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市场调查报告书
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1521791

电子资料撷取系统：市场占有率分析、产业趋势与统计、成长预测（2024-2029）

Electronic Data Capture Systems - Market Share Analysis, Industry Trends & Statistics, Growth Forecasts (2024 - 2029)
出版日期: | 出版商: Mordor Intelligence | 英文 120 Pages | 商品交期: 2-3个工作天内

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简介目录

电子资料撷取系统市场规模预计到2024年为16.6亿美元，预计到2029年将达到29.3亿美元，在预测期内（2024-2029年）复合年增长率预计为12.02%。

电子数据采集系统市场

分散临床试验的增加可能有助于 EDC 系统在医学研究中获得关注。根据 2023 年 4 月发表的一篇论文，大约 68% 的临床试验在大流行期间暂停，这导致虚拟和混合试验模型的采用激增。 EDC 系统在分散式临床试验中发挥关键作用，因为适当的资料管理至关重要。临床试验服务公司正在透过合作和收购来扩大其产品范围。例如，2023 年 7 月，Signant Health 宣布收购 DSG，该公司为分散式和基于现场的临床试验提供了一套直接资料资料技术的电子临床套件。此次收购使该公司能够为任何规模或类型的临床试验提供全面的数位解决方案。因此，新的市场进入者可能会加速现有的竞争力和效率。

美国FDA 等监管机构已向使用 EDC 系统记录临床试验资料的最终用户提出了建议。根据临床实验试验方案，临床试验赞助者必须提供系统的详细描述以及有关係统管理、系统使用人员培训和存取控制的资讯。监管干预使公司能够进行彻底的品质检查并提供安全保障措施来保护资料，从而最大限度地降低产品缺陷的风险。因此，监管合规性和建议鼓励最终用户使用 EDC 系统，从而促进整体市场成长。

然而，系统许可和託管的高昂成本预计将阻碍市场成长。此外，新兴经济体的网路基础设施不发达，这限制了最终用户使用这些系统。

电子资料撷取系统市场趋势

预计网路和云端基础市场将在预测期内占据主要市场占有率

预计云端基础的细分市场将在预测期内占据重要的市场占有率。云端基础的系统是集中式资料库，允许专业人员将云端资料库客製化为本地或特定区域，以遵守本地资料共用法规。这些优势使得研究人员更喜欢云端基础的方法。

资源有限地区的参与者正在与 Amazon Web Services (AWS) 和Oracle等云端供应商合作。例如，总部位于德国的健康科技公司 Climedo Health 使用 AWS 为医院、製药公司、医疗设备製造商和 150 个公共卫生中心开发基于云端基础的可扩展电子资料撷取系统。该公司还于 2022 年 2 月筹集了 570 万美元，以加强其在欧洲电子资料撷取系统市场的地位并扩大其在美国的业务。云端基础的解决方案使公司能够更轻鬆地进行地理扩张，而不会产生额外的产品开发成本。

市场参与者的活动，例如合作、发布和核准扩大电子资料撷取系统的供应，预计将在预测期内推动该行业的成长。 2022年10月， 资料宣布与勃林格殷格翰续签五年合作关係。根据协议， 资料将在全球提供Rave EDC系统，用于勃林格殷格翰的临床试验。

因此，资料的自由流动加上增强的资料保护通讯协定预计将提高网路和基于云端基础的电子资料撷取系统的采用率，从而导致该领域的成长。

预计北美将在预测期内占据主要市场占有率

预计北美在预测期内将占据很大的市场占有率。这是由于增加市场占有率的策略性倡议的增加以及该地区临床试验数量的增加等因素所造成的。

北美在产品开发中采用数位化和实验研究的比例很高。例如，2023 年 7 月，Astra Zeneca、IgniteData 和伦敦大学学院医院 NHS 基金会信託基金 (UCLH) 共同评估了临床试验环境中从电子健康记录(EHR) 到电子资料收集 (EDC) 的资料传输。此次合作的目标之一是扩大 EHR 到 EDC 技术在多个领域的使用。此外，该地区的新兴企业发现资金筹措比其他地区相对容易。例如，2022 年 11 月，美国临床试验软体供应商 YonaLink 宣布提供 600 万美元资金筹措，用于扩展其 EHR 到 EDC 整合平台并提高 CRO 的采用率。透过资金筹措和研究合作带来的投资预计将在预测期内推动该地区的市场成长。

