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市场调查报告书
商品编码
1736768
全球治疗性血浆置换市场规模(依适应症、最终用户、区域范围和预测)Global Therapeutic Plasma Exchange Market Size By Disease Indications (Neurological Disorders, Renal Disorders), By End User (Hospitals, Specialty Clinics), By Geographic Scope And Forecast |
预计 2024 年治疗性血浆置换市场规模将达到 11.5 亿美元,到 2032 年将达到 21.9 亿美元,2026 年至 2032 年的复合年增长率为 7.5%。
治疗性血浆置换 (TPE) 是一种医疗程序,其中从患者血液中取出血浆并用替代液(例如生理食盐水或捐赠血浆)替换。
治疗性血浆置换的主要目的是清除血浆中的有害物质,例如导致各种疾病和病症的抗体、毒素和异常蛋白质。
治疗性血浆置换通常用于治疗多种疾病,包括自体免疫疾病(如Guillain-Barré二氏症候群、重症肌无力)、血液疾病(如血栓性血小板低下紫斑症)和某些肾臟疾病。
这个过程通常涉及一台血液分离机,将血液分离成各个成分:血浆被移除,剩余的血球与替代液体混合,然后返回患者体内。
影响全球治疗性血浆置换市场的关键市场动态是:
关键驱动因素
自体免疫疾病盛行率上升:重症肌无力和Guillain-Barré二氏症候群等自体免疫疾病盛行率上升,是治疗性血浆置换需求成长的主要驱动因素。例如,美国国立卫生研究院报告称,全球每年每10万人中约有20人患有重症肌无力,凸显了对有效治疗方案的需求。
老年人口不断增长:高龄化社会更容易患上需要治疗性血浆置换的慢性疾病。预计到2050年,一些欧洲国家将有超过30%的人口年龄超过65岁,这将增加对治疗性血浆置换等治疗方法的需求,以解决与老龄化相关的健康问题。
技术进步:治疗性血浆置换技术的不断进步,提高了其疗效和安全性,使其成为首选的治疗方案。更有效率的血浆分离设备和更完善的通讯协定预计将推动市场成长。
医疗保健支出不断增长:医疗保健支出的不断增长,尤其是在北美,正在促进获得治疗性血浆置换等先进疗法。在美国,2021年医疗保健支出将达到约4.3兆美元,用于支持创新治疗方法的可近性。
主要问题
设备和耗材高成本:血浆置换费用昂贵,因为它需要专门的设备,例如血浆分离机,以及一次性零件,例如导管和过滤器。这种高成本可能会限制医疗保健提供者和患者的可及性,尤其是在开发中地区。
市场需求有限:与更广泛使用的医疗产品相比,治疗性血浆置换产品的市场需求可能相对有限。有限的生产规模可能导致单位成本较高,并使製造商难以实现规模经济。
监管挑战:遵守严格的安全性和有效性监管标准可能会使治疗性血浆置换设备和耗材的核准过程复杂化,可能延迟新产品的上市并增加开发成本。 2
潜在副作用:接受治疗性血浆置换的患者可能会出现过敏反应、低血压、电解质失衡等副作用。这些併发症可能会阻止一些医疗保健提供者采用治疗性血浆置换作为治疗选择,从而限制市场成长的潜力。
主要趋势
适应症不断扩大:治疗性血浆置换的适应症已显着扩大,涵盖了超越传统用途的多种疾病,包括自体免疫疾病、神经系统疾病、肾臟疾病等。例如,一项研究发现,肾臟疾病占治疗性血浆置换手术的36.8%,这反映出治疗性血浆置换的有效性在各个医疗环境中越来越受到认可。
手术量增加:每年进行的治疗性血浆置换手术数量显着增加。韩国的数据显示,2008年至2017年,TPE手术数量增加了约3.7倍,显示该治疗方法在临床实践中正逐渐获得认可和应用。
技术进步:血浆分离技术的创新正在提高治疗性血浆置换程序的效率和安全性。先进血浆分离设备的引入有望改善患者预后并简化流程,从而促进市场成长。
认知度和接受度的提升:医疗保健提供者对TPE在治疗复杂疾病方面的益处的认识日益加深,这推动了TPE的普及。例如,美国疾病管制与预防中心(CDC)报告称,美国每年有2万至4万例Guillain-Barré二氏症候群病例,这凸显了对TPE等有效治疗方案的需求。
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.