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市場調查報告書
商品編碼
1733556
多特異性抗體的全球市場:藥物銷售額,用量,價格,臨床試驗趨勢(2030年)Global Multispecific Antibodies Market, Drug Sales, Dosage, Price & Clinical Trials Insight 2030 |
全球多特異性抗體市場、藥品銷售、劑量、價格、臨床試驗趨勢(2030 年)報告重點
本報告彙編了關於全球多特異性抗體的全面一手和二手研究成果多特異性抗體市場,涵蓋18種已獲批准的藥物,並提供定價、劑量和銷售數據的深入分析。此外,還包括市場規模、已上市藥物的區域銷售分析以及最新發展。為了確保對多特異性抗體定價和市場表現分析的準確性和可靠性,我們利用了廣泛的資訊來源,包括公司報告、交易所備案文件、年度和季度報告以及官方新聞稿。
多特異性抗體市場是全球生物製藥行業最具活力、成長最快的領域之一,這得益於治療領域的突破,以及其透過同時靶向多種途徑治療複雜疾病的能力日益得到認可。截至2025年5月,全球已核准18種多特異性抗體,全部為雙特異性抗體。這個不斷擴展的產品組合包括一些開創性藥物,例如第一個核准的雙特異性抗體Blincyto,以及第一個獲準用於非癌症適應症的雙特異性抗體Hemlibra。該治療產品線的最新成員是再生元的Lynozyfic,該藥物於2025年4月獲得上市許可,用於治療多發性骨髓瘤,展現了該領域的持續發展勢頭。
核准的多特異性抗體種類繁多,反映了該療法對不同適應症和患者群體的靈活性。同時,總部位於中國的康方生物的卡多尼利單抗是唯一獲準的可同時靶向兩個免疫檢查點的雙特異性抗體,也是第一個在中國研發並獲批的雙特異性抗體。這種區域性研發差異凸顯了該領域創新的全球性,成熟醫藥市場和新興生技中心都積極參與其中。
監管環境仍在快速變化,預計不久的將來會有更多藥物獲批。 FDA 也正在評估奧卓奈克塔單抗和瑞博舍塔單抗的上市申請。奧卓奈克塔單抗已在歐盟獲準用於治療濾泡性淋巴瘤,瑞博舍塔單抗則獲準用於治療瀰漫性大B細胞淋巴瘤和多發性骨髓瘤。跨大西洋監管領域的這種進展反映出全球監管機構對多特異性抗體技術的接受度和信心日益增強。
預計市場表現將異常強勁,全球多特異性抗體市場在2024年的銷售額將超過126億美元,2025年第一季的銷售額將超過34.6億美元。美國是該市場收入的最大貢獻者,凸顯了該關鍵地區的市場成熟度和接受度。羅氏的成熟產品Hemlibra和Vabysmo佔了超過一半的市場佔有率,凸顯了先發優勢和有效的市場進入策略在這個競爭激烈的市場中的價值。
多特異性抗體的研發管線更是令人望而生畏,目前已有超過900種多特異性抗體處於不同的研發階段。腫瘤學領域引領這條管線,既是因為多特異性抗體研發的傳統優先性,也是因為癌症治療領域有大量未滿足的醫療需求。然而,產品線的多樣性並不局限於腫瘤學,在自體免疫、發炎和神經系統疾病領域也發現了一些有前景的候選藥物,這表明治療領域正在不斷拓寬,並有可能大幅拓展市場機會。
支持這項創新的主要產業參與者包括安進、阿斯特捷利康、基因泰克和再生元等大型製藥公司,以及ABL Bio、和鉑醫藥、信達生物、Merus和Zymeworks等新興生物技術公司。成熟公司和新興公司的結合創造了充滿活力的競爭格局,確保了持續的創新和技術進步。
策略聯盟持續對市場發展產生影響,例如勃林格殷格翰與Cue Biopharma於2025年4月合作開發雙特異性候選藥物CUE-501,該藥物可透過病毒特異性記憶T細胞攻擊致病B細胞。此次合作涉及1,200萬美元的首付款和高達3.45億美元的里程碑付款,顯示各公司正在投入大量資金推進多特異性抗體技術,尤其是在現有療法不足的自身免疫性疾病領域。
美國食品藥物管理局(FDA)將於2025年4月授予ISB 2001快速通道資格,該資格是Ichnos Glenmark Innovation公司用於治療復發或難治性多發性骨髓瘤的在研三特異性T細胞介入療法,這反映了該監管機構對推進多特異性抗體技術以治療重大未滿足醫療需求的持續熱情。由於這項持續的技術創新,全球多特異性抗體市場預計將快速成長,並成為製藥業最重要的細分市場之一。
本報告提供全球多特異性抗體市場相關調查,提供市場概要,以及藥物趨勢,臨床試驗趨勢,各地區趨勢,及加入此市場的主要企業的競爭情形等資訊。
Global Multispecific Antibodies Market, Drug Sales, Dosage, Price & Clinical Trials Insight 2030 Report Highlights:
Research Methodology
At Kuick Research, we begin by outlining the foundation of our research methodology, which is driven by an integrated approach that combines multiple data dimensions. In our work, we ensure that the report captures market estimation, regional analysis, and a carefully constructed competitive landscape. We take pride in the detailed inclusion of key components such as the assessment of available information, clinical trial data, and the nuances of dosing and pricing. Every piece of data is purposefully gathered and validated to ensure that our findings are as robust as possible, reflecting the multifaceted nature of the market landscape.
