Electronic Trial Master File (eTMF) Systems Market Research Report - Forecast till 2027

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 2027

ID: MRFR/HC/7300-HCR | February 2021 | Region: Global | 90 pages

Electronic Trial Master File (eTMF) Systems Market Overview


Electronic Trial Master File (eTMF) Systems Market is expected to reach a value of USD 1825 Million by 2025, at a CAGR of 13.11% during the assessment period of 2019 to 2025.

In the digitalized era, the concept of Electronic Trial Master File Systems has gained high popularity among diverse organizations such as pharmaceutical and biotechnology companies. An eTMF system refers to a trial master file that can digitally capture, manage, share and store actual content and documents from a clinical trial. Many organizations involved in clinical trials have been incorporating innovative technology-based solutions to manage electronic data efficiently and address the issue relating to data loss. 


The eTMF Systems Market has been showcasing promising performance in the technology-driven era. A diverse range of market players is likely to contribute to the market's solid performance during the forecasted period. The demand in the eTMF Systems market has been on the rise as the innovative solution enables the users to get a real-life insight into clinical documents and manage them efficiently.


The Electronic Trial Master File (eTMF) Systems Market Outlook report gives an integrated insight into the main factors in the global market environment. The drivers, constraints, challenges, and restraints in the eTMF Systems Market have been thoroughly examined. The major players that increase the competitive intensity in the market have been identified in the report. 


Covid 19 Analysis of Electronic Trial Master File (eTMF) Systems Market


Covid 19 has brought about considerable changes in the eTMF Systems Market. It has increased the need to integrate digital technologies in clinical activities so that the dependence on manual processes can be curtailed. The pandemic has created an opportunity to capture and manage clinical trial documents efficiently and innovatively. To capitalize on the new opportunities in the post-Covid era, organizations have shifted towards the eTMF systems concept to integrate digitalization while handling clinical data. 


Major market drivers 



  • Market drivers


A diverse range of factors exists that influence the Electronic Trial Master File Systems Market Size significantly. The major drivers that exist in the global eTMF Systems Market setting include the rise in the adoption of innovative eTMF Systems by both pharmaceutical and biotechnology organizations and the financial support that the government extends. According to the U.S. National Library of Medicine, as of August 12, 2021, a total of 386,583 registered studies are being conducted in 219 nations. 



  • Market opportunities 


Numerous opportunities exist in the eTMF Systems Market that increase its attractiveness at the global level. The main opportunity arises due to the increase in the number of clinical trials. It would serve as the catalyst and increase the opportunities for the market players to contribute to the market's growth. New digital technologies would act as one of the main Electronic Trial Master File (eTMF) Systems Market Trends that could give new opportunities. 



  • Restraining factors in the market 


The chief restraining factors that could limit the growth of the eTMF Systems Market include:



  • Rising concerns relating to the security and privacy of clinical data.

  • The absence of expert and skilled professionals.

  • Evolving nature of the regulatory landscape.


These elements restrict the ability of businesses in the industry to capitalize on the attractive eTMF Systems Market. 



  • Challenges in the market 


The major challenges that adversely affect the Electronic Trial Master File Systems Market Size include cyber security concerns and challenges relating to the financial budget. These elements act as bottlenecks that limit the ability of businesses to capture a larger Electronic Trial Master File (eTMF) Systems Market Share at the global level.


Cumulative growth analysis 


The detailed Electronic Trial Master File (eTMF) Systems Market Analysis has given a holistic market landscape. Several variables have been identified in the report that comes into play in the market and influence the performance of the business players. According to the Electronic Trial Master File (eTMF) Systems Market Forecast, some of the main elements that could increase the market's attractiveness include an increase in clinical trials and the application of eTMF Systems by diverse organizations. Some of the chief elements that limit the growth potential and negatively affect the Electronic Trial Master File (eTMF) Systems Market Value include clinical data privacy and security concerns and low availability of skilled personnel. The market has undergone rapid change in the prevailing era due to its strong interlink with evolving technology. 


Overview of market segmentation



  • By Component


Based on components, the eTMF Systems Market can be categorized into software and services. Software developers have been developing new systems by embedding security solutions. Services extend support to pharmaceutical and biotechnology firms to simplify the clinical trial management process. Both the market segments have been showcasing solid performance, and they are likely to contribute towards the growth of the Electronic Trial Master File (eTMF) Systems Market during the forecasted period. 



