Electronic Trial Master File (eTMF) Systems Market

Electronic Trial Master File (eTMF) Systems Market by Component (Services, Software), End-User (Pharmaceutical & Biotechnology Companies, Contract Research Organizations), Delivery Mode (On-Premise, Cloud-Based), and Region - Global Forecast to 2024

Report Code: HIT 7315 Aug, 2019, by marketsandmarkets.com

[112 Pages Report] The electronic trial master file (eTMF) systems market is projected to reach USD 1.8 billion by 2024 from USD 1.0 billion in 2019, at a CAGR of 12.7%. Growth in the eTMF systems market can be attributed primarily to the rising adoption of eTMF systems, rising number of clinical trials, partnerships between biopharma companies & CROs, increasing funding to support clinical trials, and the growth in the R&D spending by pharma & biotech companies. Emerging countries are expected to provide significant opportunities for players in the market. However, budget constraints, data privacy issues, and a dearth of skilled professionals will challenge market growth in the coming years

Electronic Trial Master File (eTMF) Systems Market

By delivery mode, the cloud-based eTMF segment accounted for the largest share of the eTMF systems market in 2018.

Based on delivery mode, the market is segmented into on-premise and cloud-based eTMF. In 2018, the cloud-based eTMF segment accounted for the largest share of the market. The large share of this segment is primarily due to the flexible, scalable, and affordable nature of this delivery mode.

The availability of substantial R&D budgets with large pharmaceutical & biotechnology companies will drive the adoption of the eTMF systems among pharmaceutical & biotechnology companies.

Based on end-user, the eTMF systems market is segmented into pharmaceutical & biotechnology companies, contract research organizations (CROs), and other end-users (medical device companies, academic research institutes, and consulting service companies). The pharmaceutical & biotechnology companies segment accounted for the largest market share in 2018. The increasing applications of eTMF software in clinical project management and the availability of substantial R&D budgets with large pharmaceutical & biotechnology companies will drive the adoption of eTMF systems in this end-user segment.

The heavy dependence of end-users on service providers will drive the services segment in the eTMF systems market

Based on the component, the market is segmented into services and software. The services segment accounted for the largest market share in 2018. The large share of this segment can be attributed to their indispensable nature and repetitive requirement. End-users of eTMF systems rely heavily on service providers for consulting, data storage, implementing services, training, maintenance, and regular upgrades of solutions.

North America will continue to hold a significant share of the eTMF systems market during the forecast period.

Geographically, North America accounted for the largest share of the market in 2018. The large market share of North America in the market can be attributed to the increasing government funding for clinical research, a large number of clinical trials, and the presence of several major players in the US.

Electronic Trial Master File (eTMF) Systems Market

Key Market Players

Veeva Systems (US), Oracle Corporation (US), Phlexglobal Limited (UK), TransPerfect Global Inc. (US), Aurea Software (US), LabCorp (US), ePharmaSolutions (US), Wingspan Technology, Inc. (US), MasterControl (US), SureClinical, Inc. (US), Dell EMC (US), Paragon Solutions (US), PharmaVigilant (US), Mayo Clinic (US), Database Integrations, Inc. (US), CareLex (US), Ennov (France), Forte Research (US), Freyr (US), Montrium (US), NCGS Inc. (US), SAFE-BioPharma (US), SterlingBio Inc. (US), BIOVIA Corp. (US), and arivis AG (Germany) are the key players in the eTMF systems market

Veeva Systems was the leading player in the electronic trial master file (eTMF) systems market in 2018. The company’s dominant position can be attributed to its solution, Veeva Vault eTMF. The company focuses on various inorganic and organic growth strategies such as solution deployments and expansions to maintain and enhance its market share. In the last three years, Veeva Systems has deployed its solutions at more than ten pharmaceutical companies, CROs, and other sites in the US to expand its user base with the development of innovative solutions. The company also has a strategic focus on expansions in growing emerging markets, such as the Middle East and Asia.

