eClinical Solutions and Software Market Will Generate Booming Growth Opportunities to 2032

At a CAGR of 11.7 percent from 2022-2032, the global eClinical solutions and software market is expected to reach USD 15.4 billion by 2026, up from USD 8.3 billion in 2021. Some of the major driving factors for the global demand for eClinical solutions and software include rising operational costs and compliance standards associated with clinical scientific studies, financial assistance to support clinical trials, and extensive R&D spending on drug development by pharma-biotech companies. One of the important factors driving the eClinical solutions and software market size is biopharma and pharma businesses increasing their research and development operations. Aside from that, the industry is expected to benefit from the increasing use of software solutions in clinical trials. The COVID-19 pandemic has boosted market adoption, as corporations have been investing in improved healthcare IT systems to aid in the fight against the pandemic.

As the volume of data created during clinical development processes grows, so does the demand for analyzing and managing clinical data. As a result, the use of eClinical solutions in clinical trials is becoming more common. Furthermore, eClinical technologies improve site performance, increase clinical trial efficiency, and reduce costs by removing redundant data entry. The eClinical solutions and software market is predicted to grow as a result of the aforementioned causes. In addition, the rapid use of eClinical solutions such as RTSM in order to enroll and randomize patients, as well as effective trial medication supply management, is expected to boost eClinical solutions revenue. During the research lifecycle, eClinical solutions assist researchers in organizing, standardizing, and managing their clinical research data and information. Several integrated eClinical solutions (such as CTMS and CDMS) offer clinical researchers end-to-end solutions for all clinical trial operations. However, these programs are costly and premium-priced. eClinical systems cost around USD 2 million to install and maintain, with additional expenditure for technical support for cloud-based solutions. Advanced eClinical software systems' high costs are projected to limit their ideal acceptance among price-sensitive and small-sized end customers, such as pharma-biotech businesses, independent researchers, and CROs.

As per the global market study on eClinical solution software, due to the presence of a large and genetically diverse population, high illness prevalence, and low-cost outsourced services, Asian countries are emerging as significant outsourcing destinations for clinical trials. Clinical trials are contracted to CROs in China and India in large numbers. The rise in the number of databases shared among research institutions, CROs, collaborators, and software businesses elevates the danger of data leakage. The use of electronic tools for patient databases raises privacy concerns concerning patient records, posing a significant problem for pharmaceutical companies in terms of adhering to privacy policies when utilizing eClinical software solutions.

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Key Takeaways

• In 2021, the electronic data capture (EDC) segment had a revenue share of 21.9 percent and was expected to grow at a healthy rate during the forecast period.
• The eClinical solutions and software market is divided into four phases based on the stage of the clinical trial: phase I, phase II, phase III, and phase IV. In 2021, the Phase III category generated USD 3,383.2 million in market revenue, and similar trends are predicted from 2021 to 2027. As a growing number of medications make it to phase III, segmental growth will accelerate, propelling the demand for eClinical solutions and software forward.
• During the analysis period, the contract research organization (CRO) market is predicted to grow at a stable CAGR of roughly 12.5 percent. The increasing number of CROs on the market accounts for the high segmental growth rate.
• In 2021, the eClinical solutions and software market for North American eClinical solutions topped USD 3,672.5 million, and it is expected to continue to rise steadily in the future years. The prominent presence of major pharmaceutical and medical device businesses is credited with the high growth rate. Furthermore, the availability of advanced infrastructure is likely to enhance the corporate environment.

Competitive Landscape

Companies functioning in the eClinical solutions and software market are anticipated to benefit from the adoption of business strategies because it will allow them to grow.
Oracle Corporation, PAREXEL International, Medidata, Clario, Merge Healthcare (IBM), Datatrak Int, and ALTEN Group (Axial) are among the leading market leaders in eClinical solutions sector. The most commonly used business strategies to maintain market position are new service launches, partnerships, and collaboration.

Key Developments:

• With a new edition of SmartSignals eConsent in April 2021, Signant Health increased electronic informed consent services and boosted capabilities. To fulfill the study needs of teams, SmartSignals eConsent solutions are available in three categories of functionality: silver, gold, and platinum. This method has improved the company's existing product offering, resulting in revenue from its sale.
• In January 2021, Parexel International Corporation teamed up with Signify Health to provide innovative technologies to improve clinical trial access and inclusion. This collaboration increased patient access to clinical trials by bringing studies to their homes and also identified key social determinants of health (SDoH) to help patients, caregivers, and resources connect.

Key Market Segments

By Solution:
• Randomization & Trial Management (RTSM)
• Clinical Data Management System (CDSM)
• Clinical Trial Management System (CLMS)
• Electronic Clinical Outcome Assessment (eCOA)

• Electronic Trial Master File (eTMF)
• Electronic Data Capture
• Others

By Delivery Mode:
• Licensed Enterprise (on-premise) Solution
• Cloud-based (SAAS) Solution
• Web-hosted (on-demand) Solution

By Clinical Trial:
• Phase I
• Phase II
• Phase III
• Phase IV

By End Use:
• contract Research Organization
• Medical Device Companies
• Pharma/biotech Companies
• Hospitals & Clinics
• Others

By Region:
• North America
• Latin America
• Europe
• Asia Pacific
• Middle East and Africa
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Table of Content

1. Executive Summary
1.1. Global Market Outlook
1.2. Demand-side Trends
1.3. Supply-side Trends
1.4. Technology Roadmap Analysis
1.5. Analysis and Recommendations

2. Market Overview
2.1. Market Coverage / Taxonomy
2.2. Market Definition / Scope / Limitations

3. Market Background
3.1. Market Dynamics
3.1.1. Drivers
3.1.2. Restraints
3.1.3. Opportunity
3.1.4. Trends
3.2. Scenario Forecast
3.2.1. Demand in Optimistic Scenario
3.2.2. Demand in Likely Scenario
3.2.3. Demand in Conservative Scenario
3.3. Opportunity Map Analysis
3.4. Product Life Cycle Analysis
3.5. Investment Feasibility Matrix
3.6. PESTLE and Porter's Analysis
3.7. Regulatory Landscape
3.7.1. By Key Regions
3.7.2. By Key Countries
3.8. Regional Parent Market Outlook

4. Global eClinical Solutions and Software Market Analysis 2017-2021 and Forecast, 2022-2032
4.1. Historical Market Size Value (US$ Mn) Analysis, 2017-2021
4.2. Current and Future Market Size Value (US$ Mn) Projections, 2022-2032
4.2.1. Y-o-Y Growth Trend Analysis
4.2.2. Absolute $ Opportunity Analysis
5. Global eClinical Solutions and Software Market Analysis 2017-2021 and Forecast 2022-2032, By Solution

5.1. Introduction / Key Findings
5.2. Historical Market Size Value (US$ Mn) Analysis By Solution, 2017-2021
5.3. Current and Future Market Size Value (US$ Mn) Analysis and Forecast By Solution, 2022-2032
5.3.1. Randomization & Trial Supply Management (RTSM)
5.3.2. Clinical Data Management System (CDMS)
5.3.3. Clinical Trial Management System (CLMS)
5.3.4. Electronic Clinical Outcome Assessment (eCOA)
5.3.5. Electronic Trial Master File (eTMF)
5.3.6. Electronic Data Capture
5.3.7. Others
5.4. Y-o-Y Growth Trend Analysis By Solution, 2017-2021
5.5. Absolute $ Opportunity Analysis By Solution, 2022-2032

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