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美国静脉注射免疫球蛋白市场预测至2028年 - 按类型、应用、分销渠道和终端用户分類的COVID-19影响和国家分析US Intravenous Immunoglobulin Market Forecast to 2028 - Country Analysis By Type, Application, Distribution Channel, and End User |
美国静脉免疫球蛋白市场规模在2022年为44.3926亿美元,预计到2028年将达到71.0563亿美元;估计在2023-2028年期间将以复合年增长率8.2%增长。老年人口的增加有利于美国静脉注射免疫球蛋白市场的增长。
免疫球蛋白是人体免疫系统自然产生的抗体,它有助于抵抗感染和疾病。患有免疫球蛋白缺乏症的人需要外用免疫球蛋白,称为免疫球蛋白替代疗法(IgRT)。IgRT可以通过静脉注射和皮下注射。静脉注射免疫球蛋白(IVIg)和皮下注射免疫球蛋白(SCIg)是根据适应症和严重程度来选择。IVIgs是从人类血浆中提取的。这些抗体被用于治疗各种免疫学、血液学和神经学疾病。美国的免疫缺陷病发病率上升和老年人口增加等因素推动了美国静脉免疫球蛋白市场的增长。然而,免疫球蛋白治疗的不良反应阻碍了市场的增长。
IVIGs用于治疗原发性和继发性免疫缺陷和自身免疫性疾病的患者。IVIG是治疗大多数原发性免疫缺陷(PID)的标准疗法。根据约翰-霍普金斯医学院的数据,美国总人口的约3%,即1000万人,患有自身免疫性疾病。根据美国国家过敏和传染病研究所(NIAID)的数据,有超过200种不同类型的原发性免疫缺陷病(PIDD)影响着美国约50万人。这些罕见的遗传性疾病可能是慢性的、衰弱的,而且治疗费用昂贵。免疫性血小板减少症(ITP)是一种自身免疫性的出血性疾病,其特点是血小板水平异常低;这种情况被称为血小板减少症。罕见病组织指出,在美国,成人ITP的发病率为每年每10万人中约有3.3人。根据2019年发布的全国多发性硬化症协会研究报告,在美国,~100万成年人(~913,925)受到多发性硬化症(MS)的影响。根据多发性硬化发现论坛,美国每周有~200个新病例被诊断出来。因此,免疫缺陷疾病发病率的增加推动了美国静脉注射免疫球蛋白市场的增长。
许多在美国静脉注射免疫球蛋白市场经营的市场参与者和研究机构正在开发先进的技术,以扩大他们的产品组合,增加他们的市场份额。免疫缺陷病发病率的上升、产品的批准和合作是推动美国静脉免疫球蛋白市场规模的因素之一。
以下是与美国静脉注射免疫球蛋白有关的一些最新发展:
2020年4月,Kamada Ltd.和Kedrion Biopharma合作开发、生产和销售一种人类血浆衍生的抗SARS-CoV-2(COVID-19)多克隆免疫球蛋白(IgG)产品,作为对抗COVID-19的潜在治疗方法。该公告是在这两个实体之前关于启动此类产品的开发计划的单独报告之后发布的。
2022年1月,LFB和Kedrion在一项工业合作协议中联手,为法国的患者提供更多的免疫球蛋白。在这一工业合作框架下,Kedrion在匈牙利用LFB的血浆生产免疫球蛋白,这些血浆是由 "法国血液公司"(EFS)在法国收集的。LFB进口这些由Kedrion在法国制造的免疫球蛋白,并补充其免疫球蛋白,这些免疫球蛋白在法国各地的医院都可以买到,并与法国卫生当局达成协议,受其管制。
2020年4月,2020年4月,Octapharma与CSL、武田、BPL、Biotest和LFB合作,研究用血浆衍生的超免疫免疫球蛋白治疗COVID-19的可能性。
美国静脉注射免疫球蛋白市场,以类型为基础的洞察力
基于产品类型,美国静脉注射免疫球蛋白市场被划分为IgG、IgM、IgA和其他。2022年,IgG部分占据了市场的最大份额。此外,在预测期内,该部分预计将录得最高的复合年增长率。
IVIg是一种替代疗法,用于治疗抗体缺乏的病人或患有免疫缺陷疾病的病人。例如,在原发性或继发性低丙种球蛋白血症中,IVIg替代疗法通过在血液中注入足够数量的IgG来提供保护,防止感染。IVIg是一种血液制品,由每批1,000-15,000名献血者的血清制备而成,其中只有IgG从血浆中纯化出来,以生产IVIg产品。因此,用于治疗疗法的IVIg含有95-98%的纯IgG和少量的其他血浆蛋白,包括IgA和IgM。
因此,IgG在治疗几类疾病中的广泛应用是促进美国静脉免疫球蛋白市场增长的因素之一。
美国静脉注射免疫球蛋白市场,以终端用户为基础的洞察力
美国静脉注射免疫球蛋白市场,基于终端用户,分为低丙种球蛋白血症、慢性炎症性脱髓鞘多发性神经病(CIDP)、免疫缺陷病、重症肌无力(MG)、多灶性运动神经病(MMN)、特发性血小板减少性紫癜(ITP)、炎症性肌病、特定抗体缺乏(SDA)、吉兰巴雷综合症(GBS)和其他。2022年,免疫缺陷病部分占据了最大的市场份额,在 。在未来几年里,同一细分市场预计将以最快的速度增长。
世界卫生组织(WHO)、美国人口普查局和美国国家医学图书馆是编写美国静脉免疫球蛋白市场报告时参考的几个主要主要和次要来源。
The US intravenous immunoglobulin market size was valued at US$ 4,439.26 million in 2022 and is projected to reach US$ 7,105.63 million by 2028; it is estimated to grow at a CAGR 8.2% during 2023-2028. The increasing geriatric population favors the growth of the US intravenous immunoglobulin market.
Immunoglobulins are the antibodies produced naturally by the body's immune system, which help fight infection and disease. Individuals with immunoglobulin deficiency require the external administration of immunoglobulin and known as immunoglobulin replacement therapy (IgRT). IgRT can be given intravenously and subcutaneously. Intravenous immunoglobulin (IVIg) and subcutaneous immunoglobulin (SCIg) are selected based on the indication and severity. IVIgs are extracted from human plasma. These antibodies are used in the treatment of various immunological, hematological, and neurological illnesses. Factors such as rising immunodeficiency disease prevalence and increasing geriatric population in the US drive the US intravenous immunoglobulin market growth. However, adverse effects of immunoglobulin therapy hamper the market growth.
IVIGs are used to treat patients suffering from primary and secondary immunodeficiencies and autoimmune disorders. The IVIG is a standard therapy to treat most primary immunodeficiencies (PIDs). According to data by John Hopkins Medicine, ~3% of the total US population, i.e., 10 million people, suffers from autoimmune diseases. As per the National Institute of Allergy and Infectious Diseases (NIAID), there are over 200 different types of primary immune deficiency diseases (PIDDs) affecting ~500,000 people in the US. The rare genetic diseases can be chronic, weakening, and expensive to treat. Immune Thrombocytopenia (ITP) is an autoimmune bleeding disorder characterized by abnormally low levels of platelets; a situation referred to as thrombocytopenia. The Rare Diseases Organization states that the incidence rate of ITP in adults is ~3.3 per 100,000 per year in the US. Per the National Multiple Sclerosis Society study report, published in 2019, ~1 million adults (~913,925) were affected by multiple sclerosis (MS) in the US. According to the MS Discovery Forum, ~200 new cases are diagnosed each week in the US. Thus, the increasing prevalence of immunodeficiency diseases drives the growth of the US intravenous immunoglobulin market.
Many market players and research institutes operating in the US intravenous immunoglobulin market are developing advanced technologies to expand their product portfolios and increase their market shares. Rising immunodeficiency disease prevalence, product approvals, and collaborations are among the factors driving the US intravenous immunoglobulin market size.
A few of the recent developments related to US intravenous immunoglobulin are mentioned below:
In April 2020, Kamada Ltd. and Kedrion Biopharma collaborated to develop, manufacture, and distribute a human plasma-derived Anti-SARS-CoV-2 (COVID-19) polyclonal immunoglobulin (IgG) product as a potential treatment against COVID-19. The announcement follows separate previous reports by the two entities concerning initiating development programs for such products.
In January 2022, LFB and Kedrion joined forces in an industrial cooperation agreement to increase the availability of immunoglobulins for patients in France. In the framework of this industrial partnership, Kedrion manufactured immunoglobulins in Hungary from LFB plasma which was collected in France by the "Etablissement Francais du Sang" (EFS). LFB imported these immunoglobulins manufactured by Kedrion in France and complemented its immunoglobulins, which are available in hospitals across France, in agreement with and under the control of French health authorities.
In April 2020, In April 2020, Octapharma collaborated with CSL, Takeda, BPL, Biotest, and LFB to investigate the possibility of treating COVID-19 with plasma-derived hyperimmune immunoglobulins.
US Intravenous Immunoglobulin Market, By Type-Based Insights
Based on product type, the US intravenous immunoglobulin market is segmented into IgG, IgM, IgA, and others. In 2022, the IgG segment held the largest share of the market. Moreover, the same segment is expected to record the highest CAGR during the forecast period.
IVIg is a replacement therapy and treatment for patients with antibody deficiencies or for those who suffer from immunodeficiency disorders. For instance, in primary or secondary hypogammaglobulinemia, IVIg replacement therapy provides protection against infections by administering an adequate volume of IgG in the blood. IVIg is a blood product prepared from serum derived from 1,000-15,000 donors per batch where only IgG is purified from plasma to produce IVIg products. Therefore, IVIg used for treatment therapies contains 95-98% pure IgG with small amounts of other plasma proteins, including IgA and IgM.
Thus, wide applications of IgG in treating several categories of disorders are among the factors contributing to the growth of the US intravenous immunoglobulin market.
US Intravenous Immunoglobulin Market, By End User-Based Insights
The US intravenous immunoglobulin market, based on end user, is segmented into hypogammaglobulinemia, chronic inflammatory demyelinating polyneuropathy (CIDP), immunodeficiency diseases, myasthenia gravis (MG), multifocal motor neuropathy (MMN), idiopathic thrombocytopenic purpura (ITP), inflammatory myopathies, specific antibody deficiency (SDA), Guillain-Barre syndrome (GBS), and others. In 2022, the immunodeficiency diseases segment held the largest market share in . The same segment is expected to grow at the fastest rate during the coming years.
The World Health Organization (WHO), the US Census Bureau, and the US National Library of Medicine are a few of the major primary and secondary sources referred to while preparing the report on the US intravenous immunoglobulin market.