eClinical 솔루션 시장 평가 : 제품별, 제공 방식별, 임상시험 단계별, 최종 사용자별, 지역별, 기회 및 예측(2017-2031년)

Global eClinical solutions market is projected to witness a CAGR of 13.11% during the forecast period 2024-2031, growing from USD 10.01 billion in 2023 to USD 26.81 billion in 2031. The market is expected to grow in the forecast period due to several underlying factors.

The term "eClinical solutions" describes the use of technology in clinical research to organize and evaluate clinical data. These methods aid in streamlining the clinical trial procedure, increasing its speed, effectiveness, and accuracy. Among these systems are electronic patient-reported outcomes (ePRO), randomization and trial supply management (RTSM), electronic data capture (EDC), and clinical trial management systems (CTMS). The market is expanding mostly due to the growing need for technologically sophisticated clinical trial management systems. Accordingly, the market is being positively impacted by the quick uptake of EDC and clinical data management system CDMS systems, as well as the expanding need for telemedicine and remote patient monitoring. In addition, the market is being stimulated by an increasing number of clinical trials and a growing demand for fast medical treatment. Apart from this, the market is being driven by the increasing need for precise and dependable data and the regulatory scrutiny over developing clinical trial data. Moreover, by avoiding paper-based procedures and reducing the need for human data entry, eClinical solutions can lower the expenses related to clinical trial management. It is anticipated that this will further fuel the market's expansion. In addition, the industry is benefiting from the growing significance of patient-centric studies and the fast adoption of cloud-based solutions. Furthermore, the industry is being strengthened by the increasing integration of artificial intelligence (AI) and machine learning (ML) algorithms to find patterns and trends in data and enhance decision-making. Additional factors propelling the market include the biopharmaceutical industries' notable expansion, the rise in chronic disease prevalence, the aging population, the growing use of smart medical devices, and ongoing infrastructure improvements in the healthcare system. For instance, Obvio Health USA, Inc. unveiled a cutting-edge electronic clinical outcome assessment (eCOA) solution in December 2023 that combines clinical and scientific services with cutting-edge study design technology to produce reliable trial results. Technology plays a major role in facilitating eCOA. Study schedules can be expedited, and outcomes capture can be simplified with its assistance. However, technology is only one element of an effective eCOA plan. One can only truly attain patient centricity and present better evidence when combined with smart, scientific study design and compassionate patient assistance.

Increasing Complexity of Clinical Trials Leading to Market Expansion

The market for eClinical solutions is growing at a substantial rate, mostly due to the increasing complexity of clinical trials. Sophisticated data management and analysis technologies are required for the complex procedures, heterogeneous patient groups, and multidimensional regulatory requirements of modern clinical trials. These needs are met by eClinical solutions, which include electronic patient-reported outcomes (ePRO), clinical trial management systems (CTMS), and electronic data capture (EDC). These solutions improve data accuracy, streamline data collection, and increase regulatory compliance. Managing massive volumes of data from several sources, such as wearables, electronic health records (EHR), and genomic data, gets harder as clinical trials get more complicated. eClinical solutions provide integrated systems that enable real-time monitoring and seamless data integration, leading to more effective trial management and quicker decision-making.

This efficiency is essential for pharmaceutical companies hoping to shorten the time it takes to bring new treatments to market since it will eventually save money and enhance patient outcomes..

Furthermore, because modern clinical trials are conducted worldwide, it is imperative to find solutions that can function in many regulatory environments and geographical locations. eClinical solutions offer the scale and adaptability required to oversee international trials, guaranteeing regulatory compliance and uniform data standards at every trial location. Further increasing demand for eClinical solutions is owed to the COVID-19 pandemic, which has led to the rising adoption of remote and decentralized trial methodologies. By providing digital data collection, telemedicine consultations, and remote patient monitoring, these technologies facilitate virtual trial designs and ensure trial continuity even times of disruptions. In summary, the escalating complexity of clinical trials is propelling the growth of the eClinical solutions market by demanding more advanced, integrated, and flexible data management and analysis tools, which in turn enhance trial efficiency, compliance, and overall success.

For instance, the most recent version of ICON plc's Digital Platform, which facilitates the smooth integration of sponsor, site, and patient services with harmonized data delivery, was unveiled in June 2023. The platform is adaptable for a range of therapeutic areas and study designs, offering end-to-end solutions for patient services in clinical trials. Features include an easy-to-use mobile app, direct data capture for in-home services, eCOA, telehealth visits, eConsent, and digital health technology management.

