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 – 2032

Report Overview

Global eClinical Solutions Market size is expected to be worth around USD 27 Billion by 2032 from USD 8 Billion in 2022, growing at a CAGR of 12.8% during the forecast period from 2022 to 2032.

The biopharmaceutical sector uses the term “eClinical” to describe trial automation technology. Initially, any associated technology was referred to as “eClinical.” One of the important aspects fueling the market growth is the expansion of biopharmaceutical and pharmaceutical firms’ research and development efforts. In addition, it is anticipated that the increasing use of software solutions in clinical trials will boost the market. Since businesses in the industry were investing in improved healthcare IT solutions to help in combating the pandemic, the COVID-19 pandemic boosts market adoption. 

Driving Factors

Strategies by Market Players

The key market players are anticipated to adopt a variety of methods to drive the market’s growth over the forecast period. For instance, Signiant Health acquired Vitriol in November 2020, one of the leading software solution providers for the construction of distant sites and the conduct of decentralized clinical trials. In August 2020, one of the biggest private investment firms, GI Partners, also bought Clinical Ink, a provider of clinical trial solutions. The market’s widespread use of E-clinical solutions is primarily driven by the need to uphold transparency and reduce data duplication and fabrication related to medical research.

Substantial expansion of the biopharmaceutical industry

Clinical technologies are used by pharmaceutical companies to obtain regulatory approval for recently created drugs and therapies. The sector is also being propelled forward by the rise in chronic medical conditions and the aging of the population, both of which call for immediate medical attention. As the coronavirus illness (COVID-19) spreads throughout the world, the demand for E-clinical solutions to design, monitor vaccination administration, and manage patient data has significantly increased. As a result of stricter data standards, healthcare providers are increasingly adopting smart medical devices, which is fueling the market growth.

Technological progress

The adoption of technological advances like IoT and larger digitization of the healthcare system in a universal format, demand coordinated solutions to handle the enormous amounts of data that must be processed and catalogued. E-clinical solutions are crucial for the administration of such responsibilities because they provide equivalent services within their field of expertise. In essence, the World Economic Forum claimed that since the advent of the internet, 50 Petabytes of data had been produced annually by healthcare systems all over the world. These technological developments are what fuel the market’s expansion.

Restraining Factors

Implementing and maintaining eClinical solutions can be expensive, particularly for smaller companies or research organizations with limited resources. Implementing eClinical solutions successfully necessitates skilled personnel, such as programmers, data managers, and clinical research associates. However, there is a shortage of experienced personnel – particularly in emerging economies – which could impede adoption. Clinical trial data must be safeguarded against unauthorized access and cyber-attacks. Unfortunately, there have been instances of data breaches and cyberattacks on eClinical systems, potentially damaging trust and decreasing adoption rates. The eClinical solutions market is subject to stringent regulatory requirements, particularly within the pharmaceutical sector. Noncompliance could result in fines and penalties as well as damage to an organization’s reputation.

COVID-19 Impact Analysis

The COVID-19 pandemic has had very little impact on the market growth for e-clinical solutions in 2020-21. The development of COVID-19 vaccines is the primary focus of the government and numerous health organizations, including the World Health Organization (WHO) and the US Food and Drug Administration (FDA), which prevented many upcoming or ongoing clinical studies for other diseases around the world. In the upcoming years, the market for E-clinical solutions is anticipated to expand because of the requirement for long-term approaches for carrying out clinical studies for various medications and COVID-19 vaccines.

Product Analysis

By product analysis, Electronic Clinical Outcome Assessment (eCOA) dominates the eclinical market.

Clinical Analytics Platform, Clinical Data Integration Platform, Clinical Trial Management Systems (CTMS), Electronic Clinical Outcome Assessment (eCOA), Electronic Data Capture (EDC), Clinical Data Management Systems (CDMS), Electronic Trail Master Files (eTMF), Randomization and Trial Supply Management (RTMS), Safety Solutions, and Others are the different market segments for eClinical. The market for eClinical solutions was controlled by the CTMS category, which generated the most income in the past. The projected period is expected to see eCOA develop at the quickest rate due to the growing importance of high-quality clinical data. The measurement of patient-reported, clinician-reported, and observer-reported outcomes is increasing including eCOA, which aids in the preservation of the overall quality. Using eCOA platforms to collect data enhances the quality of the data that is collected, streamlines the data-collecting process, and provides efficient data analysis.

