Allied Market Research


Electronic Trial Master File Market

Electronic Trial Master File Market Size, Share, Competitive Landscape and Trend Analysis Report by Function, by Component, by Delivery Mode and by End User : Global Opportunity Analysis and Industry Forecast, 2023-2032

LS : Healthcare

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Author's: | Roshan Deshmukh
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An electronic trial master file is a control system that provides a systematic way of managing organizing, and storing documents, images, and other content related to clinical trials.

This system saves time, money and also detects and repairs erroneous documents, this benefit increases the demand as it is an ideal system of saving time while making audits as well as providing keystrokes in respect to the site activation documentation. The ETMF system provides host benefits that lead to rapid development in the market. As the number of clinical trials is increasing the need for storing the findings such as novel drugs, treatments, and medical devices is a challenge so many organizations are opting for electronic trial master files as it provides high efficiency as well as smooth sharing of the files.

Market Scope and Structure Analysis:

Report Metric 


  Market size available for years


  Base year considered


  Forecast period


  Forecast units

  Value (USD)

  Segments covered

  Function, Component, delivery mode, End User and Region


Impact of COVID-19 on Electronic Trial Master File Market:

The global outbreak of COVID-19 had led to an ongoing downturn in the healthcare market. Apart from communities, COVID-19 was equally disastrous for major world economies, especially the healthcare sector. Prominent stakeholders are continuing to adapt their strategies to the rapidly changing situation. COVID-19 is projected to have significant long-term impacts on the healthcare industry. Countries and major players would have to undertake critical healthcare changes until the crisis takes a back seat.

Technological progress, cost containment, and increased access are projected to be an integral part of healthcare reforms in the near future. Digital health and telehealth have taken a front seat in the ongoing outbreak. COVID-19 re-emphasized the importance of remote diagnosis, care, and consultation. Over the past few years, regulatory and behavioral barriers have slowed telehealth growth. However, since many healthcare providers are currently working on video conferencing and telephone calls, the segment is anticipated to experience growth over the next two years. The social distancing measures also mandated online consultation of patients with moderate symptoms. 

It greatly reduced the burden on hospitals already swamped by counts of COVID-19 patients. Medical IoT devices that live at home with patients are now being used for optimizing outpatient treatment and minimizing repeat visits, and these devices can be further used in a crisis. The pandemic led to severe resource constraints. This is expected to result in the development of competitive pricing and value-based pricing models, which boosts the growth of the electronic trial master file market.

The COVID-19 has led to the increase in the market share of the electronic trial master file market as a greater number of clinical trials are performed to counter the COVID-19, so the market share of electronic trial master file has been increasing.

Top Impacting Factors: Market Scenario Analysis, Trends, Drivers, and Impact Analysis:

  • As the number of clinical trials is increasing with the number of increase in different kinds of diseases, the need for storing, managing, and organizing the data is a must. The electronic trial master file provides easier storing, managing, and organizing the data including pictures, documents, and other files related to the clinical trial. The documents on new findings, new treatment methods, medical devices as well as novel drugs can be effectively managed and stored. It has provided the efficiency of work, support share of the document, and provides security on the storage. It also allows the exchange, access, and arrangement of data electronically from anywhere using electronic devices.
  • The rising adaptation of the electronic trial master file by many clinical labs, research lab, and other end User are giving rise to the growth of this market. Also, factors such as an increase in the number of clinical trials, increase in the number of research and development by many pharma and biotech companies, partnerships between companies, increase in funding for clinical trials as well as awareness about the ETMF in emerging countries drives the market growth.
  • The factors that hinder the market growth include the lack of skilled professionals in operating the ETMF system, data privacy issues as everything are stored in electronic form there is a threat of data breach and budget constraints as it required high cost to manage the system. Also, factors such as the confusion in viewing the ETMF as some companies view it as a final document whereas some companies view it as a process of improving the data.
  • North America has the largest share in the market as there is advancement in clinical trials, low costs associated with cloud platforms, and easy to use management system. Asia-Pacific is growing at a fast rate because of two countries that are India and China. The development in the pharmaceutical industry, low cost of high-quality medicine are the factors that drive the market growth in this region.

Market Trend:

PRC clinical advances clinical trials by using Veeva Vault eTMF on March 27, 2020.

Electronic Trial Master File Market Report Highlights

Aspects Details
By Function
  • Document uploading or creation
  • Document classification
  • Document indexing
  • Document storage
  • Comprehensive security
  • Document QC
  • Auditability
  • Market reporting
  • Search and retrieval
By Component
  • Software
  • Services
By Delivery Mode
  • Cloud-Based eTMF
  • On Premise eTMF
By End User
  • Pharmaceutical Company
  • Biotechnology Company
  • Contract Research Organisation
  • Other End User.
By Region
  • North America  (U.S, Canada, Mexico)
  • Europe  (Germany, France, UK, Italy, Spain, Rest of Europe)
  • Asia-Pacific  (China, Japan, India, South Korea, Australia, Rest of Asia-Pacific)
  • LAMEA  (Brazil, Saudi Arabia, South Africa, Rest of LAMEA)
Key Market Players

Phlexglobal Ltd., SureClinical Inc, LabCorp(Laboratory Corporation of America Holdings)., Paragon Solutions Inc, Veeva Systems Inc., Aurea, Inc., TransPerfect Global, Inc, Ennov Inc, MasterControl, Inc., Montrium, Inc.

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Electronic Trial Master File Market

Global Opportunity Analysis and Industry Forecast, 2023-2032