The global NASH Market size was USD 2.42 billion in 2022 and is expected to grow at a CAGR of 21% during the forecast period to reach USD 13.45 billion in 2030. This growth is driven by various factors, such as rising awareness of the disease among medical professionals and patients, the increasing prevalence of obesity and type 2 diabetes, and the absence of licensed medications for treating NASH. Non-alcoholic Steatohepatitis (NASH) is a liver disease that occurs when the liver is damaged due to a buildup of fat. It can cause liver damage, cirrhosis, and liver failure if left untreated. According to the World Health Organization (WHO), NASH is one of the most common forms of non-alcoholic fatty liver disease (NAFLD), which is estimated to affect approximately 25% of the global population.

One of the major drivers of the NASH market is the rising awareness of the disease among medical professionals and patients, which has led to a growing need for efficient therapies. As more clinical trials are conducted, and more medications receive regulatory agency approval, the market revenue growth is expected to expand. The absence of licensed medications to treat NASH is a major unmet need in the market. Currently, the standard of therapy includes dietary and activity changes that can be challenging for patients to maintain. Therefore, the need for pharmaceutical therapies that can successfully treat NASH and improve patient outcomes is increasing.

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The rising incidence of obesity and type 2 diabetes, which are significant risk factors for the development of NAFLD and NASH, is further driving revenue growth in the NASH market. According to the World Health Organization, the number of obese adults worldwide has increased by three times since 1975, totaling over 650 million people. Additionally, there are currently over 460 million diabetics globally, according to the International Diabetes Federation. The demand for NASH treatments is expected to expand as the prevalence of these illnesses continues to rise.

Another factor driving revenue growth in the NASH market is the growing amount of money pharmaceutical companies are investing in research and development. Over 60 pharmaceuticals are undergoing clinical trials for the treatment of NASH, and many businesses are actively working to create new medications for this condition. These medications target multiple processes implicated in the development of NASH, including inflammation, fibrosis, and metabolic dysfunction. The NASH market revenue growth is expected to expand as new medications are created and licensed.

However, the intricacy of the disease and the high expense of drug research are two major factors restraining revenue growth in the NASH market. The pathophysiology of NASH is not fully known, and it is challenging to find efficient pharmacological targets, making drug development difficult. Additionally, it is difficult for businesses to recoup their investment in NASH medications due to the high cost of drug research and the limited patient pool. The absence of diagnostic tools for NASH is also a factor restraining market revenue growth. The sole method for diagnosing NASH currently is a liver biopsy, which is a risky and invasive surgery. Thus, many NASH patients can go undetected, reducing the market potential for NASH medications.

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In terms of government regulations, the U.S. Food and Drug Administration has approved several medications for treating NASH, including silymarin, vitamin E, pioglitazone, and obeticholic acid. The European Medicines Agency has approved elafibranor as a treatment for NASH with fibrosis in adults. The Centers for Medicare & Medicaid Services have established policies for reimbursement of NASH treatments. CMS also requires pre-authorization from a physician before any medications are prescribed for NASH treatment.

Key Players Operating in Non-Alcoholic Steatohepatitis (NASH) Market

  • Gilead Sciences, Inc.
  • Novartis AG
  • Allergan
  • Viking Therapeutics
  • Intercept Pharmaceuticals
  • Enanta Pharmaceuticals
  • Shire Plc.
  • Conatus Pharmaceuticals Inc.
  • NGM Biopharmaceuticals
  • Galmed Pharmaceuticals Ltd.

The global Non-Alcoholic Steatohepatitis (NASH) Market has been segmented as follows:

By Type Outlook:

·         Biopsy

·         Imaging

·         Biomarkers

By Treatment Outlook:

·         Lifestyle Management

·         Pharmacotherapy

·         Others

By Distribution Channel Outlook:

·         Hospital Pharmacy

·         Retail Pharmacy

·         Online Pharmacy

Regional Outlook:

·         North America

·         Europe

·         Asia Pacific

·         Latin America

·         Middle East & Africa

Country Scope:

·         U.S.

·         Canada

·         U.K.

·         Germany

·         France

·         BENELUX (Belgium, Netherlands, Luxembourg)

·         China

·         India

·         Japan

·         South Korea

·         Brazil

·         Saudi Arabia

·         UAE

·         Turkey

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