Anemia - Drug Pipeline Analysis and Market Forecasts to 2016

04 Jun 2010 • by Natalie Aster

GlobalData’s report, "Anemia - Drug Pipeline Analysis and Market Forecasts to 2016" is an essential source of information and analysis on the global anemia market. The report identifies the key trends shaping and driving the global anemia market. The report also provides insight on the prevalent competitive landscape and the emerging players expected to bring significant shift in the market positioning of the existing market leaders. Most importantly, the report provides valuable insight on the pipeline products within the global anemia sector. GlobalData valued the anemia market in 2009 at $10.4 billion. The main driver for the growth of the anemia market is the rapid utilization of Erythropoietin Stimulating Agents (ESAs) such as Aranesp (darbepoeitin alfa), Procrit (epoetin alfa), Epogen (epoetin alfa) and Neorecormon (epoetin beta). These therapies are biological in nature and the annual cost of anemia therapy with these drugs ranges between $3,000 and $8,000. GlobalData evaluated the current competition in the anemia market as weak. Though iron deficiency anemia accounts for 40% of the total anemia population, none of the drugs indicated for iron deficiency anemia became a blockbuster. However, the majority of the ESAs that are indicated for selected types of anemia are blockbusters and currently dominate the market. This report is built using data and information sourced from proprietary databases, primary and secondary research and in house analysis by GlobalData’s team of industry experts.

The Anemia Market is Expected to Witness Marginal Decline Due to Rising Safety Concerns over ESA Therapies and Weak Late-Stage Pipeline

GlobalData valued the anemia market in 2009 at $10.4 billion, indicating a CAGR of 8.5% between 2001 and 2009. The main driver for the growth of the anemia market is the rapid utilization of Erythropoietin Stimulating Agents (ESAs) such as Aranesp (darbepoeitin alfa), Procrit (epoetin alfa), Epogen (epoetin alfa) and Neorecormon (epoetin beta). These therapies are biological in nature and the annual cost of anemia therapy with these drugs ranges between $3,000 and $8,000. The majority of these therapies were launched between 2001 and 2007 and as a result market growth was pronounced in that period. In 2007, safety concerns over the use of ESAs surfaced and this has led to a decline in the sales of the drugs. Since then, the growth in the anemia market has been declining. Between 2009 and 2016, the market is expected to decline further as there are no key promising therapies expected to enter the anemia market. Further, biosimilars of ESAs have already entered the European market and are expected to enter the US market between 2009 and 2016. This factor is also expected to restrain the growth of the market.

The Current Competition in the Anemia Market Is Weak Since the Market Is Dominated By Only ESA Therapies Such As Aranesp, Procrit and Epogen

GlobalData evaluated the current competition in the anemia market as weak. Though iron deficiency anemia accounts for 40% of the total anemia population, none of the drugs indicated for iron deficiency anemia became a blockbuster. However, a majority of ESAs that are indicated for selected types of anemia are blockbusters and currently dominate the market. This shows that there is not strong competition between drugs in the anemia market. Further, the ESAs approved for anemia treatment were found to carry severe cardiovascular side effects and the FDA consequently issued guidelines about the safety of these therapies. These guidelines are expected to diminish the prescription volume of ESA therapies. Hence, the current competition in the anemia market is estimated to be weak.

The Anemia Market Pipeline Is Very Weak With Very Few Promising Drugs in Late-Stage Pipeline

GlobalData analyzed the pipeline in anemia market and concluded that the pipeline is very weak. There are only 32 molecules in clinical development and approximately 80 clinical trials are being conducted on the 32 molecules. Phase III clinical development includes nine molecules and contributes to 28.1% of the anemia pipeline. Phase II clinical development includes 12 molecules and accounts for 37.5% of the anemia pipeline. The early stage development pipeline (the Phase I, preclinical and discovery stages) includes only 11 molecules.

The majority of the pipeline drugs are either me-too versions or product extensions of the blockbuster marketed therapies. Very few first-in-class drugs exist in the anemia pipeline. Therefore, GlobalData estimated the anemia market pipeline to be weak.

High Unmet Needs Exist In the Anemia Market In Terms Of Efficacy and Safety

GlobalData analyzed the anemia market and concluded that there are severe unmet needs in terms of efficacy and safety. Anemia is a chronic disease and patients are need to take drugs for many years. In such circumstances, drugs that are efficacious for a prolonged period of time with one dose would be the ideal choice for prescription. However, very few currently marketed anemia therapies display such desired characteristics. Therefore, a huge unmet need exists in terms of efficacy and any drug that can maintain the desired hemoglobin levels for a longer duration can become the next promising therapy as well as a blockbuster in the anemia market. The other unmet need exists in terms of safety. Aranesp, Procrit and Epogen have very poor safety profiles. ESA therapies carry serious and life threatening side effects and the use of these therapies can increase the risk of death in patients. Studies conducted on ESA therapies found that use of the therapies in cancer patients either receiving radiation therapy or chemotherapy increased the risk of death and increased the rate of tumor growth. Therefore, any drug that has longer half-life and minimum side effects can become the next promising therapy in the anemia market.

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