eTMF(전자 임상시험 마스터 파일) 시스템 시장 - 시장 규모, 점유율, 동향 분석 보고서 : 전달 모드별, 임상시험별, 최종 용도별, 지역별, 부문별 예측(2024년-2030년)

Electronic Trial Master File Systems Market Growth & Trends:

The global electronic trial master file systems market size is estimated to reach USD 1.9 billion by 2030, registering a CAGR of 14.7% from 2024 to 2030, according to a new report by Grand View Research, Inc. The market growth is attributed to a stringent regulatory structure for clinical trials and a heightened need for safety monitoring. Moreover, growing adoption of electronic trial master file (eTMF) solutions owing to the increasing number of clinical trials also contributes to the market growth. As per the data available on ClinicalTrials.gov, a total of 146,164 clinical trials were registered in the U.S., while around 259,000 studies were registered in the rest of the world in January 2024.

The COVID-19 pandemic has fueled the demand for eTMF solutions. According to an article published by Egnyte, the TMF Summit held in November 2021 highlighted the impact of COVID-19 on the clinical documentation management industry, particularly in adopting eTMFs. The pandemic compelled companies to reevaluate and embrace eTMFs and remote monitoring tools, addressing the challenges of decentralized sites and disrupted workflows. Moreover, standardization, improved user interfaces, and the integration of artificial intelligence (AI) and machine learning (ML) are anticipated to streamline data collection further, fueling the market growth over a forecast period.

Moreover, key players in the market are adopting various strategies to expand their geographical presence and strengthen their market position. For instance, in May 2023, Lotus Clinical Research expanded its partnership with Veeva Systems to adopt the Veeva Vault Clinical Suite to improve its service delivery and operational efficiency. This decision builds on Lotus' previous use of the Vault Clinical Suite, which helped them conduct more connected and faster studies. The successful integration of Veeva Vault eTMF helped Lotus scale its trial operations while maintaining the highest quality standards.

Electronic Trial Master File Systems Market Report Highlights:

• In 2023, Cloud and web-based segment dominated the market with largest revenue share of 91.3%. This is attributed to associated benefits such as easy accessibility, usability, and lower investments required
• Based on clinical trials, The Phase III segment dominated the market with largest revenue share of 53.3% in 2023. The growth of drug development sector is experiencing significant growth owing to an increasing number of drugs successfully reaching phase III
• Contract Research Organizations (CROs) segment dominated the market with the largest revenue share of 37.1% in 2023.The growing adoption of electronic trial master file solutions in research contributes to the segment growth
• North America dominated the market with the largest revenue share of 49.5 % in 2023. The market growth is attributed to an increasing target population, a rise in lifestyle-associated diseases, and the launch of new products by key market players

Table of Contents

Chapter 1 Research Methodology & Scope

• 1.1 Market Segmentation & Scope
  • 1.1.1 Electronic Trial Master File (eTMF) Systems Market Segment Scope
  • 1.1.2 Regional Scope
  • 1.1.3 Estimates & Forecast Timeline
• 1.2 Research Methodology
• 1.3 Information Procurement
  • 1.3.1 Purchased database:
  • 1.3.2 GVR's Internal Database
  • 1.3.3 Secondary sources
  • 1.3.4 Primary Research:
  • 1.3.5 Details of Primary Research
    • 1.3.5.1 Region-specific Electronic Trial Master File (eTMF) Systems market data for primary interviews
    • 1.3.5.1.1 North America
    • 1.3.5.1.2 Europe
    • 1.3.5.1.3 Asia Pacific
    • 1.3.5.1.4 Latin America
    • 1.3.5.1.5 MEA
• 1.4 Information or Data Analysis
  • 1.4.1 Data Analysis Models
• 1.5 Market Formulation & Validation
• 1.6 Model Details
• 1.7 List of Secondary Sources
• 1.8 Abbreviations
• 1.9 Objectives
  • 1.9.1 Objective 1
  • 1.9.2 Objective 2
  • 1.9.3 Objective 3
• 1.10 Market Definitions

Chapter 2 Executive Summary

• 2.1 Market Outlook
• 2.2 Segment Outlook
  • 2.2.1 Delivery Mode Segment Outlook
  • 2.2.2 Clinical Trial Segment Outlook
  • 2.2.3 End-use Segment Outlook
  • 2.2.4 Competitive outlook

Chapter 3 Electronic Trial Master File (eTMF) Systems Market Variables Trends & Scope

• 3.1 Ancillary Market Analysis
• 3.2 Pricing Analysis
  • 3.2.1 By delivery mode
  • 3.2.2 By development phase
• 3.3 User/Buyer Perception Analysis
  • 3.3.1 Market influencer analysis
    • 3.3.1.1 Regulatory Requirements
    • 3.3.1.2 Technological Developments
    • 3.3.1.3 Product Differentiation
    • 3.3.1.4 Demand from Consumers
• 3.4 Technology Overview
• 3.5 Regulatory Overview
  • 3.5.1 Regulatory Landscape
    • 3.5.1.1 List of regulations, by country
• 3.6 Market Dynamics
  • 3.6.1 Market Driver Analysis
    • 3.6.1.1 Increasing externalization of clinical trial studies by large pharmaceutical and biopharmaceutical companies
    • 3.6.1.2 Increasing government support in the form of grants and funding
  • 3.6.2 Market Restraints Analysis
    • 3.6.2.1 Scarcity of skilled research professionals
    • 3.6.2.2 Lack of recognition
  • 3.6.3 Market Challenge Analysis
    • 3.6.3.1 Market-related barriers
    • 3.6.3.1.1 Lack of education and communication
    • 3.6.3.1.2 Lack of lean processes and operations
• 3.7 Industry Analysis - Porter's
• 3.8 Electronic Trial Master File (eTMF) Systems Market - SWOT Analysis, by Factor (Political & Legal, Economic, Social and Technological)
• 3.9 COVID-19 Impact Analysis

Chapter 4 Electronic Trial Master File (eTMF) Systems Market: Delivery Mode Analysis

• 4.1 Delivery Mode Business Analysis
  • 4.1.1 Cloud and Web-based
    • 4.1.1.1 Cloud and web-based market estimates and forecasts, 2018 - 2030 (USD Million)
  • 4.1.2 On-premise
    • 4.1.2.1 On-Premise market estimates and forecasts, 2018 - 2030 (USD Million)

Chapter 5 Electronic Trial Master File (eTMF) Systems Market: Clinical Trials Analysis

• 5.1 Clinical Trials Business Analysis
  • 5.1.1 Phase I
    • 5.1.1.1 Phase I market estimates and forecasts, 2018 - 2030 (USD Million)
  • 5.1.2 Phase II
    • 5.1.2.1 Phase II market estimates and forecasts, 2018 - 2030 (USD Million)
  • 5.1.3 Phase III
    • 5.1.3.1 Phase III market estimates and forecasts, 2018 - 2030 (USD Million)
  • 5.1.4 Phase IV
    • 5.1.4.1 Phase IV market estimates and forecasts, 2018 - 2030 (USD Million)

Chapter 6 Electronic Trial Master File (eTMF) Systems Market: End-use Analysis

• 6.1 End-use Business Analysis
  • 6.1.1 Hospitals/healthcare providers
    • 6.1.1.1 Hospitals market estimates and forecasts, 2018 - 2030 (USD Million)
  • 6.1.2 Contract Research Organizations (CROs)
    • 6.1.2.1 CROs market estimates and forecasts, 2018 - 2030 (USD Million)
  • 6.1.3 Academic institutes
    • 6.1.3.1 Academic institutes market estimates and forecasts, 2018 - 2030 (USD Million)
  • 6.1.4 Pharma & biotech organizations
    • 6.1.4.1 Pharma & biotech organizations market estimates and forecasts, 2018 - 2030 (USD Million)
  • 6.1.5 Medical device manufacturers
    • 6.1.5.1 Medical device manufacturers market estimates and forecasts, 2018 - 2030 (USD Million)

Chapter 7 Electronic Trial Master File (eTMF) Systems Market: Regional Market Analysis, By Delivery Mode, By Clinical Trials, and By End-use, 2018 - 2030 (USD Million)

