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市場調査レポート
商品コード
1654682
世界の凝固モニタリング製品市場-2025-2033年Global Coagulation Monitoring Products Market - 2025-2033 |
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カスタマイズ可能
適宜更新あり
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世界の凝固モニタリング製品市場-2025-2033年 |
出版日: 2025年02月13日
発行: DataM Intelligence
ページ情報: 英文 159 Pages
納期: 即日から翌営業日
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世界の凝固モニタリング製品市場は2024年に48億2,000万米ドルに達し、2033年には78億1,000万米ドルに達すると予測され、予測期間2025年のCAGRは5.6%で成長する見込みです。
凝固モニタリング製品は、血液の凝固能力を測定・評価するために設計された医療機器および診断ツールです。これらの製品は主に、抗凝固療法(ワルファリンや他の血液希釈剤を服用している患者など)の有効性をモニタリングしたり、出血や血栓症のリスクを評価したりするために使用されます。
凝固モニタリングは、深部静脈血栓症(DVT)、肺塞栓症(PE)、心房細動(AF)、血友病などの血液凝固に関連する疾患の診断や管理に役立ちます。凝固モニタリング製品の最も一般的な使用方法は、ワルファリン、ヘパリン、新しい直接経口抗凝固薬などの抗凝固薬を使用している患者の管理です。これらの検査は、治療効果を確実にし、出血や血栓形成などの有害事象のリスクを最小化するための投薬量の調整に役立ちます。
凝固モニタリング製品市場は、臨床および在宅環境における凝固モニタリングの重要性に対する認識の高まり、凝固障害の発生率の上昇、ポイントオブケア機器の技術的進歩などにより、ここ数年で大きく成長しています。
例えば、米国国立衛生研究所の調査によると、体外膜酸素療法(ECMO)患者は一般的に体調が悪く、出血問題のリスクが高まる。ECMO中の出血率は20.8%から39.6%で、カニューレ部位(13.2%)、消化管(5.5%)、肺(6.1%)、中枢神経系(3.9%)が最も多いです。ECMO患者は虚血性脳卒中、右室血栓、左室血栓、肺塞栓症などの血栓症にも罹患しやすいです。したがって、このような出血性合併症のリスクが凝固モニタリング製品の需要を高めています。
促進要因と抑制要因
血液疾患の有病率の上昇
血液疾患の有病率の上昇は、凝固モニタリング製品市場の成長を大きく促進しており、予測期間中も市場を牽引すると予想されます。血液疾患、特に静脈血栓塞栓症(VTE)、心房細動(AF)、血友病、ビタミンK欠乏症などの凝固関連疾患の有病率の上昇が、凝固モニタリング製品市場を大きく牽引しています。これらの疾患は、脳卒中、臓器障害、過剰出血などの重篤な合併症を予防するために、血液凝固の継続的なモニタリングと抗凝固療法を必要とします。
例えば、米国疾病予防管理センター(CDC)によると、米国では毎年最大90万人が静脈血栓塞栓症(VTE、血栓)の影響を受けています。推定で毎年60,000~100,000人のアメリカ人がVTEで死亡し、その他多くの人がVTEによる長期的な合併症を患っています。肺塞栓症を発症した人の約4分の1(25%)は、突然死が最初の症状です。深部静脈血栓症(DVT)または肺塞栓症(PE)の正確な患者数は不明ですが、米国では毎年90万人が罹患している可能性があります。
心房細動(AF)や深部静脈血栓症(DVT)のような血液疾患では、血栓の形成を防ぐためにワルファリン、ヘパリン、DOACなどの抗凝固療法を長期にわたって行う必要があることが多いです。これらの治療では、治療が治療範囲内にあることを確認するために、血液凝固の重要な指標である国際標準比(INR)をモニターする凝固検査を頻繁に行う必要があります。
例えば、米国国立衛生研究所によれば、心房細動は2050年までに米国で600万~1,200万人、欧州では2060年までに1,790万人が罹患すると推定されています。心房細動の世界の有病率は375億7,400万例(世界人口の0.51%)で、過去20年間に33%増加し、その多くが継続的な抗凝固療法を必要とするため、凝固モニタリング製品の需要が増加しています。
白血病、リンパ腫、骨髄腫などの血液がんは、血小板、凝固因子、その他の凝固系の主要成分の産生に影響を及ぼす可能性があります。このため、これらの患者では出血や血栓症のリスクが増加します。例えば、白血病患者は血小板減少症(血小板数の減少)を経験することがあり、出血や凝血の合併症を起こしやすくなります。
白血病リンパ腫協会によると、米国では約3分に1人が白血病、リンパ腫、骨髄腫と診断されています。2024年には、米国で合計187,740人が白血病、リンパ腫または骨髄腫と診断されると推定されます。白血病、リンパ腫、骨髄腫の新規症例は、2024年に米国で新たに診断されると推定されるがん症例2,001,140例の9.4%を占めると予想されます。
代替診断法との競合
代替診断法との競合が、予測期間中の凝固モニタリング製品市場の成長を妨げると予想されます。従来の凝固検査やポイントオブケア機器が血液凝固障害のモニタリングに広く使用されている一方で、非侵襲的技術、バイオセンサー、ウェアラブル機器などの代替診断法が競合として台頭しており、コスト、使いやすさ、患者の快適さの点で優位性を提供しています。これらの代替法は、従来の凝固モニタリング法への依存度を低下させる可能性があり、市場に課題を投げかけています。
凝固障害に関連するバイオマーカーを追跡できるスマートウォッチや特殊なバイオセンサーなどのウェアラブルデバイスの出現は、凝固モニタリング製品市場にとって関心が高まっています。これらのデバイスは、血圧、心拍数、さらには血液凝固の可能性など、さまざまな健康パラメータを最小限のユーザー介入で監視できるようになってきています。
例えば、アップルのような企業は、ウェアラブルに健康モニタリング機能を統合することを模索しており、この機能は血液凝固のような血液パラメータのモニタリングにまで拡大する可能性があるため、従来の凝固モニタリング・システムの需要が減少する可能性があります。
従来の凝固モニタリング装置は個々の患者にとって、特に在宅医療で使用するには高価である可能性があるが、バイオセンサーやウェアラブル健康機器などの代替診断方法は、ますます手頃な価格で利用できるようになってきています。このことは、コストが従来の凝固モニタリングシステム導入の大きな障壁となっている低資源環境において特に重要です。
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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