E-clinical Solutions Market Size, Share & Trends Analysis Report By Product (ECOA, EDC and CDMS, Clinical Analytics Platforms, Clinical Data Integration Platforms, Safety Solutions, CTMS, RTSM, eTMF), By Delivery Mode (Web-Hosted, Licensed Enterprise, Cloud-Based), By Development Phase (Phase I, Phase II, Phase III, Phase IV), By End-Use (Hospitals, CROS, Academic Institutes, Biotech and Pharma Organizations, Medical Device Manufacturers) and By Region(North America, Europe, APAC, Middle East and Africa, LATAM) Forecasts, 2023-2031

Market Overview

The global e-clinical solutions market size was valued at USD 8.25 billion in 2022. It is estimated to reach USD 23.24 billion by 2031, growing at a CAGR of 12.2% during the forecast period (2023–2031). The growing outsourcing and outsourcing of clinical studies by the majority of the prominent pharmaceutical and biotechnological companies are presumed to be responsible for driving the market.

E-clinical or electronic clinical solutions encompass a suite of technologies and software applications to streamline and enhance various aspects of clinical research and trials. These solutions leverage digital platforms to improve data management, communication, and operational efficiency within the clinical trial process. One key component of e-clinical solutions is the Electronic Data Capture (EDC) system. EDC systems enable the electronic collection, management, and storage of clinical trial data. These systems replace traditional paper-based data collection methods, allowing for real-time data entry, validation, and remote access for study personnel. EDC systems reduce the risk of data errors and loss and improve data quality and overall study efficiency.

Another vital component of e-clinical solutions is the Clinical Trial Management System (CTMS). CTMS platforms provide comprehensive tools and functionalities to manage and oversee all aspects of a clinical trial. These systems facilitate protocol development, patient recruitment, site selection, study monitoring, and reporting. CTMS platforms help streamline study operations, improve stakeholder collaboration, and enhance study oversight and compliance. Furthermore, e-clinical solutions include Randomization and Trial Supply Management (RTSM) systems. These systems automate the randomization process and facilitate the management of trial supplies, including drug allocation and inventory management. RTSM systems ensure proper blinding, optimize supply chain logistics, and improve efficiency in clinical trial operations.

Market Dynamics

Global e-clinical solutions market drivers

Increasing externalization of clinical trial studies by large pharmaceutical and biopharmaceutical companies

The growing outsourcing and outsourcing of clinical studies by the majority of the prominent pharmaceutical and biotechnological companies are presumed to be responsible for driving the market at an unprecedented rate throughout the forecast period. Drug development is of utmost importance as it enhances the capabilities in clinical data management, electronic data capture, data conversion, standardization, statistical programming, and data reporting. The rising inclination of major pharmaceutical companies toward these services is also presumed to be a direct consequence of reduced requirement of internal staff, enhanced cost-efficiency, efficient management of resources, and production of lucrative and unbiased results in clinical trials, further widening the scope of growth.

Presence of a strong range of products in the pipeline

Increasing competition amongst the majority of pharmaceutical companies is urging them to expand their R&D budgets, thus resulting in many pipeline products. Cumulatively, the increasing number of patent expirations is also presumed to be responsible for the extensive indulgence of pharmaceutical corporations in drug development and discovery, producing a wide range of pipeline products. This increasing pipeline of products demands a streamlined workflow of all the processes, roles, and activities, leading to efficient clinical data management.

E-clinical solutions facilitate a wide range of options for the abovementioned workflow, which presents the market with lucrative growth opportunities. These benefits include recommendations on the medical interpretation of emergent findings, elimination of data discrepancies, and medical advice to participating investigators. The other benefits of incorporating eClinical solutions include advanced statistical analysis, monitoring trends, and compilation of technical and scientific data required for the regulatory agreement to the clinical trials. The above benefits will speed up the approval process and widen the base for e-Clinical solutions market growth.