• 7.1 Regional Market Share Analysis, 2023 & 2030
• 7.2 Regional Market Snapshot
• 7.3 North America
  • 7.3.1 North America electronic trial master file (eTMF) systems market estimates and forecasts by countries, 2018 - 2030 (USD Million)
  • 7.3.2 U.S.
    • 7.3.2.1 Key Country Dynamics
    • 7.3.2.2 Regulatory framework
    • 7.3.2.3 U.S. electronic trial master file (eTMF) systems market estimates and forecasts, 2018 - 2030 (USD Million)
  • 7.3.3 Canada
    • 7.3.3.1 Key Country Dynamics
    • 7.3.3.2 Regulatory framework
    • 7.3.3.3 Canada electronic trial master file (eTMF) systems market estimates and forecasts, 2018 - 2030 (USD Million)
• 7.4 Europe
  • 7.4.1 Europe electronic trial master file (eTMF) systems market estimates and forecasts by countries, 2018 - 2030 (USD Million)
  • 7.4.2 UK
    • 7.4.2.1 Key Country Dynamics
    • 7.4.2.2 Regulatory framework
    • 7.4.2.3 UK electronic trial master file (eTMF) Systems market estimates and forecasts, 2018 - 2030 (USD Million)
  • 7.4.3 Germany
    • 7.4.3.1 Key Country Dynamics
    • 7.4.3.2 Regulatory framework
    • 7.4.3.3 Germany electronic trial master file (eTMF) systems market estimates and forecasts, 2018 - 2030 (USD Million)
  • 7.4.4 France
    • 7.4.4.1 Key Country Dynamics
    • 7.4.4.2 Regulatory framework
    • 7.4.4.3 France electronic trial master file (eTMF) systems market estimates and forecasts, 2018 - 2030 (USD Million)
  • 7.4.5 Italy
    • 7.4.5.1 Key Country Dynamics
    • 7.4.5.2 Regulatory framework
    • 7.4.5.3 Italy electronic trial master file (eTMF) systems market estimates and forecasts, 2018 - 2030 (USD Million)
  • 7.4.6 Spain
    • 7.4.6.1 Key Country Dynamics
    • 7.4.6.2 Regulatory framework
    • 7.4.6.3 Spain electronic trial master file (eTMF) systems market estimates and forecasts, 2018 - 2030 (USD Million)
  • 7.4.7 Norway
    • 7.4.7.1 Key Country Dynamics
    • 7.4.7.2 Regulatory framework
    • 7.4.7.3 Norway electronic trial master file (eTMF) systems market estimates and forecasts, 2018 - 2030 (USD Million)
  • 7.4.8 Denmark
    • 7.4.8.1 Key Country Dynamics
    • 7.4.8.2 Regulatory framework
    • 7.4.8.3 Denmark electronic trial master file (eTMF) systems market estimates and forecasts, 2018 - 2030 (USD Million)
  • 7.4.9 Sweden
    • 7.4.9.1 Key Country Dynamics
    • 7.4.9.2 Regulatory framework
    • 7.4.9.3 Sweden electronic trial master file (eTMF) systems market estimates and forecasts, 2018 - 2030 (USD Million)
• 7.5 Asia Pacific
  • 7.5.1 Asia Pacific Electronic Trial Master File (eTMF) Systems market estimates and forecasts,2018 - 2030 (USD Million)
  • 7.5.2 Japan
    • 7.5.2.1 Key Country Dynamics
    • 7.5.2.2 Regulatory framework
    • 7.5.2.3 Japan electronic trial master file (eTMF) systems market estimates and forecasts, 2018 - 2030 (USD Million)
  • 7.5.3 China
    • 7.5.3.1 Key Country Dynamics
    • 7.5.3.2 Regulatory framework
    • 7.5.3.3 China electronic trial master file (eTMF) systems market estimates and forecasts, 2018 - 2030 (USD Million)
  • 7.5.4 India
    • 7.5.4.1 Key Country Dynamics
    • 7.5.4.2 Regulatory framework
    • 7.5.4.3 India electronic trial master file (eTMF) systems market estimates and forecasts, 2018 - 2030 (USD Million)
  • 7.5.5 Australia
    • 7.5.5.1 Key Country Dynamics
    • 7.5.5.2 Regulatory framework
    • 7.5.5.3 Australia electronic trial master file (eTMF) Systems market estimates and forecasts, 2018 - 2030 (USD Million)
  • 7.5.6 South Korea
    • 7.5.6.1 Key Country Dynamics
    • 7.5.6.2 Regulatory framework
    • 7.5.6.3 South Korea electronic trial master file (eTMF) systems market estimates and forecasts, 2018 - 2030 (USD Million)
• 7.6 Latin America
  • 7.6.1 Latin America electronic trial master file (eTMF) systems market estimates and forecasts, 2018 - 2030 (USD Million)
  • 7.6.2 Brazil
    • 7.6.2.1 Key Country Dynamics
    • 7.6.2.2 Regulatory framework
    • 7.6.2.3 Brazil electronic trial master file (eTMF) Systems market estimates and forecasts, 2018 - 2030 (USD Million)
  • 7.6.3 Argentina
    • 7.6.3.1 Key Country Dynamics
    • 7.6.3.2 Regulatory framework
    • 7.6.3.3 Argentina electronic trial master file (eTMF) systems market estimates and forecasts, 2018 - 2030 (USD Million)
  • 7.6.4 Mexico
    • 7.6.4.1 Key Country Dynamics
    • 7.6.4.2 Regulatory framework
    • 7.6.4.3 Mexico electronic trial master file (eTMF) systems market estimates and forecasts, 2018 - 2030 (USD Million)
• 7.7 MEA
  • 7.7.1 MEA electronic trial master file (eTMF) systems market estimates and forecasts by countries, 2018 - 2030 (USD Million)
  • 7.7.2 South Africa
    • 7.7.2.1 Key Country Dynamics
    • 7.7.2.2 Regulatory framework
    • 7.7.2.3 South Africa electronic trial master file (eTMF) systems market estimates and forecasts, 2018 - 2030 (USD Million)
  • 7.7.3 Saudi Arabia
    • 7.7.3.1 Key Country Dynamics
    • 7.7.3.2 Regulatory framework
    • 7.7.3.3 Saudi Arabia electronic trial master file (eTMF) systems market estimates and forecasts, 2018 - 2030 (USD Million)
  • 7.7.4 UAE
    • 7.7.4.1 Key Country Dynamics
    • 7.7.4.2 Regulatory framework
    • 7.7.4.3 UAE electronic trial master file (eTMF) systems market estimates and forecasts, 2018 - 2030 (USD Million)
  • 7.7.5 Kuwait
    • 7.7.5.1 Key Country Dynamics
    • 7.7.5.2 Regulatory framework
    • 7.7.5.3 Kuwait electronic trial master file (eTMF) systems market estimates and forecasts, 2018 - 2030 (USD Million)

