Regulatory Affairs Market size is Expected to Surpass Around US$ 31 Billion by 2030

[150+ Pages Report] As per the latest Research and survey report issued by Precedence Research, the global regulatory affairs market was valued at around USD 13.9 billion in 2021 and is expected to register revenues worth USD 31 billion by the end of 2030, growing at an exceptional CAGR of approximately 9.32% between 2022 and 2030.

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Regulatory Affairs Market Report Scope

A recent study by Precedence Research on the regulatory affairs market offers a forecast for 2022 and 2030. The study analyzes crucial trends that are currently determining the growth of the regulatory affairs market. This report explicates on vital dynamics such as the drivers, restraints, and opportunities for key market players, along with key stakeholders as well as emerging players associated with the manufacturing of regulatory affairs. The study also provides the dynamics that are responsible for influencing the future status of the regulatory affairs market over the forecast period.

A detailed assessment of the regulatory affairs market value chain analysis, business execution, and supply chain analysis across regional markets has been covered in the report. A list of prominent companies operating in the regulatory affairs market along with their product portfolio enhances the reliability of this comprehensive research study.

Competition Landscape

The report has engulfed a chapter on the global regulatory affairs market’s competitive landscape, which provides detailed analysis and insights on companies offering regulatory affairs. Profiles of key companies, along with a strategic overview of their M&A and expansion plans across geographies, have been delivered in this chapter. This chapter is priceless for report readers, as its enables them in gauging their growth potential in the market and implement key strategies for extending their market reach.

This chapter offers key recommendations for both new and existing market participants, enabling them to emerge sustainably and profitably. Intelligence on the market players has been delivered on the basis of their product overview, SWOT analysis, key developments, key financials and company overview. Occupancy of these market participants has been tracked by the report and portrayed via an intensity map.

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Some of the Prominent Players in the Regulatory Affairs Market Include:

• Accell Clinical Research, LLC
• Genpact
• Promedica International
• WuXi AppTec, Inc.
• Criterium, Inc.
• PRA Health Sciences
• Medpace
• Charles River Laboratories International
• PAREXEL International Corp., Inc.
• Freyr
• ICON plc
• Covance, Inc.

Regulatory Affairs Market Segmentation

By Services

• Regulatory Consulting
• Legal Representation
• Regulatory Writing & Publishing
  • Writing
  • Publishing
• Product Registration & Clinical Trial Applications
• Other Services

By Category

• Drugs
  • Innovator
  • Preclinical
  • Clinical
  • Post Market
  • Generics
  • Preclinical
  • Clinical
  • Post Market
• Biologics
  • Biotech
  • Preclinical
  • Clinical
  • Post Market
  • ATMP
  • Preclinical
  • Clinical
  • Post Market
  • Biosimilars
  • Preclinical
  • Clinical
  • Post Market
• Medical Devices
  • Diagnostics
  • Preclinical
  • Clinical
  • Post Market
  • Therapeutics
  • Preclinical
  • Clinical
  • Post Market

By Indication

• Oncology
• Neurology
• Cardiology
• Immunology
• Others

By Stage

• Preclinical
• Clinical studies
• PMA

By Service Provider

• In-house
• Outsourced

By Company

• Small
• Medium
• Large

By End User

• Medical Device Companies
• Pharmaceutical Companies
• Biotechnology Companies

Regional Segmentation

• Asia-Pacific [China, Southeast Asia, India, Japan, Korea, Western Asia]
• Europe [Germany, UK, France, Italy, Russia, Spain, Netherlands, Turkey, Switzerland]
• North America [United States, Canada, Mexico]
• South America [Brazil, Argentina, Columbia, Chile, Peru]
• Middle East & Africa [GCC, North Africa, South Africa]

Regional Analysis

The research report includes a detailed study of regions of North America, Europe, China, Japan and Rest of the World. The report has been curated after observing and studying various factors that determine regional growth such as economic, environmental, social, technological, and political status of the particular region. Analysts have studied the data of revenue and manufacturers of each region. This section analyses region-wise revenue and volume for the forecast period of 2022 to 2030. These analyses will help the reader to understand the potential worth of investment in a particular region.

