無料セミナー : 2018年10月2日『プレシジョン・メディシンの戦略的分析、将来動向予測』 BIS Research共同開催

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市場調査レポート

臨床試験データ管理・eClinicalソリューションの世界市場:成長機会・成長予測:〜2020年

Growth Opportunities in Clinical Trial Data Management and eClinical Solutions Market, Forecast to 2020

発行 Frost & Sullivan 商品コード 604449
出版日 ページ情報 英文 87 Pages
納期: 即日から翌営業日
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本日の銀行送金レート: 1USD=113.61円で換算しております。
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臨床試験データ管理・eClinicalソリューションの世界市場:成長機会・成長予測:〜2020年 Growth Opportunities in Clinical Trial Data Management and eClinical Solutions Market, Forecast to 2020
出版日: 2018年02月06日 ページ情報: 英文 87 Pages
概要

当レポートでは、臨床試験データ管理・eClinicalソリューションの市場を調査し、市場の定義と概要、ベンダーのエコシステム、技術区分別の市場動向・成長機会の分析・市場成長予測、ケーススタディ、成長戦略・成功要件の分析などをまとめています。

第1章 エグゼクティブサマリー

  • 臨床試験のデジタル化を推進する6大テーマ
  • 市場の範囲・区分
  • 本書の主要課題
  • 4大成長機会:CTDM・eClinicalソリューション
  • ソリューションの実装上の課題
  • 市場規模・成長の潜在性の分析:地域別

第2章 市場の定義・概要

  • 市場の定義
  • 臨床試験用IT:主な用途・技術
  • ベンダーのエコシステム

第3章 マクロ&ミクロシナリオ分析

  • 臨床試験ビジネスモデルのトランスフォーメーション
  • 臨床試験のデジタル化の6大データ
  • 臨床試験の継続における課題
  • 癌の精密医療における臨床試験モデルの進化
  • 患者中心主義の事例
  • 臨床試験モデルの進化
  • 臨床試験の充実化
  • 非従来型企業の参入
  • デジタルコンティニュイティ

第4章 市場概要・予測:臨床試験データ管理・eCLINICALソリューション

  • CTDM・eClinicalソリューション市場の予測
  • 主な臨床試験ITソリューションの技術ライフサイクル
  • CTDM・eClinicalソリューションの予測

第5章 ECOA/EPRO:成長機会

  • カテゴリーの定義:eCOA技術
  • eCOAソリューションモダリティの進化:CODからBYODへ
  • eCOAソリューションの主要パフォーマンス指標:モダリティタイプ別
  • 成長機会:eCOA技術
  • eCOAシステム市場の予測
  • eCOA/ePROソリューション:主要動向
  • eCOA導入動向:デバイスモダリティタイプ別
  • ROIシナリオ分析:紙 vs eCOAのコスト比較
  • シナリオ分析:紙 vs マルチモダリティeCOAのコスト比較
  • ケーススタディ:eCOA実装上のメリット

第6章 EDCソリューションの成長機会

  • 臨床試験データ回収・管理システムの進化
  • EDCシステムの統合の展望
  • 現在の課題・重要性:eSource + EDC技術
  • 成長機会:Electronic Data Capture (EDC)
  • EDC/CDMSシステム市場の予測
  • EDC/CDMSシステムの主要動向・予測
  • ケーススタディ
  • バリューチェーンにおける主な取り組み

第7章 臨床インフォマティクス&クラウドストレージソリューション

  • カテゴリーの定義:ライフサイエンスアナリティクスソリューションの各種タイプ
  • 成長機会:臨床インフォマティクス・クラウドストレージ
  • 臨床開発インフォマティクス:市場概要
  • アナリティクスアプリケーションの展望:臨床開発活動別
  • ケーススタディ
  • 臨床開発クラウド:市場概要

第8章 RTSM/IRTシステムの成長機会

  • RTSM技術の進歩
  • 成長機会:RTSM/IRTシステム
  • RTSM/IRTシステム市場の予測
  • RTSM/IRTシステムの予測
  • ケーススタディ

