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市場調查報告書
商品編碼
1736768
全球治療性血漿置換市場規模(依適應症、最終用戶、區域範圍和預測)Global Therapeutic Plasma Exchange Market Size By Disease Indications (Neurological Disorders, Renal Disorders), By End User (Hospitals, Specialty Clinics), By Geographic Scope And Forecast |
預計 2024 年治療性血漿置換市場規模將達到 11.5 億美元,到 2032 年將達到 21.9 億美元,2026 年至 2032 年的複合年成長率為 7.5%。
治療性血漿置換 (TPE) 是一種醫療程序,其中從患者血液中取出血漿並用替代液(例如生理食鹽水或捐贈血漿)替換。
治療性血漿置換的主要目的是清除血漿中的有害物質,例如導致各種疾病和病症的抗體、毒素和異常蛋白質。
治療性血漿置換通常用於治療多種疾病,包括自體免疫疾病(如Guillain-Barré二氏症候群、重症肌無力)、血液疾病(如血栓性血小板低下紫斑症)和某些腎臟疾病。
這個過程通常涉及一台血液分離機,將血液分離成各個成分:血漿被移除,剩餘的血球與替代液體混合,然後返回患者體內。
影響全球治療性血漿置換市場的關鍵市場動態是:
關鍵促進因素
自體免疫疾病盛行率上升:重症肌無力和Guillain-Barré二氏症候群等自體免疫疾病盛行率上升,是治療性血漿置換需求成長的主要促進因素。例如,美國國立衛生研究院報告稱,全球每年每10萬人中約有20人患有重症肌無力,凸顯了對有效治療方案的需求。
老年人口不斷成長:高齡化社會更容易患上需要治療性血漿置換的慢性疾病。預計到2050年,一些歐洲國家將有超過30%的人口年齡超過65歲,這將增加對治療性血漿置換等治療方法的需求,以解決與老齡化相關的健康問題。
技術進步:治療性血漿置換技術的不斷進步,提高了其療效和安全性,使其成為首選的治療方案。更有效率的血漿分離設備和更完善的通訊協定預計將推動市場成長。
醫療保健支出不斷成長:醫療保健支出的不斷成長,尤其是在北美,正在促進獲得治療性血漿置換等先進療法。在美國,2021年醫療保健支出將達到約4.3兆美元,用於支持創新治療方法的可近性。
主要問題
設備和耗材高成本:血漿置換費用昂貴,因為它需要專門的設備,例如血漿分離機,以及一次性零件,例如導管和過濾器。這種高成本可能會限制醫療保健提供者和患者的可及性,尤其是在開發中地區。
市場需求有限:與更廣泛使用的醫療產品相比,治療性血漿置換產品的市場需求可能相對有限。有限的生產規模可能導致單位成本較高,並使製造商難以實現規模經濟。
監管挑戰:遵守嚴格的安全性和有效性監管標準可能會使治療性血漿置換設備和耗材的核准過程複雜化,可能延遲新產品的上市並增加開發成本。 2
潛在副作用:接受治療性血漿置換的患者可能會出現過敏反應、低血壓、電解質失衡等副作用。這些併發症可能會阻止一些醫療保健提供者採用治療性血漿置換作為治療選擇,從而限制市場成長的潛力。
主要趨勢
適應症不斷擴大:治療性血漿置換的適應症已顯著擴大,涵蓋了超越傳統用途的多種疾病,包括自體免疫疾病、神經系統疾病、腎臟疾病等。例如,一項研究發現,腎臟疾病佔治療性血漿置換手術的36.8%,這反映出治療性血漿置換的有效性在各個醫療環境中越來越受到認可。
手術量增加:每年進行的治療性血漿置換手術數量顯著增加。韓國的數據顯示,2008年至2017年,TPE手術數量增加了約3.7倍,顯示該治療方法在臨床實踐中正逐漸獲得認可和應用。
技術進步:血漿分離技術的創新正在提高治療性血漿置換程序的效率和安全性。先進血漿分離設備的引入有望改善患者預後並簡化流程,從而促進市場成長。
認知度和接受度的提升:醫療保健提供者對TPE在治療複雜疾病方面的益處的認知日益加深,這推動了TPE的普及。例如,美國疾病管制與預防中心(CDC)報告稱,美國每年有2萬至4萬例Guillain-Barré二氏症候群病例,這凸顯了對TPE等有效治療方案的需求。
Therapeutic Plasma Exchange Market size was valued at USD 1.15 Billion in 2024 and is projected to reach USD 2.19 Billion by 2032, growing at a CAGR of 7.5% from 2026 to 2032.
