全球照护现场血液凝固检验设备市场规模（按设备类型、技术、最终用户、区域覆盖范围和预测）

照护现场血液凝固检验设备的市场规模与预测

预计 2024 年照护现场血液凝固检验市场价值将达到 19.8 亿美元，到 2031 年将达到 34.2 亿美元，2024 年至 2031 年的复合年增长率为 7.05%。

照护现场(POC)血液凝固检验设备是一种诊断仪器，可在病患照护点或接近护理点（而非集中实验室）快速提供凝血参数结果。这些设备可评估多种凝血参数，包括凝血酶原时间 (PT)、活化部份凝血活酵素时间(aPTT) 和国际标准化比率 (INR)。这些参数对于管理患者的抗凝血和出血性疾病至关重要。血液凝固检验最常用于需要快速且准确地评估凝血功能的场所，例如急诊、手术室和抗凝血诊所。该技术可实现快速决策和快速调整治疗方案，从而提高患者安全性和医疗效率。

随着技术进步提高准确性、易用性以及与电子健康记录(EHR) 的整合度，POC血液凝固检验设备前景看好。技术创新有望提高这些设备的灵敏度和特异性，使其能够更准确地监测复杂的凝血模式。

便携式易用技术的开发有望扩大其在居家医疗环境和偏远地区的应用，从而提高可及性和患者便利性。随着持续的研究和开发，照护现场血液凝固检验设备预计将在个人化医疗和即时患者管理中发挥更重要的作用，从而改善临床疗效并简化医疗保健操作。

全球照护现场血液凝固检验设备市场动态

影响全球照护现场血液凝固检验设备市场的关键市场动态是：

关键市场驱动因素

心血管疾病发生率不断上升：根据世界卫生组织（WHO）的数据，心血管疾病是全球整体%。根据美国心臟协会的数据，在美国，每40秒就会发生一次心臟病发作，每36秒就会有一人死于心血管疾病相关事件。

出血性疾病盛行率不断上升：世界血友病联盟估计，全球约有100万人患有血友病、血管性血友病和其他罕见的遗传性出血性疾病。此外，根据2019年发表在《血栓与止血杂誌》上的一项研究，最常见的遗传性出血性疾病－血管性血友病，影响全球0.6%-1.3%的人口。

老年人口不断增加：联合国预测，全球65岁及以上人口将大幅成长，从2020年的7.27亿增加到2050年的15亿。同时，凝血障碍的盛行率随着老龄化的增长而增加，根据发表在《美国老年医学会杂誌》上的一项研究，80岁及以上的人中约有10%患有其中一种凝血障碍。

主要挑战

法规合规性照护现场血液凝固检验设备必须符合许多领域的严格监管标准。要符合美国FDA和欧洲CE认证等法规，需要进行大量的测试和认证流程，这对製造商来说既昂贵又耗时。

准确性和可靠性：照护现场血液凝固检验必须准确可靠。这些设备必须提供与实验室检测结果一致且准确的结果，因为这些设备的故障可能导致错误的治疗决策和不良的患者预后。

与电子健康记录(EHR) 整合：就地检验设备与现有 EHR 系统整合可能颇具挑战性。无缝资料传输对于有效的患者管理和记录保存至关重要，但技术挑战和相容性问题可能会阻碍这种整合。

设备维护与校准：就地检验设备必须定期维护和校准，以确保其准确性。这项要求可能会增加医疗机构的营运工作量和成本。

主要趋势：

家庭医疗保健应用日益普及：随着个人化医疗的兴起，家庭就地检验设备的需求日益增长。患有慢性疾病或服用抗凝血剂的患者可以在家中监测凝血状态，从而提高便利性和依从性。

与数位健康平台的整合：数位健康平台与行动应用程式的整合正变得越来越普遍。这些连接实现了无缝数据共用、即时监控以及更完善的患者健康记录管理​​，从而改善了整体患者照护。