第9章 総論・戦略的必須要件

  • CDTM・eClinicalソリューション:ステークホルダーのための戦略的必須要件
  • eClinicalソリューション:新技術とのコンバージェンスの潜在性
  • 臨床試験のIoTエコシステム
  • 5項目の競合因子:臨床開発ITソリューションの成功の鍵

第10章 付録

第11章 FROST & SULLIVANについて

目次
Product Code: K1EE-52

Digitization Presents Opportunities for Unified Cloud-based Platform Solutions to Optimize Clinical Trial Workflows

The global clinical trial IT market is expected to grow from $2.63 billion in 2016 to $4.29 billion in 2020 at a compound annual growth rate (CAGR) of more than 13.0%. North America will continue to hold the largest market share (by revenue) in 2017, followed by Europe. Increasing clinical trial activities in the emerging Asia-Pacific markets and recent favorable regulatory reforms (China to accept overseas trial data; Indian government allowing? academic institutions to take Drug Controller General of India (DCGI) permission) are expected to drive the demand for clinical trial IT solutions from 2017 to 2020. Clinical trial data management (CTDM) and emerging eClinical solutions comprising electronic data capture (EDC), clinical data management systems (CDMS), clinical trial management systems (CTMS), randomization and trial supply management systems (RTMS), electronic clinical outcome assessment (eCOA), trail planning and safety solutions, clinical data integration platforms, and clinical analytics platform have the largest market shares in the total clinical trial IT solutions, and are estimated to touch $4,051.6 million in 2020.

Digital transformation is leading the clinical trial industry towards a data centric approach. The increasing volume and veracity of data that can be leveraged beyond traditional clinical data sets requires clinical trial IT systems to shift from fragmented application-centric IT systems to unified data-centric solutions. Furthermore, the rising demand for quality data and novel endpoints demands CTDM solutions to migrate from point solutions that sit in silos to integrated eClinical solutions that provide a single source of truth, optimize costs by eliminating duplicate data entry, and reduce on-site verification and source data verification rate (SDVR). This involves an evolving vendor ecosystem of modular, cloud-based eClinical solutions with intuitive user interface that is capable of integrating all possible study and eSource data to enhance clinical trial digital workflows and reduce data management cost and time.

Research Scope

The research service analyzes the top four growth opportunities in the global CTDM and emerging eClinical solutions. It also evaluates and discusses market projections, key trends, technology life cycle (adoption rate vs maturity), key implementation benefits, and challenges of top four CTDM and emerging eClinical solutions. Finally, it provides industry best practices, live case studies, cost benefit analysis, and strategic imperatives (call to action) for key clinical trial industry stakeholders such as pharma sponsors, CRO, sites, and technology providers.

Key Issues Addressed:

  • What are the key trends and growth opportunities that can be derived from the emerging digitally-led clinical trials operating models?
  • Which technologies and IT systems (EDC, eSource, eCOA, RTSM) will have the strongest potential to optimize clinical workflows?
  • What is the technology lifecycle for select clinical trials IT solutions (current adoption and future growth rates)?
  • What are the gaps and inefficiencies in current CTDM workflows and how can these be filled by emerging clinical IT solutions?
  • What does the new ecosystem of unified clinical IT systems/ eClinial solution providers look like?
  • What are the key challenges while implementing these digital solutions across the clinical development value chain?

Table of Contents

1. EXECUTIVE SUMMARY

  • Six Big Themes Driving Clinical Trial Digitization
  • Scope and Segmentation-Clinical Trial Data Management and eClinical Solutions Market
  • Key Questions This Study Will Answer
  • Top 4 Growth Opportunities-CTDM and eClinical Solutions
  • Implementation Challenges for Select CTDM and eClinical Solutions
  • CDTM and eClinical Solutions Market-Regional Market Size and Growth Potential

2. MARKET DEFINITION AND OVERVIEW

  • Market Definition-CTDM and eClinical Solutions Market
  • Clinical Trial IT Market-Major Application Segments and Technologies
  • Vendor Ecosystem-Clinical Trials IT Solutions Market

