Electronic Trial Master File (eTMF) Market Analysis

Electronic Trial Master File Market Analysis

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Based on the component, the market is classified into software and services. The services segment dominated around USD 697.1 million revenue in 2023.
 

• Introduction of new services by market players is one of the significant factors contributing to the segmental growth. For instance, in September 2022, Montrium introduced its expert-guided trial master file (TMF) services along with a new educational training program focused on TMF maturity. These pioneering solutions aim to assist clinical operations and TMF teams at all phases of the clinical development process.
   
• Additionally, service providers offering customized and integrated services that seamlessly incorporate eTMF platforms with other clinical trial management systems (CTMS), electronic data capture (EDC) systems, and regulatory submission platforms are witnessing increased demand, thereby augmenting the segmental growth.
   

Based on delivery mode, the electronic trial master file market is classified into licensed enterprise (on-premises) solutions, cloud-based (SAAS) solutions, and web-hosted (On-demand) solutions. The web-hosted (On-demand) solutions segment held over 49.7% of the market share in 2023.
 

• Various advantages such as ease of accessibility, easy usability, and relatively lower investments associated with web-hosted (on-demand) solution increases the adoption of this delivery mode.
   
• Additionally, web-hosted (on-demand) solution maintain client data on cloud server which is easily accessible through web and requires only computer hardware with an internet connection.
   
• Further, web-hosted solutions are easily customizable owing to which it can be customized for different customer groups, thereby supplementing the market growth.
   

Based on clinical trial phase, the electronic trial master file market is classified into phase I, phase II, phase III, phase IV. The phase III segment is projected to experience a healthy growth throughout the forecast period.
 

• The pharmaceutical industry is witnessing substantial expansion, driven by an increasing number of drugs progressing successfully to phase III.
   
• In this stage, the examination of drug efficacy involves a participant pool exceeding 1,000 patients. As the number of participants grows, the complexity of studies increases, prompting a need for advanced data management systems, thereby, accelerating the market growth.
   

Based on end-use, the electronic trial master file market is classified into contract research organizations (CROs), medical device companies, pharmaceutical and biotechnology companies, hospitals and clinics, and other end-users. The contract research organizations (CROs) segment is set to exhibit at over 9.9% CAGR through 2032.
 

• High segmental growth can be attributed to the rising number of CROs entering the market.
   
• Moreover, increasing demand for outsourcing clinical trials to various CROs, to minimize the R&D expenses by pharma & biotech companies, further boost the segmental growth.
   
• Further, stringent regulatory requirements and the need for electronic documentation and data integrity, increases the adoption of eTMF solutions, thereby supplementing the market growth.
   

North America electronic trial master file market accounted for 48.1% of the revenue share in 2023.
 

• High regional market growth can be attributed to the presence of a well-established healthcare infrastructure, high adoption rates of advanced technologies, and a strong emphasis on regulatory compliance.
   
• Additionally, the presence of key market players, robust research and development activities, and favorable government initiatives supporting the implementation of eTMF systems, further boosts the regional market growth.
   
• Further, high volume of clinical trials in the region, increases the adoption of eTMF solutions. For instance, according to the National Library of Medicine (NLM), as of January 2024, there are 20,465 clinical trials recruiting patients in the U.S.