监管和报销变化：医疗保健法规和报销政策不断变化，影响就地检验市场。製造商必须应对不断变化的监管环境，并适应新的报销机制，才能在市场上立足并盈利。

多参数检测设备的开发：能够同时检查多个凝血指标的多参数检测设备正变得越来越流行。这些设备能够提供全面的诊断，简化检测流程，并减少多次检测的需求。

目录

第一章 引言

• 市场定义
• 市场区隔
• 调查方法

第二章执行摘要

• 主要发现
• 市场概况
• 市集亮点

第三章 市场概况

• 市场规模和成长潜力
• 市场趋势
• 市场驱动因素
• 市场限制
• 市场机会
• 波特五力分析

4. POC血液凝固检验设备市场（依产品类型）

• 凝血监测仪
• 耗材（试纸、试剂等）
• 凝血分析仪

5. POC血液凝固检验设备市场（按技术）

• 光学技术
• 机械技术
• 电化学技术

6. POC血液凝固检验设备市场（依最终用户）

• 医院
• 诊所
• 居家医疗
• 门诊手术中心

第七章区域分析

• 北美洲
• 美国
• 加拿大
• 墨西哥
• 欧洲
• 英国
• 德国
• 法国
• 义大利
• 亚太地区
• 中国
• 日本
• 印度
• 澳洲
• 拉丁美洲
• 巴西
• 阿根廷
• 智利
• 中东和非洲
• 南非
• 沙乌地阿拉伯
• 阿拉伯聯合大公国

第八章市场动态

• 市场驱动因素
• 市场限制
• 市场机会
• COVID-19 市场影响

第九章 竞争态势

• 主要企业
• 市占率分析

第十章：公司简介

• F. Hoffmann-La Roche AG
• Abbott Laboratories
• Siemens Healthineers
• Medtronic plc
• Haemonetics Corporation
• HemoSonics, LLC
• Micropoint Bioscience, Inc.
• Werfen
• Sienco, Inc.
• Koninklijke Philips NV

第十一章 市场展望与机会

• 新兴技术
• 未来市场趋势
• 投资机会

第十二章 附录

• 简称列表
• 来源和参考文献

Point Of Care Coagulation Testing Devices Market Size And Forecast

Point Of Care Coagulation Testing Devices Market size was valued at USD 1.98 Billion in 2024 and is projected to reach USD 3.42 Billion by 2031, growing at a CAGR of 7.05% from 2024 to 2031.

Point-of-care (POC) coagulation testing devices are diagnostic equipment that delivers quick results for blood coagulation parameters at or near the point of patient care, as opposed to a centralized laboratory. These devices assess a variety of blood coagulation parameters, including prothrombin time (PT), activated partial thromboplastin time (aPTT), and international normalized ratio (INR), which are critical for managing anticoagulant medication and bleeding disorders in patients. POC coagulation testing is most commonly used in environments that require rapid and accurate coagulation assessment, such as emergency rooms, surgical suites, and anticoagulation clinics. This technology enables fast decision-making and immediate therapeutic modifications, improving patient safety and healthcare efficiency.

POC coagulation testing devices appear to be promising, as technological improvements drive better accuracy, ease of use, and connection with electronic health records (EHRs). Innovations are projected to improve these devices' sensitivity and specificity, enabling for more precise monitoring of complex coagulation patterns.

The development of portable and user-friendly technologies may broaden their application in home care settings and remote places, enhancing accessibility and patient convenience. With continued research and development, point-of-care coagulation testing devices are projected to become even more important in personalized medicine and real-time patient management, resulting in improved clinical outcomes and simpler healthcare operations.

