The global regulatory affairs outsourcing market size is expected to reach around US$ 16.6 billion by 2030 from US$ 6.5 billion in 2021 and is expected to grow at an impressive double-digit rate of 10.2% from 2021 to 2030.
The study includes drivers and restraints of this market. The study provides an analysis of the global regulatory affairs outsourcing market for the period 2017-2030, wherein 2021 to 2030 is the forecast period and 2020 is considered as the base year.
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The high costs associated with the operations of regulatory affairs are significant factors that drive the demand for regulatory affairs outsourcing. Complying with the various regulatory norms of the local regulatory authorities in the major markets like North America, Asia Pacific, and Europe is a challenging task for the companies especially the multinationals. There are various companies like medical device manufacturers, pharmaceutical developers, and biotechnology companies that have increased demand for outsourcing regulatory affairs.
The outsourcing of regulatory affairs has become more important owing to the expansion activities and development of new devices and drugs by the numerous companies operating in the healthcare sector. The regular efforts for the development of new drugs and equipment result in an increased number of approvals regarding the preclinical and clinical trials. Therefore, in order to focus on the core activities and efficiently handle the regulatory affairs at low cost, the companies are increasingly adopting for the regulator affairs service providers, thereby boosting the demands for the services across the globe.
Cumulative Impact of COVID-19:
COVID-19 is an incomparable global public health emergency that has affected almost every industry, and the long-term effects are projected to impact the industry growth during the forecast period. Our ongoing research amplifies our research framework to ensure the inclusion of underlying COVID-19 issues and potential paths forward. The report delivers insights on COVID-19 considering the changes in consumer behavior and demand, purchasing patterns, re-routing of the supply chain, dynamics of current market forces, and the significant interventions of governments. The updated study provides insights, analysis, estimations, and forecasts, considering the COVID-19 impact on the market.
Market Share Analysis:
The market share analysis offers the analysis of vendors considering their contribution to the overall market. It provides the idea of its revenue generation into the overall market compared to other vendors in the space. It provides insights into how vendors are performing in terms of revenue generation and customer base compared to others. Knowing market share offers an idea of the size and competitiveness of the vendors for the base year. It reveals the market characteristics in terms of accumulation, fragmentation, dominance, and amalgamation traits.
Why should you invest in this report?
If you are aiming to enter the global regulatory affairs outsourcing market, this report is a comprehensive guide that provides crystal clear insights into this niche market. All the major application areas for regulatory affairs outsourcing 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 2021-2030, 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.
Some of the prominent players in the global regulatory affairs outsourcing market include:
- Medpace
- ICON Plc
- WuXiAppTec, Inc.
- Covance
- Genpact Ltd.
- Pharmaceutical Product Development LLC.
- Freyr
- PRA Health Sciences
- Criterium, Inc.
- Accell Clinical Research, LLC.
Market Segmentation:
By Service
- Legal Representation
- Regulatory Consulting
- Product Registration & Clinical Trial Application
- Regulatory Writing & Publication
- Others
By Category
- Biologics
- Drugs
- Medical Devices
By End User
- Medical Device Company
- Biotechnology Company
- Pharmaceutical Company
By Indication
- Neurology
- Oncology
- Immunology
- Cardiology
- Others
By Stage
- Clinical
- Preclinical
- Post Market Authorization
Regional Analysis:
The geographical analysis of the global regulatory affairs outsourcing market has been done for North America, Europe, Asia-Pacific, and the Rest of the World.
The North American Market is again segmented into the US, Canada, and Mexico. Coming to the European Market, it can be segmented further into the UK, Germany, France, Italy, Spain, and the rest. Coming to the Asia-Pacific, the global regulatory affairs outsourcing Market is segmented into China, India, Japan, and Rest of Asia Pacific. Among others, the market is segmented into the Middle East and Africa, (GCC, North Africa, South Africa and Rest of the Middle East & Africa).
Key Questions Answered by the Report:
- What will be the size of the global regulatory affairs outsourcing market in 2030?
- What is the expected CAGR for the regulatory affairs outsourcing market between 2021 and 2030?
- Which are the top players active in this global market?
- What are the key drivers of this global market?
- How will the market situation change in the coming years?
- Which region held the highest market share in this global market?
- What are the common business tactics adopted by players?
