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市場調查報告書

法規事務外包市場:全球產業分析,規模,佔有率,成長,趨勢,及2015∼2023年的預測

Regulatory Affairs Outsourcing Market - Global Industry Analysis, Size, Share, Growth, Trends and Forecast 2015 - 2023

出版商 Transparency Market Research 商品編碼 318427
出版日期 內容資訊 英文 76 Pages
商品交期: 最快1-2個工作天內
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法規事務外包市場:全球產業分析,規模,佔有率,成長,趨勢,及2015∼2023年的預測 Regulatory Affairs Outsourcing Market - Global Industry Analysis, Size, Share, Growth, Trends and Forecast 2015 - 2023
出版日期: 2016年04月08日 內容資訊: 英文 76 Pages
簡介

本報告提供全球法規事務外包市場相關調查,彙整各市場區隔,各地區的趨勢,2015∼2023年的成長率,以及參與企業簡介等資料。

第1章 序論

第2章 摘要整理

第3章 產業分析:全球法規事務外包市場

  • 簡介
  • 推動市場的要素
  • 阻礙市場的要素
  • 市場機會
  • 波特五力分析
  • 價值鏈分析
  • 市場魅力度分析
  • 競爭環境

第4章 全球法規事務外包市場區隔:各類服務

  • 簡介
  • 各類服務市場收益
  • 文件繳交業務
  • 臨床實驗申請及產品登記
  • 法務文件作成及發行
  • 諮詢及法律代表
  • 其他

第5章 全球法規事務外包市場區隔:各地區

  • 簡介
  • 各地區市場收益
  • 北美
  • 歐洲
  • 亞太地區
  • 南美
  • 中東·非洲

第6章 建議

第7章 企業簡介

  • Accell Clinical Research, LLC
  • Charles River Laboratories International, Inc.
  • Clinilabs, Inc.
  • Covance, Inc.
  • Criterium, Inc.
  • ICON plc
  • Medpace, Inc.
  • PAREXEL International Corporation
  • Pharmaceutical Product Development, (PPD) LLC
  • Promedica International
  • Quintiles Transnational Corporation
  • WuXi App Tec

圖表

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目錄

This research study analyzes the market for regulatory affairs outsourcing services in terms of revenue (US$ Mn). The stakeholders of this report comprises the clinical research organizations. The global regulatory affairs outsourcing market has been broadly segmented on the basis of services (Regulatory Submissions, Clinical Trial Applications and Product Registrations, Regulatory Writing and Publishing, Regulatory Consulting and Legal Representation and others regulatory affairs, and Geography (North America, Europe, Asia Pacific, Latin America, and Middle East & Africa). Each geographic region is further analyzed at the country level for regulatory affairs outsourcing market. The market for each of these segment has been analyzed on the basis of various market dynamics such as technological advances, its advantages and increasing use of outsourcing by leading pharmaceutical and biotechnology companies. Market revenue in terms of US$ Mn for the period between 2013 and 2023 along with the compound annual growth rate (CAGR %) from 2015 to 2023 are provided for all the segments, considering 2014 as the base year.

The regulatory affairs outsourcing market report comprises an elaborate executive summary, which includes a market snapshot that provides information about various segments and sub-segments of the market. The market overview section of the report explores market dynamics such as drivers, restraints, and opportunities affecting the demand and acceptance of outsourcing regulatory affairs activities across the globe. The report provides a detailed industry analysis of the global regulatory affairs outsourcing market with the help of Porter's Five Forces model which pose an impact on the sustainability of the companies and value chain analysis. The forces analyzed are bargaining power of buyers, bargaining power of suppliers, threat of new entrants, threat of substitutes, and degree of competition. The market attractiveness analysis has been provided in the market overview section in order to elucidate the intensity of competition in the market in different regions across the globe. The competitive scenario between different market players is evaluated through market share analysis in the competitive landscape section of the report. All these factors would help the market players to take strategic decisions in order to strengthen their positions and expand their shares worldwide.

A list of recommendations has been provided for new entrants as well as existing market players to assist them in taking strategic initiatives to establish a strong presence in the market.

