薬事申請(RA)の世界市場2021-2027:サービス別(規制コンサルティング、法定代理人、規制書作成・発行、製品登録・臨床試験用、その他)、カテゴリー別、疾患別 、製品段階別、エンドユーザー別、企業規模別、地域別

【英語タイトル】Global Regulatory Affairs Market Size study, by Service (Regulatory consulting, Legal representation, Regulatory writing & publishing, Product registration & clinical trial applications, Other services), by Category (Drugs, Biologics, Medical Devices), by Indication (Oncology, Neurology, Cardiology, Immunology, Other Indications), by product stage (Preclinical, Clinical, PMA), by end use (Medical Device Companies, Biotechnology Companies, Pharmaceutical Companies), by company size(Small, Medium and Large) and Regional Forecasts 2021-2027

Bizwit Research & Consultingが出版した調査資料(BZW21NO178)・商品コード:BZW21NO178
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・発行日:2021年10月12日
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❖ レポートの概要 ❖

Bizwit Research社は薬事申請(RA)の世界市場規模が2020年に118億ドルに達し、2021年から2027年までに8.4%成長すると予想しています。本市場調査レポートでは、世界の薬事申請(RA)市場について調査・分析し、エグゼクティブサマリー、市場定義・範囲、市場動向、産業分析、サービス別(規制コンサルティング、法定代理人、規制書作成・発行、製品登録・臨床試験用、その他)分析、カテゴリー別(薬剤、生物製剤、医療機器)分析、疾患別(腫瘍、神経、心臓病、免疫、その他)分析、製品段階別(前臨床、臨床、PMA)分析、地域別分析、競争状況、調査プロセスなど、以下の構成でまとめております。
・エグゼクティブサマリー
・市場定義・範囲
・市場動向
・産業分析
・薬事申請(RA)の世界市場規模:サービス別(規制コンサルティング、法定代理人、規制書作成・発行、製品登録・臨床試験用、その他)
・薬事申請(RA)の世界市場規模:カテゴリー別(薬剤、生物製剤、医療機器)
・薬事申請(RA)の世界市場規模:疾患別(腫瘍、神経、心臓病、免疫、その他)
・薬事申請(RA)の世界市場規模:製品段階別(前臨床、臨床、PMA)
・薬事申請(RA)の世界市場規模:地域別
・競争状況
・調査プロセス

Global Regulatory Affairs Market is valued approximately at USD 11.8 Billion in 2020 and is anticipated to grow with a healthy growth rate of more than 8.4% over the forecast period 2021-2027. Regulatory Affairs (RA) is also known as Government Affairs, it is a profession within regulation industries, such as pharmaceuticals, energy, medical devices, and banking. The global Regulatory Affairs market is being driven by demand for faster approval process for breakthrough drugs and devices, growth in emerging areas such as personalized medicine, biosimilars, and orphan drugs. Furthermore, life science companies focusing on their core competencies and economic and competitive pressures, will provide new opportunities for the global Regulatory Affairs industry.

For instance, according to Steve Gens Report published 2018, nearly around 58% of pharma companies covered under survey had planned to enhance the Regulatory Intelligence (RI) capability of their companies, while another study states that about 20 out of 22 participating companies had considered AI for RI data as a leveraging processing activities. As a result, increased in adoption of AI and RI by the companies, will serve as a catalyst for the Regulatory Affairs industry in the future. However, risk associated with data security and monitoring issues and lack of standardization, may impede market growth over the forecast period of 2021-2027.

Asia Pacific, North America, Europe, Latin America, and Rest of the World are the key region considered for the regional analysis of global regulatory affairs. Low cost for outsourcing, presence of skilled workforce along with technical expertise, tax benefits, and the expansion of healthcare companies makes the Asia Pacific the leading region across the world in terms of market share. Whereas Asia Pacific is also anticipated to exhibit the highest growth rate over the forecast period 2021-2027, due to supportive regulatory landscape.

