OpportunityAnalyzer: Idiopathic Pulmonary Fibrosis (IPF) - Opportunity Analysis and Forecasts to 2017
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OpportunityAnalyzer: Idiopathic Pulmonary Fibrosis (IPF) - Opportunity Analysis and Forecasts to 2017
Summary
Idiopathic Pulmonary fibrosis (IPF) is a chronic, progressive fibrosing interstitial pneumonia of unknown cause. Limited to the lungs it occurs primarily in older adults' =50 years old, with an abysmal prognosis (3-5 years following diagnosis). After decades of being an underserved therapeutic arena, the IPF treatment landscape is set to dramatically change with the anticipated approval and subsequent launch of two small molecule therapeutic options in 2015; InterMune's Esbriet in the US and Boehringer Ingelheim's Nintedanib globally. There is tangible excitement amongst the IPF community of changes to a therapeutic field, which was solely dominated by the off-label drug N-acetylcysteine for symptomatic relief and costly supportive palliative care. The IPF market (defined as the US, France, Germany, Italy, Spain, and the UK) within the five-year forecast period (2012–2017) is projected to undergo exponential growth with a steep increase in treatment uptake, particularly in the US, Italy and Spain. Also detailed, is future (past 2017) insight into highly anticipated novel targeted biologics expected to change the small molecule treatment paradigm, with the entry of STX-100 (Biogen) and GS-6624 (Gilead) in the market.
Highlights
Key Questions Answered
- What key R&D strategies are being employed to penetrate this rapidly developing market?
- Esbriet, the only approved IPF therapeutic in EU has suffered slow market access, despite approval in 2011. How will this change within the next 5 years?
- How will the delayed launch of Esbriet in the US impact the therapeutic market, particularly with the competition offered by Nintedanib?
- IPF is a chronic disease with much controversy over suitability of endpoints used. What is the future outlook for clinical trial design?
- Prevalence of IPF is anticipated to increase from 2012-2017 How will epidemiological changes impact the growth of the future market?
- Which biologic molecules have been flagged clinically and commercially for interest by key opinion leaders?
Key Findings
- Exponential Growth in the US and EU Idiopathic Pulmonary Fibrosis Markets Expected from 2012–2017
- Aligned R&D strategies are imperative for attaining access to a lucrative and underserved IPF market
- The IPF market is a vast continuum of unmet needs
- Opportunities remain for biomarkers that identify appropriate IPF patients
- Novel biologic drugs Biogen Idec's STX-100 and Gilead's GS-6624 that target fibrosis will alter the current IPF small molecule landscape
Scope
- Overview of IPF, including epidemiology, etiology, pathophysiology, symptoms and current treatment options.
- Annualized IPF therapeutics market revenue, annual cost of therapies and top line 5 year forecasts to 2017.
- Key topics covered include strategic product assessment, market characterization, unmet needs, R&D strategies, clinical trial design and implications for the IPF therapeutics market.
- Pipeline analysis: comprehensive data split across different phases, emerging trends and mechanisms of action under development, including disease modifying drugs.
- Analysis: of the current and future market competition in the global IPF therapeutics market. Clinical and commercial benchmarking of promising pipeline products versus standard of care treatments and competitive assessment of all therapies . Insightful review of the key industry drivers, restraints and challenges.
Key Benefits
- Identify the unmet needs and remaining opportunities in the IPF therapeutics market.
- Develop business strategies by understanding the trends shaping and driving the global IPF therapeutics market.
- Identify emerging players with potentially strong product portfolios and create effective counter-strategies to gain a competitive advantage.
- Assess the clinical and commercial viability of promising pipeline products.
- Develop and design your in-licensing and out-licensing strategies through a review of pipeline products and technologies.
- Formulate effective sales and marketing strategies by understanding the competitive landscape and by analyzing the performance of various emerging therapies.
- Organize your sales and marketing efforts by identifying the market categories and segments that present maximum opportunities for consolidations, investments and strategic partnerships.
- Drive revenues by understanding the key trends, innovative products and technologies, market and segments likely to impact the global IPF therapeutics market in future.
