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市场调查报告书
商品编码
1464227

监管业务外包的市场规模 - 按服务、类别、适应症、产品阶段和最终用户划分 - 区域展望、竞争策略和细分市场预测（截至 2033 年）

Regulatory Affairs Outsourcing Market Size- By Service, By Category, By Indication, By Product Stage, By End User- Regional Outlook, Competitive Strategies and Segment Forecast to 2033
出版日期: | 出版商: SPER Market Research Pvt. Ltd. | 英文 233 Pages | 商品交期: 最快1-2个工作天内

价格
简介目录

至2033年，全球监管业务外包市场规模预计将成长至208,961.8亿日圆，复合年增长率为10.92%。

为了保护公民的健康，监管业务涉及对农业化学品、化妆品、杀虫剂、医疗设备、药品、动物用药品以及补充和替代医学等多个行业的产品进行调查和审查。製造药品、生物医学设备和医疗用品的公司可以从外包监管问题中受益。

COVID-19 导致的广泛封锁导致包括癌症在内的多种慢性疾病的临床试验停止。临床试验数量的下降导致医药应用外包服务市场的低迷，供应链的中断影响了药品的製造和分销，大大阻碍了市场的扩张。

本报告调查了全球监管业务外包市场，并提供了市场概况、市场影响因素和市场机会分析、市场规模趋势和预测、各个细分市场和地区的详细分析、竞争格局以及我正在编制的主要企业简介。

目录

第一章简介

第二章调查方法

第三章执行摘要

第四章市场动态

  • 驱动因素、限制因素、机会与挑战分析
  • COVID-19 对市场的影响

第五章 市场变数与展望

  • SWOT分析
  • PESTEL分析
  • 波特五力分析
  • 热图分析

第六章 竞争状况

  • 製造地、销售区域、产品类型分布
  • 併购、联盟、产品发布、合作

第七章 全球监理业务外包市场：依服务分类

  • 全球市占率及预测
  • 监理咨询
    • 策略及发展规划
    • 品质保证咨询
    • 其他的
  • 法律代表
  • 撰写和发布规范文件
  • 产品註册及临床试验申请
  • 药业务
  • 监理意见书
  • 其他的

第八章全球监理业务外包市场：依类别

  • 全球市占率及预测
  • 药品
    • 监理咨询
    • 法律代表
    • 撰写和发布规范文件
    • 产品註册及临床试验申请
    • 医药应用
    • 药业务
    • 其他的
  • 医疗设备
    • 监理咨询
    • 法律代表
    • 撰写和发布规范文件
    • 产品註册及临床试验申请
    • 医药应用
    • 药业务
  • 其他的

第九章 全球监理业务外包市场：依指标分类

  • 全球市占率及预测
  • 瘤
  • 神经
  • 心臟病
  • 免疫
  • 其他的

第十章 全球监理业务外包市场：依产品阶段

  • 全球市占率及预测
  • 临床前
  • 临床
  • PMA（上市后核准）

第十一章全球监理业务外包市场：依最终使用者分类

  • 全球市占率及预测
  • 医疗设备公司
  • 製药公司
  • 生技公司
  • 其他的

第十二章 全球监理业务外包市场预测

  • 市场规模/市场占有率

第十三章全球监理业务外包市场：依服务分类

  • 市场规模/市场占有率趋势/预测

第十四章全球监理业务外包市场：依类别

  • 市场规模/市场占有率趋势/预测

第十五章 全球监理业务外包市场：依指标分类

  • 市场规模/市场占有率趋势/预测

第十六章全球监理业务外包市场：依产品阶段

  • 市场规模/市场占有率趋势/预测

第十七章全球监理业务外包市场：依最终使用者分类

  • 市场规模/市场占有率趋势/预测

第十八章 全球监理业务外包市场：依地区

  • 市场规模/市场占有率趋势/预测
  • 亚太地区
  • 欧洲
  • 中东/非洲
  • 北美洲
  • 拉丁美洲

第十九章 公司简介

  • Accell Clinical Research, LLC
  • Genpact
  • CRITERIUM, INC
  • Promedica International
  • WuXi AppTec
  • Medpace
  • Charles River Laboratories
  • ICON plc
  • Labcorp Drug Development
  • Parexel International Corporation
  • Freyr
  • PHARMALEX GMBH
  • NDA Group AB
  • Pharmexon
  • Qvigilance
  • BlueReg
  • Cambridge Regulatory Services
  • APCER Life Sciences, Inc.
  • Real Regulatory Ltd
  • VCLS
  • PrimeVigilance
  • ProPharma Group MIS Limited
  • 其他的

第20章简称

第21章参考链接

第22章结论

第二十三章 研究范围

简介目录
Product Code: BFSI2415

Regulatory Affairs Outsourcing Market Introduction and Overview

According to SPER market research, 'Regulatory Affairs Outsourcing Market Size- By Service, By Category, By Indication, By Product Stage, By End User- Regional Outlook, Competitive Strategies and Segment Forecast to 2033' state that the Regulatory Affairs Outsourcing Market is predicted to reach 20896.18 million by 2033 with a CAGR of 10.92%.

