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市場調查報告書
商品編碼
1673492
雙特異性抗體市場:全球市場機會、劑量、專利、定價、銷售、臨床試驗趨勢(2030年)Global Bispecific Antibody Market Opportunity, Drug Dosage, Patent, Price, Sales & Clinical Trials Insight 2030 |
在持續創新和病患接受度不斷提高的推動下,雙特異性抗體已成為醫藥市場上最有前景和商業上最成功的標靶方法之一。這一驚人成長的關鍵驅動因素是雙特異性抗體臨床試驗數量的急劇增加,將從2015年的不到 100個增加到2025年的650 多個。這項進步將為藥物開發商、臨床研究組織、醫生和患者等多方利害關係人帶來重大利益。截至2025年 3月,已有 17 種雙特異性抗體在主要市場獲得批准,累計銷售額超過 350億美元,而2015年首個雙特異性抗體獲得批准時銷售額為 7,700萬美元。
雙特異性抗體市場預計在2024年達到約 120億美元,到2030年將呈指數成長至 500億美元。該成長軌跡顯示對能夠滿足未滿足的醫療需求的創新生物製劑的需求不斷增加。值得注意的是,Hemlibra 和 Vabysmo 已成為全球雙特異性抗體市場的主要參與者,合計佔總銷售額的75%以上。Roche開發的雙特異性抗體Hemlibra用於治療血友病A,同樣由Roche開發的Bavismo用於治療黃斑部病變和黃斑水腫。預計到2024年,這兩種藥物的銷售額將超過 40億美元,成為各自治療領域的主要進入者,並鞏固Roche在雙特異性抗體市場的領導地位。
目前還有幾種雙特異性抗體審查核准。值得注意的是,美國 FDA 和歐洲藥品管理局(EMA)審查一種開發雙特異性抗體 Linvoseltamab,用於治療多發性骨髓瘤。另一個有希望的候選藥物Odronextamab目前接受 FDA 審查,用於治療多種血液系統惡性腫瘤。這些發展凸顯了雙特異性抗體研究的進展及其徹底改變癌症治療的潛力。
截至2025年 3月,已有 600 多種雙特異性抗體臨床試驗中,證明了該類治療在多個治療領域的巨大潛力。美國在研發和銷售方面繼續成為雙特異性抗體的最大市場,反映了其在醫藥創新和醫療保健支出方面的領導地位。
本報告研究了全球雙特異性抗體市場,並概述了市場以及藥物趨勢、臨床試驗趨勢、區域趨勢以及參與市場的公司的競爭格局。
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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