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市場調查報告書
商品編碼
1654682
全球凝血監測產品市場 - 2025 至 2033 年Global Coagulation Monitoring Products Market - 2025-2033 |
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2024 年全球凝血監測產品市場規模達到 48.2 億美元,預計到 2033 年將達到 78.1 億美元,2025-2033 年預測期間的複合年成長率為 5.6%。
凝血監測產品是用於測量和評估血液凝固能力的醫療設備和診斷工具。這些產品主要用於監測抗凝血治療的有效性(例如服用華法林或其他血液稀釋劑的患者)或評估出血和血栓形成的風險。
凝血監測有助於診斷和治療與血液凝固相關的疾病,包括深部靜脈栓塞 (DVT)、肺栓塞 (PE)、心房顫動 (AF) 和血友病等疾病。凝血監測產品最常見的用途是管理服用華法林、肝素和較新的直介面服抗凝血劑等抗凝血藥物的患者。這些測試有助於調整藥物劑量以確保治療效果並最大限度地降低出血或血栓形成等不良事件的風險。
過去幾年來,由於人們越來越意識到臨床和家庭環境中凝血監測的重要性,凝血疾病發生率不斷上升,以及即時診斷設備的技術進步,凝血監測產品市場顯著成長。
例如,根據美國國立衛生研究院的研究,體外膜氧合 (ECMO) 患者通常身體狀況不佳,這會增加出血問題的風險。 ECMO 期間出血發生率為 20.8% 至 39.6%,其中插管部位(13.2%)、胃腸道(5.5%)、肺部(6.1%)和中樞神經系統(3.9%)是最常見的部位。 ECMO患者也容易發生缺血性中風、右心室血栓、左心室血栓、肺栓塞等血栓問題。因此,出血併發症的風險增加了對凝血監測產品的需求。
促進因素與約束因素
血液疾病盛行率上升
血液疾病盛行率的上升極大地推動了凝血監測產品市場的成長,預計在預測期內仍將推動市場的發展。血液疾病盛行率不斷上升,特別是靜脈血栓栓塞症 (VTE)、心房顫動 (AF)、血友病和維生素 K 缺乏症等凝血相關疾病,大大推動了凝血監測產品市場的發展。這些疾病需要持續監測血液凝固和抗凝血治療,以防止中風、器官損傷和過度出血等嚴重併發症。
例如,根據美國疾病管制與預防中心 (CDC) 的數據,美國每年有多達 90 萬人患有靜脈血栓栓塞症 (VTE,血栓)。據估計,每年有 60,000-100,000 美國人死於 VTE,還有許多人因 VTE 而出現長期併發症。大約四分之一(25%)的肺栓塞患者的第一個症狀是猝死。受深部靜脈栓塞 (DVT) 或肺栓塞 (PE) 影響的確切人數尚不清楚,但在美國,每年可能有多達 90 萬人受到影響。
心房顫動 (AF) 和深部靜脈栓塞 (DVT) 等血液疾病通常需要長期抗凝血治療,例如華法林、肝素和 DOAC,以防止血栓形成。這些治療需要頻繁進行凝血測試以監測國際標準化比率(INR),這是凝血的關鍵指標,以確保治療在治療範圍內。
例如,根據美國國立衛生研究院的估計,到2050年,美國將有600萬至1200萬人患有心房顫動,到2060年,歐洲將有1,790萬人患有心房顫動。 全球心房顫動患病率為375.74億凝血例(佔世界人口的0.51%),在過去20%,其中許多需求增加了治療患者的需求量成長。
白血病、淋巴瘤和骨髓瘤等血癌會影響血小板、凝血因子和凝血系統其他關鍵成分的產生。這會增加這些患者出血或血栓形成的風險。例如,白血病患者可能會出現血小板減少症(血小板計數低),這使他們更容易出現出血或凝血併發症。
根據白血病和淋巴瘤協會統計,大約每 3 分鐘,美國就有一人被診斷出患有白血病、淋巴瘤或骨髓瘤。預計 2024 年美國共有 187,740 人將被診斷出患有白血病、淋巴瘤或骨髓瘤。
來自替代診斷方法的競爭
預計在預測期內,替代診斷方法的競爭將阻礙凝血監測產品市場的成長。雖然傳統凝血測試和即時診斷設備被廣泛用於監測血液凝固障礙,但非侵入性技術、生物感測器和穿戴式裝置等替代診斷方法正在成為競爭對手,在成本、易用性和患者舒適度方面具有優勢。這些替代方案有可能減少對傳統凝血監測方法的依賴,對市場構成挑戰。
能夠追蹤與凝血障礙相關的生物標記的穿戴式設備(如智慧手錶和專用生物感測器)的出現日益受到凝血監測產品市場的關注。這些設備越來越能夠監測各種健康參數,包括血壓、心率甚至血液凝固,只需要極少的使用者介入。
例如,蘋果等公司正在探索在其穿戴式裝置中整合健康監測功能,這可能擴展到監測凝血等血液參數,從而減少對傳統凝血監測系統的需求。
儘管傳統的凝血監測設備對於個人患者來說可能很昂貴,特別是對於家庭護理使用,但替代診斷方法,例如生物感測器和穿戴式健康設備正變得越來越便宜和容易獲得。這在資源匱乏的環境中尤其重要,因為成本是採用傳統凝血監測系統的主要障礙。
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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