Summary
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. 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.
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1.1 List of Tables
1.2 List of Figures
2 Introduction
2.1 Catalyst
2.2 Related Reports
3 Disease Overview
3.1 Etiology and Pathophysiology
3.1.1 Etiology
3.1.2 Pathophysiology
3.2 Classification or Staging System
3.3 Prognosis
3.4 Quality of Life
3.5 Symptoms
4 Epidemiology
4.1 Disease Background
4.2 Risk Factors and Comorbidities
4.3 Global Trends
4.3.1 Incidence
4.3.2 Prevalence
4.4 Forecast Methodology
4.4.1 Sources Used
4.4.2 Forecast Assumptions and Methods
4.4.3 Sources Not Used
4.5 Epidemiological Forecast for IPF (2015-2025)
4.5.1 Diagnosed Incident Cases
4.5.2 Diagnosed Prevalent Cases
4.5.3 IPF Mortality
4.6 Discussion
4.6.1 Epidemiological Forecast Insight
4.6.2 Limitations of the Analysis
4.6.3 Strengths of the Analysis
5 Current Treatment Options
5.1 Overview
5.2 Product Profiles - Major Brands
5.2.1 Esbriet (Pirfenidone)
5.2.2 Ofev (Nintedanib)
5.2.3 Fluimucil (N-acetylcysteine)
6 Unmet Needs Assessment and Opportunity Analysis
6.1 Overview
6.2 Lack of an Efficacious Drug
6.2.1 Overview
6.2.2 Gap Analysis
6.2.3 Opportunity
6.3 Patient Access to Costly Treatments
6.3.1 Overview
6.3.2 Gap Analysis
6.3.3 Opportunity
6.4 Early and Prompt Diagnosis
6.4.1 Overview
6.4.2 Gap Analysis
6.4.3 Opportunity
6.5 Unrecognized Disease
6.5.1 Overview
6.5.2 Gap Analysis
6.5.3 Opportunity
6.6 Lack of Treatment Options for Patients with Late Stage Disease
6.6.1 Overview
6.6.2 Gap Analysis
6.6.3 Opportunity
6.7 Improvement in Patient Quality Of Life
6.7.1 Overview
6.7.2 Gap Analysis
6.7.3 Opportunity
6.8 Improved Side Effects and Dosing Regimen
6.8.1 Overview
6.8.2 Gap Analysis
6.8.3 Opportunity
7 R&D Strategies
7.1 Overview
7.1.1 Drug Development Strategy: Combination Therapy
7.1.2 Improving Understanding of Disease Mechanism
7.1.3 Licensing and Alliances
7.1.4 Niche Patient Subgroups
7.2 Clinical Trial Design
7.2.1 Selection of Appropriate Clinical Trial Endpoints
8 Pipeline Assessment
8.1 Overview
8.2 Promising Drugs in Clinical Development
8.2.1 FG-3019
8.2.2 PRM-151
8.2.3 Lebrikizumab
8.2.4 SAR-156597
8.2.5 BG-00011
8.2.6 BMS-986020
8.2.7 AF-219
8.2.8 Tipelukast
8.3 Innovative Early-Stage Approaches
8.3.1 Combination Therapy
8.3.2 Biomarkers
8.3.3 Stem Cell Therapy
9 Pipeline Valuation Analysis
9.1 Clinical Benchmarking of Key Pipeline Drugs
9.1.1 Standards of Care - Esbriet and Ofev
9.1.2 PRM-151
9.1.3 FG-3019
9.1.4 Other Pipeline Products
9.2 Commercial Benchmarking of Key Pipeline Drugs
9.2.1 Standards of Care - Esbriet and Ofev
9.2.2 PRM-151
9.2.3 FG-3019
9.2.4 Other Pipeline Products
9.3 Competitive Assessment
9.4 Top-Line Ten-Year Forecast
9.4.1 US
9.4.2 5EU
9.4.3 Japan
10 Appendix
10.1 Bibliography
10.2 Abbreviations
10.3 Methodology
10.4 Forecasting Methodology
10.4.1 Diagnosed IPF Patients
10.4.2 Percent Drug-Treated Patients
10.4.3 Drugs Included in Each Therapeutic Class
10.4.4 Launch and Patent Expiry Dates
10.4.5 General Pricing Assumptions
10.4.6 Individual Drug Assumptions
10.4.7 Generic Erosion
10.4.8 Pricing of Pipeline Agents
10.5 Physicians and Specialists Included in this Study
10.6 Primary Research - Prescriber Survey
10.7 About the Authors
10.7.1 Author
10.7.2 Therapy Area Director
10.7.3 Epidemiologist
10.7.4 Global Director of Therapy Analysis and Epidemiology
10.7.5 Global Head of Healthcare
10.8 About us
10.9 Disclaimer
1.1 List of Tables
Table 1: Idiopathic Interstitial Pneumonias and Associated Histological Patterns
Table 2: The GAP Index
Table 3: The GAP Index and Staging System
Table 4: Risk Factors and Comorbidities of IPF
Table 5: 7MM, Sources Used to Forecast the Diagnosed Incident Cases of IPF
Table 6: 7MM, Sources Used to Forecast the Diagnosed Prevalent Cases of IPF
Table 7: 7MM, except Japan, Sources Used to Forecast Severity Segmentation of Diagnosed Incident Cases and Diagnosed Prevalent Cases of IPF
