NON-ALCOHOLIC STEATOHEPATITIS (NASH) THERAPEUTICS AND DIAGNOSTICS MARKET ANALYSIS

The global non-alcoholic steatohepatitis (NASH) therapeutics and diagnostics market was valued at US$ 14,624.2 Mn in 2022 and is forecast to reach a value of US$ 63,354.6 Mn by 2030 at a CAGR of 20.13% between 2023 and 2030. The global non-alcoholic steatohepatitis (NASH) therapeutics and diagnostics market is experiencing strong growth due to the rise in NASH-affected population and rise in diabetic and obese population across the globe. Moreover, increase in demand for safe and effective NASH therapeutics and diagnostics and initiatives by government/non-government organizations is expected to boost growth of the market. However, factors such as lack of effective diagnostics for NAFLD and slow advancements in the therapeutic field and are expected to hamper the growth of the market.

Global Non-alcoholic Steatohepatitis (NASH) Therapeutics and Diagnostics Market: Regional Insights

Based on geography, the global non-alcoholic steatohepatitis (NASH) therapeutics and diagnostics market is segmented into North America, Latin America, Europe, Asia Pacific, and Middle East & Africa.

Among regions, North America is expected to gain highest share in the market over the forecast period due to the rise in NASH-affected population and increase in diabetic and obese population in the region, especially in the U.S. NASH is an advanced form of non-alcoholic fatty liver disease (NAFLD). For instance, according to the American Liver Foundation, NAFLD is a most common chronic liver condition in the U.S. More than 25% of adults in the U.S. have NAFLD. Of those with NAFLD, more than 20% have NASH (5% of adults in the U.S.). This in turn has increased the demand for NASH therapeutics and diagnostics in the U.S.

Europe is also expected to witness significant growth in the global non-alcoholic steatohepatitis (NASH) therapeutics and diagnostics market owing to the increase in prevalence of diabetes, rise in NASH-affected population, and rise in demand for safe/effective therapeutics and diagnostics in the region. For instance, according to the European Federation of Pharmaceutical Industries and Associations (EFPIA), NASH prevalence is 10 million, or around 18% of the EU population and its prevalence in European countries is expected to increase by around 40% by 2030. It is becoming the leading cause for liver transplants. This in turn is driving the market growth.

Figure 1. Global Non-alcoholic Steatohepatitis (NASH) Therapeutics and Diagnostics Market Share (%), by Region, 2023

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Global Non-alcoholic Steatohepatitis (NASH) Therapeutics and Diagnostics Market Drivers:

Rise in NASH-affected population to propel market growth

One of the key factors expected to augment the growth of the global non-alcoholic steatohepatitis (NASH) therapeutics and diagnostics market over the forecast period is the rise in NASH-affected population across the world. According to the Global Liver Institute (or International NASH Day), around 25-30% of people worldwide currently have NAFLD and around 2-6% have NASH, and the prevalence of NASH could increase by over 50% by 2030. This in turn is expected to increase the demand for safe and effective NASH therapeutics and diagnostics, driving the growth of the NASH therapeutics and diagnostics market.

Increase in diabetic and obese population to boost market growth

Another factor which is driving the growth of the global non-alcoholic steatohepatitis (NASH) therapeutics and diagnostics market is the rise in diabetic and obese population across the globe. For instance, it is common for patients to have both NASH and diabetes and, individuals with both conditions have a higher risk of liver-related and non-liver related illness and premature death than those without liver disease. NASH is also closely related to triple epidemic of obesity. According to the Global Liver Institute, over 9.3% of the global population (463 million people) had diabetes in 2019 and project that number to increase 25% by 2030 and 51% by 2045.

Global Non-alcoholic Steatohepatitis (NASH) Therapeutics and Diagnostics Market Opportunities:

Increase in demand for safe and effective NASH therapeutics and diagnostics is expected to offer significant growth opportunities for players in the global non-alcoholic steatohepatitis (NASH) therapeutics and diagnostics market. For instance, in May 2022, Pfizer Inc. announced that U.S. Food and Drug Administration (FDA) granted Fast Track designation to Pfizer’s investigational combination (ervogastat/clesacostat) therapy for the treatment of NASH. Receiving the Fast Track designation from FDA reinforces Pfizer’s belief in ervogastat/clesacostat as a potential treatment for NASH, a serious, progressive liver disease with no currently approved therapies.

Favorable initiatives by government/non-government organizations are expected to offer lucrative growth opportunities for players in the global non-alcoholic steatohepatitis (NASH) therapeutics and diagnostics market. Because NASH symptoms are often not overt, it is often underdiagnosed and underreported. For instance, in June 2018, the public education campaign, International NASH Day (the NASH Day), is launched to raise visibility and urgency around fatty liver disease and its more advanced form, nonalcoholic steatohepatitis (NASH), which affects more than 115 million people around the world. This in turn is driving the market growth.

Global Non-alcoholic Steatohepatitis (NASH) Therapeutics and Diagnostics Market Trends:

Increase in focus on disease diagnosis is a recent trend

With the increase in the prevalence of NASH, the demand for novel therapeutics and diagnostics is also increasing at a rapid pace. NASH is diagnosed when microscopic examination of the tissue shows inflammation and damage to the liver cells along with fat. Players in the market are focusing on developing novel diagnostic tests, which can directly target the developed markets and benefit both, patients, and the firm. This trend is expected to continue over the forecast period, driving the growth of the NASH therapeutics and diagnostics market.

