北美静脉免疫球蛋白市场基于(关键地区、市场参与者、规模和份额)- 到 2030 年的预测

  • Report Code : TIPRE00030117
  • Category : Pharmaceuticals
  • Status : Published
  • No. of Pages : 107
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2022年北美静脉注射免疫球蛋白市场价值为504291万美元,预计到2030年将达到874781万美元。预计2022-2030年复合年增长率为7.1%。
市场洞察和分析师观点:
患有自身免疫性疾病的患者接受静脉注射免疫球蛋白治疗。自身免疫性疾病是免疫系统意外攻击自身组织或细胞的病症。这种针对健康细胞的异常免疫反应导致慢性炎症以及器官和系统损伤。疲劳、关节疼痛、肌肉无力、皮疹和神经系统紊乱是自身免疫性疾病的一些典型体征和症状。 IVIG 治疗可以缓解格林-巴利综合征 (GBS)、重症肌无力 (MS)、类风湿性关节炎 (RA)、系统性红斑狼疮 (LE) 和免疫性血小板减少症 (ITP) 等自身免疫性疾病的症状。这种疗法的好处包括快速缓解症状和持久效果,从而提高患者的生活质量。
根据 Intermountain Healthcare 的数据,自身免疫和免疫介导的疾病和病症影响着 23.5-5000 万美国人。根据疾病控制和预防中心的数据,类风湿性关节炎 (RA) 是最常见的自身免疫性关节炎类型,美国四分之一的成年人患有关节炎。根据美国重症肌无力基金会的数据,重症肌无力 (MG) 的患病率估计为每 100,000 人中有 14-20 人患有重症肌无力。在加拿大,MG的发病率估计为每100万人年23例,患病率为每100万人263例,并且在过去几十年中该数字一直稳定。
随着身体的下降产生 T 细胞或 B 细胞的能力,衰老会损害一个人抵抗感染和癌细胞的能力。免疫衰老,即免疫系统的减弱,是用于描述与衰老相关的免疫系统变化的术语。由于免疫衰老,老年人更容易患免疫缺陷疾病。患有这些疾病的老年患者接受 IVIG 治疗。因此,老年人口的激增和免疫缺陷疾病患病率的上升推动了北美静脉注射免疫球蛋白市场的增长。
战略见解
增长动力和挑战:
血浆源性免疫球蛋白用于治疗自身免疫性疾病和炎症性疾病等。除了自身免疫性和急性炎症性疾病外,原发性免疫缺陷病 (PIDD)、慢性炎症性脱髓鞘性多发性神经病 (CIDP) 和多灶性运动神经病 (MMN) 也是使用免疫球蛋白治疗的慢性和急性疾病。免疫球蛋白也越来越多地用于治疗传染病、皮肤病、风湿病/肾病和心脏病。因此,随着这些抗体用于治疗各种病症的激增,对静脉注射免疫球蛋白的需求也在不断增加。
近年来,北美静脉注射免疫球蛋白市场取得了各种发展。市场参与者一直在推出新产品,并为其产品寻求监管部门的批准。 2023 年 4 月,研发驱动型生物制药领军企业武田药品工业株式会社获得美国食品和药物管理局 (FDA) 的补充生物制剂许可申请 (sBLA) 批准,扩大 HYQVIA 的使用范围,用于治疗原发性免疫缺陷 (PI)属于2-16岁年龄段的儿童。只有 HYQVIA 的皮下免疫球蛋白 (ScIG) 输注允许每月给药。 2022 年,加拿大卫生部批准了 HyQvia,这是一种针对免疫缺陷加拿大人的新型免疫球蛋白 (IG) 治疗方法。 2021 年 2 月,辉瑞公司的 PANZYGA(10% 液体静脉注射免疫球蛋白制剂)获得 sBLA 批准,用于治疗慢性炎症性脱髓鞘性多发性神经病 (CIDP)。
免疫球蛋白用于输注,因此成品具有更高的纯度。因此,生产和纯化静脉注射免疫球蛋白的成本很高。这种治疗的总费用也会根据治疗时间、疾病诊断和患者体重等因素而有所不同。例如,单次 IVIG 输注程序的费用可能在 100-350 美元之间或更多。据报道,美国 IVIG 治疗的平均费用接近 9,720 美元。如果患者每月接受 4-5 次输注,费用将达到约 41,796 美元。因此,治疗成本的升高阻碍了北美静脉注射免疫球蛋白市场的增长
报告细分和范围:
北美静脉注射免疫球蛋白市场根据类型、应用、分销渠道和最终用户进行划分。根据类型,北美静脉注射免疫球蛋白市场分为 IgG、IgA、IgM 等。从应用来看,北美静脉注射免疫球蛋白市场细分为免疫缺陷疾病、慢性炎症性脱髓鞘性多发性神经病、特发性血小板减少性紫癜、多灶性运动神经病、低丙种球蛋白血症、吉兰-巴利综合征、特异性抗体缺乏、炎症性肌病、重症肌无力等。北美静脉注射免疫球蛋白市场按分销渠道分为医院药房、零售药房等。根据最终用户,北美静脉注射免疫球蛋白市场分为专科诊所、医院和其他。根据国家/地区,北美静脉注射免疫球蛋白市场分为美国、加拿大和墨西哥。
细分分析:
根据类型,静脉注射免疫球蛋白市场分为 IgG、IgA、IgM 等。 IgG(即免疫球蛋白G)是血液、淋巴液、脑脊液和腹膜液中含量最丰富的抗体,在体液免疫反应中发挥着至关重要的作用。 IgG 约占总血清抗体的 75%,在血管内和血管外血清池之间均匀分布。 IgG 是唯一一类可以穿过胎盘屏障到达胎儿循环的免疫球蛋白。根据重链恒定区结构域上独特的抗原决定簇和相关的生物学功能,人类 IgG 可分为四个亚类:IgG1、IgG2、IgG3 和 IgG4。此外,静脉注射免疫球蛋白(IVIg)是抗体缺乏或患有免疫缺陷疾病的患者的替代疗法和治疗方法。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提供足够量的 IgG 来预防感染。 IVIg 是每批由 1,000-15,000 名捐献者的血清制备的血液制品,其中仅从血浆中纯化 IgG。用于治疗的 IVIg 溶液含有 95-98% 纯 IgG 和少量其他血浆蛋白,包括 IgAs 和 IgM。因此,IgG 在治疗几类疾病中的广泛应用可能会补充预测期内 IgG 部分的增长。
静脉注射免疫球蛋白市场,按类型 – 2022 年和 2030 年
根据应用,静脉注射免疫球蛋白市场免疫球蛋白市场分为免疫缺陷疾病、慢性炎症性脱髓鞘性多发性神经病、特发性血小板减少性紫癜、多灶性运动神经病、低丙种球蛋白血症、吉兰-巴利综合征、特异性抗体缺乏症、炎症性肌病、重症肌无力等。 2022年,免疫缺陷疾病领域占据最大市场份额,预计2022-2030年复合年增长率最高。免疫缺陷疾病分为原发性(先天性)和继发性(后天性)免疫缺陷疾病。其中,原发性免疫缺陷疾病 (PIDD) 可分为 400 种不同类型。据《过敏与临床免疫学杂志》报道,美国 PIDD 的患病率估计为每 2,000 人中就有 1 人患有 PIDD。此外,针对 PIDD 的研究人员在改善治疗选择和提高客户的生活质量方面正在取得巨大进展。 IVIg 给药显然是原发性体液免疫缺陷的首选治疗方法,因为这些患者无法对病原体产生有效的免疫反应。美国食品和药物管理局 (FDA) 批准 Privigen(一种 10% IVIg 液体)作为原发性免疫缺陷病 (PIDD) 的替代疗法。 2022 年 3 月,ADMA Biologics 的 ASCENIV 和 BIVIgAM 免疫球蛋白药品获得 FDA 批准,将其在 2-8°C 储存时的有效期从 24 个月延长至 36 个月。因此,此类用于治疗免疫缺陷疾病的 IVIg 产品的监管批准有助于美国 PIDD 领域静脉注射免疫球蛋白市场的进步。
从分销渠道来看,静脉注射免疫球蛋白市场分为医院药房、零售药房和零售药房。其他的。 2022年,医院药房领域占据最大市场份额,预计2022-2030年复合年增长率最高。医院药房是任何国家医疗保健系统的重要组成部分之一。他们接待了大量患有某种适应症、需要 IVIg 替代治疗的患者。此外,所有患者都需要前往医院接受预定剂量的 IVIg,这导致医院药房对这些产品的需求。因此,医院药房部门对静脉注射免疫球蛋白市场做出了巨大贡献。
根据最终用户,静脉注射免疫球蛋白市场分为医院、专科诊所和其他。 2022年,医院细分市场占据最大市场份额,预计2022-2030年复合年增长率最高。医院是借助现代化设备提供医疗保健服务的复杂组织。住院人数的增加,加上免疫缺陷疾病患病率的上升,预计将在预测期内推动美国静脉注射免疫球蛋白市场医院领域的增长。此外,新兴国家对先进医院环境的巨大需求是为了管理庞大的患者群体和日益增长的公共卫生问题。
医院与公司合作开展研究,观察与治疗相关的剂量和不良事件,并监测治疗效果。产品的临床结果。医院是提供免疫球蛋白替代疗法的主要中心。在医院接受 IgRT 的明显优势包括更高的安全性和对患者的更密切监测,以及卫生专业人员和专家的更好支持。此外,适当的以患者为中心的护理、报销设施的可用性以及医院提供的其他类似福利预计将在预测期内推动美国医院静脉注射免疫球蛋白市场的增长。
区域分析:
基于从地域来看,静脉注射免疫球蛋白市场分为美国、加拿大和墨西哥。美国是该地区市场增长的最大贡献者,预计加拿大将在 2022 年至 2030 年期间创下最快的复合年增长率。美国免疫缺陷和自身免疫性疾病数量的增加可能会增加对静脉注射免疫球蛋白的需求。根据美国国立卫生研究院的数据,约 2350 万美国人(超过总人口的 7%)患有自身免疫性疾病。此外,美国拥有北美最大、最商业化的医药市场。仅它就占据了全球医药市场45%以上的份额。大多数活跃于生物医学研究的全球顶级药品制造公司的总部都位于美国。
2021 年 7 月,美国食品和药物管理局 (FDA) 批准了 Octapharma 的 Octagam 10% 用于治疗皮肌炎患者,皮肌炎是一种罕见的慢性全身性自身免疫性疾病,特殊的皮疹和进行性近端肌肉无力。此外,FDA 批准了 Octapharma USA 的研究性新药 (IND) 申请,进行 III 期临床试验,研究 Octagam 10% [静脉注射免疫球蛋白(人)] 治疗患有严重疾病进展的 COVID-19 患者的有效性和安全性。< br>因此,免疫缺陷和自身免疫性疾病病例的增加、制药业的蓬勃发展以及产品审批的激增预计将在预测期内推动美国静脉注射免疫球蛋白市场的发展。
竞争格局和主要公司:
武田制药有限公司;格里福斯公司;辉瑞公司; ADMA 生物制剂公司;生物制品实验室有限公司;奥克塔制药公司; Kedrion SpA.; CSL 有限公司; LFB集团;和 Prothya Biosolutions BV 是静脉注射免疫球蛋白市场上的几家知名企业。这些公司专注于扩大服务范围,以满足全球不断增长的消费者需求。他们的全球业务使他们能够为大量客户提供服务,从而扩大他们的市场份额。
Report Coverage
Report Coverage

Revenue forecast, Company Analysis, Industry landscape, Growth factors, and Trends

Segment Covered
Segment Covered

This text is related
to segments covered.

Regional Scope
Regional Scope

North America, Europe, Asia Pacific, Middle East & Africa, South & Central America

Country Scope
Country Scope

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to country scope.

Frequently Asked Questions


What are the driving factors for the North America intravenous immunoglobulin market worldwide?

The growth of the North America intravenous immunoglobulin market is attributed to a few key factors, such as increase in use of immunoglobulins and rising prevalence of immunodeficiency diseases.

What is intravenous immunoglobulin?

Intravenous Immunoglobulin (IVIG) is a therapy treatment for immunocompromised patients. It is made from a collection of immunoglobulins (antibodies) extracted from the plasma of thousands of healthy donors.

Which country is dominating the intravenous immunoglobulin market?

U.S. region is dominating the North America intravenous immunoglobulin market in terms of market share and Canada is anticipated to register the highest CAGR during the 2022-2030.

Which segment is dominating the intravenous immunoglobulin market?

The North America intravenous immunoglobulin market is analyzed based on type, application, distribution channel, and end user. Based on type, the North America intravenous immunoglobulin market is segmented into IgG, IgA, IgM, and Others. Based on application, the North America intravenous immunoglobulin market is classified as immunodeficiency diseases, chronic inflammatory demyelinating polyneuropathy, idiopathic thrombocytopenic purpura, multifocal motor neuropathy, hypogammaglobulinemia, Guillain-Barre syndrome, specific antibody deficiency, inflammatory myopathies, myasthenia gravis, and others. Based on distribution channels, the North America intravenous immunoglobulin market is segmented into hospital pharmacy, retail pharmacy, and others. Based on end users, the North America intravenous immunoglobulin market is classified into hospitals, specialty clinics, and others

Who are the major players in the intravenous immunoglobulin market?

The North America intravenous immunoglobulin market majorly consists of the players such as Takeda Pharmaceutical Co Ltd; Grifols SA; Pfizer Inc.; ADMA Biologics, Inc.; Bio Products Laboratory Ltd; Octapharma AG; Kedrion SpA.; CSL Ltd.; LFB Group; and Prothya Biosolutions B.V

The List of Companies - North America Intravenous Immunoglobulin Market

  1. Takeda Pharmaceutical Co Ltd
  2. Grifols SA
  3. Pfizer Inc
  4. ADMA Biologics, Inc
  5. Bio Products Laboratory Ltd
  6. Octapharma AG
  7. Kedrion SpA
  8. CSL Ltd
  9. LFB Group
  10. Prothya Biosolutions B.V

The Insight Partners performs research in 4 major stages: Data Collection & Secondary Research, Primary Research, Data Analysis and Data Triangulation & Final Review.

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