Electronic Trial Master File (eTMF) Systems Global Market Report 2024

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%. The growth observed during the historic period can be attributed to several factors, including the escalating regulatory compliance requirements, the increasing complexity of clinical trials, globalization of clinical trial operations, challenges associated with paper-based document management, and a growing emphasis on maintaining data quality and integrity within the clinical research landscape.

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 projected growth in the forecast period is expected to be driven by several factors, including the integration of electronic trial master files (eTMF) with electronic health records, the rapid expansion of clinical trials globally, a heightened focus on patient-centric trial methodologies, and an increased emphasis on real-time monitoring and reporting capabilities. Major trends anticipated during this period include a growing demand for AI-powered eTMF systems, an increased focus on data analytics and insights derived from clinical trial data, a rising importance of patient-centric trial approaches, and a widespread adoption of cloud-based eTMF solutions within the pharmaceutical and clinical research industries.

The escalation in the number of clinical trials is anticipated to drive the growth of the electronic trial master file (eTMF) systems market in the foreseeable future. Clinical trials, systematic investigations conducted to evaluate the safety, efficacy, and effectiveness of medical interventions, are pivotal in generating reliable data for assessing new drugs, therapies, and medical devices. As clinical research expands in volume and complexity, the adoption of electronic trial master file (eTMF) systems becomes increasingly prevalent. These systems play a crucial role in streamlining documentation processes, ensuring regulatory adherence, and facilitating seamless collaboration among stakeholders. For instance, a report by the Association of the British Pharmaceutical Industry in November 2023 revealed a notable increase in clinical trials, with 411 trials conducted in 2022 compared to 394 in 2021. Additionally, the annual recruitment to industry clinical trials in the UK witnessed a significant rise, reaching 42,088 participants in 2022-23, reflecting the growing momentum in clinical research. Consequently, the surge in clinical trials is poised to propel the electronic trial master file (eTMF) systems market forward.

Key players within the electronic trial master file (eTMF) systems market are prioritizing the development of innovative solutions such as cloud-based eTMF to cater to burgeoning demand. Cloud-based eTMF platforms, hosted on cloud infrastructure, are specifically designed to manage and organize critical documents and data associated with clinical trials in the life sciences and pharmaceutical sectors. For example, in September 2022, Montrium Inc., a Canada-based provider of cloud-based software solutions, introduced cloud-based trial master file (TMF) services and TMF maturity educational training. These offerings are tailored to support clinical operations and TMF teams across all stages of the clinical development process. Leveraging years of expertise in TMF processes and cutting-edge technology, Montrium Inc. aims to empower scaling organizations to achieve the highest standards of TMF excellence, thereby leveling the playing field and fostering industry-wide innovation and efficiency.

In December 2021, Veeva Systems Inc., a prominent US-based cloud computing company, completed the acquisition of Veracity Logic for an undisclosed sum. This strategic move is poised to streamline intricate processes and accelerate clinical trials, underscoring its significance in the eTMF systems market. Veracity Logic LLC, headquartered in the United States, specializes in providing eTMF (electronic trial master file) and eClinical solutions.

Major companies operating in the electronic trial master file (eTMF) systems market report 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.

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. The countries covered in the electronic trial master file (eTMF) systems market report are Australia, Brazil, China, France, Germany, India, Indonesia, Japan, Russia, South Korea, UK, USA, Canada, Italy, Spain.

An electronic trial master file (eTMF) is a digital repository used in the pharmaceutical industry to manage and store essential clinical study documents. It serves as a content management system, facilitating the tracking, storage, and archival of clinical trial documentation in electronic format. The primary purpose of an eTMF is to ensure compliance with regulatory requirements, such as FDA's Title 21 CFR Part 11, and to provide a secure and easily accessible centralized repository for clinical trial documents.

The key components of electronic trial master file (eTMF) systems include services and functionalities. These services encompass features provided by the eTMF system to support the management of clinical trial documentation electronically. eTMF systems can be delivered through both on-premise and cloud-based platforms and are utilized by pharmaceutical and biotechnology companies, contract research organizations, and other relevant stakeholders within the industry.

The electronic trial master file systems market research report is one of a series of new reports that provides electronic trial master file systems market statistics, including electronic trial master file systems industry global market size, regional shares, competitors with electronic trial master file systems market share, detailed electronic trial master file systems market segments, market trends, and opportunities, and any further data you may need to thrive in the electronic trial master file systems industry. This electronic trial master file systems market research report delivers a complete perspective of everything you need, with an in-depth analysis of the current and future scenarios of the industry.

The electronic trial master file (eTMF) Systems market includes revenues earned by entities through implementation and integration services, document migration services, quality control and compliance services and regulatory submission support. The market value includes the value of related goods sold by the service provider or included within the service offering. Only goods and services traded between entities or sold to end consumers are included. The electronic trial master file (eTMF) Systems market consists of sales of cloud-based eTMF solutions, eTMF software solutions, mobile applications, collaboration and communication tools. Values in this market are ‘factory gate’ values, that is the value of goods sold by the manufacturers or creators of the goods, whether to other entities (including downstream manufacturers, wholesalers, distributors and retailers) or directly to end customers. The value of goods in this market includes related services sold by the creators of the goods.

The market value is defined as the revenues that enterprises gain from the sale of goods and/or services within the specified market and geography through sales, grants, or donations in terms of the currency (in USD, unless otherwise specified).

The revenues for a specified geography are consumption values that are revenues generated by organizations in the specified geography within the market, irrespective of where they are produced. It does not include revenues from resales along the supply chain, either further along the supply chain or as part of other products.

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