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市场调查报告书
商品编码
1654682
全球凝血监测产品市场 - 2025 至 2033 年Global Coagulation Monitoring Products Market - 2025-2033 |
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2024 年全球凝血监测产品市场规模达到 48.2 亿美元,预计到 2033 年将达到 78.1 亿美元,2025-2033 年预测期间的复合年增长率为 5.6%。
凝血监测产品是用于测量和评估血液凝固能力的医疗设备和诊断工具。这些产品主要用于监测抗凝血治疗的有效性(例如服用华法林或其他血液稀释剂的患者)或评估出血和血栓形成的风险。
凝血监测有助于诊断和治疗与血液凝固相关的疾病,包括深部静脉栓塞 (DVT)、肺栓塞 (PE)、心房颤动 (AF) 和血友病等疾病。凝血监测产品最常见的用途是管理服用华法林、肝素和较新的直接口服抗凝血剂等抗凝血药物的患者。这些测试有助于调整药物剂量以确保治疗效果并最大限度地降低出血或血栓形成等不良事件的风险。
过去几年来,由于人们越来越意识到临床和家庭环境中凝血监测的重要性,凝血疾病发生率不断上升,以及即时诊断设备的技术进步,凝血监测产品市场显着成长。
例如,根据美国国立卫生研究院的研究,体外膜氧合 (ECMO) 患者通常身体状况不佳,这会增加出血问题的风险。 ECMO 期间出血发生率为 20.8% 至 39.6%,其中插管部位(13.2%)、胃肠道(5.5%)、肺部(6.1%)和中枢神经系统(3.9%)是最常见的部位。 ECMO患者也容易发生缺血性中风、右心室血栓、左心室血栓、肺栓塞等血栓问题。因此,出血併发症的风险增加了对凝血监测产品的需求。
驱动因素与约束因素
血液疾病盛行率上升
血液疾病盛行率的上升极大地推动了凝血监测产品市场的成长,预计在预测期内仍将推动市场的发展。血液疾病盛行率不断上升,特别是静脉血栓栓塞症 (VTE)、心房颤动 (AF)、血友病和维生素 K 缺乏症等凝血相关疾病,大大推动了凝血监测产品市场的发展。这些疾病需要持续监测血液凝固和抗凝血治疗,以防止中风、器官损伤和过度出血等严重併发症。
例如,根据美国疾病管制与预防中心 (CDC) 的数据,美国每年有多达 90 万人患有静脉血栓栓塞症 (VTE,血栓)。据估计,每年有 60,000-100,000 美国人死于 VTE,还有许多人因 VTE 而出现长期併发症。大约四分之一(25%)的肺栓塞患者的第一个症状是猝死。受深部静脉栓塞 (DVT) 或肺栓塞 (PE) 影响的确切人数尚不清楚,但在美国,每年可能有多达 90 万人受到影响。
心房颤动 (AF) 和深部静脉栓塞 (DVT) 等血液疾病通常需要长期抗凝血治疗,例如华法林、肝素和 DOAC,以防止血栓形成。这些治疗需要频繁进行凝血测试以监测国际标准化比率(INR),这是凝血的关键指标,以确保治疗在治疗范围内。
例如,根据美国国立卫生研究院的估计,到2050年,美国将有600万至1200万人患有心房颤动,到2060年,欧洲将有1,790万人患有心房颤动。 全球心房颤动患病率为375.74亿凝血例(占世界人口的0.51%),在过去20%,其中许多需求增加了治疗患者的需求量增长。
白血病、淋巴瘤和骨髓瘤等血癌会影响血小板、凝血因子和凝血系统其他关键成分的产生。这会增加这些患者出血或血栓形成的风险。例如,白血病患者可能会出现血小板减少症(血小板计数低),这使他们更容易出现出血或凝血併发症。
根据白血病和淋巴瘤协会统计,大约每 3 分钟,美国就有一人被诊断出患有白血病、淋巴瘤或骨髓瘤。预计 2024 年美国共有 187,740 人将被诊断出患有白血病、淋巴瘤或骨髓瘤。
来自替代诊断方法的竞争
预计在预测期内,替代诊断方法的竞争将阻碍凝血监测产品市场的成长。虽然传统凝血测试和即时诊断设备被广泛用于监测血液凝固障碍,但非侵入性技术、生物感测器和穿戴式装置等替代诊断方法正在成为竞争对手,在成本、易用性和患者舒适度方面具有优势。这些替代方案有可能减少对传统凝血监测方法的依赖,对市场构成挑战。
能够追踪与凝血障碍相关的生物标记的可穿戴设备(如智慧手錶和专用生物感测器)的出现日益受到凝血监测产品市场的关注。这些设备越来越能够监测各种健康参数,包括血压、心率甚至血液凝固,只需要极少的使用者介入。
例如,苹果等公司正在探索在其穿戴式装置中整合健康监测功能,这可能扩展到监测凝血等血液参数,从而减少对传统凝血监测系统的需求。
儘管传统的凝血监测设备对于个人患者来说可能很昂贵,特别是对于家庭护理使用,但替代诊断方法,例如生物感测器和可穿戴健康设备正变得越来越便宜和容易获得。这在资源匮乏的环境中尤其重要,因为成本是采用传统凝血监测系统的主要障碍。
The global coagulation monitoring products market reached US$ 4.82 billion in 2024 and is expected to reach US$ 7.81 billion by 2033, growing at a CAGR of 5.6% during the forecast period 2025-2033.
