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市场调查报告书
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2025年全球电子临床结果评估(eCOA)、电子资料来源(eSource)和临床试验市场报告eCOA, eSource And Clinical Trials Global Market Report 2025 |
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近年来,电子临床结果评估 (eCOA)、电子资料来源 (eSource) 和临床试验市场规模呈现强劲成长,预计将从 2024 年的 478.3 亿美元成长至 2025 年的 511.5 亿美元,复合年增长率 (CAGR) 为 6.9%。这一增长可归因于临床试验中电子数据收集的普及、电子临床结果评估 (eCOA) 监管标准的不断完善、移动和可穿戴医疗技术的蓬勃发展、临床试验规模和复杂性的日益增加,以及临床研究中对以患者为中心的理念的重视。
预计未来几年,电子临床结果评估 (eCOA)、电子资料来源 (eSource) 和临床试验市场将保持强劲成长,到 2029 年市场规模将达到 739.9 亿美元,年复合成长率(CAGR)为 9.7%。预测期内的增长可归因于全球临床试验网络的扩张、对实时数据访问和监测需求的不断增长、云端基础的电子临床解决方案的开发、远程和虚拟病患监测解决方案的增长、电子患者报告结果 (ePRO) 的日益普及、对用于持续患者病患监测的可穿戴设备的需求不断增长、用于病人参与的行动医疗应用程序的快速普及,以及用户对中心的生态预测期内的关键趋势包括生态系统解决方案的技术进步、采用区块链技术实现安全透明的临床数据管理、在临床研究中采用人工智慧进行数据分析、将机器学习整合到临床试验中进行预测分析,以及去中心化临床试验生态系统的发展。
电子临床结果评估 (eCOA) 指的是临床试验和各种医疗保健研究环境中,利用电子方法和技术来收集、管理和分析临床结果评估数据。同时,电子资料来源 (eSource) 指的是利用电子系统来收集、管理和储存临床试验过程中产生的资料。临床试验是一项旨在评估新医疗干预措施的安全性、有效性和疗效的研究。透过整合 eCOA 和 eSource,临床试验可以提高资料收集和管理流程的效率、准确性和可靠性。
eCOA、eSource 和临床试验解决方案中包含的关键解决方案包括 eCOA(电子临床结果评估)、eSource、临床试验解决方案和电子资料收集 (EDC)。这些解决方案面向各类最终用户,包括医院、医疗保健提供者、CRO(委外研发机构)、製药、生物技术和医疗设备业,并且可以部署在授权企业(本地部署)和云端基础(SaaS)环境中。
美国在2025年春季突然提高关税及其引发的贸易摩擦,对资讯科技产业,特别是硬体製造、资料基础设施和软体部署领域,产生了重大影响。进口半导体、电路基板和网路设备的关税上涨,推高了高科技公司、云端服务供应商和资料中心的生产和营运成本。在全球范围内采购笔记型电脑、伺服器和消费电子产品零件的公司,面临更长的前置作业时间和价格压力。同时,对专用软体征收的关税以及主要国际市场的报復性措施,扰乱了全球IT供应链,并降低了海外对美国製造技术的需求。为了应对这些挑战,该产业正在加大对国内晶片生产的投资,扩大供应商网络,并利用人工智慧驱动的自动化技术来增强韧性,更有效地控製成本。
这份《电子临床结果评估 (eCOA)、电子资源 (eSource) 和临床试验市场研究报告》是商业研究公司最新报告系列的一部分,提供 eCOA、eSource 和临床试验市场统计数据,例如全球市场规模、区域份额、竞争对手及其市场份额、详细的市场细分、市场趋势和商业机会。这份 eCOA、eSource 和临床试验市场研究报告对该行业的现状和未来发展趋势进行了详细分析,为您提供所需的一切全面观点。
未来五年9.7%的成长率预测较我们先前的预测略微下调了0.2%。这一下调主要是因为美国与其他国家之间的关税影响。关税可能会增加用于分散式临床试验的数位平板电脑和加密行动平台的成本,这些设备通常从东亚供应商进口,从而扰乱临床资料收集流程。此外,由于相互关税以及不断升级的贸易紧张局势和限制措施对全球经济和贸易造成的负面影响,其影响范围也将更加广泛。
预计临床试验数量的激增将推动电子临床结果评估(eCOA)、电子资料来源(eSource)和临床试验市场的成长。临床试验是评估新型医疗干预措施和治疗方法的安全性和有效性的研究,而eCOA和eSource解决方案的应用将使临床试验受益匪浅。 eCOA解决方案利用创新技术收集临床结果数据,取代了传统的纸本病患报告结果。例如,美国国家医学图书馆营运的美国临床试验註册机构ClinicalTrials.gov在2023年6月发布的一份报告预测,到2023年,註册试验的数量将达到457,100项,较2020年的362,479项显着增长。对更多临床试验日益增长的需求正在推动eCOA、eSource和临床试验市场的扩张。
云端基础方案的日益普及预计将推动电子临床结果评估 (eCOA)、电子资料来源 (eSource) 和临床试验市场的未来成长。云端基础方案包括程式、储存空间、按需服务、电脑网路以及其他可透过网际网路连接从共用云端运算框架存取的服务。这些解决方案透过促进即时资料撷取、安全储存和远端访问,简化了临床试验中的电子临床结果评估 (eCOA) 和电子资料来源流程,最终优化临床试验效率并确保资料准确性。例如,根据澳洲政府统计机构澳洲统计局 (ABS) 的数据,截至 2022 年 6 月 30 日的一年中,报告采用资讯和通讯技术 (ICT) 的公司数量从截至 2020 年 6 月 30 日的一年中的 69% 增加到 85%,其中 59% 与云端运算相关。因此,云端基础结果评估 (eCOA)、电子资料来源 (eSource) 和临床试验市场成长的因素。
