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市場調査レポート
商品コード
1374846
免疫グロブリンの世界市場-2023年~2030年Global Immunoglobulin Market - 2023-2030 |
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カスタマイズ可能
適宜更新あり
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免疫グロブリンの世界市場-2023年~2030年 |
出版日: 2023年11月01日
発行: DataM Intelligence
ページ情報: 英文 187 Pages
納期: 即日から翌営業日
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抗体としても知られる免疫グロブリン(Ig)は、形質細胞によって産生される糖タンパク質です。B細胞は、細菌タンパク質などの特異的免疫原によって、細菌、ウイルス、真菌、寄生虫、細胞抗原、化学物質、合成物質に対する体液性免疫応答に関与するタンパク質産生細胞である形質細胞に分化するよう指示されます。免疫原または抗原は、Bリンパ球の細胞表面にあるB細胞レセプターと反応します。B細胞を刺激した免疫原に特異性の高い抗体の合成を刺激するために、転写因子の活性化を指示するシグナルが産生されます。
さらに、形質細胞によって産生される様々な免疫グロブリンはアイソタイプによって分類され、それぞれは主に構造の多様性によって機能と抗原反応が異なります。胎盤哺乳類で同定されている5つの主要な抗体クラスは、IgA、IgD、IgE、IgG、IgMです。この分類は、抗体重鎖の定常領域におけるアミノ酸配列の相違に基づいています。IgGとIgAは、さらにアミノ酸重鎖配列のわずかな違いに基づいてサブクラスに分類されます。これらは多くの自己免疫疾患やその他の慢性疾患の治療に使用されています。
革新的な免疫グロブリンに対する需要の増加が、予測期間を通じて市場を牽引するとみられます。革新的免疫グロブリンは、主にさまざまな種類の疾患を治療するために設計されており、代替的または補完的な治療オプションを提供することによって、さまざまな疾患の管理および治療に関連するアンメットニーズに対処することを目的としています。FDA承認などの規制当局による承認も増加しており、免疫グロブリンの採用がさらに進んでいます。
例えば、2023年5月19日、アッヴィは、米国食品医薬品局(FDA)の承認を取得しました。EPKINLYTM(epcoritamab-bysp)は、再発または難治性(R/R)のびまん性大細胞型B細胞リンパ腫(DLBCL)、特定不能(NOS)(低悪性度リンパ腫から発生したDLBCLを含む)、および高悪性度B細胞リンパ腫(HGBL)の成人患者に対する治療薬として、2ライン以上の全身療法後の最初で唯一のT細胞関与二重特異性抗体として、米国食品医薬品局(FDA)から承認されました。EPKINLYは、Genmab社独自のDuoBody技術を用いて創製されたIgG1二重特異性抗体です。
さらに、免疫グロブリンは従来、原発性免疫不全症や自己免疫疾患などの疾患に使用されてきました。しかし、研究者や製薬会社は、免疫グロブリンを用いることで、より幅広い疾患の治療や診断の可能性を探ることに注力しています。
例えば、サービングサイエンスの世界的リーダーであるサーモフィッシャーサイエンティフィック社は、2023年8月24日、IVDR認証を取得し、EXENTソリューションを発売しました。EXENTソリューションは、多発性骨髄腫を含むモノクローナル・ガモパチー患者の診断と評価を変革するために設計された、完全に統合された自動質量分析システムです。この分析装置は、IgG、IgA、およびIgMを測定および定量するための高感度かつ特異的な免疫測定法であるEXENT免疫グロブリンアイソタイプ(GAM)免疫測定法と組み合わされます。
さらに、2022年3月29日、サノフィはIGMバイオサイエンシズと提携し、6種類の免疫グロブリンM(IgM)抗体アゴニストを創製、開発、製造、商業化しました。
さらに、免疫不全やその他の免疫関連疾患の有病率の増加、FDA承認の増加、臨床試験の増加、認知度の向上、新規製品開発の進展などが、予測期間中に市場を牽引すると予想される要因です。
輸血関連急性肺障害(TRALI)、急性腎不全、IgEやIgA対抗IgG抗体に対するアナフィラキシー、不整脈、無菌性髄膜炎、関節炎、肝炎、胸水、その他の皮膚症状など、免疫グロブリンの重篤かつ稀な副作用などの要因は、市場の妨げになると予想されます。
Immunoglobulins (Ig) which are also known as antibodies are the glycoproteins produced by plasma cells. B cells are instructed by specific immunogens, such as bacterial proteins, to differentiate into plasma cells, which are protein-making cells that participate in humoral immune responses against bacteria, viruses, fungi, parasites, cellular antigens, chemicals, and synthetic substances. The immunogen or antigen reacts with a B-cell receptor on the cell surface of B lymphocytes. A signal is produced that directs the activation of transcription factors to stimulate the synthesis of antibodies, which are highly specific for the immunogen that stimulated the B cell.
Moreover, the various immunoglobulins produced by plasma cells are classified by isotype, each differs in function and antigen responses primarily due to structure variability. The five major antibody classes that have been identified in placental mammals, they are IgA, IgD, IgE, IgG, and IgM. This classification is based on differences in amino acid sequence in the constant region of the antibody heavy chains. IgG and IgA are further grouped into subclasses based on additional small differences in the amino acid heavy chain sequences. These are used to treat many autoimmune and other chronic disorders.
The increasing demand for innovative immunoglobulins is expected to drive the market over the forecast period. The innovative immunoglobulins are mainly designed to treat various types of diseases and they aim to address the unmet needs associated with the management and treatment of various disorders by providing alternative or complementary treatment options. Regulatory approvals such as FDA approvals are also increasing, which further increases the adoption of immunoglobulins.