Coagulation monitoring products are medical devices and diagnostic tools designed to measure and evaluate the coagulation (clotting) ability of blood. These products are used primarily to monitor the effectiveness of anticoagulation therapy (such as for patients on warfarin or other blood thinners) or to assess the risk of bleeding and thrombosis.
Coagulation monitoring helps in diagnosing and managing disorders related to blood clotting, including conditions like deep vein thrombosis (DVT), pulmonary embolism (PE), atrial fibrillation (AF) and hemophilia. The most common use of coagulation monitoring products is to manage patients on anticoagulant drugs like warfarin, heparin and the newer direct oral anticoagulants. These tests help adjust medication doses to ensure therapeutic efficacy and minimize the risk of adverse events, such as bleeding or clot formation.
The coagulation monitoring products market has grown significantly over the last few years due to increased awareness of the importance of coagulation monitoring in both clinical and home settings, rising incidences of coagulation disorders and technological advancements in point-of-care devices.
For instance, according to the National Institute of Health study, extracorporeal membrane oxygenation (ECMO) patients are typically unwell, which raises the risk of bleeding problems. The bleeding rate during ECMO ranges from 20.8% to 39.6%, with the cannula site (13.2%), gastrointestinal tract (5.5%), lungs (6.1%) and central nervous system (3.9%) being the most common sites. ECMO patients are also susceptible to thrombosis problems such as ischemic stroke, right ventricular thrombus, left ventricular thrombus, and pulmonary embolism. Thus, this risk of bleeding complications increases the demand for coagulation monitoring products.
Market Dynamics: Drivers & Restraints
Rising prevalence of blood disorders
The rising prevalence of blood disorders is significantly driving the growth of the coagulation monitoring products market and is expected to drive the market over the forecast period. The rising prevalence of blood disorders, particularly coagulation-related conditions such as venous thromboembolism (VTE), atrial fibrillation (AF), hemophilia and vitamin K deficiencies, is significantly driving the coagulation monitoring products market. These disorders require continuous monitoring of blood clotting and anticoagulation therapy to prevent severe complications such as stroke, organ damage and excessive bleeding.
