The market for next generation multispecific antibodies is experiencing significant expansion, fueled by their capacity to tackle intricate diseases such as cancer, autoimmune disorders, and viral infections. This advancement builds upon the achievements of monoclonal antibodies, which were first introduced in the 1970s and transformed targeted therapies by providing specific binding to individual epitopes. Nevertheless, the intricate nature of diseases, particularly cancer, necessitates more advanced solutions. While monoclonal antibodies have proven effective, they are constrained by their inability to simultaneously target multiple pathways, prompting the creation of multispecific antibodies, which include bispecific, trispecific, and tetraspecific antibodies.
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Among these, bispecific antibodies, capable of binding to two distinct epitopes, have emerged as the foremost category of multispecific antibodies. They have attracted considerable attention for their ability to simultaneously address multiple targets, especially in the field of oncology. By redirecting T cells towards tumor cells or inhibiting various cancer-related signaling pathways, bispecific antibodies have demonstrated encouraging clinical outcomes. They have established themselves as a dominant presence in the market, with 16 approved bispecific therapies, including Blincyto, the first bispecific antibody to receive regulatory approval. Other noteworthy examples include Hemlibra, the first bispecific antibody approved for a non-cancer indication (hemophilia A), and Rybrevant, the first treatment aimed at EGFR in non-small cell lung cancer (NSCLC). In December 2024, Merus expanded this portfolio with Bizengri, a bispecific antibody targeting NRG1+ NSCLC and pancreatic adenocarcinoma.
The approved bispecific antibodies have predominantly concentrated on oncology, which continues to be the primary focus of development. However, their potential to engage multiple disease pathways has sparked increasing interest in their application for autoimmune and inflammatory diseases, as well as viral infections. The capacity of bispecific antibodies to engage immune effector cells while simultaneously targeting tumor cells or inhibiting multiple cancer-related pathways renders them particularly appealing for oncological applications. Notable example is Akeso's Cadonilimab, which uniquely targets two immune checkpoints, thereby broadening the therapeutic scope within the realm of immuno-oncology.
While bispecific antibodies currently dominate the market, trispecific and tetraspecific antibodies are beginning to emerge, although they remain in the earlier phases of development. These more intricate antibody constructs are designed to engage additional targets, potentially offering enhanced therapeutic advantages, yet they are not as commercially available or prevalent as their bispecific counterparts.
The increasing confidence in multispecific antibodies is evidenced by the substantial pipeline of bispecific therapies undergoing clinical trials. This growing pipeline highlights the potential of multispecific antibodies to meet significant unmet medical needs. Additionally, the rising volume of research publications and clinical investigations suggests that academic institutions, biotechnology companies, and pharmaceutical firms are making considerable investments to advance this area. Such collaborations are crucial for expediting development timelines and broadening the therapeutic applications of multispecific antibodies.
From a commercial perspective, the multispecific antibody market is marked by vigorous collaboration and partnerships. Leading pharmaceutical companies are actively pursuing collaborations with biotechnology firms that specialize in multispecific platforms. These alliances are typically focused on advancing the research and development of bispecific antibodies, utilizing complementary expertise to expedite the market introduction of these promising therapies.
As of the third quarter of 2024, the multispecific antibody market has exceeded US$ 8.6 Billion in sales, with Roche’s Hemlibra and Vabysmo leading the market, followed by Amgen’s Blincyto. Regulatory backing has been robust, as agencies such as the FDA have awarded designations like Fast Track and orphan drug status to numerous promising multispecific candidates, thereby accelerating their development and approval processes.
Geographically, the US and the EU continue to serve as the main centers for research, clinical trials, and regulatory approvals, with notable contributions from regions like China. The burgeoning market for multispecific antibodies underscores the increasing acknowledgment of their potential to transform treatment options for various diseases, providing renewed optimism for patients globally.