GlobalData valued the global idiopathic pulmonary fibrosis (IPF) therapeutics market at $74.0m in 2010,
and is forecast to grow at a compound annual growth rate (CAGR) of 50.2% over the next eight years to
reach $1919.9m in 2018. This high growth rate can be attributed to the expected launch of Esbriet (pirfenidone) in Europe in 2012 (except for Germany, where it is expected to be launched in September
2011). In Japan, pirfenidone is known as Pirespa and in Europe and the US it is known as Esbriet. Pirespa (pirfenidone) was approved in Japan in 2008 and it is the only approved drug to date for the treatment of IPF. Being the first drug to be approved for IPF, it was set at a premium price in Japan. In spite of its high price, it achieved a significant market share with sales of $35m within two years of its launch. This signifies that the product acceptance for Pirespa was high in Japan. Esbriet is expected to show a similar trend after its launch in Europe and the US. Another drug, Vargatef (BIBF 1120), is also expected to be launched during the forecast period, which will provide further impetus to the IPF market. Esbriet is expected to be launched in the US in 2014. In May 2010, the FDA rejected InterMune’s application for the approval of Esbriet in the US, requesting an additional clinical study. InterMune has commenced enrollment for a new Phase III study, ASCEND (Assessment of Pirfenidone to Confirm Efficacy and Safety in IPF), results for which are expected to be available in mid-2013. InterMune anticipates a New Drug Application (NDA) resubmission for pirfenidone in the second half of 2013 and FDA action in the first half of 2014.
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