Mode of Deliver Analysis

By distribution channel, the web-hosted sector, with a market of $2973.24 million, dominated the market in 2022.

By distribution channel, the eClinical market is divided into three categories, cloud-based, licensed enterprise, and web-hosted (on-demand) (SaaS). Due to the higher level of interoperability of these products, the web-hosted sector, with a market share of $2973.24 million, dominated the market in 2022. Because of its flexibility, wide accessibility, low handling costs, and simple data backup, the cloud-based category is anticipated to experience the highest CAGR of 13.4% during the projection period for eclinical solutions. The market for eClinical solutions was led by the web-hosted category, which generated the biggest revenue share during the course of history. Due to the ease of customization, accessibility, and usability of web-hosted goods, suppliers can tailor the presentation of information for various user groups. These products also have a higher degree of interoperability.

Development Phase Analysis

By development phase analysis, the phase III sector of clinical trials dominated the eClinical solutions market in 2022.

By development phase analysis, the phase III sector of clinical trials dominated the eClinical solutions market in 2022, as more pharmaceuticals successfully advanced to phase III. Due to the great significance of these systems in predicting future outcomes and removing drug candidates with the lowest likelihood of success, the phase I segment is anticipated to experience the highest CAGR of 13.0% over the course of the projection period. Phase I, Phase II, Phase III, and Phase IV comprise the segments of the eClinical market. In the past, the phase III category dominated the market for eClinical solutions and accounted for the biggest revenue share. Phase III is where a drug’s effectiveness is studied.

End-User

By End-User analysis, North America is predicted to have the largest market share.

By end-User analysis, Due to its established business infrastructure, cutting-edge technology, and accessibility of key players, North America is predicted to have the largest market share, followed by Europe, Asia-Pacific, and LAMEA. Due to the region’s rapid technological advancement in the healthcare sector and the rise in public-private investment in the eClinical solutions market, Asia-Pacific is anticipated to have the highest CAGR over the projected period.

Key Market Segments:

Product:

• Electronic Data Capture (EDC)
• Clinical Data Management Systems (CDMS)
• Clinical Trial Management Systems (CTMS)
• Electronic Clinical Outcome Assessment (eCOA)
• Randomization and Trial Supply Management Solution (RTMS)
• Safety Solutions
• Analytics and Reporting Platforms
• Integration Platforms
• Electronic Trial Master File (eTMF)

Delivery Mode:

• Web-hosted (On-Demand)
• Licensed Enterprise (On-premise)
• Cloud-based/software-as-a-service (SaaS)

Development Phase:

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

End-User:

• Academic Institutes
• Medical Device Manufactures
• Hospitals
• CROs
• Pharmaceutical & Biotechnology Companies

Growth Opportunities

The growing complexity of clinical trials, particularly those related to oncology and rare diseases, presents an opportunity for eClinical solutions providers to create tailored solutions for these trials. The growing demand for clinical trials in emerging markets, particularly Asia-Pacific and Latin America, offers eClinical solutions providers an opportunity to expand their global presence and tap into new markets. Cloud-based eClinical solutions are becoming more widely adopted, providing providers with cost-effective and scalable options to customers. The growing focus on patient-centricity in clinical trials presents an opportunity for these eClinical solution providers to create patient-centric products such as ePRO systems or mobile health (mHealth) applications.

