The IPF therapeutic market is currently dominated by the only two drugs that have gained marketing approval for IPF - Roche’s Esbriet and Boehringer Ingelheim’s Ofev. Esbriet was the first drug to gain approval for IPF in 2011 when it was approved for use in Europe, a full four years before rival Ofev. However, both gained approval into the largest IPF market of the US on the same day in October 2014.
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The top-selling drug in IPF in value terms is Roche’s Esbriet, which GlobalData estimates generated approximately $572m in 2015 from the seven major markets. There is high R&D activity for the development of new therapies for IPF and eight promising therapies can potentially enter the market from 2015 to 2025. Numerous novel targets are being studied in the IPF pipeline, with major pharmaceutical players Roche, Sanofi, Bristol-Myers Squibb, and Biogen all active in the development process. Other promising pipeline candidates include FibroGen’s CTGF inhibitor, Promedior’s PTX2 protein, Afferent’s P2X3 receptor antagonist, and MediciNova’s 5-LO/LT pathway inhibitor. The continued uptake of Esbriet and Ofev, combined with the introduction of new novel drugs will shape the future competitive landscape and drive growth in the IPF market. Highlights Key Questions Answered - What was the impact of Esbriet and Ofev on the IPF market following their FDA approval in 2014 and what is their future outlook within this market? - What do physicians think about Esbriet and Ofev, and how they will be used for IPF during the forecast period? - What is the significance of late-phase pipeline products and how will their launch shape the future treatment landscape in IPF? - What are the unmet needs within the IPF market? - What are the remaining opportunities within the IPF market? Key Findings - The main drivers of growth for the IPF market include the increasing uptake of Esbriet and Ofev, the launch of new novel treatment options during the second half of the forecast period, and the increasing number of prevalent cases of IPF. - R&D strategies include the development of novel therapies, partnerships and acquisitions, combination of therapies, and targeting niche patient subpopulations. - The IPF therapeutic market is characterized by significant unmet needs. The most pressing unmet need is the development of a product capable of either stabilizing or reversing progression of IPF. Current therapies Esbriet and Ofev do not address this need and are only capable of slowing disease progression. - With high R&D activity in the IPF therapeutic market, physicians are looking forward to pipeline products becoming available, which will enable them to improve patients’ treatment. Scope - Overview of IPF, including epidemiology, etiology, pathophysiology, symptoms, diagnosis, and current treatment options. - Annualized IPF therapeutic market revenue, annual cost of therapy and treatment usage pattern data from 2015 and forecast for ten years to 2025. - Key topics covered include strategic competitor assessment, market characterization, unmet needs, and implications for the IPF therapeutics markets. - Pipeline analysis: comprehensive data split across different phases, emerging novel trends under development, and detailed analysis of mid-stage pipeline drugs. - Analysis of the current and future market competition in the global IPF therapeutics markets. Insightful review of the key industry drivers, restraints and challenges. Each trend is independently researched to provide qualitative analysis of its implications. Reasons to buy The report will enable you to - - Develop and design in-licensing and out-licensing strategies through a review of pipeline products and technologies, and by identifying the companies with the most robust pipeline. - Develop business strategies by understanding the trends shaping and driving the global IPF therapeutic markets. - Drive revenues by understanding the key trends, innovative products and technologies, market segments, and companies likely to impact the global IPF therapeutic markets in the future. - Formulate effective sales and marketing strategies by understanding the competitive landscape and by analyzing the performance of various competitors. - Identify emerging players with potentially strong product portfolios and create effective counter-strategies to gain a competitive advantage. - Track drug sales in the global IPF therapeutic markets from 2015-2025. - Organize sales and marketing efforts by identifying the market categories and segments that present maximum opportunities for consolidations, investments and strategic partnerships.
Table of Contents
1 Table of Contents 10 1.1 List of Tables 15 1.2 List of Figures 18 2 Introduction 19 2.1 Catalyst 19 2.2 Related Reports 20 3 Disease Overview 21 3.1 Etiology and Pathophysiology 24 3.1.1 Etiology 24 3.1.2 Pathophysiology 25 3.2 Classification or Staging System 28 3.3 Prognosis 31 3.4 Quality of Life 31 3.5 Symptoms 32 4 Epidemiology 34 4.1 Disease Background 34 4.2 Risk Factors and Comorbidities 34 4.3 Global Trends 36 4.3.1 Incidence 36 4.3.2 Prevalence 37 4.4 Forecast Methodology 39 4.4.1 Sources Used 39 4.4.2 Forecast Assumptions and Methods 44 4.4.3 Sources Not Used 51 4.5 Epidemiological Forecast for IPF (2015-2025) 52 4.5.1 Diagnosed Incident Cases 52 4.5.2 Diagnosed Prevalent Cases 60 4.5.3 IPF Mortality 67 4.6 Discussion 72 4.6.1 Epidemiological Forecast Insight 72 4.6.2 Limitations of the Analysis 73 4.6.3 Strengths of the Analysis 74 5 Current Treatment Options 75 5.1 Overview 75 5.2 Product Profiles - Major Brands 77 5.2.1 Esbriet (Pirfenidone) 77 5.2.2 Ofev (Nintedanib) 82 5.2.3 Fluimucil (N-acetylcysteine) 87 6 Unmet Needs Assessment and Opportunity Analysis 91 6.1 Overview 91 6.2 Lack of an Efficacious Drug 92 6.2.1 Overview 92 6.2.2 Gap Analysis 93 6.2.3 Opportunity 93 6.3 Patient Access to Costly Treatments 93 6.3.1 Overview 93 6.3.2 Gap Analysis 94 6.3.3 Opportunity 95 6.4 Early and Prompt Diagnosis 95 6.4.1 Overview 95 6.4.2 Gap Analysis 96 6.4.3 Opportunity 97 6.5 Unrecognized Disease 97 6.5.1
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