eClinical 솔루션 시장 예측(-2030년) : 제품별, 제공 형태별, 임상시험 단계별, 사용자 디바이스별, 최종사용자별, 지역별 세계 분석

According to Stratistics MRC, the Global eClinical Solutions Market is accounted for $9.5 billion in 2023 and is expected to reach $25.6 billion by 2030 growing at a CAGR of 15.2% during the forecast period. Clinical research is intended to be revolutionized by e-clinical solutions. In order to treat patients more promptly, the clinical management organization is working to enhance the clinical research data's efficacy, efficiency, and accessibility. The goal of developing e-clinical solutions was to identify the issues with clinical research data, provide innovative fixes, and make clinical trial data easily accessible and valuable. It also aimed to streamline the standardization, reporting, and functioning of the clinical research area.

According to ClinicalTrials.gov, as of March 2023, 443,933 studies were listed in 221 countries, out of which 342,633 were interventional studies and 99,578 observational studies. According to the data updated by the National Institute of Health in March 2023, the estimated research funding for clinical trials and supportive activities in the United States in 2022 was USD 6.6 billion, and it is expected to rise to USD 6.8 billion in 2023.

Market Dynamics:

Driver:

Growing adoption of electronic health records

EHRs provide a centralized repository of patient health information, offering valuable data that can be leveraged for clinical research purposes. eClinical solutions that integrate seamlessly with EHR systems enable efficient data collection, patient recruitment, and monitoring throughout the clinical trial lifecycle. By bridging the gap between clinical care and research, these integrated solutions facilitate access to patient populations, accelerate study start-up timelines, and improve the accuracy and completeness of clinical trial data. Moreover, the ability to extract structured data from EHRs enhances data quality and reduces manual data entry errors, ultimately leading to more efficient and cost-effective clinical trials.

Restraint:

High implementation costs

Implementing eClinical solutions entails substantial upfront investments in software licenses, hardware infrastructure, customization, and staff training. These costs can be prohibitive for organizations operating on constrained budgets, deterring them from embracing eClinical technologies. Ongoing maintenance, support, and subscription fees further contribute to the total cost of ownership, exacerbating financial burdens over time. However, the complexity of eClinical solutions and the need for specialized expertise for implementation and customization also contribute to higher costs.

Opportunity:

Increasing globalization of clinical trials

The increasing globalization of clinical trials serves as a significant driver for the eClinical solutions market, as it necessitates efficient data management and collaboration tools across diverse geographic regions. With clinical trials expanding to encompass a broader range of patient populations and healthcare settings worldwide, eClinical solutions provide centralized platforms for data collection, management, and analysis, facilitating seamless collaboration among global trial sites and stakeholders. Additionally, these solutions enable real-time access to study data, streamlining communication and decision-making processes across international teams.

Threat:

Complex regulatory landscape

Clinical trials are subject to stringent regulations imposed by various regulatory bodies such as the FDA (Food and Drug Administration) in the United States and the EMA (European Medicines Agency) in Europe. Navigating these regulations, which encompass data privacy, security, and reporting standards, requires significant resources, expertise, and time. Compliance with evolving regulatory requirements adds complexity to the implementation and operation of eClinical solutions, as organizations must ensure that their systems meet the latest standards.

Covid-19 Impact:

As clinical trials faced disruptions due to lockdowns and restrictions on in-person interactions, there was a heightened demand for remote monitoring, virtual trials, and digital data capture solutions offered by eClinical platforms. The pandemic underscored the importance of real-time data access and analysis, driving the adoption of eClinical solutions for faster decision-making and regulatory compliance. These disruptions can include delays in the procurement of necessary hardware and software components due to manufacturing slowdowns or interruptions. Moreover, the COVID-19 pandemic has highlighted vulnerabilities in supply chains, prompting companies to reassess and diversify their sourcing strategies.