Major market player included in this report are:
Accell Clinical Research, LLC.
GenPact Ltd.
Criterium, Inc.
PRA Health Sciences
Promedica International
WuXi AppTec, Inc.
Medpace
Charles River Laboratories International, Inc.
ICON pl

The objective of the study is to define market sizes of different segments & countries in recent years and to forecast the values to the coming eight years. The report is designed to incorporate both qualitative and quantitative aspects of the industry within each of the regions and countries involved in the study. Furthermore, the report also caters the detailed information about the crucial aspects such as driving factors & challenges which will define the future growth of the market. Additionally, the report shall also incorporate available opportunities in micro markets for stakeholders to invest along with the detailed analysis of competitive landscape and product offerings of key players.

The detailed segments and sub-segment of the market are explained below:

By Service:
Regulatory consulting
Legal representation
Regulatory writing & publishing
Product registration & clinical trial applications
Other services

By Category:
Drugs
Biologics
Medical Devices

By Indication:
Oncology
Neurology
Cardiology
Immunology
Other Indications

By product stage:
Preclinical
Clinical
PMA

By end use:
Medical Device Companies
Biotechnology Companies
Pharmaceutical Companies

By company size:
Small
Medium
Large

By Region:
North America
U.S.
Canada
Europe
UK
Germany
France
Spain
Italy
ROE
Asia Pacific
China
India
Japan
Australia
South Korea
RoAPAC
Latin America
Brazil
Mexico
Rest of the World

Furthermore, years considered for the study are as follows:

Historical year – 2018, 2019
Base year – 2020
Forecast period – 2021 to 2027.

Target Audience of the Global Regulatory Affairs Market in Market Study:

Key Consulting Companies & Advisors
Large, medium-sized, and small enterprises
Venture capitalists
Value-Added Resellers (VARs)
Third-party knowledge providers
Investment bankers
Investors

