The Growth of the Electronic Trial Master File – eTMF Market


A number of research reports have been published over the past years trying to determine the size, growth and usability of the Electronic Trial Master File – eTMF software market. What follows is a summary view of some of these reports.

Most paper-based industries and processes, even those that are highly regulated, have matured and benefited from some kind of digital transformation. Document Management software, CRM software among other categories of software have all made workplace processes far more efficient. Legal, healthcare, IT, Financial industries along with numerous other industries have all leveraged software technologies to impact efficiency and effectiveness of their processes. The pharmaceutical and biotech industry is no different.

The managing of Clinical trial regulatory documents has historically been a paper-based process. However, paper-based processes are laborious, costly and prone to errors. Providing a digital platform and strategy around the capture, management and reporting of regulatory documents will enable clinical trial stakeholders to be more productive, effective and reduce business risk throughout the regulatory compliance process. The industry-wide momentum to streamline clinical trial processes and adopt applications to improve operational efficiency continues to drive innovation. Studies show that greater efficiencies throughout the clinical trial process are reported by organizations that use eTMF applications. In fact, the number of CROs using eTMF applications has more than doubled over the past few years.

There have been a number of reports and surveys published trying to size up the eTMF market. We will focus on specific reports and highlight some of their findings. Further analysis into the eTMF market can be made by reading the reports directly.


REPORT: Electronic Trial Master File (eTMF) Market: Global Industry Analysis and Opportunity Assessment

AUTHOR: Future Market Insights

ABOUT THE REPORT: Future Market Insights has analysed numerous aspects of the electronic trial master file (eTMF) market and has included actionable insights in a systematic manner in its new research publication. The extensive research study on the eTMF market portrays various facets of the global market such as trends, opportunities, value chain analysis, competitive landscape, drivers, restraints, regional analysis along with key recommendations that can be considered by the reader to achieve his/her strategic objectives in the long run. The research study also covers future market projections with respect to value for a period of ten years starting from 2017 till 2027.



  • The global electronic trial master file (eTMF) market is estimated to grow by a CAGR of 14.0% over the next decade.
  • The value of the eTMF market in 2018 was estimated to be US$ 190 Mn by the end of the assessment year.
  • North America to show strongest growth of eTMF market. The revenue from United States is expected to reach a high valuation of more than US$ 100 Mn by the end of 2027.
  • The high growth of the global electronic trial master file (eTMF) market can be attributed to growing number of clinical trials across the globe and government regulations keeping the eTMF mandatory for clinical trials.



REPORT: Electronic Trial Master File eTMF Market Report

AUTHOR: Coherent Market Insights

ABOUT THE REPORT: Coherent Market Insights is a prominent market research and consulting firm offering action-ready syndicated research reports, custom market analysis, consulting services, and competitive analysis through various recommendations related to emerging market trends, technologies, and potential absolute dollar opportunity. This report on the eTMF provides data on Size, Share, Outlook, and Opportunity Analysis of the eTMF market for a period from 2018 to 2026.



  • North America is expected to exhibit high growth on the electronic trial master file (eTMF) market during the forecast period (2018-2026), due to increasing adoption of cloud-based technology for application in various sectors such as healthcare.
  • Some of the major factors driving growth of the electronic trial master file (eTMF) market are the various benefits to organizations; namely time savings, saves money, and increases visibility by discovering and repairing incorrect documents quickly and also by allowing content search to be actionable, as well as saves time in audit preparation.


REPORT: EClinical Solutions Market

AUTHOR: Coherent Market Insights

ABOUT THE REPORT: eClinical solutions are used to improve the clinical development process through data management and data analysis. They offer improved transparency and utilization of the clinical and operational data by providing data management software and customized data management services. The advantages and applications of eClinical software allows users to analyze, manage, integrate, and standardize all their clinical and operational data with the help of integrated advanced visualization and analytical capabilities. This report on the eClinical Market provides data by Deployment (Web-based, Cloud-based, and Licensed Enterprise), by Product type including Electronic Trial Master File -eTMF solutions by type of End User (Pharmaceutical and Biopharmaceutical companies, Hospitals, Consulting Servicing Companies, Research Organizations, and Medical device Manufacturers), and by Region – Global Forecast to 2026



  • The global eClinical solutions market (including eTMF solutions) was valued at US$ 3.5 billion in 2017 and is expected to witness a robust CAGR of 11.2% over the forecast period (2018 – 2026).
  • Factors driving growth include gaining acceptability in clinical trials, increasing government funding, and rising R&D programs by biopharma and pharmaceutical companies.


REPORT: Global eClinical Solutions Market Size

AUTHOR: QY Research Reports

ABOUT THE REPORT: This report focuses on the global eClinical Solutions status, including the eTMF market, future forecast, growth opportunity, key market and key players. The study objectives are to present the eClinical Solutions development in United States, Europe and China. Market Size, Status and Forecast for 2019-2025.