The report also profiles major players in the XPS market on the basis of various attributes such as company overview, financial overview, business strategies, product portfolio, and recent developments. Key players in the global regulatory affairs outsourcing market are Quintiles Transnational Corporation, Covance, Inc.(LabCorp), PAREXEL International Corporation, Pharmaceutical Product Development, LLC, ICON plc, and WuXi Apptec

The global regulatory affairs outsourcing market is segmented into the following categories:

Global Regulatory Affairs Outsourcing Market, by Services

  • Regulatory Submissions
  • Clinical Trial Applications and Product Registrations
  • Regulatory Writing and Publishing
  • Regulatory Consulting and Legal Representation
  • Other Regulatory Affairs

Global Regulatory Affairs Outsourcing Market, by Geography

  • North America
    • U.S.
    • Canada
  • Europe
    • U.K.
    • Germany
    • Rest of Europe
  • Asia Pacific (APAC)
    • India
    • China
    • Japan
    • Rest of APAC
  • Latin America (LATAM)
    • Brazil
    • Mexico
    • Rest of LATAM
  • Middle East and Africa (MEA)
    • South Africa
    • Rest of MEA

Table of Contents

1. Preface

2. Executive Summary

  • 2.1. Global Regulatory Affairs Outsourcing Market Share, by Geography, 2014-2023 (US $ Mn)
  • 2.2. Global Regulatory Affairs Outsourcing Market, by Services, 2014 (US$ Mn)
  • 2.3. Global Regulatory Affairs Outsourcing: Market Snapshot

3. Industry Analysis: Global Regulatory Affairs Outsourcing Market

  • 3.1. Introduction
  • 3.2. Market Drivers
    • 3.2.1. Driver 1: Increasing research and development activities across the world
    • 3.2.2. Driver 2: Increasing cost efficiencies
    • 3.2.3. Driver 3: Extensive documentation during drug/device manufacturing
  • 3.3. Market Restraints
    • 3.3.1. Restraint 1: Risk associated with data security, system access and loss of control
    • 3.3.2. Restraint 2: Technological advances leading to rapid pricing fluctuations
  • 3.4. Market Opportunities
    • 3.4.1. Opportunity 1: Emerging economies to offer lucrative growth opportunities
  • 3.5. Porter's Five Forces Analysis
  • 3.6. Value Chain Analysis: Global Regulatory Affairs Outsourcing Market
  • 3.7. Market Attractiveness Analysis- Regulatory Affairs Outsourcing Market, by Geography (2014) (%)
  • 3.8. Competitive Landscape- Regulatory Affairs Outsourcing Market, by Key Players (2014) (%)

4. Global Regulatory Affairs Outsourcing Market Segmentation - by Services

  • 4.1. Introduction
  • 4.2. Global Regulatory Affairs Outsourcing Market Revenue, by Services 2013-2023 (US$ Mn)
  • 4.3. Global Regulatory Submissions Market Revenue, 2013-2023, (US$ Mn)
  • 4.4. Global Clinical Trial Application and Product Registration Market Revenue, 2013-2023, (US$ Mn)
  • 4.5. Global Regulatory Writing and Publishing Market Revenue, 2013-2023, (US$ Mn)
  • 4.6. Global Regulatory Consultation and legal Representation Market Revenue, 2013-2023, (US$ Mn)
  • 4.7. Global Others Regulatory Affairs Market Revenue, 2013-2023, (US$ Mn)

