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表紙：薬事申請 (RA) アウトソーシングサービスの世界市場 (2022～2030年)：成長・将来の展望・競合分析
市場調査レポート
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1162483

薬事申請 (RA) アウトソーシングサービスの世界市場 (2022～2030年)：成長・将来の展望・競合分析

Regulatory Affairs Outsourcing Services Market - Growth, Future Prospects and Competitive Analysis, 2022 - 2030
出版日: | 発行: Acute Market Reports | ページ情報: 英文 119 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=156.76円
薬事申請 (RA) アウトソーシングサービスの世界市場 (2022～2030年)：成長・将来の展望・競合分析
出版日: 2022年08月24日
発行: Acute Market Reports
ページ情報: 英文 119 Pages
納期: 即日から翌営業日
  • 全表示
  • 概要
  • 図表
  • 目次
概要

ライフサイエンス業界では、規制当局からの圧力や副作用に関する訴訟の増加、人口動態の急激な変化、製品パイプラインの枯渇、後発医薬品メーカーとの競争の激化などが主な課題として挙げられます。

医薬品の開発・承認にかかるコストのさらなる増大、規制面での責任と義務の増大により、企業は薬事申請 (RA) 業務のアウトソーシングサービスを採用するようになっています。

当レポートでは、世界の薬事申請 (RA) アウトソーシングサービスの市場を調査し、市場概要、市場成長への各種影響因子の分析、市場規模の推移・予測、各種区分・地域/主要国別の内訳、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 序文

第2章 エグゼクティブサマリー

第3章 薬事申請 (RA) アウトソーシングサービス市場：事業の見通し・市場力学

  • 世界市場の規模：2020年～2030年
  • 市場力学
    • 市場促進要因
    • 市場抑制要因
    • 主な課題
    • 主な機会
  • 促進要因・抑制要因の影響分析
  • シーソー分析
  • ポーターのファイブフォースモデル
  • PESTEL分析

第4章 薬事申請 (RA) アウトソーシングサービス市場：タイプ別

  • 市場概要
  • 成長・収益分析
  • 市場の分類
    • ライティング・パブリッシング
    • 薬事コンサルティング
    • 臨床試験・製品登録
    • 法定代理人
    • その他のサービス

第5章 北米の薬事申請 (RA) アウトソーシングサービス市場

  • 市場概要
  • 薬事申請 (RA) アウトソーシングサービス市場：タイプ別
  • 薬事申請 (RA) アウトソーシングサービス市場：地域別

第6章 英国およびEUの薬事申請 (RA) アウトソーシングサービス市場

  • 市場概要
  • 薬事申請 (RA) アウトソーシングサービス市場：タイプ別
  • 薬事申請 (RA) アウトソーシングサービス市場：地域別

第7章 アジア太平洋の薬事申請 (RA) アウトソーシングサービス市場

  • 市場概要
  • 薬事申請 (RA) アウトソーシングサービス市場：タイプ別
  • 薬事申請 (RA) アウトソーシングサービス市場：地域別

第8章 ラテンアメリカの薬事申請 (RA) アウトソーシングサービス市場

  • 市場概要
  • 薬事申請 (RA) アウトソーシングサービス市場：タイプ別
  • 薬事申請 (RA) アウトソーシングサービス市場：地域別

第9章 中東・アフリカの薬事申請 (RA) アウトソーシングサービス市場

  • 市場概要
  • 薬事申請 (RA) アウトソーシングサービス市場：タイプ別
  • 薬事申請 (RA) アウトソーシングサービス市場：地域別

第10章 企業プロファイル

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

List of Tables

  • TABLE 1 Global Regulatory Affairs Outsourcing Services Market By Type, 2020-2030, USD (Million)
  • TABLE 2 North America Regulatory Affairs Outsourcing Services Market By Type, 2020-2030, USD (Million)
  • TABLE 3 UK and European Union Regulatory Affairs Outsourcing Services Market By Type, 2020-2030, USD (Million)
  • TABLE 4 Asia Pacific Regulatory Affairs Outsourcing Services Market By Type, 2020-2030, USD (Million)
  • TABLE 5 Latin America Regulatory Affairs Outsourcing Services Market By Type, 2020-2030, USD (Million)
  • TABLE 6 Middle East and Africa Regulatory Affairs Outsourcing Services Market By Type, 2020-2030, USD (Million)

