eTMF(전자 임상시험 관련 문서) 시장 규모 : 구성요소별, 전달 모드별, 임상시험 단계별, 최종 용도별, 예측(2024-2032년)

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