电子试验主文件 (eTMF) 市场规模 - 按组件、交付模式、临床试验阶段、最终用途和预测，2024 年 - 2032 年

在领先公司技术不断进步的推动下，全球电子审判主文件 (eTMF) 市场 2024 年至 2032 年间的复合年增长率将达到 9.5%。随着这些公司不断创新，引入尖端的临床试验管理解决方案，eTMF 格局不断发展，以适应更有效率、安全和合规的文件管理系统。例如，2023 年 11 月，Egnyte 推出了其电子试验主文件 (eTMF) 应用程式的新功能：品质控制功能。此功能使用户能够在将敏感试验内容正式提交到其 TMF 之前，对 eTMF 应用程式中的文件执行审核和批准工作流程。

这些进步包括用于资料分析的人工智慧、用于安全资料储存的区块链以及用于远端存取的基于云端的平台等功能。随着监管机构越来越强调临床试验中的电子文件和资料完整性，对复杂 eTMF 解决方案的需求不断增加。对先进技术的日益依赖有助于简化试验流程，同时确保透明度、准确性和合规性，使 eTMF 成为现代临床研究方法的基石。

总体电子试验主文件 (eTMF) 产业规模根据组件、临床试验阶段、最终用途和地区进行分类。

软体部分将在 2024 年至 2032 年间经历显着发展。随着人们对数位化和资料完整性的日益重视，对根据 eTMF 要求客製化的高级软体解决方案的需求持续激增。这些软体元件提供文件追踪、版本控制和稽核追踪等功能，为利害关係人提供在当今日益复杂的研究环境中进行有效试验管理和监督所需的工具。

从 2024 年到 2032 年，许可企业（本地）细分市场的电子试验主文件 (eTMF) 市场资料将实现显着的复合年增长率。本地eTMF 系统来保持对其资料的完全控制。这些获得许可的企业解决方案提供可自订的功能、与现有基础设施的无缝整合以及增强的资料隐私，使其成为医疗保健和製药等行业的首选。儘管基于云端的解决方案越来越受欢迎，但寻求对其临床试验资料进行最大控制和安全性的企业对本地 eTMF 系统的需求仍然强劲。

亚太地区电子试验主文件(eTMF) 市场将在2024 年至2032 年呈现出值得称讚的复合年增长率。来管理临床试验的需求日益增加有效率地记录文件。

政府加强医疗保健基础设施的倡议不断增加、生命科学研究投资不断增加以及该地区进行的临床试验数量不断增加等因素，导致对针对亚太地区独特的监管要求和研究环境量身定制的eTMF 系统的需求不断增加。例如，2022年11月，达梭系统公司Medidata透露，韩国最大的合约研究组织（CRO）C&R Research已选择Medidata的临床营运和管理解决方案，包括“Rave CTMS”和“Rave eTMF”，用于他们的临床试验。

目录

第 1 章：方法与范围

第 2 章：执行摘要

第 3 章：产业洞察

• 产业生态系统分析
• 产业影响力
  • 成长动力
    • ETMF 系统的采用率不断上升
    • 大型製药和生物製药公司临床试验研究的外部化程度不断提高
    • 行动和远端存取解决方案的兴起
    • 电子审判主文件系统的技术进步
  • 产业陷阱与挑战
    • 缺乏熟练的研究专业人员
• 成长潜力分析
• 监管环境
• 波特的分析
• PESTEL分析