医疗保健参与企业积极参与扩大 EDC 系统在该地区的使用也被认为是市场成长的关键决定因素。例如，根据国家医学图书馆 2022 年 6 月发表的一篇论文，Discovery 重症监护研究网络復原力和应急准备计划 (Discovery PREP) 可以解决美国紧急情况下多中心资料收集的挑战。工具。本研究得出的结论是，EDC 工具对于季节性流感治疗通讯协定的多中心资料收集和评估是可行的。此类研究将促进EDC在各种应用中的使用并扩大市场范围。

因此，由于上述各参与者透过产品开发和市场开拓增加投资等因素，预计北美电子资料撷取系统市场在预测期内将保持其主导地位。

电子资料撷取系统产业概述

电子资料撷取系统市场是半稳固的，有多个大型参与者。这些大公司大多拥有全球业务，并积极参与收购和合作等策略性倡议。由于分散临床试验项目的增加，市场迅速扩大，新兴国家正成为主要的竞争热点。市场参与企业包括 Calyx、Castor、OpenClinica, LLC、Oracle、IQVIA Inc.、Medidata Solutions Inc.、IBM、Amazon Web Services Inc.、Veeva Systems 和 Wemedoo。

其他福利：

  • Excel 格式的市场预测 (ME) 表
  • 3 个月分析师支持

目录

第一章简介

  • 研究假设和市场定义
  • 调查范围

第二章调查方法

第三章执行摘要

第四章市场动态

  • 市场概况
  • 市场驱动因素
    • 临床试验分散化的进展
    • 临床试验期间资料的复杂性
  • 市场限制因素
    • 实施成本高
  • 波特五力分析
    • 供应商的议价能力
    • 买家/消费者的议价能力
    • 新进入者的威胁
    • 替代品的威胁
    • 竞争公司之间敌对关係的强度

第五章市场区隔（市场规模-金额）

  • 按规定形式
    • 云端基础
    • 本地
  • 按发展阶段分
    • 第一阶段
    • 第二阶段
    • 第二阶段
    • 第四阶段
  • 按最终用户
    • 製药和生物技术公司
    • 医院提供者
    • 合约研究组织
    • 其他最终用户
  • 按地区
    • 北美洲
      • 美国
      • 加拿大
      • 墨西哥
    • 欧洲
      • 德国
      • 英国
      • 法国
      • 义大利
      • 西班牙
      • 其他欧洲国家
    • 亚太地区
      • 中国
      • 日本
      • 印度
      • 澳洲
      • 韩国
      • 其他亚太地区
    • 中东/非洲
      • GCC
      • 南非
      • 其他中东和非洲
    • 南美洲
      • 巴西
      • 阿根廷
      • 南美洲其他地区

第六章 竞争状况

  • 公司简介
    • Calyx
    • Castor
    • OpenClinica LLC
    • Oracle
    • IQVIA Inc
    • Medidata Solutions Inc.
    • IBM
    • Amazon Web Services Inc.
    • Veeva Systems
    • Wemedoo

第七章 市场机会及未来趋势

简介目录
Product Code: 50002287

The Electronic Data Capture Systems Market size is estimated at USD 1.66 billion in 2024, and is expected to reach USD 2.93 billion by 2029, growing at a CAGR of 12.02% during the forecast period (2024-2029).

