The small patient cohorts the pipeline drugs are expected to be approved in will result in each having a minimal effect on any growth in market revenues over the forecast period. They will nevertheless stimulate market growth. An increase in prevalence and treatment populations, driven by aging populations across each territory will also have a positive effect on market revenues. However, as an orphan indication, the effect of population growth is also expected to have a minor effect. As a result, the global market revenues are forecast to rise at a limited CAGR of 4.8% from $632.4m in 2013 to $878.2m in 2020.
Treatment and prognosis in AML is strongly influenced by a patient’s age, and their cytogenetic profile. In the majority of cases these two prognostic influences are linked, with a higher frequency of unfavorable cytogenetic abnormalities observed in the elderly. Survival in this cohort of elderly patients is very poor, with a five year overall survival of 3–8% (Luger, 2010). Despite a relatively advanced understanding of genetic abnormalities associated with AML, the introduction of targeted therapies is lagging in this indication in comparison to other cancers such as breast and lung cancer, with no approved targeted therapies. Such slow development may be a reflection of AMLs status as an orphan indication.
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Intensive treatment in eligible patients (younger patients, and approximately 50% of diagnosed elderly patients) is typically the combination of the two chemotherapeutic agents cytarabine and daunorubicin, both of which were approved in the 1960s. In patients ineligible for intensive first-line chemotherapy, options are very poor, with the more recently approved Vidaza and Dacogen as the treatment options, which both offer unsatisfactory survival. Across all newly diagnosed patients that obtain complete remission, a stem cell transplant offers the highest chance of long-term survival. However, this procedure is risky, with a higher rate of treatment related mortality in the absence of better techniques to reduce the risk of graft-versus-host disease.
The majority of patients experience disease relapse, which is almost always fatal. Treatment options in these patients typically involve the off-label use of chemotherapeutic agents, whether in combination or as monotherapies.
There are clear gaps in the market for therapies to meet several unmet needs by increasing the initial length of remission; improving treatment options for newly-diagnosed patients, ineligible for relapsed disease treatments; improving the success of and reducing the side effects of stem cell transplantation; and improving survival, safety and quality of life in patients with relapsed disease. The current developmental pipeline addresses these gaps in the market, along with the significant lack of targeted therapies. Five of the eight pipeline products are under development as non-intensive therapies for the elderly, and six of the eight products are being investigated in relapsed disease.
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Results so far have been mixed, with several drugs offering no overwhelming clinical benefit in Phase I and II clinical trials. Some drugs have demonstrated encouraging results – namely CPX-351, quizartinib, StemEx, treosulfan and midostaurin. All of these drugs are forecast to be approved within the forecast period, a result of clinical trial data that suggest these drugs can offer improved survival in comparison to the currently marketed products. It is important to note however, that these improvements and the subsequent approval of these products is restricted to small patient cohorts – including patients with secondary AML, those with internal tandem repeats in Fms-like tyrosine kinase, and patients eligible for a stem cell transplant, but for whom a matched donor cannot be found. This fragmentation in the treatment algorithm is a reflection of the heterogeneity of AML, with continued fractionation likely to be essential for further effective treatments to be developed. This is reflected in the current developmental pipeline, with drugs targeting a high variety of molecule types and molecular targets currently under investigation in this disease.
The report analyzes treatment usage patterns, marketed and pipeline drugs, and market forecasts across indications for AML.The report covers and includes –
– A brief introduction to AML, including the disease’s pathogenesis, risk factors and diagnosis
– An in-depth analysis of the drug combinations used in the treatment of AML, including analyses of their safety, efficacy, and place in the disease treatment algorithm. This includes a heat map comparing the drug combinations in terms of safety and efficacy
– A comprehensive review of the pipeline for AML therapies, including individual analysis of a number of late-stage pipeline drugs that have the potential to enter the market during the forecast period. The pipeline is analyzed on the basis of Phase distribution, molecule types and molecular targets, as well as administration routes
– An additional in-depth analysis of pipeline drug clinical trials by phase, trial size, trial duration and program failure rate analyses for each molecule type and molecular target
– A multi-scenario forecast data for the market to 2020, taking into account how it will be affected by the introduction of new drugs, the expiry of key patents on current drugs and the changes in disease epidemiology across the key developed markets including the US, Canada, Japan, Germany, the UK, France, Italy and Spain
– A discussion of the drivers and barriers for market growth
– An in-depth analysis of licensing and co-development deals involving drugs indicated in AML, including an in-depth outline of the key deals
Reasons to buy
The report will assist business development and enable marketing executives to strategize their product launches, by allowing them to –
– Understand the efficacy and safety of the current monotherapies and drug combinations used in the treatment of AML, with in-depth analysis of the disease treatment algorithm
– Understand the key signaling pathways and molecular targets currently under investigation in drug development for AML
– Understand the vast scope of the pipeline, including which molecule types and molecular targets are most prominent
– Observe the trends in clinical trial duration and size by clinical phase and molecule type, and use the clinical trial failure rate analysis to assess the risk profiles of current and/or future developmental programs for AML cancer therapeutics
– Assess the potential clinical and commercial impact of current late-stage pipeline molecules in the AML therapeutics market
– Assess the location of involved companies, and the value of both licensing and co-development deals involving drugs under investigation for the treatment of AML