The number of blood cancer patients receiving CD19-directed chimeric antigen receptor T-cell (CD19 CAR-T) therapies is set to boom over the next decade from approximately 3,700 patients in 2021 to nearly 13,500 patients in 2031. As such, Bristol-Myers Squibb’s Breyanzi and Gilead’s Yescarta are set to enjoy a lucrative period of high annual sales over the period 2021-2031, due to increased clinical uptake and label expansions into earlier lines of therapy with higher patient numbers, says GlobalData, a leading data and analytics company.

As revealed in GlobalData’s latest series of cell therapy reports covering the non-Hodgkin’s lymphoma (NHL), acute lymphocytic leukemia (ALL), and chronic lymphocytic leukemia (CLL) markets, currently approved CD19 CAR-T agents are forecast to experience varying sales over the 2021-2031 forecast period, owing to the respective developers employing a range of different strategies to fortify the clinical usage of their CD19 CAR-T agents.

Sam Warburton, Oncology Analyst at GlobalData, comments: “The clinical and commercial landscape of CD19 CAR-T agents is expected to dramatically change over the next decade, primarily driven by label expansions into earlier and different lines of therapy, as well as increased clinical uptake supported by increased physician familiarity and the availability of more robust clinical data. This will cause the total number of patients treated with CD19 CAR-T agents to skyrocket. It is currently unclear whether or not the companies’ manufacturing capabilities will be able to withstand the increased demand; if not, this may cap the number of patients treated with these agents.”

As seen in the chart below, the total patient numbers treated with Yescarta and Breyanzi are expected to sharply increase over the next decade. Breyanzi is approved for diffuse large B-cell lymphoma (DLBCL), and a label expansion is anticipated for expansions into marginal zone lymphoma and mantle cell lymphoma in 2026 and 2028, respectively, allowing for a large total eligible patient population despite capturing less patient share relative to other CD19 CAR-T agents. Alternatively, Yescarta is targeting expansions into the first line for DLBCL and second line for follicular lymphoma in 2030, which is set to significantly expand the eligible patient population pool and boost sales.

Yescarta is set to retain its market-leading position as the most lucrative CD19 CAR-T agent in NHL, with annual sales reaching $1.7 billion in 2031 and approximately 5,000 patients treated across the eight major pharmaceutical markets (8MM: United States, France, Germany, Italy, Spain, United Kingdom, Japan, and China).

Breyanzi is also expected to capture significant CD19 CAR-T market share across the 8MM, with expected peak sales of $1.3 billion in 2031. Breyanzi will exhibit the largest compound annual growth rate (CAGR) at 30%, compared to Yescarta’s CAGR of 9%. Breyanzi sales will also be supplemented by the anticipated approval in chronic lymphocytic leukemia (CLL) in 2027, making it the first and only currently marketed CD19 CAR-T agent to penetrate the CLL market.

Warburton concludes: “Many novel cell therapy agents are set to flood the blood cancer market over the next decade, making competition fierce. However, Yescarta and Breyanzi are set to withstand the competition and continue to experience a steady increase in annual sales over 2021–31 by virtue of the first-to-market advantage and robust clinical outcomes. Novel pipeline agents are expected to be relegated to later lines of therapy until clinical evidence provides a strong rationale to move them forward.”