Market Challenges And Opportunities

Primary Biliary Cirrhosis Drugs Market – Driver

Currently, only two FDA approved drugs, Ursodeoxycholic acid and Ocaliva, are available in market to reduce cirrhosis progression. However, large number of drugs are in clinical trials and this is expected to propel growth of the primary biliary cirrhosis drug market in the near future. For instance, in 2017, NGM Biopharmaceuticals, Inc. completed phase II clinical trials for its candidate drug NGM 282, an engineered variant of human hormone FGF19, to eliminate bile acid toxicity in primary biliary cirrhosis patients. NGM282 has a unique opportunity to leverage the dual targets of FGF19 without the potential non-tumorigenic property.

Moreover, increasing FDA approvals is also expected to be major factor enhancing growth of the primary biliary cirrhosis drug market. For instance, in 2016, Intercept Pharmaceuticals, Inc., received FDA approval for its Ocaliva, obeticholic acid based drug, in combination with ursodeoxycholic acid for adults with inadequate response to ursodeoxycholic acid based monotherapy for the treatment of primary biliary cirrhosis. As on March 2018, University of Florida is investigating Fenofibrate Insoluble Drug Delivery - Micro Particle on patients with incomplete response to ursodeoxycholic acid. Moreover, Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran, is investigating Bezafibrate in combination with ursodeoxycholic acid for the treatment of primary biliary cirrhosis, which is in phase III clinical trials as on 2016. Furthermore, from the same source, it is estimated that 30 to 50% of patients with primary biliary cirrhosis shows partial response to ursodeoxycholic acid, which demands for combinational treatment. Janssen Research and Development also evaluated efficacy and safety of Ustekinumab for primary biliary cirrhosis with inadequate response to ursodeoxycholic acid. The research was in phase II clinical trial as of June 2016. These increasing pipeline products are expected to aid in growth of the primary biliary cirrhosis drugs market over the forecast period.

Increasing incidence of primary biliary cirrhosis is expected to further drive growth of the primary biliary cirrhosis drugs market. Primary biliary cirrhosis occurs in patients aged 40–60 years and affects women more often than men. According to American Association for the Study of Liver Diseases (AASLD) published in 2016, prevalence of primary biliary cirrhosis (PBC) in the U.S. was estimated to vary from 1.91 to 40.2 per 100,000 persons. In UK, the prevalence of PBC is estimated to be 12.9 per 100,000 population, of which 90% of cases where reported in women. Furthermore, increasing incidence of autoimmune disease, tobacco smoking, tonsillectomy or urinary tract infection (in women) are risk factors, for primary biliary cirrhosis.