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市场调查报告书
商品编码
1790385

美国临床试验管理系统市场规模、份额和趋势分析报告：按解决方案类型、交付模式、组件、最终用途和细分市场预测，2025 年至 2030 年

U.S. Clinical Trials Management System Market Size, Share & Trends Analysis Report By Solution Type, By Delivery Mode (Web & Cloud-based, On-premise), By Component (Software, Services), By End Use, And Segment Forecasts, 2025 - 2030
出版日期: | 出版商: Grand View Research | 英文 100 Pages | 商品交期: 2-10个工作天内

价格

美国临床试验管理系统市场概况

美国临床试验管理系统市场规模预计在2024年达到8.3122亿美元，预计2025年至2030年的复合年增长率为13.5%。医疗IT的快速发展、对分散式临床试验的偏好、主要行业参与者的积极倡议以及临床试验数量的不断增加，预计将推动市场成长。例如，美国食品药物管理局（FDA）于2024年11月最终确定了关于分散式临床试验（DCT）的指南，强调整合远距远端医疗就诊和数位医疗技术等远距元素，以提高临床试验的可及性和效率。此举旨在透过减少临床试验参与的地理和经济障碍，扩大参与者，尤其是一般大众的参与。

目前全球研发活动的情况以及对多种新型治疗方案的需求，也促使人们采用快速临床试验。因此，上述因素预计将为临床试验市场的成长提供新的途径。政府的积极支持和倡议是提升市场成长潜力的另一个因素。例如，世界卫生组织启动了名为「团结」（Solidarity）的国际临床试验，以确定针对新冠肺炎（COVID-19）的有效治疗方法。该试验将比较四种治疗方法与标准治疗方法，以评估其对抗新冠病毒的有效性。

政府倡议以及生物技术和製药公司的投资正在推动医学研究活动。这些因素加上技术进步，预计将推动市场成长。例如，2023年10月，美国卫生与公众服务部（HHS）下属机构高级卫生研究计画局（ARPA-H）宣布了一项计划，旨在加强快速、安全、公平地开展临床试验的能力。该倡议旨在促进技术进步和洞察力，并建立强大的国家临床试验基础设施，从而推动临床试验管理系统（CTMS）的采用并促进市场成长。

此外，市场参与者正在推出自己的解决方案或优化现有解决方案，以满足分散式临床试验 (DCT) 的需求。例如，Cloudbyz 提供云端基础的CTM 解决方案，该解决方案具有 ePRO、远端监控和 SDV、电子同意书 (eConsent) 和 eCRF 等功能，可支援虚拟试验。参与企业的Parexel International Corporation 已开展了 250 多个完全虚拟或混合式 DCT，并在将各种远端患者参与策略融入临床试验方面拥有丰富的经验。

生命科学和医疗设备公司不断增加的研发投入，以及急性和慢性疾病的流行，正在推动临床试验数量的激增。这一趋势预计将推动对CTMS等解决方案的需求，从而促进各种临床试验的高效管理，并最终改善患者的治疗效果。

目录

第一章调查方法与范围

第二章执行摘要

第三章市场变数、趋势和范围

  • 市场体系展望
  • 市场动态
    • 市场驱动因素分析
    • 市场限制因素分析
    • 市场机会分析
    • 市场威胁分析
  • 商业环境分析
    • 波特五力分析
    • PESTLE分析
    • COVID-19的影响

第四章：美国临床试验管理系统市场（按解决方案类型、估计和趋势分析）

  • 细分仪表板
    • 美国临床试验管理系统市场：解决方案类型变化分析，2024 年和 2030 年
  • 公司
  • 现场

第五章美国临床试验管理系统市场：按组成部分的估计和趋势分析

  • 组件细分仪表板
  • 2024年及2030年零件市场占有率变化分析
  • 市场规模、预测和趋势分析（按组成部分，2018-2030 年）
  • 软体
    • 2018-2030年市场
  • 服务
    • 2018-2030年市场

