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, Price Trends, Competitive Market Share & Forecast, 2021 – 2027

Industry trends

eClinical Solutions Market size was valued over USD 6.7 billion in 2020 and is estimated to grow at around 11.6% CAGR between 2021 and 2027. eClinical solutions manage the clinical technologies and expertise to facilitate the acceleration of clinical development process. Also, eClinical solutions are software and applications that are used for management of clinical trials and clinical research. The software helps to manage, maintain, record data, and track deadlines. Various eClinical solutions include randomization and trial supply management (RTSM), clinical data management system (CDMS) and clinical trial management system (CTMS) among others.
 

eClinical solutions refer to a range of customized cloud based and software driven services and solutions for clinical data management designed to help accelerate clinical development process. The market for eclinical solutions will expand led by widespread adoption across hospitals, medical device makers, and biotech and pharma companies. 
 

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Increasing focus of pharma and biopharma companies on novel drug development for treatment of various chronic disease is the major factor driving the market growth of eClinical solutions. Furthermore, growing investment in life sciences and clinical research will ensure adoption of eClinical solutions software. This will raise the demand and boost the market expansion over the forecast period. Growing demand for global clinical trials and requirement for quality auditing will augment the market value.
 

Various companies are developing analytical-based software to manage the impact of COVID-19 on their on-going trials. For instance, eClinical Solution, Inc. has recently developed “elluminate COVID-19 Analytics”, based on industry and client feedback to help sponsors manage the impact of COVID-19 on their ongoing trials. These analytics provide trial managers with the real-time clinical and operational insights needed to proactively manage the impact of COVID-19 on patient safety and data quality. Elluminate COVID-19 Analytics also helps to increase oversight and regulatory compliance. Thus, COVID-19 pandemic had minimal effects on the industry.
 

Rise in government funding grants for clinical trials is one of the major contributing factors to the eClinical solutions market revenue. The funding grant fosters the developments and implementation of various exploratory clinical trials on health-related outcomes. For instance, as of 2019, the National Institute of Health (NIH) being the largest public sponsor of biomedical research in the world has funded approximately USD 32 billion to improve human life and reduce illness and disability. Thus, rise in number of funding and grants for clinical trials will increase the acceptance of eClinical solutions.
 

High implementation and maintenance cost of eClinical solutions is one of the major barriers that may hamper the market demand. For example, the enterprises that deploy software on-premise are responsible for the ongoing costs of the power consumption and server hardware. Also, the maintenance coupled with upgradation of software, as the vendors are continuously developing new enhancements to the software, incur huge costs that will hinder the industry growth. Additionally, the average cost of software ranges from USD 600 to USD 6,000 per year. Similarly, the implementation cost of clinical trial management system (CTMS) may cost around USD 1,000 per month. Thus, high cost of implementation and maintenance of such solutions will restrain the market growth of eClinical solutions.
 

Electronic data capture (EDC) is most frequently and commonly adopted eClinical solutions in clinical trial and research studies

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Electronic data capture (EDC) segment held 21.8% of the eClinical solutions market share in 2020. EDC is most frequently and commonly adopted eClinical solutions in clinical trial and research studies. The EDC system is designed for collection of clinical trial data in an electronic format and further data is reviewed and verified by corresponding data. This will increase the usage of EDC in various CROs and pharma & biopharmaceutical companies.
 

Web-hosted (on demand) solution maintain client’s data on cloud server

The web-hosted (on-demand) solution exceeded USD 3.4 billion in 2020 due to various advantages associated with web-hosted (on-demand) solution, as these solutions maintain client data on cloud server instead of in-house servers located within the facility. Also, the client can access the data through web and requires only computer hardware with an internet connection. This will increase the demand for such solutions that will upsurge the industry expansion.
 

Growing demand for management of large datasets in phase III will spur the uptake of eClinical solutions

Phase III segment in the eClinical solutions market accounted for USD 3 billion in 2020. Increasing demand for randomization solutions to evaluate the new treatment with existing treatment in this phase will foster the market expansion in the coming years. In addition, phase III clinical trials demonstrate and confirm the preliminary evidence gathered in the previous trials that drug is safe, beneficial and offers effective treatment for the intended indication. Thus, phase III requires large number of participants to determine the effectiveness of the drug. This will ultimately create demand for data management solutions, thereby influencing the growth.
 

Increasing demand for outsourcing clinical trials to various CROs will upsurge the adoption of eClinical solutions by CROs

The contract research organization (CRO) segment is expected to showcase 12% growth rate till 2027 owing to growing demand for outsourcing clinical trial to various CROs, as to minimize the R&D expenses by pharma & biotech companies. Furthermore, electronic data capture (EDC) and clinical data management system (CTMS) are the most prominent eClinical solutions that are adopted by various CROs companies to manage increasing data volumes. Thus, rising usage of eClinical solutions by CROs companies will fuel the market value.
 

Extensive drug development activities in the North America region will further propel the acceptance of eClinical solutions

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North America eClinical solutions market size was USD 3.3 billion in 2020 on account of strong foothold of major pharma and medical device companies. Also, extensive drug development activities in the region will further impel the adoption of eClinical solutions software to manage the data volume. The growing clinical research activities in U.S. and rapid shift from manual data elucidation to real-time data analysis during clinical studies will further accelerate the market revenue. Moreover, increasing concern regarding efficient management of large and confidential data volume will increase the usage of eClinical solutions and boost market demand.
 

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

Prominent market players operating in the market include Oracle Corporation, PAREXEL International, Medidata, Bioclinica, 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 October 2020, Medidata announced partnership with TriNetX and Datavant aiming to accelerate the use of real-world data to empower clinical research. This has enhanced the development capabilities of the firm and assist in strengthening their market position.
   
• In January 2020, Veeva System launched its Vault Payment, a new application for Vault CTMS that help in managing and reimbursement process to clinical research site. This launching strategy enabled company to add value to their existing services portfolio in clinical research and data management, thereby strengthening their business revenue and market presence.
   

The eClinical solutions market research report includes an in-depth coverage of the industry with estimates & forecast in terms of revenue in USD from 2016 to 2027, for the following segments:

Market, 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

Market, By Delivery Mode

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

Market, By Clinical Trial Phase

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

Market, 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:

• 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