For instance, on May 19, 2023, AbbVie, cleared that the U.S. Food and Drug Administration (FDA) has approved EPKINLYTM (epcoritamab-bysp), as the first and only T-cell engaging bispecific antibody for the treatment of adult patients with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL), not otherwise specified (NOS), including DLBCL arising from indolent lymphoma, and high-grade B-cell lymphoma (HGBL), after two or more lines of systemic therapies. EPKINLY is an IgG1-bispecific antibody created using Genmab's proprietary DuoBody technology.
Moreover, immunoglobulins have traditionally been used for conditions such as primary immunodeficiency disorders and autoimmune diseases. However, researchers and pharmaceutical companies are focussing on exploring their potential for treating and diagnosing a broader range of conditions by using immunoglobulins.
For instance, on August 24, 2023, Thermo Fisher Scientific, the world leader in serving science, launched the EXENT Solution, after receiving IVDR certification. The EXENT solution is a fully integrated and automated mass spectrometry system designed to transform diagnosis and assessment for patients with monoclonal gammopathies, including multiple myeloma. The analyzer is combined with the EXENT Immunoglobulin Isotypes (GAM) immunoassay, a highly sensitive and specific immunoassay for measuring and quantifying IgG, IgA, and IgM.
Additionally, on March 29, 2022, Sanofi partnered with IGM Biosciences to create, develop, manufacture and commercialize six immunoglobulin M (IgM) antibody agonists, three against oncology targets and the other three against immunology/inflammation targets.
Further, the increasing prevalence of immunodeficiency and other immune-related disorders, rising FDA approvals, increasing clinical trials, increasing awareness and advancements in the development of novel products are the factors expected to drive the market over the forecast period.
Factors such as severe and rare side effects of immunoglobulins like transfusion-related acute lung injury (TRALI), acute renal failure, anaphylaxis to IgE or IgG antibodies to IgA, arrhythmias, aseptic meningitis, arthritis, hepatitis, pleural effusion and other dermatological manifestations are expected to hamper the market.
The global immunoglobulin market is segmented based on type, form, application, route of administration, end-user and region.
The immunoglobulin G (IgG) segment is expected to hold the largest market share over the forecast period. Immunoglobulin G is further subdivided into four types, they are IgG1, IgG2, IgG3 and IgG4. IgG is the most commonly abundant class of antibodies in the human body, constituting about 75-80% of the total immunoglobulin pool. It is found in the blood and tissues and is crucial for long-term immunity. IgG can neutralize toxins and viruses, preventing them from infecting cells.
Furthermore, intravenous immunoglobulins involve the administration of IgG antibodies extracted from the plasma of thousands of donors. These intravenous immunoglobulins are used to boost the immune system in patients with immunodeficiency disorders and to modulate immune responses in certain autoimmune conditions.
For instance, on September 21, 2023, Biotest AG launched its intravenous immunoglobulin Yimmugo (IgG Next Generation) and got approval in the United Kingdom for the treatment of patients with congenital and acquired immunodeficiencies and for immunomodulation, following approvals in Germany and Austria.
Additionally, on January 6, 2023, Eisai Co., Ltd. And Biogen Inc. released the approval from U.S. Food and Drug Administration (FDA) for lecanemab-irmb (LEQEMBI) 100 mg/mL injection for intravenous use, a humanized immunoglobulin gamma 1 (IgG1) monoclonal antibody directed against aggregated soluble and insoluble forms of amyloid beta (AB) for the treatment of Alzheimer's disease (AD).
North America region is expected to hold the largest market share over the forecast period owing to the strong presence of major players and increasing adoption of immunoglobulins. North America especially the United States is known for its strong presence of major players such as pharmaceutical companies and biotechnology companies. The presence of major players actively performing research activities to develop immunoglobulin products for the treatment of various diseases.
For instance, on April 11, 2023, Takeda cleared that the U.S. Food and Drug Administration (FDA) has approved a supplemental biologics license application to expand the use of HYQVIA to treat primary immunodeficiency (PI) in children 2-16 years old. HYQVIA is the only subcutaneous immune globulin infusion that can be administered once a month, every three or four weeks and was first approved in the U.S. for the treatment of PI in adults.
Furthermore, the increasing adoption of immunoglobulins in the region is also driving the market in the region. There is a continuously increasing prevalence of immunodeficiency disorders in the region, further increasing the adoption of immunoglobulins for the treatment and management of these disorders. For instance, according to the Journal of Allergy and Clinical Immunology (JACI), 2020, the prevalence of primary immunodeficiency disorders in the United States is estimated at 1 in 2000 individuals.
The major global players in the immunoglobulin market include: Takeda Pharmaceuticals Inc., CSL Limited, Octapharma AG, Kedrion Biopharma Inc., Grifols, S.A., ADMA Biologics, Inc., Pfizer Inc., Kamada Pharmaceuticals, Cygnus Technologies and Emergent BioSolutions Canada Inc. among others.
The COVID-19 pandemic significantly impacted the global immunoglobulin market. When infected with COVID-19, patients produce antibodies to fight off the infection. These antibodies are known as immunoglobulins and are key players in the response to COVID-19. The demand for immunoglobulins has increased due to the pandemic.
For instance, on May 21, 2021, the Defence Institute of Physiology and Allied Sciences (DIPAS), a laboratory of the Defence Research and Development Organisation (DRDO), developed an antibody detection-based kit 'DIPCOVAN', the DIPAS-VDx COVID-19 IgG Antibody Microwell ELISA for sero-surveillance. The DIPCOVAN kit can detect both spikes as well as nucleocapsid (S&N) proteins of SARS-CoV-2 virus with a high sensitivity of 97 percent and specificity of 99 percent.
The global immunoglobulin market report would provide approximately 77 tables, 84 figures, and 187 Pages.
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