Global Point of Care Coagulation Testing Devices Market Dynamics

The key market dynamics that are shaping the global Point of Care Coagulation Testing Devices Market include:

Key Market Drivers:

Increasing Incidence of Cardiovascular Disorders: Cardiovascular disorders have become a major global health concern, with the World Health Organization (WHO) reporting that in 2019, cardiovascular diseases were the leading cause of death worldwide, accounting for 17.9 million fatalities, or 32% of all global deaths. According to the American Heart Association, a heart attack occurs every 40 seconds in the United States, and a person dies from a cardiovascular disease-related event every 36 seconds.

Rising Prevalence of Bleeding Disorders: The World Federation of Hemophilia estimates that approximately 1 million people worldwide suffer from hemophilia, von Willebrand disease, and other uncommon inherited bleeding disorders. Furthermore, a 2019 study published in the Journal of Thrombosis and Haemostasis found that von Willebrand disease, the most common inherited bleeding illness, affects between 0.6 and 1.3% of the global population.

Growing Geriatric Population: The United Nations predicts that the global population aged 65 and older will grow from 727 million in 2020 to 1.5 billion by 2050, representing a significant increase in the proportion of older persons. Concurrently, a study published in the Journal of the American Geriatrics Society found that the prevalence of coagulation problems grows with age, with around 10% of those over the age of 80 suffering from one of these disorders.

Key Challenges:

Regulatory Compliance: Point-of-care coagulation testing equipment must meet strict regulatory standards in many areas. Compliance with regulations such as the FDA in the United States or CE marking in Europe necessitates extensive testing and certification processes, which may be expensive and time-consuming for producers.

Accuracy and Reliability: Point-of-care coagulation tests must be accurate and reliable. These devices must produce consistent and exact results equivalent to laboratory tests, as errors might lead to wrong treatment decisions and negative patient outcomes.

Integration with Electronic Health Records (EHRs): Linking point-of-care testing equipment to existing EHR systems might be difficult. Seamless data transfer is critical for effective patient management and record-keeping, but technological difficulties and compatibility issues might impede this integration.

Device Maintenance and Calibration: Point-of-care testing devices must be maintained and calibrated on a regular basis to ensure their accuracy. This requirement might increase operational hassles and costs for healthcare facilities.

Key Trends:

Increasing Adoption in Home Healthcare: As personalized healthcare becomes more popular, there is a growing demand for point-of-care testing devices for use at home. Patients with chronic diseases or those using anticoagulants can monitor their coagulation status at home, which improves convenience and compliance.

Integration with Digital Health Platforms: Integration with digital health platforms and mobile apps is becoming more frequent. These connections provide seamless data sharing, real-time monitoring, and better management of patient health records, hence improving overall patient care.

Regulatory and Reimbursement Changes: Healthcare rules and reimbursement policies are always changing, influencing the point-of-care testing market. Manufacturers must traverse changing regulatory landscapes and adjust to new reimbursement mechanisms to maintain market access and profitability.

Development of Multi-Parameter Testing Devices: Multi-parameter testing equipment, which can check multiple coagulation variables at the same time, is increasingly common. These devices provide comprehensive diagnostics, simplify testing procedures, and decrease the need for several tests.

Global Point of Care Coagulation Testing Devices Market Regional Analysis

Here is a more detailed regional analysis of the global point of care coagulation testing devices market:

North America:

North America dominates the point of care coagulation testing devices market owing to its advanced healthcare infrastructure, high technology adoption rates, and significant expenditures by major industry players. Major corporations such as Roche Diagnostics, Abbott Laboratories, and Siemens Healthineers make substantial contributions, investing heavily in R&D to fuel innovation. This emphasis on technical progress ensures the ongoing introduction of cutting-edge testing solutions, which fuels market expansion.

High healthcare expenditure also contributes significantly to North America's market supremacy. The overall national health spending in the United States reached USD 4.1 Trillion in 2020, with a 5.4% annual growth rate expected through 2028. The emphasis on personalized medicine, with the worldwide industry estimated to reach USD 3.18 Trillion by 2025, highlights North America's significant position (source: HHS). Furthermore, effective payment mechanisms and stringent regulatory criteria, such as those established by the FDA, promote the widespread use and ongoing development of point-of-care coagulation diagnostic equipment. The region's market leadership is driven by its comprehensive support infrastructure.

