Idiopathic Pulmonary Fibrosis (IPF) Therapeutics

Aug. 25, 2011 - PRLog -- 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.

Being a rare disease, less attention has been given to IPF by many pharmaceutical companies. The Pulmonary Fibrosis Foundation in the US estimated that National Institute of Health (NIH) spending on
IPF research in the US was $23m in 2008. This amount is very low compared to the $85m spent on cystic
fibrosis, a disease that is five to six times less common than IPF, and $48m on Lou Gehrig’s disease, another disease that is five times less common than IPF. Furthermore, the lack of clear understanding of
the etiology and pathophysiology of IPF makes it an unattractive option for pharmaceutical companies to invest in R&D as it makes the clinical development of new therapies challenging. As a result, there is only one approved drug (Pirespa) for IPF in Japan; whereas the US and European markets are still dominated by the off label usage of corticosteroids and immunosuppressants.

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However, in recent years disease awareness and recognition has increased with the rate of mortality
associated with the disease. In the US, Europe and Japan, IPF has been given an orphan disease designation to encourage companies to invest in drug development for IPF. This may help in the availability of effective treatment options in the future.

GlobalData’s research indicates that there is a high (46%) unmet need in the IPF therapeutics market due to a lack of disease modifying drugs. The current IPF market in Europe and the US is dominated by the off label usage of corticosteroids, such as prednisone or prednisolone and immunosuppressive agents, such as azathioprine or cyclophosphamide. These drugs are focused on symptomatic relief and not a cure for the disease. Moreover, they are effective in only 25-30% of patients and they have frequent and severe side effects. In spite of several drawbacks, these off label drugs are used widely in Europe and the US due to the absence of any other pharmacologic treatment options. In Japan, Pirespa was approved in 2008 for the treatment of IPF. In Europe, InterMune received an approval for the commercialization of Esbriet in March 2011. Esbriet will be launched in Germany in 2011, followed by France, Italy, and Spain in 2012 and the UK in mid-2012. Shionogi & Co. Ltd. received the rights in 1996, from Marnac for the development and commercialization of pirfenidone in Japan, Korea and Taiwan.

GlobalData, the industry analysis specialist, has released its new report, “Idiopathic Pulmonary Fibrosis
(IPF) Therapeutics - Pipeline Assessment and Market Forecasts to 2018”. The report is an essential source of information and analysis on the global Idiopathic Pulmonary Fibrosis Therapeutics market. The
report identifies the key trends shaping and driving the global Idiopathic Pulmonary Fibrosis Therapeutics 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 Idiopathic Pulmonary Fibrosis Therapeutics sector. 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

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