技术进步是推动电子临床结果评估 (eCOA)、电子资料收集 (eSource) 和临床试验市场发展的重要趋势。这些市场的主要企业正积极采用创新技术以保持竞争力。例如,2022 年 5 月,总部位于美国的电子资料撷取解决方案开发商 Clinical Research IO 发布了 CRIO Reviewer,这是业界首个旨在建立完全整合的电子资料收集或电子资料撷取 (EDC) 系统的解决方案。此解决方案利用 CRIO 的基于 Web 的资源技术,简化了 CRIO 电子资料撷取应用程式中收集的资料的审核和编码,从而优化了临床试验中心的临床资料管理工作流程。作为第一个专为临床实验中心流程设计的商用系统,CRIO Reviewer 旨在让临床实验中心更方便地进行即时电子资料撷取。
电子临床结果评估 (eCOA)、电子资料来源 (eSource) 和临床试验市场的主要企业正致力于实施电子健康记录(EHR) 资料来源解决方案,以简化资料收集、提高准确性并优化临床试验流程。 EHR 资料来源解决方案是指一种系统或技术,它能够直接从电子资料来源(例如 EHR)收集、整合和使用健康数据,用于研究、临床试验和监管目的。例如,总部位于美国的 OpenClinica, LLC 于 2022 年 1 月推出了 EHR 资料来源解决方案 OpenClinica Unite。该平台使研究团队能够一键将 EHR 中的患者资料预先填充到电子病例报告表 (eCRF) 中,从而减少手动资料输入时间并最大限度地减少转录错误。 OpenClinica Unite 透过确保电子资料撷取 (EDC) 系统中的资料与 EHR 中的资料相匹配,而无需对这些资料进行来源资料检验(SDV),从而获得更准确、更全面的资料集。
2023年8月,总部位于美国的Sitero LLC收购了Clario的eClinical技术套件,具体金额未揭露。此次收购使Sitero得以整合Clario的电子临床结果评估(eCOA)、电子资料来源(eSource)和临床试验的专业知识,从而扩展了其产品组合。 Clario是一家总部位于美国的科技公司,其创新的eCOA和eSource解决方案正为推动临床试验的发展做出重大贡献。
eCOA、eSource 和临床试验市场的主要企业包括国际商业机器公司、甲骨文公司、美国实验室控股公司、IQVIA 公司、Icon PLC、PPD 公司、Syneos Health 公司、Parexel 国际公司、Medpace Holdings 公司、TransPerfect Life Sciences 公司、Medidata Solutions 公司、Signant Health Private Limiteds、Signant Health 公司、Signant Health Private、Signa 公司公司、Kayentis SAS 公司、YPrime LLC 公司、Clinical Ink 公司、Cloudbyz 公司、Medrio 公司、OpenClinica LLC 公司、Castor EDC 公司和 Clinipace 公司。
2024年,北美是eCOA、eSource和临床试验市场最大的地区。 eCOA、eSource和临床试验市场报告涵盖的地区包括亚太地区、西欧、东欧、北美、南美以及中东和非洲。
eCOA、eSource 和临床试验市场报告涵盖的国家包括澳洲、巴西、中国、法国、德国、印度、印尼、日本、俄罗斯、韩国、英国、美国、义大利、西班牙和加拿大。
电子临床结果评估 (eCOA)、电子资料来源 (eSource) 和临床试验市场包括营业单位提供预先建构评估、即时病患资料和计划文件所获得的收入。市场价值包括服务供应商销售或包含在服务产品中的相关商品的价值。仅包括营业单位之间交易或销售给最终消费者的商品和服务。
Electronic Clinical Outcome Assessment (eCOA) involves employing electronic methods and technologies for the collection, management, and analysis of clinical outcome assessment data in clinical trials and various healthcare research settings. Simultaneously, eSource refers to the utilization of electronic systems to capture, manage, and store data generated during clinical trials. Clinical trials, which are research studies designed to assess the safety, efficacy, and effectiveness of new medical interventions, benefit from the incorporation of eCOA and eSource, enhancing the efficiency, accuracy, and reliability of data collection and management processes.