The clinical data integration platforms segment is expected to be the largest during the forecast period

With the increasing complexity and volume of clinical data generated, there is a growing demand for streamlined solutions that can efficiently consolidate and harmonize disparate datasets. Clinical Data Integration Platforms segment is projected to witness largest share in the eClinical Solutions Market throughout the domination period. Clinical Data Integration Platforms not only facilitate seamless data interoperability but also enable advanced analytics, real-time insights, and improved decision-making in clinical research and healthcare delivery. Furthermore, the integration of artificial intelligence (AI) and machine learning (ML) technologies into these platforms enhances their capabilities for predictive analytics, personalized medicine, and clinical trial optimization.

The smart phone segment is expected to have the highest CAGR during the forecast period

Smart Phone segment is expected to have the highest CAGR during the forecast period as it offers a ubiquitous platform for accessing, collecting, and transmitting healthcare data, making them instrumental in driving the adoption of eClinical solutions. Through dedicated mobile applications, patients can conveniently participate in remote clinical trials, report symptoms, adhere to medication schedules, and communicate with healthcare providers in real-time. Moreover, smartphones equipped with sensors and peripherals enable the collection of continuous health data, such as heart rate, activity levels, and sleep patterns, enhancing the richness and granularity of clinical research data. This integration of smartphones into eClinical solutions not only improves patient engagement and data quality but also enhances the efficiency and scalability of clinical trials.

Region with largest share:

Due to the rapid urbanization and expanding healthcare infrastructure across countries like China, India, and Japan are fueling demand for advanced clinical research technologies to support the burgeoning healthcare needs of their populations, Asia Pacific region commanded the largest share of the market over the extrapolated period. The increasing prevalence of chronic diseases and infectious ailments in the region has heightened the importance of efficient clinical trials and data management solutions for drug development and healthcare delivery. Additionally, favorable government initiatives and regulations aimed at promoting clinical research and innovation are encouraging the adoption of eClinical solutions among pharmaceutical companies, contract research organizations (CROs), and healthcare providers.

Region with highest CAGR:

Europe region is poised to hold profitable growth throughout the forecast period. Europe's robust infrastructure and well-established regulatory framework make it an attractive destination for pharmaceutical companies and clinical research organizations (CROs) to set up state-of-the-art laboratories. These advanced facilities enable efficient conduct of clinical trials, including the collection, analysis, and management of vast amounts of clinical data. Moreover, advancements in laboratory technologies, such as high-throughput screening, next-generation sequencing, and biomarker analysis, are facilitating more precise and personalized approaches to clinical research and drug development.

Key players in the market

Some of the key players in eClinical Solutions market include Medidata Solution, OmniComm Systems, Oracle Corp, ERT Clinical, CRF Health, PAREXEL International, IBM Watson Health, Dassault Systems, Saama Technologies, INC and Veeva Systems.

Key Developments:

In December 2023, ObvioHealth launched an innovative eCOA solution, integrating scientific and clinical services with advanced study design technology for robust trial outcomes.

In October 2023, a major provider of life science solutions announced the collaboration with the full-service CRO "Atherion Bioresearch". The strategic partnership aims to enhance the opportunities for organizations to increase and streamline processes, grow, and improve data integrity.

In October 2023, Almac Clinical Technologies announced the partnership with Exostar aiming to assist the risk associated with the intellectual property. According to the collaboration, the organizations will come to provide Federated Authentication Access and Single Sign-On (SSO) to eClinical applications for supporting clinical trials which also includes Interactive Response Technology (IRT).

In October 2023, a healthcare technology organization "Madnet" launched the latest software release having (eConsent) electronic consent capabilities in the iMednet eClinical platform. The launch was designed to generate a cost-effective, simple, and general method to collect and store participants' consent for fulfilling the virtual, hybrid, and decentralized clinical trials.

In June 2023, ICON plc announced the latest release of its Digital Platform, supporting seamless integration of site, sponsor, and patient services with harmonized data delivery. The platform is customizable for various therapeutic areas and study designs, offering end-to-end solutions for patient services in clinical trials, including a user-friendly mobile app, direct data capture for in-home services, eCOA, telehealth visits, eConsent, and digital health technology management.

