Bispecific T-cell engagers (BiTEs) are a rapidly emerging new therapeutic. By 2030, this drug category is forecast to generate $20.6 billion, an increase of 1,320% from 2023. Johnson & Johnson (J&J) is predicted to dominate this market, as its products, Tecvayli and Talvey, are forecast to become the two top-selling BiTEs by 2030, encompassing 40% of all sales in this category, says GlobalData, a leading data and analytics company.

BiTEs are a novel class of cancer therapeutics that simultaneously bind to a distinct antigen on tumor cells and a surface molecule on T-cells, crosslinking these different cell types. Via T-cell engagement, BiTEs activate the immune system, resulting in the death of a tumor cell. Currently, there are nine approved BiTEs globally. Eight of these drugs received their first approval in 2022, highlighting the very recent acceptance of this molecule type.

Amgen’s Blincyto, which received FDA approval for B-cell lymphoblastic leukemia in 2014, was the highest-selling BiTE in 2023, with $897 million in sales. In 2023, BiTEs collectively generated $1.45 billion in global sales.

J&J’s BiTE products, Tecvayli (teclistamab) and Talvey (talquetamab), currently on the market, are both monoclonal antibodies approved for multiple myeloma. Tecvayli’s first approval was from the FDA in August 2022. Talvey’s first approval came 12 months later, also by the FDA. These products both interact with CD3-positive T-cells to activate the immune system. Tecvayli redirects the T-cells to cancer cells expressing the B-cell maturation antigen, whereas Talvey interacts with GPRC5D-positive cancer cells. This redirection of the T-cells induces the death of the respective tumor cells.

GlobalData’s Sales and Forecast tool estimates Tecvayli and Talvey to begin generating revenue in 2024, collectively earning $890 million in sales that year.

Jasper Morley, Pharma Analyst at GlobalData, comments: “By 2030, Tecvayli is forecast to be the top-selling BiTE, with $6.4 billion in global sales. Talvey is estimated to become the second top-selling BiTE, with $2 billion. These two top-selling BiTEs are forecast to collectively generate $8.4 billion for J&J, an 854% increase from the forecast values of 2024.”

Roche is predicted to be the second top company in the 2030 BiTE market, with three products generating $2.9 billion. Its top product, Columnvi, is forecast to generate $1.7 billion, becoming the third top-selling BiTE behind Tecvayli and Talvey.

Morley concludes: “Despite marketing three drugs compared to J&J’s two, Roche’s total BiTE portfolio is forecast to be one-third the value of J&J’s portfolio, highlighting the dominance and estimated success of Tecvayli and Talvey.”