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市場調查報告書
商品編碼
1700049
2032 年血漿分餾療法市場預測:按類型、工藝、應用、最終用戶和地區進行的全球分析Blood Plasma Derivatives Market Forecasts to 2032 - Global Analysis By Type, Process, Application, End User and By Geography |
根據 Stratistics MRC 的數據,全球血漿分餾衍生物市場預計在 2025 年達到 567.1 億美元,到 2032 年將達到 1,155.2 億美元,預測期內的複合年成長率為 10.7%。
人體血漿是血液的液體成分,是被稱為血漿分餾衍生物的專門藥物的來源。這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質,常用於治療各種疾病。免疫力缺乏、血友病、Guillain-Barré二氏症候群等神經系統疾病都可以在它們的幫助下得到治療。血漿分餾是透過分餾獲得的,分餾是一種用於分離和精製用於醫療用途的特定蛋白質的技術。
根據世界血友病聯盟 (WFH) 的數據,全球每 10,000 人中約有 1 人患有血友病。
老年人口不斷增加
血漿療法需求不斷成長的主要驅動力是人口老化。老年人是血漿分餾的重要用戶,因為他們更容易患上凝血障礙、慢性肝病和免疫力缺乏等疾病。根據聯合國估計,到2050年,全球約有16億人,即六分之一的人口,年齡在65歲或以上。此外,感染疾病、心血管疾病和自體免疫疾病的風險也會隨著老齡化的成長而增加。許多此類疾病都是用血漿蛋白(如白蛋白和免疫球蛋白)治療的。
製造和加工成本過高
血漿分餾過程複雜且耗時,使得製造血漿衍生治療藥物的成本非常高。從血漿採集到最終產品的發布可能需要7到12個月的時間,導致營運成本很高。血漿分餾需要專門的設備、嚴格的品管測試和廣泛的儲存基礎設施來維持血漿蛋白的穩定性和功效。此外,生產少量成品需要幾公升血漿,這增加了總生產成本。例如,需要大約 130 次血漿捐贈才能生產足夠的靜脈注射免疫球蛋白 (IVIG) 來治療一名患者一年。
人們對免疫球蛋白和血漿療法的興趣日益濃厚
免疫力缺乏、神經系統疾病和自體免疫疾病的增加推動了對靜脈注射免疫球蛋白 (IVIG) 和皮下免疫球蛋白 (SCIG) 的需求。川崎病、慢性發炎性去髓鞘化多發性神經病變 (CIDP) 和原發性免疫力缺乏症 (PIDD) 等疾病需要長期免疫球蛋白治療。根據業內估計,全球對 IVIG 的需求每年以超過 8% 的速度成長,為市場創造了巨大的成長前景。此外,血漿衍生免疫球蛋白治療的適應症擴大至敗血症、多發性硬化症和阿茲海默症疾病,進一步提升了市場前景。
血漿捐獻短缺,供應有限
全球血漿供應高度依賴捐贈者的參與,而這取決於社會經濟因素、監管限制和公眾對血漿捐贈的態度。有關捐贈者補償的政策變化和倫理爭論可能會對依賴有償血漿捐獻模式的國家(如美國)造成混亂。此外,COVID-19 疫情凸顯了血漿採集的脆弱性,因為捐血大幅下降導致免疫球蛋白和凝血因子短缺。
COVID-19 疫情導致生產延遲、血漿採集中斷以及免疫球蛋白需求增加,對血漿分餾療法市場產生了重大影響。封鎖和社交隔離政策,尤其是在美國和歐洲等主要市場,導致血漿捐贈量下降,造成關鍵血漿衍生治療藥物的短缺。此外,由於針對 COVID-19 患者恢復期血漿療法的研究激增,導致產業重點暫時轉移,其他血漿衍生產品的供應鏈也受到了影響。
預計預測期內免疫球蛋白部分將達到最大程度的成長。
免疫球蛋白預計將在預測期內佔據最大的市場佔有率,因為它廣泛應用於治療自體免疫疾病、原發性和次發性免疫力缺乏缺陷以及Guillain-Barré二氏症候群和慢性脫髓鞘多發性神經炎( CIDP)等神經系統疾病。免疫球蛋白產品的需求受到人口老化、免疫力缺乏盛行率上升以及血漿衍生治療方法知識不斷增加的推動。此外,靜脈注射的改進提高了患者的便利性和治療依從性。
預測期內層析法領域預計將以最高複合年成長率成長
由於色譜法在分離血漿蛋白方面具有卓越的效率、純度和精度,預計在預測期內層析法部分將出現最高的成長率。層析法在免疫球蛋白、白蛋白和凝血因子的生產中越來越受歡迎,因為與冷乙醇分餾等傳統技術相比,它具有更高的產量和特異性。對高純度血漿治療的需求不斷成長、層析法和離子交換層析法的改進以及對生物製藥研究的投資不斷增加,正在刺激層析法的快速應用。此外,由於層析法精製具有卓越的病原體去除能力,因此受到監管機構的青睞,從而進一步推動了市場的成長。
預計北美地區將在預測期內佔據最大的市場佔有率。這是由於主要市場參與者的強大存在、高血漿捐贈率以及先進的醫療保健基礎設施。美國憑藉著完善的血漿捐獻設施和優惠的報銷政策,在該地區處於領先地位,並為全球血漿收集做出了重大貢獻。由於神經系統疾病、血友病和免疫系統疾病的盛行率不斷上升,以及人們對血漿治療方法的認知不斷提高,市場正在不斷成長。此外,北美在市場上的主導地位也是 FDA 強力的監管支持、血漿分餾技術的持續研究以及免疫球蛋白療法的廣泛採用的結果。
預計亞太地區在預測期內的複合年成長率最高。這是由於免疫不全症的盛行率不斷上升、人們對血漿療法的認知不斷提高以及醫療成本不斷上升。政府對生技藥品和血漿分餾的支持、不斷成長的血漿採集計劃以及不斷改善的醫療基礎設施正在促進中國、印度和日本等國家的快速擴張。由於對凝血因子和免疫球蛋白的需求不斷成長,以及對先進精製技術的投資和藥品生產能力的擴大,市場正在不斷擴大。
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.