第六章：美国临床试验管理系统市场（按交付模式、估计和趋势分析）

  • 交付模式细分仪表板
  • 2024年及2030年配送方式市场占有率变化分析
  • 按交付方式分類的市场规模、预测和趋势分析（2018-2030 年）
  • 云端基础的系统
    • 2018-2030年市场
  • 本地系统
    • 2018-2030年市场

第七章美国临床试验管理系统市场：按最终用途的估计和趋势分析

  • 最终用途细分仪表板
  • 2024 年及 2030 年最终用途市场占有率变化分析
  • 按最终用途分類的市场规模、预测和趋势分析（2018-2030 年）
  • 製药和生物技术公司
    • 2018-2030年市场
  • 医疗设备公司
    • 2018-2030年市场
  • CRO及其他
    • 2018-2030年市场

第八章 竞争态势

  • 参与者概览
  • 企业市场分析
  • 公司分类
  • 公司简介/上市公司
    • IQVIA, Inc.
    • Medidata（Dassault Systemes）
    • Oracle
    • DATATRAK International, Inc.
    • Clario
    • SimpleTrials
    • Calyx（原 Parexel Informatics）
    • RealTime Software Solutions, LLC
    • Laboratory Corporation of America Holdings
    • Veeva Systems
    • Wipro Limited
    • MedRhythms
Product Code: GVR-4-68040-680-0

U.S. Clinical Trials Management System Market Summary

The U.S. clinical trials management system market size was estimated at USD 831.22 million in 2024 and is expected to grow at a CAGR of 13.5% from 2025 to 2030. The rapid growth of healthcare IT, a preference for decentralized clinical trials, initiatives by key industry players, and a rising number of clinical studies are expected to fuel market growth. For instance, in November 2024, the FDA finalized its guidance on decentralized clinical trials (DCTs), emphasizing integrating remote elements like telehealth visits and digital health technologies to enhance trial accessibility and efficiency. This approach aims to broaden participation, especially among underrepresented populations, by reducing geographic and economic barriers to clinical trial involvement.

The current scenario for global research and development activities and the need for several new treatment options have also led to the adoption of fast-track clinical trials. Thus, the factors above are estimated to offer new avenues for the clinical trials market growth. Favorable government support and initiatives are another aspect boosting the market growth potential. For instance, the WHO launched Solidarity, an international clinical trial to determine effective treatment against COVID-19. It includes comparing four treatment options against the standard of care to evaluate their effectiveness against the coronavirus.

Government initiatives and investments by biotechnology and pharmaceutical firms are driving medical research activities. Combined with technological advancements, these factors are expected to propel market growth. For example, in October 2023, the Advanced Research Projects Agency for Health (ARPA-H), a U.S. Department of Health and Human Services (HHS) agency, announced plans to enhance the country's ability to conduct clinical trials rapidly, safely, and equitably. This initiative aims to promote technological advancements and insights to establish a robust national clinical trial infrastructure, thereby fostering the adoption of CTMS and strengthening the market growth.

Moreover, market players are introducing tailored solutions or optimizing existing ones to cater to the requirements of Decentralized Clinical Trials (DCTs). For instance, Cloudbyz offers a cloud-based CTM solution with features like ePRO, remote monitoring & SDV, eConsent, and eCRF, supporting virtual trials. Parexel International Corporation, a key player, has conducted over 250 fully virtual or hybrid DCTs and has experience with various remote patient engagement strategies incorporated into trials.

Increasing R&D investments by life science and medical device companies, coupled with the growing prevalence of acute & chronic disorders, are driving the surge in clinical trials. This trend is expected to boost the demand for solutions like CTMS, facilitating efficient management of diverse clinical trials and ultimately improving patient outcomes.