The primary solution categories encompassed by eCOA, eSource, and clinical trials include eCOA (Electronic Clinical Outcome Assessment), eSource, clinical trial solutions, and electronic data capture (EDC). eCOA, specifically, entails utilizing electronic systems and devices to capture, manage, and analyze patient-reported outcome measures within clinical trials and healthcare settings. This solution can be deployed in both licensed enterprise (on-premise) and cloud-based (SAAS) environments, catering to diverse end users such as hospitals, healthcare providers, Contract Research Organizations (CROs), the pharmaceutical industry, the biotechnology industry, the medical device industry, and others.
Note that the outlook for this market is being affected by rapid changes in trade relations and tariffs globally. The report will be updated prior to delivery to reflect the latest status, including revised forecasts and quantified impact analysis. The report's Recommendations and Conclusions sections will be updated to give strategies for entities dealing with the fast-moving international environment.
The sharp rise in U.S. tariffs and the ensuing trade tensions in spring 2025 are having a significant impact on the information technology sector, especially in hardware manufacturing, data infrastructure, and software deployment. Increased duties on imported semiconductors, circuit boards, and networking equipment have driven up production and operating costs for tech companies, cloud service providers, and data centers. Firms that depend on globally sourced components for laptops, servers, and consumer electronics are grappling with extended lead times and mounting pricing pressures. At the same time, tariffs on specialized software and retaliatory actions by key international markets have disrupted global IT supply chains and dampened foreign demand for U.S.-made technologies. In response, the sector is ramping up investments in domestic chip production, broadening its supplier network, and leveraging AI-powered automation to improve resilience and manage costs more effectively.
The eCOA, eSource and clinical trials market research report is one of a series of new reports from The Business Research Company that provides eCOA, eSource and clinical trials market statistics, including eCOA, eSource and clinical trials industry global market size, regional shares, competitors with a eCOA, eSource and clinical trials market share, detailed eCOA, eSource and clinical trials market segments, market trends and opportunities, and any further data you may need to thrive in the eCOA, eSource and clinical trials industry. This eCOA, eSource and clinical trials market research report delivers a complete perspective of everything you need, with an in-depth analysis of the current and future scenario of the industry.