Therapeutic plasma exchange (TPE) is a medical procedure that involves the removal of plasma from a patient's blood and its replacement with a substitute fluid, such as saline or donor plasma.
The primary goal of therapeutic plasma exchange is to eliminate harmful substances found in the plasma, such as antibodies, toxins, or abnormal proteins, which may be responsible for various diseases and symptoms.
therapeutic plasma exchange is commonly utilized to treat a range of conditions, including autoimmune diseases (e.g., Guillain-Barre syndrome, myasthenia gravis), blood disorders (e.g., thrombotic thrombocytopenic purpura), and certain kidney diseases.
The process typically involves using an apheresis machine that separates blood into its components. Plasma is removed, and the remaining blood cells are mixed with a replacement fluid before being returned to the patient.
The key market dynamics that are shaping the global therapeutic plasma exchange market include:
Key Drivers:
Rising Prevalence of Autoimmune Diseases: The increasing incidence of autoimmune disorders, such as myasthenia gravis and Guillain-Barre syndrome, is significantly driving the demand for therapeutic plasma exchange . For instance, the National Institutes of Health reported that the prevalence of myasthenia gravis affects about 20 per 100,000 people globally each year, highlighting the need for effective treatment options.
Growing Geriatric Population: The aging population is more susceptible to chronic diseases that require therapeutic plasma exch By 2050, it is projected that over 30% of the population in some European countries will be over 65 years old, increasing the demand for therapies like therapeutic plasma exchange that address age-related health issues.
Technological Advancements: Continuous advancements in therapeutic plasma exchange technology enhance its effectiveness and safety, making it a preferred treatment option. The development of more efficient apheresis machines and improved protocols are expected to drive market growth.
Increased Healthcare Spending: Rising healthcare expenditures, particularly in North America, are facilitating access to advanced treatments like therapeutic plasma exchange. In the U.S., healthcare spending was approximately $4.3 trillion in 2021, supporting the availability of innovative therapies.
Key Challenges:
High Cost of Equipment and Consumables: The cost associated with therapeutic plasma exchange procedures is significant due to the need for specialized equipment, such as apheresis machines, and single-use disposable components like tubing and filters. This high cost can limit accessibility for healthcare providers and patients, particularly in developing regions.
Limited Market Demand: Therapeutic plasma exchange products may have relatively limited market demand compared to more widely used medical products. This limited scale of production can lead to higher per-unit costs, making it challenging for manufacturers to achieve economies of scale.
Regulatory Challenges: Compliance with stringent regulatory standards for safety and efficacy can complicate the approval process for therapeutic plasma exchange devices and consumables. This can delay market entry for new products and increase development costs2.
Potential Side Effects: Patients undergoing therapeutic plasma exchange may experience side effects such as allergic reactions, hypotension, or electrolyte imbalances. These complications can deter some healthcare providers from adopting therapeutic plasma exchange as a treatment option, limiting its market growth potential.
Key Trends:
Expansion of Indications: The indications for therapeutic plasma exchange have broadened significantly, now encompassing a wide range of conditions beyond traditional uses. This includes autoimmune diseases, neurological disorders, and renal diseases. For instance, a study indicated that renal diseases accounted for 36.8% of therapeutic plasma exchange procedures, reflecting a growing recognition of therapeutic plasma exchange's effectiveness in various medical contexts.