In order to safeguard the general public's health, government affairs, also known as regulatory affairs, is the study and examination of goods from a variety of industries, including agrochemicals, cosmetics, pesticides, medical devices, pharmaceuticals, veterinary medications, and complementary and alternative medicine. Outsourcing regulatory issues may be advantageous for companies that produce pharmaceuticals, biomedical equipment, and medical supplies.

The pandemic's widespread lockdowns caused by the high number of COVID-19 cases it included disrupted clinical trials for several chronic diseases, including cancer. The pandemic's reduction in clinical study numbers resulted in a downturn in the market for healthcare regulatory affairs outsourcing services. As a result, early pandemic disruptions in the global supply chain affected pharmaceutical product manufacturing and distribution, which significantly hindered market expansion.

Scope of the Report:

Report Metric Details

Market size available for years 2020-2033

Base year considered 2023

Forecast period 2024-2033

Segments covered By Service, By Category, By Indication, By Product Stage, By End User

Regions covered North America, Asia-Pacific, Latin America, Middle East & Africa and Europe

Companies Covered Accell Clinical Research, LLC, Genpact, CRITERIUM, INC, Promedica International, WuXi AppTec, Medpace, Charles River Laboratories, Pharmexon, Qvigilance, BlueReg, Cambridge Regulatory Services, APCER Life Sciences, Inc, Real Regulatory Ltd, ProPharma Group MIS Limited.

Regulatory Affairs Outsourcing Market Segmentation

By Service: Based on the Service, Global Regulatory Affairs Outsourcing Market is segmented as; Regulatory Consulting, Legal Representation, Regulatory Writing & Publishing, Product Registration & Clinical Trial Applications, Regulatory Operations, Regulatory Submissions, Others.

By Category: Based on the Category, Global Regulatory Affairs Outsourcing Market is segmented as; Pharmaceuticals, Medical Device, Others.

By Indication: Based on the Indication, Global Regulatory Affairs Outsourcing Market is segmented as; Oncology, Neurology, Cardiology, Immunology, Others.

By Product Stage: Based on the Product Stage, Global Regulatory Affairs Outsourcing Market is segmented as; Preclinical, Clinical, PMA, Others.

Table of Contents

1. Introduction

  • 1.1. Scope of the report
  • 1.2. Market segment analysis

2. Research Methodology

  • 2.1. Research data source
    • 2.1.1. Secondary Data
    • 2.1.2. Primary Data
    • 2.1.3. SPER's internal database
    • 2.1.4. Premium insight from KOL's
  • 2.2. Market size estimation
    • 2.2.1. Top-down and Bottom-up approach
  • 2.3. Data triangulation

3. Executive Summary

4. Market Dynamics

  • 4.1. Driver, Restraint, Opportunity and Challenges analysis
    • 4.1.1. Drivers
    • 4.1.2. Restraints
    • 4.1.3. Opportunities
    • 4.1.4. Challenges
  • 4.2. COVID-19 Impacts of the Global Regulatory Affairs Outsourcing Market

5. Market variable and outlook

  • 5.1. SWOT Analysis
    • 5.1.1. Strengths
    • 5.1.2. Weaknesses
    • 5.1.3. Opportunities
    • 5.1.4. Threats
  • 5.2. PESTEL Analysis
    • 5.2.1. Political Landscape
    • 5.2.2. Economic Landscape
    • 5.2.3. Social Landscape
    • 5.2.4. Technological Landscape
    • 5.2.5. Environmental Landscape
    • 5.2.6. Legal Landscape
  • 5.3. PORTER's Five Forces
    • 5.3.1. Bargaining power of suppliers
    • 5.3.2. Bargaining power of buyers
    • 5.3.3. Threat of Substitute
    • 5.3.4. Threat of new entrant
    • 5.3.5. Competitive rivalry
  • 5.4. Heat Map Analysis

6. Competitive Landscape

  • 6.1. Global Regulatory Affairs Outsourcing Market Manufacturing Base Distribution, Sales Area, Ingredients
  • 6.2. Mergers & Acquisitions, Partnerships, Product Launch, and Collaboration in Global Regulatory Affairs Outsourcing Market

7. Global Regulatory Affairs Outsourcing Market, By Service (USD Million)

  • 7.1. Global Regulatory Affairs Outsourcing Market Value Share and Forecast, By Service 2024-2033
  • 7.2. Regulatory Consulting
    • 7.2.1. Strategy & Development Planning
    • 7.2.2. QA Consulting
    • 7.2.3. Others
  • 7.3. Legal Representation
  • 7.4. Regulatory Writing & Publishing
  • 7.5. Product Registration & Clinical Trial Applications
  • 7.6. Regulatory Operations
  • 7.7. Regulatory Submission
  • 7.8. Others

