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Biosimilars Slow to Crack the Erythropoiesis Stimulating Protein Market

Each year, an estimated 1.2 million cancer patients undergo cytotoxic chemotherapy in the United States alone; and approximately 800,000 (67%) will become anemic. Hematopoietic agents stimulate the bone marrow to increase the production of red blood cells and have been shown to result in a clinically significant improvement of anemia associated with chemotherapy.

Neutropenia is a major indication for erythropoiesis stimulating protein market (ESP). Neutropenia is a decrease in circulating neutrophils in the peripheral blood. The absolute neutrophil count (ANC) defines neutropenia. ANC is found by multiplying the percentage of bands and neutrophils on a differential by the total white blood cell count. An abnormal ANC is fewer than 1500 cells per mm3. African Americans have a lower normal ANC value of 1000 cells per mm3 but have a normal total neutrophil content. The severity of neutropenia is categorized as mild with an ANC of 1000-1500 cells per mm3, moderate with an ANC of 500-1000 cells per mm3, and severe with an ANC of fewer than 500 cells per mm3. The risk of bacterial infection is related to the severity and duration of neutropenia. Recurrent infections typically occur with neutropenia, but neutropenia per se is not necessarily a disease.

In 2007, five biosimilar ESPs were approved by the EU EMA.  In spite of these competitors, this market continues to be dominated by established protein drugs.  In 2015, the total global revenue for this class of recombinant proteins was $5.6 billion (ex-manufacturer basis). But eight years after EMA approval, the five biosimilars (Abseamed, Binocrit, Epoetin Alfa Hexal, Retacrit, Silapo), accounted for only $385 million of the market (6.8 percent).

Erythropoiesis Stimulating Protein Market

.Source: Greystone Research Associates

Biosimilar uptake has to date been highly country-specific. This indicates that at least two factors are at play. The first is country-to-country regulatory variability and the element of risk this represents for practitioners. The second is traditional physician-patient relationships, particularly when the condition is potentially life threatening and the biological therapeutic is known to have significant side effects.

Going forward, we expect ESP biosimilar uptake to continue to trail expectations due to the difficulty of prescribers to reach an adequate level of confidence in prescribing an alternate version of a powerful drug.