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市场调查报告书
商品编码
1700049
2032 年血浆分馏疗法市场预测:按类型、工艺、应用、最终用户和地区进行的全球分析Blood Plasma Derivatives Market Forecasts to 2032 - Global Analysis By Type, Process, Application, End User and By Geography |
根据 Stratistics MRC 的数据,全球血浆分馏衍生物市场预计在 2025 年达到 567.1 亿美元,到 2032 年将达到 1,155.2 亿美元,预测期内的复合年增长率为 10.7%。
人体血浆是血液的液体成分,是被称为血浆分馏衍生物的专门药物的来源。这些衍生物包括白蛋白、免疫球蛋白、凝血因子和α-1抗胰蛋白酶等必需蛋白质,常用于治疗各种疾病。免疫力缺乏、血友病、Guillain-Barré二氏症候群等神经系统疾病都可以在它们的帮助下得到治疗。血浆分馏是透过分馏获得的,分馏是一种用于分离和精製用于医疗用途的特定蛋白质的技术。
根据世界血友病联盟 (WFH) 的数据,全球每 10,000 人中约有 1 人患有血友病。
老年人口不断增加
血浆疗法需求不断增长的主要驱动力是人口老化。老年人是血浆分馏的重要用户,因为他们更容易患上凝血障碍、慢性肝病和免疫力缺乏等疾病。根据联合国估计,到2050年,全球约有16亿人,即六分之一的人口,年龄在65岁或以上。此外,感染疾病、心血管疾病和自体免疫疾病的风险也会随着老龄化的增长而增加。许多此类疾病都是用血浆蛋白(如白蛋白和免疫球蛋白)治疗的。
製造和加工成本过高
血浆分馏过程复杂且耗时,使得製造血浆衍生治疗药物的成本非常高。从血浆采集到最终产品的发布可能需要7到12个月的时间,导致营运成本很高。血浆分馏需要专门的设备、严格的品管测试和广泛的储存基础设施来维持血浆蛋白的稳定性和功效。此外,生产少量成品需要几公升血浆,这增加了总生产成本。例如,需要大约 130 次血浆捐赠才能生产足够的静脉注射免疫球蛋白 (IVIG) 来治疗一名患者一年。
人们对免疫球蛋白和血浆疗法的兴趣日益浓厚
免疫力缺乏、神经系统疾病和自体免疫疾病的增加推动了对静脉注射免疫球蛋白 (IVIG) 和皮下免疫球蛋白 (SCIG) 的需求。川崎病、慢性发炎性去髓鞘化多发性神经病变 (CIDP) 和原发性免疫力缺乏症 (PIDD) 等疾病需要长期免疫球蛋白治疗。根据业内估计,全球对 IVIG 的需求每年以超过 8% 的速度成长,为市场创造了巨大的成长前景。此外,血浆衍生免疫球蛋白治疗的适应症扩大至败血症、多发性硬化症和阿兹海默症疾病,进一步提升了市场前景。
血浆捐献短缺,供应有限
全球血浆供应高度依赖捐赠者的参与,而这取决于社会经济因素、监管限制和公众对血浆捐赠的态度。有关捐赠者补偿的政策变化和伦理争论可能会对依赖有偿血浆捐献模式的国家(如美国)造成混乱。此外,COVID-19 疫情凸显了血浆采集的脆弱性,因为捐血大幅下降导致免疫球蛋白和凝血因子短缺。
COVID-19 疫情导致生产延迟、血浆采集中断以及免疫球蛋白需求增加,对血浆分馏疗法市场产生了重大影响。封锁和社交隔离政策,尤其是在美国和欧洲等主要市场,导致血浆捐赠量下降,造成关键血浆衍生治疗药物的短缺。此外,由于针对 COVID-19 患者恢復期血浆疗法的研究激增,导致产业重点暂时转移,其他血浆衍生产品的供应链也受到了影响。
预计预测期内免疫球蛋白部分将达到最大程度的成长。
免疫球蛋白预计将在预测期内占据最大的市场份额,因为它广泛应用于治疗自体免疫疾病、原发性和次发性免疫力缺乏缺陷以及Guillain-Barré二氏症候群和慢性脱髓鞘多发性神经炎( CIDP)等神经系统疾病。免疫球蛋白产品的需求受到人口老化、免疫力缺乏盛行率上升以及血浆衍生治疗方法知识不断增加的推动。此外,静脉注射的改进提高了患者的便利性和治疗依从性。
预测期内层析法领域预计将以最高复合年增长率成长
由于色谱法在分离血浆蛋白方面具有卓越的效率、纯度和精度,预计在预测期内层析法部分将出现最高的增长率。层析法在免疫球蛋白、白蛋白和凝血因子的生产中越来越受欢迎,因为与冷乙醇分馏等传统技术相比,它具有更高的产量和特异性。对高纯度血浆治疗的需求不断增长、层析法和离子交换层析法的改进以及对生物製药研究的投资不断增加,正在刺激层析法的快速应用。此外,由于层析法精製具有卓越的病原体去除能力,因此受到监管机构的青睐,从而进一步推动了市场的成长。
预计北美地区将在预测期内占据最大的市场占有率。这是由于主要市场参与者的强大存在、高血浆捐赠率以及先进的医疗保健基础设施。美国凭藉着完善的血浆捐献设施和优惠的报销政策,在该地区处于领先地位,并为全球血浆收集做出了重大贡献。由于神经系统疾病、血友病和免疫系统疾病的盛行率不断上升,以及人们对血浆治疗方法的认识不断提高,市场正在不断增长。此外,北美在市场上的主导地位也是 FDA 强有力的监管支持、血浆分馏技术的持续研究以及免疫球蛋白疗法的广泛采用的结果。
预计亚太地区在预测期内的复合年增长率最高。这是由于免疫不全症的盛行率不断上升、人们对血浆疗法的认识不断提高以及医疗成本不断上升。政府对生技药品和血浆分馏的支持、不断增长的血浆采集计划以及不断改善的医疗基础设施正在促进中国、印度和日本等国家的快速扩张。由于对凝血因子和免疫球蛋白的需求不断增长,以及对先进精製技术的投资和药品生产能力的扩大,市场正在不断扩大。
According to Stratistics MRC, the Global Blood Plasma Derivatives Market is accounted for $56.71 billion in 2025 and is expected to reach $115.52 billion by 2032 growing at a CAGR of 10.7% during the forecast period. Human plasma, the liquid component of blood, is the source of specialized medicinal products known as blood plasma derivatives. Essential proteins like albumin, immunoglobulins, clotting factors, and alpha-1 antitrypsin are among these derivatives and are frequently used to treat a variety of illnesses. Immunodeficiencies, hemophilia, and neurological conditions like Guillain-Barre syndrome are all treated with their help. Fractionation, a technique used to isolate and purify particular proteins for medical applications, yields plasma derivatives.
