eClinical 솔루션 시장 규모, 점유율, 예측 및 동향 분석 : 제품별, 최종사용자별, 단계별 - 세계 예측(-2031년)

eClinical Solutions Market Size, Share, Forecast, & Trends Analysis by Product (CDMS, CTMS, eCOA, ePRO, eDC, eTMF, Clinical Analytics, Safety Solutions), End User (Pharmaceutical, Clinical Research Organization, Medical Device), Phase - Global Forecast to 2031

The eClinical solutions market is expected to reach $23.32 billion by 2031, at a CAGR of 13.9% from 2024 to 2031.

Following thorough secondary and primary research and in-depth analysis of the market scenario, the report discusses key industry drivers, restraints, challenges, opportunities, and trends.

The growth of the eClinical solutions market is primarily driven by the large amounts of data generated by the healthcare & life sciences industries, the growing number of clinical trials, initiatives supporting clinical research, and increasing funding for medical & pharmaceutical research & development. Moreover, IT infrastructure strengthening initiatives by large hospital chains, and the rising demand for precision medicine are expected to generate growth opportunities for the players operating in the eClinical solutions market.

Based on product, the eClinical solutions market is segmented into clinical data management systems (CDMS), clinical trial management systems (CTMS), randomization & trial supply management systems, electronic data capture (EDC), electronic clinical outcome assessments (eCOA), electronic patient-reported outcomes (ePRO), clinical analytics platforms, electronic trial master file (ETMF), clinical data integration platforms, safety solutions, and other product types. In 2024, the CDMS segment is expected to account for the largest share of 28.3% of the eClinical solutions market. The large market share of this segment is attributed to the increasing need to sort and manage the huge amount of data generated during clinical trials to gain valuable insights, and the large number of clinical trials performed each year. For instance, in 2022, 12,337 clinical trials were conducted in the Western Pacific, 13,066 in Europe, 11,935 in the Americas, 11,030 in Southeast Asia, 4,593 in the Eastern Mediterranean, and 861 in Africa (Source: World Health Organization).

Based on clinical trial phase, the eClinical solutions market is segmented into Phase I, Phase II, Phase III, and Phase IV. The Phase IV segment is expected to register the highest CAGR during the forecast period 2024-2031. The growth of this segment is attributed to the increasing importance of post-market surveillance, the growing use of real-world data and real-world evidence for the post-market surveillance of drugs, the growing number of drug approvals, and increasing R&D investments from pharmaceutical and biopharmaceutical companies.

Based on end user, the eClinical solutions market is segmented into pharmaceutical & biopharmaceutical companies, clinical research organizations, medical device manufacturers, and other end users. The clinical research organizations segment is expected to register the highest CAGR during the forecast period. The segment's growth is driven by pharmaceutical & biopharmaceutical companies' increasing outsourcing to clinical research organizations and their rising focus on R&D activities for drug discovery and development and the adoption of advanced technologies among CROs for clinical trial management.

An in-depth analysis of the geographical scenario of the eClinical solutions market provides detailed qualitative and quantitative insights about the five major geographies (North America, Europe, Asia-Pacific, Latin America, and the Middle East & Africa) along with the coverage of major countries in each region. North America is expected to account for the largest share of the global eClinical solutions market in 2024, followed by Europe and Asia-Pacific. Among the U.S. and Canada included in North America, in 2024, the U.S. is expected to account for the largest share of the eClinical solutions market in North America. The large market share of the U.S. is attributed to the presence of clinical trial sponsors, the high adoption of digital solutions in the pharmaceutical industry, the large number of clinical trials conducted each year, and the high adoption of eClinical solutions ranging from data management systems to analytics due to stringent regulatory requirements set by the U.S. FDA.

Key companies operating in the global eClinical solutions market are Dassault Systems S.E. (France), Fountayn (U.S.), Merative L.P. (U.S.), eClinical Solutions LLC (U.S.), Clario (U.S.), eClinicalWorks, LLC (U.S.), IQVIA Inc. (U.S.), Parexel International (MA) Corporation (U.S.), MaxisIT Inc. (U.S.), Signant Health (U.S.), Castor (U.S.), Veeva Systems Inc. (U.S.), and Oracle Corporation (U.S.).

Scope of the Report:

eClinical Solutions Market Assessment-by Product

• Clinical Data Management Systems (CDMS)
• Clinical Trial Management Systems (CTMS)
• Randomization & Trial Supply Management Systems
• Electronic Data Capture (EDC)
• Electronic Clinical Outcome Assessments (eCOA)
• Electronic Patient-reported Outcomes (ePRO)
• Clinical Analytics Platforms
• Electronic Trial Master File (eTMF)
• Clinical Data Integration Platforms
• Safety Solutions
• Other Product Types

(Note: Other product types include regulatory information management systems, electronic consent solutions, and institutional review board systems.)

eClinical Solutions Market Assessment-by Clinical Trial Phase

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

eClinical Solutions Market Assessment-by End User

• Pharmaceutical & Biopharmaceutical Companies
• Clinical Research Organizations
• Medical Device Manufacturers
• Other end Users

(Note: Other end users include consulting companies, academic & research institutes, and hospitals.)

eClinical Solutions Market Assessment-by Geography

• North America
  • U.S.
  • Canada
• Europe
  • Germany
  • France
  • U.K.
  • Italy
  • Spain
  • Switzerland
  • Sweden
  • Netherlands
  • Rest of Europe (RoE)
• Asia-Pacific (APAC)
  • Japan
  • China
  • India
  • South Korea
  • Australia
  • Singapore
  • Rest of Asia-Pacific (RoAPAC)
• Latin America
  • Brazil
  • Mexico
  • Rest of Latin America
• Middle East & Africa

