全球照護現場血液凝固檢驗設備市場規模（按設備類型、技術、最終用戶、區域覆蓋範圍和預測）

照護現場血液凝固檢驗設備的市場規模與預測

預計 2024 年照護現場血液凝固檢驗市場價值將達到 19.8 億美元，到 2031 年將達到 34.2 億美元，2024 年至 2031 年的複合年成長率為 7.05%。

照護現場(POC)血液凝固檢驗設備是一種診斷儀器，可在病患照護點或接近照護端（而非集中實驗室）快速提供凝血參數結果。這些設備可評估多種凝血參數，包括凝血酶原時間 (PT)、活化部份凝血活酵素時間(aPTT) 和國際標準化比率 (INR)。這些參數對於管理患者的抗凝血和出血性疾病至關重要。血液凝固檢驗最常用於需要快速且準確地評估凝血功能的場所，例如急診、手術室和抗凝血診所。該技術可實現快速決策和快速調整治療方案，從而提高患者安全性和醫療效率。

隨著技術進步提高準確性、易用性以及與電子健康記錄(EHR) 的整合度，POC血液凝固檢驗設備前景看好。技術創新有望提高這些設備的靈敏度和特異性，使其能夠更準確地監測複雜的凝血模式。

攜帶式易用技術的開發有望擴大其在居家醫療環境和偏遠地區的應用，從而提高可及性和患者便利性。隨著持續的研究和開發，照護現場血液凝固檢驗設備預計將在個人化醫療和即時患者管理中發揮更重要的作用，從而改善臨床療效並簡化醫療保健操作。

全球照護現場血液凝固檢驗設備市場動態

影響全球照護現場血液凝固檢驗設備市場的關鍵市場動態是：

關鍵市場促進因素

心血管疾病發生率不斷上升：根據世界衛生組織（WHO）的數據，心血管疾病是全球整體%。根據美國心臟協會的數據，在美國，每40秒就會發生一次心臟病發作，每36秒就會有一人死於心血管疾病相關事件。

出血性疾病盛行率不斷上升：世界血友病聯盟估計，全球約有100萬人患有血友病、血管性血友病和其他罕見的遺傳性出血性疾病。此外，根據2019年發表在《血栓與止血雜誌》上的一項研究，最常見的遺傳性出血性疾病－血管性血友病，影響全球0.6%-1.3%的人口。

老年人口不斷增加：聯合國預測，全球65歲及以上人口將大幅成長，從2020年的7.27億增加到2050年的15億。同時，凝血障礙的盛行率隨著老齡化的成長而增加，根據發表在《美國老年醫學會雜誌》上的一項研究，80歲及以上的人中約有10%患有其中一種凝血障礙。

主要挑戰

法規合規性照護現場血液凝固檢驗設備必須符合許多領域的嚴格監管標準。要符合美國FDA和歐洲CE認證等法規，需要進行大量的測試和認證流程，這對製造商來說既昂貴又耗時。

準確性和可靠性：照護現場血液凝固檢驗必須準確可靠。這些設備必須提供與實驗室檢測結果一致且準確的結果，因為這些設備的故障可能導致錯誤的治療決策和不良的患者預後。

與電子健康記錄(EHR) 整合：就地檢驗設備與現有 EHR 系統整合可能頗具挑戰性。無縫資料傳輸對於有效的患者管理和記錄保存至關重要，但技術挑戰和相容性問題可能會阻礙這種整合。

設備維護與校準：就地檢驗設備必須定期維護和校準，以確保其準確性。這項要求可能會增加醫療機構的營運工作量和成本。

主要趨勢：

家庭醫療保健應用日益普及：隨著個人化醫療的興起，家庭就地檢驗設備的需求日益成長。患有慢性疾病或服用抗凝血劑的患者可以在家中監測凝血狀態，從而提高便利性和依從性。

與數位健康平台的整合：數位健康平台與行動應用程式的整合正變得越來越普遍。這些連接實現了無縫數據共用、即時監控以及更完善的患者健康記錄管理​​，從而改善了整體患者照護。

監管和報銷變化：醫療保健法規和報銷政策不斷變化，影響就地檢驗市場。製造商必須應對不斷變化的監管環境，並適應新的報銷機制，才能在市場上立足並盈利。

多參數檢測設備的開發：能夠同時檢查多個凝血指標的多參數檢測設備正變得越來越流行。這些設備能夠提供全面的診斷，簡化檢測流程，並減少多次檢測的需求。

目錄

第1章 引言

• 市場定義
• 市場區隔
• 調查方法

第2章執行摘要

• 主要發現
• 市場概況
• 市場亮點

第3章 市場概況

• 市場規模和成長潛力
• 市場趨勢
• 市場促進因素
• 市場限制
• 市場機遇
• 波特五力分析

4. POC血液凝固檢驗設備市場（依產品類型）

• 凝血監測儀
• 耗材（試紙、試劑等）
• 凝血分析儀

5. POC血液凝固檢驗設備市場（按技術）

• 光學技術
• 機械技術
• 電化學技術

6. POC血液凝固檢驗設備市場（依最終用戶）

• 醫院
• 診所
• 居家醫療
• 門診手術中心

第7章區域分析

• 北美洲
• 美國
• 加拿大
• 墨西哥
• 歐洲
• 英國
• 德國
• 法國
• 義大利
• 亞太地區
• 中國
• 日本
• 印度
• 澳洲
• 拉丁美洲
• 巴西
• 阿根廷
• 智利
• 中東和非洲
• 南非
• 沙烏地阿拉伯
• 阿拉伯聯合大公國

第8章市場動態

• 市場促進因素
• 市場限制
• 市場機遇
• COVID-19 市場影響

第9章 競爭態勢

• 主要企業
• 市佔率分析

第10章：公司簡介

• 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11章 市場展望與機遇

• 新興技術
• 未來市場趨勢
• 投資機會

第12章 附錄

• 簡稱列表
• 來源和參考文獻

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