Although Ofev and Esbriet are welcome options in the treatment armamentarium for idiopathic pulmonary fibrosis (IPF), therapies that can further delay or reverse the disease’s progression, preserve lung function, and prolong survival are sorely needed. The diverse IPF pipeline comprises novel classes including CTGF inhibitors, Rho-associated coiled-coil kinase 2 inhibitors, and agents targeting recombinant human pentraxin-2. In this report, we assess the clinical and commercial opportunities remaining in the IPF space through a comprehensive analysis of surveyed pulmonologists’ treatment drivers and goals and their perception of the performance of key current therapies against these goals.
QUESTIONS ANSWERED
- What are the key treatment drivers and goals for IPF?
- What drug attributes are key influences, which have limited impact, and which are hidden opportunities?
- How do current therapies such as Esbriet and Ofev perform on key treatment drivers and goals for IPF?
- What are the key opportunities for drug development in IPF? Where do surveyed pulmonologists perceive the largest gaps in the treatment of IPF patients?
- What trade-offs across different clinical attributes and price are acceptable to U.S. and European pulmonologists for a hypothetical new IPF drug?
CONTENT HIGHLIGHTS
Markets covered: United States, United Kingdom, France, Germany.
Primary research: Survey of 61 U.S. and 31 European pulmonologists fielded in January 2022.
Key companies: Roche, Boehringer Ingelheim, FibroGen, Promedior / Roche.
Key drugs: Esbriet, Ofev, prednisone.
PRODUCT DESCRIPTION
Unmet Need supports clinical development decisions by identifying key attributes and assessing areas of unmet need for a specific disease or subpopulation. Based on surveys with U.S. and European physicians, this report provides insight into key treatment drivers and goals, the performance of current therapies, and the remaining commercial opportunities. One market scenario is profiled in detail by Clarivate experts, and additional customized market scenarios can be evaluated with the corresponding TPP simulator.
- Idiopathic Pulmonary Fibrosis - Unmet Need - Detailed, Expanded Analysis: (US/EU)
- Executive Summary
- Unmet Need - IPF - Executive Summary - March 2022
- Introduction
- Overview
- Methodology
- Rationale for treatment drivers and goals selection
- Rationale for drug selection
- Products for IPF and rationale for drug selection
- Treatment drivers and goals
- Key findings: attribute importance
- Relative importance of efficacy, safety and tolerability, convenience of administration, and nonclinical attributes to surveyed pulmonologists' prescribing decisions in IPF
- Importance of efficacy attributes to prescribing decisions in IPF: United States
- Importance of efficacy attributes to prescribing decisions in IPF: Europe
- Importance of safety and tolerability attributes to prescribing decisions in IPF: United States
- Importance of safety and tolerability attributes to prescribing decisions in IPF: Europe
- Importance of convenience of administration attributes to prescribing decisions in IPF: United States
- Importance of convenience of administration attributes to prescribing decisions in IPF: Europe
- Importance of nonclinical factors to prescribing decisions in IPF: United States
- Importance of nonclinical factors to prescribing decisions in IPF: Europe
- Key findings: stated vs. derived importance
- Stated vs. derived importance of key efficacy, safety and tolerability, convenience of administration, and nonclinical attributes to prescribing decisions in IPF: United States
- Stated vs. derived importance of key efficacy, safety and tolerability, convenience of administration, and nonclinical attributes to prescribing decisions in IPF: Europe
- Product performance against treatment drivers and goals
- Key findings
- Overall performance of key therapies for IPF: United States
- Overall performance of key therapies for IPF: Europe
- Mean overall performance of key therapies for IPF: United States and Europe
- Relative performance of key therapies for IPF across select efficacy attributes: United States
- Relative performance of key therapies for IPF across select efficacy attributes: Europe
- Relative performance of key therapies for IPF across select safety and tolerability attributes: United States
- Relative performance of key therapies for IPF across select safety and tolerability attributes: Europe
- Relative performance of key therapies for IPF across select convenience of administration attributes: United States
- Relative performance of key therapies for IPF across select convenience of administration attributes: Europe
- Relative Performance of key therapies for IPF across select nonclinical attributes: United States
- Relative key therapies for IPF across select nonclinical attributes: Europe
- Assessment of unmet need
- Key findings: unmet need in IPF
- Surveyed pulmonologistsu2019 satisfaction with the performance of key therapies for IPF on efficacy, safety and tolerability, convenience of administration, and nonclinical factors: United States
- Surveyed pulmonologistsu2019 satisfaction with the performance of key therapies for IPF on efficacy, safety and tolerability, convenience of administration, and nonclinical factors: Europe
- Surveyed pulmonologists' ascribed level of unmet need across key efficacy attributes in IPF: United States
- Surveyed pulmonologists' ascribed level of unmet need across key efficacy attributes in IPF: Europe
- Surveyed pulmonologists' ascribed level of unmet need across key safety and tolerability attributes in IPF: United States
- Surveyed pulmonologists' ascribed level of unmet need across key safety and tolerability attributes in IPF: Europe
- Surveyed pulmonologists' ascribed level of unmet need across key convenience of administration attributes in IPF: United States
- Surveyed pulmonologists' ascribed level of unmet need across key convenience of administration attributes in IPF: Europe
- Surveyed pulmonologists' ascribed level of unmet need across key nonclinical factors in IPF: United States
- Surveyed pulmonologists' ascribed level of unmet need across key nonclinical factors in IPF: Europe
- Key findings: unmet need in IPF and related indications
- Surveyed pulmonologists' ascribed level of unmet need in IPF and related indications: United States
- Surveyed pulmonologists' ascribed level of unmet need in IPF and related indications: Europe
- Opportunity analysis
- Areas of opportunity in the IPF market and emerging therapy insights
- Opportunity: therapies demonstrating better preservation of lung function and prolongation of survival compared with current therapies
- Opportunity: therapies that can reduce daily symptoms and improve quality of life
- Opportunity: Therapies that are more effective in preventing acute exacerbations
- Opportunity: additional effective therapies that have good safety and tolerability profiles
- Target product profiles
- Assessing drug development opportunities
- Target product profile methodology
- Attributes and attribute levels
- Attributes of key current therapies for IPF
- Attribute importance and part-worth utilities
- IPF target product profile: attribute importance
- % of patients with no decline from baseline in ppFVC at one year
- % of patients with 20-point worsening from baseline in UCSD-SOBQ at one year
- Hazard ratio compared with placebo for all-cause mortality at one year
- Hazard ratio compared with placebo for time to first acute exacerbation over one year
- Delivery burden (route of administration and dosing frequency)
- % of patients with side effects leading to discontinuation
- Price per day
- Conjoint analysis-based simulation of a market scenario
- IPF market simulation: share of preference of target product profiles included in the market scenario
- IPF market simulation: likelihood to prescribe target product profiles included in the market scenario
- IPF market simulation: target product profiles included in the market scenario
- Appendix
- Key Abbreviations
- Bibliography
Anwesh Panda
Anwesh Panda, M.Tech., is an analyst on the Infectious, Niche, & Rare Diseases (INRD) team at Clarivate. In this role, he conducts primary and secondary research on a range of indications. Prior to joining Clarivate, he was a market research analyst at Infiniti Research and Grand View Research. He holds a master’s degree in biotechnology from the Kiit School of Biotechnology in Odisha, India.