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市场调查报告书
商品编码
1776197
血液净化设备的全球市场:洞察,竞争情形,市场预测:2032年Blood Purification Devices - Market Insights, Competitive Landscape, and Market Forecast - 2032 |
2024年,血液净化设备市场规模达177.3452亿美元。预计2025年至2032年期间,该市场规模将以5.40%的复合年增长率成长,到2032年将达到268.6487亿美元。受急性肾损伤 (AKI) 和慢性肾病 (CKD) 病例增加以及高血压和糖尿病病例增加(这些病例会导致肾臟併发症)的推动,血液净化设备的需求正在稳步增长。此外,领先企业持续的产品开发和先进净化技术的推出,正在提高治疗效率和患者预后。这些因素共同为2025年至2032年期间的持续市场扩张创造了有利条件。
血液净化设备市场动态:
根据美国国立卫生研究院(2024年)的数据,急性肾损伤(AKI)每年影响全球约1330万人,其中相当一部分病例与感染有关,尤其是在中低收入国家。全球AKI的高发生率,尤其是在先进医疗保健服务有限的地区,直接刺激了血液净化设备市场的发展。由于AKI通常需要及时有效的体外血液净化来预防危及生命的併发症,因此病例数的增加推动了对可扩展、经济高效且临床可靠的治疗方案的需求。这种需求促使製造商开发和推广更适应不同医疗环境的净化技术。因此,AKI(尤其是感染相关病例)日益加重的负担,在全球血液净化设备市场的扩张中发挥关键作用。
根据美国国立卫生研究院 (2022) 的数据,CKD 影响着全球超过 10% 的人口,即超过 8 亿人,其中老年人、女性、少数族裔以及糖尿病和高血压患者尤为严重。这一庞大且不断增长的患者群体需要持续的肾臟支持,从而推动了对血液净化技术的需求。
此外,英国肾臟协会 (2022) 的数据显示,每年有 683,136 例急性肾损伤 (AKI) 病例,凸显了及时有效干预的紧迫性和普遍性。 CKD 和 AKI 的治疗通常需要血液透析和连续性肾臟替代疗法 (CRRT) 等治疗,这推动了先进血液净化设备的普及。这些肾臟疾病的规模和严重程度促使医疗保健系统采用更有效率、可靠且更容易取得的净化解决方案,从而推动了市场成长。
此外,主要市场参与者的产品开发活动不断增加,也推动了血液净化设备市场的发展。例如,2024年6月,领先的肾臟护理产品和服务提供者费森尤斯医疗(FME)在其5008X CAREsystem升级版获得FDA 510(k)批准后,启动了在美国推出高容量血液滤过(HVHDF)疗法的第二阶段。新版本包含更多功能,标誌着其朝着今年稍后在美国广泛上市迈出了重要一步,预计将于2026年全面实现商业化推广。
在这些诱人因素的推动下,预计血液净化设备市场将在2025年至2032年的预测期内大幅成长。
然而,与血液净化设备相关的併发症风险和安全问题,以及日益增多的产品召回,是可能限制血液净化设备市场成长的一些主要限制因素。
血液净化设备市场区隔分析:
血液净化设备市场:按产品类型(连续性肾臟替代疗法 (CRRT) 设备、血液透析设备、血液灌流设备、血浆置换设备)、最终用户(医院、透析中心、其他)和地区(北美、欧洲、亚太地区、其他)划分
在按产品类型划分的血液净化设备市场中,连续性肾臟替代疗法 (CRRT) 设备类别预计将在 2024 年占据最大的市场占有率。这主要是由于急性肾损伤 (AKI) 发病率的上升,尤其是在入住加护病房 (ICU) 的重症患者中。 CRRT 提供更慢、更可控且更连续的血液净化过程,使其非常适合此类环境,并且是无法耐受传统血液透析相关的快速液体和溶质转移的血流动力学不稳定患者的首选方案。
此外,败血症和多重器官衰竭等危及生命的疾病(通常会导致急性肾损伤 (AKI))的增多,进一步增加了对 CRRT 系统的需求。这些临床情况通常需要紧急且持续的肾臟支持,这使得 CRRT 成为重症监护中必不可少的干预措施。
同时,技术进步提升了 CRRT 设备的功能性和易用性。自动化液体管理、即时监控和直觉的使用者介面等创新技术减轻了医护人员的操作负担,同时提高了治疗的准确性。
监管里程碑的出现进一步支持了这一扩展,反映了 CRRT 平台日益增强的多功能性。例如,2023 年 8 月,Quanta Dialysis Technologies® 获得 FDA 510(k) 批准,扩大了其 Quanta 透析系统的 CRRT 适应症,突显了多功能和高适应性肾臟支持设备的发展趋势。
