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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
-market-fig-1.png "Electronic Trial Master File (eTMF) | CMI")
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.
| Report Coverage | Details | ||
|---|---|---|---|
| Base Year: | 2020 | Market Size in 2021: | US$ 939.6 Mn |
| Historical Data for: | 2017 to 2020 | Forecast Period: | 2021 to 2028 |
| Forecast Period 2021 to 2028 CAGR: | 8.9% | 2028 Value Projection: | US$ 1,701.3 Mn |
| Geographies covered: |
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| Segments covered: |
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| Companies covered: |
Phlexglobal, Montrium Inc., TransPerfect, IQVIA, Veeva Systems, Clinevo Technologies, Ennov, MasterControl, Inc., ArisGlobal, Florence HC, Medidata, and SureClinical Inc |
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| Growth Drivers: |
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Figure 2. Global Electronic Trial Master File (eTMF) Market Share (%), By Product Type
-market-fig-2.png "Electronic Trial Master File (eTMF) | CMI")
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.
Pharmaceutical and biotechnology companies are engaged in conducting regulated clinical trials, which must comply with regulatory requirements of the government regarding clinical trials. One of the essential criteria required for regulatory compliance involves maintaining and storing essential documents related to that clinical trial. Trial Master File refers to a set of essential documents and content that gives the idea as to how clinical trials are conducted and managed based on regulatory requirements. These essential documents allow for the evaluation of the conduct and quality of the clinical trial. Electronic Trial Master File (eTMF) refers to a digital format of capturing, sharing, managing, and storing essential documents related to clinical trials. It is a content management software for the pharmaceutical industry for efficient storage and organization of images, documents, and other content obtained from clinical trials that may be required for compliance with government regulatory agencies.
Market Dynamics
Increasing adoption of electronic trial master file (eTMF) software by the biotechnology and pharmaceutical industry for the documentation of the clinical trials is expected to drive the growth of the global electronic trial master file (eTMF) market over the forecast period. For instance, in March 2021, Veeva Systems, a cloud-computing company, announced that LSK Global Pharma Services Co. Ltd, a contract research organization (CRO), adopted and integrated softwares such as Veeva Vault eTMF, Veeva SiteVault Free, and Veeva Vault CTMS. LSK Global Pharma Services Co. Ltd, with the application of these software, will accelerate clinical trial execution. Similarly, in October 2021, Medidata announced partnership with Translational Drug Development (TD2), a precision oncology contract research organization (CRO). The TD2 signed an agreement to adopt Medidata’s Rave Clinical Trial Management System (CTMS) and eTMF electronic trial master file (eTMF) software. Rave CTMS and eTMF are major offerings, that is modifying the clinical trial experience for patients, sponsors, clinical research organizations (CROs), and research sites.
Key features of the study:
Detailed Segmentation:
“*” marked represents similar segmentation in other categories in the respective section.
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% between 2021 and 2028.
Factors such as increasing use of eTMF software by the biotechnologies companies to conduct clinical trials is expected to drive the market growth during the forecast period.
Web/ cloud segment holds a major market share in the product type segment.
The major factor hampering growth of the market include inadequate data privacy & data security.
Major players operating in the market include Phlexglobal, Montrium Inc., TransPerfect, IQVIA, Veeva Systems, Clinevo Technologies, Ennov, MasterControl, Inc., ArisGlobal, Florence HC, Medidata, and SureClinical Inc.
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