The market for NASH, a severe form of nonalcoholic fatty liver disease (NAFLD), offers substantial commercial opportunity to drug developers owing to the lack of approved agents and the disease’s large and growing prevalence. The body of evidence for the significant burden that the disease places on healthcare systems is accumulating, particularly with respect to the increased risk of cardiovascular diseases, liver failure, and NASH’s potential to quickly become the leading reason for liver transplantation. The lack of treatment options and limited awareness of the disease and its complications have kept diagnosis and treatment rates low. Despite guidelines recommending certain off-label medications, prescribing is usually limited to specialists caring for patients with more-advanced disease. However, with more education about NASH, the development of novel diagnostic tools, and the anticipated approval of therapies to treat the disease, diagnosis and treatment rates will increase and drive growth of the overall therapy market. Over the 2021-2031 forecast period, this market will see the launches of the first agents from a rich pipeline of emerging therapies, fueling massive market expansion.
Questions answered:
What is the prevalence of NASH, and what is driving the growth of this indication?
How is NASH being managed? With no approved medications, how are physicians using available prescription medications off-label to treat the disease?
Which emerging therapy will gain the greatest share in the nascent branded therapy market?
Where will Intercept’s obeticholic acid, Madrigal’s resmetirom, and Novo Nordisk’s semaglutide fit in the evolving NASH treatment paradigm?
CONTENT HIGHLIGHTS
Markets covered: United States, France, Germany, Italy, Spain, United Kingdom, Japan.
Primary research: Nineteen country-specific interviews with thought-leading hematologists. Supported by survey data collected for this and other Clarivate research.
Epidemiology: Diagnosed prevalence of NASH by country; population segmentation by stage of fibrosis.
Emerging therapies: Coverage of select emerging therapies from preclinical to preregistration stages.
Market forecast features: 10-year, annualized, drug-level sales and patient share of key NASH therapies through 2031, segmented by brands and epidemiological subpopulations.
PRODUCT DESCRIPTION
Disease Landscape & Forecast provides comprehensive market intelligence with world-class epidemiology, keen insight into current treatment paradigms, in-depth pipeline assessments, and drug forecasts supported by detailed primary and secondary research.
SOLUTION ENHANCEMENT
Disease Landscape & Forecast features continual updates to provide timely insights and analyses as meaningful indication-specific news and events unfold. Additionally, Disease Landscape & Forecast introduces a new Drug Pipeline chapter with real-time, global pipeline intelligence content directly from Cortellis. This chapter is updated daily and features interactive figures that can be easily downloaded for detailed analysis or presentations.
What factors are constraining the market for NASH?
Drug-class-specific trends
Patient share of FXR agonists by market: 2021-2031
U.S. sales of FXR agonists: 2021-2031
EU5 sales of FXR agonists: 2021-2031
Patient share of THR-u03b2 agonists by market: 2021-2031
U.S. sales of THR-u03b2 agonists: 2021-2031
EU5 sales of THR-u03b2 agonists: 2021-2031
Patient share of PPAR agonists by market: 2021-2031
U.S. sales of PPAR agonists: 2021-2031
EU5 sales of PPAR agonists: 2021-2031
Patient share of GLP-1 receptor agonists by market: 2021-2031
U.S. sales of GLP-1 receptor agonists: 2021-2031
EU5 sales of GLP-1 receptor agonists: 2021-2031
Japanese sales of GLP-1 receptor agonists: 2021-2031
Patient share of dual GLP-1/glucagon receptor agonists by market: 2021-2031
U.S. sales of dual GLP-1/glucagon receptor agonists: 2021-2031
EU5 sales of dual GLP-1/glucagon receptor agonists: 2021-2031
Japanese sales of dual GLP-1/glucagon receptor agonists: 2021-2031
Patient share of FGF analogues by market: 2021-2031
U.S. sales of FGF analogues: 2021-2031
EU5 sales of FGF analogues: 2021-2031
Forecast
Market Forecast Assumptions
Market Forecast Dashboard
Etiology and pathophysiology
Disease overview
Etiology
Risk factors associated with NAFLD and NASH
Pathophysiology
Disease pathophysiology
Multihit hypothesis for NASH pathogenesis
Substrate overload lipotoxic injury model of NASH pathogenesis
