Summary

Acute myeloid (myelogenous, myelocytic) leukemia (AML) is a rapidly progressing blood cancer with an extremely poor overall prognosis. AML predominantly affects the elderly population and this subgroup of patients has an exceptionally high level of unmet needs. GlobalData estimates the 2014 sales for AML at approximately $342 million across the 7MM covered in this report. The market will increase by almost three-fold over the forecast period, reaching $932 million in 2024 at a CAGR of 10.5%. This growth will be driven by an increase in incident cases of AML as well as the approval and uptake of premium-priced products, such as FLT3 kinase inhibitors (quizartinib and midostaurin), a PI3 kinase inhibitor (volasertib) and new formulations of existing chemotherapies such as Vyxeos (CPX-351), guadecitabine and CC-486. GlobalData expects, by the end of the forecast period, new branded therapies Vyxeos, volasertib and CC-486 will dominate the market along with generic azacitidine. The AML pipeline is weak in terms of efficacy; however, GlobalData expects none of these drugs to have a major impact on the overall AML market. The challenge for new entrants into the AML market is to meet the critically high unmet needs of AML patients and improve overall survival. One of the opportunities for the companies is to work cooperatively to develop therapies that work in combination with chemotherapy backbone.

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Highlights

Key Questions Answered

– For over forty years, there has been no major advances in the treatment for AML. The AML space is filled with excitement because the first targeted FLT3 kinase inhibitor therapies are expected to change the treatment landscape. What will be the impact of these newly approved drugs on AML sales?
– With the unmet needs of AML patients remaining critically high, what R&D strategies and opportunities are being used by drug makers to remain competitive?
– The survival of patients with AML remains dismal, especially for those who do not respond to first-line chemotherapies. Therefore, there are considerably high unmet needs within the indication. What are the main unmet needs in this market? Will the drugs under development fulfil the unmet needs of the AML market?

Key Findings

– One of the main drivers in the expansion of the AML market will be the launch of premium-priced targeted therapies (FLT3 kinase inhibitors, PI3 kinase inhibitor and reformulations of chemotherapy drugs). for patients with extremely high unmet needs, both the elderly and refractory/relapsed population. These drugs will gradually be used in combination with or replace cheaper, generic, cytarabine-based chemotherapy regimens.
– Another driver will be the few players in the AML market, and that current therapies are largely considered to be ineffective. Therefore, there is ample room for new market entrants. A major driver will also be that a growing incident elderly AML population, particularly in the US, will increase the number of treatable AML patients.
– Companies are focusing on the development of combination therapies, trying to improve the complete remission rate and duration of remission.
– One of the largest unmet needs is a need for efficacious treatment options for elderly AML patients. The majority of AML patients do not have FLT3 mutations, and are therefore ineligible for FLT3 inhibitor treatments. Other unmet needs include therapies for refractory/relapsed disease.

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Scope

– Overview of AML, including epidemiology, etiology, pathophysiology, symptoms, diagnosis, and disease management.
– Annualized AML therapeutics market revenue, cost of therapy per patient, and treatment usage patterns in four patient segments (including, young patients, elderly patients, refractory/relapsed patients and FLT3 mutated patients), forecast from 2014 to 2024.
– Key topics covered include strategic competitor assessment, market characterization, unmet needs, clinical trial mapping and implications for the AML therapeutics market.
– Pipeline analysis: comprehensive data assessing emerging trends and mechanisms of action under development for different lines of therapy. The most promising candidate in Phase III development is profiled.
– Analysis of the current and future market competition in the global AML therapeutics market. Insightful review of the key industry drivers, restraints and challenges. Each trend is independently researched to provide qualitative analysis of its implications.

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Reasons to buy

The report will enable you to –
– Develop and design your in-licensing and out-licensing strategies through a review of pipeline products and technologies, and by identifying the companies with the most robust pipeline.
– Develop business strategies by understanding the trends shaping and driving the global AML therapeutics market.
– Drive revenues by understanding the key trends, innovative products and technologies, market segments, and companies likely to impact the global melanoma therapeutics market in the future.
– Formulate effective sales and marketing strategies by understanding the competitive landscape and by analysing the performance of various competitors.
– Identify emerging players with potentially strong product portfolios and create effective counter-strategies to gain a competitive advantage.
– Organize your sales and marketing efforts by identifying the market categories and segments that present maximum opportunities for consolidations, investments and strategic partnerships.

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