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市场调查报告书
商品编码
1734916
2032 年出血性疾病检测市场预测:按产品、适应症、检测类型、最终用户和地区进行的全球分析Bleeding Disorders Testing Market Forecasts to 2032 - Global Analysis By Product (Reagents, Consumables, Instruments and Accessories), Indication, Test Type, End User and By Geography |
根据 Stratistics MRC 的数据,全球出血性疾病检测市场预计在 2025 年达到 1,133 亿美元,到 2032 年将达到 2,098 亿美元,预测期内的复合年增长率为 9.2%。
出血性疾病检测是指一组用于诊断影响血液正常凝固能力的疾病的实验室检查。即使是轻微的损伤,这些疾病也可能导致过度出血和瘀伤。常见的检测包括全血球计数 (CBC)、凝血酶原时间 (PT)、活化部份凝血活酵素时间(aPTT)、血小板功能检查和特异性因子测定。这些检测有助于识别遗传性疾病,例如血友病和血管性血友病,或后天性疾病,例如维生素 K 缺乏症和肝病。透过出血性疾病检测进行准确诊断对于指南治疗和预防与无法控制的出血和凝血障碍相关的併发症至关重要。
根据美国国家血友病基金会的数据,血管性血友病是最常见的出血性疾病,每 100 人中就有 1 人患有此病,占美国人口的 1%。
出血性疾病盛行率不断上升
血友病和血管性血友病等出血性疾病的盛行率不断上升,推动了出血性疾病检测市场的显着成长。随着人们意识的增强以及诊断对有效治疗的重要性日益提升,对精准早期检测解决方案的需求也随之激增。这一趋势正在推动技术进步和医疗保健投资的增加,尤其是在开发中地区。总体而言,不断增长的患者群体正在积极影响市场扩张,推动技术创新,并促进全球诊断工具的普及。
诊断测试成本上升
出血性疾病诊断检测的高昂费用对可近性产生了负面影响,并将检测限制在资源充足的医疗机构。这减少了早期发现和治疗的机会,导致患者预后较差。此外,它也给医疗保健系统带来了压力,尤其是在负担能力成为主要障碍的低收入地区。经济负担阻碍了及时诊断,延长了患者的痛苦,并增加了长期医疗成本。这限制了市场扩张。
诊断工具的技术进步
诊断工具的技术进步显着改善了出血性疾病检测市场,并提高了准确性、速度和可近性。次世代定序、就地检验和人工智慧主导的分析等创新技术实现了更早的检测和更个人化的治疗方案。这些进步不仅提高了诊断准确性,还降低了检测成本并改善了患者预后。更有效率、更可靠的工具使医疗保健提供者能够提供更优质的护理,从而推动了出血性疾病检测市场的成长和扩张。
监管挑战
出血性疾病检测行业的监管障碍可能会延迟新诊断技术的核准,抑制创新,并限制患者获得改进的诊断方法。严格的监管可能会导致营运成本上升,从而影响患者的负担能力。此外,不同地区的监管限制差异可能会增加营运商进入市场的难度,延迟产品的上市,并降低出血性疾病治疗方法的整体疗效,从而难以提供快速有效的治疗。
COVID-19的影响
COVID-19 疫情严重扰乱了出血性疾病检测市场。封锁措施、患者犹豫以及医疗系统向 COVID-19 治疗的重新分配,导致常规诊断程序减少。这导致血友病和血管性血友病等疾病的检测数量下降。此外,供应链中断和资源限制进一步影响了检测的可用性。然而,随着出血性疾病盛行率的上升和诊断技术的进步,市场正开始復苏。
预计诊断测试部分将成为预测期内最大的部分。
诊断检测领域预计将在预测期内占据最大的市场占有率,因为它能够早期发现并有效管理出血性疾病。基因检测和凝血分析仪等最尖端科技的整合,可提高诊断准确性和患者预后。此外,与医疗保健提供者的合作日益增多,以及人们对出血性疾病的认知不断提高,正在巩固诊断实验室作为市场发展基石的地位。
预计预测期内凝血酶原时间 (PT) 部分将以最高复合年增长率成长。
凝血酶原时间 (PT) 领域预计将在预测期内实现最高成长率,因为它能够准确评估凝血功能,这对于识别许多出血性疾病至关重要。 PT 检测透过检测血友病、维生素 K 缺乏症和肝损伤等疾病来改善早期诊断和治疗。 PT 测试在客製化治疗和准确诊断方面的能力将支持市场成长,刺激创新,并透过提高知识水平和增加医疗保健可及性来改善患者预后。
预计亚太地区将在预测期内占据最大的市场占有率,这得益于人们意识的提升、医疗基础设施的改善以及诊断技术的不断发展。出血性疾病盛行率的上升以及对早期诊断和个人化治疗的日益重视,对市场扩张产生了积极的影响。此外,由于尖端检测技术的日益普及以及政府为改善医疗保健可近性而推出的项目,该地区的市场正在稳步增长。
由于人们对血友病等出血性疾病的认识不断提高,且诊断更早,预计北美将在预测期内实现最高的复合年增长率。检测技术的进步以及对个人化治疗日益增长的需求,进一步推动了市场扩张。此外,支持性医疗政策、诊断检测管道的改善以及对以患者为中心的医疗服务的日益重视,正在产生积极影响,改善患者的治疗效果,并推动该地区医疗保健行业的持续增长。
According to Stratistics MRC, the Global Bleeding Disorders Testing Market is accounted for $113.3 billion in 2025 and is expected to reach $209.8 billion by 2032 growing at a CAGR of 9.2% during the forecast period. Bleeding disorders testing refers to a group of laboratory tests used to diagnose conditions that affect the blood's ability to clot properly. These disorders can lead to excessive bleeding or bruising, even from minor injuries. Common tests include complete blood count (CBC), prothrombin time (PT), activated partial thromboplastin time (aPTT), platelet function tests, and specific factor assays. Testing helps identify inherited conditions like hemophilia and von Willebrand disease, or acquired issues such as vitamin K deficiency or liver disease. Accurate diagnosis through bleeding disorders testing is crucial for guiding treatment and preventing complications related to uncontrolled bleeding or clotting abnormalities.