第 4 章：竞争格局

• 介绍
• 公司矩阵分析
• 主要市场参与者的竞争分析
• 竞争定位矩阵
• 战略仪表板

第 5 章：市场估计与预测：按组成部分，2018 年 - 2032 年

• 主要趋势
• 软体
• 服务

第 6 章：市场估计与预测：按交付模式，2018 年 - 2032 年

• 主要趋势
• 获得许可的企业（本地）解决方案
• 基于云端 (SAAS) 的解决方案
• 网页寄存（按需）解决方案

第 7 章：市场估计与预测：按临床试验阶段，2018 年 - 2032 年

• 主要趋势
• 第一阶段
• 第二阶段
• 第三阶段
• 第四阶段

第 8 章：市场估计与预测：按最终用途，2018 - 2032 年

• 主要趋势
• 合约研究组织 (CRO)
• 医疗器材企业
• 製药和生物技术公司
• 医院和诊所
• 其他最终用户

第 9 章：市场估计与预测：按地区划分，2018 年 - 2032 年

• 主要动向：按地区
• 北美洲
  • 我们
  • 加拿大
• 欧洲
  • 德国
  • 英国
  • 法国
  • 义大利
  • 西班牙
  • 欧洲其他地区
• 亚太地区
  • 日本
  • 中国
  • 印度
  • 澳洲
  • 亚太地区其他地区
• 拉丁美洲
  • 巴西
  • 墨西哥
  • 拉丁美洲其他地区
• 中东和非洲
  • 南非
  • 沙乌地阿拉伯
  • 中东和非洲其他地区

第 10 章：公司简介

• Anju Software, Inc.
• Aris Global LLC
• Aurea, Inc.
• Clinevo Technologies
• Cloudbyz
• Egnyte, Inc.
• MasterControl Solutions, Inc.
• Montrium Inc.
• Octalsoft
• Oracle
• SureClinical Inc.
• TransPerfect
• Veeva Systems

Global Electronic Trial Master File (eTMF) Market will witness 9.5% CAGR between 2024 and 2032, propelled by continuous advancements in technology by leading companies. As these companies innovate, introducing cutting-edge solutions for clinical trial management, the eTMF landscape evolves to accommodate more efficient, secure, and compliant document management systems. For instance, in November 2023, Egnyte unveiled a fresh addition to its electronic Trial Master File (eTMF) application: the Quality Control feature. This functionality empowers users to execute review and approval workflows on documents within the eTMF application before officially filing sensitive trial content into their TMF.

These advancements include features like artificial intelligence for data analysis, blockchain for secure data storage, and cloud-based platforms for remote accessibility. With regulatory bodies increasingly emphasizing electronic documentation and data integrity in clinical trials, the demand for sophisticated eTMF solutions is on the rise. This growing reliance on advanced technologies helps streamline trial processes while ensuring transparency, accuracy, and compliance, making eTMF a cornerstone in modern clinical research methodologies.

The overall electronic Trial Master File (eTMF) Industry size is classified based on the component, clinical trial phase, end-use, and region.

The software segment will undergo notable development from 2024 to 2032. As the backbone of eTMF systems, software components facilitate efficient document management, streamline processes, and ensure regulatory compliance within clinical trials. With a growing emphasis on digitization and data integrity, the demand for advanced software solutions tailored to eTMF requirements continues to surge. These software components offer functionalities such as document tracking, version control, and audit trails, providing stakeholders with the tools necessary for effective trial management and oversight in today's increasingly complex research landscape.

The electronic Trial Master File (eTMF) market share from the licensed enterprise (on-premises) segment will register a noteworthy CAGR from 2024 to 2032. With stringent data security requirements and regulatory compliance standards, many organizations opt for on-premise eTMF systems to maintain full control over their data. These licensed enterprise solutions offer customizable features, seamless integration with existing infrastructure, and enhanced data privacy, making them preferred choices for industries such as healthcare and pharmaceuticals. Despite the growing popularity of cloud-based solutions, the demand for on-premise eTMF systems remains robust among enterprises seeking maximum control and security over their clinical trial data.

Asia Pacific electronic Trial Master File (eTMF) market will showcase a commendable CAGR from 2024 to 2032. As countries in Asia-Pacific become key players in the global pharmaceutical and biotech industries, there is a heightened need for advanced eTMF solutions to manage clinical trial documentation efficiently.

