However, this impact is the result of innovation that does not equate to a simple, straightforward commercialization process. There is no question about the incredible clinical impact cell therapies can have on the lives of patients. With the new expanded approval, Breyanzi becomes a second-line therapy for patients whose disease has relapsed within 12 months of the initial chemotherapy regimen - this matches the expanded approval of Yescarta. The product was initially approved last year to treat diffuse large B-cell lymphoma (DLBCL) as a third-line treatment following chemotherapy plus Rituximab and an autologous stem cell transplant. Recent approvals include Bristol Myers Squibb’s Breyanzi cancer cell therapy, which the FDA cleared for an earlier line of treatment. this year, the cell and gene industry is anticipated to see its highest annual number of regulatory approvals.

1 The revenue generation is being driven by technological advancements in manufacturing processes and developments in CAR T-cell therapy for solid tumors, and the approvals and clinical success of Novartis’ Kymriah and Gilead Sciences’ Yescarta are giving encouragement to other developers of cellular immunotherapies.

Estimated at $101 billion in 2021, the global cell therapy market is projected to reach $247 billion by 2028, a CAGR of 13.64%. The cell therapy market continues to grow.

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