Global Non-alcoholic Steatohepatitis (NASH) Treatment Market Report and Forecast 2024-2032

Global Non-Alcoholic Steatohepatitis (NASH) Treatment Market Outlook

The non-alcoholic steatohepatitis (NASH) treatment market size attained a value of USD 6.55 billion in 2023. The market value is likely to rise at a CAGR of 5.7% during the forecast period of 2024-2032 to reach a value of about USD 10.79 billion by 2032. The growth can be attributed to the advanced study for diagnosis and drug development therapies.

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Non-Alcoholic Steatohepatitis (NASH) Treatment Market: Insights

Non-Alcoholic Steatohepatitis (NASH) refers to the liver inflammation caused by the accumulation of fat in the liver. It is one of several disorders known as non-alcoholic fatty liver disease (NAFLD). The fat accumulation in the liver promotes inflammation and destroys liver cells, making it difficult for the liver to function efficiently.

NASH can further progress to scarring of the liver, which leads to cirrhosis, which is a chronic liver disease that causes degeneration of cells and fibrous thickening of tissue, among other severities. However, the condition does not always worsen. NASH is identical to the type of liver disease induced by chronic, excessive drinking. However, NASH can also happen to people who do not consume alcohol.

Chronic liver inflammation can harm the organ, leading to cirrhosis and finally liver failure, if not treated timely. In order to treat NASH, it is important to address its causes and risk factors, which include reducing body fat. Diabetes type 2 and metabolic syndrome, high cholesterol, high triglycerides, and obesity are some the key factors that lead to NASH and liver damage.

Non-alcoholic steatohepatitis (NASH) treatment market is expected to grow significantly due to the increasing prevalence of obesity and diabetes due to sedentary lifestyles, increased consumption of processed food and alcohol.

Diagnosis of the Disease

A physical exam and a study of the patient's medical history are initially done for the diagnosis. If NAFLD or NASH is suspected, blood tests will be performed to establish how well the liver is functioning. Magnetic resonance imaging (MRI) or ultrasound may also be utilised to aid the diagnosis. 

A liver biopsy will also be performed if NASH is suspected. A needle is used to extract a small bit of tissue from the liver, which is subsequently inspected under a microscope. This allows the doctor to see if there is any scarring or inflammation of the liver tissue. During the liver biopsy, patients are usually anaesthetised since it is an invasive process.

The Fatty Liver Program additionally employs MR-EFF (Elastography Fat Fraction) technology to evaluate the quantity of fat and scarring present. This non-invasive diagnostic technology has the potential to eliminate the necessity for a liver biopsy.

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According to the global non-steatohepatitis (NASH) treatment market research report, the market can be categorised into the following segments: 

Market Breakup by Drug Classification

• Insulin Sensitizer
  • Ocaliva Thiazolidinediones
  • Biguanides 
  • Gucagon-like Peptide-1 Receptor Agonists
  • Dipeptidyl Peptidase IV Inhibitors
• Farnesoid X Receptor Agonists
  • Ocaliva
• Phenylimidazoles
  • Selonsertib
• Vitamin E and Pioglitazone

• Elafibranor

• Cencicriviroc

• Others

Market Breakup by Diagnosis

• Blood Tests

• CT Scan

• MRI Scan

• Abdominal Ultrasound

• Liver Biopsy

Market Breakup by Sales Channel

• Hospital Pharmacy

• Retail Pharmacy

• Online Provider

Market Breakup by Treatment Channel

• Public

• Private

Market Breakup by Region

• North America
  • United States of America
  • Canada
• Europe
  • United Kingdom
  • Germany
  • France
  • Italy
  • Others
• Asia Pacific
  • China
  • Japan
  • India
  • ASEAN
  • Australia
  • Others
• Latin America
  • Brazil
  • Argentina
  • Mexico
  • Others
• Middle East and Africa
  • Saudi Arabia
  • United Arab Emirates
  • Nigeria
  • South Africa
  • Others

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Global Non-Alcoholic Steatohepatitis Epidemiology

Non-alcoholic fatty liver disease is widespread. According to researchers, up to 25.2% of adults globally have NAFLD, although only 1.5-6.45% of those have NASH. 

NAFLD and NASH were found in 54% and 65.26% of type 2 diabetes mellitus patients, respectively. The global prevalence of NAFLD is relatively high, yet it disproportionately affects people of Hispanic descent, notably Mexicans. The increased frequency of obesity and metabolic syndrome in the context of high genetic vulnerability could explain this.

Global Non-Alcoholic Steatohepatitis Market Drivers

A rise in medical costs and rise in obesity and diabetes are the major factors influencing the non-alcoholic steatohepatitis market growth during the forecast period. Lack of access to medical care and inactive lifestyle will further accelerate the growth of the non-alcoholic steatohepatitis treatment market. 

