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eClinical 솔루션 시장 - 세계 산업 규모, 점유율, 동향, 기회, 예측, 제품별, 배포 모드별, 개발 단계별, 최종 사용자별, 지역별, 경쟁별(2020-2030년)
eClinical Solutions Market - Global Industry Size, Share, Trends, Opportunity, and Forecast, Segmented By Product, By Delivery Mode, By Development Phase, By End User, By Region and Competition, 2020-2030F
상품코드 : 1807136
리서치사 : TechSci Research
발행일 : 2025년 08월
페이지 정보 : 영문 184 Pages
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한글목차

세계의 eClinical 솔루션 시장 규모는 2024년에 105억 3,000만 달러로 평가되었고, 2030년에는 237억 2,000만 달러에 이를 것으로 예측되며 CAGR은 14.47%를 나타낼 전망입니다.

제약기업, 바이오테크놀러지 기업, 의약품 개발업무 수탁기관(CRO)이 복잡한 임상시험을 보다 효율적으로 관리하기 위해 디지털 툴을 활용하는 경향이 강해지고 있으며, 세계의 eClinical 솔루션 시장은 급속한 변모를 이루고 있습니다. 전자 데이터 수집(EDC), 임상시험 관리 시스템(CTMS), 무작위화 및 시험 약물 공급 관리(RTSM), 전자 환자 보고 결과(ePRO) 등의 e-클리니컬 플랫폼은 중요한 임상시험 데이터에 대한 실시간 액세스 및 규정 준수를 보장하기 위해 현재 널리 도입되고 있습니다. 이러한 솔루션은 의사결정 가속화, 인위적 실수 감소, 시험 결과 개선을 지원하며 최신 임상 연구 환경에서 필수적입니다.

시장 개요
예측 기간 2026-2030년
시장 규모 : 2024년 105억 3,000만 달러
시장 규모 : 2030년 237억 2,000만 달러
CAGR : 2025-2030년 14.47%
급성장 부문 단계 i
최대 시장 북미

주요 시장 성장 촉진요인으로는 제약 및 바이오테크놀러지 기업에 의한 R&D 투자 증가, 고도의 의약품 개발을 필요로 하는 만성질환의 유행, 임상시험의 분산화 등을 들 수 있습니다. 임상 연구에서 환자 확보 및 유지가 여전히 병목 현상이 되고 있는 가운데, eClinical 도구는 원격 모니터링, 웨어러블 통합, 실시간 피드백을 통해 더 나은 환자 참여를 제공합니다. 상호 운용성과 클라우드 기반 플랫폼에 대한 요구 증가는 임상시험 시스템의 확장성과 접근성을 더욱 향상시킵니다. 인공지능과 머신러닝은 데이터 분석 자동화, 임상시험 리스크 식별, 환자 결과 예측에 점점 통합되어 업무 효율성 향상과 임상시험 기간 단축을 실현하고 있습니다.

eClinical 솔루션 시장은 성장에도 불구하고 여러 과제에 직면하고 있습니다. 고급 소프트웨어 솔루션을 구축하고 유지하는 데 드는 비용은 중소규모의 후원자에게 여전히 장벽이 되고 있습니다. 레거시 시스템과 최신 플랫폼 간의 상호 운용성 문제는 종종 디지털 혁신을 지연시킵니다. 데이터 프라이버시와 GDPR(EU 개인정보보호규정), HIPAA, FDA 21 CFR Part 11과 같은 진화하는 규제 프레임워크에 대한 컴플라이언스는 더욱 복잡해지고 있습니다. 임상 연구와 디지털 기술 모두에 익숙한 숙련된 전문가의 부족은 시스템의 전개와 채용을 어렵게 만듭니다. 또한 사이버 보안, 데이터 유출 및 원격 시험 기술의 신뢰성에 대한 우려도 이해관계자의 신뢰에 영향을 미칠 수 있습니다. 시장의 지속적인 성장을 위해서는 표준화, 공급업체 협력, 규제 조화를 중시하고 이러한 과제를 해결하는 것이 필수적입니다.

