Bispecific antibody approvals top 20 as researchers develop three-target multispecifics
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The number of bispecific antibody therapies approved by global regulators has risen from 3 to more than 20 in the past five years, generating $18 billion in sales in 2025. Pharmaceutical companies and researchers are now advancing multispecific antibodies capable of binding three or more targets, aiming for higher precision against cancer. The latest designs were presented at the American Association for Cancer Research conference in Boston in late July.
The Bispecific Boom
Over 20 bispecific antibody therapies are now approved globally, up from just three five years ago, according to Christian Klein, former Roche executive. The drugs, which bind two targets simultaneously, earned $18 billion in 2025. Most are T-cell engagers that connect cancer cells with immune T cells, approved for blood cancers such as leukaemia and myeloma. Sales have surged as advances in protein production and artificial intelligence unlock new molecular designs.
Multispecific Ambitions
At the AACR conference in Boston in late July, researchers unveiled multispecific antibodies targeting three or more molecules. These experimental therapies aim to reduce toxicity to healthy cells, overcome drug resistance, and mount stronger anti-tumour responses. Paul Carter of Genentech noted the explosion of formats, while Daniel Chen of Synthetic Design Lab said AI and improved protein manufacturing are driving the next wave of candidates.
Manufacturing Breakthroughs
For decades, bispecific antibodies were plagued by production challenges, often clumping into useless aggregates, according to Jamie Spangler of Johns Hopkins University. Advances in protein engineering now allow stable, functional molecules to be designed. The first bispecific was described over 50 years ago, but the first approved treatment only came in 2009. Today, companies like Roche and Genentech are racing to patent multispecific formats.
What's Next
Further clinical trials of multispecific antibodies are expected to launch this year. It remains unclear whether these more complex molecules will prove safe and effective in patients, and regulatory hurdles could slow their path to market.
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Bispecific antibody approvals top 20 as researchers develop three-target multispecifics