As part of ongoing research projects and advanced study for diagnosis and drug development therapies, the growth of the non-alcoholic steatohepatitis treatment market is also expected to propel further during the forecast period. It is also possible that in the near future, more precise methods of diagnosing NASH and NAFLD will lead to the expansion of the non-alcoholic steatohepatitis treatment market.

The slow drug approval process is one of the primary factors that is restraining the growth of the market. 

Asia Pacific is Dominating the Global Non-Alcoholic Steatohepatitis Treatment Market

North America accounted for the largest share of the global market, almost 79.62%, in 2021. This can be attributed to the region's high disease burden, higher healthcare expenditure, improved patient awareness. The United States had the greatest prevalence of NASH cases, followed by Japan.

Among the European countries, Spain had the lowest prevalence of NASH, whereas Germany had the highest. The Asia Pacific region is predicted to witness significant growth during the forecast period. This is particularly common in nations with a high prevalence of NASH, such as Japan.

Therapeutic Landscape

NASH is characterised by lobular inflammation and hepatocellular distension, which can lead to liver cirrhosis.

In most patients, diet and lifestyle changes are not possible, so NASH needs to be treated with drugs. The progression of disease is characterised by insulin resistance, oxidative stress, and activation of inflammatory cytokines.

NASH was first treated with Thiazolidinediones like Pioglitazone and antioxidants like vitamin E. It is caused by a number of different pathways, including metabolic homeostasis, inflammation, oxidative stress, and liver fibrosis. Several new molecules have been developed in recent years that target these pathways. 

Placebo-controlled phase IIb clinical trial, Obeticholic acid (INT-747) and Elafibranor (GFT-505) showed promising results. A phase III study is currently taking place to determine whether they are safe and effective. There are phase 1 and phase 2 trials currently being conducted for potential treatments for NASH.

Emerging Therapies and Clinical trials

Non-alcoholic steatohepatitis (NASH) does not currently have FDA approved treatment but various companies are working to develop new drugs using organic and inorganic methods. There are currently more than 50 pipeline candidates.

Due to the issues such as the lack of licenced medications, the high disease burden, and difficult diagnostic techniques, the NASH therapeutic market has significant unmet needs. Off-label medications such as Pioglitazone and Vitamin E currently dominate the global market. These are regularly recommended medications in this field around the world. To meet the unmet need, prominent market participants are investing extensively in R&D operations to discover innovative therapies for NASH treatment. 

A key factor supporting the growth of the pipeline for non-alcoholic steatohepatitis treatments is the increase in research incentives and funding. It is expected that several clinical candidates will reach the global market within the next eight years after they reach the final stages of development.

Clinical Trials:

• In a phase 3 metacenter trial, Intercept Pharmaceuticals is testing its lead molecule, a farnesoid X receptor agonist.

• Genfit's Elafranor is a phase 3 drug that is a peroxisome-activated receptor alpha/delta. Two other drugs are also in phase 3 trials, Tobira Therapeutics' Cenicriviroc and Gilead's selonsertib. In the pipeline of drugs for non-alcoholic steatohepatitis, late-phase failures carry huge financial costs to their sponsors.

• In May 2023, Pfizer Inc., a pharmaceutical and biotechnology company, said that the FDA has approved ervogastat and clesacostat for the treatment of non-alcoholic steatohepatitis (NASH). A combination therapy called Fast Track, presented by Pfizer, is being tested in patients with non-alcoholic steatohepatitis (NASH) and liver fibrosis. In its decision, the FDA considered Pfizer's nonclinical studies and the results of the Phase 2a clinical trial of ervogastat/clesacostat and concluded that treatment with it reduced liver fat with a favourable safety and tolerability profile. An ongoing Pfizer study of ervogastat/clesacostat aims to evaluate the therapy's efficacy in improving non-alcoholic steatohepatitis or liver fibrosis. The study is expected to be completed by 2024.

Research and development investment and increasing interest in growth strategies by industry experts will create favorable conditions for global non- steatohepatitis treatment market expansion during the forecast period.

Competitive Landscape

The report gives an in-depth analysis of the key players involved in the global non-alcoholic steatohepatitis (NASH) treatment market, sponsors manufacturing the drugs, and putting them through trials to get FDA approvals. The companies included in the market are as follows: 

• Genfit S.A.

• Allergan Plc. (AbbVie Inc.)

• Zydus Lifesciences Ltd.

• Conatus Pharmaceuticals, Inc.

• Galmed Pharmaceuticals Ltd.

• NeuroBo Pharmaceuticals Ltd.

• Gilead Sciences, Inc.

• Pfizer Inc.

• Takeda Pharmaceutical Company Limited.

• Novartis AG

• Icon Plc.

• Novo Nordisk A/S

• GlaxoSmithKline Plc

Key Highlights of the Report