시장 성장 촉진요인

생명과학 분야에서 R&D 투자 증가

주요 시장 과제

높은 도입 비용과 운영 비용

주요 시장 동향

분산형 임상시험과 가상임상시험의 급성장

목차

제1장 개요

제2장 조사 방법

제3장 주요 요약

제4장 고객의 목소리

제5장 세계의 eClinical 솔루션 시장 전망

제6장 북미의 eClinical 솔루션 시장 전망

제7장 유럽의 eClinical 솔루션 시장 전망

제8장 아시아태평양의 eClinical 솔루션 시장 전망

제9장 남미의 eClinical 솔루션 시장 전망

제10장 중동 및 아프리카의 eClinical 솔루션 시장 전망

제11장 시장 역학

제12장 시장 동향과 발전

제13장 혼란 : 분쟁, 유행, 무역 장벽

제14장 Porter's Five Forces 분석

제15장 경쟁 구도

제16장 전략적 제안

제17장 기업 소개와 면책사항

KTH
영문 목차

영문목차

The Global eClinical Solutions Market was valued at USD 10.53 Billion in 2024 and is expected to reach USD 23.72 Billion by 2030 with a CAGR of 14.47%. The Global eClinical Solutions Market is undergoing rapid transformation as pharmaceutical, biotechnology, and contract research organizations (CROs) increasingly turn to digital tools to manage complex clinical trials more efficiently. As the demand for faster drug development intensifies, companies are seeking solutions that streamline data collection, management, and analysis. eClinical platforms such as electronic data capture (EDC), clinical trial management systems (CTMS), randomization and trial supply management (RTSM), and electronic patient-reported outcomes (ePRO) are now widely implemented to ensure real-time access to critical trial data and regulatory compliance. These solutions help accelerate decision-making, reduce human errors, and improve trial outcomes, making them indispensable in modern clinical research environments.

Market Overview
Forecast Period2026-2030
Market Size 2024USD 10.53 Billion
Market Size 2030USD 23.72 Billion
CAGR 2025-203014.47%
Fastest Growing SegmentPhase I
Largest MarketNorth America

Key market drivers include rising R&D investment by pharmaceutical and biotech companies, growing prevalence of chronic diseases requiring advanced drug development, and the shift toward decentralized clinical trials. As patient recruitment and retention remain persistent bottlenecks in clinical research, eClinical tools provide better patient engagement through remote monitoring, wearable integration, and real-time feedback. The growing need for interoperability and cloud-based platforms further enhances scalability and accessibility of clinical trial systems. Artificial intelligence and machine learning are being increasingly integrated to automate data analytics, identify trial risks, and predict patient outcomes, improving operational efficiency and reducing trial timelines.

Despite its growth, the eClinical Solutions Market faces several challenges. The high cost of implementing and maintaining advanced software solutions continues to be a barrier for small and mid-sized sponsors. Interoperability issues between legacy systems and modern platforms often slow down digital transformation. Data privacy and compliance with evolving regulatory frameworks such as GDPR, HIPAA, and FDA 21 CFR Part 11 add further complexity. A shortage of skilled professionals with expertise in both clinical research and digital technologies makes system deployment and adoption difficult. Concerns around cybersecurity, data breaches, and the reliability of remote trial technologies can also affect stakeholder confidence. Addressing these challenges will be essential for sustained market growth, with emphasis on standardization, vendor collaboration, and regulatory harmonization.

Key Market Drivers

Increased R&D Investment in Life Sciences

Increased R&D investment in the life sciences sector is a key driver accelerating the growth of the Global eClinical Solutions Market. The U.S. government's National Institutes of Health (NIH) allocated nearly USD 48 billion to biomedical and behavioral research in FY 2023, with approximately USD 28 billion dedicated to clinical trials and related activities. This surge reflects a broader trend in rising clinical study volume, complexity, and regulatory rigor, prompting sponsors to adopt eClinical platforms. Tools like Electronic Data Capture (EDC), Clinical Trial Management Systems (CTMS), and electronic Patient-Reported Outcomes (ePRO) systems are now essential for rapid data capture, real-time analytics, and regulatory compliance.

This expansion isn't limited to traditional pharmaceutical companies including academic institutions and biotech startups are also increasingly engaged in clinical research. In FY 2023, U.S. higher education institutions spent over USD 108.8 billion on R&D, an increase of 11.2% over the previous year. Many academic-led Phase I and II trials rely on digital infrastructure for accurate data handling. Global pressures to streamline trial timelines and reduce expenditure mean that digital solutions have become indispensable. Cloud-based systems provide scalable, interoperable environments that support real-time monitoring across multiple geographies, while predictive analytics enhance risk management and operational decision-making. These developments are increasing demand for advanced eClinical platforms capable of integrating with wearable devices, EHR systems, and AI-powered insights.

