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全球血浆蛋白治疗市场规模、份额和行业趋势分析报告:按最终用户、按产品类型(免疫球蛋白、白蛋白、血浆衍生因子 VIII、其他)、按应用、按地区展望和预测,2023-2029 年Global Plasma Protein Therapeutics Market Size, Share & Industry Trends Analysis Report By End User, By Product Type (Immunoglobulin, Albumin, Plasma derived factor VIII, and Others), By Application, By Regional Outlook and Forecast, 2023 - 2029 |
到 2029 年,血浆蛋白疗法市场规模预计将达到 391 亿美元,预计在预测期内将以 5.5% 的复合年增长率增长。
由于人体中的每一种组成蛋白质都有维持体内平衡的特定目的,因此缺少或不足的血浆蛋白质可能是致命的。 已註意到血浆蛋白在许多临床病理学环境中存在缺陷或功能障碍。 临床实践中使用新鲜冷冻血浆 (FFP) 和输血血浆。
输血用血浆用于治疗一般凝血因子缺乏症,在溶栓治疗中纠正纤溶亢进,在血浆置换治疗中替代缺乏的因子。 当纯化的血浆衍生产品供不应求时,它也是用于分离凝血因子缺陷的方法。 为防止输血过程中获得的血源性疾病传播,采取了供体排除、供体信息、供体筛查、隔离时间和病原体灭活等安全措施。
COVID-19 影响分析
由于许多发达国家这些药物的短缺,出现了开髮用于控制 COVID-19 的药物的大好机会。 对 COVID-19 疫苗和药物不断增长的需求预示着製药和生物技术行业的未来增长。 预计这将对血浆蛋白需求产生重大影响。 此外,由于血浆蛋白治疗产品的推出和相关研究项目的增加,市场有望扩大。 因此,可以得出结论,大流行对血浆蛋白治疗市场产生了有利影响。
市场增长因素
增加创新资金
随着技术开发出从血浆中分离蛋白质的高效且廉价的方法,血浆蛋白疗法市场预计会增长。 由于甲型和乙型肝炎、狂犬病、破伤风和水痘等传染病的增加,正在进行更多的研究和开发。 此外,还有 200 多种影响免疫和神经系统的危及生命的疾病,包括慢性炎症性脱髓鞘性多发性神经病 (CIDP) 和特发性血小板减少性紫癜。 因此,所有这些因素都将在整个预测期内推动市场的增长。
在治疗各种疾病方面对免疫球蛋白的需求不断增加
Ig 的标籤外使用涉及大量血浆。 IVIG 最常见的超适应症使用实例包括多灶性运动神经病 (MMN)、婴儿溶血病、急性全神经病、自身免疫性粘膜皮肤大疱病和急性心肌病。 近年来,由于诊断技术的进步和预期寿命的延长,对这些药物的临床需求猛增。 预计未来仍将保持增长趋势。 对 Ig 的需求正在上升,这不仅是由于免疫缺陷,而且是作为治疗各种适应症(尤其是某些神经系统疾病)的一部分的慢性超适应症处方。
市场製约因素
报销问题和严格监管导致市场受损的风险
新兴国家的血浆采集要求与分馏器不同。 在这些地区,我们遵守关于我们业务质量的严格法律和法规,从我们原材料的质量开始。 对于血浆,製造了特定的分馏器。 例如,欧洲卫生当局必须检查用于分馏的血浆池是否存在细小病毒 B、甲型肝炎、乙型肝炎、丙型肝炎和 HIV。 不幸的是,许多设施的采血操作往往无法满足这些要求,采集的血浆可能会被浪费。 医疗保健财政的压力也越来越大。 因此,这些因素可能会阻碍未来几年的市场扩张。
产品类型展望
按产品类型划分,血浆蛋白疗法市场分为免疫球蛋白、白蛋白、血浆衍生因子 VIII 等。 到 2022 年,免疫球蛋白部分将在血浆蛋白治疗市场中占据最高的收入份额。 该细分市场的增长归功于免疫球蛋白在治疗各种疾病中的使用越来越多。 免疫球蛋白是控制免疫系统并消除细菌和病毒等外来入侵者的蛋白质。 此外,它还用于治疗自身免疫性疾病以及原发性和继发性免疫缺陷。
应用展望
按应用,血浆蛋白治疗市场分为血友病、特发性血小板减少性紫癜、原发性免疫缺陷病等。 2022年,原发性免疫缺陷病领域在血浆蛋白治疗市场中占据了重要的收入份额。 原发性免疫缺陷 (PID) 是由免疫系统缺陷引起的 430 多种罕见且长期存在的疾病。 PID 影响全球超过 600 万人。 因此,预计在预测期内对治疗 PID 的血浆蛋白疗法的需求将显着增长。
最终用户视角
基于最终用户,血浆蛋白疗法市场分为医院和其他。 2022 年,血浆蛋白治疗市场在其他领域出现了显着增长。 这种增长可归因于因自身免疫性疾病(如血友病)就诊的人数增加以及医院中蛋白质疗法的可用性增加。 由于诊所和其他患者护理基础设施的可负担性、易于预约以及对患者就诊和便利的承诺,它们的使用已经扩大。
区域展望
血浆蛋白治疗市场按地区分析,横跨北美、欧洲、亚太地区和拉美。 北美部分在 2022 年血浆蛋白治疗市场中的收入份额最高。 在北美,免疫疾病的患病率正在上升,罕见病的数量在增加,血浆蛋白疗法的研究经费也在增加。 此外,製造血浆蛋白疗法的大公司的崛起也有助于该地区的市场扩张。 高购买力和成熟的医疗保健系统也是推动市场扩张的因素。
The Global Plasma Protein Therapeutics Market size is expected to reach $39.1 billion by 2029, rising at a market growth of 5.5% CAGR during the forecast period.
Pharmaceuticals known as plasma protein therapeutics are created from proteins extracted from human blood plasma. The biological actions of these proteins include controlling immunological response, blood clotting, and preserving the body's fluid balance. Blood problems, immunological deficiencies, as well as genetic disorders are just a few of the ailments that are treated with plasma protein therapeutics. They are frequently given by injection or infusion, and careful monitoring is necessary to ensure appropriate dosage and reduce any potential side effects.
Plasma is the form of fluid or a part of blood in which cellular components like leucocytes, red blood cells, and platelets are suspended. Plasma makes up 55% of total blood, with 89% of it being water, 2% salt, 3% lipids, and 6% protein. The 2,000-4,000 distinct proteins that make up the plasma proteins (60 g/L) have varying concentrations of hormones as well as about 40 mg/mL (albumin), and their total weight is 60 g/L.
An absence or deficit of a plasma protein could be fatal since each component protein in the human body has a distinct purpose in maintaining homeostasis. Plasma proteins are noted as being absent or dysfunctional in numerous clinical pathological circumstances. In clinical settings, fresh frozen plasma (FFP) or plasma for transfusion both are employed.
Plasma for transfusion is utilized in the treatment of general clotting factor deficiencies as well as in the correction of hyper-fibrinolysis in thrombolysis, replacement of deficient factors during plasmapheresis therapy. The method is also used in isolating deficiencies of clotting factor in lack of purified plasma-derived products. Safety precautions, such as a quarantine time and/or pathogen inactivation, are used in addition to donor exclusion, donor information, and donation screening to avoid the spread of blood-borne illnesses that are transferred during transfusions.
COVID-19 Impact Analysis
Large opportunities for COVID-19 management drug development were offered by the dearth of these medicines in many developed nations. Due to the increasing demand for COVID-19 vaccines and medications, future growth in the pharmaceutical and biotechnology industries is projected. This is expected to have a substantial influence on the demand for plasma protein. In addition, the market is anticipated to expand as a result of more plasma protein therapies product launches and related research projects. Therefore, it can be stated conclusively that the pandemic had a positive impact on the plasma protein therapeutics market.
Market Growth Factors
Growing funding for technological innovation
The market for plasma protein therapeutics is projected to grow due to technological developments in efficient and affordable methods for fractionating proteins from plasma. More R&D is being conducted because of the rising infectious diseases like hepatitis A&B, rabies, tetanus, and varicella. In addition, over 200 life-threatening diseases affect the immune or neurological systems, including chronic inflammatory demyelinating polyneuropathy (CIDP), idiopathic thrombocytopenic purpura. Hence, all these factors will promote the market's growth throughout the forecast period.
Rising need for immunoglobulins for the treatment of various disorders
A significant amount of plasma is used in Ig's widespread off-label usage. Examples of the most prevalent off-label IVIG usage include multifocal motor neuropathy (MMN), infant hemolytic illness, acute panautonomic polyneuropathy, autoimmune mucocutaneous blistering disorders, and acute cardiomyopathy. Due to ongoing advancements in diagnosis and higher life expectancy, the clinical demand for these medications has surged over the past several years. It is predicted to continue on its upward trajectory. The demand for Ig is rising due to immunological inadequacies as well as the chronic usage of off-label prescribing in various indications, especially as part of the treatment of certain neurological diseases.
Market Restraining Factors
Risk of market harm from reimbursement issues and strict regulation
Emerging nations' plasma collection requirements differ from those of fractionators. These areas adhere to stringent laws and norms regarding the caliber of their operations, beginning with the caliber of the raw materials. For plasma, specific fractionators have been created. For instance, the plasma pool used for fractionation must be checked for Parvovirus B, hepatitis A, B, and C, as well as HIV, by the European health authorities. Unfortunately, many facilities' blood collection efforts frequently fail to meet these requirements, wasting some recovered plasma. There is increasing pressure on health finances. Therefore, all these factors may hamper the expansion of the market in the coming years.
Product Type Outlook
Based on product type, the plasma protein therapeutics market is categorized into immunoglobulin, albumin, plasma derived factor VIII, and others. The immunoglobulin segment garnered the highest revenue share in the plasma protein therapeutics market in 2022. The growth of the segment is owed to the rising use of immunoglobulins in treating various diseases. Immunoglobulins are proteins that control the immune system and eliminate foreign invaders like bacteria and viruses. Additionally, it is employed in treating autoimmune diseases and primary and secondary immunodeficiency.
Application Outlook
On the basis of application, the plasma protein therapeutics market is divided into hemophilia, idiopathic thrombocytopenic purpura, primary immunodeficiency disorder, and others. The primary immunodeficiency disorder segment recorded a significant revenue share in the plasma protein therapeutics market in 2022. Primary Immunodeficiency Diseases (PID) are more than 430 uncommon in number, and are long-lasting illnesses brought on by immune system flaws. PID affects over 6.0 million individuals globally. Therefore, the demand for plasma protein therapeutics to treat PID is expected to grow significantly throughout the projection period.
End User Outlook
Based on end user, the plasma protein therapeutics market is segmented into hospitals and others. The others segment garnered a considerable growth rate in the plasma protein therapeutics market in 2022. This growth can be attributed to a rise in the number of people visiting hospitals with autoimmune diseases like hemophilia and the accessibility of protein therapies in hospitals. The use of clinics and other patient care infrastructure has expanded as a result of its affordability, ease of booking appointments, and commitment to patient accessibility and convenience.
Regional Outlook
On the basis of region, the plasma protein therapeutics market is analyzed across North America, Europe, Asia Pacific, and LAMEA. The North America segment procured the highest revenue share in the plasma protein therapeutics market in 2022. The prevalence of immunological illnesses is rising, uncommon diseases are becoming more common, and research funding for plasma protein therapies is increasing in North America. Additionally, an increase in the number of major companies producing plasma protein therapies contributes to the market expansion in this region. High purchasing power and the availability of well-established healthcare systems are further factors anticipated to fuel market expansion.
The major strategies followed by the market participants are Acquisitions. Based on the Analysis presented in the Cardinal matrix; CSL Limited (CSL Behring), Baxter International, Inc., Bayer AG, and Takeda Pharmaceutical Company Limited are the forerunners in the Plasma Protein Therapeutics Market. Companies such as Grifols, S.A., Kedrion S.p.A, and ADMA Biologics, Inc. are some of the key innovators in Plasma Protein Therapeutics Market.
The market research report covers the analysis of key stake holders of the market. Key companies profiled in the report include Bayer AG, Abeona Therapeutics, Inc., Takeda Pharmaceutical Company Limited, Grifols, S.A., Baxter International, Inc., Kedrion S.p.A, Octapharma AG, CSL Limited (CSL Behring), Taibang Biological Group Co., Ltd and ADMA Biologics, Inc.
Recent Strategies Deployed in Plasma Protein Therapeutics Market
Partnerships, Collaborations and Agreements:
Oct-2022: Takeda partnered with United Nations Institute for Training and Research (UNITAR), a Switzerland headquartered research and training institute. The partnership involves launching the educational program with the intention to create an UN-based platform that would enable stakeholders to gather and discuss solutions related to plasma and plasma-derived therapy shortfalls.
