Primary biliary cholangitis, previously known as primary biliary cirrhosis, is a rare chronic liver disease, primarily characterized by destruction of the bile ducts which transport bile acid out of the liver. Although the primary cause of the disease has not yet been elucidated, research across the world has attributed it to be autoimmune in nature. The progress of this disease results in the harmful accumulation of bile acid, which causes severe liver damage, resulting in cirrhosis at the later stage of the disease. The disease primarily affects women in their middle age. The lack of a definitive cure for primary biliary cholangitis (PBC) results in an immensely lucrative business opportunity to tap into this underserved market.
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Although presently the disease cannot be cured by medication, the progression of liver damage can be stalled with the help of a drug known as ursodeoxycholic acid (UDCA), the only FDA approved medication for the disease. Additionally, the symptoms of the disease in early stages which include itching and fatigue can be relieved with the aid of drugs such as antihistamines and opioid antagonists. However, if primary biliary cholangitis is diagnosed in later stages, the sole treatment option which remains viable for survival is liver transplantation. The improved diagnostic processes worldwide coupled with rise in patient awareness regarding treatment and physician check-ups upon experiencing symptomatic discomfort has led to lesser requirement of transplants. The improved scenario relating to the prognosis of primary biliary cholangitis has thus made medication a more popular course of treatment in comparison to liver transplants resulting in alleviating the progression of the disease.
Although the treatment with UDCA helps reduce advancement of liver destruction, the drug has shown to be ineffective in adequately reducing disease specific blood compounds (such as bilirubin) in over 40% patients. Moreover few patients have experienced intolerance to the drug. Thus, there is immense potential for a new cure and innovative drug to create a remedial breakthrough in the market due to the current unmet need of the patient population.
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The global primary biliary cholangitis market can been segmented on the basis of type of treatment and by region. Based on type of treatment, the global market has been segmented into drugs and liver transplantation. The drugs segment has been further segmented into primary treatment (UDCA) and symptomatic relief treatment. The symptomatic relief segment includes drugs to aid in reduction of disease symptoms which includes antihistamines, Cholestyramine, antibacterials and opioid antagonists. In addition, a pipeline assessment has also been provided to assess the drugs undergoing early stage and late stage clinical trials.
Globally, the annual incidence of the disease is estimated to be between 0.7 and 49 cases per million-population and prevalence between 6.7 and 940 cases per million-population, the variance in cases primarily based on age and gender and geographic location. However, various peer reviewed articles have suggested that the incidence is gradually increasing worldwide. Geographically the market has been segmented into five regions, namely North America, Europe, Asia Pacific, Latin America and Middle East & Africa. The market for this disease is expected to be higher in North America and Europe owing to the higher prevalence and incidence of the disease in those regions. Primary Biliary Cholangitis is more prevalent in Northern Europe, North America and Latin America and less common in Eastern Asia, Africa, and Australia. In the U.S., PBC is among the top ten causes to undergo a liver transplant. The incidence of PBC is high in U.K as compared to other regions in Europe and thus U.K is an attractive business opportunity for research as well as trial studies and drug sales pertaining to this disease. Thus, the global market for PBC is driven by rise in incidence of primary biliary cholangitis, increased exposure to environmental triggers to the immune system such as pesticides to susceptible individuals and growth in faulty lifestyle related triggers such as alcoholism, smoking and obesity.
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The key players in the market include Novartis AG, Actavis, Inc., Bristol-Myers Squibb Company, NGM Biopharmaceuticals, Lumena Pharmaceuticals, Inc., Siedco Pharmaceutical Co., and Teva Pharmaceuticals Inc. etc.