  • By Mode of deployment


Based on the deployment model, the eTMF Systems Market can be segmented into on-premise and web/cloud-based systems. The on-premise solutions rely on the computing properties of firms and only require a license from the supplier. The web/cloud-based system does not rely on an in-house server or technical staff. Based on the Electronic Trial Master File (eTMF) Systems Market Forecast, this segment will likely be the fastest-growing segment shortly. 


By End-user


The eTMF Systems Market can be divided into contract research organizations, biotechnology and pharmaceutical companies, and others based on the end-user. During the forecasted period, the contract research organizations are expected to capture a considerable portion of the Electronic Trial Master File (eTMF) Systems Market Sharedue to the rising demand for precise master file solutions. The rise in research and development activities by biotechnology and pharmaceutical companies and the increase in the number of clinical trials has fueled the growth of the segment involving biotechnology and pharmaceutical companies. The participants that are involved in the 'other' segment include medical device entities and institutes. 


Regional evaluation 


The global eTMF Systems Market can be divided into diverse geographical fragments: the Americas, Europe, Asia Pacific, and the Middle East and Africa. The Americas is the largest regional segment that contributes to the market's growth at the global level. Some of the major players that capture a significant portion of the Electronic Trial Master File (eTMF) Systems Market Value are- Oracle and Veeva Systems. The European market has been showcasing solid performance at the global level. Some of the main drivers that exist in the market include the high support from regulatory authorities.


One of the major Electronic Trial Master File (eTMF) Systems Market Trends consistent in diverse regional segments that revolves around the adoption of rapidly evolving technology in the market. During the forecasted period, the Asia Pacific region is likely to showcase solid performance in the market. The Middle East and African regional segment is the smallest geographical segment. The main reasons for the limited growth of the eTMF Systems Market include the poor development of the healthcare infrastructure in the region and the poor exposure to digital technologies and innovations. During the forecasted period, each regional division is likely to contribute to the global market performance. 


Analysis of the competitive market landscape 


Based on the comprehensive Electronic Trial Master File (eTMF) Systems Market Outlook report, a diverse range of market players operates in the market that could accelerate its growth potential during the forecasted period. The key market players that operate in the industry are:



  • Aurea, Inc.

  • Covance Inc.

  • Mastercontrol Inc.

  • Oracle

  • Transperfect

  • Veeva Systems

  • ePharmaSolutions

  • Phlexglobal

  • SureClinical Inc. 


Recent developments



  • New technologies have been integrated into the Electronic Trial Master File (eTMF) Systems Market, such as cloud-based software to upgrade the system's processes.

  • The adoption of advanced data visualization and activity-based reporting tools has enabled researchers to draw an association between data points that facilitates an improved strategic decision-making process. 


Report Overview


The Electronic Trial Master File (eTMF) Systems Market Analysis has shed light on the market's growth potential during the forecasted period. An exhaustive research process has been carried out, which has helped identify varying factors in the global market setting and influence its performance. Some of the major elements that have been analyzed in-depth in the report include market overview, analysis of the impact of the Covid 19 pandemic on the market, major market divisions, cumulative market analysis, and competitive analysis.    


Market segmentation highlights


By Component



  • Software

  • Services


By Mode of deployment



  • On-Premise

  • Web/Cloud-based 


By End-user



  • Contract Research Organizations 

  • Biotechnology and Pharmaceutical companies

  • Others  



Report Scope:
Report Attribute/Metric Details
  Market Size   2025: USD 1825 Million
  CAGR   13.11% (2019-2025)
  Base Year   2019
  Forecast Period   2020-2027
  Historical Data   2018
  Forecast Units   Value (USD Million)
  Report Coverage   Revenue Forecast, Competitive Landscape, Growth Factors, and Trends
  Segments Covered   Component, Deployment Mode and End User
  Geographies Covered   North America, Europe, Asia-Pacific, and Rest of the World (RoW)
  Key Vendors   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).
  Key Market Opportunities   Rising number of clinical trials
  Key Market Drivers

  • Increasing government funding to support clinical trials
  • High investment in research and development by pharmaceutical and biotechnology companies
  • Adherence to compliance of IT in the pharmaceutical sector


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    This table of content is tentative and subject to change as the research progresses.

    Please Note:  Financial details of company cannot be provided if the information of the company is not available in public domain and or reliable source.