- What is the growth outlook of the global regulatory affairs outsourcing 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. COVID 19 Impact on Regulatory Affairs Outsourcing Market
5.1. COVID-19 Landscape: Regulatory Affairs Outsourcing Industry Impact
5.2. COVID 19 - Impact Assessment for the Industry
5.3. COVID 19 Impact: Global Major Government Policy
5.4. Market Trends and Opportunities in the COVID-19 Landscape
Chapter 6. Market Dynamics Analysis and Trends
6.1. Market Dynamics
6.1.1. Market Drivers
6.1.2. Market Restraints
6.1.3. Market Opportunities
6.2. Porter’s Five Forces Analysis
6.2.1. Bargaining power of suppliers
6.2.2. Bargaining power of buyers
6.2.3. Threat of substitute
6.2.4. Threat of new entrants
6.2.5. Degree of competition
Chapter 7. Competitive Landscape
7.1.1. Company Market Share/Positioning Analysis
7.1.2. Key Strategies Adopted by Players
7.1.3. Vendor Landscape
7.1.3.1. List of Suppliers
7.1.3.2. List of Buyers
Chapter 8. Global Regulatory Affairs Outsourcing Market, By Service
8.1. Regulatory Affairs Outsourcing Market, by Service, 2021-2030
8.1.1. Legal Representation
8.1.1.1. Market Revenue and Forecast (2017-2030)
8.1.2. Regulatory Consulting
8.1.2.1. Market Revenue and Forecast (2017-2030)
8.1.3. Product Registration & Clinical Trial Application
8.1.3.1. Market Revenue and Forecast (2017-2030)
8.1.4. Regulatory Writing & Publication
8.1.4.1. Market Revenue and Forecast (2017-2030)
8.1.5. Others
8.1.5.1. Market Revenue and Forecast (2017-2030)
Chapter 9. Global Regulatory Affairs Outsourcing Market, By Category
9.1. Regulatory Affairs Outsourcing Market, by Category, 2021-2030
9.1.1. Biologics
9.1.1.1. Market Revenue and Forecast (2017-2030)
9.1.2. Drugs
9.1.2.1. Market Revenue and Forecast (2017-2030)
9.1.3. Medical Devices
9.1.3.1. Market Revenue and Forecast (2017-2030)
Chapter 10. Global Regulatory Affairs Outsourcing Market, By End User
10.1. Regulatory Affairs Outsourcing Market, by End User, 2021-2030
10.1.1. Medical Device Company
10.1.1.1. Market Revenue and Forecast (2017-2030)
10.1.2. Biotechnology Company
10.1.2.1. Market Revenue and Forecast (2017-2030)
10.1.3. Pharmaceutical Company
10.1.3.1. Market Revenue and Forecast (2017-2030)
Chapter 11. Global Regulatory Affairs Outsourcing Market, By Indication
11.1. Regulatory Affairs Outsourcing Market, by Indication, 2021-2030
11.1.1. Neurology
11.1.1.1. Market Revenue and Forecast (2017-2030)
11.1.2. Oncology
11.1.2.1. Market Revenue and Forecast (2017-2030)
11.1.3. Immunology
11.1.3.1. Market Revenue and Forecast (2017-2030)
11.1.4. Cardiology
11.1.4.1. Market Revenue and Forecast (2017-2030)
11.1.5. Others
11.1.5.1. Market Revenue and Forecast (2017-2030)
Chapter 12. Global Regulatory Affairs Outsourcing Market, By Stage
12.1. Regulatory Affairs Outsourcing Market, by Stage, 2021-2030
12.1.1. Clinical
12.1.1.1. Market Revenue and Forecast (2017-2030)
12.1.2. Preclinical
12.1.2.1. Market Revenue and Forecast (2017-2030)
12.1.3. Post Market Authorization
12.1.3.1.Market Revenue and Forecast (2017-2030)
Chapter 13. Global Regulatory Affairs Outsourcing Market, Regional Estimates and Trend Forecast