  • The key driving factors responsible for the growth of E-Clinical trial solutions market include rising operational costs and regulatory requirements linked with clinical research studies. Additionally, favorable grants to conduct clinical trials and rising R&D expenditure by pharma-biotech organizations with enhanced IT budgets for drug advancement lend to favorable market growth for the forecast period.
  • The ease of integration, quicker deployment, and flexible scalability with a fixed monthly fee offered by cloud-based models are expected to drive the demand for these solutions.
  • The global eClinical Solutions market is expected to grow by a CAGR of 12.5% during the forecast period of 2019-2025.


REPORT: 2016 Paperless TMF Survey


ABOUT THE REPORT: The Veeva 2016 Paperless TMF Survey explores the life sciences industry’s progress in streamlining clinical trials and unifying clinical operations. It represents the experiences and opinions of 217 trial master file (TMF) owners from around the globe. The goal of the research is to understand the impact of electronic trial master file (eTMF) adoption on broader clinical processes as well as the drivers, benefits, and expectations of eTMF solutions.



  • Adoption of advanced eTMF applications has doubled since 2014.
  • One in four (24%) sponsors now use a purpose-built eTMF application (up from 13%)
  • Over the same period, clinical operations departments at sponsor organizations have cut the use of paper for most/all TMF documents from 41% in 2014 to 28% in 2016
  • Most (80%) with an eTMF application now provide remote access to inspectors/auditors
  • Consistent with the growing demand to unify clinical processes, half (49%) of sponsors say integrating their eTMF application with their clinical trial management system (CTMS) is a key need in an effort to go paperless
  • The top business drivers motivating sponsors to move to eTMFs are improving inspection readiness (67%), speeding study startup (53%), and remote oversight of the TMF (48%)
  • Those who have adopted eTMF applications in particular, report improved audit and inspection readiness (61%), improved central and remote monitoring (59%), and better visibility into performance metrics (55%)
  • In addition to the overall benefits cited, nearly all (98%) also see specific improvements in key inspection areas after implementing an eTMF application including duplicate, missing, and incomplete documents
  • Drivers to going Paperless include: Inspection readiness (67%), speeding study startup (53%), and providing remote oversight of the TMF (48%) are the most cited business benefits driving eTMF adoption among sponsors.


REPORT: 2017 Unified Clinical Operations Survey


ABOUT THE REPORT: The Veeva 2017 Unified Clinical Operations Survey examines the life sciences industry’s progress toward a unified clinical environment by gathering the experiences and opinions of 300 clinical operations professionals from around the globe.



  • There is an industry wide drive toward a unified clinical model that is defined by end-to-end processes and systems, seamless collaboration among stakeholders, and greater insights across the clinical lifecycle to improve performance.
  • Nearly all (99%) respondents report the need to unify their clinical applications, including CTMS, EDC, and eTMF.
  • For more than half, the need to speed study execution, improve study quality, ease collaboration, and achieve greater visibility are the key drivers for adoption.
  • One in three (31%) sponsors now use an eTMF application, up from 13% in 2014.
  • Only 16% of sponsors say their clinical operations departments use paper for most/all TMF documents, down from 41% in 2014.
  • And half of document templates are now created electronically (52%), double the number from two years ago (25% in 2015).
  • Most sponsors (51%) report the need for better visibility and one-third say clinical data is tracked outside of their systems. Yet, organizations that extensively use data to improve clinical trial processes achieve greater benefits than those not leveraging data, including easier collaboration (50% to 25%, respectively), central and remote auditing (50% to 31%, respectively), and automated tracking and reporting of documents (54% to 38%, respectively).
  • Nearly all (99%) respondents report the need to unify their clinical applications. The top three most important drivers for unifying clinical applications are faster study execution (65%), improved study quality (63%), and cost savings (59%). Most (76%) say unifying their applications will drive improvements in three or more areas.


REPORT: eTMF Market and Service Provider Dynamics


ABOUT THE REPORT: For this report, ISR gauges how adoption of eTMF systems is progressing and how it will continue to progress (or not) over the next few years. In addition, this report is designed to assist clinical development sponsor organizations, CROs, and eTMF software vendors in their understanding of various market dynamics.



  • Almost 90% of respondents when asked which eClinical technologies they use answered that they use eTMF on a monthly or more often basis, and about half of respondents use an eTMF technology on a daily basis. EDC is the second most commonly used technology, with 84% of respondents using this technology on at least a monthly basis.
  • The trend towards eTMF over a paper TMF is noteworthy, with 84% of respondents reporting a preference for eTMF over a paper TMF counterpart
  • Currently, almost three-quarters of respondents report that the majority (61%-100%) of their regulatory-compliant TMF data and documents are managed with an eTMF solution.
  • Close to half of respondents indicate that more than 80% of their data is managed in this solution. ~80% of respondents foresee that more than 80% of their TMF data will be stored in eTMF solutions in three years.
  • Within current clinical studies, half of all TMF data are stored in fit-for-purpose eTMF applications. The amount of data stored in this type of solution is expected to increase to almost 70% over the next three years. The use of other TMF solutions is expected to decrease in the same time period, with paper-based TMFs expected to be used the least.
  • Data security and Overall ease of use are the most important attributes in the selection of an eTMF solution.