Natural history
Progression of NAFLD
Key pathways and drug targets
Drug targets in NASH: nuclear transcription factors
Drug targets in NASH: lipotoxicity and oxidative stress
Drug targets in NASH: cellular energy homeostasis
Drug targets in NASH: inflammation and fibrosis
Drug targets in NASH: gastrointestinal microbiome
Epidemiology
Key findings
Epidemiology populations
Disease definition, methods, and sources used
Total prevalent cases of NASH: 2021-2031
Diagnosed prevalent cases of NASH: 2021-2031
Diagnosed prevalent cases of NASH without fibrosis: 2021-2031
Diagnosed prevalent cases of NASH with F1 fibrosis: 2021-2031
Diagnosed prevalent cases of NASH with F2 fibrosis: 2021-2031
Diagnosed prevalent cases of NASH with F3 fibrosis: 2021-2031
Diagnosed prevalent cases of NASH with F4 fibrosis: 2021-2031
Drug-treated diagnosed prevalent cases of NASH: 2021-2031
Drug-treated diagnosed prevalent cases of NASH without fibrosis: 2021-2031
Drug-treated diagnosed prevalent cases of NASH with F1 fibrosis: 2021-2031
Drug-treated diagnosed prevalent cases of NASH with F2 fibrosis: 2021-2031
Drug-treated diagnosed prevalent cases of NASH with F3 fibrosis: 2021-2031
Drug-treated diagnosed prevalent cases of NASH with F4 fibrosis: 2021-2031
Current treatment
Key findings
Treatment goals
Key endpoints used in clinical trials for NASH
Key current therapies
Overview
Mechanism of action of key current drugs used for NASH
Current treatments used for NASH
Advantages and disadvantages of pioglitazone
Expert insight: pioglitazone
Advantages and disadvantages of other off-label antidiabetic agents
Expert insight: other off-label antidiabetic agents
Advantages and disadvantages of off-label lipid-modifying agents
Expert insight: off-label lipid-modifying agents
Advantages and disadvantages of vitamin E
Expert insight: vitamin E
Advantages and disadvantages of other off-label medications
Expert insight: other off-label medications
Medical practice
Overview
Factors influencing drug selection in NASH
Treatment decision tree for NASH: United States
Treatment decision tree for NASH: Europe
Treatment decision tree for NASH: Japan
Introduction
NASH Clinical Research Network scoring system
Select commercially available serum biomarker tests for NASH
Imaging tests
Select commercially available imaging tests for NASH
Unmet need overview
Current and future attainment of unmet needs in NASH
Top unmet needs in NASH: current and future attainment
Expert insight: unmet needs in NASH
Drug pipeline
Pipeline
Regulatory Milestones
Indication Comparison
Emerging therapies
Key findings
Key emerging therapies
Key therapies in development for NASH
Estimated launch dates of key emerging therapies for the treatment of NASH
Key results from select clinical trials investigating obeticholic acid for the treatment of NASH
Analysis of the clinical development program for obeticholic acid
Expert insight: obeticholic acid
Expectations for launch and sales opportunity of obeticholic acid in NASH
Key results from select clinical trials investigating vonafexor (EYP-001) for the treatment of NASH
Analysis of the clinical development program for vonafexor (EYP-001)
Expectations for launch and sales opportunity of vonafexor (EYP-001) in NASH
Key results from select clinical trials investigating resmetirom (MGL-3196) for the treatment of NASH
Analysis of the clinical development program for resmetirom (MGL-3196)
Expert insight: resmetirom (MGL-3196)
Expectations for launch and sales opportunity of resmetirom (MGL-3196) in NASH
Key results from select clinical trials investigating VK-2809 for the treatment of NASH
Analysis of the clinical development program for VK-2809
Expert insight: VK-2809
Expectations for launch and sales opportunity of VK-2809 in NASH
Key results from select clinical trials investigating lanifibranor for the treatment of NASH
Analysis of the clinical development program for lanifibranor
Expert insight: lanifibranor
Expectations for launch and sales opportunity of lanifibranor in NASH
Key results from select clinical trials investigating PXL065 for the treatment of NASH
Analysis of the clinical development program for PXL065
Expectations for launch and sales opportunity of PXL065 in NASH
Key results from select clinical trials investigating semaglutide for the treatment of NASH
Analysis of the clinical development program for semaglutide
Expert insight: semaglutide
Expectations for launch and sales opportunity of semaglutide in NASH