Global e-clinical solutions market restraints

Scarcity of skilled research professionals

The limited availability of skilled professionals is a critical growth-restraining factor of the eClinical solutions market. The lack of skilled workers can be linked to the low number of training programs and modules about these services, the under-implementation of training programs, and the high training costs involved. To improve this scenario, market players must participate in developing training programs for clinical data management software and portals developed by these prominent market players and encourage healthcare professionals and researchers to incorporate these services. Moreover, the lack of standardization of these tools makes it hard for experts and medical workers to do their jobs, as every software differs in the user interface.

Global e-clinical solutions market opportunities

Emergence of developing countries as an outsourcing hub

The emergence of developing countries as an outsourcing hub for clinical research and trials has opened up significant opportunities in the global e-clinical solutions market. Several factors, including cost-effectiveness, large patient populations, accelerated enrollment, and collaboration opportunities, drive this trend. Developing countries often offer cost advantages for conducting clinical trials. With lower operational costs, including labor and infrastructure expenses, these countries present an attractive option for sponsors and CROs seeking to optimize their research budgets. Cost savings achieved through outsourcing clinical research to these countries can be reinvested in other areas of drug development or allocated toward additional research studies.

Moreover, developing countries often boast large and diverse patient populations. This abundance of potential study participants provides researchers with a broader pool to recruit from, increasing the chances of finding suitable subjects for their clinical trials. Access to a larger patient pool can be particularly beneficial for studies focused on specific medical conditions or rare diseases, where finding an adequate number of participants can be challenging. This allows for more efficient recruitment, leading to shorter study timelines and faster completion of trials.

Regional Analysis

North america dominates the global market

Based on region, the global e-clinical solutions market is bifurcated into North America, Europe, Asia Pacific, Central and South America, the Middle East and Africa.

North America is the most significant global e-clinical solutions market shareholder and is estimated to grow at a CAGR of 10.6% over the forecast period. North America was estimated to be the largest regional market in 2020. The increasing target population and the rising prevalence of lifestyle-associated diseases, like diabetes and cardiac disorders, provide the largest revenue contribution. The National Institute of Mental Health has re-released several funding opportunity announcements addressing clinical trial-based research, which is expected to drive market growth. Also, the number of big players in the market and the availability of sophisticated infrastructure are anticipated to accentuate the growth of this region.

Europe is anticipated to exhibit a CAGR of 13.4% over the forecast period. As a developed region, Europe has a greater healthcare spending capability, boosting the demand for eClinical solutions. This has led to a growth in the number of customers for eClinical solutions. The growing geriatric population in Europe leads to an increasing prevalence of target diseases, which is further expected to foster market growth. Furthermore, the European Childhood Obesity Project is being conducted using Electronic Data Capture (EDC) for clinical trials. This minimizes the need for after-trial data checks.

Asia-Pacific is expected to bring in the most money region over the anticipated period. High medical needs that aren't being met and the growing number of target chronic diseases like cancer, cardiovascular conditions, and infectious diseases surge demand for clinical software solutions in the region. As an emerging economy, Asia Pacific is growing in government funding for clinical research and drug discovery, which is projected to enhance the market.

The Central and South American eClinical solutions market includes the following regions: Brazil, Mexico, and other Central and South American countries. The presence of untapped opportunities in emerging countries such as Brazil and Mexico is expected to propel the growth of the eClinical solutions market during the forecast period. Central and South America provides several advantages as a site for clinical trials because of its large population, well-established regulations for clinical trials, and highly qualified medical workforce in most countries. Access to these resources helps pharmaceutical and biotechnological companies reduce trial delays and speed up drug development durations.

The Middle East market is expected to surge in integrated electronic technology usage rates. High-speed internet has multiplied, leading to the growth of the market. Some African regions are inadequately equipped with basic communications infrastructure, such as telephone lines. Although they face such issues, they are overcoming the deficit by rapidly adopting cellular phones, which run on wireless networks. Middle East and Africa are effective in adopting new eClinical technologies powered by wireless communication networks or satellite links.