List of Figures

  • FIG. 1 Global Regulatory Affairs Outsourcing Services Market: Market Coverage
  • FIG. 2 Research Methodology and Data Sources
  • FIG. 3 Market Size Estimation - Top Down & Bottom-Up Approach
  • FIG. 4 Global Regulatory Affairs Outsourcing Services Market: Quality Assurance
  • FIG. 5 Global Regulatory Affairs Outsourcing Services Market, By Type, 2021
  • FIG. 6 Global Regulatory Affairs Outsourcing Services Market, By Geography, 2021
  • FIG. 7 Global Regulatory Affairs Outsourcing Services Market, By Type, 2021 Vs 2030, %
  • FIG. 8 U.S. Regulatory Affairs Outsourcing Services Market (US$ Million), 2020 - 2030
  • FIG. 9 Canada Regulatory Affairs Outsourcing Services Market (US$ Million), 2020 - 2030
  • FIG. 10 Rest of North America Regulatory Affairs Outsourcing Services Market (US$ Million), 2020 - 2030
  • FIG. 11 UK Regulatory Affairs Outsourcing Services Market (US$ Million), 2020 - 2030
  • FIG. 12 Germany Regulatory Affairs Outsourcing Services Market (US$ Million), 2020 - 2030
  • FIG. 13 Spain Regulatory Affairs Outsourcing Services Market (US$ Million), 2020 - 2030
  • FIG. 14 Italy Regulatory Affairs Outsourcing Services Market (US$ Million), 2020 - 2030
  • FIG. 15 France Regulatory Affairs Outsourcing Services Market (US$ Million), 2020 - 2030
  • FIG. 16 Rest of Europe Regulatory Affairs Outsourcing Services Market (US$ Million), 2020 - 2030
  • FIG. 17 China Regulatory Affairs Outsourcing Services Market (US$ Million), 2020 - 2030
  • FIG. 18 Japan Regulatory Affairs Outsourcing Services Market (US$ Million), 2020 - 2030
  • FIG. 19 India Regulatory Affairs Outsourcing Services Market (US$ Million), 2020 - 2030
  • FIG. 20 Australia Regulatory Affairs Outsourcing Services Market (US$ Million), 2020 - 2030
  • FIG. 21 South Korea Regulatory Affairs Outsourcing Services Market (US$ Million), 2020 - 2030
  • FIG. 22 Rest of Asia Regulatory Affairs Outsourcing Services Market (US$ Million), 2020 - 2030
  • FIG. 23 Brazil Regulatory Affairs Outsourcing Services Market (US$ Million), 2020 - 2030
  • FIG. 24 Mexico Regulatory Affairs Outsourcing Services Market (US$ Million), 2020 - 2030
  • FIG. 25 Rest of Latin America Regulatory Affairs Outsourcing Services Market (US$ Million), 2020 - 2030
  • FIG. 26 GCC Regulatory Affairs Outsourcing Services Market (US$ Million), 2020 - 2030
  • FIG. 27 Africa Regulatory Affairs Outsourcing Services Market (US$ Million), 2020 - 2030
  • FIG. 28 Rest of Middle East and Africa Regulatory Affairs Outsourcing Services Market (US$ Million), 2020 - 2030
目次
Product Code: 138653-08-22

Industry Outlook

Growing regulatory pressure and challenge of litigations over adverse or side effects, rapidly changing demographic patterns, drying product pipelines and consistent growth in competition from generic manufacturers are some of the prime challenges faced in the life sciences business. Further growth in cost of drug development, approvals and growing responsibilities and obligations on the regulatory front have driven organizations to adopt outsourcing services for regulatory operations. These activities are proven to result in improved cost efficiencies, while manufacturers becoming more focused on their core competencies. Diversification of several ancillary activities allows organizations to focus in improving core business while the third party vendors deliver optimal services. Some major advantages derived from regulatory affairs outsourcing are increased speed of market approvals, effective maintenance of product success in new and emerging markets, and swift and convenient extension of brand indications and formulations. Regulatory affairs outsourcing is also of high advantage for mid and small size companies that lack expertize in certain departments. This also reduced the work-load on the employees and management while also ensure appropriate timely and prompt regulatory submissions.

