美國臨床試驗管理系統市場規模、佔有率和趨勢分析報告：按解決方案類型、交付模式、組件、最終用途和細分市場預測，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: 2025年07月18日 | 出版商:

Grand View Research | 英文 100 Pages | 商品交期: 2-10個工作天內

價格

簡介目錄圖表

美國臨床試驗管理系統市場概況

美國臨床試驗管理系統市場規模預計在2024年達到8.3122億美元，預計2025年至2030年的複合年成長率為13.5%。醫療IT的快速發展、對分散式臨床試驗的偏好、主要行業參與者的積極舉措以及臨床試驗數量的不斷增加，預計將推動市場成長。例如，美國食品藥物管理局（FDA）於2024年11月最終確定了關於分散式臨床試驗（DCT）的指南，強調整合遠距遠端醫療就診和數位醫療技術等遠距元素，以提高臨床試驗的可及性和效率。此舉旨在透過減少臨床試驗參與的地理和經濟障礙，擴大參與者，尤其是一般大眾的參與。

目前全球研發活動的情況以及對多種新型治療方案的需求，也促使人們採用快速臨床試驗。因此，上述因素預計將為臨床試驗市場的成長提供新的途徑。政府的積極支持和舉措是提升市場成長潛力的另一個因素。例如，世界衛生組織啟動了名為「團結」（Solidarity）的國際臨床試驗，以確定針對新冠肺炎（COVID-19）的有效治療方法。該試驗將比較四種治療方法與標準治療方法，以評估其對抗新冠病毒的有效性。

政府舉措以及生物技術和製藥公司的投資正在推動醫學研究活動。這些因素加上技術進步，預計將推動市場成長。例如，2023年10月，美國衛生與公眾服務部（HHS）下屬機構高級衛生研究計畫局（ARPA-H）宣布了一項計劃，旨在加強快速、安全、公平地開展臨床試驗的能力。該舉措旨在促進技術進步和洞察力，並建立強大的國家臨床試驗基礎設施，從而推動臨床試驗管理系統（CTMS）的採用並促進市場成長。

此外，市場參與者正在推出自己的解決方案或最佳化現有解決方案，以滿足分散式臨床試驗 (DCT) 的需求。例如，Cloudbyz 提供雲端基礎的CTM 解決方案，該解決方案具有 ePRO、遠端監控和 SDV、電子同意書 (eConsent) 和 eCRF 等功能，可支援虛擬試驗。參與企業的Parexel International Corporation 已開展了 250 多個完全虛擬或混合式 DCT，並在將各種遠端患者參與策略融入臨床試驗方面擁有豐富的經驗。

生命科學和醫療設備公司不斷增加的研發投入，以及急性和慢性疾病的流行，正在推動臨床試驗數量的激增。這一趨勢預計將推動對CTMS等解決方案的需求，從而促進各種臨床試驗的高效管理，並最終改善患者的治療效果。

參與者概覽
企業市場分析
公司分類
公司簡介/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

簡介目錄圖表

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

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

簡介目錄圖表

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