Table 8: 7MM, Sources Used to Forecast IPF Deaths
Table 9: 7MM, Sources Not Used in the Epidemiological Analysis of IPF
Table 10: 7MM, Diagnosed Incident Cases of IPF, Ages =18 Years, Both Sexes, N, Selected Years 2015-2025
Table 11: 7MM, Age-Specific Diagnosed Incident Cases of IPF, Both Sexes, N (Row %), 2015
Table 12: 7MM, Sex-Specific Diagnosed Incident Cases of IPF, Ages =18 Years, N (Row %), 2015
Table 13: 7MM, Diagnosed Prevalent Cases of IPF, Ages =18 Years, Both Sexes, N, Selected Years 2015-2025
Table 14: 7MM, Age-Specific Diagnosed Prevalent Cases of IPF, Both Sexes, N (Row %), 2015
Table 15: 7MM, Sex-Specific Diagnosed Prevalent Cases of IPF, Ages =18 Years, N (Row %), 2015
Table 16: 7MM, IPF Deaths, Ages =18 Years, Both Sexes, N, Selected Years 2015-2025
Table 17: 7MM, Age-Specific IPF Deaths, Both Sexes, N (Row %), 2015
Table 18: 7MM, Sex-Specific IPF Deaths, Ages =18 Years, N (Row %), 2015
Table 19: Leading Treatments for IPF, 7MM 2016
Table 20: Product Profile - Esbriet
Table 21: Safety of Esbriet
Table 22: Esbriet SWOT Analysis, 2016
Table 23: Product Profile - Ofev
Table 24: Safety of Ofev
Table 25: Ofev SWOT Analysis, 2016
Table 26: Product Profile - Fluimucil
Table 27: Fluimucil SWOT Analysis, 2016
Table 28: Unmet Need and Opportunities in IPF, 2016
Table 29: IPF - Late-Stage Pipeline, May 2016
Table 30: Product Profile - FG-3019
Table 31: FG-3019 SWOT Analysis, 2016
Table 32: Product Profile - PRM-151
Table 33: PRM-151 SWOT Analysis, 2016
Table 34: Product Profile - Lebrikizumab
Table 35: Lebrikizumab SWOT Analysis, 2016
Table 36: Product Profile - SAR-156597
Table 37: SAR-156597 SWOT Analysis, 2016
Table 38: Product Profile - BG-00011
Table 39: BG-00011 SWOT Analysis, 2016
Table 40: Product Profile - BMS-986020
Table 41: BMS-986020 SWOT Analysis, 2016
Table 42: Product Profile - AF-219
Table 43: AF-219 SWOT Analysis, 2016
Table 44: Product Profile -Tipelukast
Table 45: Tipelukast SWOT Analysis, 2016
Table 46: Early-stage pipeline products in IPF, May 2016
Table 47: Clinical Benchmark of Key Pipeline Drugs in IPF
Table 48: Commercial Benchmark of Key Pipeline Drugs in IPF
Table 49: Top-Line Sales Forecast ($m) for IPF, 2015-2025
Table 50: Key Events Impacting Sales for IPF, 2015-2025
Table 51: IPF Market - Drivers and Barriers, 2015-2025
Table 52: Key Launch Dates
Table 53: Key Patent Expiries
Table 54: Key Historical and Projected Launch Dates
Table 55: High-Prescribing Physicians (non-KOLs) Surveyed, By Country
1.2 List of Figures
Figure 1: The Induction and Progression of IPF
Figure 2: Classifications of Idiopathic Interstitial Pneumonia
Figure 3: 7MM, Diagnosed Incident Cases of IPF, Ages =18 Years, Both Sexes, N, 2015-2025
Figure 4: 7MM, Age-Specific Diagnosed Incident Cases of IPF, Both Sexes, N, 2015
Figure 5: 7MM, Sex-Specific Diagnosed Incident Cases of IPF, Ages =18 Years, 2015
Figure 6: 7MM, Age-Standardized Diagnosed Incidence of IPF, Ages =18 Years, N, 2015
Figure 7: US and 5EU, Diagnosed Incident Cases of IPF by Severity, Both Sexes, Ages =18, 2015
Figure 8: 7MM, Diagnosed Prevalent Cases of IPF, Ages =18 Years, Both Sexes, N, Selected Years 2015-2025
Figure 9: 7MM, Age-Specific Diagnosed Prevalent Cases of IPF, Both Sexes, N, 2015
Figure 10: 7MM, Sex-Specific Diagnosed Prevalent Cases of IPF, Ages =18 Years, 2015
Figure 11: 7MM, Age-Standardized Diagnosed Prevalence of IPF, Ages =18 Years, N, 2015
Figure 12: US and 5EU, Diagnosed Prevalent Cases of IPF by Severity, Both Sexes, Ages =18 Years, 2015
Figure 13: 7MM, IPF Deaths, Ages =18 Years, Both Sexes, N, Selected Years 2015-2025
Figure 14: 7MM, Age-Specific IPF Deaths, Both Sexes, N, 2015
Figure 15: 7MM, Sex-Specific IPF Deaths, Ages =18 Years, 2015
Figure 16: Competitive Assessment of Late-Stage Pipeline Agents in IPF, 2015-2025
Figure 17: Global Sales for IPF by Region, 2015-2025
