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市场调查报告书
商品编码
1673492
双特异性抗体市场:全球市场机会、剂量、专利、定价、销售、临床试验趋势(2030年)Global Bispecific Antibody Market Opportunity, Drug Dosage, Patent, Price, Sales & Clinical Trials Insight 2030 |
在持续创新和病患接受度不断提高的推动下,双特异性抗体已成为医药市场上最有前景和商业上最成功的标靶方法之一。这一惊人成长的关键驱动因素是双特异性抗体临床试验数量的急剧增加,将从2015年的不到 100个增加到2025年的650 多个。这项进步将为药物开发商、临床研究组织、医生和患者等多方利害关係人带来重大利益。截至2025年 3月,已有 17 种双特异性抗体在主要市场获得批准,累计销售额超过 350亿美元,而2015年首个双特异性抗体获得批准时销售额为 7,700万美元。
双特异性抗体市场预计在2024年达到约 120亿美元,到2030年将呈指数成长至 500亿美元。该成长轨迹显示对能够满足未满足的医疗需求的创新生物製剂的需求不断增加。值得注意的是,Hemlibra 和 Vabysmo 已成为全球双特异性抗体市场的主要参与者,合计占总销售额的75%以上。Roche开发的双特异性抗体Hemlibra用于治疗血友病A,同样由Roche开发的Bavismo用于治疗黄斑部病变和黄斑水肿。预计到2024年,这两种药物的销售额将超过 40亿美元,成为各自治疗领域的主要进入者,并巩固Roche在双特异性抗体市场的领导地位。
目前还有几种双特异性抗体审查核准。值得注意的是,美国 FDA 和欧洲药品管理局(EMA)审查一种开发双特异性抗体 Linvoseltamab,用于治疗多发性骨髓瘤。另一个有希望的候选药物Odronextamab目前接受 FDA 审查,用于治疗多种血液系统恶性肿瘤。这些发展凸显了双特异性抗体研究的进展及其彻底改变癌症治疗的潜力。
截至2025年 3月,已有 600 多种双特异性抗体临床试验中,证明了该类治疗在多个治疗领域的巨大潜力。美国在研发和销售方面继续成为双特异性抗体的最大市场,反映了其在医药创新和医疗保健支出方面的领导地位。
本报告研究了全球双特异性抗体市场,并概述了市场以及药物趋势、临床试验趋势、区域趋势以及参与市场的公司的竞争格局。
Global Bispecific Antibody Market Opportunity, Drug Dosage, Patent, Price, Sales & Clinical Trials Insight 2030 Report findings & Highlights:
Bispecific antibodies have emerged as one of the most promising and commercially successful targeting approaches in the pharmaceutical market, driven by continuous innovations and growing patient acceptance. A major factor contributing to this phenomenal growth is the exponential increase in the number of clinical trials for bispecific antibodies, which has surpassed 650 in 2025 from less than 100 in 2015. This progress has significantly benefited multiple stakeholders like drug developers, clinical research organizations, physicians, and patients. As of March 2025, 17 bispecific antibodies have been approved across key markets, with cumulative sales exceeding US$ 35 Billion as compared to US$ 77 Million in 2015 when the first bispecific antibody was approved.
The bispecific antibody market reached approximately US$ 12 billion in 2024, with projections by Kuick Research suggesting that this market will surge to US$ 50 billion by 2030. This growth trajectory highlights the increasing demand for innovative biologics that can address unmet medical needs. Notably, Hemlibra and Vabysmo have emerged as major contributors to the global bispecific antibodies market, collectively accounting for over 75% of the total sales. Hemlibra, a bispecific antibody developed by Roche, is used to treat hemophilia A, while Vabysmo, also developed by Roche, is a treatment for macular degeneration and macular edema. Both drugs saw sales surpassing US$ 4 Billion in 2024, emerging as key players in their respective therapeutic areas and solidifying Roche's leadership in the market for bispecific antibodies.
There are also several bispecific antibodies currently under regulatory review. Notably, Linvoseltamab, an investigational bispecific antibody, is undergoing review by the US FDA and the European Medicines Agency (EMA) for the treatment of multiple myeloma. Another promising candidate, Odronextamab, is currently under FDA review for the treatment of various hematologic malignancies. These developments underscore the ongoing progress in bispecific antibody research and their potential to revolutionize cancer treatment.
As of March 2025, more than 600 bispecific antibodies are currently undergoing clinical trials, demonstrating the immense potential of these therapeutics across multiple therapeutic areas. The US remains the largest market for bispecific antibodies in terms of both research and development (R&D) and sales, reflecting the country's leadership in pharmaceutical innovation and healthcare spending.
Leading players in the bispecific antibody market include Roche, Gilead, Amgen, Pfizer, Johnson & Johnson (Janssen), and others. These companies are at the forefront of developing innovative bispecific therapies, with a focus on oncology and other high-need areas. For example, Roche has leveraged its expertise in biologics to bring to market Hemlibra and Vabysmo, while Amgen is advancing bispecific T-cell engagers for cancer immunotherapy.
In addition to these leading companies, there have been significant regulatory designations granted to bispecific antibodies, enhancing the overall market landscape. Ivonescimab, a PD-1 x VEGF bispecific antibody developed by Akeso, received FDA Fast Track Designation in October 2024 for the treatment of non-small cell lung cancer (NSCLC) with EGFR mutations in the second-line or beyond setting. This designation accelerates the development process and highlights the growing interest in bispecific antibodies for treating cancer. Akeso is collaborating with Summit Therapeutics in the US and other countries to develop Ivonescimab.
Additionally, Invenra's Novel Antibody INV724 has received both Rare Pediatric Disease and Orphan Drug Designations from the US FDA for the treatment of neuroblastoma, a rare and aggressive cancer affecting children. INV724 targets the GD2 and B7-H3 antigens and has shown promise in early-stage clinical trials, offering hope for more effective treatments for pediatric cancers.
In conclusion, the bispecific antibody market is poised for substantial growth, driven by increasing approvals, ongoing clinical trials, and strong regulatory support. With major players like Roche, Gilead, Amgen, and Pfizer leading the charge, and promising candidates undergoing review, bispecific antibodies are set to transform the landscape of modern therapeutics. The market's rapid expansion from US$ 12 Billion in 2024 to an expected US$ 50 Billion by 2030, reflects the increasing recognition of bispecific antibodies as key solutions for treating complex and life-threatening diseases.
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