Electronic Trial Master File (eTMF) Market Reportto 2027

Electronic Trial Master File (eTMF) Market to 2027 - Global Analysis and Forecasts By Component (Service, Software); Delivery Mode (Cloud-Based eTMF, On-Premise eTMF), End-User (Pharmaceutical and Biotechnology Companies, CROs, Others); and Geography

  • Report Code : TIPRE00007727
  • Category : Healthcare IT
  • Status : Published
  • No. of Pages : 145
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[Research Report] The Electronic Trial Master File in healthcare market was valued at US$ 938.32 million in 2018 and it is projected to reach US$ 3,155.64 million by 2027; it is expected to grow at a CAGR of 16.5% from 2019 to 2027.

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. The growth of the Electronic Trial Master File in healthcare market is attributed to the increasing in number of clinical trial, increasing prevalence of diseases and technology advancement have been boosting the market over the years. However, dearth of skilled professionals is likely to have a negative impact on the growth of the market in the coming years. On the other hand, increasing strategic initiatives by market players is likely to provide growth opportunities over the coming years.

The Electronic Trial Master File in healthcare market is expected to witness substantial growth post-pandemic. The COVID-19 has affected economies and industries in various countries due to lockdowns, travel bans, and business shutdowns. The COVID-19 crisis has overburdened public health systems in many countries and highlighted the strong need for sustainable investment in health systems. As the COVID-19 pandemic progresses, the healthcare industry is expected to see a drop in growth. The life sciences segment thrives due to increased demand for invitro diagnostic products and rising research and development activities worldwide. However, the medical technologies and imaging segment is witnessing drop in sales due to a smaller number of surgeries being carried out and delayed or prolonged equipment procurement. Additionally, virtual consultations by healthcare professionals are expected to become the mainstream care delivery model post-pandemic. With telehealth transforming care delivery, digital health will continue to thrive in coming years. In addition, disrupted clinical trials and the subsequent delay in drug launches is also expected to pave the way for entirely virtual trials in the future. New technologies such as mRNA is expected to emerge and shift the pharmaceutical industry and market is also expected to witness more vertical integration and joint ventures in coming years.

Lucrative Regions for Electronic Trial Master File in Healthcare Market



Lucrative Regions for Electronic Trial Master File in Healthcare Market
  • Sample PDF showcases the content structure and the nature of the information with qualitative and quantitative analysis.

Market Insights

Growing Applications of Electronic Trial Master File in Healthcare to Drive Electronic Trial Master File in Healthcare Market Growth

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. The average R&D expenditure increased moderately to 20.9 percent as a percentage of total prescription sales. Additionally, according to an annual survey of members of PhRMA in 2017 pharma companies reported spending of $71.4 billion on research and development.

The Pharmaceutical companies invested more in R&D to ramp up their clinical trial process. For instance, as of June 30, 2019, AstraZeneca blazed the path by spending 25.63% of revenues on research and development, as of March 31, 2019, Holding strong, Eli Lilly and Company spent 22.38% of its revenues on R&D, and as of June 30, 2019, Roche Holding AG wasn't far behind with 21.29% spent on R&D.

Research and development expenditures are usually incurred during processes of discovering, testing, and developing new products, upfront payments, and milestones, improving existing outcomes, as well as demonstrating product efficacy and regulatory compliance before launch. Moreover, investments for R&D by pharmaceutical companies in the US had grown consistently over the last 15 years.

Drug development and discovery is a time-consuming and expensive process. The process from early detection or design to development to regulatory approval can take more than 10 to 15 years. Throughout the development phase of a drug substance, various testing services are required to check the quality and efficacy of the product. Hence, the pharmaceutical and biotech companies prefer to save the data into electronic master file to save the cost and time, which is expected to drive the growth of the market.

Clinical trials are one of the most important and significant step in drug discovery whether the treatment, medical strategy, or device is safe and effective for human as well as veterinary use. Clinical studies help to understand and determine the best approaches to treatment for certain fields of therapy. Clinical trials are performed specifically to gather data about the safety and efficacy of the development of a new product and tool. Before the regulatory authorities approve the drug molecules and medical devices, a series of clinical studies are carried out. The increasing prevalence of various communicable and non-communicable diseases are increasing the demand for the development of new drugs or medical devices for the treatment. This in turn is expected to increase the demand for clinical trial activities for various therapeutic areas.

Biopharmaceutical and pharmaceutical companies involved in clinical trials aims to shift from paper-based document management systems in file cabinets to electronic document management systems where documents are stored in electronic archives online. By implementing a comprehensive eTMF system that allows organizations to automate, capture and manage TMF documents and records unnecessary risk and can often realize clinical trial cost savings over manual paper handling processes.

