High Prevalence of Primary Biliary Cholangitis and Approval and Launch of New Drugs to Augment Growth of Primary Biliary Cirrhosis Drugs Market

 

Primary biliary cholangitis, also known as primary biliary cirrhosis, is an autoimmune disease of the liver. The auto-immune disorder can have a number of symptoms such as abdominal pain, fever, nausea, vomiting, abdominal bloating, diarrhea, liver tenderness or enlargement, jaundice, and ascites. In most of these symptoms, the patient may be experiencing inflammation at an early stage of the illness, although in some cases, symptoms do not appear until the disease has advanced to a more serious state. A definitive diagnosis can only be made by performing blood tests and ultrasound studies in order to determine the progression of the illness and its effects on the body. At an early stage, most patients who experience mild to moderate symptoms of primary biliary cholangitis exhibit no symptoms, whereas in some cases, symptoms manifest very quickly and rapidly worsen. In both conditions, the majority of affected individuals undergo treatment that is aimed at relieving pain and treating any complications that might occur.

Market Dynamics

High prevalence of primary biliary cholangitis is expected to propel growth of the primary biliary cirrhosis drugs market. For instance, according to the study, ‘Epidemiology and clinical course of primary biliary cholangitis in the Asia-Pacific region: a systematic review and meta-analysis’, published in Hepatology International in September 2019, the overall prevalence of primary biliary cholangitis was 118.75 cases per million in the Asia Pacific region, with the high, medium and low prevalence being in Japan and China (191.18 cases per million), New Zealand (99.16 cases per million) and South Korea and Australia (39.09 cases per million), respectively.

Among regions, Europe is expected to witness significant growth in the primary biliary cirrhosis drugs market, owing to approval and launch of new products in the region. For instance, in December 2020, the European Commission, following the positive opinion from the Committee for Orphan Medicinal Products of the European Medicines Agency, granted orphan drug designation to Genkyotex’s lead drug candidate, setanaxib, for the treatment of primary biliary cholangitis.

Competitive Analysis

Major players operating in the primary biliary cirrhosis drugs market include, Intercept Pharmaceuticals, Inc., Johnson & Johnson, Zydus Cadila, GlaxoSmithKline Plc, Dr. Falk Pharma GmbH, Genkyotex, and Enanta Pharmaceuticals, Inc.

Major players operating in the primary biliary cirrhosis drugs market are focused on approval and launch of new products to expand their product portfolio. For instance, in December 2020, the United States Food and Drug Administration granted "Fast Track Designation" to Zydus Cadila’s Saroglitazar Mg for the treatment of patients with primary biliary cholangitis.