Hepatic encephalopathy (HE) is the leading cause of mortality in patients suffering from acute liver failure and also in those patients suffering from liver cirrhosis and associated with end stage liver disease. The person suffering from hepatic encephalopathy loses the ability to metabolize ammonia, which results in the buildup of ammonia in various tissues and organs of the body. Moreover, ammonia crosses the blood–brain barrier and thus cause neurocognitive impairment. Hepatic encephalopathy can be classified into two types: covert hepatic encephalopathy (CHE) and overt hepatic encephalopathy (OHE), out of which, overt hepatic encephalopathy is associated with high rates of mortality and poor quality of life, as compared to covert hepatic encephalopathy (CHE).
Global Hepatic Encephalopathy Market - Impact of the Coronavirus (COVID-19) Pandemic
COVID-19 pandemic is expected to hamper growth of the global hepatic encephalopathy market during the forecast period. For instance, according to the National Center for Biotechnology Information, 23rd September 2020, the coronavirus (COVID-19) pandemic led to the imposing of lockdown in various countries across the globe, which has impacted the financial status of businesses in all sectors. The private healthcare sector is one of the sectors, which has been majorly impacted by the pandemic. The lockdowns in various countries have created an economic burden on the private healthcare sector. Healthcare providers are facing challenges with regards to manpower, equipment, consumables, and other resources to ensure safety of patients with other diseases, and declining outpatient’s visits, among others.
Moreover, according to the same source, the pandemic has negatively impacted the development, production, and supply of drugs, and affected growth of the healthcare segment of various companies across the globe. This has led to closure of industrial establishments, except manufacturing of essential commodities and disruption in supply chain of products. For instance, according to U.S. Food and Drug Administration (FDA), 18th September 2020, in the U.S. alone, there were 148 antibiotic shortages from 2001 to 2013, and a recent penicillin shortage affected at least 39 countries throughout Europe, the Americas, and Asia Pacific. As of June 29, 2020, 10.5% of all drug shortages listed by the U.S. FDA were antibiotics.
The global hepatic encephalopathy is estimated to be valued at US$ 355.4 Mn in 2020 and is expected to exhibit a CAGR of 5.3% over the forecast period (2020-2027).
Figure 1: Global Hepatic Encephalopathy Market Share (%) Analysis, By Drug Class, 2020
Market players are indulged in conducting research and development for testing the safety and efficacy of drug candidate for the treatment of liver diseases and this is expected to drive growth of the global hepatic encephalopathy market over the forecast period.
The increasing research and development activities for the treatment of liver diseases is expected to drive the global hepatic encephalopathy market growth over the forecast period. For instance, in March 2020, Bausch Health Companies Inc. announced positive results for the Phase II study for the combination therapy, which included rifaximin in combination with the lactulose. The trial was carried out to study the effectiveness of combination therapy for the treatment of Overt Hepatic Encephalopathy (OHE). Moreover, in January 2017, Ocera Therapeutics, Inc. announced positive results for its STOP-HE Phase IIb Study which determined the safety and efficacy of Ornithine Phenylacetate (OCR-002), when administered intravenously, in hospitalized patients with hepatic encephalopathy (HE).
|Base Year:||2019||Market Size in 2020:||US$ 355.4 Mn|
|Historical Data for:||2017 to 2019||Forecast Period:||2020 to 2027|
|Forecast Period 2020 to 2027 CAGR:||5.3 %||2027 Value Projection:||US$ 511.6 Million|
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, Norgine B.V., Abbott Laboratories, and QR Science and Technology Development Co. Ltd.
|Restraints & Challenges:||
Market players are focused in submitting the abbreviated new drug application (ANDA) to the regulatory authorities for gaining approval for the generic drug for the treatment of hepatic encephalopathy, which is expected to spur growth of the hepatic encephalopathy market over the forecast period.
