The chronic myeloid leukemia (CML) therapy market is dominated by tyrosine kinase inhibitors (TKIs) targeting aberrant BCR-ABL1. However, with all but one of the currently marketed BCR-ABL1 TKIs due to lose patent protection by 2030, the global market is set to decline from $4.25 billion in 2020 to $3.35 billion in 2030, according to GlobalData, a leading data and analytics company.

According to GlobalData’s latest report, ‘Chronic Myeloid Leukemia – Global Drug Forecast and Market Analysis to 2030’, the launch or expansion of four agents, combined with an increase in the prevalent patient population, will drive some growth in the market. However, this will not be enough to offset the significant impact on sales the introduction of generic competitors to the major brands is expected to have.

Jessica McCormack, PhD, Oncology and Hematology Analyst at GlobalData, comments: “The patent expiry of Novartis’ previous market leading brand, Gleevec, saw numerous generic competitors enter the market. Even though imatinib remains the first-line treatment of choice for many patients with CML, most of these sales can now be attributed to generics.

“The impending patent expiries for the market leading brands: Novartis’ Tasigna, Bristol Myers Squibb’s Sprycel, Pfizer’s Bosulif and Takeda/Incyte’s Iclusig, will result in similar falls in sales of these branded therapies and consequently a significant fall in the total market value. This is likely to be particularly felt in the European and Canadian markets, where there is considerable pressure on healthcare systems to opt for cheaper alternatives where these are available.”

The strength of the late-stage pipeline is low, with just four pipeline agents positioned to launch during the forecast period and only a handful of agents in Phases I to III of development. The high efficacy and relative tolerability of the currently available therapies means there is limited commercial interest in developing a new therapy for CML.

McCormack continues: “Novartis’ Scemblix, which has recently been approved in the US, is expected to perform well, particularly in the third line where it will be compared to Iclusig. The cardiovascular risk profile associated with Iclusig means that sales of this agent are vulnerable to the entry of a more tolerable competitor. Scemblix appears to have a favorable safety profile, and has also been shown to be effective in patients harbouring the T315I mutation, albeit at larger doses.”

Although CML is now a largely manageable disease, unmet needs do remain. For those patients progressing to blast phase, the most advanced stage of CML, current therapies are largely inadequate. Key opinion leaders have also expressed that there is a need to increase the proportion of patients successfully discontinuing therapy.

McCormack adds: “CML has been a model disease in oncology, showcasing how identifying the causative factor behind pathogenicity, and then successfully targeting this, can transform patient outcomes. Presently, CML continues to pave the way for other indications with multiple trials now reporting on the success of treatment discontinuation.

“However, more still needs to be done to increase the number of patients who can come and stay off therapy. This is vital not only for patient wellbeing and constraining national health care spending, but also because this research can help to improve understanding of other leukemias.”