13.1. North America
13.1.1. Market Revenue and Forecast, by Service (2017-2030)
13.1.2. Market Revenue and Forecast, by Category (2017-2030)
13.1.3. Market Revenue and Forecast, by End User (2017-2030)
13.1.4. Market Revenue and Forecast, by Indication (2017-2030)
13.1.5. Market Revenue and Forecast, by Stage (2017-2030)
13.1.6. U.S.
13.1.6.1. Market Revenue and Forecast, by Service (2017-2030)
13.1.6.2. Market Revenue and Forecast, by Category (2017-2030)
13.1.6.3. Market Revenue and Forecast, by End User (2017-2030)
13.1.6.4. Market Revenue and Forecast, by Indication (2017-2030)
13.1.7. Market Revenue and Forecast, by Stage (2017-2030)
13.1.8. Rest of North America
13.1.8.1. Market Revenue and Forecast, by Service (2017-2030)
13.1.8.2. Market Revenue and Forecast, by Category (2017-2030)
13.1.8.3. Market Revenue and Forecast, by End User (2017-2030)
13.1.8.4. Market Revenue and Forecast, by Indication (2017-2030)
13.1.8.5. Market Revenue and Forecast, by Stage (2017-2030)
13.2. Europe
13.2.1. Market Revenue and Forecast, by Service (2017-2030)
13.2.2. Market Revenue and Forecast, by Category (2017-2030)
13.2.3. Market Revenue and Forecast, by End User (2017-2030)
13.2.4. Market Revenue and Forecast, by Indication (2017-2030)
13.2.5. Market Revenue and Forecast, by Stage (2017-2030)
13.2.6. UK
13.2.6.1. Market Revenue and Forecast, by Service (2017-2030)
13.2.6.2. Market Revenue and Forecast, by Category (2017-2030)
13.2.6.3. Market Revenue and Forecast, by End User (2017-2030)
13.2.7. Market Revenue and Forecast, by Indication (2017-2030)
13.2.8. Market Revenue and Forecast, by Stage (2017-2030)
13.2.9. Germany
13.2.9.1. Market Revenue and Forecast, by Service (2017-2030)
13.2.9.2. Market Revenue and Forecast, by Category (2017-2030)
13.2.9.3. Market Revenue and Forecast, by End User (2017-2030)
13.2.10. Market Revenue and Forecast, by Indication (2017-2030)
13.2.11. Market Revenue and Forecast, by Stage (2017-2030)
13.2.12. France
13.2.12.1. Market Revenue and Forecast, by Service (2017-2030)
13.2.12.2. Market Revenue and Forecast, by Category (2017-2030)
13.2.12.3. Market Revenue and Forecast, by End User (2017-2030)
13.2.12.4. Market Revenue and Forecast, by Indication (2017-2030)
13.2.13. Market Revenue and Forecast, by Stage (2017-2030)
13.2.14. Rest of Europe
13.2.14.1. Market Revenue and Forecast, by Service (2017-2030)
13.2.14.2. Market Revenue and Forecast, by Category (2017-2030)
13.2.14.3. Market Revenue and Forecast, by End User (2017-2030)
13.2.14.4. Market Revenue and Forecast, by Indication (2017-2030)
13.2.15. Market Revenue and Forecast, by Stage (2017-2030)
13.3. APAC
13.3.1. Market Revenue and Forecast, by Service (2017-2030)
13.3.2. Market Revenue and Forecast, by Category (2017-2030)
13.3.3. Market Revenue and Forecast, by End User (2017-2030)
13.3.4. Market Revenue and Forecast, by Indication (2017-2030)
13.3.5. Market Revenue and Forecast, by Stage (2017-2030)
13.3.6. India
13.3.6.1. Market Revenue and Forecast, by Service (2017-2030)
13.3.6.2. Market Revenue and Forecast, by Category (2017-2030)
13.3.6.3. Market Revenue and Forecast, by End User (2017-2030)
13.3.6.4. Market Revenue and Forecast, by Indication (2017-2030)
13.3.7. Market Revenue and Forecast, by Stage (2017-2030)
13.3.8. China
13.3.8.1. Market Revenue and Forecast, by Service (2017-2030)
13.3.8.2. Market Revenue and Forecast, by Category (2017-2030)
13.3.8.3. Market Revenue and Forecast, by End User (2017-2030)
13.3.8.4. Market Revenue and Forecast, by Indication (2017-2030)
13.3.9. Market Revenue and Forecast, by Stage (2017-2030)
13.3.10. Japan
13.3.10.1. Market Revenue and Forecast, by Service (2017-2030)
13.3.10.2. Market Revenue and Forecast, by Category (2017-2030)
13.3.10.3. Market Revenue and Forecast, by End User (2017-2030)
13.3.10.4. Market Revenue and Forecast, by Indication (2017-2030)
13.3.10.5. Market Revenue and Forecast, by Stage (2017-2030)
13.3.11. Rest of APAC
13.3.11.1. Market Revenue and Forecast, by Service (2017-2030)
13.3.11.2. Market Revenue and Forecast, by Category (2017-2030)
13.3.11.3. Market Revenue and Forecast, by End User (2017-2030)
13.3.11.4. Market Revenue and Forecast, by Indication (2017-2030)