According to the World Federation of Hemophilia (WFH), hemophilia affects approximately 1 in 10,000 people globally.
Increasing number of elderly people
A major factor in the rising demand for therapies derived from plasma is the aging population. The elderly are significant users of plasma derivatives because they are more susceptible to diseases like coagulation problems, chronic liver disease, and immunological deficiencies. Approximately 1.6 billion people, or one in six people worldwide, will be over 65 by 2050, according to UN estimates. Additionally, the risk of infections, cardiovascular conditions, and autoimmune diseases increases with age; many of these conditions are treated with plasma proteins such as albumin and immunoglobulins.
Exorbitant expenses for production and processing
The complicated and time-consuming plasma fractionation process makes the production of therapies derived from plasma extremely costly. Plasma collection and final product release can take seven to twelve months, which results in high operating costs. For plasma proteins to remain stable and effective, plasma fractionation necessitates specialized equipment, rigorous quality control testing, and a sizable storage infrastructure. Furthermore, the total cost of production is raised by the requirement for several liters of plasma to generate a small amount of the finished product. For instance, to make enough Intravenous Immunoglobulin (IVIG) to treat one patient for a year, about 130 plasma donations are needed.
Growing interest in immunoglobulin and plasma treatments
Intravenous immunoglobulins (IVIG) and subcutaneous immunoglobulins (SCIG) are in high demand due to the increasing incidence of immune deficiencies, neurological conditions, and autoimmune diseases. Long-term immunoglobulin therapy is necessary for conditions like Kawasaki disease, chronic inflammatory demyelinating polyneuropathy (CIDP), and primary immunodeficiency disorders (PIDD). Industry estimates indicate that the demand for IVIG has been rising globally at a rate of more than 8% per year, which has created significant growth prospects for the market. Moreover, prospects for the market are further enhanced by the extension of plasma-derived immunoglobulin treatment indications into conditions like sepsis, multiple sclerosis, and Alzheimer's disease.
Lack of plasma donations and limitations on supply
The worldwide supply of plasma is largely reliant on donor participation, which varies depending on socioeconomic factors, regulatory limitations, and public attitudes regarding plasma donation. Policy changes and donor compensation ethical discussions could cause disruptions for nations like the US that depend on compensated plasma donation models. Additionally, the COVID-19 pandemic brought to light the vulnerability of plasma collection, as notable drops in donations resulted in immunoglobulin and clotting factor shortages.