In June 2023, Syneos Health collaborated with uMotif Limited, leveraging an advanced digital platform that incorporates robust Electronic Clinical Outcome Assessment (eCOA) and Electronic Patient-reported Outcomes (ePRO) capabilities. This partnership aims to accelerate the pace of clinical trials, expediting the delivery of groundbreaking medications to patients more efficiently.

In May 2023, eClinical Solutions LLC. announced the expansion of its machine learning (ML) and artificial intelligence (AI) capabilities within the elluminate IQ offering. Data management teams can take advantage of these cutting-edge ML/AL capabilities to conduct data review more efficiently and scalable.

In April 2023, the Medidata subsidiary of Dassault Systemes announced Lambda Therapeutics is deploying Medidata's cloud-based clinical products, Rave EDC, Rave RTSM, and Rave Imaging, according to a statement from Dassault Systemes subsidiary Medidata. Automating and optimizing data management operations and securely delivering higher-quality data for quicker insights will further improve clinical trial productivity. This has aided the business in promoting its offerings across the globe.

In March 2023, Clario has launched a cloud-based Image Viewer tool that helps the Sponsors and CROs to see the images of their clinical trials. Previously, several organizations had to participate in the image transfer procedure to see photos for a clinical trial.

Products Covered:

• Clinical Trial Data Management Systems
• Electronic Data Capture
• Randomization and Trial Supply Management
• Clinical Data Integration Platforms
• Electronic Trial Master File Systems
• Regulatory Information Management Solutions
• Other Products

Delivery Modes Covered:

• Licensed Enterprise (On- Premises) Solutions
• Cloud-Based (SAAS) Solutions
• Web- hosted (On- demand) Solutions
• Other Delivery Modes

Clinical Trial Phases Covered:

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

User Devices Covered:

• Smart Phone
• Desktop
• Tablet
• Other User Devices

End Users Covered:

• Contract Research Organizations
• Pharmaceutical and Biopharmaceutical Companies
• Medical Device Manufacturers
• Consulting Service Companies
• Hospitals
• Other End Users

Regions Covered:

• North America
  • US
  • Canada
  • Mexico
• Europe
  • Germany
  • UK
  • Italy
  • France
  • Spain
  • Rest of Europe
• Asia Pacific
  • Japan
  • China
  • India
  • Australia
  • New Zealand
  • South Korea
  • Rest of Asia Pacific
• South America
  • Argentina
  • Brazil
  • Chile
  • Rest of South America
• Middle East & Africa
  • Saudi Arabia
  • UAE
  • Qatar
  • South Africa
  • Rest of Middle East & Africa

What our report offers:

• Market share assessments for the regional and country-level segments
• Strategic recommendations for the new entrants
• Covers Market data for the years 2021, 2022, 2023, 2026, and 2030
• Market Trends (Drivers, Constraints, Opportunities, Threats, Challenges, Investment Opportunities, and recommendations)
• Strategic recommendations in key business segments based on the market estimations
• Competitive landscaping mapping the key common trends
• Company profiling with detailed strategies, financials, and recent developments
• Supply chain trends mapping the latest technological advancements

Free Customization Offerings:

All the customers of this report will be entitled to receive one of the following free customization options:

• Company Profiling
  • Comprehensive profiling of additional market players (up to 3)
  • SWOT Analysis of key players (up to 3)
• Regional Segmentation
  • Market estimations, Forecasts and CAGR of any prominent country as per the client's interest (Note: Depends on feasibility check)
• Competitive Benchmarking
  • Benchmarking of key players based on product portfolio, geographical presence, and strategic alliances

Table of Contents

1 Executive Summary

2 Preface

• 2.1 Abstract
• 2.2 Stake Holders
• 2.3 Research Scope
• 2.4 Research Methodology
  • 2.4.1 Data Mining
  • 2.4.2 Data Analysis
  • 2.4.3 Data Validation
  • 2.4.4 Research Approach
• 2.5 Research Sources
  • 2.5.1 Primary Research Sources
  • 2.5.2 Secondary Research Sources
  • 2.5.3 Assumptions