This report on the global multispecific antibodies market is the result of comprehensive primary and secondary research, encompassing 18 approved drugs, alongside in-depth analysis of their pricing, dosing, and sales data. Market size, marketed drugs regional sales analysis and recent trends are also included in the report. To ensure the accuracy and reliability of our analysis on multispecific antibodies pricing and market performance, we leveraged an extensive array of sources, including company reports, exchange filings, annual and quarterly reports, and official press releases.
Multispecific antibodies market globally has been one of the most energetic and fast growing sectors in the biopharmaceutical business as a result of therapeutic breakthroughs and growing acceptance of their ability to treat complicated pathologies by targeting multiple pathways simultaneously. As of May 2025, 18 multispecific antibodies have gained regulatory approval globally, all of which are bispecific constructs, a monumental milestone in the history of targeted therapeutics. This expanding portfolio boasts trailblazing drugs like Blincyto, the first bispecific antibody to gain approval, and Hemlibra, which was the first bispecific antibody to be approved for a non-cancer indication. The latest entrant to this therapeutic pipeline is Regeneron's Lynozyfic, which received marketing approval in April 2025 for the treatment of multiple myeloma, with evidence of ongoing momentum in the segment.
The range of approved multispecific antibodies mirrors the flexibility of this therapeutic modality across various disease indications and patient bases. Rybrevant is another key breakthrough as the first bispecific antibody for a solid tumor, whereas China based Akeso's Cadonilimab is especially noteworthy for being solely approved bispecific antibody intended to target two immune checkpoints at once and becoming the first China developed bispecific antibody to gain regulatory approval. This regional variation in development emphasizes the world nature of innovation in this sector, with input from both mature pharmaceutical markets and developing biotechnology centers.
The regulatory environment is still changing at a rapid pace, with further approvals expected in the near future. The FDA is also evaluating marketing applications for Odronextamab and Linvoseltamab, both of which have already received approval in the EU for follicular lymphoma and diffuse large B-cell lymphoma, and multiple myeloma, respectively. Such transatlantic regulatory advancements reflect the growing acceptability and trust in multispecific antibody technologies by global regulatory bodies.
Market performance has been extremely strong, with global multispecific antibodies market sales in 2024 amounting to over US$ 12.6 Billion, followed by first quarter 2025 sales of over US$ 3.46 Billion. The US is the largest contributor to these sales, highlighting the maturity and acceptance of the market in this prime geography. Roche's mature products, Hemlibra and Vabysmo, lead the market share, with over half of total sales, emphasizing the value of first mover benefit and effective market entry strategies in this competitive market.
The pipeline for development is an even more daunting picture, with more than 900 multispecific antibodies already in various stages of development. Oncology is leading this pipeline, both due to the traditional priority of multispecific antibody development and due to the large unmet medical needs in cancer treatment. However, pipeline diversity is not confined to oncology alone with promising candidates being identified in autoimmune and inflammatory diseases and neurological disorders as well, indicating an expanding therapeutic horizon that has the potential to dramatically expand market opportunities.
Major industry players behind this innovation are well established pharma giants like Amgen, AstraZeneca, Genentech, and Regeneron, as well as new biotech firms like ABL Bio, Harbour BioMed, Innovent Biologics, Merus, and Zymeworks. This combination of well established and new players provides a vibrant competitive landscape that ensures ongoing innovation and technological progress.
Strategic alliances continue to influence the development of the market, such as in the April 2025 alliance of Boehringer Ingelheim and Cue Biopharma for the development of CUE-501, a bispecific candidate that attacks pathogenic B cells via virus-specific memory T cells. The alliance, involving a US$ 12 Million upfront payment and possible milestone payments of up to US$ 345 Million, illustrates the high financial investment that companies are undertaking to drive multispecific antibody technologies, specifically in autoimmune indications where existing treatments are still inadequate.
Regulatory encouragement of innovation continues to be robust, with the FDA's April 2025 fast track designation of ISB 2001, an Ichnos Glenmark Innovation investigational trispecific T-cell engager for relapsed or refractory multiple myeloma, reflecting ongoing regulatory enthusiasm for moving multispecific antibody technologies forward that treat important unmet medical needs. As a result of these ongoing innovations, the global multispecific antibody market is expected to grow rapidly and is on track to become one of the most important segments within the pharmaceutical industry.