eClinical Solutions Market

Updated on : May 09, 2023

The global eClinical solutions market in terms of revenue was estimated to be worth $9.6 billion in 2022 and is poised to reach $17.9 billion by 2027, growing at a CAGR of 13.3% from 2022 to 2027. The new research study consists of an industry trend analysis of the market. The new research study consists of industry trends, pricing analysis, patent analysis, conference and webinar materials, key stakeholders, and buying behaviour in the market. Market growth is primarily driven by the rising operational costs and regulatory requirements associated with clinical research studies; the growing adoption of novel software solutions in clinical research; favourable government support and funding for clinical trials; the rising need for improved data standardization; and the increasing R&D expenditure on drug development by pharma-biotech companies. However, factors such as high implementation costs associated with eClinical solutions, a shortage of skilled professionals, and limited awareness among researchers are expected to restrain the market growth to a certain extent.

Attractive Opportunities in eClinical solutions Market

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eClinical Solutions Market Dynamics

Driver: Growing adoption of novel software solutions in clinical research

Patient recruitment and retention are major operational challenges for most researchers during clinical research studies. The shortage of real-time access to research data and manual data generation for protocol matrices often results in extended timelines and increased research expenditures associated with clinical trials. This may affect all phases, particularly research planning, data capture, data management, regulatory submission and reporting, and data analysis, resulting in delayed market entry of successful drug candidates. Therefore, researchers increasingly prefer innovative eClinical solutions that offer improved efficiency of clinical trials, enhance site performance, streamline research workload, and have higher cost efficiency than conventional methodologies. These software solutions allow pharmaceutical companies and independent researchers to compare the operating characteristics of the software design options; model, forecast, and track clinical trial enrollment; and identify the procedural bottlenecks associated with clinical trials. The procedural and operational benefits offered by eClinical solutions are resulting in significant growth in the adoption of these solutions among CROs, independent researchers, and pharmaceutical, medical device, and biotechnology companies for their clinical research programs.

Restraint: High implementation costs associated with eClinical solutions

eClinical solutions help researchers efficiently organize, standardize, and manage their clinical research data and metadata during their research lifecycle. Several integrated eClinical solutions (such as CTMS and CDMS) provide end-to-end solutions to clinical researchers for all clinical trial processes. However, these software solutions are expensive and priced at a premium. The installation and maintenance of eClinical solutions cost approximately USD 2 million, with additional costs for technical assistance for cloud-based solutions. The high costs associated with advanced eClinical software solutions are expected to restrain optimal adoption among price-sensitive and small-sized end users, including pharma-biotech companies, independent researchers, and CROs.

Opportunity: Growing outsourcing of clinical trial processes to CROs

Traditionally, pharmaceutical and biotechnology product manufacturing companies were the primary end users of clinical trial products and software. However, with the increasing availability of public-private research funding and strengthening private R&D infrastructure across major markets, several CROs and research-based companies are offering specific research services to various end users. Pharmaceutical and biotechnology companies are increasingly outsourcing less important clinical research activities to these CROs and research companies. Although the pharmaceutical industry is still engaging healthcare providers [such as academic medical centres (AMCs), academic universities, hospitals, and research centers] for clinical trial capabilities, the extent of process outsourcing of clinical trials to AMCs has significantly decreased in the past decade owing to the growing preference for CROs. Rising outsourcing of activities to CROs, coupled with the growing number of CROs across emerging markets, is expected to provide new revenue growth opportunities for market players in the eClinical Solutions industry in the coming years.

Challenge: Limited adoption in emerging countries due to budgetary constraints

The adoption of eClinical solutions in emerging countries is currently very low as technology usage and awareness are restricted. However, there is higher utilisation in parts of the Asia Pacific compared to countries in the Middle East and Africa. The healthcare IT industry experiences low adoption in several developing and underdeveloped markets due to the high costs involved in implementing, maintaining, and upgrading IT solutions. Overcoming such financial constraints in emerging economies is a major challenge for healthcare organizations, as obtaining budgetary approvals for advanced HCIT solutions is challenging. Smaller healthcare organisations struggle to implement internet connectivity for medical devices due to technical difficulties in implementing multiple networks in healthcare setups, poor wireless connectivity, and an enhanced need to instal security layers to avoid data breaches. Poor in-house skilled personnel and insufficient IT infrastructure also contribute to a lower rate of eClinical software solution implementation.

The product segment of the eClinical Solutions market was dominated by EDC and CDMS.

Based on product, the market is segmented into electronic data capture (EDC) and clinical data management systems (CDMS), clinical trial management systems (CTMS), clinical analytics platforms, randomization and trial supply management (RTSM) solutions, clinical data integration platforms, electronic clinical outcome assessment (eCOA) solutions, safety solutions, electronic trial master file (eTMF) systems, eConsent (electronic consent) solutions, regulatory information management systems (RIMS), and other eClinical solutions. The electronic data capture (EDC) and clinical data management systems (CDMS) segment dominated the global market in 2021 with a share of 16.9%. Factors such as the increasing need to reduce the time and costs associated with clinical trials, the growing demand for data standardisation to meet regulatory requirements, and pharmaceutical companies increasing R&D expenditure are driving the growth of the EDC and CDMS solutions market.