U.S. Clinical Trial Management System Market Report Segmentation

This report forecasts revenue growth at country levels and provides an analysis of the latest industry trends in each of the sub-segments from 2018 to 2030. For this study, Grand View Research has segmented the U.S. clinical trial management systems market report based on solution type, component, delivery mode, and end use:

  • Solution Type Outlook (Revenue, USD Million, 2018 - 2030)
  • Enterprise
  • Site
  • Component Outlook (Revenue, USD Million, 2018 - 2030)
  • Software
  • Services
  • Delivery Mode Outlook (Revenue, USD Million, 2018 - 2030)
  • Web & Cloud Based
  • On Premise
  • End use Outlook (Revenue, USD Million, 2018 - 2030)
  • Pharmaceutical and Biotechnology Firms
  • Medical Device Firms
  • CROs & Others

Table of Contents

Chapter 1. Methodology and Scope

  • 1.1. Market Segmentation & Scope
  • 1.2. Segment Definitions
    • 1.2.1. Solution Type
    • 1.2.2. Component
    • 1.2.3. Delivery Mode
    • 1.2.4. End use
  • 1.3. Estimates and Forecast Timeline
  • 1.4. Research Methodology
  • 1.5. Information Procurement
    • 1.5.1. Purchased Database
    • 1.5.2. GVR's Internal Database
    • 1.5.3. Secondary Sources
    • 1.5.4. Primary Research
  • 1.6. Information Analysis
    • 1.6.1. Data Analysis Models
  • 1.7. Market Formulation & Data Visualization
  • 1.8. Model Details
    • 1.8.1. Commodity Flow Analysis
  • 1.9. List of Secondary Sources
  • 1.10. Objectives

Chapter 2. Executive Summary

  • 2.1. Market Snapshot
  • 2.2. Segment Snapshot
  • 2.3. Competitive Landscape Snapshot

Chapter 3. Market Variables, Trends, & Scope

  • 3.1. Market Lineage Outlook
  • 3.2. Market Dynamics
    • 3.2.1. Market Driver Analysis
      • 3.2.1.1. Shift Toward Decentralized and Hybrid Trials
      • 3.2.1.2. Need for Operational Efficiency and Cost Reduction
      • 3.2.1.3. Growing Focus on Patient-Centric Trials
    • 3.2.2. Market Restraint Analysis
      • 3.2.2.1. High Implementation and Maintenance Costs
      • 3.2.2.2. Data privacy and Security Concerns
      • 3.2.2.3. Complex regulatory environment
    • 3.2.3. Market Opportunity Analysis
    • 3.2.4. Market Threat Analysis
  • 3.3. Business Environment Analysis
    • 3.3.1. Porter's Five Forces Analysis
      • 3.3.1.1. Supplier power
      • 3.3.1.2. Buyer power
      • 3.3.1.3. Substitution threat
      • 3.3.1.4. Threat of new entrant
      • 3.3.1.5. Competitive rivalry
    • 3.3.2. PESTLE Analysis
      • 3.3.2.1. Political Analysis
      • 3.3.2.2. Economic Analysis
      • 3.3.2.3. Technological Analysis
      • 3.3.2.4. Environmental Analysis
      • 3.3.2.5. Social Analysis
    • 3.3.3. Impact of COVID 19

Chapter 4. U.S. Clinical Trial Management System Market: Solution Type Estimates & Trend Analysis

  • 4.1. Segment Dashboard
    • 4.1.1. U.S. Clinical Trial Management System Market: Solution Type Movement Analysis, 2024& 2030 (USD Million)
  • 4.2. Enterprise
    • 4.2.1. Enterprise Market Revenue Estimates and Forecasts, 2018 - 2030 (USD Million)
  • 4.3. Site
    • 4.3.1. Site Market Revenue Estimates and Forecasts, 2018 - 2030 (USD Million)

Chapter 5. U.S. Clinical Trial Management System Market: Component Estimates & Trend Analysis

