eClinical Solutions Market Size, Share & Trends Analysis Report By Product (eCOA, CTMS, EDC & CDMS), By Delivery Mode (Web-hosted, Licensed Enterprise, Cloud-based), By Development Phase, By End Use, By Region, And Segment Forecasts, 2023 - 2030

Report Overview

The global eClinical solutions market size was estimated at USD 7.89 billion in 2022 and is expected to expand at a compound annual growth rate (CAGR) of 13.9% from 2023 to 2030. Increasing research and development activities by biopharma and pharma companies is one of the key trends escalating market growth. Besides this, the growing incorporation of software solutions in clinical trials is also projected to provide a fillip to the market. The COVID-19 pandemic boosts the adoption of the market, as companies in the market were investing in better healthcare IT solutions to help in tackling the pandemic.

For instance, in April 2020, eClinical Solutions LLC, developed the elluminate COVID-19 analytics, which was based on feedback from the industry and its clients for helping the sponsors manage the impact of COVID-19 on their ongoing clinical trials. The burgeoning trend of outsourcing clinical trials to contract research organizations (CROs) along with a rising number of CROs and life sciences organizations is poised to help the market gain tremendous traction in the coming years. In addition, growing research programs in Asian countries and the development of cost-effective modules are anticipated to stir up the demand for eClinical solutions.

Moreover, the presence of a stringent regulatory structure for clinical trials and a heightened need for safety monitoring is playing a vital role in the growth of the market for eClinical solutions in developed economies such as the U.S.For instance, the U.S. Department of Health and Human Services and the National Institutes of Health are tightening clinical trial registration requirements and promoting clinical data sharing. Surging demand for software solutions for clinical trials by pharma and biopharma companies is one of the primary growth stimulants of the market for eClinical solutions. Apart from this, increasing government grants to substantiate trials and widening the end-user base for eClinical solutions are likely to boost the market for eClinical solutions during the review period.

Product Insights

The CTMS segment dominated the market for eClinical solutions and accounted for the largest revenue share of over 21.0% in 2022. eCOA is estimated to be the fastest-growing segment with CAGR of 15.2 % owing to the rising significance of high-quality clinical data. eCOA facilitates the preservation of overall quality and is being increasingly incorporated in the measurement of patient-reported, clinician-reported, and observer-reported outcomes. The data-capturing process using eCOA platforms improves the quality of information captured, streamlines data collection procedures, and offers effective data analysis.

Soaring need for patient compliance is further pushing the usage of eCOA solutions, which can effectively meet challenges posed by paper-based records. Elimination of data variance risk streamlined information and lowering of site monitoring cost are key advantages associated with eCOA. These aforementioned benefits are expected to fuel its demand in the coming years. Moreover, the need for integration of patient care with clinical research studies, which leads to a more patient-centric approach, is projected to supplement the growth of the segment.

Delivery Mode Insights

The cloud and web-based segment dominated the market for eClinical solutions in 2022. The dominance of the segment can be attributed to associated benefits such as easy accessibility, usability, and lower investments required. Web-hosted products are easily customizable, owing to which, providers can customize the presentation of information for different user groups. Additionally, these products have a greater level of interoperability. The segment is poised to maintain its position throughout the forecast period.

The cloud and web-based segment is anticipated to exhibit an exponential CAGR during the forecast period owing to integrated features such as flexibility, high accessibility, negligible handling costs, and easy data backup. Real-time data is available through these systems, which enables users to take quick decisions and provide high-quality information for risk-based monitoring. These associated advantages are anticipated to bolster the demand for cloud-based systems.

Development Phase Insights

The phase III segment dominated the eClinical solutions market and accounted for the largest revenue share of over 53.1% in 2022. Spiraling needs for incorporation of clinical data management software to curb overall cost and improve process efficiency is contributing to the growth of the segment. An increasing number of drugs successfully reaching phase III is providing a significant push to the growth of the segment. Phase III involves the study of the efficacy of a drug by using a group of more than 1,000 patients. The complexity of the study increases with an increase in the number of patients, which triggers the demand for computer-based systems for data management, thereby revving up the adoption of eClinical solutions.

The phase I segment is estimated to be the most promising segment with CAGR of 14.8% over the forecast period owing to the high significance of these systems to predict future outcomes and eliminate drug candidates possessing the least probability of success. Developments in biological modeling systems and personalized medicine technologies are leading to a boom in the development of newer drugs. A large number of phase I trials and complex management and analysis of data acquired during various studies is expected to propel the growth of the segment.

End-use Insights

The CROs segment dominated the market for eClinical solutions and held the largest revenue share of over 37% in 2022. The CROs segment is anticipated to grow at the fastest CAGR of 14.2% during the forecast period owing to the growing inclination of pharmaceutical companies to reduce overall expenditure. The rising usage of eClinical solutions in research is further widening the scope of segment growth. The benefits involved in outsourcing clinical trials to CROs are responsible for the heightened growth of this segment. These benefits include cost advantages, increased efficiency of services, enhanced productivity, and a higher focus on core areas of development critical to a company’s growth.

The pharma and biotech organizations segment is expected to witness significant growth over the forecast period. This is attributed to the increasing adoption of eClinical solutions by researchers that provide improved clinical trials and streamlined research workload. Such software solutions allow biotechnology and pharmaceutical companies to identify procedural bottlenecks related to clinical trials. This, in turn, is driving the demand for eClinical solutions among researchers in pharmaceutical and biotechnology companies for clinical research programs.

Regional Insights

North America dominated the market for eClinical solutions and accounted for the largest revenue share of over 51% in 2021. An increasing target population, coupled with the rising prevalence of lifestyle-associated diseases such as diabetes and cardiac disorders, is poised to stimulate the growth of the market. In addition, the launch of new products by eClinical solution vendors and an increase in government grants is driving the market in the region. Moreover, the domicile of prominent players and the availability of sophisticated infrastructure are some additional factors that are anticipated to accentuate the growth of the regional market.