Growth in Market Due to Adoption of Web-based eClinical Solutions

The eClinical solutions market is growing at a substantial rate due to the use of web-based eClinical solutions. These technologies provide several advantages over conventional techniques, such as using the Internet to facilitate and streamline clinical trials. One of the most important benefits is improved data management. Real-time data access and capture are made possible by web-based eClinical solutions, which increase data handling efficiency and accuracy. Additionally, its real-time capabilities speed up decision-making, allowing faster trial modifications and results. Web-based platforms also provide better flexibility and scalability. They can be easily expanded and updated to meet the needs of both big international trials and small-scale investigations, regardless of the size and complexity of the trials. This flexibility is essential as clinical studies get bigger and more complex. Another driving force is cost-effectiveness; web-based solutions save operating costs by avoiding the need for manual processes and physical infrastructure. Due to their low cost, more organizations, including academic institutions and smaller biotech firms, can afford to use modern eClinical tools, expanding the industry. Furthermore, these solutions improve stakeholder collaborations as well. Trial operations are more unified and well-coordinated when sponsors, investigators, and regulatory agencies can exchange information and interact with ease. This cooperative setting encourages creativity and speeds up the creation of novel treatments. Web-based eClinical solutions are becoming increasingly popular as a result of the increased focus on patient-centric approaches in clinical research. These solutions provide virtual trials and remote monitoring, which improve patient convenience and boost recruitment and retention rates. Overall, the integration of web-based eClinical solutions into the clinical trial process is driving market growth by offering efficiency, scalability, cost savings, and improved collaboration, thereby transforming the landscape of clinical research. The extension of eClinical Solutions LLC.'s ML and AI capabilities within the elluminate IQ platform was announced in May 2023. These state-of-the-art ML/AL capabilities allow data management teams to conduct more scalable and efficient data reviews.

Increasing Dominance of Clinical Data Management Segment Leading to Market Growth

A crucial stage in clinical research is clinical data management (CDM), which produces high-quality, dependable, and statistically sound data from clinical trials. This contributes to a significant reduction in the time taken between drug development and marketing. The integration of the CDM with supply management, trial, clinical randomization, and patient recruiting systems is a key trend propelling this market. Additionally, businesses are improving their current eClinical technologies to increase their functionality and make conducting clinical trials an easy process. Furthermore, considering the complexity of data management procedures in clinical trials for diabetes and the pervasive use of information technologies, a study published in the Journal of Healthcare Engineering in February 2022 states that the use of clinical data management systems in these trials appears inevitable. Software that helps with data management during clinical trials and reduces the chances of errors that might happen when data is manipulated manually. Over the course of the projection period, it is expected that the advantages of clinical data management in clinical trials will propel segment expansion. Furthermore, significant market players' developments are fostering segment growth.

For instance, Veeva Systems Inc. stated in February 2022 that Idorsia Pharmaceuticals Ltd. had added Veeva Vault CDM for electronic data capture (EDC) and coding to its list of applications using Veeva Vault Clinical Suite.

Asia-Pacific to Dominate the eClinical Solutions Market

Due to significant unmet medical requirements and the increased prevalence of chronic diseases like cancer, cardiovascular problems, and infectious diseases, Asia-Pacific is expected to achieve promising growth throughout the projection period. Owing to their vast patient populations and low costs, China, India, Korea, and Japan are seeing an increase in the number of studies that are outsourced to them. Government funding for drug development and research is a major factor driving the growth of the Asia-Pacific market, which is expected to continue to rise over the projected period despite being an emerging economy.

The Ministry of Health and Family Welfare (MoHFW) in India received an allocation of USD 10.5 billion (INR 86,201 crore) for 2022-2023; of which, the Department of Health Research in India received USD 391 million (INR 3,201 crore) for research purposes in 2022, according to data published by the Policy Research Studied (PRS) Legislative Research. As a result, an increase in government financing for medical development and research is driving up market growth overall. The advancements made by different industry participants are also contributing to the expansion of the market. One of the top Japanese clinical trial companies, 3H Medi Solution Inc., announced in February 2023 that it had chosen THREAD research to increase decentralized research capacity and enhance patient access to clinical research in Japan. THREAD's tested technology platform and advisory services, along with 3H Medi Solution Inc.'s extensive recruitment, home visit assistance, and general clinical research delivery skills, provide clients with improved options. Such technological advancements in the region lead to growth and fuel market expansion.

Future Market Scenario (2024-2031F)

The global eClinical solutions market, which is growing in significance as the healthcare industry undergoes a digital transformation, is influencing the direction of clinical research and patient care in the future. eClinical technologies, which combine state-of-the-art data analytics, cloud computing, and innovative software platforms, are revolutionizing clinical trials, increasing data accuracy, and speeding up the drug development process. The main factors contributing to the anticipated growth of the eClinical solutions market are the increasing complexity of clinical trials and the rising problems associated with data management. Not only this, but the rising adoption of cloud-based and web-based solutions is a significant factor contributing to the growth of this market in the forecast period. Players in this market are expanding at an unparalleled rate, introducing cost-effective and efficient technologies. In January 2023, oral dosage form-focused contract development and manufacturing organization (CDMO) Adare Pharma Solutions selected Veeva Systems Inc.'s Veeva Vault Quality Suite to standardize quality systems throughout the entire enterprise.

