Electronic Trial Master File eTMF Market

Electronic Trial Master File Market Size

Electronic Trial Master File (eTMF) Market size was valued at USD 1.2 billion in 2023 and is expected to grow at a CAGR of 9.5% between 2024 and 2032. The market growth is propelled by factors such as the growing adoption of ETMF systems, and technological advancements in electronic trial master file systems. Additionally, increasing government funding for clinical trials is one of the key contributing factors to the market growth.

For instance, as of 2022, the National Institute of Health (NIH) has funded approximately USD 45 billion to improve human life and reduce illness and disability. Similarly, NIH has also granted exploratory clinical trials grant that aimed to foster clinical trials that will lead to clinically meaningful improvements in diagnosis, prevention, and treatment of disease conditions. Such funding fosters the development and implementation of various exploratory clinical trials, thereby boosting the market growth.

An electronic trial master file (eTMF) is a digital repository or system designed to securely store, organize, and manage the extensive documentation generated during the conduct of a clinical trial. It serves as a centralized platform for housing essential trial-related documents, such as study protocols, investigator brochures, case report forms, informed consent forms, regulatory submissions, correspondence, and other pertinent materials.

Electronic Trial Master File Market Trends

• Growing number of clinical trials conducted worldwide makes it imperative to maintain clinical data in a format that is easily readable and accessible.
  
• For instance, as per the data published by Clinicaltrials.gov in 2022 data, there are around 423,514 clinical trials listed with locations in all 50 States and 221 countries to date.
  
• Thus, to manage vast amounts of data, companies are concentrating more on developing sophisticated and user-friendly software that can lessen the load of massive amounts of data produced by clinical trials.
  
• Furthermore, the healthcare sector is undergoing a digital revolution in both developed and emerging nations, which is hastening the uptake of technologies like electronic trial master files, thereby fostering the market growth.
  

Electronic Trial Master File Market Analysis

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Based on the component, the market is classified into software and services. The services segment dominated around USD 697.1 million revenue in 2023.

• Introduction of new services by market players is one of the significant factors contributing to the segmental growth. For instance, in September 2022, Montrium introduced its expert-guided trial master file (TMF) services along with a new educational training program focused on TMF maturity. These pioneering solutions aim to assist clinical operations and TMF teams at all phases of the clinical development process.
  
• Additionally, service providers offering customized and integrated services that seamlessly incorporate eTMF platforms with other clinical trial management systems (CTMS), electronic data capture (EDC) systems, and regulatory submission platforms are witnessing increased demand, thereby augmenting the segmental growth.
  

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Based on delivery mode, the electronic trial master file market is classified into licensed enterprise (on-premises) solutions, cloud-based (SAAS) solutions, and web-hosted (On-demand) solutions. The web-hosted (On-demand) solutions segment held over 49.7% of the market share in 2023.

• Various advantages such as ease of accessibility, easy usability, and relatively lower investments associated with web-hosted (on-demand) solution increases the adoption of this delivery mode.
  
• Additionally, web-hosted (on-demand) solution maintain client data on cloud server which is easily accessible through web and requires only computer hardware with an internet connection.
  
• Further, web-hosted solutions are easily customizable owing to which it can be customized for different customer groups, thereby supplementing the market growth.
  

Based on clinical trial phase, the electronic trial master file market is classified into phase I, phase II, phase III, phase IV. The phase III segment is projected to experience a healthy growth throughout the forecast period.

• The pharmaceutical industry is witnessing substantial expansion, driven by an increasing number of drugs progressing successfully to phase III.
  
• In this stage, the examination of drug efficacy involves a participant pool exceeding 1,000 patients. As the number of participants grows, the complexity of studies increases, prompting a need for advanced data management systems, thereby, accelerating the market growth.
  

Based on end-use, the electronic trial master file market is classified into contract research organizations (CROs), medical device companies, pharmaceutical and biotechnology companies, hospitals and clinics, and other end-users. The contract research organizations (CROs) segment is set to exhibit at over 9.9% CAGR through 2032.

• High segmental growth can be attributed to the rising number of CROs entering the market.
  
• Moreover, increasing demand for outsourcing clinical trials to various CROs, to minimize the R&D expenses by pharma & biotech companies, further boost the segmental growth.
  
• Further, stringent regulatory requirements and the need for electronic documentation and data integrity, increases the adoption of eTMF solutions, thereby supplementing the market growth.
  

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North America electronic trial master file market accounted for 48.1% of the revenue share in 2023.

• High regional market growth can be attributed to the presence of a well-established healthcare infrastructure, high adoption rates of advanced technologies, and a strong emphasis on regulatory compliance.
  
• Additionally, the presence of key market players, robust research and development activities, and favorable government initiatives supporting the implementation of eTMF systems, further boosts the regional market growth.
  
• Further, high volume of clinical trials in the region, increases the adoption of eTMF solutions. For instance, according to the National Library of Medicine (NLM), as of January 2024, there are 20,465 clinical trials recruiting patients in the U.S.
  

Electronic Trial Master File Market Share

The competitive landscape of the electronic trial master file industry is characterized by the presence of established pharmaceutical companies vying for market share. Key players are engaging in strategic initiatives such as mergers, acquisitions, and partnerships to strengthen their software/services portfolios. The companies are actively adopting a multi-pronged approaches to address the rising demand for effective electronic trial master file.

Electronic Trial Master File Market Companies

Prominent players operating in the electronic trial master file industry are as mentioned below:

• 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
  

Electronic Trial Master File Industry News

• In June 2022, Anju Software introduced eTMF Master, an advanced cloud-based eTMF software. This cutting-edge solution is designed to improve collaboration among sponsors, contract research organizations (CROs), and trial sites by offering an effective and secure platform for managing clinical trial content while fully complying with regulatory standards.
  
• In November 2023, Egnyte unveiled a quality control feature within its eTMF application, empowering users to conduct review and approval workflows seamlessly within the application itself. This simplifies the process prior to officially archiving sensitive trial content into the trial master file (TMF), eliminating difficulties related to managing operations across multiple systems. This helped the company to widen the applications of its software.
  

The electronic trial master file (eTMF) market research report includes an in-depth coverage of the industry with estimates & forecast in terms of revenue in USD Million from 2018 - 2032 for the following segments:

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Market, By Component

• Software
• Services

Market, By Delivery Mode

• Licensed enterprise (on-premise) solutions
• Cloud-based (SAAS) solutions
• Web-hosted (On-demand) solutions

Market, By Clinical Trial Phase

• Phase I
• Phase II
• Phase III
• Phase IV

Market, By End-use

• Contract research organizations (CROs)
• Medical device companies
• Pharmaceutical and biotechnology companies
• Hospitals and clinics
• Other end-users

The above information has been provided for the following regions and countries:

• North America
  • U.S.
  • Canada 
• Europe
  • Germany
  • UK
  • France
  • Italy
  • Spain
  • Rest of Europe
• Asia Pacific
  • Japan
  • China
  • India
  • Australia
  • Rest of Asia Pacific
• Latin America
  • Brazil
  • Mexico
  • Rest of Latin America
• Middle East and Africa
  • South Africa
  • Saudi Arabia
  • Rest of Middle East and Africa