According to the National Hemophilia Foundation, Von Willebrand disease is the most common bleeding disorder, affecting approximately 1 in every 100 people or up to 1% of the U.S. population.
Increasing Prevalence of Bleeding Disorders
The increasing prevalence of bleeding disorders, such as hemophilia and von Willebrand disease, is driving significant growth in the bleeding disorders testing market. As awareness rises and diagnosis becomes more critical for effective treatment, demand for accurate and early testing solutions has surged. This trend is encouraging technological advancements and expanded healthcare investments, particularly in developing regions. Overall, the rising patient pool is positively impacting market expansion, fostering innovation and improved accessibility to diagnostic tools worldwide.
High Costs of Diagnostic Tests
High costs of diagnostic tests for bleeding disorders negatively impact accessibility, limiting testing to only well-funded healthcare settings. This reduces early detection and treatment opportunities, leading to poor patient outcomes. Additionally, it strains healthcare systems, especially in low-income regions, where affordability is a major barrier. The financial burden may discourage timely diagnosis, prolonging patient suffering and increasing long-term healthcare costs. Thus, it limits the market expansion.
Technological Advancements in Diagnostic Tools
Technological advancements in diagnostic tools have significantly improved the bleeding disorders testing market by enhancing accuracy, speed, and accessibility. Innovations like next-generation sequencing, point-of-care testing, and AI-driven analytics enable earlier detection and more personalized treatment plans. These advancements not only increase diagnostic precision but also reduce testing costs and improve patient outcomes. With more efficient and reliable tools, healthcare providers can offer better care, driving growth and expansion in the bleeding disorders testing market.
Regulatory Challenges
Regulatory hurdles in the bleeding disorders testing industry can cause delays in the approval of new diagnostic technologies, impeding innovation and limiting patient access to improved diagnostics. Tight rules might make operations more expensive, which would affect affordability. Furthermore, different regulatory restrictions in different regions might make it more difficult for businesses to enter the market, which can slow down the availability of products and lower the overall efficacy of therapies for bleeding disorders. This makes it more difficult to provide prompt, efficient care.