In the eClinical Solutions market, cloud-based delivery models are expected to grow the most.

Based on delivery mode, the market is segmented into web-hosted (on-demand), licenced enterprise (on-premises), and cloud-based (SaaS) models. The cloud-based eClinical solutions segment is estimated to register the highest CAGR of 17.8% during the forecast period. The ease of integration, fast deployment, and flexible scalability with a fixed monthly fee offered by cloud-based models are expected to drive the demand for these solutions during the forecast period.

Phase III clinical trials held the largest share of the eClinical solutions market.

Based on the clinical trial phase, the market is segmented into phases I, II, III, and IV. The significant demand for eClinical solutions in phase III clinical trials is mainly due to the involvement of a large patient sample population, the globalisation of clinical trials, and the rising need to increase the efficiency of clinical trials.

Contract research organizations (CROs) will experience the most rapid growth in the eClinical Solutions market.

Based on end users, the market is segmented into pharmaceutical and biopharmaceutical companies, contract research organizations, consultancy service companies, medical device manufacturers, hospitals, and academic and research institutes. Contract research organizations (CROs) form the fastest-growing segment of the global market, registering the highest CAGR of 15.5% during the forecast period. The increasing trend of outsourcing clinical trial activities to CROs is expected to drive market growth for this segment in the coming years.

The eClinical Solutions market was dominated by North America.

North America held the largest share of the market. The large regional share can be attributed to factors such as increasing government grants to support clinical trials, the large number of ongoing clinical trials, continuous product development by eClinical Solution vendors, the growing number of partnerships for drug development projects, and the high prevalence of lifestyle diseases coupled with a growing senior population.

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Among the prominent players in the eClinical solutions market are Oracle Corporation (US), Parexel International Corporation (US), Dassault Systèmes (France), Clario (US), Datatrak International (US), Signant Health (US), 4G Clinical (US), MaxisIT (US), IBM Watson Health (US), eClinical Solutions LLC (US), Veeva Systems (US), Research Manager (US), Saama Technologies, LLC (US), Mednet (US), Anju Software, Inc (US), Medrio, Inc. (US), Castor (US), Clinipace (US), ArisGlobal (US), Quretec Ltd. (Estonia), OpenClinica, LLC (US), Advarra (US), RealTime Software Solutions, LLC (US), YPrime LLC. (US) and Vial (US).

eClinical Solutions Market Report Scope

This report categorizes the eClinical solutions market to forecast revenue and analyze trends in each of the following submarkets:

By Product

• Electronic Data Capture (EDC) & Clinical Data Management Systems (CDMS)
• Clinical Trial Management Systems (CTMS)
• Clinical Analytics Platforms
• Randomization & Trial Supply Management Systems (RTSM)
• Clinical Data Integration Platforms
• Electronic Clinical Outcome Assessment Solutions (eCOA)
• Safety Solutions
• Electronic Trial Master File (eTMF) Systems
• Electronic Consent Solutions (eConsent)
• Regulatory Information Management Systems (RIMS)
• Other eClinical Solutions

By Delivery Mode

• Web-hosted Models
• Licensed Enterprise Models
• Cloud-based Models

By Clinical Trial Phases

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

By End User

• Pharmaceutical & Biopharmaceutical Companies
• Contract Research Organizations
• Consultancy Service Companies
• Medical Device Manufacturers
• Hospitals
• Academic & Research Institutes

By Region

• North America
  • US
  • Canada
• Europe
  • Germany
  • UK
  • France
  • Italy
  • Spain
  • Rest of Europe (RoE)
• Asia Pacific
  • Japan
  • China
  • India
  • Rest of APAC (RoAPAC)
• RoW

Recent Developments

• In November 2022, Medidata (US) introduced Rave Companion, the first scalable solution, to automate the entry of EHR data into Rave EDC. Several potential errors are avoided by clinical trial sites and data managers owing to the modernization of the EDC user experience by Rave Companion.
• In July 2022, Oracle Corporation (US) partnered with Microsoft (US) to give Azure customers direct and streamlined access to Oracle databases on Oracle Cloud Infrastructure (OCI).
• In June 2022, Clario (US) partnered with IDDI (Belgium) to distribute software to its clientele through its Randomized Trial Supply Management (RTSM) Software as a Service business. IDDI will be able to launch clinical studies efficiently and affordably in various markets with the use of Clario RTSM.
• In April 2021, Datatrak International (US) launched Datatrak Direct, an all-in-one iOS and Android data collection app for ePRO, eCOA, and eConsent.
• In February 2021, Parexel (US) partnered with NeoGenomics (US) to improve the application of precision medicine in oncology clinical trials to optimise the patient selection process.

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