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電子臨床試験ソリューション市場:ますます複雑化する臨床試験および正確性・効率性への注目の高まりが試験スポンサーによる新技術の導入を促進

e-Clinical Trial Solutions Market to 2018 - Growing Complexity of Clinical Trials and Increased Focus on Accuracy and Efficiency Drive Trial Sponsors to Adopt Novel Technologies

発行 GBI Research 商品コード 248226
出版日 ページ情報 英文 70 Pages
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電子臨床試験ソリューション市場:ますます複雑化する臨床試験および正確性・効率性への注目の高まりが試験スポンサーによる新技術の導入を促進 e-Clinical Trial Solutions Market to 2018 - Growing Complexity of Clinical Trials and Increased Focus on Accuracy and Efficiency Drive Trial Sponsors to Adopt Novel Technologies
出版日: 2012年07月31日 ページ情報: 英文 70 Pages
概要

当レポートは、世界の医薬品企業およびCRO(開発業務受託機関)に幅広く導入されている電子臨床試験(eクリニカルトライアル)ソリューションについて調査し、電子臨床試験ソリューションの市場規模、導入技術、将来予測、主要地域におけるデータ分析、および将来の市場に影響を及ぼしうる主要イベントの分析とレビューなどを提供しており、産業の主な促進因子・阻害因子・課題、各システムのケーススタディ、主要企業のプロファイルおよび競合情勢などをまとめ、概略下記の構成でお届けいたします。

第1章 目次

第2章 イントロダクション

第3章 概要

  • 臨床試験の計画
  • 臨床データの取得
  • 臨床データの管理
  • 臨床データの分析・報告
  • 電子臨床試験ソリューションの概要

第4章 市場特徴

  • 電子臨床試験ソリューションの市場規模・予測
  • 市場促進因子
  • 市場課題
  • 市場動向
  • 導入動向

第5章 技術動向

  • ビジネスモデル
  • CDISC標準における近年の発展

第6章 競合情勢

  • 競合ベンチマーキング:提供ソリューション別

第7章 付録

図表

目次

Summary

GBI Research, the leading business intelligence provider, has released its latest research, "e-Clinical Trial Solutions Market to 2018 - Growing Complexity of Clinical Trials and Increased Focus on Accuracy and Efficiency Drive Trial Sponsors to Adopt Novel Technologies", which provides key data and analysis of the major factors affecting the market for eClinical trial solutions in the pharmaceuticals industry. The report also analyzes the opportunities and threats in the eClinical trial solutions market, and the key market drivers and barriers to the adoption of eClinical trial solutions in the industry.

The report is based on proprietary databases, primary and secondary research, and in-house analysis by GBI Research's team of industry experts.

Scope

  • Detailed market characterization, including market size and technology adoption, and forecasts until 2018.
  • Data and analysis on the eClinical trial solutions market in the leading geographies of the world - the US, Europe and Asia-Pacific.
  • Analysis and review of the key events and milestones that will impact the future of the global eclinical trial solutions market. Each trend is independently researched to provide qualitative analysis of its implications.
  • Insightful review of key industry drivers, restraints and challenges which are likely to impact the global eclinical trial solutions market in the long run.
  • Case studies on cost cutting in clinical trials for clinical trial management systems, clinical supply chain management systems, clinical data management systems, intellectual voice response systems, e-diaries and standardization.
  • The report also covers information on the leading market players and the competitive landscape.

Reasons to buy

  • Develop business strategies by understanding the trends shaping and driving the eClinical trial solutions market.
  • Drive revenues by understanding key trends, innovative products and technologies, market segments and companies likely to impact the eClinical trial solutions market in the future.
  • Formulate effective sales and marketing strategies by understanding the competitive landscape and by analyzing the performance of various competitors.
  • Identify emerging players with a potentially strong product portfolio, and create effective counter-strategies to gain a competitive advantage.
  • Organize your sales and marketing efforts by identifying the market categories and segments that present maximum opportunities for consolidations, investments and strategic partnerships.
  • What's the next big thing in the eClinical trial solutions market landscape? - Identify, understand and capitalize.

Executive Summary

Pharma Research Companies Dragged into the The Technological Age, as eClinical Trial Solutions Dominate.

The global economic recession has led to many pharma companies cutting their spending, but investments in technology could help to improve the efficiency of clinical trials, states a new report by healthcare experts GBI Research.

The new report shows that eClinicaltrial solutions can increase the annual savings made by a medical research facility, as automated data processing improves functionality, security, compliance and costs within clinical trials.