3. MACRO AND MICRO SCENARIO ANALYSIS

  • Evolving Clinical Trial Business Model Transformation
  • Six Big Themes Driving Clinical Trial Digitization
  • Continuing Clinical Trial Challenges
  • Evolving Clinical Trials Models for Precision Oncology Therapeutics
  • Focus on Patient-centricity-Case Examples
  • Evolving Clinical Trial Models
  • Clinical Trial Enrichment
  • Entry of Non-traditional Players
  • Digital Continuity

4. MARKET OVERVIEW AND FORECAST-CLINICAL TRIAL DATA MANAGEMENT AND ECLINICAL SOLUTIONS

  • Market Projection for CTDM and eClinical Solutions Market
  • Technology Lifecycle for Select Clinical Trial IT Solutions
  • Forecast for CTDM and eClinical Solutions
  • Forecast for CTDM and eClinical Solutions (continued)
  • Forecast for CTDM and eClinical Solutions (continued)

5. ECOA/EPRO GROWTH OPPORTUNITIES

  • Category Definition-eCOA Technologies
  • Evolving eCOA Solutions Modalities for Trials-From COD to BYOD
  • Key Performance Indicator for eCOA Solutions by Modality Types
  • Growth Opportunity 1-eCOA Technologies
  • eCOA Systems Market Forecast
  • Forecast for eCOA Systems
  • Forecast-Key Trends for eCOA/ePRO Solutions
  • eCOA Adoption Trend by Device Modality Types
  • ROI Scenario Analysis-Cost Comparison of Paper vs eCOA
  • Scenario Analysis-Cost Comparison of Paper versus Multi-modality eCOA
  • Case Study-eCOA Implementation Benefits for Top 10 Pharmas

6. EDC SOLUTIONS GROWTH OPPORTUNITIES

  • Evolving Clinical Trials Data Capture and Management Systems
  • EDC System Integration Scope with Traditional Clinical IT Systems and Emerging eSource Data Capture Solutions
  • Current Challenges and Role of eSource + EDC Technologies
  • Growth Opportunity 2-Electronic Data Capture (EDC)
  • EDC/CDMS Systems Market Forecast
  • Forecast for EDC Systems
  • Forecast-Key Trends for EDC/CDMS Systems
  • Forecast-Key Trends for EDC/CDMS Systems (continued)
  • Case Study-Integrated eSource and EDC Solution
  • Case Study-eSource Data Monitoring ROI Analysis by Major Value Chain Activities

7. CLINICAL INFORMATICS AND CLOUD STORAGE SOLUTIONS

  • Category Definition-Life Sciences Analytics Solutions Types
  • Growth Opportunity 4-Clinical Informatics and Cloud Storage
  • Clinical Development Informatics Market Overview
  • Analytics Application Scope by Key Clinical Development Activities
  • Case Study-Advanced Clinical Informatics Visualization to Optimize Clinical Trial Safety Study and Adverse Event (AE) Reporting
  • Clinical Development Cloud Market Overview

8. RTSM/IRT SYSTEMS GROWTH OPPORTUNITIES

  • Evolution of RTSM Technology and Terminology
  • Growth Opportunity 5-RTSM/IRT Systems
  • RTSM/IRT Systems Market Forecast
  • Forecast for RTSM/IRT Systems
  • Case Study-RTSM Systems Benefits for Sponsors

9. KEY CONCLUSIONS AND STRATEGIC IMPERATIVES

  • CDTM and eClinical Solutions-Strategic Imperatives for Key Industry Stakeholders
  • eClinical Solutions Convergence Potential with Emerging Technologies
  • Clinical Trials IoT Ecosystem-2025
  • 5 Competitive Factors Key to the Success of Clinical Development IT Solutions
  • Legal Disclaimer

10. APPENDIX

  • List of Exhibits
  • List of Exhibits (continued)
  • List of Exhibits (continued)

11. THE FROST & SULLIVAN STORY

  • The Frost & Sullivan Story
  • Value Proposition-Future of Your Company & Career
  • Global Perspective
  • Industry Convergence
  • 360° Research Perspective
  • Implementation Excellence
  • Our Blue Ocean Strategy
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