Overview and Scope
An electronic trial master file (eTMF) is a trial master file in electronic or digital format, serving as a content management system for the pharmaceutical industry. The eTMF system manages, stores, tracks, and archives essential clinical study documents electronically. It is designed to ensure compliance with regulatory requirements, such as the FDA’s Title 21 CFR Part 11, and to provide a secure, centralized, and easily accessible repository for clinical trial documents.
Sizing and Forecast
The electronic trial master file (eTMF) market size has grown rapidly in recent years. It will grow from $1.19 billion in 2023 to $1.36 billion in 2024 at a compound annual growth rate (CAGR) of 14.0%. The growth in the historic period can be attributed to increasing regulatory compliance requirements, rise in clinical trial complexity, globalization of clinical trials, paper-based document challenges, and increasing emphasis on data quality and integrity.
The electronic trial master file (eTMF) market size is expected to see rapid growth in the next few years. It will grow to $2.17 billion in 2028 at a compound annual growth rate (CAGR) of 12.3%. The growth in the forecast period can be attributed to integration with electronic health records (eTMF), rapid growth in clinical trials, focus on patient-centric trials, and emphasis on real-time monitoring and reporting.
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Segmentation & Regional Insights
The electronic trial master file (eTMF) systems market covered in this report is segmented –
1) By Component: Services, Software
2) By Delivery Mode: On-Premise, Cloud-Based
3) By End-User: Pharmaceutical And Biotechnology Companies, Contract Research Organizations (CROs), Other End-Users
North America was the largest region in the electronic trial master file (eTMF) systems market in 2023. Asia-Pacific is expected to be the fastest-growing region in the forecast period. The regions covered in the electronic trial master file (eTMF) systems market report are Asia-Pacific, Western Europe, Eastern Europe, North America, South America, Middle East, Africa.
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Major Driver Impacting Market Growth
The increase in the number of clinical trials is expected to propel the growth of the electronic trial master file (eTMF) systems market going forward. Clinical trials are systematic investigations or studies conducted to assess the safety, efficacy, and effectiveness of human medical interventions, treatments, or procedures. These trials aim to generate reliable data and evidence to determine whether a new drug, therapy, medical device, or intervention is safe and effective for use in a specific patient population. The upsurge in clinical trials is intricately linked to the widespread adoption of electronic trial master file (eTMF) systems. As the volume and complexity of clinical research expand, eTMF systems play a pivotal role in streamlining documentation processes, ensuring regulatory compliance, and facilitating efficient collaboration among stakeholders. For instance, in November 2023, according to a report published by the Association of the British Pharmaceutical Industry, a UK-based trade association, the total number of clinical trials increased to 411 trials in 2022 and 394 trials in 2021. The annual recruitment to industry clinical trials in the UK is up by 5,366 participants yearly to 42,088 in 2022–23. Therefore, the increase in clinical trials is expected to propel the growth of the electronic trial master file (eTMF) systems market.
Key Industry Players
Major companies operating in the electronic trial master file (eTMF) systems market are Veeva Systems, Oracle, TransPerfect, Phlexglobal, SureClinical Inc. , Aurea, Inc., MasterControl, Inc, Clinevo Technologies , Covance Inc.,, Ennov, Care Lex, ePharma Solutions, Database Integrations, Inc, Aris Global LLC, Mayo Foundation for Medical Education and Research, Montrium Inc., StrelingBio Inc., PHARMAVIGILANT, Forte research, IQVIA, Labcorp Drug Development, NCGD Inc, arivis AG , Wingspan Technology, Dell EMC, Paragon Solutions, Freyr, SAFE-BioPharma, BIOVIA Corp
The electronic trial master file (etmf) systems market report table of contents includes:
1. Executive Summary
2. Electronic Trial Master File (eTMF) Systems Market Characteristics
3. Electronic Trial Master File (eTMF) Systems Market Trends And Strategies
4. Electronic Trial Master File (eTMF) Systems Market – Macro Economic Scenario
5. Global Electronic Trial Master File (eTMF) Systems Market Size and Growth
…..
32. Global Electronic Trial Master File (eTMF) Systems Market Competitive Benchmarking
33. Global Electronic Trial Master File (eTMF) Systems Market Competitive Dashboard
34. Key Mergers And Acquisitions In The Electronic Trial Master File (eTMF) Systems Market
35. Electronic Trial Master File (eTMF) Systems Market Future Outlook and Potential Analysis
36. Appendix
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