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市場調查報告書
商品編碼
1666711

電子臨床解決方案市場機會、成長動力、產業趨勢分析與 2025 - 2034 年預測

eClinical Solutions Market Opportunity, Growth Drivers, Industry Trend Analysis, and Forecast 2025 - 2034

出版日期: | 出版商: Global Market Insights Inc. | 英文 145 Pages | 商品交期: 2-3個工作天內

價格
簡介目錄

2024 年全球電子臨床解決方案市場價值為 111 億美元,資料2025 年至 2034 年的複合年成長率為 12.1%。穿戴式裝置、行動健康應用程式和電子健康記錄的日益普及正在提高即時監控和資料準確性。

電子臨床解決方案市場 - IMG1

監管機構也在提倡使用數位化工具來最佳化試驗效率並維護病患安全標準。此外,隨著個人化醫療和慢性病治療的進步,全球臨床試驗的數量不斷增加,也增加了對先進的電子臨床解決方案的需求。這些平台簡化了患者招募、合規性監控和即時資料分析等複雜流程,使其對於管理日益複雜的大規模試驗至關重要。

市場範圍
起始年份 2024
預測年份 2025-2034
起始值 111億美元
預測值 353億美元
複合年成長率 12.1%

eClinical 解決方案包括旨在簡化臨床試驗管理的先進軟體和數位平台。這些工具整合了來自多個來源的資料,包括電子資料收集 (EDC) 系統、臨床試驗管理系統 (CTMS) 和電子病患報告結果 (ePRO),確保提高準確性和法規遵循。 EDC 部門在 2024 年引領市場,創造 25 億美元的收入,因為它能夠增強資料處理、最大限度地減少人工錯誤並加速即時監控。隨著試驗變得越來越複雜,對此類系統的需求持續上升。

2024 年,網頁寄存解決方案佔據了最大的市場佔有率,為 50.9%。這些解決方案支援遠端存取、與其他數位工具的無縫整合以及強大的安全功能,從而推動了其廣泛應用。他們促進即時協作和資料共享的能力進一步鞏固了他們的市場地位。

2024 年,III 期臨床試驗領域佔據市場主導地位,預計到 2034 年將達到 151 億美元。 此階段涉及大規模測試以評估治療的安全性和有效性,因此需要高效的資料管理和監控。電子臨床工具透過實現即時資料擷取和確保符合監管要求來增強這些流程。

預測期內,合約研究組織 (CRO) 的複合年成長率將達到 12.5%。由於 CRO 的專業知識和效率,將臨床研究外包給 CRO 的趨勢日益明顯,成為市場的主要驅動力。這些組織利用 eClinical 解決方案來管理複雜的跨國試驗、簡化操作並確保即時資料分析。

2024 年美國將主導北美市場,預計將以 11.7% 的複合年成長率保持領先地位。這歸功於該國強勁的製藥和生物技術產業,以及對技術創新和分散試驗的重視。主要研究機構和監管機構的存在進一步支持了先進的電子臨床技術的採用。

目錄

第 1 章:方法論與範圍

第 2 章:執行摘要

第 3 章:產業洞察

  • 產業生態系統分析
  • 產業衝擊力
    • 成長動力
      • 政府對臨床試驗的資助增加
      • 將臨床試驗外包給 CRO 的需求不斷成長
      • 臨床試驗中越來越多採用軟體解決方案
      • 全球研發支出增加
    • 產業陷阱與挑戰
      • 植入成本高
      • 發展中國家對電子臨床解決方案的採用率低且缺乏認知
  • 成長潛力分析
  • 監管格局
  • 軟體格局
  • 波特的分析
  • PESTEL 分析

第4章:競爭格局

  • 介紹
  • 公司矩陣分析
  • 主要市場參與者的競爭分析
  • 競爭定位矩陣
  • 策略儀表板

第 5 章:市場估計與預測:按解決方案,2021 年至 2034 年

  • 主要趨勢
  • 隨機化和試驗供應管理
  • 臨床資料管理系統 (CDMS)
  • 臨床試驗管理系統(CTMS)
  • 電子臨床結果評估 (eCOA)
  • 電子審判主文件 (eTMF)
  • 電子資料採集 (EDC)
  • 其他解決方案

第6章:市場估計與預測:依交付方式,2021 – 2034 年

  • 主要趨勢
  • 獲得許可的企業(本地)解決方案
  • 基於雲端的(SAAS)解決方案(CBS)
  • 網路託管(按需)解決方案 (WHS)