Latest Trends

Cloud-based eClinical solutions are becoming more and more popular, due to their scalability, cost-effectiveness, and ease of deployment. Furthermore, cloud-based systems offer improved data security and accessibility. The integration of AI and Machine Learning into eClinical solutions is growing, providing opportunities to enhance efficiency and accuracy in clinical trial data management and analysis. This includes predictive analytics, natural language processing, and image recognition. There is an increasing emphasis on patient-centricity in clinical trials, creating a unique opportunity for eClinical solution providers to create patient-centric products such as ePRO systems and mHealth applications. There is an increasing emphasis on regulatory compliance, particularly within the pharmaceutical industry. This includes using electronic signatures and audit trails to guarantee data integrity and adherence to regulatory requirements. Overall, the eClinical solutions market is rapidly transforming with an emphasis on cloud-based solutions, AI/ML technologies, patient centricity, wearable devices & IoT applications, virtual trials & regulatory compliance.

Recent Development

2022: Oracle’s Clinical One Randomization and Supplies Management Cloud Service is set to go live in February 2022. The goal of this innovative approach is to streamline supply management and randomization procedures in clinical trials.

2021: The new eConsent solution from IQVIA, which enables patients to electronically give their informed permission, became life in September 2021. The technology also offers alternatives for remote consenting, which makes it simpler for patients to take part in clinical studies from any location.

2021: The debut of Medidata’s new eCOA solution, which enables patients to complete clinical trial questionnaires and surveys remotely using their own devices, was announced in March 2021. Medidata is a Dassault Systèmes business.

Regional Analysis

The e-clinical solutions market is examined, and insights and trends on the market size are given by country, product, delivery method, stage of development, and end-user, as previously said. The e-clinical solutions market report includes data for the United States, Canada, and Mexico in North America; Germany, France, the United Kingdom, the Netherlands, Switzerland, Belgium, Russia, Italy, Spain, and Turkey in Europe; China, Japan, India, South Korea, Singapore, Malaysia, Australia, Thailand, Indonesia, and the Philippines in Asia-Pacific (APAC); Saudi Arabia, the United Arab Emirates, South Africa, Egypt, and Israel in the Middle East and Africa (MEA), as well as the rest of the region. Because of the expanding target population and escalating incidence of lifestyle-related disorders including diabetes and heart conditions, North America has led the market for e-clinical solutions.   Due to large unmet medical needs and growth in the frequency of important chronic diseases like cancer, cardiovascular issues, and communicable diseases, Asia-Pacific is predicted to see a remarkable CAGR of 15.4% during the projection period of 2023–2030.

Key Regions and Countries Covered in this Report:

North America

• Canada
• Mexico

Europe

• Germany
• France
• Italy
• Spain
• Netherlands
• Sweden
• Denmark

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

Market Share & Key Players Analysis:

The major players are utilizing a variety of growth methods, including new product development, mergers and acquisitions, and collaborations, to strengthen their market positions. To provide innovative solutions to their customers and give them access to a more diverse and historically underrepresented population for their clinical trials, Paraxial International Corporation and Signify Health partnered in January 2021. Moreover, ERT and Bioclinica declared their merger in December 2020. By joining forces, ERT and Bioclinica hope to become industry leaders in clinical trial endpoint technologies. Leading companies in the market for eClinical solutions include. To pinpoint the most lucrative eClinical solutions market opportunities, this study offers a comprehensive analysis of the market segments, current trends, projections, and dynamics from 2022 to 2032.

Market Key Players:

Listed below are some of the most prominent bio-based surface disinfectant industry players.

• Oracle Corporation
• Medidata Solutions, Inc.
• Parexel International Corporation
• BioClinica, Inc.
• Signant Health
• Datatrak International, Inc.
• ERT
• eClinical Solutions, Inc.
• MaxisIT Inc.
• Bio-Optronics, Inc.
• Dassault Systemes
• IBM Watson Health
• Anju Life Sciences Software
• Merge Healthcare Incorporated
• OmniComm System
• Other Key Players

Recent Developments:

With the introduction of SmartSignalsTM eConsent in 2021, Signiant Health expanded its electronic informed consent options and capabilities. Sponsors now have more control over getting electronic informed consent and re-consent for any research design due to changes in key product features and tiered licensing options. The most recent iteration of the Bright Clinical Data CloudTM, which was released in 2021 by eClinical Solutions LLC, delivers stronger analytics, more visualizations, and enhanced automation of data review and mapping capabilities across the platform.

Report Scope: