Boston, MA -- (SBWIRE) -- 09/18/2013 -- Acute myeloid (myelogenous, myelocytic) leukemia is a rapidly progressing blood cancer with a poor overall prognosis. AML is relatively rare, and predominantly affects older adults. AML is a heterogeneous disease, and many subtypes have been identified. The current standard of care consists of cytarabine-based chemotherapy, which can often achieve remission. However, the majority of patients relapse, and survival rates are grim. There are clear unmet needs for treatments that can prolong the overall survival of these patients, but drug manufacturers have struggled to gain regulatory approval for new therapies.

This report focuses on the remaining opportunity in AML exclusive of the acute promyleocytic leukemia (APL) subtype.

Highlights

Key Questions Answered

- Which AML patients have the greatest unmet needs?
- What are the R&D strategies drug makers are pursuing in the AML space?
- Why has it been so difficult for Pharma to develop successful therapies for AML?
- How are players aiming to circumvent difficulties that have historically plagued AML drug development?
- What are the most promising pipeline agents for AML? How do their clinical and commercial attributes compare to one another?
- What opportunities will remain following the launch of these pipeline agents?
- Do KOLs see a role for targeted therapies and immunotherapies in the treatment of AML?

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Key Findings

- GlobalData forecasts the AML therapeutics market in the 6MM to grow from $151.0m in 2012 to $430.7m in 2017, at a CAGR of 23.3%. The main driver of growth in the global AML market will be the uptake of premium-priced pipeline agents.
- Despite high levels of unmet need, uptake of new drugs will be limited, as KOLs are relatively unimpressed by these agents. Therefore, ample market opportunity will remain at the end of the forecast period.
- To circumvent historical difficulties with regulatory approval, companies are designing early- and late-stage clinical trials more rigorously. Randomization of early-stage trials is critical, and the designation of overall survival (OS) as the primary endpoint of pivotal studies is mandatory.
- Key R&D trends include developing therapies for the patients with greatest unmet need, particularly the elderly, developing combination therapies, and investigating new targets (i.e. FLT3) involved in the pathogenesis of AML.
- Despite the hype around FLT3 inhibitors, KOLs are unconvinced that these drugs will be successful as monotherapies in AML.

Scope

- Overview of AML, including epidemiology, etiology, pathophysiology, symptoms, diagnosis, and disease management.
- Topline AML therapeutics market revenue from 2012-2017. Annual cost of therapy, and peak pipeline drug sales of drugs launching during this forecast period are included.

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