Home > Healthcare & Medical Devices > eClinical solutions Market

eClinical solutions Market Size By Solution (Randomization and Trial Supply Management (RTSM), Clinical Data Management System (CDMS), Clinical Trial Management System (CTMS), Electronic Clinical Outcome Assessment (eCOA), Electronic Trial Master Files (ETMF), Electronic Data Capture (EDC)), By Delivery Mode (Licensed Enterprise (On-premise) solutions, Cloud-based (SAAS) solutions, Web-hosted (On-demand) solutions), By Clinical Trial Phase (Phase I, Phase II, Phase III, Phase IV), By End-use (Contract Research Organizations (CROs), Medical Device Companies, Pharma/Biotech Companies, Hospitals & Clinics), Industry Analysis Report, Regional Outlook, Application Potential, Covid-19 Impact Analysis, Competitive Market Share & Forecast, 2022 – 2028

  • Report ID: GMI1774
  • Published Date: Mar 2022
  • Report Format: PDF

Industry Overview

eClinical Solutions Market accounted for about USD 7,563.3 million in 2021 and is estimated to grow at 12.1% between 2022 and 2028 owing to the increasing prevalence of chronic diseases such as diabetes and cancer will boost the demand for novel drug development.

eClinical Solutions Market
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Moreover, growing investment in life sciences and clinical research will ensure a robust adoption of eClinical solutions software, thereby supplementing the market growth. Furthermore, technological advancement such as electronic data capture and Wi-Fi connectivity will further boost the market in the forthcoming years.

eClinical solutions are software and applications employed for an efficient management of clinical trials and clinical research. The different software under the umbrella of eClinical solutions assist in managing, maintaining, and recording data as well as tracking deadlines, among other features. Various eClinical solutions include randomization and trial supply management (RTSM), clinical data management system (CDMS) and clinical trial management system (CTMS), among others.

COVID-19 pandemic has shown positive impact on eClinical solutions market as most of the biotechnological and pharmaceutical companies focused their R&D efforts to support in the development of COVID-19 vaccine. Furthermore, owing to the pandemic, several clinical trials adopted a completely virtual/hybrid model leading to a significantly increased demand for eClinical solutions.

For instance, in June 2020, eClinical Solutions LLC, collaborated with Karyopharm Therapeutics on randomized clinical trials for low-dose selinexor, an XPO1 inhibitor, in hospitalized patients with severe COVID-19. Thus, with increasing severity of pandemic, the demand for development of COVID-19 vaccine increases thereby, accelerating the market growth.

Moreover, various companies developed analytical software to manage the impact of COVID-19 on their on-going trials. For instance, eClinical Solutions, Inc. developed “elluminate COVID-19 Analytics”, based on industry and client feedback to help sponsors manage the impact of COVID-19 on their ongoing trials.

Increasing adoption of software solutions in clinical trials will spur the market statistics

Owing to the increasing volume of data generated at the time of clinical development processes, the demand for analysing and tracking clinical data increases, thus, the adoption of eClinical solutions is noted to increase in clinical trials.

Moreover, eClinical solutions offer enhanced site performance, improved efficiency of clinical trials and optimize the cost by eliminating redundant data entries. Such aforementioned factors are expected to boost the market growth. Furthermore, the fast-paced adoption of eClinical solutions such as RTSM in order to enrol and randomize patients coupled with efficient trial drug supply management is noted to augment the eClinical solutions Market forecasts.

High implementation and maintenance cost may slow down the market demand

High capital cost coupled with periodic maintenance costs of eClinical solutions is one of the major barriers that can affect the widespread market adoption. Moreover, the drug development processes require high investment, and the cost is noted to further increase by implementation of software. The costs further intensify as recently several sponsors are focusing on simultaneously operating multi-site clinical trials.

For instance, the cost of an Electronic Data Capture (EDC) software is in the range of USD 1,000 and USD 5,000 per month of usage, depending on the type of solution. Similarly, the implementation cost of clinical trial management system (CTMS) offered by Medidata costs around USD 1,000 per month. Thus, high cost of implementation and maintenance of such solutions will restrain the eClinical solutions market growth.

Electronic Data Capture is expected to dominate throughout the analysis period

eClinical Solution Market Share By Solution

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Based on solution, the eClinical solutions market is segmented into randomization and trial supply management (RTSM), clinical data management system (CDMS), clinical trial management system (CTMS), electronic clinical outcome assessment (eCOA), electronic trial master file (eTMF), electronic data capture (EDC) and others. Electronic data capture (EDC) segment held the revenue share of 21.9% in 2021 and is projected to show robust CAGR over the forecast period.

Electronic data capture (EDC) is used for collecting and analysing clinical trial data in an electronic format. Thus, EDC reduces the time to collect data and increases data accuracy for studies of medical devices and drugs. As the adoption of virtual clinical trial models increases, the segment is estimated to gain prominence throughout the pharma & biopharmaceutical industries.

 Advantages of web-hosted solutions increase its adoption over the coming years

Based on delivery mode, the eClinical solutions market is divided into licensed enterprise (on-premises) solutions, cloud-based (SAAS) solutions and web-hosted (On-Demand) solutions. The web-hosted (on-demand) solution accounted for USD 3,869.0 million in 2021 and is expected to register lucrative CAGR during the forecast period. High growth rate is due to various advantages associated with web-hosted (on-demand) solution such as easy usability, accessibility and relatively lower investments required.