  • 5.1. Component Segment Dashboard
  • 5.2. Component Market Share Movement Analysis, 2024 & 2030
  • 5.3. Market Size & Forecasts and Trend Analysis, by Component, 2018 to 2030 (USD Million)
  • 5.4. Software
    • 5.4.1. Software market 2018 - 2030 (USD Million)
  • 5.5. Services
    • 5.5.1. Services market, 2018 - 2030 (USD Million)

Chapter 6. U.S. Clinical Trial Management System Market: Delivery Mode Estimates & Trend Analysis

  • 6.1. Delivery Mode Segment Dashboard
  • 6.2. Delivery Mode Market Share Movement Analysis, 2024 & 2030
  • 6.3. Market Size & Forecasts and Trend Analysis, by Deliver Mode, 2018 to 2030 (USD Million)
  • 6.4. Web & Cloud-Based Systems
    • 6.4.1. Web & cloud-based Systems market, 2018 - 2030 (USD Million)
  • 6.5. On premise systems
    • 6.5.1. On premise systems market, 2018 - 2030 (USD Million)

Chapter 7. U.S. Clinical Trial Management System Market: End Use Estimates & Trend Analysis

  • 7.1. End Use Segment Dashboard
  • 7.2. End Use Market Share Movement Analysis, 2024 & 2030
  • 7.3. Market Size & Forecasts and Trend Analysis, by End Use, 2018 to 2030 (USD Million)
  • 7.4. Pharmaceutical and Biotechnology Firms
    • 7.4.1. Pharmaceutical and Biotechnology Firms market, 2018 - 2030 (USD Million)
  • 7.5. Medical Device Firms
    • 7.5.1. Medical Device Firms market, 2018 - 2030 (USD Million)
  • 7.6. CROs & Others
    • 7.6.1. CROs & Others market, 2018 - 2030 (USD Million)

Chapter 8. Competitive Landscape

  • 8.1. Participant Overview
  • 8.2. Company Market Position Analysis
  • 8.3. Company Categorization
  • 8.4. Company Profiles/Listing
    • 8.4.1. IQVIA, Inc.
      • 8.4.1.1. Overview
      • 8.4.1.2. Financial performance
      • 8.4.1.3. Product benchmarking
      • 8.4.1.4. Strategic initiatives
    • 8.4.2. Medidata (Dassault Systemes)
      • 8.4.2.1. Overview
      • 8.4.2.2. Financial performance
      • 8.4.2.3. Product benchmarking
      • 8.4.2.4. Strategic initiatives
    • 8.4.3. Oracle
      • 8.4.3.1. Overview
      • 8.4.3.2. Financial performance
      • 8.4.3.3. Product benchmarking
      • 8.4.3.4. Strategic initiatives
    • 8.4.4. DATATRAK International, Inc.
      • 8.4.4.1. Overview
      • 8.4.4.2. Financial performance
      • 8.4.4.3. Product benchmarking
      • 8.4.4.4. Strategic initiatives
    • 8.4.5. Clario
      • 8.4.5.1. Overview
      • 8.4.5.2. Financial performance
      • 8.4.5.3. Product benchmarking
      • 8.4.5.4. Strategic initiatives
    • 8.4.6. SimpleTrials
      • 8.4.6.1. Overview
      • 8.4.6.2. Financial performance
      • 8.4.6.3. Product benchmarking
      • 8.4.6.4. Strategic initiatives
    • 8.4.7. Calyx (formerly Parexel Informatics)
      • 8.4.7.1. Overview
      • 8.4.7.2. Financial performance
      • 8.4.7.3. Product benchmarking
      • 8.4.7.4. Strategic initiatives
    • 8.4.8. RealTime Software Solutions, LLC
      • 8.4.8.1. Overview
      • 8.4.8.2. Financial performance
      • 8.4.8.3. Product benchmarking
      • 8.4.8.4. Strategic initiatives
    • 8.4.9. Laboratory Corporation of America Holdings
      • 8.4.9.1. Overview
      • 8.4.9.2. Financial performance
      • 8.4.9.3. Product benchmarking
      • 8.4.9.4. Strategic initiatives
    • 8.4.10. Veeva Systems
      • 8.4.10.1. Overview
      • 8.4.10.2. Financial performance
      • 8.4.10.3. Product benchmarking
      • 8.4.10.4. Strategic initiatives
    • 8.4.11. Wipro Limited
      • 8.4.11.1. Overview
      • 8.4.11.2. Financial performance
      • 8.4.11.3. Product benchmarking
      • 8.4.11.4. Strategic initiatives
    • 8.4.12. MedRhythms
      • 8.4.12.1. Overview
      • 8.4.12.2. Financial performance
      • 8.4.12.3. Product benchmarking
      • 8.4.12.4. Strategic initiatives

