Nonalcoholic Steatohepatitis – Unmet Need – Detailed, Expanded Analysis (US/EU)
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Nonalcoholic steatohepatitis (NASH) has the potential to be a large and lucrative therapy market owing to the prevalence of the disease and the lack of approved agents. Patients with NASH are at risk of liver fibrosis, cardiovascular disease, and cancer. Currently, physicians are limited to off-label therapies that have limited evidence to support prescribing. Consequently, there is a pressing need for new, effective drug treatments. In this report, hepatologists and gastroenterologists reveal what attributes drive their prescribing and what they are looking for in terms of efficacy, safety, and delivery from future treatments. Using the Target Product Profile (TPP) simulator, we can establish physicians’ preference for emerging drugs and assess if these drugs can capitalize on the untapped NASH space.
Questions answered
- What are the treatment drivers and goals for NASH?
- What drug attributes are key influences, which have limited impact, and which are hidden opportunities?
- How do current therapies perform on key treatment drivers and goals for NASH?
- What are the prevailing areas of unmet need and opportunity in NASH?
- What trade-offs across different clinical attributes and price are acceptable to U.S. and European hepatologists and gastroenterologists for a hypothetical new NASH drug?
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.
Markets covered: United States, United Kingdom, France, Germany.
Primary research: Survey of 60 U.S. and 30 European hepatologists and gastroenterologists fielded in January 2023.
Key companies: Intercept Pharmaceuticals, Madrigal Pharmaceuticals, Akero Therapeutics, Novo Nordisk, AstraZeneca, Inventiva Pharma, Eli Lilly.
Key drugs: Obeticholic acid, resmetirom, pioglitazone, vitamin E, metformin, GLP-1 receptor agonists, SGLT-2 inhibitors, statins, ursodeoxycholic acid.
Table of contents
- Nonalcoholic Steatohepatitis - Unmet Need - Detailed, Expanded Analysis (US/EU)
- Executive summary
- Unmet need - nonalcoholic steatohepatitis - executive summary - March 2023
- Introduction
- Overview
- Methodology
- Rationale for treatment drivers and goals selection
- Rationale for drug selection
- Products for NASH 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 hepatologists' and gastroenterologists' prescribing decisions in NASH
- Importance of efficacy attributes to prescribing decisions in NASH: United States
- Importance of efficacy attributes to prescribing decisions in NASH: Europe
- Importance of safety and tolerability attributes to prescribing decisions in NASH: United States
- Importance of safety and tolerability attributes to prescribing decisions in NASH: Europe
- Importance of convenience of administration attributes to prescribing decisions in NASH: United States
- Importance of convenience of administration attributes to prescribing decisions in NASH: 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 NASH: United States
- Stated vs. derived importance of key efficacy, safety and tolerability, convenience of administration, and nonclinical attributes to prescribing decisions in NASH: Europe
- Product performance against treatment drivers and goals
- Key findings
- Overall performance of key therapies for NASH: United States
- Overall performance of key therapies for NASH: Europe
- Mean overall performance of key therapies for NASH: United States and Europe
- Relative performance of key therapies for NASH across select efficacy attributes: United States
- Relative performance of key therapies for NASH across select efficacy attributes: Europe
- Relative performance of key therapies for NASH across select safety and tolerability attributes: United States
- Relative performance of key therapies for NASH across select safety and tolerability attributes: Europe
- Relative performance of key therapies for NASH across select convenience of administration attributes: United States
- Relative performance of key therapies for NASH across select convenience of administration attributes: Europe
- Assessment of unmet need
- Key findings: unmet need in NASH
- Surveyed hepatologists' and gastroenterologists' satisfaction with the performance of key therapies for NASH on efficacy, safety and tolerability, convenience of administration, and nonclinical factors: United States
- Surveyed hepatologists' and gastroenterologists' satisfaction with the performance of key therapies for NASH on efficacy, safety and tolerability, convenience of administration, and nonclinical factors: Europe
- Surveyed hepatologists' and gastroenterologists' ascribed level of unmet need across key efficacy attributes in NASH: United States
- Surveyed hepatologists' and gastroenterologists' ascribed level of unmet need across key efficacy attributes in NASH: Europe
- Surveyed hepatologists' and gastroenterologists' ascribed level of unmet need across key safety and tolerability attributes in NASH: United States
- Surveyed hepatologists' and gastroenterologists' ascribed level of unmet need across key safety and tolerability attributes in NASH: Europe
- Surveyed hepatologists' and gastroenterologists' ascribed level of unmet need across key convenience of administration attributes in NASH: United States
- Key findings: unmet need in NASH and related indications
- Surveyed hepatologists' and gastroenterologists' ascribed level of unmet need in NASH and related indications: United States
- Surveyed hepatologists' and gastroenterologists' ascribed level of unmet need in NASH and related indications: Europe
- Opportunity analysis
- Areas of opportunity in the NASH market and emerging therapy insights
- Opportunity: a novel agent that demonstrates efficacy in improving hepatic fibrosis
- Opportunity: a novel agent that reduces hepatic inflammation and steatosis
- Opportunity: a novel agent that is safe and tolerable
- Areas of opportunity in the NASH market and emerging therapy insights
- Target product profiles
- Assessing drug development opportunities
- Target product profile methodology
- Attributes and attribute levels
- Attribute importance and part-worth utilities
- NASH target product profile: attribute importance
- Improvement of u2265 1 stage of hepatic fibrosis
- NASH resolution without worsening of hepatic fibrosis
- Effect on risk of adverse liver-related outcomes
- Effect on all-cause mortality
- Discontinuation rate at one year owing to treatment tolerability
- Dosing burden
- Price per patient per day
- Conjoint analysis-based simulation of a market scenario
- Market scenario
- NASH market simulation: share of preference of target product profiles included in the market scenario
- NASH market simulation: likelihood to prescribe of target product profiles included in the market scenario
- NASH market simulation: target product profiles included in the market scenario
- Appendix
- Key abbreviations
- Bibliography
- Executive summary
Manasa Kadagathur, M.S. (Pharm.), Ph.D., Research associate, Cardiovascular, Metabolic, Renal, and Hematologic Disorders. Dr. Kadagathur holds an M.S. (Pharm.) degree in medicinal chemistry from the National Institute of Pharmaceutical Education and Research (NIPER) in S.A.S. Nagar, India, and a bachelor’s degree in pharmacy from Jawaharlal Nehru Technological University in Hyderabad, India. She earned her Ph.D. in medicinal chemistry from NIPER in Hyderabad, India.