Oracle Corporation held the second position in the electronic trial master file (eTMF) systems market in 2018.  The company’s dominant position can be attributed to its eClinical Solution Suite. The company’s diversified geographic presence and large customer base contribute to its position in the market. The growing demand for cloud-based solutions will offer new growth opportunities for the company. Oracle’s solution suite helps sponsors & CROs gain advanced visibility into study performance, reduce study cycle times, risks, and costs; and increase staff & site productivity

Report Scope

Report Metric

Details

Market Size Available for Years

2017–2024

Base Year Considered

2018

Forecast Period

2019–2024

Forecast Units

Value (USD)

Segments Covered

Delivery Mode, Component, End User, and Region

Geographies Covered

North America (US & Canada), Europe (Germany, UK, France, & RoE), Asia Pacific (China, Japan, & RoAPAC), and the RoW

Companies Covered

10 major players, including Veeva Systems (US), Oracle Corporation (US), and Phlexglobal Limited (UK),

This research report categorizes the electronic trial master file (eTMF) systems market based on delivery mode, component, end-user, and region.

On the basis of Delivery Mode, the electronic trial master file (eTMF) systems market has been segmented as follows:

  • Cloud-based eTMF
  • On-premise eTMF

Based on the Component, the electronic trial master file (eTMF) systems market has been segmented as follows:

  • Services
  • Software

Based on End-User, the electronic trial master file (eTMF) systems market has been segmented as follows:

  • Pharmaceutical & biotechnology companies
  • Contract Research Organizations (CROs)
  • Other end-users

On the basis of Region, the electronic trial master file (eTMF) systems market has been segmented as follows:

  • North America
    • US
    • Canada
  • Europe
    • Germany
    • UK
    • France
    • RoE
  • Asia Pacific
    • China
    • Japan
    • RoAPAC
  • Rest of the World (RoW)

Critical questions the report answers:

  • Where will all these developments take the industry in the mid to long term?
  • What are the upcoming electronic trial master file (eTMF) systems?
  • Which of the end-user segments will dominate the electronic trial master file (eTMF) systems market in the future?
  • Emerging countries have immense opportunities for the growth and adoption of electronic trial master file (eTMF) systems. Will this scenario continue in the next five years?
  • Where will all the advancements in electronic trial master file (eTMF) systems offered by various companies take the industry in the mid to long term?

To speak to our analyst for a discussion on the above findings, click Speak to Analyst

Table of Contents

1 Introduction (Page No. - 13)
    1.1 Objectives of the Study
    1.2 Market Definition
    1.3 Market Scope
           1.3.1 Markets Covered
           1.3.2 Years Considered for the Study
    1.4 Currency
    1.5 Limitations
    1.6 Stakeholders

2 Research Methodology (Page No. - 16)
    2.1 Research Data
           2.1.1 Secondary Data
                    2.1.1.1 Secondary Sources
           2.1.2 Primary Data
                    2.1.2.1 Key Data From Primary Sources
                    2.1.2.2 Breakdown of Primaries
                    2.1.2.3 Key Industry Insights
    2.2 Market Size Estimation
    2.3 Market Breakdown and Data Triangulation
    2.4 Assumptions for the Study

3 Executive Summary (Page No. - 25)

4 Premium Insights (Page No. - 28)
    4.1 Electronic Trial Master File (eTMF) Systems: Market Overview
    4.2 Geographic Analysis: North American eTMF Market, By Delivery Mode
    4.3 Us: eTMF Systems Market Share, By Component and Delivery Mode
    4.4 Geographical Snapshot of the eTMF Systems Market

5 Market Overview (Page No. - 31)
    5.1 Introduction
    5.2 Market Dynamics
           5.2.1 Drivers
                    5.2.1.1 Rising Adoption of eTMF Systems
                    5.2.1.2 Rising Number of Clinical Trials
                    5.2.1.3 Rising Government Funding and Grants to Support Clinical Trials
                    5.2.1.4 Increasing R&D Expenditure By Pharma-Biotech Companies and It Expenditure Allocations
           5.2.2 Restraints
                    5.2.2.1 Budget Constraints
           5.2.3 Opportunities
                    5.2.3.1 Emerging Asian Markets
           5.2.4 Challenges
                    5.2.4.1 Clinical Data Privacy
                    5.2.4.2 Dearth of Skilled Professionals for Operating eTMF Systems