❖ レポートの目次 ❖

Chapter 1. Executive Summary
1.1. Market Snapshot
1.2. Global & Segmental Market Estimates & Forecasts, 2019-2027 (USD Billion)
1.2.1. Regulatory Affairs Market , by Region, 2019-2027 (USD Billion)
1.2.2. Regulatory Affairs Market , by Service, 2019-2027 (USD Billion)
1.2.3. Regulatory Affairs Market , by Category , 2019-2027 (USD Billion)
1.2.4. Regulatory Affairs Market , by Indication, 2019-2027 (USD Billion)
1.2.5. Regulatory Affairs Market , by Product stage, 2019-2027 (USD Billion)
1.2.6. Regulatory Affairs Market , by End Use, 2019-2027 (USD Billion)
1.2.7. Regulatory Affairs Market , by company size, 2019-2027 (USD Billion)
1.2.8.
1.3. Key Trends
1.4. Estimation Methodology
1.5. Research Assumption
Chapter 2. Global Regulatory Affairs Market Definition and Scope
2.1. Objective of the Study
2.2. Market Definition & Scope
2.2.1. Scope of the Study
2.2.2. Industry Evolution
2.3. Years Considered for the Study
2.4. Currency Conversion Rates
Chapter 3. Global Regulatory Affairs Market Dynamics
3.1. Regulatory Affairs Market Impact Analysis (2019-2027)
3.1.1. Market Drivers
3.1.1.1. Demand for faster approval process for breakthrough drugs and devices
3.1.1.2. Growth in emerging areas such as personalized medicine, biosimilars, and orphan drugs
3.1.2. Market Restraint
3.1.2.1. Risk associated with data security
3.1.2.2. Monitoring issues and lack of standardization
3.1.3. Market Opportunities
3.1.3.1. Life science companies focusing on their core competencies
3.1.3.2. Economic and competitive pressures
Chapter 4. Global Regulatory Affairs Market Industry Analysis
4.1. Porter’s 5 Force Model
4.1.1. Bargaining Power of Suppliers
4.1.2. Bargaining Power of Buyers
4.1.3. Threat of New Entrants
4.1.4. Threat of Substitutes
4.1.5. Competitive Rivalry
4.1.6. Futuristic Approach to Porter’s 5 Force Model (2018-2027)
4.2. PEST Analysis
4.2.1. Political
4.2.2. Economical
4.2.3. Social
4.2.4. Technological
4.3. Investment Adoption Model
4.4. Analyst Recommendation & Conclusion
Chapter 5. Global Regulatory Affairs Market , by Service
5.1. Market Snapshot
5.2. Global Regulatory Affairs Market by Service, Performance – Potential Analysis
5.3. Global Regulatory Affairs Market Estimates & Forecasts by Service 2018-2027 (USD Billion)
5.4. Regulatory Affairs Market , Sub Segment Analysis
5.4.1. Regulatory consulting
5.4.2. Legal representation
5.4.3. Regulatory writing & publishing
5.4.4. Product registration & clinical trial applications
5.4.5. Other services
Chapter 6. Global Regulatory Affairs Market , by Category
a. Market Snapshot
6.1. Global Regulatory Affairs Market by Category, Performance – Potential Analysis
6.2. Global Regulatory Affairs Market Estimates & Forecasts by Category 2018-2027 (USD Billion)
6.3. Regulatory Affairs Market , Sub Segment Analysis
6.3.1. Drugs
6.3.2. Biologics
6.3.3. Medical Devices
Chapter 7. Global Regulatory Affairs Market , by Indication
b. Market Snapshot
7.1. Global Regulatory Affairs Market by Indication, Performance – Potential Analysis
7.2. Global Regulatory Affairs Market Estimates & Forecasts by Indication 2018-2027 (USD Billion)
7.3. Regulatory Affairs Market , Sub Segment Analysis
7.3.1. Oncology
7.3.2. Neurology
7.3.3. Cardiology
7.3.4. Immunology
7.3.5. Other Indications
Chapter 8. Global Regulatory Affairs Market , by Product stage
c. Market Snapshot
8.1. Global Regulatory Affairs Market by Product stage, Performance – Potential Analysis
8.2. Global Regulatory Affairs Market Estimates & Forecasts by product stage 2018-2027 (USD Billion)
8.3. Regulatory Affairs Market , Sub Segment Analysis
8.3.1. Preclinical
8.3.2. Clinical
8.3.3. PMA
Chapter 9. Global Regulatory Affairs Market , by End use
d. Market Snapshot
9.1. Global Regulatory Affairs Market by Product stage, Performance – Potential Analysis
9.2. Global Regulatory Affairs Market Estimates & Forecasts by product stage 2018-2027 (USD Billion)
9.3. Regulatory Affairs Market , Sub Segment Analysis
9.3.1. Medical Device Companies
9.3.2. Biotechnology Companies
9.3.3. Pharmaceutical Companies
Chapter 10. Global Regulatory Affairs Market , by Company size
e. Market Snapshot
10.1. Global Regulatory Affairs Market by Product stage, Performance – Potential Analysis
10.2. Global Regulatory Affairs Market Estimates & Forecasts by product stage 2018-2027 (USD Billion)
10.3. Regulatory Affairs Market , Sub Segment Analysis
10.3.1. Small
10.3.2. Medium
10.3.3. Large
Pharmaceutical Companies
Chapter 11. Global Regulatory Affairs Market , Regional Analysis
11.1. Regulatory Affairs Market , Regional Market Snapshot
11.2. North America Regulatory Affairs Market
11.2.1. U.S. Regulatory Affairs Market
11.2.1.1. Service breakdown estimates & forecasts, 2018-2027
11.2.1.2. Category breakdown estimates & forecasts, 2018-2027
11.2.1.3. Indication breakdown estimates & forecasts, 2018-2027
11.2.1.4. Product stage breakdown estimates & forecasts, 2018-2027 (USD Billion)
11.2.1.5. End Use breakdown estimates & forecasts, 2018-2027 (USD Billion)
11.2.1.6. Company Size breakdown estimates & forecasts, 2018-2027 (USD Billion)
11.2.2. Canada Regulatory Affairs Market
11.3. Europe Regulatory Affairs Market Snapshot
11.3.1. U.K. Regulatory Affairs Market
11.3.2. Germany Regulatory Affairs Market
11.3.3. France Regulatory Affairs Market
11.3.4. Spain Regulatory Affairs Market
11.3.5. Italy Regulatory Affairs Market
11.3.6. Rest of Europe Regulatory Affairs Market
11.4. Asia-Pacific Regulatory Affairs Market Snapshot
11.4.1. China Regulatory Affairs Market
11.4.2. India Regulatory Affairs Market
11.4.3. Japan Regulatory Affairs Market
11.4.4. Australia Regulatory Affairs Market
11.4.5. South Korea Regulatory Affairs Market
11.4.6. Rest of Asia Pacific Regulatory Affairs Market
11.5. Latin America Regulatory Affairs Market Snapshot
11.5.1. Brazil Regulatory Affairs Market
11.5.2. Mexico Regulatory Affairs Market
11.6. Rest of The World Regulatory Affairs Market
Chapter 12. Competitive Intelligence
12.1. Top Market Strategies
12.2. Company Profiles
12.2.1. Accell Clinical Research, LLC.
12.2.1.1. Key Information
12.2.1.2. Overview
12.2.1.3. Financial (Subject to Data Availability)
12.2.1.4. Product Summary
12.2.1.5. Recent Developments
12.2.2. GenPact Ltd.
12.2.3. Criterium, Inc.
12.2.4. PRA Health Sciences
12.2.5. Promedica International
12.2.6. WuXi AppTec, Inc.
12.2.7. Medpace
12.2.8. Charles River Laboratories International, Inc.
12.2.9. ICON plc
12.2.10. Covance

