POC(Point of Care) 응고 검사 기기 시장 규모는 2024년에 19억 8,000만 달러로 평가되며, 2024-2031년에 CAGR 7.05%로 성장하며, 2031년에는 34억 2,000만 달러에 달할 것으로 예측됩니다.
POC(Point of Care) 응고 검사 기기는 혈액 응고 파라미터의 신속한 결과를 센트럴 랩과 달리 환자의 치료 시점 또는 그 근처에서 제공하는 진단 장비입니다. 이 기기들은 프로트롬빈 시간(PT), 활성화 부분 트롬보플라스틴 시간(aPTT), 국제 표준화 비율(INR) 등 다양한 혈액 응고 파라미터를 평가합니다. 이러한 매개변수는 환자의 항응고제 및 출혈성 질환 관리에 필수적입니다. POC 응고 검사는 응급실, 수술실, 항응고 클리닉 등 신속하고 정확한 응고 평가가 필요한 환경에서 가장 많이 사용되고 있습니다. 이 기술은 빠른 의사결정과 신속한 치료 변경을 가능하게 하여 환자의 안전과 의료의 효율성을 향상시킵니다.
POC 응고검사 장비는 기술적 개선으로 정확도가 향상되고, 사용이 간편해졌으며, 전자건강기록(EHR)과의 연동이 가능해지면서 유망하게 여겨지고 있습니다. 기술 혁신을 통해 이러한 기기의 민감도와 특이도가 향상되어 복잡한 응고 패턴을 보다 정확하게 모니터링할 수 있게 될 것으로 예측됩니다.
휴대가 가능하고 사용하기 쉬운 기술이 개발되면 재택의료 현장이나 원격지에서의 적용이 확대되어 이용의 편의성과 환자의 편의성이 향상될 수 있습니다. 지속적인 연구개발을 통해 맞춤형 의료와 실시간 환자 관리에서 현장 응고 검사 기기의 중요성이 더욱 커질 것으로 예상되며, 임상 결과 개선과 의료 업무의 간소화로 이어질 것으로 전망됩니다.
세계의 POC(Point of Care) 응고 검사 기기 시장을 형성하는 주요 시장 역학은 다음과 같습니다.
주요 시장 성장 촉진요인
심혈관 질환 발생률 증가: 세계보건기구(WHO)의 보고에 따르면 2019년 심혈관 질환은 전 세계 사망자의 32%인 1,790만 명을 차지하며 세계 사망 원인 1위로 나타났습니다. 미국심장협회에 따르면 미국에서는 40초에 한 번씩 심장마비가 발생하며, 36초에 한 명씩 심혈관 질환으로 사망하는 것으로 나타났습니다.
출혈성 질환의 유병률 증가: 세계혈우연맹은 전 세계에서 약 100만 명이 혈우병, 폰빌레브란트병 및 기타 희귀한 유전성 출혈성 질환을 앓고 있는 것으로 추정하고 있습니다. 또한 2019년 Journal of Thrombosis and Haemostasis에 발표된 연구에 따르면 가장 흔한 유전성 출혈성 질환인 폰 빌레브란트병은 전 세계 인구의 0.6-1.3%가 앓고 있는 것으로 나타났습니다.
노령인구 증가: 유엔은 65세 이상 세계 인구가 2020년 7억 2,700만 명에서 2050년 15억 명으로 증가하여 노인 인구 비율이 크게 증가할 것으로 예측했습니다. 동시에, Journal of the American Geriatrics Society에 발표된 연구에 따르면 응고 장애의 유병률은 나이가 들어감에 따라 증가하며, 80세 이상 노인의 약 10%가 응고 장애를 앓고 있다고 합니다.
주요 과제
규제 준수 POC(Point-Of-Care) 응고 검사 기기는 많은 분야에서 엄격한 규제 기준을 충족해야 합니다. 미국 FDA, 유럽 CE 마킹 등의 규제를 준수하기 위해서는 대규모 시험 및 인증 프로세스가 필요하며, 제조업체에게는 비용과 시간이 많이 소요됩니다.
정확성과 신뢰성: 현장 응고 검사는 정확하고 신뢰할 수 있어야 합니다. 이러한 검사 장비는 실험실 검사와 동등한 수준의 일관되고 정확한 결과를 내야 합니다. 왜냐하면, 이러한 검사 장비의 오류는 잘못된 치료 방침 결정과 환자 예후로 이어질 수 있기 때문입니다.
전자의무기록(EHR)과의 통합: 현장 검사 장비와 기존 EHR 시스템과의 연동은 어려울 수 있습니다. 원활한 데이터 전송은 효과적인 환자 관리와 기록 관리에 필수적이지만, 기술적 어려움과 호환성 문제가 이러한 통합을 방해할 수 있습니다.
장비의 정비 및 교정 : POC(Point-Of-Care) 검사 장비는 정확성을 보장하기 위해 정기적으로 정비 및 교정을 수행해야합니다. 이 요구사항은 의료시설의 운영상의 번거로움과 비용을 증가시킬 수 있습니다.
주요 동향 :
재택 헬스케어의 채택 증가: 개인 맞춤형 헬스케어의 확산과 함께 집에서 사용할 수 있는 현장 검사 장비에 대한 수요가 증가하고 있습니다. 만성질환을 앓고 있거나 항응고제를 복용하는 환자들은 집에서 응고 상태를 모니터링할 수 있으며, 편의성과 순응도를 높일 수 있습니다.
디지털 헬스 플랫폼과의 통합: 디지털 헬스 플랫폼 및 모바일 앱과의 통합이 빈번하게 이루어지고 있습니다. 이러한 연결은 원활한 데이터 공유, 실시간 모니터링, 환자 건강 기록의 더 나은 관리를 통해 전체 환자 치료를 개선할 수 있습니다.
규제와 상환의 변화: 의료 규정과 상환 정책은 끊임없이 변화하고 있으며, 이는 현장 진료 검사 시장에 영향을 미치고 있습니다. 제조업체는 시장 진입과 수익성을 유지하기 위해 규제 환경의 변화를 극복하고 새로운 상환 메커니즘에 적응해야 합니다.
멀티파라미터 검사 장비의 개발 : 여러 응고 변수를 동시에 검사할 수 있는 멀티파라미터 검사 장비의 보급이 진행되고 있습니다. 이러한 장비는 종합적인 진단을 제공하고 검사 절차를 간소화하며 여러 검사의 필요성을 감소시킵니다.
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.
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.
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.
The Global Point of Care Coagulation Testing Devices Market is Segmented on the basis of Device Type, Technology, End-User, And Geography.
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.
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.
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.
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.
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.