6 eTMF Systems Market, By Component (Page No. - 37)
    6.1 Introduction
    6.2 Services
           6.2.1 Reliance on Services Will Remain High in the Coming Years, Ensuring Strong Growth in Demand
    6.3 Software
           6.3.1 Rising Adoption of Software is Driving High Growth in the Market

7 eTMF Systems Market, By Delivery Mode (Page No. - 43)
    7.1 Introduction
    7.2 Cloud-Based eTMF
           7.2.1 Cloud-Based eTMF Segment to Register Higher Growth During the Forecast Period
    7.3 On-Premise eTMF
           7.3.1 Lack of Remote Access Capabilities to Restrain the Demand for On-Premise eTMF

8 eTMF Systems Market, By End User (Page No. - 48)
    8.1 Introduction
    8.2 Pharmaceutical & Biotechnology Companies
           8.2.1 Pharmaceutical & Biotechnology Companies are Major End Users of eTMF Systems
    8.3 Contract Research Organizations
           8.3.1 Increasing Outsourcing of Clinical Trials By Pharmaceutical & Biotechnology Companies to Cros is Driving the Adoption of eTMF Systems
    8.4 Other End Users

9 Electronic Trial Master File (eTMF) Systems Market, By Region (Page No. - 57)
    9.1 Introduction
    9.2 North America
           9.2.1 US
                    9.2.1.1 Favorable Government Funding Scenario and A Large Number of Ongoing Clinical Trials are Driving the Adoption of eTMF Systems in the US
           9.2.2 Canada
                    9.2.2.1 Favorable Regulatory Conditions and Growing Partnerships in Canada to Support Market Growth
    9.3 Europe
           9.3.1 Germany
                    9.3.1.1 Germany to Register the Highest Growth in the European eTMF Systems Market During the Forecast Period
           9.3.2 UK
                    9.3.2.1 Growing Number of Biopharmaceutical and Medical Device Companies to Propel the Adoption of eTMF Systems in the UK
           9.3.3 France
                    9.3.3.1 Rising Focus on Biosimilars to Create A Potential Market for eTMF Systems in France
           9.3.4 Rest of Europe
    9.4 Asia Pacific
           9.4.1 China
                    9.4.1.1 Growing Outsourcing of Clinical Trials to Cros to Support Market Growth in China
           9.4.2 Japan
                    9.4.2.1 Government Initiatives and Partnerships Among Pharmaceutical Companies and Cros to Drive Market Growth in Japan
           9.4.3 Rest of Asia Pacific
    9.5 Rest of the World

10 Competitive Landscape (Page No. - 84)
     10.1 Overview
     10.2 Market Ranking of Players, 2018
     10.3 Competitive Leadership Mapping
             10.3.1 Visionary Leaders
             10.3.2 Innovators
             10.3.3 Dynamic Differentiators
             10.3.4 Emerging Companies
     10.4 Competitive Scenario
             10.4.1 Solution Deployments
             10.4.2 Solution Enhancements
             10.4.3 Expansions
             10.4.4 Partnerships

11 Company Profiles (Page No. - 91)
(Business Overview, Products Offered, Recent Developments, MnM View)* 
     11.1 Veeva Systems
     11.2 Oracle Corporation
     11.3 Phlexglobal
     11.4 Transperfect
     11.5 Aurea Software
     11.6 Labcorp
     11.7 Epharmasolutions
     11.8 Wingspan Technology
     11.9 Mastercontrol
     11.1 Sureclinical
*Business Overview, Products Offered, Recent Developments, MnM View Might Not Be Captured in Case of Unlisted Companies. 