Chapter 13. Research Process
13.1. Research Process
13.1.1. Data Mining
13.1.2. Analysis
13.1.3. Market Estimation
13.1.4. Validation
13.1.5. Publishing
13.2. Research Attributes
13.3. Research Assumption

List of Tables
TABLE 2. Global Regulatory Affairs Market , report scope
TABLE 3. Global Regulatory Affairs Market estimates & forecasts by region 2018-2027 (USD Billion)
TABLE 4. Global Regulatory Affairs Market estimates & forecasts by Service 2018-2027 (USD Billion)
TABLE 5. Global Regulatory Affairs Market estimates & forecasts by Catagory 2018-2027 (USD Billion)
TABLE 6. Global Regulatory Affairs Market estimates & forecasts by Indication 2018-2027 (USD Billion)
TABLE 7. Global Regulatory Affairs Market by segment, estimates & forecasts, 2018-2027 (USD Billion)
TABLE 8. Global Regulatory Affairs Market by region, estimates & forecasts, 2018-2027 (USD Billion)
TABLE 9. Global Regulatory Affairs Market by segment, estimates & forecasts, 2018-2027 (USD Billion)
TABLE 10. Global Regulatory Affairs Market by region, estimates & forecasts, 2018-2027 (USD Billion)
TABLE 11. Global Regulatory Affairs Market by segment, estimates & forecasts, 2018-2027 (USD Billion)
TABLE 12. Global Regulatory Affairs Market by region, estimates & forecasts, 2018-2027 (USD Billion)
TABLE 13. Global Regulatory Affairs Market by segment, estimates & forecasts, 2018-2027 (USD Billion)
TABLE 14. Global Regulatory Affairs Market by region, estimates & forecasts, 2018-2027 (USD Billion)
TABLE 15. Global Regulatory Affairs Market by segment, estimates & forecasts, 2018-2027 (USD Billion)
TABLE 16. Global Regulatory Affairs Market by region, estimates & forecasts, 2018-2027 (USD Billion)
TABLE 17. Global Regulatory Affairs Market by segment, estimates & forecasts, 2018-2027 (USD Billion)
TABLE 18. Global Regulatory Affairs Market by region, estimates & forecasts, 2018-2027 (USD Billion)
TABLE 19. Global Regulatory Affairs Market by segment, estimates & forecasts, 2018-2027 (USD Billion)
TABLE 20. Global Regulatory Affairs Market by region, estimates & forecasts, 2018-2027 (USD Billion)
TABLE 21. Global Regulatory Affairs Market by segment, estimates & forecasts, 2018-2027 (USD Billion)
TABLE 22. Global Regulatory Affairs Market by region, estimates & forecasts, 2018-2027 (USD Billion)
TABLE 23. U.S. Regulatory Affairs Market estimates & forecasts, 2018-2027 (USD Billion)
TABLE 24. U.S. Regulatory Affairs Market estimates & forecasts by segment 2018-2027 (USD Billion)
TABLE 25. U.S. Regulatory Affairs Market estimates & forecasts by segment 2018-2027 (USD Billion)
TABLE 26. Canada Regulatory Affairs Market estimates & forecasts, 2018-2027 (USD Billion)
TABLE 27. Canada Regulatory Affairs Market estimates & forecasts by segment 2018-2027 (USD Billion)
TABLE 28. Canada Regulatory Affairs Market estimates & forecasts by segment 2018-2027 (USD Billion)
TABLE 29. UK Regulatory Affairs Market estimates & forecasts, 2018-2027 (USD Billion)
TABLE 30. UK Regulatory Affairs Market estimates & forecasts by segment 2018-2027 (USD Billion)
TABLE 31. UK Regulatory Affairs Market estimates & forecasts by segment 2018-2027 (USD Billion)
TABLE 32. Germany Regulatory Affairs Market estimates & forecasts, 2018-2027 (USD Billion)
TABLE 33. Germany Regulatory Affairs Market estimates & forecasts by segment 2018-2027 (USD Billion)
TABLE 34. Germany Regulatory Affairs Market estimates & forecasts by segment 2018-2027 (USD Billion)
TABLE 35. France Regulatory Affairs Market estimates & forecasts, 2018-2027 (USD Billion)
TABLE 36. France Regulatory Affairs Market estimates & forecasts by segment 2018-2027 (USD Billion)
TABLE 37. France Regulatory Affairs Market estimates & forecasts by segment 2018-2027 (USD Billion)
TABLE 38. Spain Regulatory Affairs Market estimates & forecasts, 2018-2027 (USD Billion)
TABLE 39. Spain Regulatory Affairs Market estimates & forecasts by segment 2018-2027 (USD Billion)