Key Players Landscape and Outlook

Several companies, such as Oracle Corporation, Dassault Systemes, Parexel International Corporation, Clario, ICON plc, Signant Health, MaxisIT Inc., 4G Clinical, Veeva Systems Inc., eClinical Solutions LLC, etc., are expanding their businesses by planning and adopting new strategies. They are complying with new strategic initiatives regarding the launches of newly developed eClinical solutions to help researchers and strengthen their presence in the market. New product launches, agreements based on contracts, acquisitions and mergers, investments, and partnerships are a few ways through which they are trying to achieve the same.

For instance, Syneos Health and uMotif Limited partnered in June 2023, utilizing a cutting-edge digital platform with strong electronic clinical outcome assessment (eCOA) and electronic patient-reported outcomes (ePRO) functionalities. Through this collaboration, clinical trials will become quicker, leading to more effective patient delivery of innovative drugs.

Table of Contents

1. Research Methodology

2. Project Scope and Definitions

3. Executive Summary

4. Global eClinical Solutions Market Outlook, 2017-2031F

• 4.1. Market Size & Forecast
  • 4.1.1. By Value
• 4.2. By Product
  • 4.2.1. Clinical Data Management Systems (CDMS)
  • 4.2.2. Clinical Trial Management Systems (CTMS)
  • 4.2.3. Randomization and Trial Supply Management
  • 4.2.4. Electronic Data Capture (EDC)
  • 4.2.5. Electronic Clinical Outcome Assessments (eCOA)
  • 4.2.6. Electronic Patient-reported Outcomes (ePRO)
  • 4.2.7. Clinical Analytics Platforms
  • 4.2.8. Electronic Trial Master File (eTMF)
  • 4.2.9. Others
• 4.3. By Mode of Delivery
  • 4.3.1. Web-Hosted Models
  • 4.3.2. Licenced-Enterprise Models
  • 4.3.3. Cloud-Based Solutions
• 4.4. By Clinical Trial Phase
  • 4.4.1. Phase I
  • 4.4.2. Phase II
  • 4.4.3. Phase III
  • 4.4.4. Phase IV
• 4.5. By End-user
  • 4.5.1. Pharmaceutical and Biopharmaceutical Companies
  • 4.5.2. Contract Research Organisations
  • 4.5.3. Others
• 4.6. By Region
  • 4.6.1. North America
  • 4.6.2. Europe
  • 4.6.3. Asia-Pacific
  • 4.6.4. South America
  • 4.6.5. Middle East and Africa
• 4.7. By Company Market Share (%), 2023

5. Global eClinical Solutions Market Outlook, By Region, 2017-2031F

• 5.1. North America*
  • 5.1.1. Market Size & Forecast
    • 5.1.1.1. By Value
  • 5.1.2. By Product
    • 5.1.2.1. Clinical Data Management Systems (CDMS)
    • 5.1.2.2. Clinical Trial Management Systems (CTMS)
    • 5.1.2.3. Randomization and Trial Supply Management
    • 5.1.2.4. Electronic Data Capture (EDC)
    • 5.1.2.5. Electronic Clinical Outcome Assessments (eCOA)
    • 5.1.2.6. Electronic Patient-reported Outcomes (ePRO)
    • 5.1.2.7. Clinical Analytics Platforms
    • 5.1.2.8. Electronic Trial Master File (eTMF)
    • 5.1.2.9. Others
  • 5.1.3. By Mode of Delivery
    • 5.1.3.1. Web-Hosted Models
    • 5.1.3.2. Licenced-Enterprise Models
    • 5.1.3.3. Cloud-Based Solutions
  • 5.1.4. By Clinical Trial Phase
    • 5.1.4.1. Phase I
    • 5.1.4.2. Phase II
    • 5.1.4.3. Phase III
    • 5.1.4.4. Phase IV
  • 5.1.5. By End-user
    • 5.1.5.1. Pharmaceutical and Biopharmaceutical Companies
    • 5.1.5.2. Contract Research Organisations
    • 5.1.5.3. Others
  • 5.1.6. United States*
    • 5.1.6.1. Market Size & Forecast
      • 5.1.6.1.1. By Value
    • 5.1.6.2. By Product
      • 5.1.6.2.1. Clinical Data Management Systems (CDMS)
      • 5.1.6.2.2. Clinical Trial Management Systems (CTMS)
      • 5.1.6.2.3. Randomization and Trial Supply Management
      • 5.1.6.2.4. Electronic Data Capture (EDC)
      • 5.1.6.2.5. Electronic Clinical Outcome Assessments (eCOA)
      • 5.1.6.2.6. Electronic Patient-reported Outcomes (ePRO)
      • 5.1.6.2.7. Clinical Analytics Platforms
      • 5.1.6.2.8. Electronic Trial Master File (eTMF)
      • 5.1.6.2.9. Others
    • 5.1.6.3. By Mode of Delivery
      • 5.1.6.3.1. Web-Hosted Models
      • 5.1.6.3.2. Licenced-Enterprise Models
      • 5.1.6.3.3. Cloud-Based Solutions
    • 5.1.6.4. By Clinical Trial Phase
      • 5.1.6.4.1. Phase I
      • 5.1.6.4.2. Phase II
      • 5.1.6.4.3. Phase III
      • 5.1.6.4.4. Phase IV
    • 5.1.6.5. By End-user
      • 5.1.6.5.1. Pharmaceutical and Biopharmaceutical Companies
      • 5.1.6.5.2. Contract Research Organisations
      • 5.1.6.5.3. Others
  • 5.1.7. Canada
  • 5.1.8. Mexico