Regulatory writing and publishing to be the major revenue generator, while clinical trial and product registration services to pick pace within the forecast period

Among the major regulatory affairs outsourcing services, regulatory writing and publishing occupy the largest revenue share in the global market. As the global market is condensing, there is a prominent visibility of distinct regulatory scenarios in different regions. Companies domiciled in Europe and North America often face challenge in terms of regulatory submissions to emerging markets of Asia Pacific, and Middle East & Africa. The regulations worldwide are also changing rapidly due to growing interest to ensure rapid commercialization of products with assured safety profile. Therefore, it has become imperative for manufacturers to provide timely data updating of regulatory submissions and literature. Furthermore, it is anticipated that the market for clinical trials and product registration services shall be witnessing rapid growth during the forecast period. Impending patent expiries, and increasing focus of drug manufacturers on delivering drugs for rare diseases have prompted emergence of pipeline for specialty drugs. With growth in the number of such drug candidates, the demand for clinical trial and product registration services shall be growing in the years to come.

Asia Pacific to become the global outsourcing hub

Manufacturers of several blockbuster drugs are domiciled in Europe and North America, where the patents for such drugs are rapidly expiring. In order to enable extension to the product life cycle, several of such manufacturers have increased their efforts in introducing their drugs and medical devices to the emerging markets of Asia Pacific. Companies are harnessing the potential of the emerging economies as an introduction opportunity for their businesses and products in the developed markets. CDMO and regulatory outsourcing activities are being increasingly set up in emerging economies due to cheap labor, improving skills and low service costs.

This report also includes company profiles section that gives insights on the company overview, product portfolio, financial information and key developments of major market players. The major players profiled in this report include ICON plc, Quintiles Transnational Corporation, PAREXEL International Corporation, Covance, Inc., Clinilabs, Inc., Charles River Laboratories International, Inc., Accell Clinical Research, LLC, Criterium, Inc., Medpace, Inc., Promedica International, WuXi App Tec, Genpact Ltd, PRA Health Sciences, Inc. and Pharmaceutical Product Development (PPD), LLC.

Historical & Forecast Period

This study report represents analysis of each segment from 2020 to 2030 considering 2021 as the base year. Compounded Annual Growth Rate (CAGR) for each of the respective segments estimated for the forecast period of 2022 to 2030.

The current report comprises of quantitative market estimations for each micro market for every geographical region and qualitative market analysis such as micro and macro environment analysis, market trends, competitive intelligence, segment analysis, porters five force model, top winning strategies, top investment markets, emerging trends and technological analysis, case studies, strategic conclusions and recommendations and other key market insights.

Research Methodology

The complete research study was conducted in three phases, namely: secondary research, primary research, and expert panel review. key data point that enables the estimation of Regulatory Affairs Outsourcing Services market are as follows:

  • Research and development budgets of manufacturers and government spending
  • Revenues of key companies in the market segment
  • Number of end users and consumption volume, price and value.

Geographical revenues generate by countries considered in the report:

Micro and macro environment factors that are currently influencing the Regulatory Affairs Outsourcing Services market and their expected impact during the forecast period.

Market forecast was performed through proprietary software that analyzes various qualitative and quantitative factors. Growth rate and CAGR were estimated through intensive secondary and primary research. Data triangulation across various data points provides accuracy across various analyzed market segments in the report. Application of both top down and bottom-up approach for validation of market estimation assures logical, methodical and mathematical consistency of the quantitative data.

Market Segmentation

Type

  • Regulatory Writing & Publishing
  • Regulatory Consulting
  • Clinical Trial & Product Registration
  • Legal Representation
  • Other Services

Region Segment (2020-2030; US$ Million)

  • North America
    • U.S.
    • Canada
    • Rest of North America
  • UK and European Union
    • UK
    • Germany
    • Spain
    • Italy
    • France
    • Rest of Europe
  • Asia Pacific
    • China
    • Japan
    • India
    • Australia
    • South Korea
    • Rest of Asia Pacific
  • Latin America
    • Brazil
    • Mexico
    • Rest of Latin America
  • Middle East and Africa
    • GCC
    • Africa
    • Rest of Middle East and Africa

Global Impact of COVID-19 Segment (2020-2021; US$ Million )

  • Pre COVID-19 situation
  • Post COVID-19 situation

Key questions answered in this report:

  • What are the key micro and macro environmental factors that are impacting the growth of Regulatory Affairs Outsourcing Services market?
  • What are the key investment pockets with respect to product segments and geographies currently and during the forecast period?
  • Estimated forecast and market projections up to 2030.
  • Which segment accounts for the fastest CAGR during the forecast period?
  • Which market segment holds a larger market share and why?
  • Are low and middle-income economies investing in the Regulatory Affairs Outsourcing Services market?
  • Which is the largest regional market for Regulatory Affairs Outsourcing Services market?
  • What are the market trends and dynamics in emerging markets such as Asia Pacific, Latin America, and Middle East & Africa?
  • Which are the key trends driving Regulatory Affairs Outsourcing Services market growth?
  • Who are the key competitors and what are their key strategies to enhance their market presence in the Regulatory Affairs Outsourcing Services market worldwide?

