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市場調查報告書
商品編碼
1776197
血液淨化設備的全球市場:洞察,競爭情形,市場預測:2032年Blood Purification Devices - Market Insights, Competitive Landscape, and Market Forecast - 2032 |
2024年,血液淨化設備市場規模達177.3452億美元。預計2025年至2032年期間,該市場規模將以5.40%的複合年增長率成長,到2032年將達到268.6487億美元。受急性腎損傷 (AKI) 和慢性腎病 (CKD) 病例增加以及高血壓和糖尿病病例增加(這些病例會導致腎臟併發症)的推動,血液淨化設備的需求正在穩步增長。此外,領先企業持續的產品開發和先進淨化技術的推出,正在提高治療效率和患者預後。這些因素共同為2025年至2032年期間的持續市場擴張創造了有利條件。
血液淨化設備市場動態:
根據美國國立衛生研究院(2024年)的數據,急性腎損傷(AKI)每年影響全球約1330萬人,其中相當一部分病例與感染有關,尤其是在中低收入國家。全球AKI的高發生率,尤其是在先進醫療保健服務有限的地區,直接刺激了血液淨化設備市場的發展。由於AKI通常需要及時有效的體外血液淨化來預防危及生命的併發症,因此病例數的增加推動了對可擴展、經濟高效且臨床可靠的治療方案的需求。這種需求促使製造商開發和推廣更適應不同醫療環境的淨化技術。因此,AKI(尤其是感染相關病例)日益加重的負擔,在全球血液淨化設備市場的擴張中發揮關鍵作用。
根據美國國立衛生研究院 (2022) 的數據,CKD 影響著全球超過 10% 的人口,即超過 8 億人,其中老年人、女性、少數族裔以及糖尿病和高血壓患者尤為嚴重。這一龐大且不斷增長的患者群體需要持續的腎臟支持,從而推動了對血液淨化技術的需求。
此外,英國腎臟協會 (2022) 的數據顯示,每年有 683,136 例急性腎損傷 (AKI) 病例,凸顯了及時有效幹預的緊迫性和普遍性。 CKD 和 AKI 的治療通常需要血液透析和連續性腎臟替代療法 (CRRT) 等治療,這推動了先進血液淨化設備的普及。這些腎臟疾病的規模和嚴重程度促使醫療保健系統採用更有效率、可靠且更容易取得的淨化解決方案,從而推動了市場成長。
此外,主要市場參與者的產品開發活動不斷增加,也推動了血液淨化設備市場的發展。例如,2024年6月,領先的腎臟護理產品和服務提供者費森尤斯醫療(FME)在其5008X CAREsystem升級版獲得FDA 510(k)批准後,啟動了在美國推出高容量血液濾過(HVHDF)療法的第二階段。新版本包含更多功能,標誌著其朝著今年稍後在美國廣泛上市邁出了重要一步,預計將於2026年全面實現商業化推廣。
在這些誘人因素的推動下,預計血液淨化設備市場將在2025年至2032年的預測期內大幅成長。
然而,與血液淨化設備相關的併發症風險和安全問題,以及日益增多的產品召回,是可能限制血液淨化設備市場成長的一些主要限制因素。
血液淨化設備市場區隔分析:
血液淨化設備市場:按產品類型(連續性腎臟替代療法 (CRRT) 設備、血液透析設備、血液灌流設備、血漿置換設備)、最終用戶(醫院、透析中心、其他)和地區(北美、歐洲、亞太地區、其他)劃分
在按產品類型劃分的血液淨化設備市場中,連續性腎臟替代療法 (CRRT) 設備類別預計將在 2024 年佔據最大的市場佔有率。這主要是由於急性腎損傷 (AKI) 發病率的上升,尤其是在入住加護病房 (ICU) 的重症患者中。 CRRT 提供更慢、更可控且更連續的血液淨化過程,使其非常適合此類環境,並且是無法耐受傳統血液透析相關的快速液體和溶質轉移的血流動力學不穩定患者的首選方案。
此外,敗血症和多重器官衰竭等危及生命的疾病(通常會導致急性腎損傷 (AKI))的增多,進一步增加了對 CRRT 系統的需求。這些臨床情況通常需要緊急且持續的腎臟支持,這使得 CRRT 成為重症監護中必不可少的干預措施。
