July 17, 2013 I The idiopathic pulmonary fibrosis (IPF) therapy market across the US and EU will surpass USD 1 billion by 2017, and pharma companies could stand to benefit handsomely if they can add to the limited knowledge of the disease, states new analysis by research and consulting firm GlobalData.
The new research* states that over 70,000 people in the US and EU are thought to suffer from IPF, representing a commercially attractive patient population size with a financially appealing orphan drug status. So why has IPF been overlooked by the healthcare industry until the last decade?
IPF is a chronic disease characterized by damage to the lung resulting from inflammation and scarring. With no fully-effective therapies other than lung transplantation, very little is understood about the heterogeneous nature of the disease, which has a disease course that further greatly varies between affected individuals.
Dr. Samantha Fernando, GlobalData’s Analyst covering Immunology, explains: “Future R&D strategies require the identification of critical biomarkers, so that disease progression and treatment response can be tracked – imperative to this is investment in research. 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. However, increased regulatory rigidness and extended trial duration is essential for this progressive disease, making drug development difficult. Approved medications also face a challenging economy, as increased emphasis is placed on the cost-effectiveness of drugs, particularly in the EU where various austerity measures are in place.”
The severely underserved market currently only has one licensed pharmacological treatment, InterMune’s Esbriet, an immunosuppressant with dual anti-fibrotic and anti-inflammatory properties licensed for use by the European Medicines Agency in 2011. However, despite being an orphan drug, it is not readily available across the region, due to its exorbitant price (more than EURO 22,000) relative to small therapeutic effect.
2012 sales of Esbriet in the EU were attributed to the launch and availability of the drug in France and Germany, while a small number of patients were enrolled in the InterMune early access program in Spain, Italy, and the UK, where approval is anticipated for the second quarter of 2013. The US granted the drug Orphan Drug and Fast Track designation in 2004, but safety concerns resulted in the FDA requesting an additional Phase III trial, which is currently ongoing (with anticipated completion in 2015).
Boehringer Ingelheim’s (BI’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. Nintedanib is expected to be priced at a 25% premium to Esbriet. Promising fibrosis-targeting monoclonal antibodies, Biogen’s STX-100 and Gilead’s GS-6624, are also currently undergoing Phase II trials.
GlobalData expects IPF therapy sales across the US, France, Germany, Italy, Spain, and the UK to rise from USD 49 mln in 2012 to over USD 1.1 billion by 2017, at a Compound Annual Growth Rate (CAGR) of 86.6%. The EU has so far dominated the IPF market, but the US is set to reclaim market share in the future.
The IPF therapeutics market in the US is predicted to grow from a value of USD 6.5 mln in 2012 to USD 696 mln in 2017, at a Compound Annual Growth Rate (CAGR) of 154%. Dr. Fernando notes: “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 USD 500 mln in 2015 from only USD 19 mln in 2014. In contrast, the European IPF market was valued at a far stronger USD 43 mln in 2012, but is forecast to grow to USD 419 mln in 2017 at a CAGR of 58%.”
*Opportunity Analyzer: Idiopathic Pulmonary Fibrosis (IPF) – Opportunity Analysis and Forecasts to 2017
SOURCE: GlobalData
Post Views: 240
July 17, 2013 I The idiopathic pulmonary fibrosis (IPF) therapy market across the US and EU will surpass USD 1 billion by 2017, and pharma companies could stand to benefit handsomely if they can add to the limited knowledge of the disease, states new analysis by research and consulting firm GlobalData.
The new research* states that over 70,000 people in the US and EU are thought to suffer from IPF, representing a commercially attractive patient population size with a financially appealing orphan drug status. So why has IPF been overlooked by the healthcare industry until the last decade?
IPF is a chronic disease characterized by damage to the lung resulting from inflammation and scarring. With no fully-effective therapies other than lung transplantation, very little is understood about the heterogeneous nature of the disease, which has a disease course that further greatly varies between affected individuals.
Dr. Samantha Fernando, GlobalData’s Analyst covering Immunology, explains: “Future R&D strategies require the identification of critical biomarkers, so that disease progression and treatment response can be tracked – imperative to this is investment in research. 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. However, increased regulatory rigidness and extended trial duration is essential for this progressive disease, making drug development difficult. Approved medications also face a challenging economy, as increased emphasis is placed on the cost-effectiveness of drugs, particularly in the EU where various austerity measures are in place.”
The severely underserved market currently only has one licensed pharmacological treatment, InterMune’s Esbriet, an immunosuppressant with dual anti-fibrotic and anti-inflammatory properties licensed for use by the European Medicines Agency in 2011. However, despite being an orphan drug, it is not readily available across the region, due to its exorbitant price (more than EURO 22,000) relative to small therapeutic effect.
2012 sales of Esbriet in the EU were attributed to the launch and availability of the drug in France and Germany, while a small number of patients were enrolled in the InterMune early access program in Spain, Italy, and the UK, where approval is anticipated for the second quarter of 2013. The US granted the drug Orphan Drug and Fast Track designation in 2004, but safety concerns resulted in the FDA requesting an additional Phase III trial, which is currently ongoing (with anticipated completion in 2015).
Boehringer Ingelheim’s (BI’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. Nintedanib is expected to be priced at a 25% premium to Esbriet. Promising fibrosis-targeting monoclonal antibodies, Biogen’s STX-100 and Gilead’s GS-6624, are also currently undergoing Phase II trials.
GlobalData expects IPF therapy sales across the US, France, Germany, Italy, Spain, and the UK to rise from USD 49 mln in 2012 to over USD 1.1 billion by 2017, at a Compound Annual Growth Rate (CAGR) of 86.6%. The EU has so far dominated the IPF market, but the US is set to reclaim market share in the future.
The IPF therapeutics market in the US is predicted to grow from a value of USD 6.5 mln in 2012 to USD 696 mln in 2017, at a Compound Annual Growth Rate (CAGR) of 154%. Dr. Fernando notes: “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 USD 500 mln in 2015 from only USD 19 mln in 2014. In contrast, the European IPF market was valued at a far stronger USD 43 mln in 2012, but is forecast to grow to USD 419 mln in 2017 at a CAGR of 58%.”
*Opportunity Analyzer: Idiopathic Pulmonary Fibrosis (IPF) – Opportunity Analysis and Forecasts to 2017
SOURCE: GlobalData
Post Views: 240