Pharmaceutical companies are continually looking for better ways to reduce the time from the end-of-study to FDA submission. Delays in collecting, verifying and auditing the accuracy of data, and converting that data into the right format for statistical analysis, must therefore be addressed. As pharmaceutical companies and Clinical Research Organizations (CROs)manage increasing amounts of clinical information, ensuring data integrity and complying with industry standards becomes more important than ever, and minimizing the time between conducting a trial and producing finalized data set is crucial in speeding up the process of getting drugs to the FDA and the market.

GBI Research finds that eClinical trial solutions are widely adopted by pharmaceutical companies and CROs around the world due to the many advantages offered by the technology. Clinical Data Management Systems (CDMS), Electronic Data Capture (EDC), Clinical Trial Management Systems (CTMS), Electronic Patient Reported Outcomes (ePROs), Radio Frequency Identification Tags (RFIDs) and eDiaries all embody eClinical trial solutions, and the market is witnessing increasing innovation.

The growing complexity of clinical trials and an increased focus on accuracy and costs have brought several eClinical technologies into the market, as companies allocate special budgets to increase their annual savings.

EDC is the most commonly used method for capturing data electronically in clinical trials, replacing paper-based methods. EDC is set to witness huge growth in the next five years, and vendors are ready to take on complex issues in order to meet industry expectations.

However, a high dependence on traditional methods of capturing clinical trial data still holds some pharma companies from investing in eClinical trial solutions. Even with the phenomenal rise in demand, many companies are reluctant to embrace the technological age, for fear of problems caused by initial models. However, currently marketed products are less complex and more user friendly. In the long term future companies must adapt to eClinical technologies, else the overwhelming data volumes that clinical trials provide will cause various issues like loss of data, delays in approval processes and decline in overall Return on Investment (ROI).

e-Clinical Trial Solutions Market to 2018 - Growing Complexity of Clinical Trials and Increased Focus on Accuracy and Efficiency Drive Trial Sponsors to Adopt Novel Technologies

This report provides data and analysis of the major factors affecting the market for eClinical trial solutions in the pharmaceuticals industry. The report also analyzes the opportunities and threats in the eClinical trial solutions market, and the key market drivers and barriers to the adoption of eClinical trial solutions in the industry.

This report was built using data and information sourced from proprietary databases, primary and secondary research, and in-house analysis conducted by GBI Research's team of industry experts.

Table of Contents

1 Table of Contents 5

  • 1.1 List of Tables 6
  • 1.2 List of Figures 7

2 eClinical Trial Solutions Market - Introduction 9

  • 2.1 Introduction to eClinical Trial Solutions 9
    • 2.1.1 Need for eClinical Trial Solutions 9
  • 2.2 Technological Overview 10

3 eClinical Trial Solutions Market - Overview of eClinical Trials 11

  • 3.1 Clinical Trial Planning 12
    • 3.1.1 Clinical Trial Project Planning 12
    • 3.1.2 Pain Points in Clinical Trial Project Planning 12
    • 3.1.3 Clinical Trial Supply Chain Planning 13
    • 3.1.4 Pain Points in Clinical Trial Supply Chain Management 13
    • 3.1.5 Planning Issues 13
    • 3.1.6 Manufacturing Issues 13
    • 3.1.7 Distribution Issues 14
    • 3.1.8 Visibility Issues 14
  • 3.2 Clinical Data Capture 15
    • 3.2.1 Pain Points in Data Capturing 15
    • 3.2.2 Issues with Paper-Based Data Collection 15
    • 3.2.3 Issues with Paper-Based Diaries 15
    • 3.2.4 Issues with Paper-Based Data Management 16
  • 3.3 Clinical Data Management 17
    • 3.3.1 Pain Points in Clinical Data Management 17
  • 3.4 Clinical Data Analysis and Reporting 17
    • 3.4.1 Pain Points in Clinical Data Analysis and Reporting 17
  • 3.5 Overview of eClinical Trial Solutions 18
    • 3.5.1 Clinical Trial Management Systems (CTMS) 18
    • 3.5.2 Benefits of Clinical Trial Management Systems 18
    • 3.5.3 Electronic Data Capture (EDC) 21
    • 3.5.4 Cost Saving Scenario in EDC 22
    • 3.5.5 Cost Saving Scenario for Phase I and Phase II Trials 24
    • 3.5.6 SaaS-based EDC 25
    • 3.5.7 Electronic Patient Report Outcome System (ePRO) 25
    • 3.5.8 Cost Saving Scenario with eDiaries 27
    • 3.5.9 ePRO Adoption Rates 27
    • 3.5.10 Interactive Voice Response Systems (IVRS) 28
    • 3.5.11 Clinical Data Management Systems (CDMS) 29
    • 3.5.12 Clinical Trial Supply Chain Management System 29