预计这些因素将推动 CRRT 设备类别的显着增长,并在 2025 年至 2032 年的预测期内显着促进整个血液净化设备市场的扩张。
预计北美将主导整个血液净化设备市场:
预计 2024 年北美将占据血液净化设备市场的最大占有率,这主要得益于几个关键因素。该地区的主导地位主要归因于慢性肾病 (CKD) 及其相关风险因素(例如高血压和糖尿病)的普遍存在。该地区还受益于发达的医疗保健基础设施、支持性的报销政策以及对肾臟护理进步的日益关注。这些因素共同促进了血液净化技术的广泛应用,巩固了北美在整个预测期内作为领先市场的地位。
根据美国疾病管制与预防中心 (CDC, 2024) 的数据,超过七分之一的美国成年人(约 3,550 万人,占总人口的 14%)患有慢性肾臟病 (CKD)。此疾病对老年人的影响尤其严重,65 岁及以上族群的盛行率为 34%,而 45 至 64 岁族群的盛行率为 12%,18 至 44 岁族群的盛行率为 6%。女性 CKD 的盛行率 (14%) 略高于男性 (12%)。美国国家肾臟基金会 (2024) 报告显示,约有 80.8 万人患有肾衰竭,2022 年新增确诊肾衰竭病例 13.5 万例。
患者群体日益多样化,日益增长,这推动了对肾臟支持疗法的需求,包括透析和持续性血液净化,尤其是在医院、透析中心和重症监护室。
到 2025 年,近一半的美国成年人(48.1%),约 1.199 亿人,将患有高血压(收缩压≥130 mmHg,舒张压≥80 mmHg,或正在服用药物控制病情)。然而,只有四分之一的高血压成年人(22.5%,即 2,700 万人)的病情受到控制。此外,据报道,到2024年,约有3,800万人将患有糖尿病。
高血压和糖尿病都是CKD和AKI的主要危险因素,这些疾病通常需要及时有效的血液净化疗法来控制体液超负荷、毒素清除和电解质失衡。这些慢性疾病日益加重的负担不仅增加了需要肾臟支持的患者数量,也促使医疗保健提供者采用先进的血液净化技术。因此,高血压和糖尿病盛行率的上升直接促进了血液净化设备市场的成长和扩张。
此外,该地区的产品开发活动预计将进一步推动血液净化设备市场的发展。例如,2024年7月,由美国医疗技术公司Outset Medical开发的突破性、全整合式行动血液透析系统Tablo®上市。该系统旨在治疗急性和慢性肾衰竭患者。
预计这些临床、技术和策略推动因素将在2025年至2032年的预测期内显着推动美国血液净化设备市场的成长。
血液净化设备市场的主要参与者
血液净化设备市场的主要市场参与者包括B. Braun Melsungen AG、旭化成株式会社、费森尤斯株式会社、百特、Infomed SA、健帆生物医学株式会社、钟渊株式会社、日机装株式会社、SWS医疗集团、美敦力、CytoSorbents Europe*Sorbent、Hcontra Corporation、Theconra Corporation、Thekben)
血液净化设备市场的最新发展:
血液净化设备市场研究报告重点
血液净化设备市场常被询问的问题
Blood Purification Devices Market by Product Type (Continuous Renal Replacement Therapy (CRRT) Device, Hemodialysis Device, Hemoperfusion Device, and Plasma Exchange Device), End-User (Hospitals, Dialysis Centers, and Others), and Geography (North America, Europe, Asia-Pacific, and Rest of the World) is expected to grow at a steady CAGR forecast till 2032 owing to rising instances of various kidney diseases, surge in the cases of hypertension and diabetes leading to kidney disorders, and growing product development activities by the key players.