同時,技術進步提升了 CRRT 設備的功能性和易用性。自動化液體管理、即時監控和直覺的使用者介面等創新技術減輕了醫護人員的操作負擔,同時提高了治療的準確性。
監管里程碑的出現進一步支持了這一擴展,反映了 CRRT 平台日益增強的多功能性。例如,2023 年 8 月,Quanta Dialysis Technologies® 獲得 FDA 510(k) 批准,擴大了其 Quanta 透析系統的 CRRT 適應症,突顯了多功能和高適應性腎臟支持設備的發展趨勢。
預計這些因素將推動 CRRT 設備類別的顯著增長,並在 2025 年至 2032 年的預測期內顯著促進整個血液淨化設備市場的擴張。
預計北美將主導整個血液淨化設備市場:
預計 2024 年北美將佔據血液淨化設備市場的最大佔有率,這主要得益於幾個關鍵因素。該地區的主導地位主要歸因於慢性腎病 (CKD) 及其相關風險因素(例如高血壓和糖尿病)的普遍存在。該地區還受益於發達的醫療保健基礎設施、支持性的報銷政策以及對腎臟護理進步的日益關注。這些因素共同促進了血液淨化技術的廣泛應用,鞏固了北美在整個預測期內作為領先市場的地位。
根據美國疾病管制與預防中心 (CDC, 2024) 的數據,超過七分之一的美國成年人(約 3,550 萬人,佔總人口的 14%)患有慢性腎臟病 (CKD)。此疾病對老年人的影響尤其嚴重,65 歲及以上族群的盛行率為 34%,而 45 至 64 歲族群的盛行率為 12%,18 至 44 歲族群的盛行率為 6%。女性 CKD 的盛行率 (14%) 略高於男性 (12%)。美國國家腎臟基金會 (2024) 報告顯示,約有 80.8 萬人患有腎衰竭,2022 年新增確診腎衰竭病例 13.5 萬例。
患者群體日益多樣化,日益增長,這推動了對腎臟支持療法的需求,包括透析和持續性血液淨化,尤其是在醫院、透析中心和重症監護室。
到 2025 年,近一半的美國成年人(48.1%),約 1.199 億人,將患有高血壓(收縮壓≥130 mmHg,舒張壓≥80 mmHg,或正在服用藥物控制病情)。然而,只有四分之一的高血壓成年人(22.5%,即 2,700 萬人)的病情受到控制。此外,據報道,到2024年,約有3,800萬人將患有糖尿病。
高血壓和糖尿病都是CKD和AKI的主要危險因素,這些疾病通常需要及時有效的血液淨化療法來控制體液超負荷、毒素清除和電解質失衡。這些慢性疾病日益加重的負擔不僅增加了需要腎臟支持的患者數量,也促使醫療保健提供者採用先進的血液淨化技術。因此,高血壓和糖尿病盛行率的上升直接促進了血液淨化設備市場的成長和擴張。
此外,該地區的產品開發活動預計將進一步推動血液淨化設備市場的發展。例如,2024年7月,由美國醫療技術公司Outset Medical開發的突破性、全整合式行動血液透析系統Tablo®上市。該系統旨在治療急性和慢性腎衰竭患者。
預計這些臨床、技術和策略推動因素將在2025年至2032年的預測期內顯著推動美國血液淨化設備市場的成長。
血液淨化設備市場的主要參與者
血液淨化設備市場的主要市場參與者包括B. Braun Melsungen AG、旭化成株式會社、費森尤斯株式會社、百特、Infomed SA、健帆生物醫學株式會社、鍾淵株式會社、日機裝株式會社、SWS醫療集團、美敦力、CytoSorbents Europe*Sorbent、Hcontra Corporation、Theconra Corporation、Thekben)
血液淨化設備市場的最新發展:
血液淨化設備市場研究報告重點
血液淨化設備市場常被詢問的問題
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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