The ecoa, esource and clinical trials market size has grown strongly in recent years. It will grow from $47.83 billion in 2024 to $51.15 billion in 2025 at a compound annual growth rate (CAGR) of 6.9%. The growth in the historic period can be attributed to adoption of electronic data capture in clinical trials, evolution of regulatory standards for electronic clinical outcome assessments (ecoa), growth of mobile and wearable health technology, increase in complexity and scale of clinical trials, emphasis on patient-centric approaches in clinical research.
The ecoa, esource and clinical trials market size is expected to see strong growth in the next few years. It will grow to $73.99 billion in 2029 at a compound annual growth rate (CAGR) of 9.7%. The growth in the forecast period can be attributed to expansion of global clinical trial networks, rise in demand for real-time data access and monitoring, development of cloud-based eclinical solutions, growth of remote and virtual patient monitoring solutions, increase in the use of electronic patient-reported outcomes, rise in demand for wearables for continuous patient monitoring, surge in adoption of mobile health apps for patient engagement, emphasis on user-friendly and patient-centric ecoa designs. Major trends in the forecast period include technological advancements in esource solutions, adoption of blockchain for secure and transparent clinical data management, adoption of artificial intelligence for data analysis in clinical research, integration of machine learning for predictive analytics in clinical trials, development of decentralized clinical trial ecosystems.
The forecast of 9.7% growth over the next five years reflects a slight reduction of 0.2% from the previous projection. This reduction is primarily due to the impact of tariffs between the US and other countries. Tariffs may disrupt clinical data collection workflows by increasing costs for digital tablets and encrypted mobile platforms used in decentralized clinical trials, often imported from East Asian suppliers. The effect will also be felt more widely due to reciprocal tariffs and the negative effect on the global economy and trade due to increased trade tensions and restrictions.
The anticipated surge in clinical trials is expected to drive the growth of the eCOA, eSource, and clinical trials market. Clinical trials, which are research studies assessing the safety and efficacy of new medical interventions or treatment approaches, can benefit from the use of eCOA and eSource solutions. These technologies enable pharmaceutical companies to expedite trials, conducting them more efficiently within shorter time frames. eCOA solutions replace traditional paper-based patient-reported outcomes by employing innovative technologies for collecting clinical outcome data. For example, a report published on ClinicalTrials.gov in June 2023, a US-based registry of clinical trials run by the United States National Library of Medicine, projects the number of registered studies to reach 457,100 in 2023, a substantial increase from 362,479 in 2020. Thus, the growing demand for more clinical trials is a driving force behind the expansion of the eCOA, eSource, and clinical trials market.
The increasing adoption of cloud-based solutions is poised to propel the future growth of the eCOA, eSource, and clinical trials market. Cloud-based solutions encompass programs, storage spaces, on-demand services, computer networks, and other services accessible through a shared cloud computing framework via an internet connection. These solutions streamline eCOA (electronic Clinical Outcome Assessments) and eSource in clinical trials by facilitating real-time data capture, secure storage, and remote accessibility, ultimately optimizing trial efficiency and ensuring data accuracy. As an example, according to the Australian Bureau of Statistics in June 2023, an Australia-based government agency for statistics, 85% of firms reported employing information and communication technologies (ICTs) for the year ending June 30, 2022, up from 69% during the year ending June 30, 2020, with 59% related to cloud computing. Hence, the increasing adoption of cloud-based solutions is a driving factor for the growth of the eCOA, eSource, and clinical trials market.
Technological advancements constitute a prominent trend gaining traction in the eCOA, eSource, and clinical trials market. Leading companies in these markets are actively engaged in introducing innovative technologies to maintain their competitive positions. For example, in May 2022, Clinical Research IO, a US-based developer of eSource solutions, unveiled CRIO Reviewer, an industry-first solution designed to establish a fully integrated eSource or EDC (electronic data capture) system. This solution facilitates the review and coding of data collected by the CRIO eSource application, utilizing CRIO's web-based resource technology to optimize site workflows in clinical data management. As the first commercial system designed for site processes, CRIO Reviewer aims to make real-time electronic data gathering more accessible for sites.
