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Idiopathic Pulmonary Fibrosis – Opportunity Analysis and Forecasts to 2029 (Event Driven Update)

Idiopathic pulmonary fibrosis (IPF) is the most common subtype of idiopathic interstitial pneumonias (IIPs), which belong to a group of rare diseases termed interstitial lung diseases (ILDs). Idiopathic pulmonary fibrosis (IPF) is a new and rapidly-establishing market, which, before 2011 was non-existent, with no approved pharmaceutical treatments for the chronic, debilitating disease, which has an abysmal prognosis. However, the last decade has seen a period of explosive growth in the IPF market following the entry of two pharmacological small molecule treatments; Roche’s Esbriet and Boehringer Ingelheim’s Ofev. The landscape will continue to evolve and the increasing uptake of current therapies and approval of new products will be the primary drivers of growth over the forecast period.

The catalyst for this event-driven update is the discontinuation of GLPG-1690 by Gilead/Galapagos for development in all indications, including IPF and Systemic Sclerosis (SSc) in Q1 2021. Due to IPF’s high clinical unmet needs, the discontinuation of GLPG-1690 represents a major setback in the disease space, since ziritaxestat was expected to be the first late-state pipeline product to launch for IPF in the next several years. The next earliest pipeline agent set to launch is pamrevlumab in 2024.

KEY QUESTIONS ANSWERED

– Which unmet needs are limiting the treatment of IPF in the 7MM?

– What strategies can the pharmaceutical industry employ to increase treatment rates for IPF? How should these strategies differ across different geographical markets?

– What effect will the launch of generics have on the sales of branded agents?

– What are the main R&D trends in the IPF market and which companies are leading the way? Are there major differences in the mechanisms of action used by therapies in late-stage versus early-stage clinical development?

– What was the impact of the COVID-19 pandemic on the IPF treatment, clinical trial conduct, and looking forward?

Scope

Overview of IPF including epidemiology, etiology, pathophysiology, symptoms, diagnosis, and treatment guidelines.

Topline IPF market revenue, annual cost of therapy, and major pipeline product sales in the forecast period.

Key topics covered include current treatment and pipeline therapies, unmet needs and opportunities, and the drivers and barriers affecting IPF therapeutics sales in the 7MM.

Pipeline analysis: Comprehensive data split across different phases, emerging novel trends under development, and detailed analysis of late-stage pipeline drugs.

Analysis of the current and future market competition in the global IPF therapeutics market. Insightful review of the key industry drivers, restraints and challenges. Each trend is independently researched to provide qualitative analysis of its implications.

Key Highlights

The greatest drivers of growth in the global IPF market include the launch of six new pipeline therapies during the forecast period and an increasing diagnosed prevalence in many 7MM countries.

The main barriers to growth in the IPF market include low diagnostic and treatment rates and the patent expiries of both Ofev and Esbriet in all markets.

The late-stage pipeline products are completely distinct mechanisms of action both from each other and the available marketed therapies.

The most important unmet needs in the IPF market are improved drug safety and efficacy and improvement in patient quality of life.

Reasons to Buy

The report will enable you to:

Develop and design your in-licensing and out-licensing strategies, using a detailed overview of current pipeline products and technologies to identify companies with the most robust pipelines.

Develop business strategies by understanding the trends shaping and driving the global IPF therapeutics market.

Drive revenues by understanding the key trends, innovative products and technologies, market segments, and companies likely to impact the global IPF market 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 therapeutics market from 2019-2029.

Organize your sales and marketing efforts by identifying the market categories and segments that present maximum opportunities for consolidations, investments and strategic partnerships.