TABLE 40. Spain Regulatory Affairs Market estimates & forecasts by segment 2018-2027 (USD Billion)
TABLE 41. Italy Regulatory Affairs Market estimates & forecasts, 2018-2027 (USD Billion)
TABLE 42. Italy Regulatory Affairs Market estimates & forecasts by segment 2018-2027 (USD Billion)
TABLE 43. Italy Regulatory Affairs Market estimates & forecasts by segment 2018-2027 (USD Billion)
TABLE 44. ROE Regulatory Affairs Market estimates & forecasts, 2018-2027 (USD Billion)
TABLE 45. ROE Regulatory Affairs Market estimates & forecasts by segment 2018-2027 (USD Billion)
TABLE 46. ROE Regulatory Affairs Market estimates & forecasts by segment 2018-2027 (USD Billion)
TABLE 47. China Regulatory Affairs Market estimates & forecasts, 2018-2027 (USD Billion)
TABLE 48. China Regulatory Affairs Market estimates & forecasts by segment 2018-2027 (USD Billion)
TABLE 49. China Regulatory Affairs Market estimates & forecasts by segment 2018-2027 (USD Billion)
TABLE 50. India Regulatory Affairs Market estimates & forecasts, 2018-2027 (USD Billion)
TABLE 51. India Regulatory Affairs Market estimates & forecasts by segment 2018-2027 (USD Billion)
TABLE 52. India Regulatory Affairs Market estimates & forecasts by segment 2018-2027 (USD Billion)
TABLE 53. Japan Regulatory Affairs Market estimates & forecasts, 2018-2027 (USD Billion)
TABLE 54. Japan Regulatory Affairs Market estimates & forecasts by segment 2018-2027 (USD Billion)
TABLE 55. Japan Regulatory Affairs Market estimates & forecasts by segment 2018-2027 (USD Billion)
TABLE 56. Australia Regulatory Affairs Market estimates & forecasts, 2018-2027 (USD Billion)
TABLE 57. Australia Regulatory Affairs Market estimates & forecasts by segment 2018-2027 (USD Billion)
TABLE 58. Australia Regulatory Affairs Market estimates & forecasts by segment 2018-2027 (USD Billion)
TABLE 59. South Korea Regulatory Affairs Market estimates & forecasts, 2018-2027 (USD Billion)
TABLE 60. South Korea Regulatory Affairs Market estimates & forecasts by segment 2018-2027 (USD Billion)
TABLE 61. South Korea Regulatory Affairs Market estimates & forecasts by segment 2018-2027 (USD Billion)
TABLE 62. ROPAC Regulatory Affairs Market estimates & forecasts, 2018-2027 (USD Billion)
TABLE 63. ROPAC Regulatory Affairs Market estimates & forecasts by segment 2018-2027 (USD Billion)
TABLE 64. ROPAC Regulatory Affairs Market estimates & forecasts by segment 2018-2027 (USD Billion)
TABLE 65. Brazil Regulatory Affairs Market estimates & forecasts, 2018-2027 (USD Billion)
TABLE 66. Brazil Regulatory Affairs Market estimates & forecasts by segment 2018-2027 (USD Billion)
TABLE 67. Brazil Regulatory Affairs Market estimates & forecasts by segment 2018-2027 (USD Billion)
TABLE 68. Mexico Regulatory Affairs Market estimates & forecasts, 2018-2027 (USD Billion)
TABLE 69. Mexico Regulatory Affairs Market estimates & forecasts by segment 2018-2027 (USD Billion)
TABLE 70. Mexico Regulatory Affairs Market estimates & forecasts by segment 2018-2027 (USD Billion)
TABLE 71. ROLA Regulatory Affairs Market estimates & forecasts, 2018-2027 (USD Billion)
TABLE 72. ROLA Regulatory Affairs Market estimates & forecasts by segment 2018-2027 (USD Billion)
TABLE 73. ROLA Regulatory Affairs Market estimates & forecasts by segment 2018-2027 (USD Billion)
TABLE 74. ROW Regulatory Affairs Market estimates & forecasts, 2018-2027 (USD Billion)
TABLE 75. ROW Regulatory Affairs Market estimates & forecasts by segment 2018-2027 (USD Billion)
TABLE 76. ROW Regulatory Affairs Market estimates & forecasts by segment 2018-2027 (USD Billion)
TABLE 77. List of secondary sources used in the study of global Regulatory Affairs Market .
TABLE 78. List of primary sources used in the study of global Regulatory Affairs Market .
TABLE 79. Years considered for the study.
TABLE 80. Exchange rates considered.