Factors such as increasing government initiatives to boost healthcare infrastructure, rising investments in life sciences research, and a growing number of clinical trials conducted in the region contribute to the escalating demand for eTMF systems tailored to Asia-Pacific's unique regulatory requirements and research landscape. For instance, in November 2022, Medidata, a Dassault Systemes company, revealed that C&R Research, the largest Korean Contract Research Organization (CRO), has chosen Medidata's clinical operation and management solutions, including 'Rave CTMS' and 'Rave eTMF', for their clinical trials.

Table of Contents

Chapter 1 Methodology & Scope

• 1.1 Market scope & definitions
• 1.2 Base estimates & calculations
• 1.3 Data collection
• 1.4 Forecast parameters
• 1.5 Data validation
• 1.6 Data sources
  • 1.6.1 Primary
  • 1.6.2 Secondary
    • 1.6.2.1 Paid sources
    • 1.6.2.2 Public sources

Chapter 2 Executive Summary

• 2.1 Industry 360 degree synopsis

Chapter 3 Industry Insights

• 3.1 Industry ecosystem analysis
• 3.2 Industry impact forces
  • 3.2.1 Growth drivers
    • 3.2.1.1 Rising adoption of ETMF systems
    • 3.2.1.2 Increasing externalization of clinical trial studies by large pharmaceutical and biopharmaceutical companies
    • 3.2.1.3 Rise of mobile and remote access solutions
    • 3.2.1.4 Technological advancements in electronic trial master file systems
  • 3.2.2 Industry pitfalls & challenges
    • 3.2.2.1 Dearth of skilled research professionals
• 3.3 Growth potential analysis
• 3.4 Regulatory landscape
• 3.5 Porter's analysis
  • 3.5.1 Supplier power
  • 3.5.2 Buyer power
  • 3.5.3 Threat of new entrants
  • 3.5.4 Threat of substitutes
  • 3.5.5 Industry rivalry
• 3.6 PESTEL analysis

Chapter 4 Competitive Landscape, 2023

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

Chapter 5 Market Estimates and Forecast, By Component, 2018 - 2032 ($ Million)

• 5.1 Key trends
• 5.2 Software
• 5.3 Services

Chapter 6 Market Estimates and Forecast, By Delivery Mode, 2018 - 2032 ($ Million)

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

Chapter 7 Market Estimates and Forecast, By Clinical Trial Phase, 2018 - 2032 ($ Million)

• 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, 2018 - 2032 ($ Million)

• 8.1 Key trends
• 8.2 Contract research organizations (CROs)
• 8.3 Medical device companies
• 8.4 Pharmaceutical and biotechnology companies
• 8.5 Hospitals and clinics
• 8.6 Other end-users

Chapter 9 Market Estimates and Forecast, By Region, 2018 - 2032 ($ Million)

• 9.1 Key trends, by region
• 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 Italy
  • 9.3.5 Spain
  • 9.3.6 Rest of Europe
• 9.4 Asia Pacific
  • 9.4.1 Japan
  • 9.4.2 China
  • 9.4.3 India
  • 9.4.4 Australia
  • 9.4.5 Rest of Asia Pacific
• 9.5 Latin America
  • 9.5.1 Brazil
  • 9.5.2 Mexico
  • 9.5.3 Rest of Latin America
• 9.6 Middle East and Africa
  • 9.6.1 South Africa
  • 9.6.2 Saudi Arabia
  • 9.6.3 Rest of Middle East and Africa

Chapter 10 Company Profiles

• 10.1 Anju Software, Inc.
• 10.2 Aris Global LLC
• 10.3 Aurea, Inc.
• 10.4 Clinevo Technologies
• 10.5 Cloudbyz
• 10.6 Egnyte, Inc.
• 10.7 MasterControl Solutions, Inc.
• 10.8 Montrium Inc.
• 10.9 Octalsoft
• 10.10 Oracle
• 10.11 SureClinical Inc.
• 10.12 TransPerfect
• 10.13 Veeva Systems