Key results from select clinical trials investigating efruxifermin (AKR-001) for the treatment of NASH
Analysis of the clinical development program for efruxifermin (AKR-001)
Expert insight: efruxifermin (AKR-001)
Expectations for launch and sales opportunity of efruxifermin (AKR-001) in NASH
Key results from select clinical trials investigating pegozaferminn (BIO89-100) for the treatment of NASH
Analysis of the clinical development program for pegozafermin (BIO89-100)
Expert insight: pegozafermin (BIO89-100)
Expectations for launch and sales opportunity of pegozafermin (BIO89-100) in NASH
Key results from select clinical trials investigating aldafermin (NGM282) for the treatment of NASH
Analysis of the clinical development program for aldafermin (NGM282)
Expert insight: aldafermin (NGM282)
Expectations for launch and sales opportunity of aldafermin (NGM282) in NASH
Key results from select clinical trials investigating cotadutide for the treatment of NASH
Analysis of the clinical development program for cotadutide
Expert insight: cotadutide
Expectations for launch and sales opportunity of cotadutide in NASH
Key results from select clinical trials investigating denifanstat (TVB-2640) for the treatment of NASH
Analysis of the clinical development program for denifanstat (TVB-2640)
Expectations for launch and sales opportunity of denifanstat (TVB-2640) in NASH
Key results from select clinical trials investigating aramchol for the treatment of NASH
Analysis of the clinical development program for aramchol
Expert insight: aramchol
Expectations for launch and sales opportunity of aramchol in NASH
Key results from select clinical trials investigating MSDC-0602K for the treatment of NASH
Analysis of the clinical development program for MSDC-0602K
Expert insight: MSDC-0602K
Expectations for launch and sales opportunity of MSDC-0602K in NASH
Key results from select clinical trials investigating LPCN 1144 for the treatment of NASH
Analysis of the clinical development program for LPCN 1144
Expectations for launch and sales opportunity of LPCN 1144 in NASH
Key results from select clinical trials investigating belapectin (GR-MD-02) for the treatment of NASH
Analysis of the clinical development program for belapectin (GR-MD-02)
Expert insight: belapectin
Expectations for launch and sales opportunity of belapectin in NASH
Key results from select clinical trials investigating cilofexor / firsocostat for the treatment of NASH
Analysis of the clinical development program for cilofexor / firsocostat
Expert insight: cilofexor / firsocostat
Expectations for launch and sales opportunity of cilofexor / firsocostat in NASH
Key results from select clinical trials investigating HTD1801 for the treatment of NASH
Analysis of the clinical development program for HTD1801
Expectations for launch and sales opportunity of HTD1801 in NASH
Early-phase pipeline analysis
Select compounds in Phase II development for NASH
Key discontinuations and failures in NASH
Access & reimbursement overview
Region-specific reimbursement practices
Key market access considerations in NASH: United States
General reimbursement environment: United States
Key market access considerations in NASH: EU5
General reimbursement environment: EU5
Key market access considerations in NASH: Japan
General reimbursement environment: Japan
Appendix
Abbreviations table
NASH bibliography
Sayani Datta, M.Sc.
Sayani Datta, M.Sc.,Lead Healthcare Research & Data Analyst – Cardiovascular, Metabolic, Renal, and Hematologic (CMRH) Disorders. Sayani’s primary areas of focus are nonalcoholic steatohepatitis (NASH) and pulmonary hypertension (PH). Previously, she was an associate consultant with IQVIA. She has worked on various types of custom and syndicated research projects in several therapeutic areas and has experience in sales- and epidemiology-based forecasting, commercial opportunity assessments, and market tracking and intelligence. She is an M.Sc. in biotechnology from the University of Leeds, where she gained exposure to life sciences research and development working as a postgraduate research intern.
Shilpa Thakur
Shilpa Thakur, M.P.H., is an epidemiologist at Clarivate. Previously, she monitored HIV sentinel surveillance in Himachal Pradesh. She has also studied the patterns of antimicrobial resistance in India. She received her M.P.H. from the Postgraduate Institute of Medical Education and Research with a specialization in epidemiology and biostatistics.