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市場調查報告書
商品編碼
1734916
2032 年出血性疾病檢測市場預測:按產品、適應症、檢測類型、最終用戶和地區進行的全球分析Bleeding Disorders Testing Market Forecasts to 2032 - Global Analysis By Product (Reagents, Consumables, Instruments and Accessories), Indication, Test Type, End User and By Geography |
根據 Stratistics MRC 的數據,全球出血性疾病檢測市場預計在 2025 年達到 1,133 億美元,到 2032 年將達到 2,098 億美元,預測期內的複合年成長率為 9.2%。
出血性疾病檢測是指一組用於診斷影響血液正常凝固能力的疾病的實驗室檢查。即使是輕微的損傷,這些疾病也可能導致過度出血和瘀傷。常見的檢測包括全血球計數 (CBC)、凝血酶原時間 (PT)、活化部份凝血活酵素時間(aPTT)、血小板功能檢查和特異性因子測定。這些檢測有助於識別遺傳性疾病,例如血友病和血管性血友病,或後天性疾病,例如維生素 K 缺乏症和肝病。透過出血性疾病檢測進行準確診斷對於指南治療和預防與無法控制的出血和凝血障礙相關的併發症至關重要。
根據美國國家血友病基金會的數據,血管性血友病是最常見的出血性疾病,每 100 人中就有 1 人患有此病,占美國人口的 1%。
出血性疾病盛行率不斷上升
血友病和血管性血友病等出血性疾病的盛行率不斷上升,推動了出血性疾病檢測市場的顯著成長。隨著人們意識的增強以及診斷對有效治療的重要性日益提升,對精準早期檢測解決方案的需求也隨之激增。這一趨勢正在推動技術進步和醫療保健投資的增加,尤其是在開發中地區。總體而言,不斷成長的患者群體正在積極影響市場擴張,推動技術創新,並促進全球診斷工具的普及。
診斷測試成本上升
出血性疾病診斷檢測的高昂費用對可近性產生了負面影響,並將檢測限制在資源充足的醫療機構。這減少了早期發現和治療的機會,導致患者預後較差。此外,它也給醫療保健系統帶來了壓力,尤其是在負擔能力成為主要障礙的低收入地區。經濟負擔阻礙了及時診斷,延長了患者的痛苦,並增加了長期醫療成本。這限制了市場擴張。
診斷工具的技術進步
診斷工具的技術進步顯著改善了出血性疾病檢測市場,並提高了準確性、速度和可近性。次世代定序、就地檢驗和人工智慧主導的分析等創新技術實現了更早的檢測和更個人化的治療方案。這些進步不僅提高了診斷準確性,還降低了檢測成本並改善了患者預後。更有效率、更可靠的工具使醫療保健提供者能夠提供更優質的護理,從而推動了出血性疾病檢測市場的成長和擴張。
監管挑戰
出血性疾病檢測行業的監管障礙可能會延遲新診斷技術的核准,抑制創新,並限制患者獲得改進的診斷方法。嚴格的監管可能會導致營運成本上升,從而影響患者的負擔能力。此外,不同地區的監管限制差異可能會增加營運商進入市場的難度,延遲產品的上市,並降低出血性疾病治療方法的整體療效,從而難以提供快速有效的治療。
COVID-19的影響
COVID-19 疫情嚴重擾亂了出血性疾病檢測市場。封鎖措施、患者猶豫以及醫療系統向 COVID-19 治療的重新分配,導致常規診斷程序減少。這導致血友病和血管性血友病等疾病的檢測數量下降。此外,供應鏈中斷和資源限制進一步影響了檢測的可用性。然而,隨著出血性疾病盛行率的上升和診斷技術的進步,市場正開始復甦。
預計診斷測試部分將成為預測期內最大的部分。
診斷檢測領域預計將在預測期內佔據最大的市場佔有率,因為它能夠早期發現並有效管理出血性疾病。基因檢測和凝血分析儀等最尖端科技的整合,可提高診斷準確性和患者預後。此外,與醫療保健提供者的合作日益增多,以及人們對出血性疾病的認知不斷提高,正在鞏固診斷實驗室作為市場發展基石的地位。
預計預測期內凝血酶原時間 (PT) 部分將以最高複合年成長率成長。
凝血酶原時間 (PT) 領域預計將在預測期內實現最高成長率,因為它能夠準確評估凝血功能,這對於識別許多出血性疾病至關重要。 PT 檢測透過檢測血友病、維生素 K 缺乏症和肝損傷等疾病來改善早期診斷和治療。 PT 測試在客製化治療和準確診斷方面的能力將支持市場成長,刺激創新,並透過提高知識水平和增加醫療保健可及性來改善患者預後。
預計亞太地區將在預測期內佔據最大的市場佔有率,這得益於人們意識的提升、醫療基礎設施的改善以及診斷技術的不斷發展。出血性疾病盛行率的上升以及對早期診斷和個人化治療的日益重視,對市場擴張產生了積極的影響。此外,由於尖端檢測技術的日益普及以及政府為改善醫療保健可近性而推出的項目,該地區的市場正在穩步成長。
由於人們對血友病等出血性疾病的認知不斷提高,且診斷更早,預計北美將在預測期內實現最高的複合年成長率。檢測技術的進步以及對個人化治療日益成長的需求,進一步推動了市場擴張。此外,支持性醫療政策、診斷檢測管道的改善以及對以患者為中心的醫療服務的日益重視,正在產生積極影響,改善患者的治療效果,並推動該地區醫療保健行業的持續成長。
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.