北美电子临床解决方案市场 – 行业趋势和 2030 年预测

北美电子临床解决方案市场分析和规模

北美电子临床解决方案市场本质上是分散的，因为它由许多全球参与者组成，例如 Oracle、IQVIA Inc.、Dassault Systemes 和 Clario 等。这些公司的存在为整个地区的系统服务和软件提供了具有竞争力的价格。由于这些参与者在区域和国际层面的存在，供应商和制造商提供具有不同规格和特点的产品，适合所有预算。电子数据采集 (EDC) 系统和基于云的系统的日益普及正在推动市场增长。此外，对以患者为中心的临床试验的日益关注预计将推动市场增长。

Data Bridge Market Research 分析，北美电子临床解决方案市场预计到 2030 年将达到 81.6732 亿美元，预测期内复合年增长率为 14.5%。本市场报告还深入介绍了定价分析和技术进步。

Market Definition

The goal of e-clinical solutions is to revolutionize the field of clinical research. The clinical management organization is trying to improve the effectiveness, efficiency, and accessibility of clinical research data to treat patients more quickly. The idea behind the creation of eClinical Solutions was to pinpoint the problems with clinical research data, fix them, and offer creative solutions to make clinical trial data useful and simple to obtain, as well as to facilitate the standardization, reporting, and operation of the clinical research domain. The rising adoption and growing focus towards the e clinical solutions and software are expected to drive market growth.

 The e-clinical solutions, such as electronic data capture (EDC), electronic patient-reported outcomes (ePRO), clinical trial management systems (CTMS), and electronic trial master file (eTMF) systems, are software programs used in clinical research to manage clinical data. However, strict regulations and standards for the approval of clinical trial studies and product approvals are expected to restrain the market growth.

North America E-Clinical Solutions Market Dynamics

This section deals with understanding the market drivers, opportunities, restraints, and challenges. All of this is discussed in detail below:

Drivers

Increasing R&D Activities and Corresponding Expenditure

R&D is crucial in all industries, including life science and healthcare. The life science industry carries out extensive research and development to generate revenue and often brings results that embrace saving or enhancing a patient's life. Drug development requires going through clinical trials to check clinical data analysis and review its study and new data insights.

The e-clinical solutions are used for comprehensive data review, automating the data transformation process, and analytics to accelerate timelines. Pharmaceutical and biopharmaceutical companies conduct many clinical trials to complete successful drug or biologic development. Pharmaceutical and biopharmaceutical companies have increased their focus on research and development, raising the demand for e-clinical solutions.

Improved Healthcare Infrastructure and Establishment of Advanced Laboratories

Infrastructure is a key pillar supporting the fundamental aim of promoting improved standards of care and well-being for all patients, together with a good healthcare system experience. In parallel, the healthcare system and staff must support effective health promotion, prevention, and self-care of the whole population.

Infrastructure must integrate the hospital, as the acute and in-patient care center, into the broader healthcare system. It should facilitate the seven domains of quality patient experience, effectiveness, efficiency, timeliness, safety, equity, and sustainability. Infrastructure includes the built environment and supporting elements such as equipment, access, information technology (IT), systems and processes, sustainability initiatives, and staff. This improved healthcare infrastructure and staff more opportunities for e-clinical solutions to grow and give better results.

Opportunity

• Increasing Investments By Various Governments In Clinical Trials 

Clinical trial funding comes from various sources, including the government, commercial investors, nonprofit organizations, academic institutions, and other research organizations. Historically, the National Institutes of Health (NIH) has made the biggest government investments in fundamental drug development research. The Defense Advanced Research Agency (DARPA) has also contributed to the discovery stage by accepting a few relatively high-risk biological initiatives. State governments are also increasingly taking the lead in this area, partly due to the public's frustration with the lengthy discovery process. Thus, government initiatives and investments toward discovering new drugs with trial studies are expected to act as market growth opportunities.

Restraint / Challenge

Data Safety and Privacy issues

Information systems are heavily concerned with privacy and security. Access to individual health information is made possible by digitalizing healthcare services from any electronic device with an internet connection anywhere globally. Users typically are unaware of how their data is handled. Healthcare data on the cloud has caught the attention of hackers, who target systems to launch attacks and steal sensitive data in exchange for financial benefit.

Data breaches have been common since 2019, over 50 million electronic medical records have been hacked, and in 2021, the number of security breaches is predicted to increase from the previous year. The creation of inter-jurisdictional data-sharing agreements and the storage and manipulation of data holdings are significantly hampered by concerns about personal privacy and information confidentiality and the recent enactment of privacy and confidentiality legislation across the provinces and territories (exceptionally patient records). Thus, it is expected to restrain market growth.