8. Global Regulatory Affairs Outsourcing Market, By Category (USD Million)

  • 8.1. Global Regulatory Affairs Outsourcing Market Value Share and Forecast, By Category 2024-2033
  • 8.2. Pharmaceuticals
    • 8.2.1. Regulatory Consulting
    • 8.2.2. Legal Representation
    • 8.2.3. Regulatory Writing & Publishing
    • 8.2.4. Product Registration & Clinical Trial Applications
    • 8.2.5. Regulatory Submissions
    • 8.2.6. Regulatory Operations
    • 8.2.7. Others
  • 8.3. Medical Device
    • 8.3.1. Regulatory Consulting
    • 8.3.2. Legal Representation
    • 8.3.3. Regulatory Writing & Publishing
    • 8.3.4. Product Registration & Clinical Trial Applications
    • 8.3.5. Regulatory Submissions
    • 8.3.6. Regulatory Operations
  • 8.4. Others

9. Global Regulatory Affairs Outsourcing Market, By Indication (USD Million)

  • 9.1. Global Regulatory Affairs Outsourcing Market Size Value Share and Forecast, By Indication 2024-2033
  • 9.2. Oncology
  • 9.3. Neurology
  • 9.4. Cardiology
  • 9.5. Immunology
  • 9.6. Others

10. Global Regulatory Affairs Outsourcing Market, By Product Stage (USD Million)

  • 10.1. Global Regulatory Affairs Outsourcing Market Size Value Share and Forecast, By Product Stage 2024-2033
  • 10.2. Preclinical
  • 10.3. Clinical
  • 10.4. PMA (Post Market Authorization

11. Global Regulatory Affairs Outsourcing Market, By End User (USD Million)

  • 11.1. Global Regulatory Affairs Outsourcing Market Size Value Share and Forecast, By End User 2024-2033
  • 11.2. Medical Device Companies
  • 11.3. Pharmaceutical Companies
  • 11.4. Biotechnology Companies
  • 11.5. Others

12. Global Regulatory Affairs Outsourcing Market, Forecast, 2020-2033 (USD Million)

  • 12.1. Global Regulatory Affairs Outsourcing Market Size and Market Share

13. Global Regulatory Affairs Outsourcing Market, By Service 2020-2033 (USD Million)

  • 13.1. Global Regulatory Affairs Outsourcing Market Size and Market Share, By Service (2020-2026)
  • 13.2. Global Regulatory Affairs Outsourcing Market Size and Market Share, By Service (2027-2033)

14. Global Regulatory Affairs Outsourcing Market, By Category 2020-2033 (USD Million)

  • 14.1. Global Regulatory Affairs Outsourcing Market Size and Market Share, By Category (2020-2026)
  • 14.2. Global Regulatory Affairs Outsourcing Market Size and Market Share, By Category (2027-2033)

15. Global Regulatory Affairs Outsourcing Market, By Indication 2020-2033 (USD Million)

  • 15.1. Global Regulatory Affairs Outsourcing Market Size and Market Share, By Indication (2020-2026)
  • 15.2. Global Regulatory Affairs Outsourcing Market Size and Market Share, By Indication (2027-2033)

16. Global Regulatory Affairs Outsourcing Market, By Product Stage 2020-2033 (USD Million)

  • 16.1. Global Regulatory Affairs Outsourcing Market Size and Market Share, By Product Stage (2020-2026)
  • 16.2. Global Regulatory Affairs Outsourcing Market Size and Market Share, By Product Stage (2027-2033)

17. Global Regulatory Affairs Outsourcing Market, By End User 2020-2033 (USD Million)

  • 17.1. Global Regulatory Affairs Outsourcing Market Size and Market Share, By End User (2020-2026)
  • 17.2. Global Regulatory Affairs Outsourcing Market Size and Market Share, By End User (2027-2033)

18. Global Regulatory Affairs Outsourcing Market, By Region, 2020-2033 (USD Million)

  • 18.1. Global Regulatory Affairs Outsourcing Market Size and Market Share, By Region (2020-2026)
  • 18.2. Global Regulatory Affairs Outsourcing Market Size and Market Share, By Region (2027-2033)
  • 18.3. Asia-Pacific
    • 18.3.1. Australia
    • 18.3.2. China
    • 18.3.3. India
    • 18.3.4. Japan
    • 18.3.5. South Korea
    • 18.3.6. Rest of Asia-Pacific
  • 18.4. Europe
    • 18.4.1. France
    • 18.4.2. Germany
    • 18.4.3. Italy
    • 18.4.4. Spain
    • 18.4.5. United Kingdom
    • 18.4.6. Rest of Europe
  • 18.5. Middle East and Africa
    • 18.5.1. Kingdom of Saudi Arabia
    • 18.5.2. United Arab Emirates
    • 18.5.3. Rest of Middle East & Africa
  • 18.6. North America
    • 18.6.1. Canada
    • 18.6.2. Mexico
    • 18.6.3. United States
  • 18.7. Latin America
    • 18.7.1. Argentina
    • 18.7.2. Brazil
    • 18.7.3. Rest of Latin America