Market players are involved in submitting the abbreviated new drug application (ANDA), which is an important step for launching new drugs in the market. For instance, in February 2016, Allergan plc announced that the U.S. Food and Drug Administration (FDA) accepted its abbreviated new drug application (ANDA) for gaining approval to market generic rifaximin tablets, 550 mg, which is indicated for the treatment of overt hepatic encephalopathy (HE) recurrence in adults.
Global Hepatic Encephalopathy Market - Restraints
High cost of rifaximin for the treatment of hepatic encephalopathy is one of the factors that is expected to restrain growth of the market. For instance, according to the National Center for Biotechnology Information: 2017, hepatic encephalopathy is the second most common reason for hospitalization in patients suffering from liver cirrhosis, in the U.S., after ascites. According to the same source, the national expenditures for U.S., related to hospitalizations for hepatic encephalopathy have been estimated to range from around US$ 1 billion per year to above US$ 7 billion per year. Moreover, according to the World Journal of Gastrointestinal Pharmacology and Therapeutics: August 2012, various research studies would propose long-term, probably life-long, rifaximin therapy for preventing hepatic encephalopathy recurrence, as liver cirrhosis is an irreversible disease. The above factor is expected to restrain the global hepatic encephalopathy market over the forecast period.
Global Hepatic Encephalopathy Market – Regional Analysis
North America is expected to dominate the global hepatic encephalopathy market, owing to the increasing prevalence of liver diseases in the region. For instance, in the U.S., according to the statistics provided by the Centers for Disease Control and Prevention (CDC), in 2017, in the U.S.,around 4.5 million adults were diagnosed with liver diseases. The number of deaths due to chronic liver disease and cirrhosis accounted for 40,545 in 2017 in the U.S. Furthermore, according to the data published in American Liver Foundation in 2017, hepatitis C infection caused by hepatitis C virus (HCV), 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.
Moreover, Europe is also an emerging hepatic encephalopathy market, owing to the increase in the research and development activities for the treatment and management of liver diseases. For instance, in 2019, ALIVER, a research and awareness project from the European Union's Horizon 2020 research and innovation program received funding of US$ 8.5 million for the project. ALIVER consortium developed a novel and innovative liver dialysis machine that will help the liver to naturally regenerate and to keep patients alive and healthy until a liver donor is available. The project was initiated on January 1, 2017 and ended on September 30, 2020.
Figure 2: Global Hepatic Encephalopathy Market Value (US$ Mn), by Region, 2020
Global Hepatic Encephalopathy Market – Competitive Landscape
Major 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, Norgine B.V., Abbott Laboratories, and QR Science and Technology Development Co. Ltd.
Hepatic encephalopathy (HE) is the complication of advanced liver disease. Hepatic encephalopathy is a major challenge to the healthcare system due to frequent hospital contacts and admissions. Hepatic encephalopathy can be further divided into type A, type B, and type C that results from acute liver failure, portosystemic encephalopathy (PSS), and liver cirrhosis, respectively.
Key players are indulged in conducting clinical trials for the development of new therapeutic products for the treatment for liver diseases, which is expected to drive the global hepatic encephalopathy market growth over the forecast period. For instance, in December 2019, Kaleido Biosciences, Inc., a clinical-stage healthcare company announced positive results from a proof-of-concept clinical study, in which they used KB174, a novel microbiome metabolic therapy (MMT) in combination with a 15N-labeled tracer, a biomarker of microbiome ammonia production, in patients with liver cirrhosis. The treatment reduced the 15N urinary output and was well tolerated among the patients.
Market players are engaged in launching new products, in order to expand their market share, which is expected to spur growth of the market over the forecast period. For instance, in April 2015, Lupin Pharma Canada Limited, a subsidiary of Lupin Limited, launched Zaxine, indicated for the treatment of hepatic encephalopathy, under a strategic licensing agreement with the Salix Pharmaceuticals Inc. The agreement granted Lupin Pharma Canada Limited exclusive rights for the promotion, distribution, and marketing of Zaxine in Canada.
Key features of the study:
“*” marked represents similar segmentation in other categories in the respective section.