Covid-19 Impact
The COVID-19 pandemic significantly disrupted the bleeding disorder testing market. Routine diagnostic procedures declined due to lockdowns, patient hesitancy, and healthcare system reallocation towards COVID-19 care. This led to reduced testing for conditions like hemophilia and Von Willebrand disease. Additionally, supply chain disruptions and resource constraints further impacted testing availability. However, the market is recovering, driven by increasing bleeding disorder prevalence and advancements in diagnostic technologies.
The diagnostic laboratories segment is expected to be the largest during the forecast period
The diagnostic laboratories segment is expected to account for the largest market share during the forecast period as these laboratories enable early detection and effective management of bleeding disorders. Their integration of cutting-edge technologies, such as genetic testing and coagulation analyzers, enhances diagnostic precision and patient outcomes. Moreover, increasing collaborations with healthcare providers and growing awareness about bleeding disorders continue to expand market reach, solidifying diagnostic laboratories as a cornerstone of market development.
The prothrombin time (PT) segment is expected to have the highest CAGR during the forecast period
Over the forecast period, the prothrombin time (PT) segment is predicted to witness the highest growth rate because it makes it possible to precisely evaluate clotting function, which is essential for identifying a number of bleeding conditions. PT testing improves early diagnosis and treatment by detecting diseases such as hemophilia, vitamin K insufficiency, and liver disorders. PT testing's function in customized treatment and precise diagnosis supports the growing market, encouraging innovation and enhancing patient outcomes as knowledge and accessibility to healthcare increase.
During the forecast period, the Asia Pacific region is expected to hold the largest market share because of growing awareness, better healthcare infrastructure, and developments in diagnostic technologies. Market expansion has been positively impacted by the increasing prevalence of bleeding disorders as well as a growing emphasis on early diagnosis and individualized treatment. Furthermore, the region's market is expanding favorably due to the growing use of cutting-edge testing techniques and government programs to improve access to healthcare.
Over the forecast period, the North America region is anticipated to exhibit the highest CAGR, owing to increased awareness and early diagnosis of bleeding disorders such as hemophilia. Advancements in testing technologies, along with the rising demand for personalized treatment, are further fueling market expansion. Additionally, supportive healthcare policies, improved accessibility to diagnostic tests, and a growing focus on patient-centered care contribute to a positive impact, enhancing patient outcomes and fostering continued growth in the region's healthcare sector.
Key players in the market
Some of the key players profiled in the Bleeding Disorders Testing Market include Siemens Healthineers, F. Hoffmann-La Roche Ltd., Abbott Laboratories, Sysmex Corporation, HORIBA Ltd., Thermo Fisher Scientific Inc., Bio-Rad Laboratories, Inc., Grifols S.A., Danaher Corporation, Helena Laboratories Corporation, DiaPharma Group Inc., Atlas Medical GmbH, Hyphen BioMed, Precision BioLogic Incorporated, Trinity Biotech plc, Sekisui Diagnostics LLC, Takeda Pharmaceutical Company Limited, Nihon Kohden Corporation and Novo Nordisk A/S.
In May 2025, Cadrenal Therapeutics has entered into a collaboration agreement with Abbott to support the pivotal TECarfarin Anticoagulation and Hemocompatibility with Left Ventricular Assist Devices (TECH-LVAD) trial. This trial aims to evaluate the efficacy and safety of tecarfarin, a new oral vitamin K antagonist (VKA), in patients with implanted HeartMate 3(TM) left ventricular assist devices (LVADs).
In December 2024, Abbott Laboratories and DexCom have resolved all their ongoing patent disputes concerning continuous glucose monitoring (CGM) devices. This settlement, announced on December 23, 2024, includes the dismissal of all pending legal cases worldwide and prohibits both companies from initiating any patent, trade dress, or design rights litigation against each other for the next decade.
Note: Tables for North America, Europe, APAC, South America, and Middle East & Africa Regions are also represented in the same manner as above.