Non-Alcoholic Steatohepatitis (NASH) Therapeutics and Diagnostics Market - Growth, Trends, and Forecasts (2023 - 2028)

The non-alcoholic steatohepatitis (NASH) market is expected to record a CAGR of 25.89% over the forecast period.

COVID-19 had a significant impact on the market over the pandemic period. As per the Wiley article published in May 2021, considering that immunological dysregulation and inflammation were linked to chronic liver disease (CLD), people with CLD were more likely to experience negative consequences after contracting COVID-19. Initial COVID-19 data also revealed that healthy infected people showed abnormal liver function tests, raising the possibility that COVID-19 was directly responsible for liver damage. Additionally, as per the article published by Wolters Kluwer Journal in November 2022, patients with or without pre-existing liver disease may present with elevated aminotransferases in COVID-19. Hence, COVID-19 significantly impacted the non-alcoholic steatohepatitis therapeutics and diagnostics market due to the liver disease risk among the infected patients. In addition, the demand for non-alcoholic steatohepatitis therapeutics is expected to remain intact due to the increasing focus on liver disease treatment and diagnosis during the post-pandemic period, thereby contributing to the growth of the market over the forecast period.

The major factors driving the market's growth are the increase in the NASH-affected population, the rising global prevalence of diabetic and obese populations, and the increasing awareness about NAFLD/NASH. For instance, as per the Global Liver Institute 2022 update, NASH is a progressive form of nonalcoholic fatty liver disease (NAFLD) and will affect more than 115 million people worldwide in 2021. The same source also reported that an estimated 357 million people will likely be affected by 2030. Also, according to the International Diabetes Federation Diabetes Atlas Tenth edition 2021, in 2021, around 537 million adults worldwide were found to have diabetes, projected to grow to 643 million by 2030 and 783 million by 2045. Such increasing prevalence of diabetes leading to the increase of non-alcoholic fatty liver diseases is expected to drive the demand for NASH diagnostics and therapeutics, thereby contributing to the market's growth.

Also, increased research and development of products by various key market players are anticipated to boost market growth. For instance, as per the report from 2021, an investigator-led Phase II trial investigating AbbVie's nonalcoholic steatohepatitis (NASH) asset cenicriviroc (CVC) in hospitalized COVID-19 patients has so far recruited 45 patients of its 183-participant target. The understanding of the pathogenesis and progression of NASH has evolved, and several promising novel therapies associated with the same are being evaluated.

However, the lack of effective diagnostics for nonalcoholic fatty liver disease (NAFLD) and slow advancements in the therapeutic field restrains the market growth.

Non-Alcoholic Steatohepatitis Therapeutics and Diagnostics Market Trends

Diagnostic Tests is Projected to Have Notable Market Growth Over the Forecast Period

The major diagnostic tests for non-alcoholic steatohepatitis (NASH) are Lipid profile tests, liver function tests, and fibrosis assessment tests. NASH is diagnosed when examination of the tissue with a microscope shows fat along with inflammation and damage to liver cells.

Increased obesity and lifestyle diseases are expected to be the major driving factors for the progression of NASH diagnostic tests, thereby driving the market's growth. For instance, as per the World Obesity Atlas 2022, annually, it is predicted that 1 in 5 women and 1 in 7 men is anticipated to be living with obesity (BMI ≥30kg/m2). Additionally, as per the same source, half of all women living with obesity are from the USA, China, India, Brazil, Mexico, Russia, Egypt, Indonesia, Iran, Turkey, and Pakistan. Half of all men living with obesity are from the USA, China, India, Brazil, Mexico, Russia, Egypt, Germany, and Turkey. As per the same source, 150 million more women than men are expected to be affected by obesity by 2030. Also, the data published by WHO in March 2022 in 2022, more than 1 billion people worldwide are obese, including 650 million adults, 340 million adolescents, and 39 million children, and this number is increasing. Thus, the increasing prevalence of obesity leading to the risk of non-alcoholic fatty liver disease is also expected to drive the demand for effective diagnostics tests, fueling segment growth.

The increasing product launches by various market players are also expected to drive the growth of the studied segment. For instance, in July 2022, SRL Diagnostics announced the launch of the 'Fatty Liver Index,'' a first-line diagnostic test for Non-Alcoholic Fatty Liver Disease (NAFLD). Fatty Liver Index (FLI) is an algorithm-based index that includes multiple parameters; results of the GGT test (gamma-glutamyl-transferase), triglycerides test (TG), weight, height, body mass index (BMI), and waist circumference for the prediction of Non-alcoholic fatty liver disease.

Hence, as per the facts mentioned above, such as rising obesity, growing demand for diagnostic tests, and increasing product launches, the diagnostic tests segment will likely boost market growth over the forecast period.

North America is Expected to Hold Significant Share in the Non-alcoholic Steatohepatitis (NASH) Therapeutics and Diagnostics Market Over the Forecast Period

The North American market is expected to grow due to the increasing prevalence of the non-alcoholic fatty liver disease, and rising demand for effective diagnostics and therapeutics. The presence of key market players along with frequent product developments in the North American countries are also expecetd to boost the growth of the market in this region. For instance, according to an NCBI study published in 2022, the number of population NASH in the United States was 1,867,000 in 2021. Furthermore, factors such as the rising prevalence of diabetic and obese populations in this region, and increased awareness of NASH and liver diseases boost the market growth in the studied region. For instance, as per the report from World Obesity Atlas 2022, the anticipated number of the female population to be affected by obesity are 64 million and the expected count for the male population is 61 million by 2030 in the United States. Also, the data published by Statistics Canada in 2022, mentioned that there were 2.37 million people suffering with diabetes in Canada in 2021. Thus, the rising orevalence of obesity and diabetes leading to the high risk of non-alcoholic fatty liver disease is expected to drive the demand for effective diagnostics and theraoeutics, thereby contributing to the growth of the market.

The presence of major market players, along with frequent product developments in North America region is also expecte to bolster the growth of the market. For instance, in March 2021, California-based DiscernDx reported that preliminary study results from its non-invasive liquid biopsy test for diagnosing early stages of nonalcoholic steatohepatitis (NASH) showed the multi-omics and machine learning combination for NASH diagnosis as an alternative to liver biopsy. Blood samples were collected from 29 centers across the US and Canada forming a cohort of 517 patients suspected of having NASH F2-F4 fibrosis grades. The liquid biopsy test's preliminary performance characterized by the area under the receiver operating characteristic (AUROC) in the development set of 90 samples showed exceptional performance in reproducing liver biopsy results, with an AUROC of 0.92. Hence this non-invasive test is likely to facilitate earlier disease diagnosis and thus more adoption of diagnostic tests like this is likely to boost the market growth.

Therefore, the factors, such as rising prevalence of liver diseases, obesity, diabetes and presence of key market players, North America is expected to register a high growth rate for the studied market over the forecast period.

Non-Alcoholic Steatohepatitis Therapeutics and Diagnostics Industry Overview

The Nonalcoholic Steatohepatitis Therapeutics & Diagnostics Market is moderately consolidated and competitive. The key market players operating in the market include Galmed, Intercept, Genfit SA, Intercept Pharmaceuticals, Inc., General Electric Company (GE Healthcare), Siemens Healthineers, Tawazun Health, and others.

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