by Precedence Research a new report on regulatory affairs market size, share, growth, industry trends, and forecast 2030, covering various industry elements and growth trends helpful for predicting the market’s future. The global regulatory affairs market size was valued at US$ 13.9 billion in 2021. The global regulatory affairs market is projected to reach US$ 31 billion by 2030, registering a compound annual growth rate (CAGR) of 9.32% during the forecast period from 2022 to 2030.
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The global regulatory affairs market report offers various segments analysis by size, trends, growth factors, opportunities and key country outlook to 2030. The report offers a detailed analysis and information as per regulatory affairs, market segments helping our readers to get a comprehensive overview of the global market. Several players are planning to focus on developing cost-effective products or services, aiming to maintain a strong foothold in the market.
Regulatory Affairs Market Report Scope
| 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 company profiling of leading market players is included this report with Porter’s five forces analysis and Value Chain analysis. Further, the strategies exercised by the companies for expansion of business through mergers, acquisitions, and other business development measures are discussed in the report. The financial parameters which are assessed include the sales, profits and the overall revenue generated by the key players of Market.
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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]
Key Questions are
- What are the key factors influencing the regulatory affairs market in each region?
- How much value will the global market generate by the end of the forecast period?
- What will be the CAGR of the global market between 2022 and 2030?
- What would be the Y-o-Y growth trend of the global market between 2022 and 2030?
- What is the future scope and current trends in technologies of the global market?
- What is the revenue of the global market based on segments?
- Which key strategies are used by top players of the global market?
- Which are the leading companies in the global market?
- What are the essential strategies by key stakeholders in the market to expand their geographic presence?
- What are the major advancements witnessed in the global market?
Research Objectives and Research Approach
The comprehensive report on the global regulatory affairs market begins with an overview, followed by the scope and objectives of the study. The report provides detailed explanation of the objectives behind this study and key vendors and distributors operating in the market and regulatory scenario for approval of products. Following this, the report provides detailed explanation of objectives of this study and laid down by accredited agencies in the purview of research in the global regulatory affairs market.
It is followed by market introduction, market dynamics, and an overview of the global market, which includes analysis of market drivers, restraints, and trends pertaining to the global market. Furthermore, Y-o-Y growth analysis with elaborated insights has been provided in order to understand the Y-o-Y growth trend of the global market.
For reading comprehensibility, the report has been compiled in a chapter-wise layout, with each section divided into smaller sections. The report comprises an exhaustive collection of graphs and tables that are appropriately interspersed. Pictorial representation of actual and projected values of key segments is visually appealing to readers. This also allows comparison of the market shares of key segments in the past and at the end of the forecast period.
The report analyzes the global regulatory affairs market in terms of type, application, region and others. Key segments under each criteria are studied at length, and the market share for each of these at the end of 2030 has also been provided. Such valuable insights enable market stakeholders in making informed business decisions for investment in the global market.
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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