1 Table of Contents
1 Table of Contents 8
1.1 List of Tables 12
1.2 List of Figures 14
2 Introduction 15
2.1 Catalyst 15
3 Disease Overview 17
3.1 Etiology and Pathophysiology 20
3.2 Pathophysiology 21
3.2.1 Overview 21
3.2.2 Genetic Predisposition 22
3.2.3 New theories 22
3.2.4 The vulnerable alveolar epithelium in IPF 23
3.2.5 Emergence of pathologic mesenchymal phenotypes 24
3.2.6 From AECII injury to lung fibrosis 25
3.3 Prognosis and Biomarkers 26
3.4 Symptoms 27
4 Epidemiology 29
4.1 Risk Factors and Comorbidities 30
4.1.1 There is almost no risk of IPF among long-term heavy smokers 30
4.1.2 Common workplace inhalants pose a large risk in many occupations 31
4.1.3 Gastroesophageal reflux is common in IPF patients 32
4.2 Global and Historical Trends 33
4.2.1 US 33
4.2.2 5EU 34
4.3 Forecast Methodology 35
4.3.1 Sources Used 36
4.3.2 Forecast Assumptions and Methods 37
4.3.3 Sources Not Used 41
4.4 Epidemiology Forecast for Idiopathic Pulmonary Fibrosis (2012–2022) 42
4.4.1 Total Incident Cases of Idiopathic Pulmonary Fibrosis 42
4.4.2 Age-Specific Incident Cases of Idiopathic Pulmonary Fibrosis 44
4.4.3 Sex-Specific Incident Cases of Idiopathic Pulmonary Fibrosis 45
4.4.4 Total Prevalent Cases of Idiopathic Pulmonary Fibrosis 46
4.4.5 Age-Specific Prevalent Cases of Idiopathic Pulmonary Fibrosis 48
4.4.6 Sex-Specific Prevalent Cases of Idiopathic Pulmonary Fibrosis 49
4.5 Discussion 51
4.5.1 Conclusions on Epidemiology Trends 51
4.5.2 Limitations of the Analysis 52
4.5.3 Strengths of the Analysis 52
5 Current Treatment Options 53
5.1 Overview 53
5.2 Product Profiles – Major Brands 54
5.2.1 Esbriet (pirfenidone) 54
5.2.2 Fluimucil (N-acetylcysteine) 59
6 Unmet Needs Assessment and Oppportunity Analysis 63
6.1 Overview 63
6.2 Unmet Needs Analysis 64
6.2.1 Absence of an efficacious drug 64
6.2.2 Access to treatment/cost 65
6.2.3 Early and prompt diagnosis 66
6.2.4 Unrecognized disease 67
6.2.5 Lack of biomarkers and suitable clinical trials 68
6.2.6 Better side effects and dosing regimen 68
6.2.7 Understanding the complexity of the disease 69
6.3 Opportunity Analysis 70
6.3.1 A drug that can reach a satisfactory level of efficacy 70
6.3.2 The standardization of HRCT images 70
6.3.3 A drug with improved dosing and side effects 70
6.3.4 Improvement in patient quality of life 70
6.3.5 Increased collaboration with academia 71
7 R&D Strategies 72
7.1 Overview 72
7.1.1 Drug development strategies: the oncology approach 72
7.1.2 Improved understanding of disease mechanism 73
7.1.3 Niche patient subgroups 74
7.1.4 Licensing and Alliances 74
7.2 Clinical Trial Design 75
7.2.1 Selection of Appropriate Clinical Trial Endpoints 75
7.2.2 Approval Disparities Between the FDA and EMA 76
7.2.3 Current Clinical Trial Design 78
7.2.4 Future outlook in IPF clinical trial design 80
8 Pipeline Assessment 82
8.1 Overview 82
8.2 Promising Drugs in Clinical Development 86
8.2.1 Ninetedanib 86
8.2.2 STX-100 91
8.2.3 GS-6624 95
8.3 Innovative Early-Stage Approaches 98
8.3.1 Biomarkers/Personal Medicine 99
8.3.2 Stem Cells 100
8.3.3 MicroRNA 100
8.3.4 Antiviral Therapy 101
9 Pipeline Valuation Analysis 102
9.1 Clinical Benchmark of Key Pipeline Drugs 102
9.2 Commercial Benchmark of Key Pipeline Drugs 104
9.3 Competitive Assessment 105
9.4 Top-Line Five-Year Forecast 107
9.4.1 US 109
9.4.2 5EU 110
10 Appendix 113
10.1 Bibliography 113
10.2 Abbreviations 123
10.3 Methodology 127
10.4 Forecasting Methodology 127
10.4.1 Prevalant IPF Patients 127
10.4.2 Percent Drug-Treated Patients 127
10.4.3 Drugs Included in Each Therapeutic Class 128
10.4.4 Launch and Patent Expiry Dates 128
10.4.5 General Pricing Assumptions 128