Asia Pacific:

The Asia Pacific region is seeing the fastest growth rate in the point of care coagulation testing devices market, owing to a variety of factors. This rapid rise is being fueled by considerable advances in healthcare infrastructure, improved healthcare awareness, and an increasing prevalence of chronic diseases. Emerging economies such as China and India are making significant progress in increasing healthcare access and quality, which is driving up the adoption of point-of-care testing solutions. For example, healthcare spending in China is predicted to increase to 6.5% of GDP by 2025, up from 5.3% in 2019.

The rising demand for point-of-care coagulation testing devices is also being driven by the region's increased emphasis on improving diagnostic capabilities and extending healthcare services. According to the World Health Organization, the prevalence of chronic diseases such as cardiovascular disease and diabetes is increasing, necessitating the development of sophisticated diagnostic technologies.

Government initiatives such as India's "Ayushman Bharat" program, which aims to provide universal health coverage and enhance access to quality healthcare, are propelling the market forward. These characteristics, combined with increased awareness among healthcare professionals and patients, help to drive Asia Pacific's rapid rise in the point-of-care coagulation testing market.

Global Point of Care Coagulation Testing Devices Market: Segmentation Analysis

The Global Point of Care Coagulation Testing Devices Market is Segmented on the basis of Device Type, Technology, End-User, And Geography.

Point of Care Coagulation Testing Devices Market, By Device Type

Anticoagulation Monitoring Devices

Platelet Function Monitoring Devices

Viscoelastic Coagulation Monitoring Devices

Based on Device Type, the market is bifurcated into Anticoagulation Monitoring Devices, Platelet Function Monitoring Devices, and Viscoelastic Coagulation Monitoring Devices. Anticoagulation monitoring devices now dominate the point-of-care coagulation testing market due to the widespread usage of anticoagulant drugs. However, the fastest-growing segment is viscoelastic coagulation monitoring devices, which provide a more comprehensive assessment of the clotting process and are becoming increasingly popular in critical care settings.

Point of Care Coagulation Testing Devices Market, By Technology

Optical Technology

Mechanical Technology

Electrochemical Technology

Based on Technology, the market is segmented into Optical Technology, Mechanical Technology, and Electrochemical Technology. Electrochemical technology currently dominates the point-of-care coagulation testing market due to its dependability, sensitivity, and low cost. Optical technology is emerging as the fastest-growing area, with benefits such as non-invasive testing, quick results, and the ability to integrate with other diagnostic equipment. This trend indicates an increasing desire for technologies that deliver efficient, accurate, and patient-friendly testing solutions.

Point of Care Coagulation Testing Devices Market, By End-User

Hospitals

Clinics

Home Care Settings

Ambulatory Surgical Centers

Based on End-User, the market is segmented into Hospitals, Clinics, Home Care Settings, and Ambulatory Surgical Centers. Hospitals is expected to lead the point-of-care coagulation testing market due to the large number of patients that require frequent monitoring. Home care settings are witnessing the quickest expansion, owing to an increase in the number of patients with chronic diseases who require ongoing coagulation control. This trend is spurred by technological improvements that allow for accurate testing outside of healthcare facilities, giving patients more convenience and flexibility.

Point of Care Coagulation Testing Devices Market, By Geography

North America

Europe

Asia Pacific

Rest of the World

On the basis of Geography, the Global Point of Care Coagulation Testing Devices Market is classified into North America, Europe, Asia Pacific, and the Rest of the World. North America dominates the point-of-care coagulation testing market, owing to its well-established healthcare infrastructure, improved technology adoption, and high prevalence of chronic disorders. However, the Asia Pacific area is experiencing the highest growth, owing to rising healthcare spending, increased awareness of chronic illnesses, and rapid urbanization. Growing populations, improved healthcare facilities, and rising disposable incomes are all helping to drive the region's major market growth.

