The global eClinical solutions market size was USD 9.85 billion in 2023, calculated at USD 11.25 billion in 2024 and is expected to reach around USD 37.16 billion by 2033, expanding at a CAGR of 14.2% from 2024 to 2033. North America dominated the market and accounted for the largest revenue share of 49.75% in 2023
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The market is driven by cost efficiency, reduced research effort, site performance, and clinical trial efficiency. The operational benefits of eclinical solutions are also fueling this market across biotech/pharmaceutical companies, researchers, and contract research organizations (CROS) in this sector.
The eclinical solutions market is revolutionizing the clinical research sector. The clinical management organization is trying to improve the accessibility, efficiency, and effectiveness of clinical research data to quickly treat patients. The aim behind the production of e-clinical solutions was to find the problems with clinical research data, fix them, and provide creative solutions to make clinical trial data simple and useful to facilitate and obtain the operation, reporting, and standardization of the clinical research domain. The growing focus and rising adoption of e-clinical software and solutions are estimated to boost market growth.
Eclinical solutions, such as electronic trial master file systems, clinical trial management systems (CTMS), electronic patient-reported outcomes, and electronic data capture are software programs used in clinical research to manage clinical data. In addition, growing incorporation of software solutions in clinical trials. Increasing research and development activities by pharma and biopharma companies, the presence of a heightened need for safety monitoring, and a strict regulatory structure for clinical trials are expected to enhance market growth.
eClinical Solutions Market Key Takeaways
- The CTMS segment dominated the market and accounted for the largest revenue share of 20.62% in 2023. ECOA is estimated to be the fastest-growing segment during the forecast period.
- Contract Research Organizations (CROs) segment dominated the market and held the largest revenue share of 37.88% in 2023. The segment is projected to rise at a remarkable CAGR during the forecast period
- The pharma and biotech organizations segment is expected to witness significant growth over the forecast period.
- Web and cloud-based segment dominated the market and accounted for the largest revenue share of 91.33% in 2023.
- Phase III segment dominated the market and accounted for the largest revenue share of 53.61% in 2023.
- Phase I segment is estimated to be the most promising segment during the forecast period
- North America dominated the market and accounted for the largest revenue share of 49.75% in 2023.
- In Asia Pacific, the market for eClinical solutions is likely to register a noteworthy CAGR of 15.9% over the forecast period.
- The collective value of Japan, India, and South Korea eClinical Solutions Market is anticipated to grow at a CAGR of 15.9% from 2024 to 2033.
- Europe eClinical Solutions Market is anticipated to grow at a 15.6% CAGR from 2024 to 2033
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U.S. eClinical Solutions Market Size, Industry Report, 2033
The U.S. eClinical solutions market is estimated to be valued at USD 3.93 billion in 2024 and is expected to reach USD 13.26 billion by 2033, exhibiting a compound annual growth rate (CAGR) of 14.5% from 2024 to 2033.
North America’s Technologies to Sustain the Market’s Position
North America dominated the eclinical solutions market in 2023. The growing target population, coupled with the increasing prevalence of lifestyle-related diseases such as cardiac diseases and diabetes and increasing new product launches by eclinical solution vendors are driving the market growth in the region. In addition, the increasing availability of sophisticated infrastructure, the domicile of major market players, and an increase in government grants are further anticipated to drive the market growth. The U.S. and Canada are the major countries in the market growth.
U.S. eClinical Solutions Market Trends
The U.S. is a significant country in the market due to the increasing adoption and digitalization of patient health information via eConent solutions. Furthermore, increasing stringent regulations for drug approvals and a rising number of clinical trials driving the market growth during the forecast period.
- For instance, In May 2024, a leading provider of innovative clinical trial solutions, EDETEK announced the release of CONFORM™ eClinical Version 5.1. This latest version provides a fully integrated suite of components. The aim behind this launch was to enhance and streamline the clinical trial management process.
Asia Pacific to Grow at the Rapid Pace
The increasing prevalence of infectious diseases, increasing incidence of target chronic diseases such as cardiovascular diseases and cancer, increasing high unmet medical needs, and growing pharmaceutical and biopharmaceutical industries are expected to drive market growth in the region. An increasing number of trials are outsourced to nations such as Japan, Korea, India, and China leading to a low cost and large patient population.
China and India eClinical Solutions Market Trends
The increasing government initiatives supporting the development of new drugs and increasing pharmaceutical research and development investments are expected to enhance the market growth in China.
- For instance, In September 2023, the National Policy on Innovation in the Pharma-MedTech sector and research and Development was launched by the Government of India. The aim behind this launch was to promote research and development in the med-tech and pharmaceutical sectors.
- For instance, In September 2023, a leading global provider of innovative solutions for data collection and patient management, Datacubed Health is thrilled to announce the official launch of its eClinical platform app in China. In expanding its presence in the Chinese market, this milestone achievement represents a significant step forward for Datacubed Health’s commitment.
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eClinical Solutions Market Segment Insights
By product type, the CTMS segment led the market.
The CTMS segment dominated the market and accounted for the largest revenue share of 20.62% in 2023. Leading to the rising significance of high-quality clinical data, ECOA is expected to be the fastest-growing segment during the forecast period. ECOA is increasingly corporated in the measurement of observer-reported outcomes, clinician-reported, and patient-reported and facilitates the preservation of overall quality. The data capturing procedure utilizing eCOA platforms offers effective data analysis, streamlines data collection procedures, and improves the quality of information captured.
The increasing need for patient compliance is further accelerating the usage of eCOA services, which can efficiently address challenges created by paper-based records. Elimination of data variance risk lowering of site monitoring cost and streamlined information are major benefits associated with eCOA.
- For instance, In August 2022, Clario Translation Workbench, eCOA digital solutions were launched by Clario (US). This helped to reduce translation by 20-23%, which increased patient access and speeded up eCOA studies to clinical trials.
By End-use , the Contract Research Organizations (CROs) segment led the market.
Contract Research Organizations (CROs) segment dominated the market and held the largest revenue share of 37.88% in 2023. Leading to the growing inclination of pharmaceutical companies to minimize overall expenditure, the segment is also projected to rise at significant growth during the forecast period. The increasing usage of eclinical solutions in research is further driving the scope of segment growth. Advantages included in outsourcing clinical trials to CROs are expected for the increased growth of this segment. These advantages include enhanced productivity, increased efficiency of services, higher focus on core areas, and cost advantages to a company’s growth.
- For instance, In February 2024, an “anti-CRO” running radically faster, more reliable clinical trials for life science pioneers, Lindus Health announced the launch of its CRO services, site services, and unified technology package for digital health trials and digital therapeutics. This will enable sponsors to higher quality studies and run radically faster for payor access and regulatory approvals.
By delivery mode type, the Web and cloud-based segment led the market.
Web and cloud-based segment dominated the market and accounted for the largest revenue share of 91.33% in 2023. The dominance of the segment can be attributed to related advantages such as lower investments required, usability, and accessibility. Cloud-based and web products are easily customizable. In addition, these products have a greater level of adaptability. The web and cloud-based segment is expected to maintain its position throughout the estimated period.
On-premises delivery mode involves installing services and solutions on computers present within the organization. Though the software needs to be installed within the organization’s premises, it can be accessed from remote locations, providing the benefit of reduced costs due to power consumption and system maintenance. The on-premise eClinical solution is the most commonly preferred solution due to its benefits, such as security and ease of access. Preference for these services is mainly due to complete access to information and full control within the premise.
By Development Phase, the Phase III segment led the market.
Phase III segment dominated the market and accounted for the largest revenue share of 53.61% in 2023. Spiraling need 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.
Phase I segment is estimated to be the most promising segment during 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.
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eClinical Solutions Market Survey Insights
The increased use of eConsent is driving its integration with other eClinical solutions, supporting market growth. As noted in the bar chart below, according to the State of eConsent 2020 report by Signant Health, 28% of survey respondents integrated eConsent with EDC products and CTMS, while 26%, 19%, & 17% integrated eConsent with eCOA, electronic trial master file, and randomization & trial supply management solutions, respectively. However, 28% of respondents had not integrated eConsent with other eClinical systems, likely due to the early adoption phase of eConsent. Simplifying processes and minimizing reconciliation through eClinical integration remains a focus in the industry.
eClinical Solutions Market Company Insights
The market for eclinical solutions is highly competitive with major market players such as Oracle, Clario, eClinicalWorks, Anju Software, CRF Health, Fountayn, eClinical Solutions, and others. Market players are focused on developing technologically advanced and cost-effective devices for consumer comfort. Market dynamics include innovative product development and strategic alliances, such as acquisitions, promotions, partnerships, and collaboration to sustain competitiveness.
- For instance, In June 2023, a leading life science technologies provider, Anju Software announced that ClinChoice is expanding its footprint with Anju and TrialMaster’s eclinical Suite. The partnership allows ClinChoice to deliver a full suite of adaptable and cost-efficient eclinical solutions providing accelerated results and impactful insights.
- Castor is a leading provider of hybrid and decentralized clinical trial solutions to democratize research. Castor’s modular platform offers rapid deployment at scale, with the highest-rated eClinical platform, enabling researchers to create a trial in a matter of clicks, with real-world data capture and easy enrollment.
- For instance, In November 2022, a leading provider of decentralized and hybrid clinical trial technology solutions, Castor announced a new offering to simplify post-marketing clinical trials. Automating trial processes and integrating real-world data (RWD) by extending global reach, Castor’s latest offering can reduce deployment timelines to only 4 weeks on average and reduce trial costs by 30%
eClinical Solutions Market Top Key Companies:
- Fountayn, formerly known as Datatrak International, Inc.
- Oracle
- Calyx, formerly part of Parexel International Corporation
- Medidata (Dassault Systemes)
- CRF Health (Signant Health)
- Clario (ERT and Bioclinica)
- eClinicalWorks
- Merative (IBM Watson Health)
- Anju Software
- eClinical Solutions
- MaxisIT
- IQVIA
- Castor
- Veeva Systems
Recent Developments
- In December 2023, ObvioHealth launched an innovative eCOA solution, integrating scientific and clinical services with advanced study design technology for robust trial outcomes.
- In August 2024, a global provider of digital clinical software and services, eClinical Solutions LLC announced AI-enabled functionality and newly released product enhancements within the elluminate Clinical Data Cloud. Recent platform updates offered advanced AI technology footprint of life sciences organizations, efficiency amid trial complexity, and clinical teams increased oversight.
- In April 2023, a healthcare technology company, Mednet announced its latest software release featuring the launch of medical imaging management capabilities within the iMednet eClinical platform. The aim behind this launch was to provide a secure, cost-effective, and simple method to review, store, and upload medical imaging in clinical trials.
- “Technology is a great enabler when it comes to eCOA. It helps us to streamline outcomes capture and accelerate study timelines. But, tech is just one component of a successful eCOA strategy. It’s only when you combine it with smart, scientific study design and empathetic patient support that you achieve true patient centricity and deliver stronger evidence.”
- -Ivan Jarry, ObvioHealth’s CEO
- In June 2023, ICON plc announced the latest release of its Digital Platform, supporting seamless integration of site, sponsor, and patient services with harmonized data delivery. The platform is customizable for various therapeutic areas and study designs, offering end-to-end solutions for patient services in clinical trials, including a user-friendly mobile app, direct data capture for in-home services, eCOA, telehealth visits, eConsent, and digital health technology management.
- In June 2023, Syneos Health collaborated with uMotif Limited, leveraging an advanced digital platform that incorporates robust Electronic Clinical Outcome Assessment (eCOA) and Electronic Patient-reported Outcomes (ePRO) capabilities. This partnership aims to accelerate the pace of clinical trials, expediting the delivery of groundbreaking medications to patients more efficiently.
- In May 2023, eClinical Solutions LLC. announced the expansion of its machine learning (ML) and artificial intelligence (AI) capabilities within the elluminate IQ offering. Data management teams can take advantage of these cutting-edge ML/AL capabilities to conduct data review more efficiently and scalable.
eClinical Solutions Market Report Segmentation
This report forecasts revenue growth at country levels and provides an analysis of the latest industry trends in each of the sub-segments from 2021 to 2033. For this study, Nova one advisor, Inc. has segmented the eClinical Solutions market.
By Product
- 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)
- Electronic Consent (eConsent)
By Delivery Mode
- Cloud and Web Based
- On-Premise
By Development Phase
- Phase I
- Phase II
- Phase III
- Phase IV
By End-use
- Hospitals/Healthcare providers
- Contract Research Organizations (CROs)
- Academic Institutes
- Pharma & Biotech Organizations
- Medical Device Manufacturers
By Region
- North America
- Europe
- Asia-Pacific
- Latin America
- Middle East & Africa (MEA)
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Browse More Insights:
Healthcare Contract Research Organization (CRO) Market : The global healthcare contract research organization market size was valued at USD 52.19 billion in 2023 and is anticipated to reach around USD 104.60 billion by 2033, growing at a CAGR of 7.2% from 2024 to 2033.
Biologics Market: The global biologics market size was estimated at USD 511.04 billion in 2023 and is projected to hit around USD 1,374.51 billion by 2033, growing at a CAGR of 10.4% during the forecast period from 2024 to 2033.
Clinical Trials Market: The global clinical trials market size was estimated at USD 81.90 billion in 2023 and is projected to hit around USD 153.59 billion by 2033, growing at a CAGR of 6.49% during the forecast period from 2024 to 2033.
Biotechnology Market: The global biotechnology market size was estimated at USD 1.54 Trillion in 2023 and is projected to hit around USD 5.68 Trillion by 2033, growing at a CAGR of 13.95% during the forecast period from 2024 to 2033.
U.S. Clinical Trials Market : The U.S. clinical trials market size was valued at USD 25.81 billion in 2023 and is projected to surpass around USD 41.57 billion by 2033, registering a CAGR of 4.88% over the forecast period of 2024 to 2033.
U.S. Pharmaceutical Market : The U.S. pharmaceutical market size was valued at USD 602.19 billion in 2023 and is projected to surpass around USD 1,093.79 billion by 2033, registering a CAGR of 6.15% over the forecast period of 2024 to 2033.
U.S. Digital Therapeutics Market : The U.S. digital therapeutics market size was valued at USD 1.95 billion in 2023 and is anticipated to reach around USD 13.01 billion by 2033, growing at a CAGR of 20.9% from 2024 to 2033.
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