Moreover, web-hosted product is easily customizable owing to which it can be customize for different customer groups, thereby supplementing the market growth. Additionally, these products maintain client data on cloud server which is easily accessible through web and requires only computer hardware with an internet connection.

Growing complexity of study in phase III will foster the uptake of eClinical solutions

Based on clinical trial phase, the eClinical solutions market is segmented into phase I, phase II, phase III and phase IV. Phase III segment accounted for market revenue of USD 3,383.2 million in 2021 and is expected to show similar trends between 2021 to 2027. Increasing number of drugs successfully reach to phase III will push the segmental growth, thereby propelling the market expansion. Furthermore, phase III clinical trial requires large number of participants for determining the effectiveness of drug, owing to which the complexity of study increases.

Growing usage of eClinical solutions by CROs will upsurge the market statistics

The end-use segment of eClinical solutions market is bifurcated into contract research organizations, medical device companies, pharma & biopharmaceutical companies, hospitals & clinics, and others. The contract research organization (CRO) segment is expected to show steady CAGR of around 12.5% during the analysis period. High segmental growth rate is due to the rising number of CROs in the market.

Moreover, increasing demand for outsourcing clinical trials to various CROs, to minimize the R&D expenses by pharma & biotech companies will further boost the segmental growth, thereby supplementing the market. Furthermore, clinical data management system (CDMS) and electronic data capture (EDC) are the most prominent eClinical solutions adopted by various CROs to manage growing data volumes.

Increasing clinical research activities in the North America region will further boost the adoption of eClinical solution

eClinical Solution Market Size By Region

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North America eClinical solutions market surpassed USD 3,672.5 million in 2021 and is anticipated to show steady growth during the forthcoming years. High growth is attributed to strong foothold of major pharma and medical device companies. Moreover, availability of sophisticated infrastructure will further boost the business landscape.

Furthermore, launch of new product by eClinical solution vendors and rising funding from government is driving the market. Additionally, increasing clinical research activities in U.S. coupled with growing concern regarding efficient management of large and confidential data volume will increase the adoption of eClinical solutions and boost regional market size.

Adoption of business strategies will pave growth opportunities for companies operating in the market

Prominent market players operating in the eClinical solutions industry include Oracle Corporation, PAREXEL International, Medidata, Clario, Merge Healthcare (IBM), Datatrak Int, and ALTEN Group (Aixial) among others. New service launch, partnerships and collaboration are the most commonly adopted business strategies to sustain market position.

Some of the recent industry developments:

  • In April 2021, Signant Health expanded electronic informed consent offerings and enhanced capabilities with a new release of SmartSignals eConsent. The SmartSignals eConsent solutions are available in three tiers of functionality: silver, gold, and platinum to meet the study need of teams. This strategy has enhanced the existing product offering of company, thereby generating revenue from its sale.
  • In January 2021, Parexel International Corporation collaborated with Signify Health to develop new solutions to promote access and inclusion in clinical trials. This partnership improved patient access to clinical trials by bringing studies in their own homes and identified relevant social determinants of health (SDoH) to facilitate connections among patients, resources and caregivers.

The eClinical solutions market report includes an in-depth coverage of the industry with estimates & forecast in terms of revenue in USD from 2022 to 2028, for the following segments:

By Solution

  • Randomization & trial supply management (RTSM)
  • Clinical data management system (CDMS)
  • Clinical trial management system (CLMS)
  • Electronic clinical outcome assessment (eCOA)
  • Electronic trial master file (eTMF)
  • Electronic data capture
  • Others

By Delivery Mode

  • Licensed enterprise (on-premise) solution (LES)
  • Cloud-based (SAAS) solution (CBS)
  • Web-hosted (on-demand) solution (WHS)

By Clinical Trial Phase

  • Phase I
  • Phase II
  • Phase III
  • Phase IV

By End-use

  • Contract research organization (CRO)
  • Medical device companies
  • Pharma/biotech companies
  • Hospitals & clinics
  • Others

The above information is provided for the following regions and countries:

By Region

  • North America
    • U.S.
    • Canada
  • Europe
    • Germany
    • UK
    • France
    • Italy
    • Spain
  • Asia Pacific
    • China
    • India
    • Japan
    • Australia
  • Latin America
    • Brazil
    • Mexico
  • Middle East & Africa
    • South Africa
    • Saudi Arabia


Authors: Sumant Ugalmugle, Rupali Swain

Frequently Asked Questions (FAQ) :

The global eClinical solutions industry share had exceeded USD 7,563.3 million in 2021 and is poised to record a growth rate of over 12.1% between 2022 and 2028 driven by the higher burden of chronic diseases, like diabetes and cancer for novel drug development.

The electronic data capture solution segment accounted for over 21.9% of the overall market share in 2021 and will grow with their rising adoption for collecting and analyzing clinical trial data in an electronic format.

The eClinical solutions industry revenue from contract research organizations is expected to witness growth at a rate of over 12.5% through 2028 due to the higher need to minimize R&D expenses by pharma & biotech companies.

The eClinical solutions industry share in North America crossed USD 3,672.5 million in 2021 and will expand with the strong presence of major pharma and medical device companies in the region.

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Premium Report Details

  • Base Year: 2021
  • Companies covered: 19
  • Tables & Figures: 239
  • Countries covered: 15
  • Pages: 176

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