4 eClinical Trial Solutions Market - Market Characterization 31

  • 4.1 Market Size and Forecasts for eClinical Trial Solutions 31
    • 4.1.1 Clinical Trial Management System Market 31
    • 4.1.2 Key Players in the CTMS Market 33
    • 4.1.3 Electronic Data Capture Market 35
    • 4.1.4 Key Players in the EDC Market 36
    • 4.1.5 ePRO Market 38
    • 4.1.6 Key Players in the ePRO Market 39
    • 4.1.7 IVRS Market 40
    • 4.1.8 Key Players in the IVRS Market 41
    • 4.1.9 Emerging Trend of Virtual Clinical Trials 42
  • 4.2 Market Drivers 42
    • 4.2.1 Cutting Down Clinical Trial Costs is the Driving Motivation for the Adoption of eClinical Trial Solutions 42
    • 4.2.2 Improved Data Standardization Increases Adoption of IT Solutions 43
    • 4.2.3 Adaptive Clinical Trials are Preferred by Large Biopharmaceutical Companies 44
    • 4.2.4 Increasing Phase III and Phase II Trials Escalates eClinical Solution Adoption 45
    • 4.2.5 "Expansion of Indication" for the Existing Drugs is a New Market Opportunity 46
  • 4.3 Market Challenges 46
    • 4.3.1 The Traditional Approaching Activities of Pharmaceutical Companies Towards eClinical Trial Solutions 46
    • 4.3.2 Lack of Standardization of Data Collection Methods Might Limit the Value of eClinical Trial Technologies 46
    • 4.3.3 The Need for Improvisation of Solutions 47
  • 4.4 Market Trends 48
    • 4.4.1 Clinical Trial Spending is Increasing at a Faster Rate 48
    • 4.4.2 R&D Spending is High in the US 49
    • 4.4.3 Phase II Spending is Highest in the US and Europe 50
    • 4.4.4 Market Potential for eClinical Solutions by Phases (US and Europe) is Largely from Phase III 51
    • 4.4.5 Electronic Data Capture will Witness the Highest Investment for the Next Five Years 52
  • 4.5 Adoption Trends 53

5 eClinical Trial Solutions Market - Technology Trends 57

  • 5.1 Business Models 57
    • 5.1.1 Outsourcing of Clinical Data Management 57
    • 5.1.2 Individual Project Outsourcing Model 57
    • 5.1.3 Full Time Equivalent Model 57
    • 5.1.4 Functional Service Provider Model 57
    • 5.1.5 The Need for Outsourcing 58
  • 5.2 Recent Developments in CDISC Standards 62
    • 5.2.1 SDTM 63
    • 5.2.2 ADaM 63
    • 5.2.3 ODM 63
    • 5.2.4 LAB 63
    • 5.2.5 CRT-DDS 63
    • 5.2.6 Protocol standard 63
    • 5.2.7 CDISC Sponsored Studies Save Time and Costs 64

6 eClinical Trial Solutions Market: Competetive Landscape 65

  • 6.1 Competitive Benchmarking by Solution Offerings 65

7 eClinical Trial Solutions Market - Appendix 67

  • 7.1 Market Definitions 67
  • 7.2 Abbreviations 67
  • 7.3 Bibliography 68
  • 7.4 Research Methodology 68
    • 7.4.1 Coverage 68
    • 7.4.2 Secondary Research 69
    • 7.4.3 Primary Research 69
    • 7.4.4 Expert Panel Validation 70
  • 7.5 Contact Us 70
  • 7.6 Disclaimer 70

List of Tables

  • Table 1: eClinical Trial Solutions Market, Global, Phase I: II Cost Saving Scenario by Adopting EDC, 2012 24
  • Table 2: eClinical Trial Solutions Market, Global, Data Management Set Up Cost in India, 2010 61
  • Table 3: eClinical Trial Solutions Market, Global, CDISC Sponsored Studies, 2010 64
  • Table 4: eClinical Trial Solutions Market, Global, Competitive Benchmarking by Solutions Offering, 2012 65

