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市场调查报告书
商品编码
1733556
多特异性抗体的全球市场:药物销售额,用量,价格,临床试验趋势(2030年)Global Multispecific Antibodies Market, Drug Sales, Dosage, Price & Clinical Trials Insight 2030 |
全球多特异性抗体市场、药品销售、剂量、价格、临床试验趋势(2030 年)报告重点
本报告彙编了关于全球多特异性抗体的全面一手和二手研究成果多特异性抗体市场,涵盖18种已获批准的药物,并提供定价、剂量和销售数据的深入分析。此外,还包括市场规模、已上市药物的区域销售分析以及最新发展。为了确保对多特异性抗体定价和市场表现分析的准确性和可靠性,我们利用了广泛的资讯来源,包括公司报告、交易所备案文件、年度和季度报告以及官方新闻稿。
多特异性抗体市场是全球生物製药行业最具活力、成长最快的领域之一,这得益于治疗领域的突破,以及其透过同时靶向多种途径治疗复杂疾病的能力日益得到认可。截至2025年5月,全球已核准18种多特异性抗体,全部为双特异性抗体。这个不断扩展的产品组合包括一些开创性药物,例如第一个核准的双特异性抗体Blincyto,以及第一个获准用于非癌症适应症的双特异性抗体Hemlibra。该治疗产品线的最新成员是再生元的Lynozyfic,该药物于2025年4月获得上市许可,用于治疗多发性骨髓瘤,展现了该领域的持续发展势头。
核准的多特异性抗体种类繁多,反映了该疗法对不同适应症和患者群体的灵活性。同时,总部位于中国的康方生物的卡多尼利单抗是唯一获准的可同时靶向两个免疫检查点的双特异性抗体,也是第一个在中国研发并获批的双特异性抗体。这种区域性研发差异凸显了该领域创新的全球性,成熟医药市场和新兴生技中心都积极参与其中。
监管环境仍在快速变化,预计不久的将来会有更多药物获批。 FDA 也正在评估奥卓奈克塔单抗和瑞博舍塔单抗的上市申请。奥卓奈克塔单抗已在欧盟获准用于治疗滤泡性淋巴瘤,瑞博舍塔单抗则获准用于治疗瀰漫性大B细胞淋巴瘤和多发性骨髓瘤。跨大西洋监管领域的这种进展反映出全球监管机构对多特异性抗体技术的接受度和信心日益增强。
预计市场表现将异常强劲,全球多特异性抗体市场在2024年的销售额将超过126亿美元,2025年第一季的销售额将超过34.6亿美元。美国是该市场收入的最大贡献者,凸显了该关键地区的市场成熟度和接受度。罗氏的成熟产品Hemlibra和Vabysmo占了超过一半的市场占有率,凸显了先发优势和有效的市场进入策略在这个竞争激烈的市场中的价值。
多特异性抗体的研发管线更是令人望而生畏,目前已有超过900种多特异性抗体处于不同的研发阶段。肿瘤学领域引领这条管线,既是因为多特异性抗体研发的传统优先性,也是因为癌症治疗领域有大量未满足的医疗需求。然而,产品线的多样性并不局限于肿瘤学,在自体免疫、发炎和神经系统疾病领域也发现了一些有前景的候选药物,这表明治疗领域正在不断拓宽,并有可能大幅拓展市场机会。
支持这项创新的主要产业参与者包括安进、阿斯特捷利康、基因泰克和再生元等大型製药公司,以及ABL Bio、和铂医药、信达生物、Merus和Zymeworks等新兴生物技术公司。成熟公司和新兴公司的结合创造了充满活力的竞争格局,确保了持续的创新和技术进步。
策略联盟持续对市场发展产生影响,例如勃林格殷格翰与Cue Biopharma于2025年4月合作开发双特异性候选药物CUE-501,该药物可透过病毒特异性记忆T细胞攻击致病B细胞。此次合作涉及1,200万美元的首付款和高达3.45亿美元的里程碑付款,显示各公司正在投入大量资金推进多特异性抗体技术,尤其是在现有疗法不足的自身免疫性疾病领域。
美国食品药物管理局(FDA)将于2025年4月授予ISB 2001快速通道资格,该资格是Ichnos Glenmark Innovation公司用于治疗復发或难治性多发性骨髓瘤的在研三特异性T细胞介入疗法,这反映了该监管机构对推进多特异性抗体技术以治疗重大未满足医疗需求的持续热情。由于这项持续的技术创新,全球多特异性抗体市场预计将快速成长,并成为製药业最重要的细分市场之一。
本报告提供全球多特异性抗体市场相关调查,提供市场概要,以及药物趋势,临床试验趋势,各地区趋势,及加入此市场的主要企业的竞争情形等资讯。
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.