3 Market Trend Analysis

• 3.1 Introduction
• 3.2 Drivers
• 3.3 Restraints
• 3.4 Opportunities
• 3.5 Threats
• 3.6 Product Analysis
• 3.7 End User Analysis
• 3.8 Emerging Markets
• 3.9 Impact of Covid-19

4 Porters Five Force Analysis

• 4.1 Bargaining power of suppliers
• 4.2 Bargaining power of buyers
• 4.3 Threat of substitutes
• 4.4 Threat of new entrants
• 4.5 Competitive rivalry

5 Global eClinical Solutions Market, By Product

• 5.1 Introduction
• 5.2 Clinical Trial Data Management Systems
• 5.3 Electronic Data Capture
• 5.4 Randomization and Trial Supply Management
• 5.5 Clinical Data Integration Platforms
• 5.6 Electronic Trial Master File Systems
• 5.7 Regulatory Information Management Solutions
• 5.8 Other Products

6 Global eClinical Solutions Market, By Delivery Mode

• 6.1 Introduction
• 6.2 Licensed Enterprise (On- Premises) Solutions
• 6.3 Cloud-Based (SAAS) Solutions
• 6.4 Web- hosted (On- demand) Solutions
• 6.5 Other Delivery Modes

7 Global eClinical Solutions Market, By Clinical Trial Phase

• 7.1 Introduction
• 7.2 Phase II
• 7.3 Phase I
• 7.4 Phase IV
• 7.5 Phase III

8 Global eClinical Solutions Market, By User Device

• 8.1 Introduction
• 8.2 Smart Phone
• 8.3 Desktop
• 8.4 Tablet
• 8.5 Other User Devices

9 Global eClinical Solutions Market, By End User

• 9.1 Introduction
• 9.2 Contract Research Organizations
• 9.3 Pharmaceutical and Biopharmaceutical Companies
• 9.4 Medical Device Manufacturers
• 9.5 Consulting Service Companies
• 9.6 Hospitals
• 9.7 Other End Users

10 Global eClinical Solutions Market, By Geography

• 10.1 Introduction
• 10.2 North America
  • 10.2.1 US
  • 10.2.2 Canada
  • 10.2.3 Mexico
• 10.3 Europe
  • 10.3.1 Germany
  • 10.3.2 UK
  • 10.3.3 Italy
  • 10.3.4 France
  • 10.3.5 Spain
  • 10.3.6 Rest of Europe
• 10.4 Asia Pacific
  • 10.4.1 Japan
  • 10.4.2 China
  • 10.4.3 India
  • 10.4.4 Australia
  • 10.4.5 New Zealand
  • 10.4.6 South Korea
  • 10.4.7 Rest of Asia Pacific
• 10.5 South America
  • 10.5.1 Argentina
  • 10.5.2 Brazil
  • 10.5.3 Chile
  • 10.5.4 Rest of South America
• 10.6 Middle East & Africa
  • 10.6.1 Saudi Arabia
  • 10.6.2 UAE
  • 10.6.3 Qatar
  • 10.6.4 South Africa
  • 10.6.5 Rest of Middle East & Africa

11 Key Developments

• 11.1 Agreements, Partnerships, Collaborations and Joint Ventures
• 11.2 Acquisitions & Mergers
• 11.3 New Product Launch
• 11.4 Expansions
• 11.5 Other Key Strategies

12 Company Profiling

• 12.1 Medidata Solution
• 12.2 OmniComm Systems
• 12.3 Oracle Corp
• 12.4 ERT Clinical
• 12.5 CRF Health
• 12.6 PAREXEL International
• 12.7 IBM Watson Health
• 12.8 Dassault Systems
• 12.9 Saama Technologies, INC
• 12.10 Veeva Systems