TABLE OF CONTENTS

1. Overview

• 1.1. Market Definition & Scope
• 1.2. Market Ecosystem
• 1.3. Currency & Limitations
• 1.4. Key Stakeholders

2. Research Methodology

• 2.1. Research Approach
• 2.2. Data Collection & Validation Process
  • 2.2.1. Secondary Research
  • 2.2.2. Primary Research/Interviews with Key Opinion Leaders from the Industry
• 2.3. Market Sizing & Forecasting
  • 2.3.1. Market Size Estimation Approach
  • 2.3.2. Growth Forecast Approach
  • 2.3.3. Market Share Analysis
• 2.4. Assumptions for the Study

3. Executive Summary

4. Market Insights

• 4.1. Overview
• 4.2. Factors Affecting Market Growth
  • 4.2.1. Drivers
    • 4.2.1.1 Large Amounts of Data Generated from the Healthcare & Lifesciences Industries
    • 4.2.1.2. Growing Number of Clinical Trials
    • 4.2.1.3. Initiatives Supporting Clinical Research
  • 4.2.2. Restraints
  • 4.22.1. High Costs of Supporting Infrastructure for eClinical Solutions
  • 4.2.3. Opportunities
    • 4.2.3.1. Growing Funding for Medical & Pharmaceutical Research
    • 4.2.3.2. Infrastructure Strengthening Initiatives in the Healthcare Sector
    • 4.2.3.3. Growing Demand for Precision Medicine
  • 4.2.4. Challenges
    • 4.2.4.1. Data Security Concerns
    • 4.2.4.2. Low Awareness Regarding Data Systems in Developing Countries
• 4.3. Trends
  • 4.3.1. Integration of Artificial Intelligence and Machine Learning
  • 4.3.2. Decentralized Clinical Trials
• 4.4. Factors Analysis
• 4.5. Regulatory Analysis
• 4.6. Case Studies/Use Cases

5. eClinical Solutions Market Assessment-by Product

• 5.1. Overview
• 5.2. Clinical Data Management Systems (CDMS)
• 5.3. Clinical Trial Management Systems (CTMS)
• 5.4. Randomization & Trial Supply Management Systems
• 5.5. Electronic Data Capture (EDC)
• 5.6. Electronic Clinical Outcome Assessments (eCOA)
• 5.7. Electronic Patient-reported Outcomes (ePRO)
• 5.8. Clinical Analytics Platforms
• 5.9. Electronic Trial Master File (eTMF)
• 5.10. Clinical Data Integration Platforms
• 5.11. Safety Solutions
• 5.12. Other Product Types

6. eClinical Solutions Market Assessment-by Clinical Trial Phase

• 6.1. Overview
• 6.2. Phase I
• 6.3. Phase II
• 6.4. Phase III
• 6.5. Phase IV

7. eClinical Solutions Market Assessment-by End User

• 7.1. Overview
• 7.2. Pharmaceutical & Biopharmaceutical Companies
• 7.3. Clinical Research Organizations
• 7.4. Medical Device Manufacturers
• 7.5. Other End Users

8. eClinical Solutions Market Assessment-by Geography

• 8.1. Overview
• 8.2. North America
  • 8.2.1. U.S.
  • 8.2.2. Canada
• 8.3. Europe
  • 8.3.1. Germany
  • 8.3.2. France
  • 8.3.3. U.K.
  • 8.3.4. Italy
  • 8.3.5. Spain
  • 8.3.6. Switzerland
  • 8.3.7. Netherlands
  • 8.3.8. Sweden
  • 8.3.9. Rest of Europe
• 8.4. Asia-Pacific
  • 8.4.1. China
  • 8.4.2. India
  • 8.4.3. Japan
  • 8.4.4. South Korea
  • 8.4.5. Australia
  • 8.4.6. Rest of Asia-Pacific
• 8.5. Latin America
• 8.6. Brazil
• 8.7. Mexico
• 8.8. Rest of Latin America
• 8.6. Middle East & Africa

9. Competition Analysis

• 9.1. Overview
• 9.2. Key Growth Strategies
• 9.3. Competitive Benchmarking
• 9.4. Competitive Dashboard
  • 9.4.1. Industry Leaders
  • 9.4.2. Market Differentiators
  • 9.4.3. Vanguards
  • 9.4.4. Emerging Companies
• 9.5. Market Share Analysis/Market Rankings of Key Players (2023)

10. Company Profiles (Business Overview, Financial Overview, Product Portfolio, Strategic Developments, and SWOT Analysis*)

• 10.1. Dassault Systems S.E.
• 10.2. Fountayn
• 10.3. Merative L.P.
• 10.4. eClinical Solutions LLC
• 10.5. Clario (ERT and Bioclinica)
• 10.6. eClinicalWorks, LLC
• 10.7. IQVIA Inc.
• 10.8. Parexel International (MA) Corporation
• 10.9. MaxisIT Inc.
• 10.10. Signant Health
• 10.11. Castor
• 10.12. Veeva Systems Inc.
• 10.13. Oracle Corporation

(Note*: SWOT analysis will be provided for the top 5 companies.)

11. Appendix

• 11.1. Available Customization
• 12.2. Related Reports