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市场调查报告书
商品编码
1372565
北美静脉免疫球蛋白市场规模和预测、区域份额、趋势和成长机会分析报告范围:按类型、应用、配销通路、最终用户和国家/地区North America Intravenous Immunoglobulin Market Size and Forecasts, Regional Share, Trends, and Growth Opportunity Analysis Report Coverage: By Type, Application, Distribution Channel, End User, and Country |
2022年北美静脉注射免疫球蛋白市场规模为50.42亿美元,预计到2030年将达87.47亿美元;预计2022年至2030年复合年增长率为7.1%。北美静脉注射免疫球蛋白市场的成长主要是由免疫球蛋白使用量的增加和免疫缺陷疾病盛行率的上升所推动的
新产品的推出和批准为静脉免疫球蛋白市场的成长提供了机会
近年来,北美静脉注射免疫球蛋白市场取得了多方面的发展。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,研发驱动型生物製药领军企业武田药品工业株式会社获得美国食品药物管理局(FDA) 的补充生物製剂许可申请(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岁年龄层的儿童。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製剂)获得 sBLA 批准,用于治疗慢性发炎性脱髓鞘性多发性神经病变(CIDP)
基于类型的见解
北美静脉注射免疫球蛋白市场依类型分为 IgG、IgA、IgM 等。 2022年,IgG细分市场占据最大份额,预计2022-2030年复合年增长率最快。
基于应用程式的见解
根据应用,北美静脉注射免疫球蛋白市场分为免疫缺陷疾病、慢性发炎性脱髓鞘多发性神经病变、特发性血小板减少性紫斑症、多灶性运动神经病变、低丙种球蛋白血症、吉兰-巴利症候群、特异性抗体缺乏、发炎性肌肉病变、重症肌无力等。 2022年,免疫缺陷疾病领域占据最大的市场份额,预计2022-2030年复合年增长率最高。
基于配销通路的见解
根据配销通路,北美静脉注射免疫球蛋白市场分为医院药房、零售药房等。 2022年,医院药局板块占最大份额,预计2022-2030年复合年增长率最快。
基于最终用户的见解
根据最终用户,北美静脉注射免疫球蛋白市场分为医院、专科诊所等。 2022年,医院板块占最大份额,预计2022-2030年复合年增长率最快。
患有自体免疫疾病的患者接受静脉注射免疫球蛋白治疗。自体免疫疾病是免疫系统意外攻击自身组织或细胞的疾病。这种针对健康细胞的异常免疫反应导致慢性发炎以及器官和系统损伤。疲劳、关节疼痛、肌肉无力、皮疹和神经系统失调是自体免疫疾病的一些典型征兆和症状。 IVIG 治疗可以缓解格林巴利症候群(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) 等自体免疫疾病的症状。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品质。
根据 Intermountain Healthcare 的数据,自体免疫性和免疫介导的疾病和疾病影响 2350-5000 万美国人。根据疾病管制与预防中心的数据,类风湿性关节炎 (RA) 是最常见的自体免疫关节炎类型,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) 的盛行率估计为每 10 万人中有 14-20 人患有重症肌无力。在加拿大,MG 的发生率估计为每 100 万人年 23 例,盛行率为每 100 万人 263 例,并且该数字在过去几十年中一直稳定。
免疫球蛋白使用的增加促进了北美静脉免疫球蛋白市场
血浆源性免疫球蛋白用于治疗自体免疫疾病和发炎性疾病等。除了自体免疫和急性发炎性疾病外,原发性免疫缺陷症(PIDD)、慢性发炎性脱髓鞘性多发性神经病变(CIDP) 和多灶性运动神经病变(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/肾臟病和心臟病。因此,随着这些抗体用于治疗各种病症的大量使用,静脉注射免疫球蛋白的需求正在增加。
武田製药股份有限公司;格里福斯公司;辉瑞公司; ADMA 生物製剂公司;生物製品实验室有限公司;奥克塔製药公司; 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的领先公司之一。
在准备北美静脉注射免疫球蛋白市场报告时提到的一些主要主要和次要来源包括美国重症肌无力基金会、过敏和临床免疫学杂誌、遗传和罕见疾病资讯中心、免疫缺陷基金会、GBS 基金会, 疾病预防与控制中心
The North America intravenous immunoglobulin market size was valued at US$ 5.042 Bn in 2022 and is expected to reach US$ 8.747 Bn by 2030; it is estimated to record a CAGR of 7.1% from 2022 to 2030. The North America intravenous immunoglobulin market growth is primarily driven by increase in use of immunoglobulins and rising prevalence of immunodeficiency diseases
New Product Launches and Approvals Opportunity for Growth of Intravenous Immunoglobulin Market
In recent years, there have been various developments in the intravenous immunoglobulin market in North America. Market players have been launching new products and seeking regulatory approvals for their offerings. In April 2023, Takeda Pharmaceutical Company Limited, an R&D-driven biopharmaceutical leader, received a supplemental Biologics License Application (sBLA) approval from the US Food and Drug Administration (FDA) to expand the use of HYQVIA to treat primary immunodeficiencies (PI) in children belonging to the age group of 2-16 years. Only HYQVIA's subcutaneous immune globulin (ScIG) infusion allows for monthly administration. In 2022, Health Canada approved HyQvia, a new Immunoglobulin (IG) treatment for Canadians with immune deficiencies. In February 2021, Pfizer Inc. received an sBLA approval for PANZYGA (10% liquid intravenous immunoglobulin preparation) to treat chronic inflammatory demyelinating polyneuropathy (CIDP)
Type-Based Insights
The North America intravenous immunoglobulin market, by type, is segmented into IgG, IgA, IgM, and others. In 2022, the IgG segment held the largest share and is expected to record the fastest CAGR during 2022-2030.
Application-Based Insights
Based on application, the North America intravenous immunoglobulin market is classified into 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. In 2022, the immunodeficiency diseases segment held the largest market share, and it is expected to register the highest CAGR during 2022-2030.
Distribution Channel -Based Insights
Based on distribution channel, the North America intravenous immunoglobulin market is segmented into hospital pharmacy, retail pharmacy, and others. In 2022, the hospital pharmacy segment held the largest share, and it is expected to record the fastest CAGR during 2022-2030.
End User - Based Insights
Based on end user, the North America intravenous immunoglobulin market is classified into hospitals, specialty clinics, and others. In 2022, the hospitals segment held the largest share, and it is expected to register the fastest CAGR during 2022-2030.
Patients with autoimmune diseases are treated with intravenous immunoglobulins. Autoimmune diseases are conditions wherein the immune system accidentally attacks its own tissues or cells. Chronic inflammation, and organ and system damage result from this aberrant immune reaction against healthy cells. Fatigue, joint pain, muscle weakness, skin rashes, and neurological disturbances are a few of the typical signs and symptoms of autoimmune diseases. Symptoms of autoimmune diseases such as Guillain-Barre syndrome (GBS), myasthenia gravis (MS), rheumatoid arthritis (RA), systemic lupus erythematosus (LE), and immune thrombocytopenia (ITP) can be alleviated with the IVIG therapy. Benefits of this therapy include the rapid relief of symptoms and long-lasting effects, leading to improved quality of life among patients.
According to the Intermountain Healthcare, autoimmune and immune-mediated diseases and conditions affect 23.5-50 million Americans. According to the Centers for Disease Control and Prevention, rheumatoid arthritis (RA) is the most prevalent type of autoimmune arthritis, and 1 in 4 adults in the US has arthritis. As per the Myasthenia Gravis Foundation of America, Inc., the prevalence of myasthenia gravis (MG) is estimated at 14-20 per 100,000 of the US population. In Canada, the incidence of MG is estimated to be 23 per 1 million person-years, with a prevalence of 263 per 1 million people, and the numbers have been stable over the past few decades.
Increase in Use of Immunoglobulins Bolsters North America Intravenous Immunoglobulins Market
Plasma-derived immunoglobulins are used for treating autoimmune and inflammatory disorders, among others. In addition to autoimmune and acute inflammatory conditions, primary immune deficiency disease (PIDD), chronic inflammatory demyelinating polyneuropathy (CIDP), and multifocal motor neuropathy (MMN) are the chronic and acute conditions that are treated with immunoglobulins. Immunoglobulins are also increasingly used to manage infectious diseases, dermatological conditions, rheumatological/nephrological conditions, and heart disease. Thus, the demand for intravenous immunoglobulins is rising with the surging use of these antibodies for treating various conditions.
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 are among the leading companies operating in the intravenous immunoglobulin market.
A few of the major primary and secondary sources referred to while preparing the report on the North America intravenous immunoglobulin market are the Myasthenia Gravis Foundation of America, Journal of Allergy and Clinical Immunology, Genetic and Rare Diseases Information Center, Immune Deficiency Foundation, GBS Foundation, Centers for Disease Control and Prevention