Recent Developments

• In April 2023, the Medidata subsidiary of Dassault Systèmes announced Lambda Therapeutics is deploying Medidata's cloud-based clinical products, Rave EDC, Rave RTSM, and Rave Imaging, according to a statement from Dassault Systèmes 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, Clarion launched a cloud-based Image Viewer to help the Sponsors and CR to see the images of their clinical trials. Previously, several nations had to participate in the image transfer procedure to see photos for a clinical trial. This complicated the already risky process and increased the possibility of delays and mistakes. This has aided the business in growing its service offering.

North America E-Clinical Solutions Market Scope  

North America e-clinical solutions market is segmented into six notable segments on the basis of product, delivery mode, clinical trial phase, organization size, user device, and end user.

The growth amongst these segments will help you analyze meager growth segments in the industries and provide the users with a valuable market overview and insights to help them make strategic decisions for identifying core market applications.

Product

• Electronic Data Capture and Clinical Data Management Systems
• Clinical Trial Management Systems
• Clinical Analytics Platforms
• Care Coordination Medical Record (CCMR)
• Randomization and Trial Supply Management
• Clinical Data Integration Platforms
• Electronic Clinical Outcome Assessment Solutions
• Safety Solutions
• Electronic Trial Master File  Systems
• Regulatory Information Management Solutions
• Others

根据产品，市场细分为电子数据采集和临床数据管理、临床试验管理系统、临床分析平台、护理协调医疗记录 (CCMR)、随机化和试验供应管理、临床数据集成平台、电子临床结果评估解决方案、安全解决方案、电子试验主文件系统、监管信息管理解决方案等。

交付方式

• Web 托管（按需）解决方案
• 许可企业（本地）解决方案
• 基于云的（SAAS）解决方案

根据交付模式，市场分为网络托管（按需）解决方案、许可企业（本地）解决方案和基于云（SAAS）的解决方案。

临床试验阶段

• 第一阶段
• 第二阶段
• 第三阶段
• 第四阶段

根据临床试验阶段，市场分为 I ​​期、II 期、III 期和 IV 期。

组织规模

• 小型和中型
• 大的

根据组织规模，市场分为小型、中型和大型。

用户设备

• 桌面
• 药片
• 手持式 PDA 设备
• 手机
• 其他的

根据用户设备，市场分为台式机、平板电脑、手持 PDA 设备、智能手机和其他。

最终用户

• 制药和生物制药公司
• 合同研究组织
• 咨询服务公司
• 医疗器械制造商
• 医院
• 学术研究机构

根据最终用户，市场细分为制药和生物制药公司、合同研究组织、咨询服务公司、医疗器械制造商、医院和学术研究机构。

北美电子临床解决方案市场区域分析/见解

对北美电子临床解决方案市场进行分析，市场规模信息基于产品、交付模式、临床试验阶段、组织规模、用户设备和最终用户。

本市场报告涵盖的国家包括美国、加拿大和墨西哥。

由于美国对药物研发和输送的投资不断增加，且拥有强大的关键参与者，预计美国将主导北美地区。

报告的国家部分还提供了影响市场当前和未来趋势的各个市场影响因素和国内市场监管变化。新销售、替代销售、国家人口统计、监管法案和进出口关税等数据点是用于预测各个国家市场情景的一些主要指标。此外，在对国家数据进行预测分析时，还考虑了亚太品牌的存在和可用性以及它们因来自本地和国内品牌的激烈或稀少竞争而面临的挑战以及销售渠道的影响。

竞争格局和市场份额分析

北美电子临床解决方案市场竞争格局提供了竞争对手的详细信息。详细信息包括公司概况、公司财务状况、产生的收入、市场潜力、新市场计划、全球影响力、生产基地和设施、生产能力、公司优势和劣势、产品发布、产品宽度和广度以及应用主导地位。以上提供的数据点仅与公司对市场的关注有关。

北美电子临床解决方案市场的一些主要市场参与者包括 Oracle、Signant Health、MaxisIT、Paraxel International Corporation、Dassault Systèmes、Clario、Mednet、OpenClinica, LLC、4G Clinical、Veeva Systems、Saama Technologies, LLC.、Anju、Castor.、Medrio, Inc.、ArisGlobal、Merative、Advarra、eClinical Solutions, LLC.、Y-Prime LLC、RealTime Software Solutions LLC、Quretec、Research Manager、Datatrack Int. 和 IQVIA Inc. 等。

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