Real-world evidence (RWE) initiatives and regulatory endorsement of adaptive, patient-centric trial models are further bolstering digital trial technologies. With such robust R&D investment from federal agencies, universities, and private biotechs, it's clear why eClinical solutions are growing so rapidly. As clinical research transforms, digital infrastructure supporting it is expanding in scope and sophistication, firmly establishing the eClinical Solutions Market on a steep growth trajectory.

Key Market Challenges

High Implementation and Operational Costs

High implementation and operational costs represent a significant challenge in the Global eClinical Solutions Market, particularly for small and mid-sized pharmaceutical companies, biotech firms, and academic research institutions. Deploying eClinical platforms such as Clinical Trial Management Systems (CTMS), Electronic Data Capture (EDC), and ePRO tools requires substantial upfront investment in software licensing, customization, validation, and IT infrastructure. These systems often need to be tailored to meet the specific requirements of a trial, which increases complexity and cost. The expense is not limited to initial deployment; it extends to ongoing maintenance, periodic software upgrades, user training, and cybersecurity measures, all of which add to the long-term financial burden.

For organizations operating with limited budgets or conducting fewer trials, justifying such high capital and operational expenditure becomes difficult. The cost of system validation and compliance with global regulatory standards such as 21 CFR Part 11 or GDPR adds another layer of expense. Training clinical staff to operate and manage these platforms can also be resource-intensive, especially in regions with limited access to skilled professionals. Smaller sponsors may opt for less sophisticated or manual processes, which can hinder data accuracy and slow down trial timelines. These cost-related barriers limit the widespread adoption of eClinical technologies and slow down digital transformation across the clinical research ecosystem.

Key Market Trends

Rapid Growth of Decentralized and Virtual Clinical Trials

The rapid growth of decentralized and virtual clinical trials is a defining trend in the global eClinical Solutions Market, reshaping how clinical research is conducted across geographies. Traditional site-based models are increasingly being replaced or supplemented by decentralized approaches that leverage digital technologies to enhance participant access, reduce logistical burdens, and accelerate trial timelines. eClinical platforms have become essential in enabling this shift, offering integrated solutions such as eConsent, electronic patient-reported outcomes (ePRO), wearable device integration, remote monitoring, and telehealth capabilities. These tools allow sponsors and CROs to collect real-time data from diverse patient populations without requiring physical site visits, thereby expanding recruitment and retention rates while minimizing disruptions.

The demand for decentralized trials is driven by the need to improve patient-centricity, increase data reliability, and reduce the high costs associated with on-site trial management. eClinical systems support these objectives by enabling seamless coordination between stakeholders, ensuring protocol compliance, and providing centralized oversight. Cloud-based platforms allow real-time data access and remote monitoring of safety parameters, which are crucial for adaptive trial designs and quick decision-making. Pharmaceutical companies and research organizations are adopting hybrid trial models that combine digital and on-site elements to optimize both operational flexibility and data quality. This growing reliance on decentralized models is reinforcing demand for scalable, interoperable, and secure eClinical technologies.

Key Market Players

Report Scope:

In this report, the Global eClinical Solutions Market has been segmented into the following categories, in addition to the industry trends which have also been detailed below:

eClinical Solutions Market, By Product:

eClinical Solutions Market, By Delivery Mode:

eClinical Solutions Market, By Development Phase:

eClinical Solutions Market, By End User:

eClinical Solutions Market, By Region:

Competitive Landscape

Company Profiles: Detailed analysis of the major companies present in the Global eClinical Solutions Market.

Available Customizations:

Global eClinical Solutions Market report with the given market data, TechSci Research offers customizations according to a company's specific needs. The following customization options are available for the report:

Company Information

Table of Contents

1. Product Overview

2. Research Methodology

3. Executive Summary

4. Voice of Customer

5. Global eClinical Solutions Market Outlook

6. North America eClinical Solutions Market Outlook

7. Europe eClinical Solutions Market Outlook

8. Asia-Pacific eClinical Solutions Market Outlook

9. South America eClinical Solutions Market Outlook

10. Middle East and Africa eClinical Solutions Market Outlook

11. Market Dynamics

12. Market Trends & Developments

13. Disruptions: Conflicts, Pandemics and Trade Barriers

14. Porters Five Forces Analysis

15. Competitive Landscape

16. Strategic Recommendations

17. About Us & Disclaimer

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