Major companies in the eCOA, eSource, and clinical trials market are concentrating on introducing electronic health record (EHR) eSource solutions to streamline data collection, enhance accuracy, and improve the efficiency of clinical trial processes. An EHR eSource solution refers to a system or technology that facilitates the direct collection, integration, and use of health data from electronic sources, such as EHRs, for research, clinical trials, and regulatory purposes. For example, in January 2022, OpenClinica, LLC, a US-based company, launched OpenClinica Unite, an EHR eSource solution. This platform allows research teams to pre-populate electronic case report forms (eCRFs) with patient data from EHRs with a single click, reducing the time spent on manual data entry and minimizing transcription errors. By ensuring that the data in the electronic data capture (EDC) system aligns with that in the EHR, OpenClinica Unite removes the need for source data verification (SDV) for those items, resulting in more accurate and comprehensive datasets.
In August 2023, Sitero LLC, a US-based company, acquired Clario's eClinical technology suite for an undisclosed sum. This acquisition enables Sitero to broaden its portfolio by integrating Clario's expertise in electronic Clinical Outcome Assessment (eCOA), eSource, and clinical trials. Clario Co. is a US-based company that significantly contributes to the advancement of clinical trials through its innovative eCOA and eSource solutions.
Major companies operating in the eCOA, eSource and clinical trials market include The International Business Machines Corporation, Oracle Corporation, Laboratory Corporation of America Holdings, IQVIA Inc., Icon PLC, PPD Inc., Syneos Health Inc, Parexel International Corporation, Medpace Holdings Inc., TransPerfect Life Sciences, Medidata Solutions Inc., Signant Health Private Limited, Clario, Advarra Inc., Medable Inc., ArisGlobal LLC, Kayentis SAS, YPrime LLC, Clinical Ink, Cloudbyz Inc., Medrio Inc., OpenClinica LLC, Castor EDC, Clinipace Inc.
North America was the largest region in the eCOA, eSource and clinical trials market in 2024. The regions covered in the ecoa, esource and clinical trials market report are Asia-Pacific, Western Europe, Eastern Europe, North America, South America, Middle East, Africa
The countries covered in the ecoa, esource and clinical trials market report are Australia, Brazil, China, France, Germany, India, Indonesia, Japan, Russia, South Korea, UK, USA, Italy, Spain, Canada.
The eCOA, eSource, and clinical trials markets include revenues earned by entities by providing pre-built assessments, real-time patient data, and project documentation. The market value includes the value of related goods sold by the service provider or included within the service offering. Only goods and services traded between entities or sold to end consumers are included.
The market value is defined as the revenues that enterprises gain from the sale of goods and/or services within the specified market and geography through sales, grants, or donations in terms of the currency (in USD, unless otherwise specified).
The revenues for a specified geography are consumption values that are revenues generated by organizations in the specified geography within the market, irrespective of where they are produced. It does not include revenues from resales along the supply chain, either further along the supply chain or as part of other products.
eCOA, eSource And Clinical Trials Global Market Report 2025 from The Business Research Company provides strategists, marketers and senior management with the critical information they need to assess the market.
This report focuses on ecoa, esource and clinical trials market which is experiencing strong growth. The report gives a guide to the trends which will be shaping the market over the next ten years and beyond.
Where is the largest and fastest growing market for ecoa, esource and clinical trials ? How does the market relate to the overall economy, demography and other similar markets? What forces will shape the market going forward, including technological disruption, regulatory shifts, and changing consumer preferences? The ecoa, esource and clinical trials market global report from the Business Research Company answers all these questions and many more.
The report covers market characteristics, size and growth, segmentation, regional and country breakdowns, competitive landscape, market shares, trends and strategies for this market. It traces the market's historic and forecast market growth by geography.
The forecasts are made after considering the major factors currently impacting the market. These include the technological advancements such as AI and automation, Russia-Ukraine war, trade tariffs (government-imposed import/export duties), elevated inflation and interest rates.