All segments will be provided for all regions and countries covered

• 5.2. Europe
  • 5.2.1. Germany
  • 5.2.2. France
  • 5.2.3. Italy
  • 5.2.4. United Kingdom
  • 5.2.5. Russia
  • 5.2.6. Netherlands
  • 5.2.7. Spain
  • 5.2.8. Turkey
  • 5.2.9. Poland
• 5.3. Asia-Pacific
  • 5.3.1. India
  • 5.3.2. China
  • 5.3.3. Japan
  • 5.3.4. Australia
  • 5.3.5. Vietnam
  • 5.3.6. South Korea
  • 5.3.7. Indonesia
  • 5.3.8. Philippines
• 5.4. South America
  • 5.4.1. Brazil
  • 5.4.2. Argentina
• 5.5. Middle East and Africa
  • 5.5.1. Saudi Arabia
  • 5.5.2. UAE
  • 5.5.3. South Africa

6. Market Mapping, 2023

• 6.1. By Product
• 6.2. By Mode of Delivery
• 6.3. By Clinical Trial Phase
• 6.4. By End-user
• 6.5. By Region

7. Macro Environment and Industry Structure

• 7.1. Demand Supply Analysis
• 7.2. Value Chain Analysis
• 7.3. PESTEL Analysis
  • 7.3.1. Political Factors
  • 7.3.2. Economic System
  • 7.3.3. Social Implications
  • 7.3.4. Technological Advancements
  • 7.3.5. Environmental Impacts
  • 7.3.6. Legal Compliances and Regulatory Policies (Statutory Bodies Included)
• 7.4. Porter's Five Forces Analysis
  • 7.4.1. Supplier Power
  • 7.4.2. Buyer Power
  • 7.4.3. Substitution Threat
  • 7.4.4. Threat From New Entrant
  • 7.4.5. Competitive Rivalry

8. Market Dynamics

• 8.1. Growth Drivers
• 8.2. Growth Inhibitors (Challenges and Restraints)

9. Regulatory Framework and Innovation

• 9.1. Patent Landscape
• 9.2. Regulatory Approvals
• 9.3. Innovations/Emerging Technologies

10. Key Players Landscape

• 10.1. Competition Matrix of Top Five Market Leaders
• 10.2. Market Revenue Analysis of Top Five Market Leaders (By Value, 2023)
• 10.3. Mergers and Acquisitions/Joint Ventures (If Applicable)
• 10.4. SWOT Analysis (For Five Market Players)
• 10.5. Patent Analysis (If Applicable)

11. Case Studies

12. Key Players Outlook

• 12.1. Oracle Corporation
  • 12.1.1. Company Details
  • 12.1.2. Key Management Personnel
  • 12.1.3. Products and Services
  • 12.1.4. Financials (As Reported)
  • 12.1.5. Key Market Focus and Geographical Presence
  • 12.1.6. Recent Developments
• 12.2. Dassault Systemes
• 12.3. Parexel International Corporation
• 12.4. Clario
• 12.5. ICON plc
• 12.6. Signant Health
• 12.7. MaxisIT Inc.
• 12.8. 4G Clinical
• 12.9. Veeva Systems Inc.
• 12.10. eClinical Solutions LLC

Companies mentioned above DO NOT hold any order as per market share and can be changed as per information available during research work.

13. Strategic Recommendations

14. About Us & Disclaimer