Idiopathic Pulmonary Fibrosis - Drug Pipeline Analysis and Market Forecasts to 2016

29 Mar 2010 • by Natalie Aster

GlobalData’s report, “Idiopathic Pulmonary Fibrosis - Drug Pipeline Analysis and Market Forecasts to 2016”, is an essential source of information and analysis on the global idiopathic pulmonary fibrosis (IPF) market. The report identifies the key trends shaping and driving the global IPF market. The report also provides insight into the prevalent competitive landscape and the emerging players expected to significantly alter the positioning of the existing market leaders. Most importantly, the report provides valuable insight into the pipeline products within the global IPF 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.

The Idiopathic Pulmonary Fibrosis Market is Forecast to Show High Growth until 2016

The global idiopathic pulmonary fibrosis (IPF) market was valued at $84m in 2009. It is expected to increase with a compound annual growth rate (CAGR) of 25.1% from $84m in 2009 to $348m by 2016. Earlier the IPF market was underserved due to a lack of approved products. In October 2008, the Japanese manufacturer Shionogi received approval for Pirespa in Japan. It is under regulatory review for approval in the US and the EU. The expected increase in sales is due to the expected approval of Pirespa in the US and the EU and also the expected launch of Tracleer and Letiaris. Growth in the IPF market is being driven by the sales of Pirespa, off-label drug use and the anticipated approval of Letiaris and Tracleer. Gilead’s Letiaris and Actelion’s Tracleer are the most anticipated molecules in the IPF market.

Competition in the Idiopathic Pulmonary Fibrosis Market is Weak

GlobalData found that the current competition in the IPF market is weak due to the unavailability of products for treatment of the disease. There is only one product approved for the treatment of IPF. Shionogi’s Pirespa got approved in 2008 in Japan for the treatment of IPF. Prior to the approval of Pirespa, the market had no approved products. The market was dominated by the off-label use of corticosteroids and immunosuppresants. The minimal efficacy and safety of off-label drugs and the poor response rates exhibited by patients demonstrate the huge unmet need existing in the market.

Strong Late Stage Pipeline for Idiopathic Pulmonary Fibrosis

GlobalData has found that there are over 40 molecules in the various stages of the pipeline. Tracleer and Letiaris are some of the late stage pipeline molecules. Enbrel and Veldona in Phase II are also showing promising activity in treating IPF. These pipeline molecules differ in their targets of action from the existing therapies. All these molecules are already approved for other indications and are in clinical trials for IPF. Tracleer and Letiaris are approved for pulmonary arterial hypertension. Enbrel is already an approved biologic for other indications. Hence, the probable approval of these molecules shows that there is a strong pipeline for IPF. However, IPF is an orphan disease and all these drugs in the pipeline have orphan drug status. Thus, the launch of potential molecules can be expected in the near future.

Weak Current Market Leads to Low Patient Compliance and Physician Satisfaction

GlobalData has found that there is a lack of available treatment options in the IPF market. There is no approved drug available to IPF patients outside Japan. The market has only off-label drugs as pharmacological therapy for patients. A poor response rate and minimal safety and efficacy has led to low patient compliance and physican satisfaction towards these treatments. Although it has fewer survival benefits than the other treatments, lung transplantation appears to be the only option available for patients with end-stage idiopathic pulmonary fibrosis. Thus, the lack of available options has led to a weak market.

Current Market Presents High Unmet Need

Pirespa is the only product to be approved in 2008 for the treatment of IPF. The IPF market is dominated by the off-label use of corticosteroids and immunosuppresants. The patient response rate has been only 30% with the use of off-label drugs. This is due to the minimal efficacy and safety attributed to the off-label use of prednisone, azathioprine, colchicines and others. Thus, unmet need exists in terms of the safety and efficacy of off-label drugs. Also, in the CAPACITY I and CAPACITY II trials, gastrointestinal and skin related adverse events were common in pirfenisone-treated patients. Liver transaminase levels were slightly elevated and more common in pirfenidone-treated patients. In trials, 31.4% of patients showed treatment-related side-effects compared to the placebo. However, patients treated with pirfenidone had a 35% lower risk of death from any cause than those treated with placebo. Thus, these data suggest that the present marketed and off-label products leave unmet need in terms of safety and efficacy.

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