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市場調查報告書
商品編碼
1372565
北美靜脈免疫球蛋白市場規模和預測、區域佔有率、趨勢和成長機會分析報告範圍:按類型、應用、配銷通路、最終用戶和國家/地區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年北美靜脈注射免疫球蛋白市場規模為50.42億美元,預計到2030年將達87.47億美元;預計2022年至2030年年複合成長率為7.1%。北美靜脈注射免疫球蛋白市場的成長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動的
新產品的推出和批准為靜脈免疫球蛋白市場的成長提供了機會
近年來,北美靜脈注射免疫球蛋白市場取得了多方面的發展。市場參與者一直在推出新產品,並為其產品尋求監管部門的批准。 2023 年4 月,研發驅動型生物製藥領軍企業武田藥品工業株式會社獲得美國食品藥物管理局(FDA) 的補充生物製劑許可申請(sBLA) 批准,擴大HYQVIA 的使用範圍,用於治療原發性免疫缺陷(PI)屬於2-16歲年齡層的兒童。只有 HYQVIA 的皮下免疫球蛋白 (ScIG) 輸注允許每月給藥。 2022 年,加拿大衛生部批准了 HyQvia,這是一種針對免疫缺陷加拿大人的新型免疫球蛋白 (IG) 治療方法。 2021年2月,輝瑞公司的 PANZYGA(10%液體靜脈注射免疫球蛋白製劑)獲得 sBLA 批准,用於治療慢性發炎性脫髓鞘性多發性神經病變(CIDP)
基於類型的見解
北美靜脈注射免疫球蛋白市場依類型分為 IgG、IgA、IgM 等。 2022年,IgG細分市場佔據最大佔有率,預計2022-2030年年複合成長率最快。
基於應用程式的見解
根據應用,北美靜脈注射免疫球蛋白市場分為免疫缺陷疾病、慢性發炎性脫髓鞘多發性神經病變、特發性血小板減少性紫斑症、多灶性運動神經病變、低丙種球蛋白血症、吉蘭-巴利症候群、特異性抗體缺乏、發炎性肌肉病變、重症肌無力等。 2022年,免疫缺陷疾病領域佔據最大的市場佔有率,預計2022-2030年年複合成長率最高。
基於配銷通路的見解
根據配銷通路,北美靜脈注射免疫球蛋白市場分為醫院藥房、零售藥房等。 2022年,醫院藥局板塊佔最大佔有率,預計2022-2030年年複合成長率最快。
基於最終用戶的見解
根據最終用戶,北美靜脈注射免疫球蛋白市場分為醫院、專科診所等。 2022年,醫院板塊佔最大佔有率,預計2022-2030年年複合成長率最快。
患有自體免疫疾病的患者接受靜脈注射免疫球蛋白治療。自體免疫疾病是免疫系統意外攻擊自身組織或細胞的疾病。這種針對健康細胞的異常免疫反應導致慢性發炎以及器官和系統損傷。疲勞、關節疼痛、肌肉無力、皮疹和神經系統失調是自體免疫疾病的一些典型徵兆和症狀。 IVIG 治療可以緩解格林巴利症候群(GBS)、重症肌無力(MS)、類風濕性關節炎(RA)、系統性紅斑狼瘡(LE) 和免疫性血小板減少症(ITP) 等自體免疫疾病的症狀。這種療法的好處包括快速緩解症狀和持久效果,從而提高患者的生活品質。
根據 Intermountain Healthcare 的數據,自體免疫性和免疫介導的疾病和疾病影響 2350-5000 萬美國人。根據疾病管制與預防中心的數據,類風濕性關節炎 (RA) 是最常見的自體免疫關節炎類型,美國四分之一的成年人患有關節炎。根據美國重症肌無力基金會的數據,重症肌無力 (MG) 的盛行率估計為每 10 萬人中有 14-20 人患有重症肌無力。在加拿大,MG 的發生率估計為每 100 萬人年 23 例,盛行率為每 100 萬人 263 例,並且該數字在過去幾十年中一直穩定。
免疫球蛋白使用的增加促進了北美靜脈免疫球蛋白市場
血漿源性免疫球蛋白用於治療自體免疫疾病和發炎性疾病等。除了自體免疫和急性發炎性疾病外,原發性免疫缺陷症(PIDD)、慢性發炎性脫髓鞘性多發性神經病變(CIDP) 和多灶性運動神經病變(MMN) 也是使用免疫球蛋白治療的慢性和急性疾病。免疫球蛋白也擴大用於治療傳染病、皮膚病、風濕病/腎臟病和心臟病。因此,隨著這些抗體用於治療各種病症的大量使用,靜脈注射免疫球蛋白的需求正在增加。
武田製藥股份有限公司;格里福斯公司;輝瑞公司; ADMA 生物製劑公司;生物製品實驗室有限公司;奧克塔製藥公司; Kedrion SpA.; CSL 有限公司; LFB集團;和 Prothya Biosolutions BV 是靜脈注射免疫球蛋白市場的領先公司之一。
在準備北美靜脈注射免疫球蛋白市場報告時提到的一些主要主要和次要來源包括美國重症肌無力基金會、過敏和臨床免疫學雜誌、遺傳和罕見疾病資訊中心、免疫缺陷基金會、GBS 基金會, 疾病預防與控制中心
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