第 7 章:市場估計與預測:按臨床試驗階段,2021 年至 2034 年

  • 主要趨勢
  • 第一階段
  • 第二階段
  • 第三階段
  • 第四階段

第 8 章:市場估計與預測:依最終用途,2021 年至 2034 年

  • 主要趨勢
  • 合約研究組織 (CRO)
  • 醫療器材公司
  • 製藥/生物技術公司
  • 醫院和診所
  • 其他最終用途

第 9 章:市場估計與預測:按地區,2021 年至 2034 年

  • 主要趨勢
  • 北美洲
    • 美國
    • 加拿大
  • 歐洲
    • 德國
    • 英國
    • 法國
    • 西班牙
    • 義大利
    • 波蘭
    • 瑞士
    • 荷蘭
  • 亞太地區
    • 中國
    • 日本
    • 印度
    • 澳洲
    • 韓國
    • 印尼
    • 泰國
  • 拉丁美洲
    • 巴西
    • 墨西哥
    • 阿根廷
    • 阿根廷
    • 智利
  • 中東和非洲
    • 南非
    • 沙烏地阿拉伯
    • 阿拉伯聯合大公國
    • 埃及

第10章:公司簡介

  • Acralyon
  • Anju Software (OmniComm System)
  • Bio-optronics
  • Clario
  • Dassault Systemes (Medidata)
  • Datatrak
  • Ennov
  • IBM
  • Medsharing
  • Multihealth Group (Clinfile)
  • OpenClinica
  • Oracle Corporation
  • Parexel International
  • Signant Health (CRF Health)
  • Veeva Systems
簡介目錄
Product Code: 1774

The Global EClinical Solutions Market, valued at USD 11.1 billion in 2024, is forecasted to grow at a CAGR of 12.1% from 2025 to 2034. This rapid growth is driven by the increasing adoption of decentralized clinical trials, which utilize digital technologies to streamline data collection and improve patient engagement. The rising use of wearable devices, mobile health applications, and electronic health records is enhancing real-time monitoring and data accuracy.

eClinical Solutions Market - IMG1

Regulatory bodies are also advocating for digital tools to optimize trial efficiency and maintain patient safety standards. Additionally, the escalating volume of clinical trials worldwide, fueled by advancements in personalized medicine and treatments for chronic conditions, is amplifying the need for advanced eClinical solutions. These platforms simplify complex processes such as patient recruitment, compliance monitoring, and real-time data analytics, making them essential in managing the growing intricacies of large-scale trials.

Market Scope
Start Year2024
Forecast Year2025-2034
Start Value$11.1 Billion
Forecast Value$35.3 Billion
CAGR12.1%

eClinical solutions encompass advanced software and digital platforms designed to streamline clinical trial management. These tools integrate data from multiple sources, including electronic data capture (EDC) systems, clinical trial management systems (CTMS), and electronic patient-reported outcomes (ePRO), ensuring improved accuracy and regulatory compliance. The EDC segment led the market in 2024, generating USD 2.5 billion, due to its ability to enhance data processing, minimize manual errors, and accelerate real-time monitoring. As trials become more complex, the demand for such systems continues to rise.

Web-hosted solutions accounted for the largest market share of 50.9% in 2024. Their scalability, affordability, and ease of deployment make them ideal for decentralized trials. These solutions enable remote access, seamless integration with other digital tools, and robust security features, driving their widespread adoption. Their ability to facilitate real-time collaboration and data sharing has further solidified their market position.

The phase III clinical trial segment dominated the market in 2024, projected to reach USD 15.1 billion by 2034. This phase involves large-scale testing to evaluate treatment safety and efficacy, necessitating efficient data management and monitoring. eClinical tools enhance these processes by enabling real-time data capture and ensuring compliance with regulatory requirements.

Contract research organizations (CROs) are set to grow at a 12.5% CAGR over the forecast period. The rising trend of outsourcing clinical research to CROs, driven by their expertise and efficiency, is a key market driver. These organizations utilize eClinical solutions to manage complex multinational trials, streamline operations, and ensure real-time data analysis.

The US dominated the North American market in 2024 and is expected to maintain its lead with a CAGR of 11.7%. This is attributed to the country's robust pharmaceutical and biotechnology industries, as well as its emphasis on technological innovation and decentralized trials. The presence of major research institutions and regulatory bodies further supports the adoption of advanced eClinical technologies.

