5.9. Rest of LATAM

14.5.9.1. Market Revenue and Forecast, by Services (2021-2032)

14.5.9.2. Market Revenue and Forecast, by Category (2021-2032)

14.5.9.3. Market Revenue and Forecast, by Indication (2021-2032)

14.5.9.4. Market Revenue and Forecast, by Stage (2021-2032)

14.5.9.5. Market Revenue and Forecast, by Service Provider (2021-2032)

14.5.9.6. Market Revenue and Forecast, by End User (2021-2032)

14.5.9.7. Market Revenue and Forecast, by Company (2021-2032)

Chapter 15. Company Profiles

15.1. Accell Clinical Research, LLC

15.1.1. Company Overview

15.1.2. Product Offerings

15.1.3. Financial Performance

15.1.4. Recent Initiatives

15.2. Genpact

15.2.1. Company Overview

15.2.2. Product Offerings

15.2.3. Financial Performance

15.2.4. Recent Initiatives

15.3. Promedica International

15.3.1. Company Overview

15.3.2. Product Offerings

15.3.3. Financial Performance

15.3.4. Recent Initiatives

15.4. WuXi AppTec, Inc.

15.4.1. Company Overview

15.4.2. Product Offerings

15.4.3. Financial Performance

15.4.4. Recent Initiatives

15.5. Criterium, Inc.

15.5.1. Company Overview

15.5.2. Product Offerings

15.5.3. Financial Performance

15.5.4. Recent Initiatives

15.6. PRA Health Sciences

15.6.1. Company Overview

15.6.2. Product Offerings

15.6.3. Financial Performance

15.6.4. Recent Initiatives

15.7. Medpace

15.7.1. Company Overview

15.7.2. Product Offerings

15.7.3. Financial Performance

15.7.4. Recent Initiatives

15.8. Charles River Laboratories International

15.8.1. Company Overview

15.8.2. Product Offerings

15.8.3. Financial Performance

15.8.4. Recent Initiatives

15.9. PAREXEL International Corp., Inc.

15.9.1. Company Overview

15.9.2. Product Offerings

15.9.3. Financial Performance

15.9.4. Recent Initiatives

15.10. Freyr

15.10.1. Company Overview

15.10.2. Product Offerings

15.10.3. Financial Performance

15.10.4. Recent Initiatives

Chapter 16. Research Methodology

16.1. Primary Research

16.2. Secondary Research

16.3. Assumptions

Chapter 17. Appendix

17.1. About Us

17.2. Glossary of Terms

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