The blood purification devices market was valued at USD 17,734.52 million in 2024, growing at a CAGR of 5.40% during the forecast period from 2025 to 2032 to reach USD 26,864.87 million by 2032. The demand for the blood purification devices market is witnessing steady growth, driven by the rising instances of acute kidney injury (AKI) and chronic kidney disease (CKD), along with the increasing cases of hypertension and diabetes that contribute to kidney complications. Additionally, ongoing product development and the launch of advanced purification technologies by key players are enhancing treatment efficiency and patient outcomes. These are the combined factors that are creating a favorable landscape for sustained market expansion from 2025 to 2032.
Blood Purification Devices Market Dynamics:
As per data from the National Institutes of Health (2024), acute kidney injury (AKI) affects approximately 13.3 million people worldwide each year, with a significant portion of cases linked to infections, particularly in low- and lower-middle-income countries. This high global occurrence, especially in regions with limited access to advanced healthcare, is directly accelerating the market for blood purification devices. Since AKI often requires timely and effective extracorporeal blood purification to prevent life-threatening complications, the growing number of cases is driving demand for scalable, cost-effective, and clinically reliable treatment options. This need is prompting manufacturers to develop and distribute more adaptable purification technologies tailored to diverse healthcare environments. As a result, the increasing burden of AKI, particularly infection-induced cases, is playing a critical role in expanding the global blood purification devices market.
According to the National Institutes of Health (2022), CKD affects over 10% of the global population, more than 800 million individuals, particularly impacting older adults, women, racial minorities, and those with diabetes or hypertension. This large and growing patient population requires ongoing renal support, thereby increasing demand for blood purification technologies.
Additionally, data from the UK Kidney Association (2022) reported 683,136 instances of AKI in a single year, highlighting the urgent and widespread need for timely and effective interventions. Conditions like CKD and AKI often necessitate treatments such as hemodialysis and Continuous Renal Replacement Therapy (CRRT), driving the adoption of advanced blood purification devices. The scale and severity of these renal conditions are pushing healthcare systems to adopt more efficient, reliable, and accessible purification solutions, thereby propelling market growth.
Furthermore, an increase in product development activities among the key market players is escalating the market for blood purification devices. For example, in June 2024, Fresenius Medical Care (FME), a leading provider of kidney care products and services, started the second phase of bringing high-volume hemodiafiltration (HVHDF) therapy to the U.S. after receiving FDA 510(k) clearance for its updated 5008X CAREsystem. This new version included added features and marked an important step toward a wider U.S. launch later in the year, with full commercial rollout planned for 2026.
Driven by these compelling factors, the blood purification devices market is poised for substantial growth during the forecast period from 2025 to 2032.
However, the risk of complications & safety concerns associated with blood purification devices and the increasing number of product recalls, among others, are some of the key constraints that may limit the growth of the blood purification devices market.
Blood Purification Devices Market Segment Analysis:
Blood Purification Devices Market by Product Type (Continuous Renal Replacement Therapy (CRRT) Device, Hemodialysis Device, Hemoperfusion Device, and Plasma Exchange Device), End-User (Hospitals, Dialysis Centers, and Others), and Geography (North America, Europe, Asia-Pacific, and Rest of the World)
In the product type segment of the blood purification devices market, the continuous renal replacement therapy (CRRT) device category is projected to account for the largest market share in 2024. This is driven by the primary factor that is rising cases of acute kidney injury (AKI), particularly among critically ill patients admitted to intensive care units (ICUs). CRRT is uniquely suited for these settings as it delivers a slower, more controlled, and continuous blood purification process, making it the preferred option for hemodynamically unstable patients who cannot tolerate the rapid fluid and solute shifts associated with conventional hemodialysis.