5. Global Regulatory Affairs Outsourcing Market Segmentation - by Geography

  • 5.1. Introduction
  • 5.2. Global Regulatory Affairs Outsourcing Market Revenue, by Geography, 2013-2023 (US$ Mn)
  • 5.3. North America Regulatory Affairs Outsourcing Market Revenue, 2013-2023 (US$ Mn)
    • 5.3.1. U.S. Regulatory Affairs Outsourcing Market Revenue, 2013-2023 (US$Mn)
    • 5.3.2. Canada Regulatory Affairs Outsourcing Market Revenue, 2013-2023 (US$Mn)
  • 5.4. Europe Regulatory Affairs Outsourcing Market Revenue, 2013-2023 (US$ Mn)
    • 5.4.1. U.K. Regulatory Affairs Outsourcing Market Revenue, 2013-2023 (US$Mn)
    • 5.4.2. Germany Regulatory Affairs Outsourcing Market Revenue, 2013-2023 (US$Mn)
    • 5.4.3. Rest of Europe Regulatory Affairs Outsourcing Market Revenue, 2013-2023 (US$Mn)
  • 5.5. Asia Pacific (APAC) Regulatory Affairs Outsourcing Market Revenue, 2013-2023 (US$ Mn)
    • 5.5.1. India Regulatory Affairs Outsourcing Market Revenue, 2013-2023 (US$ Mn)
    • 5.5.2. China Regulatory Affairs Outsourcing Market Revenue, 2013-2023 (US$ Mn)
    • 5.5.3. Japan Regulatory Affairs Outsourcing Market Revenue, 2013-2023 (US$ Mn)
    • 5.5.4. Rest of APAC Regulatory Affairs Outsourcing Market Revenue, 2013-2023 (US$ Mn)
  • 5.6. Latin America (LATAM) Regulatory Affairs Outsourcing Market Revenue, 2013-2023 (US$ Mn)
    • 5.6.1. Brazil Regulatory Affairs Outsourcing Market Revenue, 2013-2023 (US$ Mn)
    • 5.6.2. Mexico Regulatory Affairs Outsourcing Market Revenue, 2013-2023 (US$ Mn)
    • 5.6.3. Rest of LATAM Regulatory Affairs Outsourcing Market Revenue, 2013-2023 (US$ Mn)
  • 5.7. Middle East and Africa (MEA) Regulatory Affairs Outsourcing Market Revenue, 2013-2023 (US$ Mn)
    • 5.7.1. South Africa Regulatory Affairs Outsourcing Market Revenue, 2013-2023 (US$ Mn)
    • 5.7.2. Rest of MEA Regulatory Affairs Outsourcing Market Revenue, 2013-2023 (US$ Mn)

6. Recommendations

7. Company Profiles

  • 7.1. Accell Clinical Research, LLC
    • 7.1.1. Company Overview
    • 7.1.2. Financial Overview
    • 7.1.3. Product Portfolio
    • 7.1.4. Business Strategies
    • 7.1.5. Recent Developments
  • 7.2. Charles River Laboratories International, Inc.
    • 7.2.1. Company Overview
    • 7.2.2. Financial Overview
    • 7.2.3. Product Portfolio
    • 7.2.4. Business Strategies
    • 7.2.5. Recent Developments
  • 7.3. Clinilabs, Inc.
    • 7.3.1. Company Overview
    • 7.3.2. Financial Overview
    • 7.3.3. Product Portfolio
    • 7.3.4. Business Strategies
    • 7.3.5. Recent Developments
  • 7.4. Covance, Inc.
    • 7.4.1. Company Overview
    • 7.4.2. Financial Overview
    • 7.4.3. Product Portfolio
    • 7.4.4. Business Strategies
    • 7.4.5. Recent Developments
  • 7.5. Criterium, Inc.
    • 7.5.1. Company Overview
    • 7.5.2. Financial Overview
    • 7.5.3. Product Portfolio
    • 7.5.4. Business Strategies
    • 7.5.5. Recent Developments
  • 7.6. ICON plc
    • 7.6.1. Company Overview
    • 7.6.2. Financial Overview
    • 7.6.3. Product Portfolio
    • 7.6.4. Business Strategies
    • 7.6.5. Recent Developments
  • 7.7. Medpace, Inc.
    • 7.7.1. Company Overview
    • 7.7.2. Financial Overview
    • 7.7.3. Product Portfolio
    • 7.7.4. Business Strategies
    • 7.7.5. Recent Developments
  • 7.8. PAREXEL International Corporation
    • 7.8.1. Company Overview
    • 7.8.2. Financial Overview
    • 7.8.3. Product Portfolio
    • 7.8.4. Business Strategies
    • 7.8.5. Recent Developments
  • 7.9. Pharmaceutical Product Development, (PPD) LLC
    • 7.9.1. Company Overview
    • 7.9.2. Financial Overview
    • 7.9.3. Product Portfolio
    • 7.9.4. Business Strategies
    • 7.9.5. Recent Developments
  • 7.10. Promedica International
    • 7.10.1. Company Overview
    • 7.10.2. Financial Overview
    • 7.10.3. Product Portfolio
    • 7.10.4. Business Strategies
    • 7.10.5. Recent Developments
  • 7.11. Quintiles Transnational Corporation
    • 7.11.1. Company Overview
    • 7.11.2. Financial Overview
    • 7.11.3. Product Portfolio
    • 7.11.4. Business Strategies
    • 7.11.5. Recent Developments
  • 7.12. WuXi App Tec
    • 7.12.1. Company Overview
    • 7.12.2. Financial Overview
    • 7.12.3. Product Portfolio
    • 7.12.4. Business Strategies
    • 7.12.5. Recent Developments