Electronic Data Capture Systems - Market

An increase in decentralized clinical trials will likely assist EDC systems in gaining momentum in medical research. According to an article published in April 2023, the disruption of around 68% of clinical trials during the pandemic caused the surge in the adoption of virtual and hybrid trial models. Good data management is crucial in decentralized trials; therefore, the EDC system plays a vital role. Companies in clinical trial services are expanding their offerings through collaboration and acquisitions. For instance, in July 2023, Signant Health announced the acquisition of DSG, a direct data capture and electronic data capture technology provider in the eClinical suite for decentralized and site-based clinical trials. This acquisition enabled the company to offer comprehensive digital solutions to any size and type of clinical trial. Thus, new entrants in the market are likely to accelerate the existing competitiveness and efficiency.

Regulatory bodies, such as the US FDA, offer recommendations to end users who employ the EDC system to record data in clinical investigations. As per the clinical investigation protocol, the sponsor must provide an in-detailed description of the system and information on system management, staff training on the use of the system, and access control. The regulatory intervention minimizes the risk of product failure as companies ensure thorough quality checks and offer security safeguards in order to protect the data. Hence, regulatory compliance and recommendations encourage the use of EDC systems among end users, boosting overall market growth.

However, the high cost of licensing and hosting the system is anticipated to hamper market growth. Additionally, under-developed cyberinfrastructure in emerging economies restrains end users from utilizing the system.

Electronic Data Capture Systems Market Trends

The Web and Cloud-Based Segment is Expected to Hold a Significant Market Share Over the Forecast Period

The web and cloud-based segment is estimated to have a substantial market share during the forecast period. A cloud-based system is a centralized database that enables professionals to tailor the cloud database to the region or local specific to adhere to local data sharing regulations. Such advantages increase the preference for the web and cloud-based approach amongst researchers.

Regional players with limited resources collaborate with cloud providers, including Amazon Web Services (AWS) and Oracle. For instance, Climedo Health, a Germany-based health tech company, uses AWS to develop cloud-based and scalable electronic data capture systems for hospitals, pharmaceutical companies, medical device manufacturers, and 150 public health offices. The company also raised USD 5.7 million in February 2022 in order to strengthen its position in the European electronic data capture system market and expand its presence in the United States. Cloud-based solutions ease regional expansion for companies without incurring extra costs for product development.

The activities of market players, such as partnerships, launches, and approvals, to expand their electronic data capture system offerings are expected to boost the segment's growth over the forecast period. In October 2022, Medidata announced the renewal of the partnership with Boehringer Ingelheim for five years. Under this agreement, Medidata is expected to offer its Rave EDC system for Boehringer Ingelheim's clinical trials globally.

Hence, the free flow of data, coupled with strengthening the protocols for data protection, is likely to increase the adoption rate of web and cloud-based electronic data capture systems, resulting in the growth of the segment.

North America is Expected to Hold a Significant Market Share Over the Forecast Period

North America is anticipated to hold a substantial market share during the forecast period. This can be attributed to factors such as increasing strategic initiatives to enhance the market presence and the growing number of clinical trials in the region.

North America has a high adoption rate of digitalization and experimental studies in product development. For instance, in July 2023, AstraZeneca, IgniteData, and University College London Hospitals NHS Foundation Trust (UCLH) collaborated to evaluate data transfer from Electronic Health Records (EHR) to Electronic Data Capture (EDC) in a clinical trial setting. One of the purposes of this collaboration was to expand the usage of EHR-to-EDC technology across multiple domains. Additionally, funding accessibility for emerging players in the region is relatively easier than in other regions. For instance, in November 2022, YonaLink, a US clinical trial software provider, announced that it would raise USD 6 million in funding to expand its integration platform of EHR-to-EDC and increase its adoption rate amongst the CROs. The inflow of investments through funding and collaborative studies is expected to propel market growth in the region during the forecast period.

The active participation of healthcare professionals in scaling up the use of EDC systems in the region is also considered an important growth determinant of the market. For instance, in June 2022, an article published in the National Library of Medicine stated that the Discovery Critical Care Research Network Program for Resilience and Emergency Preparedness (Discovery PREP) collaborated with technology vendors to develop an EDC tool that can address multisite data collection challenges during the emergencies in the United States. The study concluded that the EDC tool is feasible for collecting multisite data and assessing treatment protocols for seasonal influenza. Such studies boost the use of EDC in various applications and enlarge the market scope.