Also, the growing cases of life-threatening conditions such as sepsis and multi-organ failure, which frequently result in AKI, have further intensified the demand for CRRT systems. These clinical scenarios often require immediate and sustained renal support, positioning CRRT as an essential intervention in critical care.
Simultaneously, technological advancements have enhanced the functionality and ease of use of CRRT devices. Innovations such as automated fluid management, real-time monitoring, and intuitive user interfaces have improved therapeutic precision while reducing the operational burden on healthcare providers.
This expansion is further supported by regulatory milestones that reflect the growing versatility of CRRT platforms. For example, in August 2023, Quanta Dialysis Technologies(R) received FDA 510(k) clearance for expanded CRRT indications on its Quanta Dialysis System, highlighting the trend toward multifunctional and adaptable renal support devices.
Therefore, driven by these combined factors, the CRRT device category is anticipated to witness substantial growth, significantly contributing to the overall expansion of the blood purification devices market during the forecast period from 2025 to 2032.
North America is expected to dominate the overall blood purification devices market:
North America is projected to hold the largest share of the blood purification devices market in 2024, driven by several key factors. This regional dominance is largely driven by the high instances of chronic kidney disease CKD and its associated risk factors, including hypertension and diabetes. The region also benefits from a well-developed healthcare infrastructure, supportive reimbursement policies, and an increasing focus on advancing renal care. These factors collectively contribute to the widespread adoption of blood purification technologies, solidifying North America's position as a leading market throughout the forecast period.
According to the Centers for Disease Control and Prevention (CDC, 2024), over one in seven U.S. adults, approximately 35.5 million people, or 14 percent of the population, were affected by CKD. The condition disproportionately affected older adults, with a case rate of 34 percent in those aged 65 and above, compared to 12 percent among individuals aged 45 to 64, and 6 percent in the 18 to 44 age group. CKD is also slightly more common in women (14 percent) than in men (12 percent). Supporting this, the American Kidney Fund (2024) reported that around 808,000 individuals were living with kidney failure, with 135,000 new cases diagnosed in 2022, underscoring the escalating burden of kidney-related conditions in the country.
This growing and demographically diverse patient base is fueling demand for renal support therapies such as dialysis and continuous blood purification, particularly in hospitals, dialysis centers, and critical care settings.
Same source in 2025 stated that, in 2022, nearly half of U.S. adults that is 48.1% or roughly 119.9 million people, are affected by high blood pressure, defined as having a systolic reading over 130 mm Hg, a diastolic reading over 80 mm Hg, or currently taking medication to manage the condition. However, only about 1 in 4 adults with high blood pressure (22.5%, or 27 million people) have their condition under control. Additionally, in 2024 above source reported that approximately 38 million people were affected by diabetes.
Both hypertension and diabetes are major risk factors for the development of CKD and AKI, conditions that often require timely and effective blood purification treatments to manage fluid overload, toxin removal, and electrolyte imbalances. The growing burden of these chronic diseases is not only increasing the patient pool requiring renal support but also prompting healthcare providers to adopt advanced blood purification technologies. As a result, the escalating rates of hypertension and diabetes are directly contributing to the growth and expansion of the blood purification devices market.
Moreover, product development activities in the region are further expected to boost the market for blood purification devices. For instance, in July 2024, Tablo(R) is a groundbreaking, fully integrated mobile hemodialysis system developed by Outset Medical, a U.S.-based medical technology company, designed for the treatment of patients with both acute and chronic renal failure.
Together, these clinical, technological, and strategic drivers are expected to significantly propel the growth of the U.S. blood purification devices market throughout the forecast period from 2025 to 2032.
Blood Purification Devices Market Key Players:
Some of the key market players operating in the blood purification devices market include B. Braun Melsungen AG, Asahi Kasei Corporation, Fresenius SE and Co. KGaA, Baxter, Infomed SA, Jafron Biomedical Co., Ltd., Kaneka Corporation, Nikkiso Co., Ltd., SWS Medical Group, Medtronic, CytoSorbents Europe GmbH, Spectral Medical Inc., Haemonetics Corporation, Baihe Medical, ExThera Medical Corporation, and others.
Recent Developmental Activities in the Blood Purification Devices Market:
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