The market for acute lymphocytic leukemia (ALL), the most commonly diagnosed form of leukemia, is expected to see strong growth at a compound annual growth rate (CAGR) of 5% over the next decade across the world’s eight major markets (8MM*). This is driven primarily by the increased use of cell therapies, with the CAR-T market alone expected to reach $1.2 billion in 2031, accounting for 40% of the total ALL market, according to GlobalData, a leading data and analytics company.

GlobalData’s latest report, “Acute Lymphocytic Leukemia (ALL): Cell Therapies 15-Market Assessment and Forecast,” reveals that Novartis’ anti-CD19 CAR-T therapy, Kymriah, is expected to retain its position as the market-leading ALL brand, with label expansion into front-line therapy and uptake in additional markets driving substantial growth.

Avigayil Chalk, PhD, Oncology & Hematology Analyst at GlobalData, comments: “The approval of Kymriah and Gilead’s Tecartus has revolutionized the ALL therapeutic landscape, with patients who previously had a very poor prognosis entering long-term remission.

“Expansion into additional patient populations for these already approved CAR-Ts, as well as the anticipated approval of next-generation CAR-Ts over the next decade, make CAR-Ts the leading class of therapy in the ALL setting. The lack of other curative therapies for relapsed and refractory patients has reduced the barrier to access, despite the hefty price tag these novel therapies carry.”

GlobalData has identified 118 cell therapies in clinical trials for the treatment of ALL, of these 82 are CAR-T cell therapies. Both autologous and allogeneic CAR-Ts are in the pipeline, however, autologous are significantly more numerous, making up 80% of the CAR-T pipeline.

Chalk continues: “The success of CAR-Ts in ALL has led to an explosion in research and development in this field, with an abundance of CAR-Ts now in development. The ALL CAR-T pipeline is saturated, with more products in development than the market can sustain. To gain approval agents will have to outperform the marketed anti-CD19 CAR-Ts in clinical efficacy or provide a commercial advantage.

“Allogeneic agents, if clinically efficacious, have a competitive advantage over autologous CAR-Ts, with the lack of personalized manufacture allowing up-scaling of production, which drives the price down, increases the number of patients that can be treated, and reduces the time to therapy initiation. The originality of the target antigen or targeting of more than one antigen may also be the key to the success of an agent.”

Outside of CAR-T therapies, Gamida Cell’s NiCord is identified by GlobalData as the leading cell therapy pipeline brand. This is an ex vivo expanded stem cell transplant product that is generated from a single umbilical cord blood donation. Clinical trial data shows NiCord results in faster hematopoietic recovery and reduces early transplant-related complications compared to a standard umbilical cord stem cell transplant.

Chalk concludes: “Allogeneic hematopoietic stem cell transplants have been a key part of the ALL treatment paradigm for decades, with transplants often being curative. However, for a significant subset of patients, a matched donor cannot be found. NiCord is now set to become the standard of care for patients without a matched transplant donor.

“The ALL market is fast evolving with the future outlook for patients set to be transformed by innovation in cell therapy technology.”