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Global Electronic Trial Master File (eTMF) Systems Market: By Component (Software, Services), Deployment Mode (Cloud/Web-Based, On-Premise), End User (Pharmaceutical and Biotechnology Companies, Contract Research Organizations, Others), Region (Americas, Europe, Asia-Pacific, Middle East & Africa) – Forecast to 2025

Market Highlights

According to MRFR analysis, Global Electronic Trial Master File Systems Industry is expected to register a CAGR of 13.11% during the forecast period of 2019 to 2025 and anticipated to reach USD 1,825 Million by 2025.

The eTMF serves as a central repository to store and manage essential clinical trial documents and content for possible use in regulatory submissions. The eTMF software streamlines agency compliance with standards-based exports, and eSubmissions enables sharing between clinical trial stakeholders with language-independent taxonomy.

The growth of the global eTMF systems market is fueled by several factors such as rising activities in terms of acquisitions, new solution and service deployments, and collaborations by key players operating in the market, coupled with the increasing number of clinical trial studies. For instance, in October 2019, SureClinical Inc. launched a transparent eTMF pricing policy. To provide value to the prospective users, the company has posted its prices and terms online to battle price discrimination in this industry. However, budget constraints of the small and medium-sized enterprises, along with the dearth of skilled professionals for operating the electronic systems, can hinder the preference of such solutions. As a result, such elements can hamper the growth of the market during the forecast period.

Several market players currently dominate the global eTMF systems market. The key players are involved in product launches and strategic collaborations to strengthen their market positions. For instance, in June 2018, Phlexglobal, a UK-based specialist provider of TMF and eTMF management solutions, is adopting Version 1 of the eTMF Exchange Mechanism Standard (eTMF-EMS) of the TMF Reference Model (TMF-RM) into PhlexEview, the company’s eTMF technology. Such strategies push the growth of the eTMF systems market.

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Regional Analysis

The market has been divided, by region, into the Americas, Europe, Asia-Pacific, and the Middle East & Africa. The Americas held the maximum share in the base year 2018, owing to the presence of established key players in countries such as the US and Canada. The eTMF systems market in the Americas has been segmented into North America and Latin America, with the North American market divided into the US and Canada. The European eTMF systems market has been categorized as Western Europe and Eastern Europe. The Western European market has further been classified as Germany, France, the UK, Italy, Spain, and the rest of Western Europe. The eTMF systems market in Asia-Pacific has been segmented into Japan, China, India, South Korea, Australia, and the rest of Asia-Pacific. The eTMF systems market in this region is anticipated to be the fastest-growing during the assessment period due to the increased adoption rate of eTMF software and services in the Asian countries. The eTMF systems market in the Middle East & Africa has been divided into the Middle East and Africa.


The Global eTMF Systems Market has been segmented based on Component, Deployment Mode, and End User.

The global eTMF systems market has been segmented, based on the component, into software and services. The software segment is expected to hold the majority share of the market owing to the increasing number of solution launches by the prominent players in recent years. The services segment is expected to be the fastest-growing due to the increasing uptake of eTMF services by pharmaceutical and life science companies.

The global eTMF systems market, based on deployment model, has been segmented into cloud/web-based, and on-premise. The cloud/web-based segment holds the maximum share owing to the technological advancements in cloud-based solutions in recent years.

The end-users of the market are pharmaceutical and biotechnology companies, contract research organizations, and others. The increasing number of clinical trials conducted by pharma firms is leading to the market size of the pharmaceutical and biotechnology companies’ segment.

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Key Players

Some of the Key Players in the Global eTMF Systems Market are Aurea, Inc. (US), Covance Inc. (US), ePharmaSolutions (US), MasterControl, Inc. (US), Oracle (US), Phlexglobal (UK), SureClinical Inc. (US), TransPerfect (US), Veeva Systems (US), and Wingspan (IQVIA) (US).

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