For instance, according to the Centers for Disease Control and Prevention (CDC), up to 900,000 people in the United States are affected by venous thromboembolism (VTE, a blood clot), each year. An estimated 60,000-100,000 Americans die of VTE each year and many others have long-term complications from VTE. Sudden death is the first symptom in about one-quarter (25%) of people who have a pulmonary embolism. The precise number of people affected by either deep vein thrombosis (DVT) or pulmonary embolism (PE) is unknown, although as many as 900,000 people could be affected each year in the United States.
Blood disorders like atrial fibrillation (AF) and deep vein thrombosis (DVT) often require long-term anticoagulation therapy such as warfarin, heparin and DOACs to prevent clot formation. These treatments require frequent coagulation tests to monitor the International Normalized Ratio (INR), a key measure of clotting, to ensure the therapy is within the therapeutic range.
For instance, according to the National Institute of Health, atrial fibrillation has been estimated that 6-12 million people will suffer from this condition in the US by 2050 and 17.9 million people in Europe by 2060. The worldwide prevalence of atrial fibrillation is 37,574 million cases (0.51% of the worldwide population), which increased by 33% during the last 20 years, with many requiring ongoing anticoagulation therapy, thereby increasing demand for coagulation monitoring products.
Blood cancers, such as leukemia, lymphomas and myeloma, can affect the production of platelets, clotting factors and other key components of the coagulation system. This leads to an increased risk of bleeding or thrombosis in these patients. For instance, leukemia patients can experience thrombocytopenia (low platelet count), making them more susceptible to bleeding or clotting complications.
According to the Leukemia & Lymphoma Society, approximately every 3 minutes, one person in the US is diagnosed with leukemia, lymphoma or myeloma. An estimated combined total of 187,740 people in the US are expected to be diagnosed with leukemia, lymphoma or myeloma in 2024. New cases of leukemia, lymphoma and myeloma are expected to account for 9.4 percent of the estimated 2,001,140 new cancer cases that will be diagnosed in the US in 2024.
Competition from alternative diagnostic methods
Competition from alternative diagnostic methods is expected to hamper the growth of the coagulation monitoring products market over the forecast period. While traditional coagulation tests and point-of-care devices are widely used for monitoring blood clotting disorders, alternative diagnostic methods, such as non-invasive technologies, biosensors and wearable devices, are emerging as competitors, offering advantages in terms of cost, ease of use and patient comfort. These alternatives pose a challenge to the market by potentially reducing the reliance on traditional coagulation monitoring methods.
The advent of wearable devices, such as smartwatches and specialized biosensors, capable of tracking biomarkers associated with coagulation disorders is a growing concern for the coagulation monitoring products market. These devices are increasingly able to monitor various health parameters, including blood pressure, heart rate and potentially even blood clotting, with minimal user intervention.
For instance, companies like Apple are exploring the integration of health-monitoring capabilities in their wearables, which could potentially extend to monitoring blood parameters like clotting, thus reducing the demand for traditional coagulation monitoring systems.
While traditional coagulation monitoring devices can be expensive for individual patients, particularly for home care use, alternative diagnostic methods, such as biosensors and wearable health devices are increasingly becoming more affordable and accessible. This is particularly important in low-resource settings, where cost is a major barrier to the adoption of traditional coagulation monitoring systems.
The global coagulation monitoring products market is segmented based on product type, end-user and region.
The reagents segment is expected to dominate the coagulation monitoring products market share
Coagulation reagents are specialized products used in diagnostic testing to evaluate blood clotting mechanisms. Reagents are used in tests like prothrombin time, aPTT, and fibrinogen, detecting clotting factor deficiencies, anticoagulant therapy efficacy and bleeding disorders. These reagents are essential in hematology, particularly in health screening, illness diagnosis and the treatment of blood clotting disorders.
Advancements in reagent formulations have improved test sensitivity, stability and compatibility with automated analyzers. The demand for high-quality, standardized reagents is driven by the increasing prevalence of coagulation disorders, growing surgical procedures, and the adoption of point-of-care testing devices.
