OpportunityAnalyzer: Idiopathic Pulmonary Fibrosis – Opportunity Analysis and Forecast to 2025

1Table of Contents

1.1List of Tables

1.2List of Figures

2Introduction

2.1Catalyst

2.2Related Reports

3Disease Overview

3.1Etiology and Pathophysiology

3.1.1Etiology

3.1.2Pathophysiology

3.2Classification or Staging System

3.3Prognosis

3.4Quality of Life

3.5Symptoms

4Epidemiology

4.1Disease Background

4.2Risk Factors and Comorbidities

4.3Global Trends

4.3.1Incidence

4.3.2Prevalence

4.4Forecast Methodology

4.4.1Sources Used

4.4.2Forecast Assumptions and Methods

4.4.3Sources Not Used

4.5Epidemiological Forecast for IPF (2015–2025)

4.5.1Diagnosed Incident Cases

4.5.2Diagnosed Prevalent Cases

4.5.3IPF Mortality

4.6Discussion

4.6.1Epidemiological Forecast Insight

4.6.2Limitations of the Analysis

4.6.3Strengths of the Analysis

5Current Treatment Options

5.1Overview

5.2Product Profiles – Major Brands

5.2.1Esbriet (Pirfenidone)

5.2.2Ofev (Nintedanib)

5.2.3Fluimucil (N-acetylcysteine)

6Unmet Needs Assessment and Opportunity Analysis

6.1Overview

6.2Lack of an Efficacious Drug

6.2.1Overview

6.2.2Gap Analysis

6.2.3Opportunity

6.3Patient Access to Costly Treatments

6.3.1Overview

6.3.2Gap Analysis

6.3.3Opportunity

6.4Early and Prompt Diagnosis

6.4.1Overview

6.4.2Gap Analysis

6.4.3Opportunity

6.5Unrecognized Disease

6.5.1Overview

6.5.2Gap Analysis

6.5.3Opportunity

6.6Lack of Treatment Options for Patients with Late Stage Disease

6.6.1Overview

6.6.2Gap Analysis

6.6.3Opportunity

6.7Improvement in Patient Quality Of Life

6.7.1Overview

6.7.2Gap Analysis

6.7.3Opportunity

6.8Improved Side Effects and Dosing Regimen

6.8.1Overview

6.8.2Gap Analysis

6.8.3Opportunity

7R&D Strategies

7.1Overview

7.1.1Drug Development Strategy: Combination Therapy

7.1.2Improving Understanding of Disease Mechanism

7.1.3Licensing and Alliances

7.1.4Niche Patient Subgroups

7.2Clinical Trial Design

7.2.1Selection of Appropriate Clinical Trial Endpoints

8Pipeline Assessment

8.1Overview

8.2Promising Drugs in Clinical Development

8.2.1FG-3019

8.2.2PRM-151

8.2.3Lebrikizumab

8.2.4SAR-156597

8.2.5BG-00011

8.2.6BMS-986020

8.2.7AF-219

8.2.8Tipelukast

8.3Innovative Early-Stage Approaches

8.3.19.3.1 Combination Therapy

8.3.2Biomarkers

8.3.3Stem Cell Therapy

9Pipeline Valuation Analysis

9.1Clinical Benchmarking of Key Pipeline Drugs

9.1.1Standards of Care – Esbriet and Ofev

9.1.2PRM-151

9.1.3FG-3019

9.1.4Other Pipeline Products

9.2Commercial Benchmarking of Key Pipeline Drugs

9.2.1Standards of Care – Esbriet and Ofev

9.2.2PRM-151

9.2.3FG-3019

9.2.4Other Pipeline Products

9.3Competitive Assessment

9.4Top-Line Ten-Year Forecast

9.4.1US

9.4.25EU

9.4.3Japan

10Appendix

10.1Bibliography

10.2Abbreviations

10.3Methodology

10.4Forecasting Methodology

10.4.1Diagnosed IPF Patients

10.4.2Percent Drug-Treated Patients

10.4.3Drugs Included in Each Therapeutic Class

10.4.4Launch and Patent Expiry Dates

10.4.5General Pricing Assumptions

10.4.6Individual Drug Assumptions

10.4.7Generic Erosion

10.4.8Pricing of Pipeline Agents

10.5Physicians and Specialists Included in this Study

10.6Primary Research – Prescriber Survey

10.7About the Authors

10.7.1Author

10.7.2Therapy Area Director

10.7.3Epidemiologist

10.7.4Global Director of Therapy Analysis and Epidemiology

10.7.5Global Head of Healthcare

10.8About GlobalData

10.9Disclaimer

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

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