The report provides in-depth segment analysis of the global regulatory affairs market, thereby providing valuable insights at macro as well as micro levels. Analysis of major countries, which hold growth opportunities or account for significant share has also been included as part of geographic analysis of the regulatory affairs market.

The report includes country-wise and region-wise market size for the period 2022-2030. It also includes market size and forecast by segments in terms of production capacity, price and revenue for the period 2022-2030.

Why should you invest in this report?

If you are aiming to enter the global regulatory affairs market, this report is a comprehensive guide that provides crystal clear insights into this niche market. All the major application areas for regulatory affairs are covered in this report and information is given on the important regions of the world where this market is likely to boom during the forecast period of 2022-2030 so that you can plan your strategies to enter this market accordingly.

Besides, through this report, you can have a complete grasp of the level of competition you will be facing in this hugely competitive market and if you are an established player in this market already, this report will help you gauge the strategies that your competitors have adopted to stay as market leaders in this market. For new entrants to this market, the voluminous data provided in this report is invaluable.

Table of Contents

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, 2022-2030

7.1.1. Regulatory Consulting

7.1.1.1. Market Revenue and Forecast (2017-2030)

7.1.2. Legal Representation

7.1.2.1. Market Revenue and Forecast (2017-2030)

7.1.3. Regulatory Writing & Publishing

7.1.3.1. Market Revenue and Forecast (2017-2030)

7.1.4. Product Registration & Clinical Trial Applications

7.1.4.1. Market Revenue and Forecast (2017-2030)

7.1.5. Other Services

7.1.5.1. Market Revenue and Forecast (2017-2030)

Chapter 8. Global Regulatory Affairs Market, By Category

8.1. Regulatory Affairs Market, by Category, 2022-2030

8.1.1. Drugs

8.1.1.1. Market Revenue and Forecast (2017-2030)

8.1.2. Biologics

8.1.2.1. Market Revenue and Forecast (2017-2030)

8.1.3. Medical Devices

8.1.3.1. Market Revenue and Forecast (2017-2030)

Chapter 9. Global Regulatory Affairs Market, By Indication

9.1. Regulatory Affairs Market, by Indication, 2022-2030

9.1.1. Oncology

9.1.1.1. Market Revenue and Forecast (2017-2030)

9.1.2. Neurology

9.1.2.1. Market Revenue and Forecast (2017-2030)

9.1.3. Cardiology

9.1.3.1. Market Revenue and Forecast (2017-2030)

9.1.4. Immunology

9.1.4.1. Market Revenue and Forecast (2017-2030)

9.1.5. Others

9.1.5.1. Market Revenue and Forecast (2017-2030)

Chapter 10. Global Regulatory Affairs Market, By Stage

10.1. Regulatory Affairs Market, by Stage, 2022-2030

10.1.1. Preclinical

10.1.1.1. Market Revenue and Forecast (2017-2030)

10.1.2. Clinical studies

10.1.2.1. Market Revenue and Forecast (2017-2030)

10.1.3. PMA

10.1.3.1. Market Revenue and Forecast (2017-2030)

Chapter 11. Global Regulatory Affairs Market, By Service Provider

11.1. Regulatory Affairs Market, by Service Provider, 2022-2030

11.1.1. In-house

11.1.1.1. Market Revenue and Forecast (2017-2030)

11.1.2. Outsourced

11.1.2.1. Market Revenue and Forecast (2017-2030)

Chapter 12. Global Regulatory Affairs Market, By Company

12.1. Regulatory Affairs Market, by Company, 2022-2030

12.1.1. Small

12.1.1.1. Market Revenue and Forecast (2017-2030)

12.1.2. Medium

12.1.2.1. Market Revenue and Forecast (2017-2030)

12.1.3. Large

12.1.3.1. Market Revenue and Forecast (2017-2030)

Chapter 13. Global Regulatory Affairs Market, By End User

13.1. Regulatory Affairs Market, by End User, 2022-2030

13.1.1. Medical Device Companies

13.1.1.1. Market Revenue and Forecast (2017-2030)

13.1.2. Pharmaceutical Companies

13.1.2.1. Market Revenue and Forecast (2017-2030)

13.1.3. Biotechnology Companies

13.1.3.1. Market Revenue and Forecast (2017-2030)

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

14.1. North America

14.1.1. Market Revenue and Forecast, by Services (2017-2030)

14.1.2. Market Revenue and Forecast, by Category (2017-2030)

14.1.3. Market Revenue and Forecast, by Indication (2017-2030)

14.1.4. Market Revenue and Forecast, by Stage (2017-2030)

14.1.5. Market Revenue and Forecast, by Service Provider (2017-2030)

14.1.6. Market Revenue and Forecast, by End User (2017-2030)

14.1.7. Market Revenue and Forecast, by Company (2017-2030)

14.1.8. U.S.

14.1.8.1. Market Revenue and Forecast, by Services (2017-2030)

14.1.8.2. Market Revenue and Forecast, by Category (2017-2030)

14.1.8.3. Market Revenue and Forecast, by Indication (2017-2030)

14.1.8.4. Market Revenue and Forecast, by Stage (2017-2030)

14.1.8.5. Market Revenue and Forecast, by Service Provider (2017-2030)

14.1.8.6. Market Revenue and Forecast, by End User (2017-2030)

14.1.8.7. Market Revenue and Forecast, by Company (2017-2030)

14.1.9. Rest of North America

14.1.9.1. Market Revenue and Forecast, by Services (2017-2030)

14.1.9.2. Market Revenue and Forecast, by Category (2017-2030)

14.1.9.3. Market Revenue and Forecast, by Indication (2017-2030)

14.1.9.4. Market Revenue and Forecast, by Stage (2017-2030)

14.1.9.5. Market Revenue and Forecast, by Service Provider (2017-2030)

14.1.9.6. Market Revenue and Forecast, by End User (2017-2030)

14.1.9.7. Market Revenue and Forecast, by Company (2017-2030)

14.2. Europe

14.2.1. Market Revenue and Forecast, by Services (2017-2030)

14.2.2. Market Revenue and Forecast, by Category (2017-2030)

14.2.3. Market Revenue and Forecast, by Indication (2017-2030)

14.2.4. Market Revenue and Forecast, by Stage (2017-2030)

14.2.5. Market Revenue and Forecast, by Service Provider (2017-2030)

14.2.6. Market Revenue and Forecast, by End User (2017-2030)

14.2.7. Market Revenue and Forecast, by Company (2017-2030)

14.2.8. UK

14.2.8.1. Market Revenue and Forecast, by Services (2017-2030)

14.2.8.2. Market Revenue and Forecast, by Category (2017-2030)

14.2.8.3. Market Revenue and Forecast, by Indication (2017-2030)

14.2.8.4. Market Revenue and Forecast, by Stage (2017-2030)

14.2.8.5. Market Revenue and Forecast, by Service Provider (2017-2030)

14.2.8.6. Market Revenue and Forecast, by End User (2017-2030)

14.2.8.7. Market Revenue and Forecast, by Company (2017-2030)

14.2.9. Germany

14.2.9.1. Market Revenue and Forecast, by Services (2017-2030)

14.2.9.2. Market Revenue and Forecast, by Category (2017-2030)

14.2.9.3. Market Revenue and Forecast, by Indication (2017-2030)

14.2.9.4. Market Revenue and Forecast, by Stage (2017-2030)

14.2.9.5. Market Revenue and Forecast, by Service Provider (2017-2030)

14.2.9.6. Market Revenue and Forecast, by End User (2017-2030)

14.2.9.7. Market Revenue and Forecast, by Company (2017-2030)

14.2.10. France

14.2.10.1. Market Revenue and Forecast, by Services (2017-2030)

14.2.10.2. Market Revenue and Forecast, by Category (2017-2030)

14.2.10.3. Market Revenue and Forecast, by Indication (2017-2030)

14.2.10.4. Market Revenue and Forecast, by Stage (2017-2030)

14.2.10.5. Market Revenue and Forecast, by Service Provider (2017-2030)

14.2.10.6. Market Revenue and Forecast, by End User (2017-2030)

14.2.10.7. Market Revenue and Forecast, by Company (2017-2030)

14.2.11. Rest of Europe

14.2.11.1. Market Revenue and Forecast, by Services (2017-2030)

14.2.11.2. Market Revenue and Forecast, by Category (2017-2030)

14.2.11.3. Market Revenue and Forecast, by Indication (2017-2030)

14.2.11.4. Market Revenue and Forecast, by Stage (2017-2030)

14.2.11.5. Market Revenue and Forecast, by Service Provider (2017-2030)

14.2.11.6. Market Revenue and Forecast, by End User (2017-2030)

14.2.11.7. Market Revenue and Forecast, by Company (2017-2030)

14.3. APAC

14.3.1. Market Revenue and Forecast, by Services (2017-2030)

14.3.2. Market Revenue and Forecast, by Category (2017-2030)

14.3.3. Market Revenue and Forecast, by Indication (2017-2030)

14.3.4. Market Revenue and Forecast, by Stage (2017-2030)

14.3.5. Market Revenue and Forecast, by Service Provider (2017-2030)

14.3.6. Market Revenue and Forecast, by End User (2017-2030)

14.3.7. Market Revenue and Forecast, by Company (2017-2030)

14.3.8. India

14.3.8.1. Market Revenue and Forecast, by Services (2017-2030)

14.3.8.2. Market Revenue and Forecast, by Category (2017-2030)

14.3.8.3. Market Revenue and Forecast, by Indication (2017-2030)

14.3.8.4. Market Revenue and Forecast, by Stage (2017-2030)

14.3.8.5. Market Revenue and Forecast, by Service Provider (2017-2030)

14.3.8.6. Market Revenue and Forecast, by End User (2017-2030)

14.3.8.7. Market Revenue and Forecast, by Company (2017-2030)

14.3.9. China

14.3.9.1. Market Revenue and Forecast, by Services (2017-2030)

14.3.9.2. Market Revenue and Forecast, by Category (2017-2030)

14.3.9.3. Market Revenue and Forecast, by Indication (2017-2030)

14.3.9.4. Market Revenue and Forecast, by Stage (2017-2030)

14.3.9.5. Market Revenue and Forecast, by Service Provider (2017-2030)

14.3.9.6. Market Revenue and Forecast, by End User (2017-2030)

14.3.9.7. Market Revenue and Forecast, by Company (2017-2030)

14.3.10. Japan

14.3.10.1. Market Revenue and Forecast, by Services (2017-2030)

14.3.10.2. Market Revenue and Forecast, by Category (2017-2030)

14.3.10.3. Market Revenue and Forecast, by Indication (2017-2030)

14.3.10.4. Market Revenue and Forecast, by Stage (2017-2030)

14.3.10.5. Market Revenue and Forecast, by Service Provider (2017-2030)

14.3.10.6. Market Revenue and Forecast, by End User (2017-2030)

14.3.10.7. Market Revenue and Forecast, by Company (2017-2030)

14.3.11. Rest of APAC

14.3.11.1. Market Revenue and Forecast, by Services (2017-2030)

14.3.11.2. Market Revenue and Forecast, by Category (2017-2030)

14.3.11.3. Market Revenue and Forecast, by Indication (2017-2030)

14.3.11.4. Market Revenue and Forecast, by Stage (2017-2030)

14.3.11.5. Market Revenue and Forecast, by Service Provider (2017-2030)

14.3.11.6. Market Revenue and Forecast, by End User (2017-2030)

14.3.11.7. Market Revenue and Forecast, by Company (2017-2030)

14.4. MEA

14.4.1. Market Revenue and Forecast, by Services (2017-2030)

14.4.2. Market Revenue and Forecast, by Category (2017-2030)

14.4.3. Market Revenue and Forecast, by Indication (2017-2030)

14.4.4. Market Revenue and Forecast, by Stage (2017-2030)

14.4.5. Market Revenue and Forecast, by Service Provider (2017-2030)

14.4.6. Market Revenue and Forecast, by End User (2017-2030)

14.4.7. Market Revenue and Forecast, by Company (2017-2030)

14.4.8. GCC

14.4.8.1. Market Revenue and Forecast, by Services (2017-2030)

14.4.8.2. Market Revenue and Forecast, by Category (2017-2030)

14.4.8.3. Market Revenue and Forecast, by Indication (2017-2030)

14.4.8.4. Market Revenue and Forecast, by Stage (2017-2030)

14.4.8.5. Market Revenue and Forecast, by Service Provider (2017-2030)

14.4.8.6. Market Revenue and Forecast, by End User (2017-2030)

14.4.8.7. Market Revenue and Forecast, by Company (2017-2030)

14.4.9. North Africa

14.4.9.1. Market Revenue and Forecast, by Services (2017-2030)

14.4.9.2. Market Revenue and Forecast, by Category (2017-2030)

14.4.9.3. Market Revenue and Forecast, by Indication (2017-2030)

14.4.9.4. Market Revenue and Forecast, by Stage (2017-2030)

14.4.9.5. Market Revenue and Forecast, by Service Provider (2017-2030)

14.4.9.6. Market Revenue and Forecast, by End User (2017-2030)

14.4.9.7. Market Revenue and Forecast, by Company (2017-2030)

14.4.10. South Africa

14.4.10.1. Market Revenue and Forecast, by Services (2017-2030)

14.4.10.2. Market Revenue and Forecast, by Category (2017-2030)

14.4.10.3. Market Revenue and Forecast, by Indication (2017-2030)

14.4.10.4. Market Revenue and Forecast, by Stage (2017-2030)

14.4.10.5. Market Revenue and Forecast, by Service Provider (2017-2030)

14.4.10.6. Market Revenue and Forecast, by End User (2017-2030)

14.4.10.7. Market Revenue and Forecast, by Company (2017-2030)

14.4.11. Rest of MEA

14.4.11.1. Market Revenue and Forecast, by Services (2017-2030)

14.4.11.2. Market Revenue and Forecast, by Category (2017-2030)

14.4.11.3. Market Revenue and Forecast, by Indication (2017-2030)

14.4.11.4. Market Revenue and Forecast, by Stage (2017-2030)

14.4.11.5. Market Revenue and Forecast, by Service Provider (2017-2030)

14.4.11.6. Market Revenue and Forecast, by End User (2017-2030)

14.4.11.7. Market Revenue and Forecast, by Company (2017-2030)

14.5. Latin America

14.5.1. Market Revenue and Forecast, by Services (2017-2030)

14.5.2. Market Revenue and Forecast, by Category (2017-2030)

14.5.3. Market Revenue and Forecast, by Indication (2017-2030)

14.5.4. Market Revenue and Forecast, by Stage (2017-2030)

14.5.5. Market Revenue and Forecast, by Service Provider (2017-2030)

14.5.6. Market Revenue and Forecast, by End User (2017-2030)

14.5.7. Market Revenue and Forecast, by Company (2017-2030)

14.5.8. Brazil

14.5.8.1. Market Revenue and Forecast, by Services (2017-2030)

14.5.8.2. Market Revenue and Forecast, by Category (2017-2030)

14.5.8.3. Market Revenue and Forecast, by Indication (2017-2030)

14.5.8.4. Market Revenue and Forecast, by Stage (2017-2030)

14.5.8.5. Market Revenue and Forecast, by Service Provider (2017-2030)

14.5.8.6. Market Revenue and Forecast, by End User (2017-2030)

14.5.8.7. Market Revenue and Forecast, by Company (2017-2030)

14.5.9. Rest of LATAM

14.5.9.1. Market Revenue and Forecast, by Services (2017-2030)

14.5.9.2. Market Revenue and Forecast, by Category (2017-2030)

14.5.9.3. Market Revenue and Forecast, by Indication (2017-2030)

14.5.9.4. Market Revenue and Forecast, by Stage (2017-2030)

14.5.9.5. Market Revenue and Forecast, by Service Provider (2017-2030)

14.5.9.6. Market Revenue and Forecast, by End User (2017-2030)

14.5.9.7. Market Revenue and Forecast, by Company (2017-2030)

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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