The idiopathic pulmonary fibrosis (IPF) therapy market across the US and European Union (EU) will be worth more than $1.1 billion by 2017, and pharma companies could stand to benefit handsomely if they can add to the limited knowledge of the disease, says new research.With more than 70,000 people in the US and EU estimated to be suffering from IPF, it represents a commercially attractive patient population size with a financially appealing orphan drug status, according to the research, from GlobalData.
However, the disease - a chronic condition characterised by damage to the lung resulting from inflammation and scarring - has been overlooked by the healthcare industry until the last decade and, with no fully-effective therapies other than lung transplantation, very little is understood about its heterogeneous nature. Moreover, it has a disease course that varies greatly between affected individuals.
"Future R&D strategies require the identification of critical biomarkers, such that disease progression and treatment response can be tracked - imperative to this is investment in research," says Dr Samantha Fernando, GlobalData's analyst covering immunology.
"The majority of existing knowledge on IPF has been captured by academics, and collaboration between academics and pharmaceutical companies is key to the advancement of this developing market," she emphasises.
However, increased regulatory rigidness and the necessity for extended clinical trial duration, owing to the progressive nature of the disease, will make drug development challenging, while approved medications will also face a constrained economy as increased emphasis is placed on the cost-effectiveness of drugs - particularly in the EU, where various austerity measures are in place, adds Dr Fernando.
The IPF market is currently severely underserved, with just one licensed pharmacological treatment - InterMune's Esbriet (pirfenidone) - an immunosuppressant with dual anti-fibrotic and anti-inflammatory properties which was licensed for use by the European Medicines Agency (EMA) in 2011. However, despite being an orphan drug, it is not readily available across the EU, because of what GlobalData describes as its "exorbitant" price - up to 22,000 euros - relative to small therapeutic effect.
Sales of Esbriet in the EU last year were attributed to the launch and availability of the drug in France and Germany, while a small number of patients were enrolled in InterMune's early-access scheme in Spain, Italy and the UK.The US granted Esbriet Orphan Drug and Fast Track designation in 2004, but safety concerns resulted in the Food and Drug Administration (FDA) requesting an additional Phase III trial. This is currently ongoing, with completion anticipated for 2015.
Boehringer Ingelheim's nintedanib (BIBF 1120) is another small-molecule triple angiokinase inhibitor under investigation for the treatment of IPF. It was granted Orphan Drug status by the FDA in June 2011, and is currently in Phase III studies with completion expected in late 2013, and is forecast to be priced at a 25% premium to Esbriet.
Biogen's STX-100 and Gilead's GS-6624, two promising fibrosis-targeting monoclonal antibodies (MAbs), are both currently undergoing Phase II trials, the report adds.
GlobalData says it is expecting IPF therapy sales across the US, France, Germany, Italy, Spain and the UK to rise from $49 million in 2012 to over $1.1 billion by 2017, at a compound annual growth rate (CAGR) of 86.6%. While the EU has dominated the market so far, the US is set to reclaim market share in the future, rising from a value of $6.5 million in 2012 to $696 million in 2017, at a CAGR of 154%, it adds.
"The anticipated launch of Esbriet and nintedanib in 2015, to a market that previously had no therapeutic option, will cause the US market to experience exponential growth, reaching nearly $500 million in 2015 from only $19 million in 2014," forecasts Dr Fernando.
"In contrast, the European IPF market was valued at a far stronger $43 million in 2012, but is forecast to grow to $419 million in 2017, at a CAGR of 58%," she says.