Global Non-Alcoholic Steatohepatitis (NASH) Market and Forecast Analysis to 2038

The report “Non-alcoholic steatohepatitis (NASH) market analysis and forecast to 2038” has been added to ResearchAndMarkets.com from offer.

There is currently no approved disease-specific therapy for non-alcoholic steatohepatitis (NASH), creating a significant unmet need due to the high clinical and economic burden on healthcare systems and the large prevalent population. NASH is expected to become the main indication for liver transplantation in the United States in the coming years, increasing the urgency to find an effective treatment.

The slow and largely unsuccessful path to a promising treatment has been hampered by the complicated and poorly understood pathophysiology of NASH. Due to the multifactorial nature of the disease, there is a diverse range of modes of action in the pipeline and substantial interest in combination therapies.

The publisher estimates that in 2018, there were approximately 869.3 million prevalent cases of NASH worldwide among 20-year-old adults, and predicts that number will increase to 965.4 million prevalent cases by 2027.

In order to obtain expedited approval by the United States Food and Drug Administration (FDA), one of the following criteria must be met: 1) improvement of a stage of fibrosis without worsening of NASH; 2) improvement in NASH resolution without worsening fibrosis.

While the FDA only requires that one of the above parameters be met, the European Medicines Agency (EMA) requires co-primary efficacy on these two parameters, which could restrict or delay approvals on the five main European markets (France, Germany, Italy, Spain and United Kingdom). In particular, the guidelines of the EMA are still at the draft stage and could therefore be modified in response to industry lobbying before finalization.

Considering the lack of NASH therapies released to date, the NASH market landscape is expected to grow significantly over the forecast period, owing to a sharp increase in new product approvals in the space.

The story continues

Despite the recent FDA rejection of Ocaliva, the publisher expects the drug to be approved in Q2 2022 following NDA’s early re-submission from Intercept with additional data requested by the FDA. However, this still means that the drug will lose its chance to monopolize the market for a significant period of time.

While the FDA described an imbalance in Ocaliva’s risk / benefit profile as the reason for rejecting the drug, growing skepticism about the reliability of surrogate endpoints following major trial failures could have influenced its decision. It is also possible that the FDA retrospectively raises the bar for expedited approval (after agreeing on surrogate parameters required for expedited approval), and since Ocaliva was the first NDA submitted to NASH, the FDA may act with particular caution in setting a precedent for future NASH therapies.

Although the first approvals in the market will see rapid adoption, the label recommendations will initially limit use to NASH F2 / F3 patients, reflecting the recruitment criteria for phase III trials.

Main topics covered:

PREVIEW

BACKGROUND OF THE ILLNESS

• Definition

• Symptoms

• Diagnostic

• Patient segmentation

TREATMENT

EPIDEMIOLOGY

PIPELINE MEDICINES

KEY REGULATORY EVENTS

• Intercept’s NASH plans better alignment with the FDA

• Intercept unlikely to top up OCA for NASH before end of 2021

• BTD Confirms Lanifibranor As NASH Pack Leader (For Now)

• Intercept’s CRL continues to disrupt NASH

• Intercept Eyes EU NASH Market

• Could the postponement of Intercept’s expected NASH panel have an impact on its PDUFA date?

• Genfit delays NASH data as it confers with US FDA on methodology

LIKELIHOOD OF SUCCESS

LICENSE AND ASSET ACQUISITION OFFERS

• Deal Watch: Merck & Co. Seeks To Advance NASH Ambitions With Aligos

• Israeli team Galmed and MyBiotics to improve therapeutic response to NASH

• Novartis licenses NASH candidate to Boston Pharmaceuticals

• LG Chem Expands NASH Pipeline Through Licensing Agreement with TransThera

• Takeda seeks direct anti-fibrotic targets with Engitix

• Merck chooses Hanmi’s dual agonist Efinopegdutide, but for NASH

• Promethera Links with Hao Tian on JV for NASH, ACLF, and Liver Cancer

CLINICAL TRIAL LANDSCAPE

• Sponsors by status

• Sponsors by phase

• Recent events

DRUG EVALUATION MODEL

• Farnesoid X Receptor Agonists (FXR)

• FXR agonist and allosteric acetyl-CoA carboxylase (ACC) inhibitor

• CCR2 / 5 chemokine receptor antagonist

• Thyroid hormone selective agonists

• Fibroblast Growth Factor (FGF) Analogs

• Glucagon-like peptide-1 (GLP-1) agonist

• Peroxisome Proliferator Activated Receptor Agonists (PPARs)

MARKET DYNAMICS

FUTURE TRENDS

• Payers’ restrictions will limit market access for first-generation NASH agents at prohibitive prices

• Ocaliva’s advantage of monopolizing the market was eliminated following CRLs

• Increased competition from new product launches will shape the NASH market

• GLP-1 agonists will experience rapid absorption in diabetic patients NASH

• No treatment for F4 NASH patients on the horizon

• The use of combination therapies will be limited to severe patients due to prohibitive prices

CONSENSUS FORECASTS

RECENT EVENTS AND ANALYST ADVICE

• LPCN 1144 for NASH (January 12, 2021)

• Icosabutate for NASH (January 8, 2021)

• Multiple Drugs for NASH (November 15, 2020)

• PXL770 for NASH (October 1, 2020)

• BIO89-100 for NASH (September 14, 2020)

• Aldafermin for NASH (August 29, 2020)

• Nidufexor for NASH (August 28, 2020)

• VK2809 for NASH (Aug 28, 2020)

• Elobixibat for NASH (August 18, 2020)

• Efruxifermin for NASH (June 30, 2020)

• Namodenoson for NASH (June 30, 2020)

• Ocaliva for NASH (June 29, 2020)

• TVB-2640 for NASH (June 17, 2020)

• Cotadutide for NASH (June 15, 2020)

• Lanifibranor for NASH (June 15, 2020)

• Elafibranor for NASH (May 11, 2020)

• Seladelpar for NASH (May 8, 2020)

• Ozempic for NASH (May 6, 2020)

KEY UPCOMING EVENTS

KEY OPINION LEADER OVERVIEW

UNMATCHED NEEDS

• Pharmacological treatment

• Clinical trials in advanced NASH patients

• Non-invasive diagnostic tools

BIBLIOGRAPHY

ANNEX

For more information on this report, visit https://www.researchandmarkets.com/r/6d4j3v

See the source version on businesswire.com: https://www.businesswire.com/news/home/20210322005306/en/

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