12 Appendix (Page No. - 106)
     12.1 Discussion Guide
     12.2 Knowledge Store: Marketsandmarkets’ Subscription Portal
     12.3 Available Customizations
     12.4 Related Reports
     12.5 Author Details


List of Tables (79 Tables)

Table 1 eTMF Systems Market, By Component, 2017–2024 (USD Million)
Table 2 eTMF Services Market, By Region, 2017–2024 (USD Million)
Table 3 North America: eTMF Services Market, By Country, 2017–2024 (USD Million)
Table 4 Europe: eTMF Services Market, By Country, 2017–2024 (USD Million)
Table 5 Asia Pacific: eTMF Services Market, By Country, 2017–2024 (USD Million)
Table 6 eTMF Software Market, By Region, 2017–2024 (USD Million)
Table 7 North America: eTMF Software Market, By Country, 2017–2024 (USD Million)
Table 8 Europe: eTMF Software Market, By Country, 2017–2024 (USD Million)
Table 9 Asia Pacific: eTMF Software Market, By Country, 2017–2024 (USD Million)
Table 10 eTMF Systems Market, By Delivery Mode, 2017–2024 (USD Million)
Table 11 Cloud-Based eTMF Market, By Region, 2017–2024 (USD Million)
Table 12 North America: Cloud-Based eTMF Market, By Country, 2017–2024 (USD Million)
Table 13 Europe: Cloud-Based eTMF Market, By Country, 2017–2024 (USD Million)
Table 14 Asia Pacific: Cloud-Based eTMF Market, By Country, 2017–2024 (USD Million)
Table 15 On-Premise eTMF Market, By Region, 2017–2024 (USD Million)
Table 16 North America: On-Premise eTMF Market, By Country, 2017–2024 (USD Million)
Table 17 Europe: On-Premise eTMF Market, By Country, 2017–2024 (USD Million)
Table 18 Asia Pacific: On-Premise eTMF Market, By Country, 2017–2024 (USD Million)
Table 19 eTMF Systems Market, By End User, 2017–2024 (USD Million)
Table 20 eTMF Systems Market for Pharmaceutical & Biotechnology Companies, By Region, 2017–2024 (USD Million)
Table 21 North America: eTMF Systems Market for Pharmaceutical & Biotechnology Companies, By Country, 2017–2024 (USD Million)
Table 22 Europe: eTMF Systems Market for Pharmaceutical & Biotechnology Companies, By Country, 2017–2024 (USD Million)
Table 23 Asia Pacific: eTMF Systems Market for Pharmaceutical & Biotechnology Companies, By Country, 2017–2024 (USD Million)
Table 24 List of Partnerships Between Cros & Drug Manufacturers
Table 25 eTMF Systems Market for Cros, By Region, 2017–2024 (USD Million)
Table 26 North America: eTMF Systems Market for Cros, By Country, 2017–2024 (USD Million)
Table 27 Europe: eTMF Systems Market for Cros, By Country, 2017–2024 (USD Million)
Table 28 Asia Pacific: eTMF Systems Market for Cros, By Country, 2017–2024 (USD Million)
Table 29 eTMF Systems Market for Other End Users, By Region, 2017–2024 (USD Million)
Table 30 North America: eTMF Systems Market for Other End Users, By Country, 2017–2024 (USD Million)
Table 31 Europe: eTMF Systems Market for Other End Users, By Country, 2017–2024 (USD Million)
Table 32 Asia Pacific: eTMF Systems Market for Other End Users, By Country, 2017–2024 (USD Million)
Table 33 eTMF Systems Market, By Region, 2017–2024 (USD Million)
Table 34 North America: eTMF Systems Market, By Country, 2017–2024 (USD Million)
Table 35 North America: eTMF Systems Market, By Delivery Mode, 2017–2024 (USD Million)
