Global Hepatic Encephalopathy Market – Global Industry Insights
Hepatic encephalopathy (HE) is a neuropsychiatric complication commonly associated with the liver disease: cirrhosis. The inability of the liver to metabolize ammonia results in a buildup of ammonia, which can cross the blood–brain barrier and cause significant neurocognitive impairment. A significant number of patients with cirrhosis may experience HE and may be at high risk of recurrent HE.
The severity of hepatic encephalopathy can be broadly categorized into two classes: Covert Hepatic Encephalopathy (CHE) and Overt Hepatic Encephalopathy (OHE). OHE is associated with high rates of mortality and hospitalizations and poor quality of life. Factors such as infections, gastrointestinal bleeding, metabolic disturbance, and dietary protein overload may cause OHE. According to a study conducted by the U.S. National Library of Medicine in 2016, 30 to 50% of patients who have cirrhosis during their clinical care are likely to develop OHE.
The global hepatic encephalopathy market was valued at US$ 2,408.3 Mn in 2017, and is expected to witness a CAGR of 6.3% during the forecast period (2018 – 2026).
Global Hepatic Encephalopathy Market Share (%) By Drug Class, 2018 & 2026
Source: Coherent Market Insights Analysis (2019)
Increasing number of drugs in pipeline for the treatment of HE is expected to drive the market growth during the forecast period
There are different types of therapeutic drugs in pipeline for the treatment of HE. Increasing number of products in pipeline for the treatment of HE is expected to drive growth of the market over the forecast period.
Umecrine Cognition, a Sweden-based pharmaceutical company, is developing a therapy that represents a new target class for several major central nervous system (CNS)-related disorders. The lead compound GR3027 is presently in clinical development for HE. The company plans to demonstrate Phase II data of GR3027 for the treatment of HE in 2020.
Rebiotix Inc. is developing the drug: RBX2477 that can be administered orally. The drug is presently under Phase I clinical trial. It is an antibiotic that reduces the production of ammonia by inhibiting growth of ammonia-producing colonic bacteria.
OCR-002 (Ornithine phenylacetate) is an oral drug developed by Ocera Therapeutics Inc. It is presently under Phase I clinical trial. OCR-002 is a small molecule that acts as an ammonia scavenger and decreases the abnormally increasing ammonia.
KLS-13019 is a drug developed by Kanna Life Sciences and is currently under pre-clinical phase. It is a cannabinoid, which acts on cannabinoid receptors in cells that alter the neurotransmitter release inside the brain.
Global Hepatic Encephalopathy Market Share (%) By Distribution Channel, 2018 & 2026
Source: Coherent Market Insights Analysis (2019)
Increasing prevalence of various types of liver diseases is expected to aid in the market growth
HE is a sign of poor prognosis and correlates with mortality in both patients with acute liver failure and those with cirrhosis associated with end stage liver disease. Liver cirrhosis is a gastroenterological condition that is characterized by a slow, progressive, and irreversible replacement of liver cells by fibrous tissue (scar) that prevents normal liver functioning.
According to the National Center for Biotechnology Information (NCBI): 2014, generally liver cirrhosis affects up to 1% of the U.S. and EU population. Between 180,000 and 290,000 patients with cirrhosis in the U.S. are hospitalized due to complications of HE. Once HE develops, mortality reaches 22-35% after five years. HE is also associated with increased hospitalization and treatment costs. Moreover, subtle signs of HE are observed in around 70% of patients with cirrhosis.
Furthermore, increasing number of liver failure cases is expected to drive growth of the hepatic encephalopathy market over the forecast period. For instance, according to European Association for the Study of the Liver (EASL): 2019, an estimated 170,000 patients die due to liver failure, annually in Europe. During liver failure, an accumulation of protein-bound toxins and increased susceptibility to infection cause multi-organ failure and death.
Moreover, acute liver failure that causes complications such as elevated pressure and excessive bleeding in the brain is known as fulminant hepatic failure that requires emergency hospitalization.
Among regions, North America is expected to be the most lucrative market for hepatic encephalopathy, owing to increasing prevalence of liver diseases in the U.S. For instance, according to the Centers for Disease Control and Prevention (CDC), in 2017, around 4.5 million adults were diagnosed with liver disease in the U.S. Moreover, the number of deaths due to chronic liver disease and cirrhosis accounted for 40,545 in the U.S. in 2017.
Moreover, increasing awareness programs for liver disease, liver cancer, and wellness is also expected to boost growth of the market in the U.S. For instance, America Liver Foundation, in partnership with Bayer and Gilead, organizes Liver Cancer Awareness Program annually in the month of October, in U.S. The program focuses on spreading awareness about liver cancer risks and liver wellness.
Key players operating in the global hepatic encephalopathy market include, ASKA Pharmaceutical Co., Ltd., Cosmo Pharmaceuticals N.V., Lupin Limited, Kaleido Biosciences, Kannalife Sciences, Inc., Bausch Health Companies Inc., Ferring Pharmaceuticals Inc., Mallinckrodt Pharmaceuticals, Umecrine Cognition AB, and Norgine B.V.
Hepatic encephalopathy (HE) is a common complication of advanced liver disease. HE covers a complex set of non-specific neuropsychiatric symptoms and clinical signs affecting quality of life of patients. HE is a major challenge to the healthcare system due to frequent hospital contacts and admissions. The 2014 AASLD and EASL clinical practice guidelines for managing HE recommend to classify HE according to the underlying liver disease, the severity of the manifestations, the time course, and precipitating factors. HE may be divided into type A that results from acute liver failure, type B that results predominantly from portosystemic encephalopathy (PSS), and type C that results from cirrhosis.
HE is a rare disease. Several drugs are available such as antibiotics, laxatives, probiotics, and lactulose that aid in the treatment of this disease. Key players in the market are focused on adopting acquisition strategies to expand their product portfolio. For instance, in December 2017, Mallinckrodt Pharmaceuticals announced acquisition of Ocera Therapeutics, a clinical-stage biopharmaceutical company. Ocera Therapeutics is focused on the development and commercialization of novel therapeutics for orphan and other severe liver diseases.
Hepatic encephalopathy is a syndrome majorly observed in patients suffering from liver cirrhosis, advance liver diseases, and alcohol consumption related cirrhosis. According to the data published in American Liver Foundation in 2017, hepatitis C virus (HCV) infection is the leading cause of liver cirrhosis in the U.S., followed by alcohol consumption related cirrhosis, contributing to around 20% to 25% cases of liver cirrhosis.
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