Therefore, owing to the above-mentioned factors, such as the players' growing investments via product development and market expansion, the North American electronic data capture systems market is expected to maintain its dominant position during the forecast period.

Electronic Data Capture Systems Industry Overview

The electronic data capture systems market is semi-consolidated with several major players. Most of these major players enjoy a global presence and indulge in strategic initiatives such as acquisitions and collaborations. Emerging countries are becoming hotspots for significant competition due to the rapidly expanding market fueled by growing decentralized clinical trial programs. Some of the market players include Calyx, Castor, OpenClinica, LLC, Oracle, IQVIA Inc., Medidata Solutions Inc., IBM, Amazon Web Services Inc., Veeva Systems, and Wemedoo.

Additional Benefits:

  • The market estimate (ME) sheet in Excel format
  • 3 months of analyst support

TABLE OF CONTENTS

1 INTRODUCTION

  • 1.1 Study Assumptions and Market Definition
  • 1.2 Scope of the Study

2 RESEARCH METHODOLOGY

3 EXECUTIVE SUMMARY

4 MARKET DYNAMICS

  • 4.1 Market Overview
  • 4.2 Market Drivers
    • 4.2.1 Growing Decentralized Clinical Trials
    • 4.2.2 Increasing Complexity of Data during the Clinical Study
  • 4.3 Market Restraints
    • 4.3.1 High Implementation Cost
  • 4.4 Porter's Five Forces Analysis
    • 4.4.1 Bargaining Power of Suppliers
    • 4.4.2 Bargaining Power of Buyers/Consumers
    • 4.4.3 Threat of New Entrants
    • 4.4.4 Threat of Substitute Products
    • 4.4.5 Intensity of Competitive Rivalry

5 MARKET SEGMENTATION (Market Size by Value - USD)

  • 5.1 By Delivery Mode
    • 5.1.1 Web and Cloud-based
    • 5.1.2 On-Premise
  • 5.2 By Development Stage
    • 5.2.1 Phase l
    • 5.2.2 Phase ll
    • 5.2.3 Phase lll
    • 5.2.4 Phase lV
  • 5.3 By End User
    • 5.3.1 Pharmaceutical and Biotechnology Firms
    • 5.3.2 Hospitals Providers
    • 5.3.3 Contract Research Organisations
    • 5.3.4 Other End Users
  • 5.4 Geography
    • 5.4.1 North America
      • 5.4.1.1 United States
      • 5.4.1.2 Canada
      • 5.4.1.3 Mexico
    • 5.4.2 Europe
      • 5.4.2.1 Germany
      • 5.4.2.2 United Kingdom
      • 5.4.2.3 France
      • 5.4.2.4 Italy
      • 5.4.2.5 Spain
      • 5.4.2.6 Rest of Europe
    • 5.4.3 Asia-Pacific
      • 5.4.3.1 China
      • 5.4.3.2 Japan
      • 5.4.3.3 India
      • 5.4.3.4 Australia
      • 5.4.3.5 South Korea
      • 5.4.3.6 Rest of Asia-Pacific
    • 5.4.4 Middle East and Africa
      • 5.4.4.1 GCC
      • 5.4.4.2 South Africa
      • 5.4.4.3 Rest of Middle East and Africa
    • 5.4.5 South America
      • 5.4.5.1 Brazil
      • 5.4.5.2 Argentina
      • 5.4.5.3 Rest of South America

6 COMPETITIVE LANDSCAPE

  • 6.1 Company Profiles
    • 6.1.1 Calyx
    • 6.1.2 Castor
    • 6.1.3 OpenClinica LLC
    • 6.1.4 Oracle
    • 6.1.5 IQVIA Inc
    • 6.1.6 Medidata Solutions Inc.
    • 6.1.7 IBM
    • 6.1.8 Amazon Web Services Inc.
    • 6.1.9 Veeva Systems
    • 6.1.10 Wemedoo

7 MARKET OPPORTUNITIES AND FUTURE TRENDS