Increasing awareness about NASH is another trend

There are an increasing number of awareness programs for the disease to help patients, healthcare professionals, and researchers better diagnose/treat NASH. For instance, International NASH Day is an initiative started by the Global Liver Institute to raise awareness of the growing worldwide epidemic of non-alcoholic fatty liver disease (NAFLD) and its more advanced form, non-alcoholic steatohepatitis (NASH). This trend is also expected to continue during the forecast period, driving the growth of the NASH therapeutics and diagnostics market.

Global Non-alcoholic Steatohepatitis (NASH) Therapeutics and Diagnostics Market Restraints:

Lack of advancements in therapeutic field to hinder market growth

One of the key factors expected to hamper the growth of the global non-alcoholic steatohepatitis (NASH) therapeutics and diagnostics market is the slow advancements in the therapeutic field. It has been observed that an increasing number of people worldwide are being diagnosed with NASH and NAFLD each year, and the only primary method of treatment is weight loss. Moreover, it has been observed that after almost 35 years its formal description and 15 years of intense study from researchers worldwide, there is still no approved drug for the treatment of NASH.

However, with the increase in research and development (R&D) and technological advancements, the market is expected to witness robust growth during the forecast period.

Lack of effective diagnostics for NAFLD to hamper market growth

Another factor which is hampering the growth of the global non-alcoholic steatohepatitis (NASH) therapeutics and diagnostics market is the lack of effective diagnostics for non-alcoholic fatty liver disease (NAFLD). Screening is not generally recommended, and thus, doctors use medical history, physical exams, and tests to diagnose NAFLD and NASH. Thus, diagnosis and staging of NAFLD remain complex. Furthermore, there are no FDA-cleared diagnostic tests, specifically designed for the identification of NASH. This in turn is restraining the market growth.

Figure 2. Global Non-alcoholic Steatohepatitis (NASH) Therapeutics and Diagnostics Market Share (%), by Product, 2023

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Global Non-alcoholic Steatohepatitis (NASH) Therapeutics and Diagnostics Market Segmentation:

The global non-alcoholic steatohepatitis (NASH) therapeutics and diagnostics market report is segmented into Therapeutics, Diagnostics, and Geography.

Based on Therapeutics, the non-alcoholic steatohepatitis (NASH) therapeutics and diagnostics market is segmented into Elafibranor, Ocaliva, Selonsertib, Cenicriviroc, Emricasan, and Other Therapeutics. Out of which, Elafibranor Segment is expected to dominate the market during the forecast period and this is attributed to the increase in demand for novel therapeutics. Elafibranor has achieved the FDA-recommended endpoint of NASH resolution without worsening of fibrosis, which is the primary endpoint of the ongoing global Phase 3 clinical trial.

Ocaliva Segment is also expected to witness significant growth in the near future and this is owing to the increase in prevalence of liver diseases. Ocaliva has been approved by FDA to treat different type of liver disorder. It is in Phase III for NASH, and Intercept has manufactured the drug under the brand name Ocaliva.

Based on Diagnostics, the market is segmented into Imaging Techniques, Diagnostic Tests, and Biopsy. Out of which, Imaging Techniques Segment is expected to dominate the market over the forecast period and this is attributed to the increase in prevalence of NAFLD and NASH. Imaging modalities, such as Ultrasound, MRI, and CT can be used to diagnose NAFLD.

Diagnostic Tests Segment is also expected to witness robust growth in the near future and this is due to the increase in demand for novel diagnostics. The available diagnostics tests include blood tests and imaging tests. Liver biopsy is also used to diagnose NAFLD and NASH.

Global Non-alcoholic Steatohepatitis (NASH) Therapeutics and Diagnostics Market: Key Developments

In March 2019, Madrigal Pharmaceuticals, Inc. announced that it has initiated its Phase 3 trial in non-alcoholic steatohepatitis (NASH) with its once daily, oral thyroid hormone receptor beta selective agonist, MGL-3196 (resmetirom). This double-blind, placebo-controlled study will be conducted at more than 150 sites in the United States and the rest of the world.

In March 2019, Genfit started trading on NASDAQ, and issued new shares in its existing Euronext Paris listing. The company raised a total of EUR 120 million (about US$ 135 million).

In February 2019, Intercept Pharmaceuticals, Inc. announced positive results from its pivotal Phase 3 REGENERATE study of obeticholic acid (OCA) in patients with liver fibrosis owing to non-alcoholic steatohepatitis (NASH).

In October 2018, Novartis entered into a clinical development agreement with Pfizer, which will include a study combining tropifexor and one/more Pfizer compounds for the treatment of NASH.

Global Non-alcoholic Steatohepatitis (NASH) Therapeutics and Diagnostics Market: Key Companies Insights

The global non-alcoholic steatohepatitis (NASH) therapeutics and diagnostics market is highly competitive. This is attributed to the rise in demand for safe and effective NASH therapeutics and diagnostics, as a result, market players are focusing on launching novel products in the market.

Some of the key players in the global non-alcoholic steatohepatitis (NASH) therapeutics and diagnostics market are Novartis AG, Allergan Plc., Viking Therapeutics, Merck & Co., Zydus Cadila, Novo Nordisk A/S, GENFIT SA, Gilead Sciences Inc., Galmed Pharmaceuticals, Madrigal Pharmaceuticals, and Intercept Pharmaceuticals Inc., among others.

*Definition: Non-alcoholic steatohepatitis (NASH) is inflammation of the liver caused by excess fat cells in it (fatty liver disease). It is caused when that extra fat turns into inflammation (swelling in the liver) and fibrosis (scarring) of the liver. NASH is a hidden epidemic, and thus, there is an increase demand for safe and effective therapeutics and diagnostics.