Table of Contents

Chapter 1 Methodology and Scope

  • 1.1 Market scope and definition
  • 1.2 Research design
    • 1.2.1 Research approach
    • 1.2.2 Data collection methods
  • 1.3 Base estimates and calculations
    • 1.3.1 Base year calculation
    • 1.3.2 Key trends for market estimation
  • 1.4 Forecast model
  • 1.5 Primary research and validation
    • 1.5.1 Primary sources
    • 1.5.2 Data mining sources

Chapter 2 Executive Summary

  • 2.1 Industry 360° synopsis

Chapter 3 Industry Insights

  • 3.1 Industry ecosystem analysis
  • 3.2 Industry impact forces
    • 3.2.1 Growth drivers
      • 3.2.1.1 Rise in government funding grants for clinical trials
      • 3.2.1.2 Growing demand for outsourcing clinical trials to CROs
      • 3.2.1.3 Increasing adoption of software solutions in clinical trials
      • 3.2.1.4 Increasing R&D expenditure across the globe
    • 3.2.2 Industry pitfalls and challenges
      • 3.2.2.1 High implantation cost
      • 3.2.2.2 Low adoption and lack of awareness pertaining to eClinical solutions in developing countries
  • 3.3 Growth potential analysis
  • 3.4 Regulatory landscape
  • 3.5 Software landscape
  • 3.6 Porter’s analysis
  • 3.7 PESTEL analysis

Chapter 4 Competitive Landscape, 2024

  • 4.1 Introduction
  • 4.2 Company matrix analysis
  • 4.3 Competitive analysis of major market players
  • 4.4 Competitive positioning matrix
  • 4.5 Strategy dashboard

Chapter 5 Market Estimates and Forecast, By Solution, 2021 – 2034 ($ Mn)

  • 5.1 Key trends
  • 5.2 Randomization and trial supply management
  • 5.3 Clinical data management system (CDMS)
  • 5.4 Clinical trial management system (CTMS)
  • 5.5 Electronic clinical outcome assessment (eCOA)
  • 5.6 Electronic trial master file (eTMF)
  • 5.7 Electronic data capture (EDC)
  • 5.8 Other solutions

Chapter 6 Market Estimates and Forecast, By Delivery Mode, 2021 – 2034 ($ Mn)

  • 6.1 Key trends
  • 6.2 Licensed enterprise (on-premise) solutions
  • 6.3 Cloud-based (SAAS) solution (CBS)
  • 6.4 Web-hosted (on-demand) solution (WHS)

Chapter 7 Market Estimates and Forecast, By Clinical Trial Phase, 2021 – 2034 ($ Mn)

  • 7.1 Key trends
  • 7.2 Phase I
  • 7.3 Phase II
  • 7.4 Phase III
  • 7.5 Phase IV

Chapter 8 Market Estimates and Forecast, By End Use, 2021 – 2034 ($ Mn)

  • 8.1 Key trends
  • 8.2 Contract research organizations (CROs)
  • 8.3 Medical device companies
  • 8.4 Pharma/biotech companies
  • 8.5 Hospitals and clinics
  • 8.6 Other end use

Chapter 9 Market Estimates and Forecast, By Region, 2021 – 2034 ($ Mn)

  • 9.1 Key trends
  • 9.2 North America
    • 9.2.1 U.S.
    • 9.2.2 Canada
  • 9.3 Europe
    • 9.3.1 Germany
    • 9.3.2 UK
    • 9.3.3 France
    • 9.3.4 Spain
    • 9.3.5 Italy
    • 9.3.6 Poland
    • 9.3.7 Switzerland
    • 9.3.8 Netherlands
  • 9.4 Asia Pacific
    • 9.4.1 China
    • 9.4.2 Japan
    • 9.4.3 India
    • 9.4.4 Australia
    • 9.4.5 South Korea
    • 9.4.6 Indonesia
    • 9.4.7 Thailand
  • 9.5 Latin America
    • 9.5.1 Brazil
    • 9.5.2 Mexico
    • 9.5.3 Argentina
    • 9.5.4 Argentina
    • 9.5.5 Chile
  • 9.6 Middle East and Africa
    • 9.6.1 South Africa
    • 9.6.2 Saudi Arabia
    • 9.6.3 UAE
    • 9.6.4 Egypt

Chapter 10 Company Profiles

  • 10.1 Acralyon
  • 10.2 Anju Software (OmniComm System)
  • 10.3 Bio-optronics
  • 10.4 Clario
  • 10.5 Dassault Systemes (Medidata)
  • 10.6 Datatrak
  • 10.7 Ennov
  • 10.8 IBM
  • 10.9 Medsharing
  • 10.10 Multihealth Group (Clinfile)
  • 10.11 OpenClinica
  • 10.12 Oracle Corporation
  • 10.13 Parexel International
  • 10.14 Signant Health (CRF Health)
  • 10.15 Veeva Systems