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【英語タイトル】Regulatory Affairs Outsourcing Market (Services - Regulatory Submissions, Clinical Trial Applications and Product Registrations, Regulatory Writing and Publishing, and Consulting and Legal Representation) - Global Industry Analysis, Size, Share, Growth, Trends and Forecast 2017 - 2023

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・発行日:2018年4月
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・産業分野:Pharmaceutical
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Transparency Market Researchの本調査レポートは、法務関連業務アウトソーシングの世界市場について調べ、法務関連業務アウトソーシングの世界規模、市場動向、市場環境、サービス別(書類提出業務、治験申請・製品登録、法務書類作成・発行、コンサルティング・法的代表)分析、アメリカ市場規模、ヨーロッパ市場規模、アジア市場規模、日本市場規模、中国市場規模、バリューチェーン分析、関連企業情報などをまとめた調査レポートです。
・序文・調査範囲・調査手法
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・法務関連業務アウトソーシングの世界市場動向
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・法務関連業務アウトソーシングのバリューチェーン分析
・法務関連業務アウトソーシングの世界市場規模
・法務関連業務アウトソーシングの世界市場規模:サービス別(書類提出業務、治験申請・製品登録、法務書類作成・発行、コンサルティング・法的代表)
・法務関連業務アウトソーシングの世界市場:地域別市場規模・分析
・法務関連業務アウトソーシングの北米市場規模・予測
・法務関連業務アウトソーシングのアメリカ市場規模・予測
・法務関連業務アウトソーシングの中南米市場規模・予測
・法務関連業務アウトソーシングのヨーロッパ市場規模・予測
・法務関連業務アウトソーシングのアジア市場規模・予測
・法務関連業務アウトソーシングの日本市場規模・予測
・法務関連業務アウトソーシングの中国市場規模・予測
・法務関連業務アウトソーシングのインド市場規模・予測
・法務関連業務アウトソーシングの中東市場規模・予測
・法務関連業務アウトソーシングのアフリカ市場規模・予測
・競争状況・関連企業情報
【レポートの概要】

Global Regulatory Affairs Outsourcing Market: Overview

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 2017 to 2023 are provided for all the segments, considering 2016 as the base year.

Global Regulatory Affairs Outsourcing Market: Key Research Aspects

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.

Global Regulatory Affairs Outsourcing Market: Company Profiles

The report also profiles major players in the this 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 Criterium, Inc., Covance, Inc., Clinilabs, Inc., Charles River Laboratories International, Inc., and Accell Clinical Research, LLC.

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

By Services

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

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

【レポートの目次】

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 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)

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)

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