List of Figures

  • Figure 1: eClinical Trial Solutions Market, Global, Segmentation by Activities, 2012 11
  • Figure 2: eClinical Trial Solutions Market, Global, Supply Chain in Clinical Trials, 2012 14
  • Figure 3: eClinical Trial Solutions Market, Global, Paper CRF Method of Data Capturing, 2012 16
  • Figure 4: eClinical Trial Solutions Market, Global, Typical Clinical Trial Management System, 2012 20
  • Figure 5: eClinical Trial Solutions Market, Global, Electronic Data Capture Through e-CRF, 2012 21
  • Figure 6: eClinical Trial Solutions Market, Global, EDC System - Cost Saving Scenario, 2012 22
  • Figure 7: eClinical Trial Solutions Market, Global, Data Quality Gap, 2012 23
  • Figure 8: eClinical Trial Solutions Market, Global, SaaS-based EDC System, 2012 25
  • Figure 9: eClinical Trial Solutions Market, Global, Cost Saving Scenario of ePRO Solutions, 2012 26
  • Figure 10: eClinical Trial Solutions Market, Global, Case Study of ePRO Solutions, 2012 27
  • Figure 11: eClinical Trial Solutions Market, Global, Case Study of ePRO Solutions, 2012 28
  • Figure 12: eClinical Trial Solutions Market, Global, Clinical Data Management Flow, 2012 29
  • Figure 13: eClinical Trial Solutions Market, Global, Clinical Trial Supply Chain Management System, 2012 30
  • Figure 14: eClinical Trial Solutions Market, Global, Clinical Trial Management System Market ($m), 2010-2018 31
  • Figure 15: eClinical Trial Solutions Market, Global, Electronic Data Capture Market ($m), 2010-2018 35
  • Figure 16: eClinical Trial Solutions Market, Global, Electronic Patient Reported Outcomes Market ($m), 2010-2018 38
  • Figure 17: eClinical Trial Solutions Market, Global, Interactive Voice Response System Market ($m), 2010-2018 40
  • Figure 18: eClinical Trial Solutions Market, Global, Cutting Down Clinical Trial Cost is a High Priority Task for Pharmaceutical Companies - Impact Analysis, 2012 42
  • Figure 19: eClinical Trial Solutions Market, Global, Research and Development Spending Split by Phases - Impact Analysis, 2012 43
  • Figure 20: eClinical Trial Solutions Market, Global, Adaptive Clinical Trials are Preferred by Large Biopharmaceutical Companies - Impact Analysis, 2012 44
  • Figure 21: eClinical Trial Solutions Market, Global, Increasing Phase III and Phase II Trials Escalates eClinical Solution Adoption - Impact Analysis, 2012 45
  • Figure 22: eClinical Trial Solutions Market, Global, Increasing Phase III and Phase II Trials Escalates eClinical Solution Adoption - Impact Analysis, 2012 46
  • Figure 23: eClinical Trial Solutions Market, Global, the Need for Improvisation of Solutions - Impact Analysis, 2012 47
  • Figure 24: eClinical Trial Solutions Market, Global, Research and Development Spending Split by Phases - Impact Analysis (%), 2012 48
  • Figure 25: eClinical Trial Solutions Market, Global, Spending on Research and Development in the US and Europe, 2004-2010 49
  • Figure 26: eClinical Trial Solutions Market, Global, Value of Spending in R&D by Clinical Trial Phases, 2010 50
  • Figure 27: eClinical Trial Solutions Market, Global, Market Potential for eClinical Trial Solutions, 2010 51
  • Figure 28: eClinical Trial Solutions Market, Global, Investment Trends in Future eClinical Trial Solutions, 2012 52
  • Figure 29: eClinical Trial Solutions Market, Global, CTMS - Technology Adoption, 2009 53
  • Figure 30: eClinical Trial Solutions Market, Global, Investigator Portal - Technology Adoption, 2009 54
  • Figure 31: eClinical Trial Solutions Market, Global, System Integration - Technology Adoption, 2009 54
  • Figure 32: eClinical Trial Solutions Market, Global, ePRO Solutions - Technology Adoption, 2009 55
  • Figure 33: eClinical Trial Solutions Market, Global, IVRS Solutions - Technology Adoption, 2009 56
  • Figure 34: eClinical Trial Solutions Market, Global, Factors Impacting Clinical Data Management Outsourcing - 2011 58
  • Figure 35: eClinical Trial Solutions Market, Global, End-to-End Services Offered by Large IT Vendors, 2011 59
  • Figure 36: eClinical Trial Solutions Market, Global, Supply Chain in Clinical Trials, 2011 60
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