10.4.6 Individual Drug Assumptions 129
10.4.7 Pricing of Pipeline Agents 130
10.5 Physicians and Specialists Included in this Study 131
10.6 About the Authors 132
10.6.1 Author 132
10.6.2 Epidemiologists 133
10.6.3 Global Director of Epidemiology and Clinical Trials Analysis 135
10.6.4 Global Head of Healthcare 135
10.7 About GlobalData 136
10.8 Contact Us 136
10.9 Disclaimer 136
List of Tables
Table 1: Idiopathic Interstitial Pneumonias and Associated Histological Pattern 20
Table 2: Risk Factors and Comorbidities for Idiopathic Pulmonary Fibrosis 30
Table 3: 6MM, Sources of Prevalence and Incidence Data Used in the Idiopathic Pulmonary Fibrosis Epidemiological Forecast 35
Table 4: 6MM, Incident Cases of Idiopathic Pulmonary Fibrosis, Ages ?50 Years, Men and Women, N, Selected Years, 2012–2022 43
Table 5: 6MM, Incident Cases of Idiopathic Pulmonary Fibrosis, By Age*, Men and Women, N (Row %), 2012 44
Table 6: 6MM, Incident Cases of Idiopathic Pulmonary Fibrosis, Ages ?50 Years, By Sex, N (Row %), 2012 45
Table 7: 6MM, Prevalent Cases of Idiopathic Pulmonary Fibrosis, Ages ?50 Years, Men and Women, N, Selected Years, 2012–2022 47
Table 8: 6MM, Prevalent Cases of Idiopathic Pulmonary Fibrosis, By Age*, Men and Women, N (Row %), 2012 48
Table 9: 6MM, Prevalent Cases of Idiopathic Pulmonary Fibrosis, Ages ?50 Years, By Sex, N (Row %), 2012 50
Table 10: Leading Treatments for IPF 53
Table 11: Product Profile – Esbriet 55
Table 12: Esbriet SWOT Analysis, 2013 58
Table 13: Product Profile – Fluimucil 59
Table 14: Fluimucil SWOT Analysis, 2013 62
Table 15: Overall Unmet Needs – Current Level of Attainment 63
Table 16: Clinical Trial Design of Current Pipeline Drugs for IPF, 2013 78
Table 17: IPF – Late Stage Pipeline, 2013 86
Table 18: Product Profile – Nintedanib 87
Table 19: Nintedanib SWOT Analysis, 2013 90
Table 20: Product Profile – STX-100 92
Table 21: STX-100 SWOT Analysis, 2013 94
Table 22: Product Profile – GS-6624 96
Table 23: GS-6624 SWOT Analysis, 2013 97
Table 24: Early-Stage Pipeline Products in IPF, 2013 98
Table 25: Clinical Benchmark of Key Pipeline Drugs 102
Table 26: Commercial Benchmark of Key Pipeline Drugs 104
Table 27: Top Line Sales Forecasts ($) for IPF, 2012–2017 107
Table 28: Key Events Impacting Sales for IPF, 2017 109
Table 29: US IPF Market – Drivers and Barriers, 2012–2017 110
Table 30: EU IPF Market – Drivers and Barriers, 2012–2017 112
Table 31: Key Launch Dates 128
Table 32: Key Patent Expiries 128
List of Figures
Figure 1: Development of Fibrosis in IPF 17
Figure 2: Classification of Idiopathic Interstitial Pneumonia 18
Figure 3: Implication of continual epithelial cell damage in IPF 24
Figure 4: Overview of disrupted signalling pathways in fibrosis and honeycombing developements 25
Figure 5: The Varying Clinical Course of IPF Progression 28
Figure 6: 6MM, Incident Cases of Idiopathic Pulmonary Fibrosis, Ages ?50 Years, Men and Women, N, Selected Years, 2012–2022 43
Figure 7: 6MM, Incident Cases of Idiopathic Pulmonary Fibrosis, By Age*, Men and Women, N, 2012 45
Figure 8: 6MM, Incident Cases of Idiopathic Pulmonary Fibrosis, Ages ?50 Years, By Sex, N, 2012 46
Figure 9: 6MM, Prevalent Cases of Idiopathic Pulmonary Fibrosis, Ages ?50 Years, Men and Women, N, Selected Years, 2012–2022 47
Figure 10: 6MM, Prevalent Cases of Idiopathic Pulmonary Fibrosis, By Age*, Men and Women, N, 2012 49
Figure 11: Six Major Markets, Prevalent Cases of Idiopathic Pulmonary Fibrosis, Ages ?50 Years, By Sex, N, 2012 50
Figure 12: Competitive Assessment of Late-Stage Pipeline Agents in IPF, 2012–2017 106
Figure 13: Global Sales for IPF by Region, 2012–2017 108
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