Nonalcoholic Steatohepatitis – Landscape & Forecast – Disease Landscape & Forecast
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.
Table of contents
- Nonalcoholic Steatohepatitis - Landscape & Forecast - Disease Landscape & Forecast
- Key findings
- NASH - Key findings - January 2023
- Key updates
- January 2023
- Q4 2022
- December 2022
- Q3 2022
- September 2022
- August 2022
- July 2022
- Q2 2022
- June 2022
- May 2022
- April 2022
- Q1 2022
- March 2022
- February 2022
- Market outlook
- Key findings
- Market share of drug classes for NASH: 2021
- Patient share of drug classes for NASH: 2021
- Market share of drug classes for NASH: 2031
- Patient share of drug classes for NASH: 2031
- NASH SWOT analysis
- Market drivers and constraints
- What factors are driving the market for NASH?
- 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
- Key findings
- 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
- Disease overview
- 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
- Key findings
- 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
- Key findings
- 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
- Key findings
- 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
- Region-specific reimbursement practices
- Appendix
- Abbreviations table
- NASH bibliography
- Key findings
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, 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.