Segmental Analysis

The global e-clinical solutions market is bifurcated into products, delivery mode, development phase, and end-use.

Based on products, the global market is bifurcated into ECOA, EDC, and CDMS, clinical analytics platforms, clinical data integration platforms, safety solutions, CTMS, RTSM, and eTMF.

The ECOA segment dominates the global market and is projected to exhibit a CAGR of 13.2% over the forecast period. ECOA is a system that measures the overall patient state in terms of symptoms, effects of disease, patient response, etc. ECOA checks the accuracy of the data obtained post-study. ECOA facilitates data accuracy, patient engagement, patient preferences, and real-time data monitoring. PAREXEL is a company that provides services to design and implement clinical outcome assessment studies. Smartphones, tablets, and telephone systems are used to collect the data. Most companies opt for ECOA vendors to provide electronic devices for clinical use.

Bring Your Own Device (BYOD) is the alternative strategy implemented by the sponsors to save start-up time and cost spent on data collection. Increasing demand for patient-centric products is attributed to the rising adoption of ECOA solutions as they help streamline patient data collection and offer review and monitoring of the information collected. These solutions are also used to enhance patient engagement capabilities and improve the accuracy and integrity of clinical trial studies.

The global e-clinical solutions market is bifurcated based on delivery mode into web-hosted, licensed enterprise, and cloud-based.

The web-hosted segment dominates the global market and is projected to exhibit a CAGR of 11.9% over the forecast period. Through the app, the physicians can easily find the exact clinical term for the patient's condition and justify the treatment course. Enlisting the correct clinical terms fills the gap between the patient and the coder for payment. The app focuses on 45 conditions, which require the most compliance and generate most of the queries from coding staff. The app covers chest pain, angina, dementia, heart failure, kidney disease, myocardial infarction, perinatal care, pneumonia, sepsis, spinal disorders, syncope and collapse, and venous thromboembolism.

Moreover, in September 2016, RedHill Biopharma Ltd. collaborated with Stanford University School of Medicine to evaluate RedHill’s Phase II drug, YELIVA (ABC294640). The research has received USD 1.8 million in grants from the National Cancer Institute. The research studies related to YELIVA (ABC294640) are registered on a web-based public service site of the U.S. National Institute of Health. www.ClinicalTrials.gov would provide information about private as well as publicly supported clinical trials.

Based on the development phase, the global e-clinical solutions market is bifurcated into phase I, phase II, phase III, and phase IV.

The phase I segment dominates the global market and is projected to exhibit a CAGR of 11.9% over the forecast period. Many phases I trials and complex management and analysis processes of the data acquired during various studies have boosted the demand for computer-assisted devices. The tools we have now reduced the number of mistakes made by hand and made us more efficient by cutting huge costs incurred by bypassing the processes of manual sourcing of data, transcribing, and double data entry. Direct data capture processes and remote data capturing are the factors aiding in the rising popularity of these products during the forecast period. There are separate systems available in the market for different applications, such as database and clinical trial management systems. Integration of such systems is expected to lower the prices, which is anticipated to boost the market in developing regions.

Based on end use, the global market is bifurcated into hospitals, CROS, academic institutes, biotech and pharma organizations, and medical device manufacturers.

The hospital segment dominates the global market and is projected to exhibit a CAGR of 12.2% over the forecast period. The physicians have to select the organ system and enter the symptoms and complaints provided by the patients. The app will provide imaging modalities with evidence to physicians. Hospitals are undertaking healthcare technologies allowing single access points to all the patient information required. In August 2016, Yeovil District Hospital installed the TrakCare system. The system would provide information on maternity, emergency, outpatient, and inpatient patient records.

Recent Developments

• January 2023- Oracle Corporation acquired Vicarious, an artificial intelligence-powered clinical trial management software provider.
• March 2023- Veeva Systems launched a new version of its Veeva Vault eClinical platform.