Table 36 North America: eTMF Systems Market, By Component, 2017–2024 (USD Million)
Table 37 North America: eTMF Systems Market, By End User, 2017–2024 (USD Million)
Table 38 US: eTMF Systems Market, By Delivery Mode, 2017–2024 (USD Million)
Table 39 US: eTMF Systems Market, By Component, 2017–2024 (USD Million)
Table 40 US: eTMF Systems Market, By End User, 2017–2024 (USD Million)
Table 41 Canada: eTMF Systems Market, By Delivery Mode, 2017–2024 (USD Million)
Table 42 Canada: eTMF Systems Market, By Component, 2017–2024 (USD Million)
Table 43 Canada: eTMF Systems Market, By End User, 2017–2024 (USD Million)
Table 44 Europe: eTMF Systems Market, By Country, 2017–2024 (USD Million)
Table 45 Europe: eTMF Systems Market, By Delivery Mode, 2017–2024 (USD Million)
Table 46 Europe: eTMF Systems Market, By Component, 2017–2024 (USD Million)
Table 47 Europe: eTMF Systems Market, By End User, 2017–2024 (USD Million)
Table 48 Germany: eTMF Systems Market, By Delivery Mode, 2017–2024 (USD Million)
Table 49 Germany: eTMF Systems Market, By Component, 2017–2024 (USD Million)
Table 50 Germany: eTMF Systems Market, By End User, 2017–2024 (USD Million)
Table 51 UK: eTMF Systems Market, By Delivery Mode, 2017–2024 (USD Million)
Table 52 UK: eTMF Systems Market, By Component, 2017–2024 (USD Million)
Table 53 UK: eTMF Systems Market, By End User, 2017–2024 (USD Million)
Table 54 France: eTMF Systems Market, By Delivery Mode, 2017–2024 (USD Million)
Table 55 France: eTMF Systems Market, By Component, 2017–2024 (USD Million)
Table 56 France: eTMF Systems Market, By End User, 2017–2024 (USD Million)
Table 57 RoE: eTMF Systems Market, By Delivery Mode, 2017–2024 (USD Million)
Table 58 RoE: eTMF Systems Market, By Component, 2017–2024 (USD Million)
Table 59 RoE: eTMF Systems Market, By End User, 2017–2024 (USD Million)
Table 60 Asia Pacific: eTMF Systems Market, By Country, 2017–2024 (USD Million)
Table 61 Asia Pacific: eTMF Systems Market, By Delivery Mode, 2017–2024 (USD Million)
Table 62 Asia Pacific: eTMF Systems Market, By Component, 2017–2024 (USD Million)
Table 63 Asia Pacific: eTMF Systems Market, By End User, 2017–2024 (USD Million)
Table 64 China: eTMF Systems Market, By Delivery Mode, 2017–2024 (USD Million)
Table 65 China: eTMF Systems Market, By Component, 2017–2024 (USD Million)
Table 66 China: eTMF Systems Market, By End User, 2017–2024 (USD Million)
Table 67 Japan: eTMF Systems Market, By Delivery Mode, 2017–2024 (USD Million)
Table 68 Japan: eTMF Systems Market, By Component, 2017–2024 (USD Million)
Table 69 Japan: eTMF Systems Market, By End User, 2017–2024 (USD Million)
Table 70 RoAPAC: eTMF Systems Market, By Delivery Mode, 2017–2024 (USD Million)
Table 71 RoAPAC: eTMF Systems Market, By Component, 2017–2024 (USD Million)
Table 72 RoAPAC: eTMF Systems Market, By End User, 2017–2024 (USD Million)
Table 73 Rest of the World: eTMF Systems Market, By Delivery Mode, 2017–2024 (USD Million)
Table 74 Rest of the World: eTMF Systems Market, By Component, 2017–2024 (USD Million)
Table 75 Rest of the World: eTMF Systems Market, By End User, 2017–2024 (USD Million)
Table 76 Solution Deployments
Table 77 Solution Enhancements
Table 78 Expansions
Table 79 Partnerships