Sep-2022: Grifols entered into an agreement with the National Blood Authority of Canada, a Canadian provider of Blood Services. With this agreement, the entities aimed to accelerate the self-sufficiency of the country in terms of immunoglobulin medicines, which are necessary plasma-protein therapies in order to cure a broad range of immunodeficiencies as well as other medical malignancies.
Feb-2022: Grifols came into collaboration with Endpoint Health, a US-based therapeutics company. The collaboration includes Grifols supporting through its expertise in plasma protein therapies and would act as an exclusive supplier of AT-III. AT-III is a plasma protein that is intended for the treatment of patients with blood clotting. This collaboration reinforces Grifols plasma economics.
Mergers and Acquisitions:
Mar-2023: Takeda took over Nimbus Lakshmi from Nimbus Therapeutics. Nimbus Lakshmi is a US-based developer of medicines for various autoimmune diseases. The addition of Nimbus Lakshmi reinforces Takeda's evolving pipeline and perfectly aligns with its strategy and competence.
Dec-2022: Kedrion acquired UNICAplasma s.r.o and UNICAplasma Morava s.r.o., Czech companies that operate five plasma collection centers in the Czech Republic. The addition of the two Czech-based companies would add significant value to the acquiring company and would further provide Kedrion with high-quality plasma for their production facilities, which in turn would enable the company to develop therapeutics for rare conditions.
Jan-2022: Kedrion formed a merger with Bio Products Laboratory, a company involved in the manufacture of human blood plasma products. Following this merger, the companies aimed to manufacture and develop a strong player within the global plasma derivatives market. Moreover, the new merger would allow the companies to treat patients with hazardous and rare conditions with human blood plasma-derived medicines.
Oct-2202: Kedrion Biopharma took over Prometic, a life sciences business. Through this acquisition, the company aimed to integrate the first-ever FDA-approved Congenital Plasminogen Deficiency treatment medicine of Prometic, Ryplazim. Furthermore, this acquisition would allow Kedrion to expand its footprint throughout North America.
Aug-2021: Bayer acquired Vividion Therapeutics, a US-based developer of a drug discovery platform. The addition of Vividion reinforces the acquiring company's small molecule capabilities and broadens its presence into new modalities. Further, this acquisition acts as a base for Bayer's strategy to power its pipeline with innovation.
Mar-2021: Takeda completed its acquisition of Maverick Therapeutics, a biopharmaceutical company. Under this acquisition, Takeda would leverage the COBRA T-cell engager platform of Maverick to develop more efficient therapies.
Mar-2021: Grifols acquired BPL Plasma, a subsidiary of Bio Products Laboratory. Through this acquisition, the company aimed to reinforce, expand, and diversify its robust network capacity as well as centers in order to deliver life-improving plasma-derived medicines.
Trials and Approvals:
Feb-2023: Octapharma received approval from Europea Medical Authorities for the lyophilized presentation of the well-established octaplasLG, an S/D treated plasma for transfusion. The approved product would be sold in Europe in the form of powder and solvent. The octaplasLG can be reconstituted in a short span of time and can be stored at room temperature. Further, the approval complements the company's commitment to supporting the prevention of uncontrolled hemorrhage.
Feb-2023: FDA approved ADMA's eighth plasma collection center located in Hammond, Louisiana, United States of America. This FDA approval enables the company's eighth collection center to collect, and introduce into interstate commerce, human source plasma. Further, this approval complements the company's aim to be plasma self-sufficient and supports the company in improving its profitability.
Geographical Expansions:
Mar-2023: Takeda expanded its global footprint by setting up a new facility intended for plasma-derived therapies. The new facility is located in Japan. The therapy developing facility reinforces the company's manufacturing and supply capabilities and further enables the company to better take care of the evolving needs for Plasma-Derived Therapies (PDTs) in Japan as well as the rest of the world.
Oct-2022: Grifols established a new manufacturing facility in Ireland. The new facility is established to cater to the evolving needs for plasma-based medicines. The new facility in Ireland triples the company's annual filling production capacity. Further, the geographical expansion demonstrates the company's commitment to investing in plasma medicines infrastructure.
Sep-2022: Takeda expanded its global footprint by setting up a new manufacturing facility in Belgium and expanding its already existing warehouse in Lessines, Belgium. The new facility in Belgium would be equipped with a water recycling system that would reduce freshwater consumption by 90%.
Market Segments covered in the Report:
By End User
By Product Type
By Application
By Geography
Companies Profiled
Unique Offerings from KBV Research
List of Figures