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市場調查報告書
商品編碼
1464227

監管業務外包的市場規模 - 按服務、類別、適應症、產品階段和最終用戶分類 - 區域展望、競爭策略和細分市場預測（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個工作天內

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簡介目錄

至2033年，全球監管業務外包市場規模預計將成長至208,961.8億日圓，年複合成長率為10.92%。

為了保護公民的健康，監管業務涉及對農業化學品、化妝品、殺蟲劑、醫療設備、藥品、動物用藥品以及補充和替代醫學等多個行業的產品進行調查和審查。製造藥品、生物醫學設備和醫療用品的公司可以從外包監管問題中受益。

COVID-19 導致的廣泛封鎖導致包括癌症在內的多種慢性疾病的臨床試驗停止。臨床試驗數量的下降導致醫藥應用外包服務市場的低迷，供應鏈的中斷影響了藥品的製造和分銷，大大阻礙了市場的擴張。

本報告調查了全球監管業務外包市場，並提供了市場概況、市場影響因素和市場機會分析、市場規模趨勢和預測、各個細分市場和地區的詳細分析、競爭格局以及我正在編制的主要企業簡介。

目錄

第1章簡介

第2章調查方法

第3章執行摘要

第4章市場動態

  • 促進因素、限制因素、機會與挑戰分析
  • COVID-19 對市場的影響

第5章 市場變數與展望

  • SWOT分析
  • PESTEL分析
  • 波特五力分析
  • 熱圖分析

第6章 競爭狀況

  • 製造地、銷售區域、產品類型分佈
  • 併購、聯盟、產品發布、合作

第7章 全球監理業務外包市場：依服務分類

  • 全球市佔率及預測
  • 監理諮詢
    • 策略及發展規劃
    • 品質保證諮詢
    • 其他
  • 法律代表
  • 撰寫和發布規範文件
  • 產品註冊及臨床試驗申請
  • 藥業務
  • 監理意見書
  • 其他

第8章全球監理業務外包市場：依類別

  • 全球市佔率及預測
  • 藥品
    • 監理諮詢
    • 法律代表
    • 撰寫和發布規範文件
    • 產品註冊及臨床試驗申請
    • 醫藥應用
    • 藥業務
    • 其他
  • 醫療設備
    • 監理諮詢
    • 法律代表
    • 撰寫和發布規範文件
    • 產品註冊及臨床試驗申請
    • 醫藥應用
    • 藥業務
  • 其他

第9章 全球監理業務外包市場：依指標分類

  • 全球市佔率及預測
  • 瘤
  • 神經
  • 心臟病
  • 免疫
  • 其他

第10章 全球監理業務外包市場：依產品階段

  • 全球市佔率及預測
  • 臨床前
  • 臨床
  • PMA（上市後核准）

第11章全球監理業務外包市場：依最終使用者分類

  • 全球市佔率及預測
  • 醫療設備公司
  • 製藥公司
  • 生技公司
  • 其他

第12章 全球監理業務外包市場預測

  • 市場規模/市場佔有率

第13章全球監理業務外包市場：依服務分類

  • 市場規模/市場佔有率趨勢/預測

第14章全球監理業務外包市場：依類別

  • 市場規模/市場佔有率趨勢/預測

第15章 全球監理業務外包市場：依指標分類

  • 市場規模/市場佔有率趨勢/預測

第16章全球監理業務外包市場：依產品階段

  • 市場規模/市場佔有率趨勢/預測

第17章全球監理業務外包市場：依最終使用者分類

  • 市場規模/市場佔有率趨勢/預測

第18章 全球監理業務外包市場：依地區

  • 市場規模/市場佔有率趨勢/預測
  • 亞太地區
  • 歐洲
  • 中東/非洲
  • 北美洲
  • 拉丁美洲

第19章 公司簡介

  • 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

第20章簡稱

第21章參考鏈接

第22章結論

第23章 研究範圍

簡介目錄
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