List of Figures (27 Figures)

Figure 1 Research Methodology: Electronic Trial Master File (eTMF) Systems
Figure 2 Research Design
Figure 3 Primary Research
Figure 4 Market Size Estimation Methodology: Bottom-Up Approach
Figure 5 Market Size Estimation Methodology: Top-Down Approach
Figure 6 Data Triangulation Methodology
Figure 7 Electronic Trial Master File (eTMF) Systems Market Share, By Delivery Mode, 2018
Figure 8 Electronic Trial Master File (eTMF) Systems Market Share, By End User, 2018
Figure 9 Electronic Trial Master File (eTMF) Systems Market Share, By Component, 2018
Figure 10 Geographic Snapshot of the Electronic Trial Master File (eTMF) Systems Market
Figure 11 Rising Adoption of eTMF Systems to Drive Market Growth During the Forecast Period
Figure 12 Cloud-Based eTMF Accounted for the Largest Share of the North American Market in 2018
Figure 13 Services and Cloud-Based eTMF Accounted for the Largest Shares in 2018
Figure 14 Asia Pacific to Witness the Highest Growth During the Forecast Period
Figure 15 eTMF Systems Market: Drivers, Restraints, Opportunities, and Challenges
Figure 16 Global Increase in the Number of Clinical Trials, 2010–2018
Figure 17 North America Dominates the eTMF Systems Market
Figure 18 North America: eTMF Systems Market Snapshot
Figure 19 Europe: eTMF Systems Market Snapshot
Figure 20 Asia Pacific: Laboratory Information Systems Market Snapshot
Figure 21 RoW: eTMF Systems Market Snapshot
Figure 22 Key Developments in the eTMF Systems Market Between 2016 and 2019
Figure 23 eTMF Systems Market Ranking, By Key Player (2018)
Figure 24 eTMF Systems Market, Competitive Leadership Mapping, 2018
Figure 25 Veeva Systems: Company Snapshot
Figure 26 Oracle Corporation: Company Snapshot
Figure 27 Labcorp: Company Snapshot

The study involved four major activities in estimating the current size of the electronic trial master file (eTMF) systems market. Exhaustive secondary research was done to collect information on the market and its different subsegments. The next step was to validate these findings, assumptions, and sizing with industry experts across the value chain through primary research. Both top-down and bottom-up approaches were employed to estimate the complete market size. After that, market breakdown and data triangulation procedures were used to estimate the market size of segments and subsegments.

Secondary Research

In the secondary research process, various secondary sources such as D&B Hoovers, Bloomberg Businessweek, and Factiva have been referred to identify and collect information for this study. These secondary sources included annual reports, press releases & investor presentations of companies, white papers, certified publications, articles by recognized authors, gold-standard & silver-standard websites, regulatory bodies, and databases.

Primary Research

The eTMF systems market comprises several stakeholders such as eTMF systems vendors, pharmaceutical/biopharmaceutical companies, clinical research organizations (CROs), medical device companies, Research and Development (r&d) companies, business research and consulting service providers, medical research laboratories, academic medical centers/universities, and government bodies. Various primary sources from both the supply and demand sides of the market were interviewed to obtain qualitative and quantitative information. The following is a breakdown of the primary respondents:

Electronic Trial Master File (eTMF) Systems Market

To know about the assumptions considered for the study, download the pdf brochure

Market Size Estimation

Both top-down and bottom-up approaches were used to estimate and validate the total size of the eTMF systems market. These methods were also used extensively to estimate the size of various subsegments in the market. The research methodology used to estimate the market size includes the following:

  • The key players in the industry and markets have been identified through extensive secondary research
  • The industry’s supply chain and market size, in terms of value, have been determined through primary and secondary research processes
  • All percentage shares, splits, and breakdowns have been determined using secondary sources and verified through primary sources

Data Triangulation

After arriving at the overall market size—using the market size estimation processes as explained above—the market was split into several segments and subsegments. To complete the overall market engineering process and arrive at the exact statistics of each market segment and subsegment, data triangulation, and market breakdown procedures were employed, wherever applicable. The data was triangulated by studying various factors and trends from both the demand and supply sides.

Report Objectives

  • To define, describe, segment, and forecast the eTMF systems market by delivery mode, component, end-user, and region
  • To provide detailed information about the factors (such as drivers, restraints, opportunities, and challenges) influencing market growth
  • To analyze micro markets with respect to individual growth trends, prospects, and contributions to the overall market
  • To analyze market opportunities for stakeholders and provide details of the competitive landscape for key players
  • To forecast the size of the market segments with respect to four regions, namely, North America, Europe, Asia Pacific, and the Rest of the World (RoW)
  • To strategically analyze the market structure and profile the key players in the market and comprehensively analyze their core competencies
  • To track and analyze competitive developments such as solutions enhancements, deployments, expansions, and partnerships in the market

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