Increased Procedure Volume: There has been a notable increase in the number of therapeutic plasma exchange procedures performed annually. Data from South Korea showed that the number of TPE procedures increased approximately 3.7 times from 2008 to 2017, indicating a rising acceptance and utilization of this therapy in clinical practice.
Technological Advancements: Innovations in apheresis technology are enhancing the efficiency and safety of therapeutic plasma exchange procedures. The introduction of advanced apheresis machines is expected to improve patient outcomes and streamline the process, contributing to market growth.
Growing Awareness and Acceptance: Increased awareness among healthcare providers regarding the benefits of TPE for managing complex conditions is driving its adoption. For example, the CDC reported between 20,000 to 40,000 cases of Guillain-Barre syndrome annually in the U.S., highlighting the need for effective treatment options like TPE.
Here is a more detailed regional analysis of the global therapeutic plasma exchange market:
North America:
The North American therapeutic plasma exchange market is projected to reach approximately USD 280 Million by 2027, growing at a CAGR of 6.2% from 2022 to 2027, reflecting robust market potential.
The region has a high prevalence of autoimmune diseases, with the National Institutes of Health reporting that conditions like myasthenia gravis affect approximately 20 per 100,000 people annually, driving demand for TPE treatments.
According to the American Heart Association, nearly 92.1 million individuals in the U.S. suffered from cardiovascular diseases in 2018, which increases the need for therapeutic plasma exchange interventions.
North America benefits from an advanced healthcare infrastructure that supports the widespread adoption of TPE procedures, ensuring patient access to effective treatments.
Europe:
The European market is projected to grow significantly, with estimates indicating it will reach approximately USD 19 Billion by 2032, reflecting a CAGR of 7.5% from 2026 to 2032. This growth is driven by increasing prevalence of neurological, renal, and hematological disorders.
Many European countries have established healthcare systems that ensure broad access to medical treatments, including therapeutic plasma exchange. This accessibility enhances patient care and treatment outcomes.
The presence of numerous biotech companies and research institutions in Europe supports innovation and development in therapeutic plasma exchange technologies, contributing to the market's expansion.
The aging population in Europe is increasing the demand for chronic disease management solutions, with projections indicating that by 2030, nearly 20% of the European population will be over 65 years old, further driving the need for therapies like therapeutic plasma exchange.
The Global Therapeutic Plasma Exchange Market is segmented on the basis of Disease Indications, End-User and Geography.
Based on Disease Indications, the Global Therapeutic Plasma Exchange is divided into Neurological Disorders, Renal Disorders, Hematology Disorders, Metabolic Disorders, and Others. The neurological disorder segment is expected to capture the largest market share due to the high incidence of these diseases, especially in the aging population. Reports indicate that neurological conditions account for a substantial portion of TPE applications.
Based on End-User, the Global Therapeutic Plasma Exchange is divided into Hospitals, Specialty Clinics, and Ambulatory Surgical Centers. Hospitals account for a significant share of the therapeutic plasma exchange market due to their ability to accommodate patients requiring extended care and monitoring during TPE procedures.
Based on Geography, the Therapeutic Plasma Exchange Market is classified into North America, Europe, Asia Pacific, Middle East & Africa, and Latin America. The North American therapeutic plasma exchange market is projected to reach approximately USD 280 Million by 2027, growing at a CAGR of 6.2% from 2022 to 2027, reflecting robust market potential.
The "Global Therapeutic Plasma Exchange Market" study report will provide valuable insight with an emphasis on the global market including some of the major players such as Asahi Kasei Corporation, Baxter International, Inc., Terumo Corporation, B. Braun Melsungen AG, Fresenius Kabi AG, Kawasumi Laboratories, Inc., Haemonetics Corporation, Cerus Corporation, Hemacare Corporation, Medica S.p.A., and others.
Our market analysis also entails a section solely dedicated to such major players wherein our analysts provide an insight into the financial statements of all the major players, along with its product benchmarking and SWOT analysis. The competitive landscape section also includes key development strategies, market share, and market ranking analysis of the above-mentioned players globally.