A rise in the adoption of an electronic trial master file system in the clinical process likely to boost the market. For instance, NextDocs by Aurea Software is an electronic trial master file (eTMF) forum for clinical cooperation in the management of clinical trial records. It is a content management system for the pharmaceutical industry which offers a formalized means of organizing and storing documents, photographs, and other digital content for clinical pharmaceutical trials that may be required to comply with government regulatory agencies. In clinical trials, EMA fully supports the use of eTMF systems for electronic storage as a substitute for paper. The agency cites quality problems with TMFs and eTMFs in a cautionary statement due to paper content and inconsistencies such as missing pages, unsuitable labeling, or incomplete documents. Because of innovative features of eTMF such as centralization and management of clinical trial documentation, powerful search capabilities (with Metadata), and multiple methods of adding documents, eTMF is becoming important for business efficiency, cost savings, and shortened timelines for the production of BioPharma products to implement electronic document management processes. The secret to introducing interoperable eTMF frameworks is the use of a common content model; vocabulary-based standards; and web-based standards technologies.

Due to advancement in trial master file to electronic trial master file, the contract research organization and pharmaceutical & biotechnology companies are adopting the eTMF for better clinical data management and clinical trial management process. The above mentioned reasons and factors are owing to boost the growth of electronic trial master file market.

Component-Based Insights

In terms of component, the Electronic Trial Master File in healthcare market is segmented into service, and software. The service segment held the largest share of the market in 2019.

Electronic Trial Master File in Healthcare Market, by Component – 2018 and 2027



Electronic Trial Master File in Healthcare Market, by Component – 2018 and 2027
  • Sample PDF showcases the content structure and the nature of the information with qualitative and quantitative analysis.

Delivery Mode -Based Insights

Based on delivery mode, the Electronic Trial Master File in healthcare market is segmented into cloud-based etmf, and on-premise etmf. The cloud-based eTMF segment held the largest share of the market in 2019.

End User-Based Insights

In terms of end user, the Electronic Trial Master File in healthcare 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.


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Electronic Trial Master File (eTMF) Market: Strategic Insights

electronic-trial-master-file-etmf-market
Market Size Value inUS$ 938.32 Million in 2018
Market Size Value byUS$ 3,155.64 Million by 2027
Growth rateCAGR of 16.5% from 2019-2027
Forecast Period2019-2027
Base Year2019
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The Electronic Trial Master File in healthcare market players are adopting the product launch and expansion strategies to cater to changing customer demands worldwide, which also allows them to maintain their brand name globally.

Electronic Trial Master File in Healthcare Market – by Component

  • Service
  • Software

Electronic Trial Master File in Healthcare Market – by Delivery Mode

  • Cloud-Based eTMF
  • On-Premise eTMF

Electronic Trial Master File in Healthcare Market – by End User

  • Pharmaceutical and Biotechnology Companies
  • CROs
  • Others

Electronic Trial Master File in Healthcare Market – by Geography

  • North America

    • US
    • Canada
    • Mexico
  • Europe

    • France
    • Germany
    • Italy
    • UK
    • Spain
    • Rest of Europe
  • Asia Pacific (APAC)

    • China
    • India
    • South Korea
    • Japan
    • Australia
    • Rest of APAC
  • Middle East & Africa (MEA)

    • South Africa
    • Saudi Arabia
    • UAE
    • Rest of MEA
  • South America and Central America (SCAM)

    • Brazil
    • Argentina
    • Rest of SCAM

Company Profiles

  • Aurea, Inc.
  • Transperfect.
  • Covance Inc (Lab Corp)
  • Oracle
  • Ennov
  • Mastercontrol, Inc.
  • Omnicomm
  • Pharmavigilalnce
  • Veeva Systems
  • Phlexglobal
Report Coverage
Report Coverage

Revenue forecast, Company Analysis, Industry landscape, Growth factors, and Trends

Segment Covered
Segment Covered

Component ; Delivery Mode , End-User ; and Geography

Regional Scope
Regional Scope

North America, Europe, Asia Pacific, Middle East & Africa, South & Central America

Country Scope
Country Scope

Argentina, Australia, Brazil, Canada, China, France, Germany, India, Italy, Japan, Mexico, Saudi Arabia, South Africa, South Korea, Spain, United Arab Emirates, United Kingdom, United States

Frequently Asked Questions


What is electronic trial master file (eTMF)?

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.

What are the driving factors for the electronic trial master file (eTMF) market across the globe?

Increasing in number of clinical trial, increasing prevalence of diseases and technology advancement have been boosting the market over the years. However, dearth of skilled professionals is likely to have a negative impact on the growth of the market in the coming years. On the other hand, increasing strategic initiatives by market players is likely to provide growth opportunities over the coming years.

Which industries can use electronic trial master file (eTMF)?

Pharmaceutical and biotechnology companies, contract research organizations (CROs) and other users can make use of electronic trial master file (eTMF).

The List of Companies - Electronic Trial Master File (eTMF) Market

  1. Aurea, Inc.
  2. TRANSPERFECT
  3. Covance Inc (Lab Corp)
  4. Oracle
  5. Ennov
  6. Mastercontrol, Inc.
  7. Omnicomm
  8. Pharmavigilalnce
  9. Veeva Systems
  10. Phlexglobal

The Insight Partners performs research in 4 major stages: Data Collection & Secondary Research, Primary Research, Data Analysis and Data Triangulation & Final Review.