Table of Contents

1. Preface

  • 1.1. Report Description
    • 1.1.1. Purpose of the Report
    • 1.1.2. Target Audience
    • 1.1.3. Key Offerings
  • 1.2. Market Segmentation
  • 1.3. Research Methodology
    • 1.3.1. Phase I - Secondary Research
    • 1.3.2. Phase II - Primary Research
    • 1.3.3. Phase III - Expert Panel Review
    • 1.3.4. Assumptions
    • 1.3.5. Approach Adopted

2. Executive Summary

  • 2.1. Market Snapshot: Global Regulatory Affairs Outsourcing Services Market
  • 2.2. Global Regulatory Affairs Outsourcing Services Market, By Type, 2021 (US$ Million)
  • 2.3. Global Regulatory Affairs Outsourcing Services Market, By Geography, 2021 (US$ Million)
  • 2.4. Impact of Covid 19
  • 2.5. Attractive Investment Proposition by Geography, 2021
  • 2.6. Competitive Analysis
    • 2.6.1. Market Positioning of Key Regulatory Affairs Outsourcing Services Market Vendors
    • 2.6.2. Strategies Adopted by Regulatory Affairs Outsourcing Services Market Vendors
    • 2.6.3. Key Industry Strategies

3. Regulatory Affairs Outsourcing Services Market: Business Outlook & Market Dynamics

  • 3.1. Introduction
  • 3.2. Global Regulatory Affairs Outsourcing Services Market Value, 2020 - 2030, (US$ Million)
  • 3.3. Market Dynamics
    • 3.3.1. Market Drivers
    • 3.3.2. Market Restraints
    • 3.3.3. Key Challenges
    • 3.3.4. Key Opportunities
  • 3.4. Impact Analysis of Drivers and Restraints
  • 3.5. See-Saw Analysis
  • 3.6. Porter's Five Force Model
    • 3.6.1. Supplier Power
    • 3.6.2. Buyer Power
    • 3.6.3. Threat Of Substitutes
    • 3.6.4. Threat Of New Entrants
    • 3.6.5. Competitive Rivalry
  • 3.7. PESTEL Analysis
    • 3.7.1. Political Landscape
    • 3.7.2. Economic Landscape
    • 3.7.3. Technology Landscape
    • 3.7.4. Legal Landscape
    • 3.7.5. Social Landscape

4. Regulatory Affairs Outsourcing Services Market: By Type, 2020-2030, USD (Million)

  • 4.1. Market Overview
  • 4.2. Growth & Revenue Analysis: 2021 Versus 2030
  • 4.3. Market Segmentation
    • 4.3.1. Regulatory Writing & Publishing
    • 4.3.2. Regulatory Consulting
    • 4.3.3. Clinical Trial & Product Registration
    • 4.3.4. Legal Representation
    • 4.3.5. Other Services

5. North America Regulatory Affairs Outsourcing Services Market, 2020-2030, USD (Million)

  • 5.1. Market Overview
  • 5.2. Regulatory Affairs Outsourcing Services Market: By Type, 2020-2030, USD (Million)
  • 5.3.Regulatory Affairs Outsourcing Services Market: By Region, 2020-2030, USD (Million)
    • 5.3.1.North America
      • 5.3.1.1. U.S.
      • 5.3.1.2. Canada
      • 5.3.1.3. Rest of North America

6. UK and European Union Regulatory Affairs Outsourcing Services Market, 2020-2030, USD (Million)

  • 6.1. Market Overview
  • 6.2. Regulatory Affairs Outsourcing Services Market: By Type, 2020-2030, USD (Million)
  • 6.3.Regulatory Affairs Outsourcing Services Market: By Region, 2020-2030, USD (Million)
    • 6.3.1.UK and European Union
      • 6.3.1.1. UK
      • 6.3.1.2. Germany
      • 6.3.1.3. Spain
      • 6.3.1.4. Italy
      • 6.3.1.5. France
      • 6.3.1.6. Rest of Europe