List of Tables

  • Table 1 List of secondary sources
  • Table 2 List of abbreviations
  • Table 3 U.S. Clinical trial management system market, by Solution Type, 2018 - 2030 (USD Million)
  • Table 4 U.S. Clinical trial management system market, by Component, 2018 - 2030 (USD Million)
  • Table 5 U.S. Clinical trial management system market, by Delivery Mode, 2018 - 2030 (USD Million)
  • Table 6 U.S. Clinical trial management system market, by End Use, 2018 - 2030 (USD Million)

List of Figures

  • Fig. 1 Market research process
  • Fig. 2 Information procurement
  • Fig. 3 Primary research pattern
  • Fig. 4 Market research approaches
  • Fig. 5 Value chain-based sizing & forecasting
  • Fig. 6 Market formulation & validation
  • Fig. 7 Market segmentation
  • Fig. 8 Market snapshot
  • Fig. 9 Segment snapshot
  • Fig. 10 Competitive landscape snapshot
  • Fig. 11 Market trends & outlook
  • Fig. 12 Market driver relevance analysis (current & future impact)
  • Fig. 13 Market restraint relevance analysis (current & future impact)
  • Fig. 14 PESTLE analysis
  • Fig. 15 Porter's five forces analysis
  • Fig. 16 U.S clinical trial management system market solution type outlook: Key Takeaways
  • Fig. 17 U.S clinical trial management system market: solution type movement analysis, 2018 & 2030
  • Fig. 18 Enterprise market estimates and forecasts 2018 - 2030 (USD Million)
  • Fig. 19 Site market estimates and forecasts 2018 - 2030 (USD Million)
  • Fig. 20 U.S Clinical trial management system Market component outlook: Key takeaways
  • Fig. 21 U.S Clinical trial management system market: Component movement analysis, 2018 & 2030
  • Fig. 22 Software market estimates and forecasts 2018 - 2030 (USD Million)
  • Fig. 23 Services market estimates and forecasts 2018 - 2030 (USD Million)
  • Fig. 24 U.S clinical trial management system market delivery mode outlook: Key takeaways
  • Fig. 25 U.S clinical trial management system market: delivery mode movement analysis, 2018 & 2030 (USD Million)
  • Fig. 26 Web & cloud systems based market estimates and forecasts 2018 - 2030 (USD Million)
  • Fig. 27 On-premises systems market estimates and forecasts 2018 - 2030 (USD Million)
  • Fig. 28 U.S clinical trial management system market end use outlook: Key takeaways
  • Fig. 29 U.S clinical trial management system market: end use movement analysis, 2018 & 2030 (USD Million)
  • Fig. 30 Clinical market estimates and forecasts 2018 - 2030 (USD Million)
  • Fig. 31 Pharmaceutical and biotechnology firms market estimates and forecasts 2018 - 2030 (USD Million)
  • Fig. 32 Medical device firms market estimates and forecasts 2018 - 2030 (USD Million)
  • Fig. 33 CROs & Others market estimates and forecasts 2018 - 2030 (USD Million)
  • Fig. 34 Market Participant Categorization
  • Fig. 35 Strategy mapping
  • Fig. 36 Company market position analysis