The acute lymphocytic leukemia (ALL) market has enjoyed explosive growth since 2015 and is expected to increase further, albeit at a slower pace, from $1.46bn in 2019 to $2.26bn in 2029 across the eight major markets (8MM*) at a moderate compound annual growth rate (CAGR) of 4.4%, according to GlobalData, a leading data and analytics company.

According to GlobalData’s latest report, ‘Acute Lymphocytic Leukemia: Opportunity Analysis and Forecasts to 2029’, such an increase is projected to come about by the introduction of the already successful agents Novartis’ Kymriah, Amgen’s Blincyto and Pfizer’s Besponsa in more patient populations and by the regulatory approval of late-stage pipeline agents.

Sakis Paliouras, PhD, Oncology Analyst at GlobalData, comments: “ALL presents some of the most interesting market dynamics in oncology. Despite being a rare disease, it has a market value on par with more prevalent diseases such as Acute Myeloid Leukemia. This is due to all lines of therapy consisting of high-priced agents such as Kymriah, Blincyto and Besponsa in the relapsed/refractory setting, some of which involve multiple years of treatment, such as Servier’s Oncaspar and Asparlas in the front-line setting. Special regulatory designations, mainly in the US, have allowed pharmaceutical companies to pursue innovative efforts in ALL despite the relatively smaller pay-out compared to other, more lucrative indications.”

The market was revolutionized first with the introduction of the bispecific antibody Blincyto in 2015 and further in 2017 with the approval of the CAR-T cell product Kymriah. CAR-T cells are viewed as the most impactful class of therapy in ALL but have been held back by a high cost of therapy and challenging manufacturing & infusion logistics that require treatment in large, research hospitals.

GlobalData forecasts five novel agents will enter the market in the period to 2029, the most important of which are considered Gilead’s Tecartus and Autolus Therapeutics’ AUTO1.

Paliouras continues: “If AUTO1 delivers on its promise to move CAR-T cell infusions to the outpatient setting, it will gain a significant competitive advantage over Tecartus and Kymriah. CAR-T cells are forecast to consolidate their market share through label expansions and introduction in other markets, and are expected to become the leading class of therapy by 2029.”

Key opinion leaders (KOLs) interviewed by GlobalData hypothesize that the biggest change in the treatment paradigm will not come from any of the current late-stage pipeline agents, but rather from the earlier, combinational, and minimal residual disease-guided use of the current monoclonal antibodies and CAR-T cells.

Paliouras adds: “Unmet needs remain that offer the potential for truly innovative approaches to disrupt the market, raising the possibility of a true paradigm shift happening after 2029.”

*8MM = US, France, Germany, Italy, Spain, the UK, Japan, and China