In Asia Pacific, the market for eClinical solutions is likely to register a noteworthy CAGR at 15.4% over the forecast period. High unmet medical needs and the rising prevalence of target chronic diseases such as cancer, cardiovascular conditions, and infectious diseases are stoking the demand for software solutions in the region. An increasing number of trials are outsourced to countries such as China, India, Korea, and Japan owing to a large patient population and low cost. This outsourcing has, thereby, boosted the adoption of eClinical solutions in these regions. As an emerging economy, the growth of the APAC market is largely driven by government funding related to research and drug discovery, which is estimated to enhance its growth over the forecast period.

Key Companies & Market Share Insights

The key players are involved in various growth strategies such as new product development, mergers and acquisitions, and collaborations, which are helping them consolidate their position in the market. In January 2021, Parexel International Corporation collaborated with Signify Health for offering new solutions to their customers for enabling access to a more diverse and traditionally underrepresented population for their clinical trials. Furthermore, in December 2020, ERT and Bioclinica announced their merger. The merger is aimed at making ERT and Bioclinica leaders in clinical trial endpoint technology. Some of the prominent players in the eClinical solutions market include:

• Datatrak International, Inc.

• Oracle

• Parexel International Corporation

• Dassault Systemes

• Bioclinica

• CRF Health

• ERT Clinical

• eClinicalWorks

• IBM Watson Health

• Anju Life Sciences Software

• eClinical Solutions

Recent Developments

• In June 2023, eClinicalWorks, the crucial ambulatory cloud EHR, announced the transition of Chicago Stem Cell Therapy & Pain Management Institute to eClinicalWorks’ cloud-based, unified solution for ambulatory surgery centers (ASCs) and clinics. The solution for ASCs deploys an integrated system, empowering pre-visit consultations, clinical data exchange, documentation, and reminders post-operation.

• In May 2023, eClinical Solutions expanded its AI and ML capabilities in the elluminate IQ offering for delivering quality and increased efficiencies to clinical data management.

• In April 2023, Medidata, a part of Dassault Systèmes, announced that Medidata AI Intelligent Trials was selected by Launch Therapeutics to support its groundbreaking approach for boosting clinical trials of late-stage therapies. Launch Therapeutics is a company specializing in clinical development with a motive to disrupt the paradigm of late-stage development, quicken timelines for regulatory success, and deliver new medicines to patients.

• In February 2023, Parexel, one of the largest CROs in the world unveiled the launch of New Medicines, Novel Insights, a new expert series. This series was purposed to feature the latest insights from Parexel’s cross-functional, global experts analyzing trends that impact drug development. It will also offer evidence-based assistance to the biopharmaceutical market. 

• In June 2022, Anju unveiled the launch of eTMF Master, an innovative cloud-based electronic trial master file solution. This software facilitates the collaboration between CROs, sponsors, and sites to securely and efficiently manage clinical trial data in a regulatory-aligned environment. 

• In February 2022, Clinixir Company Limited, a Thailand-based startup operating in Clinical Research Organization (CRO) in Thailand, selected Oracle’s advanced solutions of clinical research and pharmacovigilance as the company’s eClinical platform. Further, Clinixir also chose Oracle Argus for safety management. 

• In April 2021, Datatrak International, an international SaaS provider, launched eCOA, ePRO, and eConsent Solution in an app called Datatrak Direct for supporting global advancements in decentralized trials. This advanced solution is available across the world for data collection from patients or sites at any given time. 

eClinical Solutions Market Report Scope

Segments Covered in the Report

This report forecasts revenue growth at global, regional, and country levels and provides an analysis of the latest industry trends in each of the sub-segments from 2017 to 2030. For the purpose of this study, Grand View Research has segmented the global eClinical solutions market report on the basis of product, delivery mode, development phase, end-use, and region:

• Product Outlook (Revenue, USD Million, 2018 - 2030)

  • Electronic Data Capture (EDC) and Clinical Data Management Systems (CDMS) 

  • Clinical Trial Management Systems (CTMS)

  • Clinical Analytics Platforms

  • Randomization and Trial Supply Management (RTSM) 

  • Clinical Data Integration Platforms

  • Electronic Clinical Outcome Assessment (eCOA)

  • Safety Solutions

  • Electronic Trial Master File (eTMF)

  • eConsent

• Delivery Mode Outlook (Revenue, USD Million, 2018 - 2030)

  • On-premise

  • Cloud and web-based

• Development Phase Outlook (Revenue, USD Million, 2018 - 2030)

  • Phase I

  • Phase II

  • Phase III

  • Phase IV

• End-use Outlook (Revenue, USD Million, 2018 - 2030)

  • Hospitals/Healthcare providers

  • CROs

  • Academic Institutes

  • Pharma & Biotech Organizations

  • Medical Device Manufacturers

• Regional Outlook (Revenue, USD Million, 2018 - 2030)

  • North America

    • U.S.

    • Canada

    • Mexico

  • Europe

    • U.K.

    • Germany

    • France

    • Italy

    • Spain

    • Netherlands

    • Sweden

    • Denmark

    • Norway

  • Asia Pacific

    • Japan

    • China

    • India

    • South Korea

    • Australia

    • New Zealand

    • Taiwan

    • Hong Kong

    • Singapore

    • Thailand

    • Vietnam

  • Central & South America

    • Brazil

    • Argentina

    • Chile

  • Middle East & Africa

    • South Africa

    • Saudi Arabia

    • UAE

    • Egypt

    • Qatar