Coagulation reagents are essential components in diagnostic procedures, specifically for determining the blood's capacity to clot properly. They play an important role in a variety of medical settings, including routine health screenings and emergency medicine. Commonly used coagulation reagents include PT Reagents, aPPT Reagents, Thrombin Time Reagents, D-Dimer Reagents and Others.
North America is expected to hold a significant position in the coagulation monitoring products market share
The North America region is expected to hold the largest market share over the forecast period owing to the presence of major market players particularly in the United States such as F. Hoffmann-La Roche Ltd., Siemens Healthcare AG, Abbott Laboratories and other startups and emerging players. These major market players mainly focus on market expansion by novel product launches, advancements in the products, expansion strategies to enhance the company's product portfolio for coagulation monitoring, which is expected to further drive the market growth.
For instance, in February 2024, Roche launched three new coagulation tests for the oral Factor Xa inhibitors apixaban, edoxaban and rivaroxaban. These anticoagulants were added to the World Health Organization's Model List of Essential Medicines due to their potential advantages for patients. The tests could aid in clinical decision-making in patients receiving direct oral anticoagulants for the prevention of stroke and systemic embolism in patients with non-valvular atrial fibrillation, coronary artery disease (CAD), peripheral arterial disease (PAD) and venous thromboembolism (VTE).
Additionally, in July 2023, Baxter International launched the PERCLOT Absorbable Hemostatic Powder in the U.S., a passive, absorbable powder designed for patients with intact coagulation to address mild bleeding.
Moreover, the rising prevalence of blood disorders in the region especially in the United States is driving the demand for coagulation monitoring products market. For instance, according to Leukemia & Lymphoma Society, about every 3 minutes, a person in the US is diagnosed with either leukemia, lymphoma or myeloma. In the year 2024, the overall projected case of leukemia, lymphoma or myeloma in the US is 187,740. New incidences of leukemia, lymphoma and myeloma cases will represent 9.4% of the new cancer cases projected for diagnosis in the US in the year 2024 which will be 2,001,140 cases.
Asia-Pacific is growing at the fastest pace in the coagulation monitoring products market
The Asia-Pacific region is experiencing the fastest growth in the coagulation monitoring products market. This is due to a rise in the cases of blood disorders and also non-communicable diseases that require monitoring of blood coagulation such as diabetes and cardiovascular diseases. Other factors stimulating the growth of the market are change in people's perception towards the attention that needs to be given
to the diagnosis and treatment of various complications arising from blood coagulability. Improvements in health care systems and more adoption of diagnostic products and services are also driving the growth of the market.
For instance, in September 2024, Sysmex Corporation has officially dispensed the HISCL HIT IgG Assay Kit in Japan which measures IgG antibody levels of platelet factor 4 and heparin complexes. The kit is for use in Automated Blood Coagulation Analyzers CN-6500/CN-3500 which include HISCL-Series technology.
Additionally, in May 2023, QuidelOrtho and Render launched the IHTEG6 thromboelastography at the 20th China Association of Clinical Laboratory Practice Expo. Thromboelastography is a crucial tool for monitoring coagulation during surgery and has become a vital tool for managing blood products in sophisticated nations worldwide.
The major global players in the coagulation monitoring products market include Siemens Healthcare AG, Abbott Laboratories, Beckman Coulter, Inc., Sysmex Corporation, Thermo Fisher Scientific Inc., HemoSonics, LLC., Helena Laboratories Corporation., F. Hoffmann-La Roche Ltd., Horiba Group, Maccura Biotechnology Co., Ltd., Shenzhen Mindray Bio-Medical Electronics Co., Ltd., Sclavo Diagnostics International SpA, BIOGENIX INC. PVT. LTD. and among others.
The global coagulation monitoring products market report delivers a detailed analysis with 63 key tables, more than 46 visually impactful figures, and 159 pages of expert insights, providing a complete view of the market landscape.
Target Audience 2024
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