Electronic trial master file (eTMF) systems can be defined as an integration of software and hardware components collectively responsible for the optimal management of clinical trial data. These solutions help to streamline the data generated during the course of a clinical trial in an easy-to-store digital format, which can be retrieved by dissimilar users beneficial in easy accessibility and reduction the cost associated with the administrative and manual data maintenance operations in clinical trials.
Research & development (R&D) is a significant and essential part of a company's business. The operations of the pharmaceutical industry have significant socio-economic impacts on society in the form of R&D and manufacturing investments. The research & development is the "backbone" of any drug discovery system to success, and the electronic trial master file is an essential software in research and development of new pharmaceutical and biotechnology-based therapeutic entities. Pharmaceutical and biotech companies majorly focuses on research and development (R&D) to come up with new molecules for various therapeutic applications with the most significant medical and commercial potential. The companies invest majorly in the R&Ds intending to deliver high quality and innovative products to the market. For instance, Global R&D spending in 2017 increased by 3.9 percent to $165 billion compared to 2016.
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Leading companies operating in the electronic trial master file (eTMF) market are Covance Inc (Lab Corp), Oracle, Ennov, Mastercontrol, Inc., Omnicomm, Pharmavigilalnce, Veeva Systems, and Phlexglobal, Aurea, Inc and TRANSPERFECT among others.
The global electronic trial master file (eTMF) market, based on the component, is segmented into software and service. The service segment held the largest share of the market in 2019. Moreover, the same segment is anticipated to register the highest CAGR of 17.0% in the market during the forecast period. The clinical trial process is a very complex and highly regulated stage for pharmaceutical, biotechnology, and other life science companies. eTMF solutions enable these companies to manage their workflow efficiently and accurately. The development of information technology has allowed healthcare IT companies to offers solutions and services for clinical trial administration.
The global electronic trial master file (eTMF) market, based on component, has been segmented into service and software.
In 2019, the services segment accounted for the largest market share in the global electronic trial master file market, by component. This is primarily attributed the increasing number of increasing R&D expenditure and adoption of eTMF technology. Moreover, the encouragement received towards government funding under appropriate regulatory supervision is also one of the important parameters facilitating the growth of this segment. Another factor responsible for the growth of the service segment include usage of electronic clinical trial systems, adopting the outsourcing trend due to lengthy process involved, lack of intelligence for drug development within the company and unavailability of appropriate equipment and facility to conduct clinical trials.
Delivery Mode Insights
The electronic trial master file market, by delivery mode, is segmented into cloud-based eTMF, and on-premise eTMF. The cloud-based eTMF segment held the largest share of the market in 2019. Moreover, the same segment is estimated to register the highest CAGR of 17.0% in the market during the forecast period. The greatest advantage of the cloud-based eTMF is that various users across the world can access it. The cloud-based software is secured and cost-effective solutions, it allows easy collaboration with sites and regulatory bodies such as Institutional Review Boards (IRBs) and Independent Ethics Committees (IECs) and others. The advantages offered by the cloud-based eTMF software are expected to influence the growth of the market during the forecast period.
Based on end-user, the electronic trial master file market is segmented into pharmaceutical and biotechnology companies, CROs, and others. The pharmaceutical and biotechnology companies segment held the largest share of the market in 2019. However, CROs segment is estimated to register the highest CAGR of 17.4% in the market during the forecast period. These solutions help the pharmaceutical and biotechnology to organize the data of drug development appropriately, avoiding the regulatory risk of missing files during audits. The rising R&D budgets and advantages offered by eTMF are thus expected to be responsible for the growth of the pharmaceutical and biotechnology companies segment over the coming years.
Global Electronic Trial Master File (eTMF) Market - By Component
Global Electronic Trial Master File (eTMF) Market - By Delivery Mode
Global Electronic Trial Master File (eTMF) Market - By End User
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