Key Players

The "Global Point of Care Coagulation Testing Devices Market" study report will provide valuable insight with an emphasis on the global market. The major players in the market are Hoffmann-La Roche AG, Abbott Laboratories, Siemens Healthineers, Medtronic plc, Haemonetics Corporation, HemoSonics LLC, Micropoint Bioscience, Inc., Werfen, Sienco, Inc., and Koninklijke Philips N.V. The competitive landscape section also includes key development strategies, market share, and market ranking analysis of the above-mentioned players globally.

Our market analysis also entails a section solely dedicated to such major players wherein our analysts provide an insight into the financial statements of all the major players, along with product benchmarking and SWOT analysis. The competitive landscape section also includes key development strategies, market share, and market ranking analysis of the above-mentioned players globally.

• Point of Care Coagulation Testing Devices Market Recent Developments
• In October 2023, Universal Biosensors (UBI) got approval to offer Xprecia Prime 4U directly to patients for self-testing in Europe. The Xprecia Prime is a portable coagulation testing equipment that allows for quick and accurate blood clotting testing.
• In November 2022, The FDA granted HemoSonics, LLC. 510(k) market clearance for the Quantra Hemostasis System with QStat Cartridge. It contributed to Quantra's overall diagnostic capabilities and provided the widest range of clinical indications of any point-of-care hemostasis analyzer available in the United States.
• In January 2022, Werfen gained 510(k) clearance from the US Food and Drug Administration (FDA) for the GEM Hemochron 100 whole-blood hemostasis system. The GEM Hemochron 100 system provides quick, actionable active clotting time (ACT) results in minutes, informs patient-management decisions, and improves workflow at the point of care (POC).
• In May 2021, The European Commission granted Perosphere Technologies Inc. the CE mark for its Point-of-Care (PoC) Coagulometer System.

TABLE OF CONTENTS

1. Introduction

• Market Definition
• Market Segmentation
• Research Methodology

2. Executive Summary

• Key Findings
• Market Overview
• Market Highlights

3. Market Overview

• Market Size and Growth Potential
• Market Trends
• Market Drivers
• Market Restraints
• Market Opportunities
• Porter's Five Forces Analysis

4. Point Of Care Coagulation Testing Devices Market, By Product Type

• Coagulation Monitors
• Consumables (like test strips, reagents)
• Coagulation Analyzers

5. Point Of Care Coagulation Testing Devices Market, By Technology

• Optical Technology
• Mechanical Technology
• Electrochemical Technology

6. Point Of Care Coagulation Testing Devices Market, By End-User

• Hospitals
• Clinics
• Home Care Settings
• Ambulatory Surgical Centers

7. Regional Analysis

• North America
• United States
• Canada
• Mexico
• Europe
• United Kingdom
• Germany
• France
• Italy
• Asia-Pacific
• China
• Japan
• India
• Australia
• Latin America
• Brazil
• Argentina
• Chile
• Middle East and Africa
• South Africa
• Saudi Arabia
• UAE

8. Market Dynamics

• Market Drivers
• Market Restraints
• Market Opportunities
• Impact of COVID-19 on the Market

9. Competitive Landscape

• Key Players
• Market Share Analysis

10. Company Profiles

• F. Hoffmann-La Roche AG
• Abbott Laboratories
• Siemens Healthineers
• Medtronic plc
• Haemonetics Corporation
• HemoSonics, LLC
• Micropoint Bioscience, Inc.
• Werfen
• Sienco, Inc.
• Koninklijke Philips N.V.

11. Market Outlook and Opportunities

• Emerging Technologies
• Future Market Trends
• Investment Opportunities

12. Appendix

• List of Abbreviations
• Sources and References