Primary biliary cirrhosis, known as primary biliary cholangitis is a chronic liver disease, which causes liver inflammation, fibrosis, and obstruction in the bile duct leading to destruction of small bile ducts within liver. Cause for primary biliary cirrhosis can be autoimmunity, infection and/or genetic predisposition. Symptoms of primary biliary cirrhosis includes itching, osteoporosis, elevated serum cholesterol, and malabsorption of fat and fat soluble vitamins, which can advance to hepatomegaly, hyperpigmentation, splenomegaly, jaundice, sicca syndrome or Kayser-Fleischer rings. Primary biliary cirrhosis develops over time and may cause the liver to stop working completely in later stages. Most people are diagnosed early, before the disease progresses. Delay in treatment of cirrhosis can cause liver failure and a liver transplant is necessary for survival. Diagnostic tests for primary biliary cirrhosis includes examination of elevated levels of IgM immunoglobulin levels, lipids, cholesterol and bilirubin, liver biopsy, ultrasonography, CT scanning or MRI. Increasing research and development activities and rising incidence of primary biliary cirrhosis is expected to be a major driver for growth of the primary biliary cirrhosis drugs market.
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.
Primary Biliary Cirrhosis Drugs Market - Regional Analysis
Based on geography, the primary biliary cirrhosis drugs market is segmented into North America, Latin America, Europe, Middle East, Asia Pacific, and Africa. North America holds dominant position in the primary biliary cirrhosis drugs market over the forecast period, owing to increasing research and developmental activities by market players in the region. For instance, Enanta Pharmaceutical, Inc. is examining its EDP – 305, a potent FXR agonist for the treatment of primary biliary cirrhosis, which was in phase II clinical trials in 2017. However, Asia Pacific is expected to witness fastest growth in primary biliary cirrhosis drugs market due to high incidence of liver cirrhosis in the region. According to article published in 2014 of BMC medicine, mortality from liver cirrhosis was also comparatively high in Central Asia countries, particularly Mongolia, Uzbekistan and Kyrgyzstan,
Primary Biliary Cirrhosis Drugs Market – Competitor
Key players in the primary biliary cirrhosis drugs market are Intercept Pharmaceuticals, Inc., Johnson & Johnson, GlaxoSmithKline Plc, Dr. Falk Pharma GmbH, and Enanta Pharmaceuticals, Inc.
Primary Biliary Cirrhosis Drugs Market - Taxonomy
By Drug Type
- Ursodeoxycholic acid (USDA)
- Obeticholic acid
- Others (anti-inflamatory, anti-pruritics, and anti-histamines)
By Distribution Channel
- Hospital Pharmacies
- Retail Pharmacies
- Online Pharmacies