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Global Electronic Trial Master File (eTMF) Systems Market – Industry Trends and Forecast to 2030

  • Healthcare
  • Upcoming Report
  • Dec 2022
  • Global
  • 350 Pages
  • No of Tables: 220
  • No of Figures: 60

Global Electronic Trial Master File (eTMF) Systems Market – Industry Trends and Forecast to 2030

Market Size in USD Billion

CAGR - % Diagram

Diagram Forecast Period 2022–2030
Diagram Market Size (Base Year) USD 1.44 Billion
Diagram Market Size (Forecast Year) USD 3.80 Billion
Diagram CAGR %

Global Electronic Trial Master File (eTMF) Systems Market, By Component (Services and Software), Delivery Mode (Cloud-Based eTMF and On-Premise eTMF), End-User (Pharmaceutical and Biotechnology Companies, CROs and Others) – Industry Trends and Forecast to 2030.

 Electronic Trial Master File (eTMF) Systems Market Analysis and Size

According to the Pharmaceutical Researchers and Manufacturers of America (PhRMA), the United States will have a 58% share of R&D expenditure in 2020. Furthermore, according to the same source, biopharmaceutical companies spent approximately 79.6 billion USD on R&D in the United States. Furthermore, clinical trials report that as of 2 August 2022, approximately 133,993 studies have been registered in the United States, with this number expected to grow by the end of the year. The United States alone is responsible for 32% of all registered study locations. This indicates that a large number of clinical trials are being conducted in the country, which is advantageous for the market under consideration because a suitable tool will be required to help researchers keep track of data and store the data effectively.

Data Bridge Market Research analyses that the electronic trial master file (eTMF) systems market which was USD 1.44 billion in 2022, is expected to reach USD 3.80 billion by 2030, at a CAGR of 12.9% during the forecast period 2023 to 2030. In addition to the insights on market scenarios such as market value, growth rate, segmentation, geographical coverage, and major players, the market reports curated by the Data Bridge Market Research also include depth expert analysis, patient epidemiology, pipeline analysis, pricing analysis, and regulatory framework.

Electronic Trial Master File (eTMF) Systems Market Scope and Segmentation      

Report Metric

Details

Forecast Period

2023 to 2030

Base Year

2022

Historic Years

2021 (Customizable to 2015 - 2020)

Quantitative Units

Revenue in USD Billion, Volumes in Units, Pricing in USD

Segments Covered

Component (Services and Software), Delivery Mode (Cloud-Based eTMF and On-Premise eTMF), End-User (Pharmaceutical and Biotechnology Companies, CROs and Others)

Countries Covered

U.S., Canada and Mexico in North America, Germany, France, U.K., Netherlands, Switzerland, Belgium, Russia, Italy, Spain, Turkey, Rest of Europe in Europe, China, Japan, India, South Korea, Singapore, Malaysia, Australia, Thailand, Indonesia, Philippines, Rest of Asia-Pacific (APAC) in the Asia-Pacific (APAC), Saudi Arabia, U.A.E, South Africa, Egypt, Israel, Rest of Middle East and Africa (MEA) as a part of Middle East and Africa (MEA), Brazil, Argentina and Rest of South America as part of South America

Market Players Covered

Wingspan (IQVIA) (U.S.), Labcorp Drug Development (U.S.), TransPerfect (U.S.), Oracle (U.S.), Phlexglobal (U.S.), SureClinical Inc. (U.S.), Aurea, Inc. (U.S.), Veeva Systems (U.S.), MasterControl, Inc. (U.S.), Clinevo Technologies (India), Mayo Foundation for Medical Education and Research (MFMER) (U.S.), Montrium Inc. (U.S.), NCGD Inc. (U.S.), sterling (U.S.), arivis AG (Germany), Forte research (U.S.), PHARMAVIGILANT (U.S.)

Market Opportunities

  • Rising demand for eTMF systems in the pharmaceutical and biotechnology industries

Market Definition

A trial master file in electronic (digital content) format is referred to as an electronic trial master file (eTMF). It is a type of pharmaceutical content management system that provides a formalised method of organising and storing documents, images, and other digital content for pharmaceutical clinical trials that may be required for compliance with government regulatory agencies.

