by According to Precedence Research, during the forecast period of 2022 to 2030, the global regulatory affairs market is estimated to develop at a compound annual growth rate (CAGR) of 9.32%. The global regulatory affairs market was valued at USD 13.9 billion in 2021, and it is predicted to exceed USD 31 billion by 2030. The study investigates several elements and their consequences on the growth of the regulatory affairs market.
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This report focuses on regulatory affairs market volume and value at the global level, regional level and company level. From a global perspective, this report represents overall regulatory affairs market size by analyzing historical data and future prospect. Regionally, this report focuses on several key regions: North America, Europe, Middle East & Africa, Latin America, etc.
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 |
The research report includes specific segments by region (country), by company, by all segments. This study provides information about the growth and revenue during the historic and forecasted period of 2017 to 2030. Understanding the segments helps in identifying the importance of different factors that aid the market growth.
In-Depth Analysis on Competitive Landscape
The report sheds light on leading manufacturers of regulatory affairs, along with their detailed profiles. Essential and up-to-date data related to market performers who are principally engaged in the production of regulatory affairs has been brought with the help of a detailed dashboard view. Market share analysis and comparison of prominent players provided in the report permits report readers to take preemptive steps in advancing their businesses.
Company profiles have been included in the report, which include essentials such as product portfolio, key strategies, along with all-inclusive SWOT analysis on each player. Company presence is mapped and presented through a matrix for all the prominent players, thus providing readers with actionable insights, which helps in thoughtfully presenting market status and predicting the competition level in the regulatory affairs market.
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.
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Segments Covered in the Report
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]
Some of the important ones are:
- What can be the best investment choices for venturing into new product and service lines?
- What value propositions should businesses aim at while making new research and development funding?
- Which regulations will be most helpful for stakeholders to boost their supply chain network?
- Which regions might see the demand maturing in certain segments in near future?
- What are the some of the best cost optimization strategies with vendors that some well-entrenched players have gained success with?
- Which are the key perspectives that the C-suite are leveraging to move businesses to new growth trajectory?
- Which government regulations might challenge the status of key regional markets?
- How will the emerging political and economic scenario affect opportunities in key growth areas?
- What are some of the value-grab opportunities in various segments?
- What will be the barrier to entry for new players in the market?
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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