The global electronic trial master file systems market size is estimated to reach USD 1.9 billion by 2030, registering a CAGR of 14.7% from 2024 to 2030, according to a new report by Grand View Research, Inc. The market growth is attributed to a stringent regulatory structure for clinical trials and a heightened need for safety monitoring. Moreover, growing adoption of electronic trial master file (eTMF) solutions owing to the increasing number of clinical trials also contributes to the market growth. As per the data available on ClinicalTrials.gov, a total of 146,164 clinical trials were registered in the U.S., while around 259,000 studies were registered in the rest of the world in January 2024.
The COVID-19 pandemic has fueled the demand for eTMF solutions. According to an article published by Egnyte, the TMF Summit held in November 2021 highlighted the impact of COVID-19 on the clinical documentation management industry, particularly in adopting eTMFs. The pandemic compelled companies to reevaluate and embrace eTMFs and remote monitoring tools, addressing the challenges of decentralized sites and disrupted workflows. Moreover, standardization, improved user interfaces, and the integration of artificial intelligence (AI) and machine learning (ML) are anticipated to streamline data collection further, fueling the market growth over a forecast period.
Moreover, key players in the market are adopting various strategies to expand their geographical presence and strengthen their market position. For instance, in May 2023, Lotus Clinical Research expanded its partnership with Veeva Systems to adopt the Veeva Vault Clinical Suite to improve its service delivery and operational efficiency. This decision builds on Lotus' previous use of the Vault Clinical Suite, which helped them conduct more connected and faster studies. The successful integration of Veeva Vault eTMF helped Lotus scale its trial operations while maintaining the highest quality standards.
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In 2023, Cloud and web-based segment dominated the market with largest revenue share of 91.3%. This is attributed to associated benefits such as easy accessibility, usability, and lower investments required
Based on clinical trials, The Phase III segment dominated the market with largest revenue share of 53.3% in 2023. The growth of drug development sector is experiencing significant growth owing to an increasing number of drugs successfully reaching phase III
Contract Research Organizations (CROs) segment dominated the market with the largest revenue share of 37.1% in 2023.The growing adoption of electronic trial master file solutions in research contributes to the segment growth
North America dominated the market with the largest revenue share of 49.5 % in 2023. The market growth is attributed to an increasing target population, a rise in lifestyle-associated diseases, and the launch of new products by key market players
Grand View Research has segmented the global electronic trial master file systems market based on delivery mode, clinical trials, end-use, and region:
eTMF Systems Delivery Mode Outlook (Revenue, USD Million, 2018 - 2030)
Cloud And Web Based
On-premise
eTMF Systems Clinical Trials Outlook (Revenue, USD Million, 2018 - 2030)
Phase I
Phase II
Phase III
Phase IV
eTMF SystemsEnd-use Outlook (Revenue, USD Million, 2018 - 2030)
Hospitals/Healthcare Providers
Contract Research Organizations (CROs)
Academic Institutes
Pharma & Biotech Organizations
Medical Device Manufacturers
eTMF SystemsRegional Outlook (Revenue, USD Million, 2018 - 2030)
North America
U.S.
Canada
Europe
UK
Germany
France
Italy
Spain
Norway
Sweden
Denmark
Rest of Europe (EU) {RoE}
Asia Pacific
Japan
China
India
South Korea
Australia
Rest of Asia Pacific (RoAPAC)
Latin America
Brazil
Argentina
Mexico
Rest of Latin America (RoLA)
Middle East & Africa
South Africa
Saudi Arabia
UAE
Kuwait
Rest of Middle East & Africa (RoMEA)
List of Key Players in the Electronic Trial Master File Systems Market
Oracle
Clinevo Technologies
MasterControl Solutions, Inc.
Veeva Systems
Aris Global LLC
PHARMALEX GMBH
TransPerfect
Aurea, Inc.
ePharmaSolutions (WCG Clinical)
SureClinical Inc.
Ennov
Montrium Inc.
Cloudbyz
TRIAL INTERACTIVE
Anju Software
Octalsoft
Egnyte, Inc.
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