Key Players

Boehringer-Ingelheim

F. Hoffman La Roche

Fibrogen

Bristol Myers Squibb’s Celgene

Galecto Biosciences

PharmAkea Therapeutics

Liminal Biosciences

Table of Contents

1 Table of Contents

1.1 List of Tables

1.2 List of Figures

2 Idiopathic Pulmonary Fibrosis: Executive Summary

2.1 IPF Market to Experience Conservative Growth over the Forecast Period

2.2 Innovative Small Pharma Require Partnerships to Sustain Development

2.3 High Unmet Clinical Needs Remain

2.4 Late-Stage Pipeline Fractured Among Many Differing Mechanisms of Action

2.5 What Do Physicians Think?

3 Introduction

3.1 Catalyst

3.2 Related Reports

3.3 Upcoming Related Reports

4 Disease Overview

4.1 Etiology and Pathophysiology

4.1.1 Etiology

4.1.2 Pathophysiology

4.2 Classification or Staging Systems

4.2.1 GAP Model

4.2.2 Stratification by Decline in Forced Vital Capacity (FVC)

5 Epidemiology

5.1 Disease Background

5.2 Risk Factors and Comorbidities

5.3 Global and Historical Trends

5.4 Forecast Methodology

5.4.1 Sources Used

5.4.2 Forecast Assumptions and Methods

5.5 Epidemiological Forecast for IPF (2019-2029)

5.5.1 Diagnosed Incident Cases of IPF

5.5.2 Sex-Specific Diagnosed Incident Cases of IPF

5.5.3 Age-Specific Diagnosed Incident Cases of IPF

5.5.4 Diagnosed Prevalent Cases of IPF

5.5.5 Sex-Specific Diagnosed Prevalent Cases of IPF

5.5.6 Age-Specific Diagnosed Prevalent Cases of IPF

5.5.7 Diagnosed Prevalent Cases of IPF by Severity

5.5.8 Diagnosed Prevalent Cases of IPF by Comorbidities

5.5.9 Total Prevalent Cases of IPF

5.6 Discussion

5.6.1 Epidemiological Forecast Insight

5.6.2 Coronavirus Disease 2019 (COVID-19) Impact

5.6.3 Limitations of Analysis

5.6.4 Strengths of Analysis

6 Current Treatment Options

6.1 Overview

6.2 Current Treatment Guidelines

6.3 Symptomatic Treatments

7 Unmet Needs and Opportunity Assessment

7.1 Overview

7.2 Earlier Diagnosis

7.3 Improved Drug Safety and Efficacy

7.4 Improvement in Patient Quality of Life

7.5 Treatments for Patients with Severe Disease

8 R&D Strategies

8.1 Overview

8.1.1 Corporate Partnerships

8.1.2 Combination Therapy

8.2 Clinical Trial Design

8.2.1 Appropriate Endpoints

8.2.2 Increased Use of Quality of Life Measures

8.2.3 Add-Ons to Standard of Care

8.2.4 Selection of Patient Population

9 Impact of COVID-19 on the IPF Disease Space

9.1 Overview

9.2 Continuity of Care

9.3 Trial Logistics

9.3.1 Recruitment

9.3.2 Trial Conduct in Isolation

9.3.3 Supply Chain

9.4 Long-Term Impact on the Disease Space

10 Pipeline Assessment

10.1 Overview

10.2 Innovative Early-Stage Approaches

11 Pipeline Valuation Analysis

11.1 Clinical Benchmark of Key Pipeline Drugs

11.2 Commercial Benchmark of Key Pipeline Drugs

11.3 Competitive Assessment

11.4 Top-Line 10-Year Forecast

11.4.1 US

11.4.2 5EU

11.4.3 Japan

12 Appendix

12.1 Bibliography

12.2 Abbreviations

12.3 Methodology

12.3.1 Forecasting Methodology

12.3.2 Diagnosed Patients

12.3.3 Percent Drug-Treated Patients

12.3.4 Drugs Included in Each Therapeutic Class

12.3.5 Launch and Patent Expiry Dates

12.3.6 General Pricing Assumptions

12.3.7 Individual Drug Assumptions

12.3.8 Generic Erosion

12.3.9 Pricing of Pipeline Agents

12.4 Primary Research – KOLs Interviewed for This Report

12.4.1 KOLs

12.4.2 Payers

12.5 Primary Research – Prescriber Survey

12.6 About the Authors

12.6.1 Analyst

12.6.2 Therapy Area Director

12.6.3 Epidemiologist

12.6.4 Managing Epidemiologist

12.6.5 Global Director of Therapy Analysis and Epidemiology

12.6.6 Global Head and EVP of Healthcare Operations and Strategy

12.7 About GlobalData

12.8 Contact Us

12.9 Disclaimer

List of Tables

Table 1: IPF: Key Metrics in the 7MM

Table 2: The GAP Index

Table 3: Risk Factors and Comorbidities for IPF

Table 4: Diagnosed Prevalent Cases of IPF by Comorbidities, N, Both Sexes, Ages ≥18 Years, 2019