7. Asia Pacific Regulatory Affairs Outsourcing Services Market, 2020-2030, USD (Million)

  • 7.1. Market Overview
  • 7.2. Regulatory Affairs Outsourcing Services Market: By Type, 2020-2030, USD (Million)
  • 7.3.Regulatory Affairs Outsourcing Services Market: By Region, 2020-2030, USD (Million)
    • 7.3.1.Asia Pacific
      • 7.3.1.1. China
      • 7.3.1.2. Japan
      • 7.3.1.3. India
      • 7.3.1.4. Australia
      • 7.3.1.5. South Korea
      • 7.3.1.6. Rest of Asia Pacific

8. Latin America Regulatory Affairs Outsourcing Services Market, 2020-2030, USD (Million)

  • 8.1. Market Overview
  • 8.2. Regulatory Affairs Outsourcing Services Market: By Type, 2020-2030, USD (Million)
  • 8.3.Regulatory Affairs Outsourcing Services Market: By Region, 2020-2030, USD (Million)
    • 8.3.1.Latin America
      • 8.3.1.1. Brazil
      • 8.3.1.2. Mexico
      • 8.3.1.3. Rest of Latin America

9. Middle East and Africa Regulatory Affairs Outsourcing Services Market, 2020-2030, USD (Million)

  • 9.1. Market Overview
  • 9.2. Regulatory Affairs Outsourcing Services Market: By Type, 2020-2030, USD (Million)
  • 9.3.Regulatory Affairs Outsourcing Services Market: By Region, 2020-2030, USD (Million)
    • 9.3.1.Middle East and Africa
      • 9.3.1.1. GCC
      • 9.3.1.2. Africa
      • 9.3.1.3. Rest of Middle East and Africa

10. Company Profile

  • 10.1. ICON plc
    • 10.1.1. Company Overview
    • 10.1.2. Financial Performance
    • 10.1.3. Product Portfolio
    • 10.1.4. Strategic Initiatives
  • 10.2. Quintiles Transnational Corporation
    • 10.2.1. Company Overview
    • 10.2.2. Financial Performance
    • 10.2.3. Product Portfolio
    • 10.2.4. Strategic Initiatives
  • 10.3. PAREXEL International Corporation
    • 10.3.1. Company Overview
    • 10.3.2. Financial Performance
    • 10.3.3. Product Portfolio
    • 10.3.4. Strategic Initiatives
  • 10.4. Covance, Inc.
    • 10.4.1. Company Overview
    • 10.4.2. Financial Performance
    • 10.4.3. Product Portfolio
    • 10.4.4. Strategic Initiatives
  • 10.5. Clinilabs, Inc.
    • 10.5.1. Company Overview
    • 10.5.2. Financial Performance
    • 10.5.3. Product Portfolio
    • 10.5.4. Strategic Initiatives
  • 10.6. Charles River Laboratories International, Inc.
    • 10.6.1. Company Overview
    • 10.6.2. Financial Performance
    • 10.6.3. Product Portfolio
    • 10.6.4. Strategic Initiatives
  • 10.7. Accell Clinical Research, LLC
    • 10.7.1. Company Overview
    • 10.7.2. Financial Performance
    • 10.7.3. Product Portfolio
    • 10.7.4. Strategic Initiatives
  • 10.8. Criterium, Inc.
    • 10.8.1. Company Overview
    • 10.8.2. Financial Performance
    • 10.8.3. Product Portfolio
    • 10.8.4. Strategic Initiatives
  • 10.9. Medpace, Inc.
    • 10.9.1. Company Overview
    • 10.9.2. Financial Performance
    • 10.9.3. Product Portfolio
    • 10.9.4. Strategic Initiatives
  • 10.10. Promedica International
    • 10.10.1. Company Overview
    • 10.10.2. Financial Performance
    • 10.10.3. Product Portfolio
    • 10.10.4. Strategic Initiatives
  • 10.11. WuXi App Tec
    • 10.11.1. Company Overview
    • 10.11.2. Financial Performance
    • 10.11.3. Product Portfolio
    • 10.11.4. Strategic Initiatives
  • 10.12. Genpact Ltd
    • 10.12.1. Company Overview
    • 10.12.2. Financial Performance
    • 10.12.3. Product Portfolio
    • 10.12.4. Strategic Initiatives
  • 10.13. PRA Health Sciences, Inc.
    • 10.13.1. Company Overview
    • 10.13.2. Financial Performance
    • 10.13.3. Product Portfolio
    • 10.13.4. Strategic Initiatives
  • 10.14. Pharmaceutical Product Development (PPD), LLC
    • 10.14.1. Company Overview
    • 10.14.2. Financial Performance
    • 10.14.3. Product Portfolio
    • 10.14.4. Strategic Initiatives