List of Figures

  • FIGURE 1 Market Segmentation: Regulatory Affairs Outsourcing Market
  • FIGURE 2 Global Regulatory Affairs Outsourcing Market Share, by Geography, 2014 and 2023 (Value %)
  • FIGURE 3 Global Regulatory Affairs Outsourcing Market, by Services, (US$ Mn) 2014
  • FIGURE 4 Porter's Five Forces Analysis: Regulatory Affairs Outsourcing Market
  • FIGURE 5 Value Chain Analysis: Regulatory Affairs Outsourcing Market
  • FIGURE 6 Market Attractiveness Analysis: Regulatory Affairs Outsourcing Market
  • FIGURE 7 Competitive Landscape: Regulatory Affairs Outsourcing Market
  • FIGURE 8 Global Outsourcing of Regulatory Submissions Market Revenue, 2013 - 2023 (US$ Mn)
  • FIGURE 9 Global Outsourcing of Clinical Trial Application & Product Registration Market Revenue, 2013 - 2023 (US$ Mn)
  • FIGURE 10 Global Outsourcing of Regulatory Writing and Publishing Market Revenue, 2013 - 2023 (US$ Mn)
  • FIGURE 11 Global Outsourcing of Regulatory Consulting & Legal Representation Market Revenue, 2013 - 2023 (US$ Mn)
  • FIGURE 12 Global Outsourcing of Other Regulatory Affairs Services Market Revenue, 2013 - 2023 (US$ Mn)
  • FIGURE 13 Charles River Laboratories International, Inc.: Financial Overview, 2012 - 2014 (US$ Mn)
  • FIGURE 14 Covance, Inc.: Financial Overview, 2012 - 2014 (US$ Mn)
  • FIGURE 15 ICON plc: Financial Overview, 2012 - 2014 (US$ Mn)
  • FIGURE 16 PAREXEL International Corporation: Financial Overview, 2013 - 2015 (US$ Mn)
  • FIGURE 17 Quintiles Transnational Corporation: Financial Overview, 2012 - 2014 (US$ Mn)
  • FIGURE 18 Wuxi AppTec: Financial Overview, 2011 - 2013 (US$ Mn)

List of Tables

  • TABLE 1 Market Snapshot: Global Regulatory Affairs Outsourcing Market, 2014 and 2023
  • TABLE 2 Percentage of Registered Studies by Location
  • TABLE 3 Share of Total Global R&D Spending
  • TABLE 4 Global Regulatory Affairs Outsourcing Market Revenue, by Services, 2013 - 2023 (US$ Mn)
  • TABLE 5 Global Regulatory Affairs Outsourcing Market Revenue, by Geography, 2013 - 2023 (US$ Mn)
  • TABLE 6 North America Regulatory Affairs Outsourcing Market Revenue, by Country, 2013 - 2023 (US$ Mn)
  • TABLE 7 Europe Regulatory Affairs Outsourcing Market Revenue, by Country, 2013 - 2023 (US$ Mn)
  • TABLE 8 Asia Pacific Regulatory Affairs Outsourcing Market Revenue, by Country, 2013 - 2023 (US$ Mn)
  • TABLE 9 Latin America Regulatory Affairs Outsourcing Market Revenue, by Country, 2013 - 2023 (US$ Mn)
  • TABLE 10 Middle East and Africa Regulatory Affairs Outsourcing Market Revenue, by Country, 2013 - 2023 (US$ Mn)
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