Non-alcoholic Steatohepatitis (NASH) Biomarkers Market : Business Growth, Development Factors, Applications, and Future Prospects

Non-alcoholic Steatohepatitis (NASH) Biomarkers Market: Introduction

According to the report, the global non-alcoholic steatohepatitis (NASH) biomarkers market was valued at ~US$ 300 Mn in 2018 and is projected to expand at a high CAGR during the forecast period. Non-alcoholic steatohepatitis is an advanced stage of non-alcoholic fatty liver disease (NAFLD), which arises when the excess fat accumulation causes inflammation and damage leading to liver scarring. A biomarker is the most effective diagnosis tool for measuring the biological state and is termed as an indicator for measuring normal biological processes and pathogenic process in the body. Biomarker tools available for diagnosing NASH condition are known as non-invasive tools and few of them are serum biomarkers, biomarker panels, fibrosis biomarkers, Imaging Biomarkers, and others. The others category includes gene biomarkers and oxidative stress biomarkers. Rise in research & development is likely to offer promising biomarkers for the accurate diagnosis of NASH condition.

The global non-alcoholic steatohepatitis (NASH) biomarkers market is driven by the increase in prevalence of NAFLD & NASH disease; large unmet needs in terms of disease epidemiology and available diagnostic and therapeutic tools; rise in demand for non-invasive diagnostic methods; increase in geriatric population; growing incidences of obesity and type 2 diabetes; awareness about diagnostic tools; and shift of government focus toward providing better healthcare facilities. These factors are likely to propel the non-alcoholic steatohepatitis (NASH) biomarkers market across the globe.

North America dominated the global non-alcoholic steatohepatitis (NASH) biomarkers market in 2018 and the trend is anticipated to continue during the forecast period. The region’s dominance can be ascribed to the availability of innovative non-invasive biomarkers, presence of key players, growing NASH patient population, technological advancements, awareness about the diagnosis procedure, increase in obesity and type 2 diabetes, and surge in awareness about various causes leading to fatty liver. However, limited accuracy of NASH diagnostic tools such as biomarkers in proper diagnosis are likely to restrain the global non-alcoholic steatohepatitis (NASH) biomarkers market during the forecast period.

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Rise in Prevalence of NAFLD and NASH to Propel Global Market

The incidence rate of non-alcoholic liver diseases has increased significantly. Patients with obesity and type 2 diabetes are estimated to be more prone to NAFLD and other liver diseases. This is expected to augment the prevalence of non-alcoholic liver diseases. Changes in lifestyle and high pollution levels are anticipated to boost the prevalence of nonalcoholic liver diseases. This, in turn, is estimated to drive the NASH biomarkers market in the near future.

As per research, worldwide prevalence of NAFLD was estimated to be 25.2%, and NASH was estimated to be in a range of 1.5% to 6.45% respectively in 2019. NASH prevalence across the globe is expected to grow by 63% by 2030.

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Increase in Prevalence of Obesity & Type 2 Diabetes to Drive Global Market

Obesity and Type 2 diabetes are the two major lifestyle diseases, which are likely to increase the prevalence of NASH and NAFLD condition. As per NCBI, prevalence of obesity has tripled since 1980 and nearly one-third of the world population is categorized as overweight or obese. According to the Centers for Disease Control and Prevention (CDC), in the U.S., prevalence of obesity was estimated to be 42.4% from 2017 to 2018. The prevalence of severe obesity in the adults in the U.S. was estimated around 9.2% in 2017–2018. Growing incidence of obesity across the population is likely to increase the NASH incidence in the population. People suffering from type 2 diabetes are on verge of developing NAFLD and further into NASH condition. As per the International Diabetes Federation, in 2019, approximately, 463 million adults were suffering from diabetes and the patient population is likely to rise by 700 million by 2045. This statistics is likely to boost the risk of developing NASH condition. Around 70% to 80% of the obese are estimated to suffer from NAFLD, while around 55% of patients with type 2 diabetes are prone to NAFLD.

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Rise in Demand for Non-invasive Diagnostics to Drive Global Market

Liver biopsies are the gold standard in diagnosis and monitoring of NASH in the absence of any alternative diagnostic tools. Liver biopsy is a painful procedure for most patients; bleeding occurs in most cases. The mortality rate associated with liver biopsy stands at one in 10,000. Furthermore, liver biopsies are not entirely accurate, for the diagnosis of the NASH condition. These drive the need of developing non-invasive diagnostic techniques, which includes novel biomarkers for diagnosis and routine monitoring of NASH. Various key players in the pharmaceutical and biotechnology industries are investing in this field. The NASH therapeutics market is projected to reach US$ 35 Bn to US$ 40 Bn by 2024. Companies such as Allergan, Novo Nordisk, and Genfit, and Intercept are investing significantly in the NASH therapeutics market. This is likely to benefit companies offering innovative and emerging noninvasive diagnostic tools such as imaging biomarkers, and gene biomarkers.

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Non-alcoholic Steatohepatitis (NASH) Biomarkers Market: Prominent Regions

In terms of region, the global non-alcoholic steatohepatitis (NASH) biomarkers market has been segmented into North America, Europe, Asia Pacific, Latin America, and Middle East & Africa. North America dominated the global non-alcoholic steatohepatitis (NASH) biomarkers market in 2018, followed by Europe. North America accounted for major share of the global non-alcoholic steatohepatitis (NASH) biomarkers market in 2018. This can be attributed to the large patient pool suffering from NASH and NAFLD indication, along with increasing liver diseases. Rise in prevalence of obesity and Type 2 diabetes, rise in demand of non-invasive diagnostic tool such as biomarkers, and adoption of emerging and innovative biomarkers are few major attributable factors for the NASH biomarkers market.

Technological advancements leading to the development of innovative emerging biomarkers is another major factor expected to augment the market in North America. The non-alcoholic steatohepatitis (NASH) biomarkers market in Latin America is likely to expand at a highest CAGR from 2019 to 2027. This can be attributed to rise in prevalence of NASH indication in the population in Latin America, rising liver disease, awareness about diagnosis of NASH indication, increase in healthcare expenditure, and large patient population suffering from type 2 diabetes and obesity and other metabolic syndrome.

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Mergers by Key Players to Drive Global Market
The global non-alcoholic steatohepatitis (NASH) biomarkers market is consolidated in terms of number of players. The market is dominated by key players with strong geographic presence and strong product offerings. Leading players operating in the global non-alcoholic steatohepatitis (NASH) biomarkers market include Biopredictive, Quest Diagnostics, Exalenz Bioscience Ltd, GENFIT, Siemens Healthineers, ONE WAY LIVER, S.L, Prometheus Laboratories Inc., and Gilead Sciences, Inc. Merger & acquisition is a major strategy adopted by key players offering NASH biomarkers for non-alcoholic steatohepatitis condition for faster and continuous diagnosis of the condition. For instance, in November 2019, Galectin Therapeutics entered into agreement with Siemens Healthineers, which would enable Siemens Healthineers to utilize Galectin’s Phase 2 NASH-CX clinical trial for supporting the regulatory filing of its ADVIA Centaur Enhanced Liver Fibrosis (ELF) test. This would also allow Siemens Healthineers to use ADVIA Centaur ELF test data from Galectin Therapeutics Phase 3 NASH belapectin clinical trial in the treatment of NASH liver cirrhosis.

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