The AML Therapeutics Market is Forecast to Show Increased Growth until 2017

Friday 27 July 2012, Amsterdam

The new Acute Myeloid Leukemia (AML) Therapeutics - Pipeline Assessment and Market Forecasts to 2017 report is an essential source of information and analysis on the global acute myeloid leukemia (AML) therapeutic market. The report identifies the key trends shaping and driving the global AML therapeutic market. The report also provides insights on the prevalent competitive landscape and the emerging players expected to significantly alter the market positioning of the current market leaders. Most importantly, the report provides valuable insights on the pipeline products within the global AML therapeutics sector. This report is built using data and information sourced from proprietary databases, primary and secondary research and in-house analysis by a team of industry experts.

The AML Therapeutics Market is Forecast to Show Increased Growth until 2017

This report estimated the global Acute Myeloid Leukemia (AML) therapeutics market to be worth $204m in 2010. It is expected to grow to $617m, with a Compound Annual Growth Rate (CAGR) of 17.1% by 2017. This growth is attributed to the entry of premium priced products, and the market will be dominated by metabolic inhibitors such as midostaurin, from Novartis, an inhibitor of FLT-3 receptor tyrosine kinase, as well as Clolar (clofarabine), from Genzyme (Sanofi), an inhibitor of DNA polymerase. These are expected to occupy the majority share of the market. Vidaza (azacitidine) of Celgene and Dacogen (decitabine) of Eisai are also the major promising molecules in AML therapeutics.

In the future, Novartis is targeting an approximate 30% of the AML patient population that has FLT-3 mutations. There is a high level of unmet need in the current AML market in terms of both safety and efficacy.

Ageing Population with High Incidence to Boost the AML Market

The median age of AML patients is 67 years, and people aged 60 and over are growing faster than all other age groups. Between 2009 and 2017 it is expected to increase from 950 m to 1.2 bn. The yearly incidence of AML in the US is 17.6/100,000 for people 65 years of age or older, compared to 1.8/100,000 for people <65 years. The key factor for this is the improvement in health options which has prolonged the life expectancy. The incidence of AML increases with age. A significant increase in the incidence of AML has occurred over the past 10 years, especially in the elderly population. Assessing the data above, it is clear that the greater number of AML patients seeking treatment in the next five to ten years will lead to increased usage of therapeutic drugs, which in turn will drive the AML therapeutics market.

Strong Pipeline Dominated by Targeted Therapies will Drive the AML Market

The AML pipeline is strong, with 106 molecules in different phases of clinical development. First-in-class molecules (101) are dominant in the AML pipeline. These first-in-class molecules have distinct advantages over the currently marketed products, which could bring a change in the disease course and clinical outcome. These molecules are expected to compete strongly with the currently approved products, offering equal or better efficacy and safety, leading to increased patient and physician satisfaction. A significant number of pipeline candidates are being developed as combination therapies.

A number of pipeline molecules have entered Phase III trials for AML in the past few years. There are 13 molecules in late stage development (one is in pre-registration and 12 are in Phase III). There are 12 first-in-class molecules in the late stage. Some of these late stage molecules will have an impact in the AML therapeutics market when launched. The growth in the market will be attributed to the continuous shift from the use of untargeted, small molecule based chemotherapy regimens to regimens containing high price targeted and biological agents. Promising Phase III molecules which will impact the AML market include Clolar (clofarabine), Dacogen (decitabine), Vidaza (azacitadine), sapacitabine, midostaurin, quizaetinib, tosedostat and vosaroxin.

New targeted drugs that specifically target some of the genetic changes seen in AML are now being developed. About one person out of three with AML has a mutation in the FLT3 gene. Several new drugs, called FLT3 (Fms-like tyrosine kinase-3) inhibitors, target this gene. They have shown activity against AML in early studies, especially when combined with chemotherapy. So far, they are only available in clinical trials. Other gene mutations, such as changes in the c-KIT gene, also appear to be important in some cases of AML, and may become important targets for new therapies. Drugs that target this gene, such as Gleevec (imatinib) and Sprycel (dasatinib), are already used against other types of leukemia, and are now being studied for AML. Aurora kinase inhibitors, HDAC (Histone Deacetylase) inhibitors and immunomodulators are also the focus of biotechnology based pharmaceutical companies, and a lots of research is occurring in these areas, especially for cancers.

The AML Therapeutics Market Has High Unmet Need

Cytarabine and anthracycline based chemotherapy regimens are the standard treatment approach for the majority of AML patients. Different regimens of cytarabine with anthracyclines have been used for AML treatment. However, the prognosis for AML remains poor, especially for patients with high-risk disease. The cytarabine and anthracycline based chemotherapy has low complete remission rate, disease-free survival and overall survival, and high treatment related morbidity and mortality.With cytarabine and anthracyclines, approximately 75% of AML patients relapsed within one year. Moreover, approximately 70% of AML patients are >60 years old and 67% of these patients do not tolerate intensive chemotherapy. There is a significant unmet medical need in elderly AML patients for well tolerated agents with better efficacy and oral dosing. Therefore, there is an opportunity for companies with novel drugs to enter into the market with high safety and efficacy profiles. Many new agents are currently under clinical development, which may offer better efficacy and safety, leading to increased patient and physician satisfaction.