13.3.11.5. Market Revenue and Forecast, by Stage (2017-2030)
13.4. MEA
13.4.1. Market Revenue and Forecast, by Service (2017-2030)
13.4.2. Market Revenue and Forecast, by Category (2017-2030)
13.4.3. Market Revenue and Forecast, by End User (2017-2030)
13.4.4. Market Revenue and Forecast, by Indication (2017-2030)
13.4.5. Market Revenue and Forecast, by Stage (2017-2030)
13.4.6. GCC
13.4.6.1. Market Revenue and Forecast, by Service (2017-2030)
13.4.6.2. Market Revenue and Forecast, by Category (2017-2030)
13.4.6.3. Market Revenue and Forecast, by End User (2017-2030)
13.4.6.4. Market Revenue and Forecast, by Indication (2017-2030)
13.4.7. Market Revenue and Forecast, by Stage (2017-2030)
13.4.8. North Africa
13.4.8.1. Market Revenue and Forecast, by Service (2017-2030)
13.4.8.2. Market Revenue and Forecast, by Category (2017-2030)
13.4.8.3. Market Revenue and Forecast, by End User (2017-2030)
13.4.8.4. Market Revenue and Forecast, by Indication (2017-2030)
13.4.9. Market Revenue and Forecast, by Stage (2017-2030)
13.4.10. South Africa
13.4.10.1. Market Revenue and Forecast, by Service (2017-2030)
13.4.10.2. Market Revenue and Forecast, by Category (2017-2030)
13.4.10.3. Market Revenue and Forecast, by End User (2017-2030)
13.4.10.4. Market Revenue and Forecast, by Indication (2017-2030)
13.4.10.5. Market Revenue and Forecast, by Stage (2017-2030)
13.4.11. Rest of MEA
13.4.11.1. Market Revenue and Forecast, by Service (2017-2030)
13.4.11.2. Market Revenue and Forecast, by Category (2017-2030)
13.4.11.3. Market Revenue and Forecast, by End User (2017-2030)
13.4.11.4. Market Revenue and Forecast, by Indication (2017-2030)
13.4.11.5. Market Revenue and Forecast, by Stage (2017-2030)
13.5. Latin America
13.5.1. Market Revenue and Forecast, by Service (2017-2030)
13.5.2. Market Revenue and Forecast, by Category (2017-2030)
13.5.3. Market Revenue and Forecast, by End User (2017-2030)
13.5.4. Market Revenue and Forecast, by Indication (2017-2030)
13.5.5. Market Revenue and Forecast, by Stage (2017-2030)
13.5.6. Brazil
13.5.6.1. Market Revenue and Forecast, by Service (2017-2030)
13.5.6.2. Market Revenue and Forecast, by Category (2017-2030)
13.5.6.3. Market Revenue and Forecast, by End User (2017-2030)
13.5.6.4. Market Revenue and Forecast, by Indication (2017-2030)
13.5.7. Market Revenue and Forecast, by Stage (2017-2030)
13.5.8. Rest of LATAM
13.5.8.1. Market Revenue and Forecast, by Service (2017-2030)
13.5.8.2. Market Revenue and Forecast, by Category (2017-2030)
13.5.8.3. Market Revenue and Forecast, by End User (2017-2030)
13.5.8.4. Market Revenue and Forecast, by Indication (2017-2030)
13.5.8.5. Market Revenue and Forecast, by Stage (2017-2030)
Chapter 14. Company Profiles
14.1. Medpace
14.1.1. Company Overview
14.1.2. Product Offerings
14.1.3. Financial Performance
14.1.4. Recent Initiatives
14.2. ICON Plc
14.2.1. Company Overview
14.2.2. Product Offerings
14.2.3. Financial Performance
14.2.4. Recent Initiatives
14.3. WuXiAppTec, Inc.
14.3.1. Company Overview
14.3.2. Product Offerings
14.3.3. Financial Performance
14.3.4. Recent Initiatives
14.4. Covance
14.4.1. Company Overview
14.4.2. Product Offerings
14.4.3. Financial Performance
14.4.4. Recent Initiatives
14.5. Genpact Ltd.
14.5.1. Company Overview
14.5.2. Product Offerings
14.5.3. Financial Performance
14.5.4. Recent Initiatives
14.6. Pharmaceutical Product Development LLC.
14.6.1. Company Overview
14.6.2. Product Offerings
14.6.3. Financial Performance
14.6.4. Recent Initiatives
14.7. Freyr
14.7.1. Company Overview
14.7.2. Product Offerings
14.7.3. Financial Performance
14.7.4. Recent Initiatives
14.8. PRA Health Sciences
14.8.1. Company Overview
14.8.2. Product Offerings
14.8.3. Financial Performance
14.8.4. Recent Initiatives
14.9. Criterium, Inc.
14.9.1. Company Overview
14.9.2. Product Offerings
14.9.3. Financial Performance
14.9.4. Recent Initiatives
14.10. Accell Clinical Research, LLC.
14.10.1. Company Overview
14.10.2. Product Offerings
14.10.3. Financial Performance
14.10.4. Recent Initiatives
Chapter 15. Research Methodology
15.1. Primary Research
15.2. Secondary Research
15.3. Assumptions
Chapter 16. Appendix
16.1. About Us
16.2. Glossary of Terms
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