List of figures
FIG 1. Global Regulatory Affairs Market , research methodology
FIG 2. Global Regulatory Affairs Market , market estimation techniques
FIG 3. Global market size estimates & forecast methods
FIG 4. Global Regulatory Affairs Market , key trends 2020
FIG 5. Global Regulatory Affairs Market , growth prospects 2021-2027
FIG 6. Global Regulatory Affairs Market , porters 5 force model
FIG 7. Global Regulatory Affairs Market , pest analysis
FIG 8. Global Regulatory Affairs Market , value chain analysis
FIG 9. Global Regulatory Affairs Market by segment, 2018 & 2027 (USD Billion)
FIG 10. Global Regulatory Affairs Market by segment, 2018 & 2027 (USD Billion)
FIG 11. Global Regulatory Affairs Market by segment, 2018 & 2027 (USD Billion)
FIG 12. Global Regulatory Affairs Market by segment, 2018 & 2027 (USD Billion)
FIG 13. Global Regulatory Affairs Market by segment, 2018 & 2027 (USD Billion)
FIG 14. Global Regulatory Affairs Market by segment, 2018 & 2027 (USD Billion)
FIG 15. Global Regulatory Affairs Market by segment, 2018 & 2027 (USD Billion)
FIG 16. Global Regulatory Affairs Market by segment, 2018 & 2027 (USD Billion)
FIG 17. Global Regulatory Affairs Market , regional snapshot 2018 & 2027
FIG 18. North America Regulatory Affairs Market 2018 & 2027 (USD Billion)
FIG 19. Europe Regulatory Affairs Market 2018 & 2027 (USD Billion)
FIG 20. Asia-Pacific Regulatory Affairs Market 2018 & 2027 (USD Billion)
FIG 21. Latin America Regulatory Affairs Market 2018 & 2027 (USD Billion)
FIG 22. Global Regulatory Affairs Market , company market share analysis (2020)

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