Global Electronic Trial Master File (eTMF) Systems Market Dynamics

Drivers

  • Rising usage of eTMF

ETMF use is increasing as information technology is becoming more widely used in the healthcare industry. There are several advantages to using eTMF, including the fact that it only needs to be installed once and can be reused multiple times. Furthermore, as the clinical trial progresses and expands, the eTMF application easily manages the burden of large amounts of data. Clinical trials have increased dramatically across various countries as the COVID-19 burden has increased. For instance, according to the official clinical trials, the burden of clinical trials data is expected to double as a result of COVID-19. This implies that massive amounts of data will be generated during the trials, which are expected to accelerate the demand for eTMF in this sector.

Opportunities

  • Rising demand for eTMF systems in the pharmaceutical and biotechnology industries

Pharmaceutical and Biotechnology Companies are expected to show significant growth in the market, primarily due to the increasing investments in research and development activities. According to the India Brand Equity Foundation's (IBEF) 2021 report, approximately USD 1.206 billion was invested in the pharmaceutical industry in 2021. Such large investments are increasing the number of clinical trials being conducted, which is fuelling the market. Furthermore, the number of trials is growing, necessitating the use of the eTMF system to manage patient and drug data. According to the European Medicines Agency, 37,293 clinical trials will be registered in Europe by 2021. As a result, these factors are expected to increase demand for eTMF systems in the pharmaceutical and biotechnology industries.

Restraints/Challenges

  • Lack of trained specialists

Budget constraints are expected to hamper the growth of the electronic trial master file (eTMF) systems market during the forecast period. On the other hand, the lack of trained specialists for operating electronic trial master file (eTMF) systems, may pose a further challenge to the market's growth.

This electronic trial master file (eTMF) systems market report provides details of new recent developments, trade regulations, import-export analysis, production analysis, value chain optimization, market share, impact of domestic and localized market players, analyses opportunities in terms of emerging revenue pockets, changes in market regulations, strategic market growth analysis, market size, category market growths, application niches and dominance, product approvals, product launches, geographic expansions, technological innovations in the market. To gain more info on the electronic trial master file (eTMF) systems market contact Data Bridge Market Research for an Analyst Brief, our team will help you take an informed market decision to achieve market growth.

COVID-19 Impact on the Electronic Trial Master File (eTMF) Systems Market

With the increased development of SARS-CoV-2 vaccines, pharmaceutical companies are attempting to improve their agility and speed through the use of electronic trial master file (eTMF) systems. eTMF systems are proving to be critical in managing critical clinical trial documents. Using eTMF systems, innovators have accelerated clinical trials and developed a reliable filing strategy from the start. On the other hand, those who have not been quick enough to adopt these systems are currently experiencing delays. In short, the novel coronavirus has increased demand for electronic trial master file systems and can assist the market in remaining resilient in the face of a lockdown and economic recession.

Recent Developments

  • In June 2022, Anju Software Inc. launched eTMF Master, a new cloud-based electronic trial master file software product. The solution enables collaboration among sponsors, CROs, and sites to efficiently and securely manage clinical trial content in a regulatory-compliant environment.
  • In April 2021, Phlexglobal, one of the ETMF providers, announced that an increasing number of pharmaceutical companies, including five of the global Top 10, are utilizing Phlexglobal's innovative TMF Quality Review solution to identify and mitigate potential regulatory risk for mergers and acquisitions and improve inspection readiness.

Global Electronic Trial Master File (eTMF) Systems Market Scope

The electronic trial master file (eTMF) systems market is segmented on the basis of component, delivery mode, and end-user. The growth amongst these segments will help you analyze meagre growth segments in the industries and provide the users with a valuable market overview and market insights to help them make strategic decisions for identifying core market applications.

Component

  • Services
  • Software

 Delivery Mode

  • Cloud-Based eTMF
  • On-Premise eTMF

 End-User

  • Pharmaceutical and Biotechnology Companies
  • CROs
  • Others

Electronic Trial Master File (eTMF) Systems Market Regional Analysis/Insights

The electronic trial master file (eTMF) systems market is analysed and market size insights and trends are provided by country, component, delivery mode, and end-user as referenced above.

The countries covered in the electronic trial master file (eTMF) systems market report are U.S., Canada and Mexico in North America, Germany, France, U.K., Netherlands, Switzerland, Belgium, Russia, Italy, Spain, Turkey, Rest of Europe in Europe, China, Japan, India, South Korea, Singapore, Malaysia, Australia, Thailand, Indonesia, Philippines, Rest of Asia-Pacific (APAC) in the Asia-Pacific (APAC), Saudi Arabia, U.A.E, South Africa, Egypt, Israel, Rest of Middle East and Africa (MEA) as a part of Middle East and Africa (MEA), Brazil, Argentina and Rest of South America as part of South America.

North America dominates the electronic trial master file (eTMF) systems market due to the rise in the regulatory authorities.

Asia-Pacific is expected to grow at the highest growth rate in the forecast period of 2023 to 2030 owing to the rise in the major companies that are actively involved in the uptake of eTMF systems. 

The country section of the report also provides individual market impacting factors and changes in regulation in the market domestically that impacts the current and future trends of the market. Data points like down-stream and upstream value chain analysis, technical trends and porter's five forces analysis, case studies are some of the pointers used to forecast the market scenario for individual countries. Also, the presence and availability of global brands and their challenges faced due to large or scarce competition from local and domestic brands, impact of domestic tariffs and trade routes are considered while providing forecast analysis of the country data.

Healthcare Infrastructure Growth Installed base and New Technology Penetration

The electronic trial master file (eTMF) systems market also provides you with detailed market analysis for every country growth in healthcare expenditure for capital equipment, installed base of different kind of products for electronic trial master file (eTMF) systems market, impact of technology using life line curves and changes in healthcare regulatory scenarios and their impact on the electronic trial master file (eTMF) systems market. The data is available for historic period 2011-2021.

Competitive Landscape and Electronic Trial Master File (eTMF) Systems Market Share Analysis

The electronic trial master file (eTMF) systems market competitive landscape provides details by competitor. Details included are company overview, company financials, revenue generated, market potential, investment in research and development, new market initiatives, global presence, production sites and facilities, production capacities, company strengths and weaknesses, product launch, product width and breadth, application dominance. The above data points provided are only related to the companies' focus related to electronic trial master file (eTMF) systems market.

Some of the major players operating in the electronic trial master file (eTMF) systems market are:

  • IQVIA (U.S.)
  • Labcorp Drug Development (U.S.)
  • TransPerfect (U.S.)
  • Oracle (U.S.)
  • Phlexglobal (U.S.)
  • SureClinical Inc. (U.S.)
  • Aurea, Inc. (U.S.)
  • Veeva Systems (U.S.)
  • MasterControl, Inc. (U.S.)
  • Clinevo Technologies (India)
  • Mayo Foundation for Medical Education and Research (MFMER) (U.S.)
  •  Montrium Inc. (U.S.)
  •  NCGD Inc. (U.S.)
  •  sterling (U.S.)
  •  arivis AG (Germany), Forte research (U.S.)
  •  PHARMAVIGILANT (U.S.)


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Research Methodology:

Data collection and base year analysis are done using data collection modules with large sample sizes. The stage includes obtaining market information or related data through various sources and strategies. It includes examining and planning all the data acquired from the past in advance. It likewise envelops the examination of information inconsistencies seen across different information sources. The market data is analysed and estimated using market statistical and coherent models. Also, market share analysis and key trend analysis are the major success factors in the market report. To know more, please request an analyst call or drop down your inquiry.

The key research methodology used by DBMR research team is data triangulation which involves data mining, analysis of the impact of data variables on the market and primary (industry expert) validation. Data models include Vendor Positioning Grid, Market Time Line Analysis, Market Overview and Guide, Company Positioning Grid, Patent Analysis, Pricing Analysis, Company Market Share Analysis, Standards of Measurement, Global versus Regional and Vendor Share Analysis. To know more about the research methodology, drop in an inquiry to speak to our industry experts.

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Customization Available:

Data Bridge Market Research is a leader in advanced formative research. We take pride in servicing our existing and new customers with data and analysis that match and suits their goal. The report can be customized to include price trend analysis of target brands understanding the market for additional countries (ask for the list of countries), clinical trial results data, literature review, refurbished market and product base analysis. Market analysis of target competitors can be analyzed from technology-based analysis to market portfolio strategies. We can add as many competitors that you require data about in the format and data style you are looking for. Our team of analysts can also provide you data in crude raw excel files pivot tables (Fact book) or can assist you in creating presentations from the data sets available in the report.

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FREQUENTLY ASK QUESTIONS

The electronic trial master file (eTMF) systems market value was USD 1.44 billion in 2022.
The electronic trial master file (eTMF) systems market is projected to grow at a CAGR of 12.9% during the forecast period of 2023-2030.
The Electronic Trial Master File (eTMF) Systems Market report is segmented into Component, Delivery Mode, and End-User.
North America dominates the electronic trial master file (eTMF) systems market due to the rise in the regulatory authorities.
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