The COVID-19 pandemic had a major effect on the market for blood plasma derivatives because it caused delays in manufacturing, disruptions in plasma collection, and an increase in demand for immunoglobulins. Lockdowns and social distancing policies caused plasma donations to drop, particularly in important markets like the US and Europe, which resulted in a shortage of vital therapies derived from plasma. Furthermore, the supply chain for other plasma-derived products was also impacted by the brief shift in industry focus caused by the explosion in research on convalescent plasma therapy for COVID-19 patients.
The Immunoglobulin segment is expected to be the largest during the forecast period
The Immunoglobulin segment is expected to account for the largest market share during the forecast period, motivated by its extensive application in the treatment of autoimmune diseases, primary and secondary immunodeficiency's, and neurological disorders like Guillain-Barre syndrome and chronic inflammatory demyelinating polyneuropathy (CIDP). The demand for immunoglobulin products has been driven by the growing number of elderly people, the increasing prevalence of immunodeficiency diseases, and the growing knowledge of plasma-derived treatments. Furthermore, improvements in immunoglobulin formulations for intravenous (IVIG) and subcutaneous (SCIG) administration have enhanced patient convenience and treatment compliance.
The Chromatography segment is expected to have the highest CAGR during the forecast period
Over the forecast period, the Chromatography segment is predicted to witness the highest growth rate, motivated by its exceptional efficiency, purity, and precision in plasma protein separation. Chromatography is becoming more and more popular for producing immunoglobulins, albumin, and coagulation factors because it provides superior yield and specificity compared to conventional techniques like cold ethanol fractionation. Its quick adoption is being fueled by the rising demand for high-purity plasma-derived treatments, improvements in affinity and ion-exchange chromatography, and rising investments in biopharmaceutical research. Moreover, the market growth of chromatography-based purification is further enhanced by regulatory bodies' preference for it because of its superior pathogen removal capabilities.
During the forecast period, the North America region is expected to hold the largest market share, driven by a robust presence of major market players, high plasma donation rates, and sophisticated healthcare infrastructure. Because of its well-established plasma donation facilities and advantageous reimbursement policies, the United States leads the region and contributes significantly to global plasma collection. The market is growing due to the rising incidence of neurological diseases, hemophilia, and immune disorders, as well as increased awareness of therapies derived from plasma. Additionally, North America's dominant market position is also a result of the FDA's strong regulatory support, continuous research into plasma fractionation technologies, and widespread use of immunoglobulin treatments.
Over the forecast period, the Asia Pacific region is anticipated to exhibit the highest CAGR, driven by the growing prevalence of immunodeficiency disorders, growing awareness of plasma-derived therapies, and rising healthcare costs. Government support for biologics and plasma fractionation, growing plasma collection programs, and better healthcare infrastructure are all contributing to the rapid expansion of nations like China, India, and Japan. The market is growing as a result of rising demand for coagulation factors and immunoglobulins, as well as investments in sophisticated purification technologies and growing pharmaceutical manufacturing capacities.
Key players in the market
Some of the key players in Blood Plasma Derivatives Market include Bayer AG, Fusion Health Care Pvt. Ltd., Grifols, S.A., Takeda Pharmaceutical Company, Sanofi, CSL Limited, LFB S.A., Baxter International Inc., Syntegon, Green Cross Corporation, Octapharma AG, Biotest AG, Kedrion Biopharma, Inc., SK Plasma Co., Ltd. and Intas Pharmaceuticals Ltd.
In February 2025, Sanofi and CD&R have signed the share purchase agreement for the sale of a 50% controlling stake in its consumer health business Opella to US private equity firm Clayton Dubilier & Rice (CD&R). The terms of the transaction remain unchanged from those previously announced and closing is expected in the second quarter of 2025 at the earliest.
In January 2025, Bayer announced that the company has signed a new exclusive distribution agreement with UK-based Ecospray to market a biological liquid nematicide sourced from garlic. The product presents a biological alternative to traditional synthetic chemical nematicides in vegetable and potato crops, and will be marketed in the European Union under the new name Velsinum(TM).
In June 2024, Takeda announced the signing of an option agreement with Ascentage Pharma to enter into an exclusive license agreement for olverembatinib, an oral, potentially best-in-class, third-generation BCR-ABL tyrosine kinase inhibitor (TKI), which is currently in development for chronic myeloid leukemia (CML) and other hematological cancers.