Biogenerics and new technologies compete with 1st generation major protein products


The Business Intelligence firm La Merie S.L. reported that the US$ 32 bln market of major protein products with commencing patent expiry is endangered by generic products and by innovator solutions including engineered molecules and drug delivery solutions. Examples are the first biogeneric somatotropin now approved in the US and the European Union and Pfizer's inhaled insulin. Both examples mark the entry of new players into the lucrative human growth hormone (hGH) and insulin markets. More hGH biogeneric products including slow release formulations are approaching the US$ 2.3 bln market and lead to erosion and conversion from an innovator to a biogeneric market. Although estimated price cuts of 25 to 30% will be less than those for small molecule generics, cost pressure in the health care markets will support acceptance of biogeneric products. The US$ 11.2 bln erythropoietin market will face tough competition by consolidated biogeneric manufacturers. Numerous drug delivery solutions and protein engineering approaches are filling the pipelines with interferon, G-CSF, insulin and FSH products. These results and more were found in a search conducted by La Merie Business Intelligence.

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