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, with generics set to account for an estimated $2.23 billion worth of sales by 2030.
Jessica McCormack, Ph.D., 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 (in the form of branded Gleevec or a generic version) 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 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.
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 other drugs.
The cardiovascular risk profile associated with Iclusig means that entry of a competitor associated with fewer risks is likely to negatively impact sales of Iclusig, as physicians may switch to the safer drug.
Scemblix appears to have a favorable safety profile and is also seen to be effective in patients harboring the T315I mutation, albeit at larger doses.
Although CML is now a largely manageable disease, unmet needs do remain. For those patients progressing to the most advanced stage of CML, the blast phase, 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.
However, more still needs to be done to increase the number of patients who no longer need the therapy. This is vital not only for patient wellbeing and constraining national healthcare spending but also because this research can help to improve understanding of other leukemias.
Source: Medindia
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