19. Company Profile

  • 19.1. Accell Clinical Research, LLC
    • 19.1.1. Company details
    • 19.1.2. Financial outlook
    • 19.1.3. Product summary
    • 19.1.4. Recent developments
  • 19.2. Genpact
    • 19.2.1. Company details
    • 19.2.2. Financial outlook
    • 19.2.3. Product summary
    • 19.2.4. Recent developments
  • 19.3. CRITERIUM, INC
    • 19.3.1. Company details
    • 19.3.2. Financial outlook
    • 19.3.3. Product summary
    • 19.3.4. Recent developments
  • 19.4. Promedica International
    • 19.4.1. Company details
    • 19.4.2. Financial outlook
    • 19.4.3. Product summary
    • 19.4.4. Recent developments
  • 19.5. WuXi AppTec
    • 19.5.1. Company details
    • 19.5.2. Financial outlook
    • 19.5.3. Product summary
    • 19.5.4. Recent developments
  • 19.6. Medpace
    • 19.6.1. Company details
    • 19.6.2. Financial outlook
    • 19.6.3. Product summary
    • 19.6.4. Recent developments
  • 19.7. Charles River Laboratories
    • 19.7.1. Company details
    • 19.7.2. Financial outlook
    • 19.7.3. Product summary
    • 19.7.4. Recent developments
  • 19.8. ICON plc
    • 19.8.1. Company details
    • 19.8.2. Financial outlook
    • 19.8.3. Product summary
    • 19.8.4. Recent developments
  • 19.9. Labcorp Drug Development
    • 19.9.1. Company details
    • 19.9.2. Financial outlook
    • 19.9.3. Product summary
    • 19.9.4. Recent developments
  • 19.10. Parexel International Corporation
    • 19.10.1. Company details
    • 19.10.2. Financial outlook
    • 19.10.3. Product summary
    • 19.10.4. Recent developments
  • 19.11. Freyr
    • 19.11.1. Company details
    • 19.11.2. Financial outlook
    • 19.11.3. Product summary
    • 19.11.4. Recent developments
  • 19.12. PHARMALEX GMBH
    • 19.12.1. Company details
    • 19.12.2. Financial outlook
    • 19.12.3. Product summary
    • 19.12.4. Recent developments
  • 19.13. NDA Group AB
    • 19.13.1. Company details
    • 19.13.2. Financial outlook
    • 19.13.3. Product summary
    • 19.13.4. Recent developments
  • 19.14. Pharmexon
    • 19.14.1. Company details
    • 19.14.2. Financial outlook
    • 19.14.3. Product summary
    • 19.14.4. Recent developments
  • 19.15. Qvigilance
    • 19.15.1. Company details
    • 19.15.2. Financial outlook
    • 19.15.3. Product summary
    • 19.15.4. Recent developments
  • 19.16. BlueReg
    • 19.16.1. Company details
    • 19.16.2. Financial outlook
    • 19.16.3. Product summary
    • 19.16.4. Recent developments
  • 19.17. Cambridge Regulatory Services
    • 19.17.1. Company details
    • 19.17.2. Financial outlook
    • 19.17.3. Product summary
    • 19.17.4. Recent developments
  • 19.18. APCER Life Sciences, Inc.
    • 19.18.1. Company details
    • 19.18.2. Financial outlook
    • 19.18.3. Product summary
    • 19.18.4. Recent developments
  • 19.19. Real Regulatory Ltd
    • 19.19.1. Company details
    • 19.19.2. Financial outlook
    • 19.19.3. Product summary
    • 19.19.4. Recent developments
  • 19.20. VCLS
    • 19.20.1. Company details
    • 19.20.2. Financial outlook
    • 19.20.3. Product summary
    • 19.20.4. Recent developments
  • 19.21. PrimeVigilance
    • 19.21.1. Company details
    • 19.21.2. Financial outlook
    • 19.21.3. Product summary
    • 19.21.4. Recent developments
  • 19.22. ProPharma Group MIS Limited
    • 19.22.1. Company details
    • 19.22.2. Financial outlook
    • 19.22.3. Product summary
    • 19.22.4. Recent developments
  • 19.23. Others

20. List of Abbreviations

21. Reference Links

22. Conclusion

23. Research Scope