Table 5: Treatment Guidelines for IPF, 2020

Table 6: Leading Treatments for IPF, 2020

Table 7: Early Stage Pipeline Agents for IPF, 2020

Table 8: Clinical Benchmark of Key Pipeline Drugs – IPF

Table 9: Commercial Benchmark of Key Pipeline Drugs – IPF

Table 10: IPF Market – Global Drivers and Barriers, 2019–2029

Table 11: Key Events Impacting US Sales for IPF, 2019–2029

Table 12: Key Events Impacting 5EU Sales for IPF, 2019–2029

Table 13: Key Events Impacting Japan Sales for IPF, 2019–2029

Table 14: Key Historical and Projected Launch Dates for IPF

Table 15: Key Historical and Projected Patent Expiry Dates for IPF

Table 16: High-Prescribing Physicians (non-KOLs) Surveyed, By Country

List of Figures

Figure 1: Global Sales Forecast by Country for IPF in 2019 and 2029

Figure 2: Competitive Assessment of the Marketed and Pipeline Drugs Benchmarked Against the Standard of Care (SOC), Esbriet and Ofev

Figure 3: The Induction and Progression of IPF

Figure 4: 7MM, Diagnosed Incidence of IPF (Cases per 100,000 Population), Both Sexes, Ages ≥18 Years, 2019

Figure 5: 7MM, Diagnosed Prevalence of IPF, Both Sexes, Ages ≥18 Years, 2019

Figure 6: 7MM, Total Prevalence of IPF, Both Sexes, Ages ≥18 Years, 2019

Figure 7: 7MM, Sources Used and Not Used to Forecast the Diagnosed Incident and Diagnosed Prevalent Cases of IPF

Figure 8: 7MM, Sources Used to Forecast the Diagnosed Prevalent Cases of IPF by Severity

Figure 9: 7MM, Sources Used to Forecast the Diagnosed Prevalent Cases of IPF by Comorbidities

Figure 10: 7MM, Diagnosed Incident Cases of IPF, N, Both Sexes, Ages ≥18 Years, 2019

Figure 11: 7MM, Diagnosed Incident Cases of IPF, N, by Sex, Ages ≥18 Years, 2019

Figure 12: 7MM, Diagnosed Incident Cases of IPF by Age, N, Both Sexes, 2019

Figure 13: 7MM, Diagnosed Prevalent Cases of IPF, N, Both Sexes, Ages ≥18 Years, 2019

Figure 14: 7MM, Diagnosed Prevalent Cases of IPF, N, by Sex, Ages ≥18 Years, 2019

Figure 15: 7MM, Diagnosed Prevalent Cases of IPF by Age, N, Both Sexes, 2019

Figure 16: 7MM, Diagnosed Prevalent Cases of IPF by Severity, N, Both Sexes, Ages ≥18 Years, 2019

Figure 17: 7MM, Total Prevalent Cases of IPF, N, Both Sexes, Ages ≥18 Years, 2019

Figure 18: Unmet Needs and Opportunities in IPF

Figure 19: Overview of the Development Pipeline in IPF

Figure 20: Key Phase II/III Trials for Therapeutic Agents that Target IPF Disease Progression

Figure 21: Competitive Assessment of the Marketed and Pipeline Drugs Benchmarked Against the Standard of Care (SOC)

Figure 22: Global (7MM) Sales Forecast by Country for IPF in 2019 and 2029

Figure 23: Global Sales Forecast by Molecule for IPF in 2019 and 2029

Figure 24: Sales Forecast by Class for IPF in the US in 2019 and 2029

Figure 25: Sales Forecast by Class for IPF in the 5EU in 2019 and 2029

Figure 26: Sales Forecast by Class for IPF in Japan in 2019 and 2029

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