Chapter 8 Electronic Trial Master File (eTMF) Systems Market: Competitive Landscape

• 8.1 Company Categorization
  • Oracle
  • Clinevo Technologies
  • MasterControl Solutions, Inc.
  • Veeva Systems
  • Aris Global LLC
  • PHARMALEX GMBH
  • TransPerfect
  • Aurea, Inc.
  • ePharmaSolutions (WCG Clinical)
  • SureClinical Inc.
  • Ennov
  • Montrium Inc.
  • Cloudbyz
  • TRIAL INTERACTIVE
  • Anju Software
  • Octalsoft
  • Egnyte, Inc.
• 8.2 Participants' Overview
• 8.3 Financial Performance
  • 8.3.1 Electronic Trial Master File (eTMF) Systems Market
    • 8.3.1.1 Public Market Players
    • 8.3.1.2 Private Market Players
• 8.4 Product Benchmarking
  • 8.4.1 Electronic Trial Master File (eTMF) Systems Market
• 8.5 Heat Map Analysis
  • 8.5.1 Electronic Trial Master File (eTMF) Systems Market-Heat Map Analysis
• 8.6 Electronic trial master file (eTMF) systems market: Company market share analysis, 2023
• 8.7 Strategy Mapping
  • 8.7.1 Electronic Trial Master File (eTMF) Systems Market
    • 8.7.1.1 Collaborations/Partnership
    • 8.7.1.2 New Product Launches
    • 8.7.1.3 Mergers/Acquisitions
    • 8.7.1.4 Others
• 8.8 List of Other Companies

Chapter 9 KOL Recommendations/Conclusion

Chapter 10 Survey insights/Use cases