  1. Data Collection and Secondary Research:

As a market research and consulting firm operating from a decade, we have published many reports and advised several clients across the globe. First step for any study will start with an assessment of currently available data and insights from existing reports. Further, historical and current market information is collected from Investor Presentations, Annual Reports, SEC Filings, etc., and other information related to company’s performance and market positioning are gathered from Paid Databases (Factiva, Hoovers, and Reuters) and various other publications available in public domain.

Several associations trade associates, technical forums, institutes, societies and organizations are accessed to gain technical as well as market related insights through their publications such as research papers, blogs and press releases related to the studies are referred to get cues about the market. Further, white papers, journals, magazines, and other news articles published in the last 3 years are scrutinized and analyzed to understand the current market trends.

  1. Primary Research:

The primarily interview analysis comprise of data obtained from industry participants interview and answers to survey questions gathered by in-house primary team.

For primary research, interviews are conducted with industry experts/CEOs/Marketing Managers/Sales Managers/VPs/Subject Matter Experts from both demand and supply side to get a 360-degree view of the market. The primary team conducts several interviews based on the complexity of the markets to understand the various market trends and dynamics which makes research more credible and precise.

A typical research interview fulfils the following functions:

  • Provides first-hand information on the market size, market trends, growth trends, competitive landscape, and outlook
  • Validates and strengthens in-house secondary research findings
  • Develops the analysis team’s expertise and market understanding

Primary research involves email interactions and telephone interviews for each market, category, segment, and sub-segment across geographies. The participants who typically take part in such a process include, but are not limited to:

  • Industry participants: VPs, business development managers, market intelligence managers and national sales managers
  • Outside experts: Valuation experts, research analysts and key opinion leaders specializing in the electronics and semiconductor industry.

Below is the breakup of our primary respondents by company, designation, and region:

Research Methodology

Once we receive the confirmation from primary research sources or primary respondents, we finalize the base year market estimation and forecast the data as per the macroeconomic and microeconomic factors assessed during data collection.

  1. Data Analysis:

Once data is validated through both secondary as well as primary respondents, we finalize the market estimations by hypothesis formulation and factor analysis at regional and country level.

  • 3.1 Macro-Economic Factor Analysis:

We analyse macroeconomic indicators such the gross domestic product (GDP), increase in the demand for goods and services across industries, technological advancement, regional economic growth, governmental policies, the influence of COVID-19, PEST analysis, and other aspects. This analysis aids in setting benchmarks for various nations/regions and approximating market splits. Additionally, the general trend of the aforementioned components aid in determining the market's development possibilities.

  • 3.2 Country Level Data:

Various factors that are especially aligned to the country are taken into account to determine the market size for a certain area and country, including the presence of vendors, such as headquarters and offices, the country's GDP, demand patterns, and industry growth. To comprehend the market dynamics for the nation, a number of growth variables, inhibitors, application areas, and current market trends are researched. The aforementioned elements aid in determining the country's overall market's growth potential.

  • 3.3 Company Profile:

The “Table of Contents” is formulated by listing and analyzing more than 25 - 30 companies operating in the market ecosystem across geographies. However, we profile only 10 companies as a standard practice in our syndicate reports. These 10 companies comprise leading, emerging, and regional players. Nonetheless, our analysis is not restricted to the 10 listed companies, we also analyze other companies present in the market to develop a holistic view and understand the prevailing trends. The “Company Profiles” section in the report covers key facts, business description, products & services, financial information, SWOT analysis, and key developments. The financial information presented is extracted from the annual reports and official documents of the publicly listed companies. Upon collecting the information for the sections of respective companies, we verify them via various primary sources and then compile the data in respective company profiles. The company level information helps us in deriving the base number as well as in forecasting the market size.

  • 3.4 Developing Base Number:

Aggregation of sales statistics (2020-2022) and macro-economic factor, and other secondary and primary research insights are utilized to arrive at base number and related market shares for 2022. The data gaps are identified in this step and relevant market data is analyzed, collected from paid primary interviews or databases. On finalizing the base year market size, forecasts are developed on the basis of macro-economic, industry and market growth factors and company level analysis.

  1. Data Triangulation and Final Review:

The market findings and base year market size calculations are validated from supply as well as demand side. Demand side validations are based on macro-economic factor analysis and benchmarks for respective regions and countries. In case of supply side validations, revenues of major companies are estimated (in case not available) based on industry benchmark, approximate number of employees, product portfolio, and primary interviews revenues are gathered. Further revenue from target product/service segment is assessed to avoid overshooting of market statistics. In case of heavy deviations between supply and demand side values, all thes steps are repeated to achieve synchronization.

We follow an iterative model, wherein we share our research findings with Subject Matter Experts (SME’s) and Key Opinion Leaders (KOLs) until consensus view of the market is not formulated – this model negates any drastic deviation in the opinions of experts. Only validated and universally acceptable research findings are quoted in our reports.

We have important check points that we use to validate our research findings – which we call – data triangulation, where we validate the information, we generate from secondary sources with primary interviews and then we re-validate with our internal data bases and Subject matter experts. This comprehensive model enables us to deliver high quality, reliable data in shortest possible time.

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