ELECTRONIC TRIAL MASTER FILE (ETMF) MARKET ANALYSIS

Electronic trial master file is a solution for collecting and managing clinical trial documents in a centralized repository. The main advantage of this software is that it helps in streamlining processes, automating information transfer and reducing the administrative process associated with conducting a clinical trial. This software is used in various life science industries such as pharmaceutical, biotechnology, and medical device companies. In order to reduce the costs associated with the clinical trials approval process, government agencies such as the European Medicines Agency (EMA) and the U.S. Food and Drug Administration (FDA) are developing technology initiatives for supporting the use of digital media, electronic records, and digital signatures in clinical trials.

The global electronic trial master file (eTMF) market is estimated to be valued at US$ 939.6 million in 2021 and is expected to exhibit a CAGR of 8.9% during the forecast period (2021-2028).

Figure 1. Global Electronic Trial Master File (eTMF) Market in Terms of Value (US$ Million), By Region, 2021

The increasing use of eTMF software by biotechnologies companies to conduct clinical trials is expected to drive the growth of the electronic trial master file (eTMF) market during the forecast period.

Increasing use of eTMF software by life-science industries such as pharmaceutical and biotechnology companies for conducting efficient clinical trials is expected to boost the global electronic trial master file (eTMF) market growth during the forecast period. For instance, on August 4, 2021, CytoDyn, a biotechnology company, received approval from Brazil’s Agência Nacional de Vigilância Sanitária (ANVISA), the Brazilian regulatory agency to initiate subject enrolment in a Phase III CD17 clinical trial of leronlimab, a monoclonal antibody in patients with severe Covid-19. According to  CtoDyn, the company used eTMF software for all the documentation of the clinical trials.

Figure 2. Global Electronic Trial Master File (eTMF) Market Share (%), By Product Type

Increasing launch of advanced versions of electronic trial master file (eTMF) is projected to propel the global electronic trial master file (eTMF) market growth during the forecast period.

Key market players are focusing on software updates and launching new versions of eTMF software, which is expected to propel the market growth during the forecast period. For instance, in May 2019, TransPerfect, a technology solutions provider released version 1.2 of myTI, the mobile application that allows study teams on-the-go to manage and enabling real-time eTMF management. This new launch of the mobile version of the Trial Interactive e-clinical platform simplifies clinical research associate (CRA) site visits, providing even more ways to speedup timelines and reduce risk.

Global Electronic Trial Master File (eTMF) Market – Impact of Coronavirus (COVID-19) Pandemic

The COVID-19 virus outbreak has impacted the healthcare sector substantially. Pharmaceutical companies and research institutes are increasingly focusing on advancing their digital platforms related to clinical trials such as software for the rapid development of therapeutic drugs and vaccines. The COVID-19 pandemic has triggered a change in the way clinical trials will be conducted. According to the TMF Futures: Keeping Data Alive, industry report published by Arkivum Ltd. a software and services company, 56% of the life science professionals say that they need to conduct more virtual trials by adopting telemedicine, remote monitoring of patients, wearable technologies, mobile apps, and devices for ensuring participants’ safety.

In addition, companies operating in the market are introducing new clinical trial solutions, which can be further attributed to the growth of the global electronic trial master file (eTMF) market. For instance, in August 2021, Cloudbyz, a clinical research and development solutions firm, launched a new cloud-based solution for decentralized clinical trials (DCTs). The solution offers advantages such as fewer data processing times and improved study administration to ensure better safety monitoring and patient enrolment campaigns.

Global Electronic Trial Master File (eTMF) Market: Restraint

Increasing awareness of cloud-based eTMF among the market players is leading to increased usage of eTMF in large pharmaceutical companies. Moreover, all the documentation related to clinical trials can be stored and accessed from any part of the globe using cloud-based eTMF. However, there are some disadvantages for cloud-based eTMF. The absence of inadequate data privacy and data security of the electronic trial master file makes it vulnerable to cyber-attacks, which may hamper its adoption to a certain extent.

Key Players                                                               

Major players operating in the global electronic trial master file (eTMF) market include Phlexglobal, Montrium Inc., TransPerfect, IQVIA, Veeva Systems, Clinevo Technologies, Ennov, MasterControl, Inc., ArisGlobal, Florence HC, Medidata, and SureClinical Inc.