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市場調查報告書

商品編碼

1465568

電子試驗主文件 (eTMF) 市場規模 - 按組件、交付模式、臨床試驗階段、最終用途和預測，2024 年 - 2032 年

Electronic Trial Master File (eTMF) Market Size - By Component, Delivery Mode, Clinical Trial Phase, End-use & Forecast, 2024 - 2032

出版日期: 2024年02月28日 | 出版商:

Global Market Insights Inc. | 英文 165 Pages | 商品交期: 2-3個工作天內

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簡介目錄

在領先公司技術不斷進步的推動下，全球電子審判主文件 (eTMF) 市場 2024 年至 2032 年間的複合年成長率將達到 9.5%。隨著這些公司不斷創新，引入尖端的臨床試驗管理解決方案，eTMF 格局不斷發展，以適應更有效率、安全和合規的文件管理系統。例如，2023 年 11 月，Egnyte 推出了其電子試驗主文件 (eTMF) 應用程式的新功能：品質控制功能。此功能使用戶能夠在將敏感試驗內容正式提交到其 TMF 之前，對 eTMF 應用程式中的文件執行審核和批准工作流程。

這些進步包括用於資料分析的人工智慧、用於安全資料儲存的區塊鏈以及用於遠端存取的基於雲端的平台等功能。隨著監管機構越來越強調臨床試驗中的電子文件和資料完整性，對複雜 eTMF 解決方案的需求不斷增加。對先進技術的日益依賴有助於簡化試驗流程，同時確保透明度、準確性和合規性，使 eTMF 成為現代臨床研究方法的基石。

總體電子試驗主文件 (eTMF) 產業規模根據組件、臨床試驗階段、最終用途和地區進行分類。

軟體部分將在 2024 年至 2032 年間經歷顯著發展。隨著人們對數位化和資料完整性的日益重視，對根據 eTMF 要求客製化的高級軟體解決方案的需求持續激增。這些軟體元件提供文件追蹤、版本控制和稽核追蹤等功能，為利害關係人提供在當今日益複雜的研究環境中進行有效試驗管理和監督所需的工具。

從 2024 年到 2032 年，許可企業（本地）細分市場的電子試驗主文件 (eTMF) 市場資料將實現顯著的複合年成長率。本地eTMF 系統來保持對其資料的完全控制。這些獲得許可的企業解決方案提供可自訂的功能、與現有基礎設施的無縫整合以及增強的資料隱私，使其成為醫療保健和製藥等行業的首選。儘管基於雲端的解決方案越來越受歡迎，但尋求對其臨床試驗資料進行最大控制和安全性的企業對本地 eTMF 系統的需求仍然強勁。

亞太地區電子試驗主文件(eTMF) 市場將在2024 年至2032 年呈現出值得稱讚的複合年成長率。來管理臨床試驗的需求日益增加有效率地記錄文件。

政府加強醫療保健基礎設施的舉措不斷增加、生命科學研究投資不斷增加以及該地區進行的臨床試驗數量不斷增加等因素，導致對針對亞太地區獨特的監管要求和研究環境量身定做的eTMF 系統的需求不斷增加。例如，2022年11月，達梭系統公司Medidata透露，韓國最大的合約研究組織（CRO）C&R Research已選擇Medidata的臨床營運和管理解決方案，包括“Rave CTMS”和“Rave eTMF”，用於他們的臨床試驗。

產業生態系統分析
產業影響力
- 成長動力
  - ETMF 系統的採用率不斷上升
  - 大型製藥和生物製藥公司臨床試驗研究的外部化程度不斷提高
  - 行動和遠端存取解決方案的興起
  - 電子審判主文件系統的技術進步
- 產業陷阱與挑戰
  - 缺乏熟練的研究專業人員
成長潛力分析
監管環境
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
戰略儀表板

第 5 章：市場估計與預測：按組成部分，2018 年 - 2032 年

主要趨勢
軟體
服務

第 6 章：市場估計與預測：按交付模式，2018 年 - 2032 年

主要趨勢
獲得許可的企業（本地）解決方案
基於雲端 (SAAS) 的解決方案
網頁寄存（按需）解決方案

第 7 章：市場估計與預測：按臨床試驗階段，2018 年 - 2032 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：按最終用途，2018 - 2032 年

主要趨勢
合約研究組織 (CRO)
醫療器材企業
製藥和生物技術公司
醫院和診所
其他最終用戶

第 9 章：市場估計與預測：按地區分類，2018 年 - 2032 年

主要動向：按地區
北美洲
- 美國
- 加拿大
歐洲
- 德國
- 英國
- 法國
- 義大利
- 西班牙
- 歐洲其他地區
亞太地區
- 日本
- 中國
- 印度
- 澳洲
- 亞太地區其他地區
拉丁美洲
- 巴西
- 墨西哥
- 拉丁美洲其他地區
中東和非洲
- 南非
- 沙烏地阿拉伯
- 中東和非洲其他地區

第 10 章：公司簡介

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

簡介目錄

Product Code: 8312

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.

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