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規制関連業務アウトソーシングの市場規模 - サービス・カテゴリー・適応症・製品ステージ・エンドユーザー別 - 地域別展望・競合戦略・セグメント予測 (～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: | 発行: SPER Market Research Pvt. Ltd. | ページ情報: 英文 233 Pages | 納期: 即日から翌営業日

価格
価格表記: USDを日本円(税抜)に換算
本日の銀行送金レート: 1USD=156.91円
規制関連業務アウトソーシングの市場規模 - サービス・カテゴリー・適応症・製品ステージ・エンドユーザー別 - 地域別展望・競合戦略・セグメント予測 (～2033年)
出版日: 2024年04月04日
発行: SPER Market Research Pvt. Ltd.
ページ情報: 英文 233 Pages
納期: 即日から翌営業日
  • 全表示
  • 概要
  • 目次
概要

世界の規制関連業務アウトソーシングの市場規模は、2033年にかけて10.92％のCAGRで推移し、 208億9,618万の規模に成長すると予測されています。

市民の健康を守るため、農薬、化粧品、殺虫剤、医療機器、医薬品、動物用医薬品、補完代替医療など、さまざまな業界の製品を調査・審査するのが規制関連業務です。医薬品、生物医学機器、医療用品を製造する企業にとって、規制問題のアウトソーシングは有利に働く可能性があります。

COVID-19による広範なロックダウンにより、癌を含むいくつかの慢性疾患の臨床試験が中断しました。臨床試験数の減少により、薬事申請のアウトソーシングサービス市場は低迷し、サプライチェーンにおける混乱は、医薬品の製造・流通に影響を及ぼし、市場の拡大を大きく妨げることとなりました。

当レポートでは、世界の規制関連業務アウトソーシングの市場を調査し、市場概要、市場影響因子および市場機会の分析、市場規模の推移・予測、各種区分・地域別の詳細分析、競合情勢、主要企業のプロファイルなどをまとめています。

目次

第1章 イントロダクション

第2章 調査手法

第3章 エグゼクティブサマリー

第4章 市場力学

  • 促進要因・抑制・機会・課題の分析
  • COVID-19による市場への影響

第5章 市場変数と見通し

  • SWOT分析
  • PESTEL分析
  • ポーターのファイブフォース分析
  • ヒートマップ分析

第6章 競合情勢

  • 製造拠点の分布・販売エリア・製品タイプ
  • M&A・提携・製品発売・協力

第7章 世界の規制関連業務アウトソーシング市場：サービス別

  • 世界の市場規模のシェア・予測
  • 規制コンサルティング
    • 戦略と開発計画
    • QAコンサルティング
    • その他
  • 法的代理
  • 規制文書の執筆と出版
  • 製品登録と臨床試験申請
  • 薬事業務
  • 規制当局への提出
  • その他

第8章 世界の規制関連業務アウトソーシング市場：カテゴリー別

  • 世界の市場規模のシェア・予測
  • 医薬品
    • 規制コンサルティング
    • 法的代理
    • 規制文書の執筆と出版
    • 製品登録と臨床試験申請
    • 薬事申請
    • 薬事業務
    • その他
  • 医療機器
    • 規制コンサルティング
    • 法的代理
    • 規制文書の執筆と出版
    • 製品登録と臨床試験申請
    • 薬事申請
    • 薬事業務
  • その他

第9章 世界の規制関連業務アウトソーシング市場：適応症別

  • 世界の市場規模のシェア・予測
  • 腫瘍
  • 神経
  • 心臓病
  • 免疫
  • その他

第10章 世界の規制関連業務アウトソーシング市場：製品ステージ別

  • 世界の市場規模のシェア・予測
  • 前臨床
  • 臨床
  • PMA（市販後承認）

第11章 世界の規制関連業務アウトソーシング市場：エンドユーザー別

  • 世界の市場規模のシェア・予測
  • 医療機器企業
  • 製薬会社
  • バイオテクノロジー企業
  • その他

第12章 世界の規制関連業務アウトソーシング市場の予測

  • 市場規模・市場シェア

第13章 世界の規制関連業務アウトソーシング市場：サービス別

  • 市場規模・市場シェアの推移・予測

第14章 世界の規制関連業務アウトソーシング市場：カテゴリー別

  • 市場規模・市場シェアの推移・予測

第15章 世界の規制関連業務アウトソーシング市場：適応症別

  • 市場規模・市場シェアの推移・予測

第16章 世界の規制関連業務アウトソーシング市場：製品ステージ別

  • 市場規模・市場シェアの推移・予測

第17章 世界の規制関連業務アウトソーシング市場：エンドユーザー別

  • 市場規模・市場シェアの推移・予測

第18章 世界の規制関連業務アウトソーシング市場：地域別

  • 市場規模・市場シェアの推移・予測
  • アジア太平洋
  • 欧州
  • 中東・アフリカ
  • 北米
  • ラテンアメリカ

第19章 企業プロファイル

  • 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
  • その他

第20章 略語一覧

第21章 参考リンク

第22章 結論

第23章 調査範囲

目次
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