Overview:
According to American Liver Foundation, primary biliary cholangitis formerly known as primary biliary cirrhosis (PBC), is a chronic liver disease that gradually destroys the medium-sized bile ducts within the liver. These bile ducts are damaged by inflammation which causes bile to remain in the liver, where gradual injury damages liver cells and causes liver cirrhosis. As cirrhosis progresses and the amount of scar tissue in the liver increases, the liver loses its ability to function. Cirrhosis also prevents return of the blood to heart from intestine. In early stages of PBC most of the patients do not have any prominent symptoms. Over the period of time the most common symptom is pruritus, or intense itching of the skin, often in the arms, legs and back. Other symptoms may include fatigue, jaundice, fluid build-up in the ankles and abdomen, and darkening of the skin. According to Cleveland Clinic, 90% of the patients suffering with PBC are women. The prevalence is higher in northern European population groups and lower in Japan. Disease prevalence estimates have ranged from 40 to 400 cases per 1,000,000 population, with an incidence between 4 and 30 cases per 1,000,000 per year.
In May 2016, Intercept Pharmaceuticals, Inc., a biopharmaceutical company announced that the U.S. Food and Drug Administration (FDA) granted accelerated approval to Ocaliva (obeticholic acid) for the treatment of primary biliary cholangitis, in combination with ursodeoxycholic acid(UDCA) especially in adults with an inadequate response to UDCA or as monotherapy in adults unable to tolerate UDCA. The reports published by company suggests that in Phase 3 POISE trial, Ocaliva administration in combination with UDCA (or as monotherapy in UDCA-intolerant patients) met the primary composite endpoint in 46% of patients in the titration group, as compared to 10% of those receiving placebo added to UDCA (p<0.0001). The press release published by company reports that, pruritus (itching), a common symptom of PBC that is unrelated to disease stage or outcomes, was the most common side effect observed in Ocaliva-treated patients. However, pruritus associated with Ocaliva treatment was generally less in patients who were on the dose titration regimen (5 mg once-daily increasing to 10 mg once-daily); one patient (1%) in the titration group discontinued from the study due to pruritus. Additional side effects observed during the trial included fatigue, abdominal pain and discomfort, rash, oropharyngeal pain, dizziness, constipation, arthralgia, thyroid function abnormality and eczema.
North America was observed as the largest market for primary biliary cholangitis treatment followed by Europe. Asia Pacific was anticipated to grow at a fastest CAGR during the forecast period 2016 to 2023. The key factors assisting the growth of Asia Pacific primary biliary cholangitis treatment market are the rising awareness associated with the rare diseases, developing healthcare infrastructure, high disposable income and government support for novel treatment against autoimmune diseases.
The global primary biliary cholangitis (PBC) treatment market is segmented on the following bases:
1. Type of Therapeutic Treatment
a. Drugs for PBC Treatment
i. Ursodeoxycholic acid
ii. Obeticholic Acid (Ocaliva)
b. Drugs for treatment of Symptoms & Complications in PBC
i. Antihistamines (Itching)
ii. Pilocarpine (Dry Eyes & Mouth)
iii. Cevimeline (Dry Eyes & Mouth)
iv. Beta-blocker (Portal Hypertension)
v. Nitrates (Portal Hypertension)
vi. Others
2. Pipeline Analysis (Phase I, Phase II and Phase III Clinical Trials)
a. Projected sales of Phase III Drugs estimated till 2023 (US$ Mn)
i. Fenofibrate (Xijing Hospital of Digestive Diseases)
ii. Bezafibrate (Assistance Publique - Hôpitaux de Paris)
b. Tabular Representation of Phase II and I Drugs
3. Geography
a. North America
i. US
ii. Canada
b. Europe
i. UK
ii. Germany
iii. Rest of Europe
c. Asia-Pacific
i. Japan
ii. China
iii. Rest of APAC
d. Latin America
e. Middle East and Africa
Key Players Identified for Primary Biliary Cholangitis (PBC) Treatment Market Include but are Not Limited to:
The key players in the market are Actavis, Inc., Epic Pharma, LLC, Mylan Pharmaceuticals Inc., Teva Pharmaceuticals, Glenmark Pharmaceuticals Ltd., Par Pharmaceutical Inc., Intercept Pharmaceuticals, Inc. and others.
This report offers:
