eClinical Solutions Market Size, Share & Trends

Updated on : September 24, 2024

Overview of the eClinical Solutions Market

eClinical Solutions market forecasted to transform from USD 11.6 billion in 2024 to USD 22.1 billion in 2029, driven by a CAGR of 13.7%. eClinical solutions outperform traditional ways of clinical trials in terms of clinical trial efficiency, site performance, reduced research effort, and cost efficiency; this has significantly contributed to market growth. The operational advantages of eClinical solutions are also driving this market among contract research organizations (CROS), researchers, and pharmaceutical/biotech companies in this sector. Additionally, regulatory authorities standardize clinical data, and eClinical solutions like electronic data capture (EDC) and clinical data management systems (CDMS) include regulatory data compliance. This fuels the market for eClinical solutions that ensure data compliance.

eClinical Solutions Market Trends

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Eclinical Solutions Market Overview

eClinical solutions Market Dynamics

Driver: An increase in the use of novel software solutions in clinical research.

Throughout any clinical study, the majority of researchers are shown to be facing huge operational challenges surrounding patient recruitment and retention. In most cases, clinical trials are of longer duration, and it costs more to research because there has been no real-time access to research data and manual compilation of data for protocol matrices. This might affect all phases, but most of all, research design, data collection, data management, and reporting regulations, and the analysis of data, and it might delay the market entry of successful candidates of drugs. Example: In November 2022, Medidata released Rave Companion, the first scalable answer for automating Rave EDC data capture. Clinical trial sites and data managers avoid several potential errors due to Rave Companion's modernization of the EDC user experience.

It takes ~13 years and an overall investment of up to USD 1.3 billion (~USD 146 million annually) to commercialize a successful drug candidate; this includes initial drug screening, product synthesis, preclinical and clinical studies, and regulatory filing & approvals. (Source: London School of Hygiene and Tropical Medicine). Therefore, researchers are favoring cutting-edge eclinical solutions over traditional approaches since they provide better clinical trial efficiency, boost site performance, and streamline research workload. These software solutions enable pharmaceutical corporations and independent researchers to assess the operating characteristics of different software design options, model, forecast, and track clinical trial enrolment, and detect procedural bottlenecks associated with clinical trials. The procedural and operational benefits provided by eClinical systems are driving significant growth in their adoption by CROS, independent researchers, and pharmaceutical, medical device, and biotechnology corporations for clinical research programs.

Restraint: High implementation costs associated with clinical solutions.

eClinical systems enable researchers to efficiently organise, standardise, and manage clinical research data and information across the research lifecycle. Several integrated eClinical solutions (such as CTMS and CDMS) offer clinical researchers comprehensive solutions for all clinical trial operations. However, many software solutions are expensive and come with a fee. The installation and maintenance of clinical solutions cost around USD 2 million, with additional fees for technical support for cloud-based systems. The significant costs associated with advanced clinical software solutions are expected to be borne by low-income and small end-customers, such as pharmaceutical and biotechnology businesses, independent researchers, and CROs.

Opportunity: Growing number of clinical trials in developing nations.

The life science industry is witnessing a global increase in the number of clinical trials conducted each year. An increasing number of industry and government sponsors across developed countries are outsourcing their clinical trial processes to developing countries owing to procedural affordability and efficiency, lower operational costs, availability of a large population base, faster patient recruitment, limited regulatory barriers, effective compliance with regulatory guidelines, and stronger intellectual property protections. Asian countries are developing as significant outsourcing destinations for clinical trials, owing to their vast and genetically diverse populations, high illness prevalence, and low-cost outsourced services. Many clinical studies are outsourced to CROS companies in China and India.

The growing number of pharmaceutical companies in developing Asian countries such as China, India, Taiwan, and Korea have also created growth opportunities for the eclinical solutions market in this region. China is the key emerging market for the establishment of pharma and biopharmaceutical companies. Funding support from governments, private entities, and other non-profit organizations in the country is also expected to drive market growth in China for the next decade. India is also one of the top five locations for clinical trial sites, with numerous large-scale global research being undertaken there. The expanding number of clinical trials in emerging nations is expected to create significant market opportunities for well-known and new software businesses to strengthen and improve their market positions in the worldwide clinical solutions industry.

Challenge: Concerns pertaining to patient privacy.

Data integration points to the increased problem of patient privacy, with the escalating number of databases amongst research institutions, CROS, partners, and software companies, the risks of data breach augment. The 2009 Health Information Technology for Economic and Clinical Health Act (HITECH Act) states that covered entities must protect individual health records and other identifiable health information by acquiring appropriate safeguards to protect privacy As such, applying the electronics tools to the patient databases raises concerns on the privacy of the patient record, thus creating another key challenge for pharmaceutical enterprises in to complying with privacy policies while using eClinical software solutions.

eClinical Solutions Market Ecosystem

This section highlights the market's key participants, which include network connection and hardware providers (telecommunications firms), infrastructure service providers (computer tools and electronics makers), and software and service providers. It also contains an overview of firms that provide solutions in the eClinical industry, including recent corporate advancements and MarketsandMarkets' assessment of these suppliers. Additionally, it underscores each company's distinctive features and expertise within the market.

The electronic clinical outcome assessment solutions segment is expected to register highest growth rate during the forecast period in the eClinical solutions industry, by product.

The electronic clinical outcome assessment solutions register the highest growth rate during the forecast period in the eClinical solutions market. This highest growth can be attributed to factors such as eCOA solutions enhancing data accuracy and reliability by reducing manual data entry errors and providing real-time data capture, which is crucial for clinical trials; these solutions improve patient engagement and compliance through user-friendly interfaces and mobile accessibility, allowing patients to conveniently report outcomes. Additionally, regulatory bodies are increasingly endorsing electronic data collection methods, driving the adoption of eCOA solutions to ensure compliance with evolving standards.

Web-Hosted & Cloud-Based model segment accounted for the largest market share by the deployment model of eClinical solutions industry.

In 2023 the web-hosted and cloud-based model was the largest segment in the eClinical solutions market by deployment model. This is due to factors like easy integration with existing infrastructure without significant capital expenditure; flexibility and accessibility so researchers, clinicians and other stakeholders can access data and applications from anywhere and hence more collaboration and efficiency. Web-hosted and cloud-based systems have advanced security features and automatic updates, which make them compliant with the latest regulations and are protected against data breaches, which increases their share in the eClinical solutions market.

North America accounted for largest market share of the eClinical solutions industry in 2023.

In 2023, North America held the largest share of the eClinical Solutions market. The region's high digital literacy and technological innovation, as demonstrated by companies such as Medidata Solutions, drive the broad use of eClinical solutions. The availability of regulatory frameworks, such as the FDA's 21 CFR Part 11, promotes compliance while increasing demand for sophisticated data management and clinical trial solutions. Further, Asia Pacific to have the highest growth rate during the forecast period in the eClinical solutions market. This is driven by factors such as the rapidly expanding healthcare sector, increasing government support for clinical research, and a growing number of clinical trials being conducted in the region.

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The eClinical solutions market key established players include Medidata (A Dassault Systèmes Company) (France), Veeva Systems (US), IQVIA Inc. (US), ICON plc (Ireland), Oracle (US) among others.

Scope of the eClinical Solutions Industry:

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

By Segment

• Product
  • Electronic Data Capture & Clinical Data Management Solutions
  • Clinical Trial Management Solutions
  • Clinical Analytics Platforms
  • Randomization & Trial Supply Management
  • Electronic Clinical Outcome Assessment Solutions
  • Electronic Trial Master File Solutions
  • Electronic Consent Solutions
  • Regulatory Information Management Solutions
  • Clinical Data Integration Platforms
  • Safety Solutions
  • Other eClinical Solutions
• Deployment Model
  • Web-Based & Cloud-Based Model
  • On-Premise Model
• Application
  • Data Collection
  • Document Management & Storage
  • Supply Management
  • Data Analytics
  • Regulatory Information Management
  • Other Applications
• Clinical Trial Phase
  • Phase I
  • Phase II
  • Phase III
  • Phase IV
• End User
  • Pharmaceutical & Biopharmaceutical Companies
  • Contract Research Organizations
  • Consulting Service Companies
  • Medical Device Manufacturers
  • Hospitals & Healthcare Providers
  • Academic Research Institutes
  • Government Organizations
  • Other End Users

By Region

• North America
  • US
  • Canada
• Europe
  • Germany
  • France
  • UK
  • Italy
  • Spain
  • RoE
• Asia Pacific
  • Japan
  • China
  • India
  • RoAPAC
• Latin America
  • Brazil
  • Mexico
  • RoLATAM
• Middle East & Africa
  • GCC
  • RoMEA

Recent Developments of eClinical Solutions Industry:

• In February 2023, Medidata, Dassault Systèmes (US) launched a Clinical Data Studio a software to modernize the data experience to clinical trials using AI.
• In October 2023, Mednet (US) developed its latest eConsent software which provides a simple and cost-effective method for collecting and storing participant consent. The requirements of decentralized, virtual, and hybrid clinical trials are met by this feature.
• In August 2022, Clario (US) launched eCOA digital solutions, Clario Translation Workbench, this will help to reduce translation time by 20–30%, which will speed up eCOA studies and increase patient access to clinical trials.
• In November 2022, Medidata, Dassault Systèmes (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 Rave Companion's modernization of the EDC user experience.

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