Regulatory Affairs Market Size At Around US$ 31 Bn In 2030

The regulatory affairs market would grow at a CAGR of 9.32% over the predicted time frame. The market is expected to increase in value from US$ 15.2 Bn in 2022 to US$ 9.32Bn in 2030.

The on regulatory affairs Market, which provides a business strategy, research & development activities, concise outline of the market valuation, valuable insights pertaining to market share, size, supply chain analysis, competitive landscape and regional proliferation of this industry.

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Report Scope of the Regulatory Affairs Market

Report Coverage	Details
Market Size in 2022	USD 15.2 Billion
Market Size by 2030	USD 31 Billion
Growth Rate from 2022 to 2030	CAGR of 9.32%
Base Year	2021
Forecast Period	2022 to 2030
Segments Covered	Services, Category, Indication, Stage, Service Provider, Company, End User, Geography

A recent report provides crucial insights along with application based and forecast information in the Global Regulatory affairs Market. The report provides a comprehensive analysis of key factors that are expected to drive the growth of this market. This study also provides a detailed overview of the opportunities along with the current trends observed in the Regulatory affairs market.

A quantitative analysis of the industry is compiled for a period of 10 years in order to assist players to grow in the market. Insights on specific revenue figures generated are also given in the report, along with projected revenue at the end of the forecast period.

Companies and Manufacturers Covered

The study covers key players operating in the market along with prime schemes and strategies implemented by each player to hold high positions in the industry. Such a tough vendor landscape provides a competitive outlook of the industry, consequently existing as a key insight. These insights were thoroughly analysed and prime business strategies and products that offer high revenue generation capacities were identified. Key players of the global Regulatory affairs market are included as given below:

Regulatory affairs Market Key Players

• 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.

Market Segments

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

By Geography

• North America
  • U.S.
  • Canada
• Europe
  • U.K.
  • Germany
  • France
• Asia-Pacific
  • China
  • India
  • Japan
  • South Korea
  • Malaysia
  • Philippines
• Latin America
  • Brazil
  • Rest of Latin America
• Middle East & Africa (MEA)
  • GCC
  • North Africa
  • South Africa
  • Rest of the Middle East & Africa

Report Objectives

• To define, describe, and forecast the global regulatory affairs market based on product, and region
• To provide detailed information regarding the major factors influencing the growth of the market (drivers, opportunities, and industry-specific challenges)
• To strategically analyze micromarkets1 with respect to individual growth trends, future prospects, and contributions to the total market
• To analyze opportunities in the market for stakeholders and provide details of the competitive landscape for market leaders
• To forecast the size of market segments with respect to four main regions—North America, Europe, Asia Pacific and the Rest of the World (RoW)2
• To strategically profile key players and comprehensively analyze their product portfolios, market shares, and core competencies3
• To track and analyze competitive developments such as acquisitions, expansions, new product launches, and partnerships in the regulatory affairs market

Table of Content

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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