Idiopathic Pulmonary Fibrosis | Niche & Rare Disease Landscape & Forecast | US/EU5 | 2016

Idiopathic pulmonary fibrosis (IPF), although a rare disease, is one of the most common interstitial lung diseases (ILDs) and is characterized by irreversible loss of lung function leading to high morbidity and mortality. IPF usually affects people aged 50 or older and is associated with poor prognosis and most patients die within 3-5 years of diagnosis. Experts interviewed for this report note that the etiology of IPF is unclear but that there is growing consensus that epithelial injury followed by abnormal wound healing can lead to IPF. In 2011, Roche/InterMune’s Esbriet (pirfenidone) became the first putative disease-modifying therapy approved for the treatment of mild-to-moderate adult IPF patients in the European Union. In October 2014, the U.S. FDA followed suit by approving both Esbriet and Boehringer Ingelheim’s Ofev (nintedanib) for IPF. With EMA approval of Ofev in January 2015, the stage is set for a fierce head-to-head battle as physicians incorporate these new treatment options and additional competitors rush to enter the growing IPF therapeutics market.  
This report provides an overview of the IPF market in the United States and five major European markets (France, Germany, Italy, Spain, and the United Kingdom), including a comprehensive analysis of patient populations, current therapies and medical practice, and opportunities for emerging therapies. The findings described in this report are derived from detailed interviews with expert U.S. and European pulmonologists, comprehensive secondary research, and best-in-class epidemiological analysis. This report provides deep insights into this complex and evolving clinical space and includes a detailed analysis of specific opportunities for current and emerging therapies, including experts’ views on which unmet needs have not yet been addressed by developers of new therapies.

Questions Answered:

• IPF is a rare lung disease affecting only a small percentage of the population. What is the size of the U.S. and EU5 (France, Germany, Italy, Spain, and the United Kingdom) diagnosed prevalent population for IPF? How will these populations change over the ten-year forecast period? How many diagnosed prevalent IPF cases are in GAP stage I, II, and III, now and through 2024?
• IPF therapies have entered a new era with the approvals of pirfenidone and nintedanib. How will pirfenidone and nintedanib reshape the IPF treatment paradigm? What considerations will drive physician choice between these two agents? What are thought leaders’ views on the potential to combine pirfenidone with nintedanib?
•  The pathogenesis of IPF involves multiple complicated pathways. What new insights are informing experts’ understanding of IPF? What are the key avenues of preclinical and clinical research and development?
• Unmet needs in IPF are many and span a range of challenging issues. What are the emerging therapies in the late-stage development and what unmet needs are expected to remain unaddressed? What are the key avenues of preclinical and clinical research and development?

Scope:

Market covered: United States, France, Germany, Italy, Spain, and the United Kingdom.

Primary research: Eight country-specific interviews with thought-leading IPF specialists.

Epidemiology: Diagnosed prevalent cases of IPF.

Emerging Therapies: Phase II: 7; coverage of select preclinical and Phase I products.