Market Insights
According to the 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 the return of blood to the heart from the intestine.
In the early stages of PBC, most patients do not have any prominent symptoms. Over the course 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 buildup in the ankles and abdomen, and darkening of the skin. According to the Cleveland Clinic, 90% of the patients suffering from PBC are women. The prevalence is higher in northern European population groups and lowers in Japan. Disease prevalence estimates have ranged from 40 to 400 cases per 1,000,000 people, 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 the company suggest that in the 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 the company reports that pruritus (itching), a common symptom of PBC that is unrelated to the 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 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 abnormalities, 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 the fastest CAGR during the forecast period of 2016–2022. The key factors assisting the growth of the Asia-Pacific primary biliary cholangitis treatment market are the rising awareness associated with rare diseases, the 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:
- cevimeline (dry eyes and mouth)
- Pilocarpine (Dry Eyes and Mouth)
- Antihistamines (Itching)
- Drugs for treatment of symptoms and complications in PBC
- Obeticholic Acid (Ocaliva)
- Ursodeoxycholic acid
- Drugs for PBC Treatment
- Type of Therapeutic Treatment
- beta-blocker (portal hypertension)
- Nitrates (Portal Hypertension)
- Others
- Pipeline Analysis (Phase I, Phase II, and Phase III Clinical Trials)
- Projected sales of Phase III drugs are estimated to continue until 2023 (US$ Mn).
- Fenofibrate (Xijing Hospital of Digestive Diseases)
- Bezafibrate (Assistance Publique, Hôpitaux de Paris)
- Tabular Representation of Phase II and I Drugs
Geography
- North America
- Europe
- Germany
- France
- UK.
- Italy
- Spain
- Rest of Europe
- Asia Pacific
- China
- Japan
- India
- South Korea
- South-east Asia
- Rest of Asia Pacific
- Latin America
- Brazil
- Mexico
- Rest of Latin America
- Middle East & Africa
- GCC Countries
- South Africa
- Rest of the Middle East and Africa
Key players identified for the 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 the following:
- An overview of the global markets for primary biliary cholangitis treatment
- Market trends assessment for the period 2013-2023, with historical information for 2013, 2014, and 2015, and projections through 2023, with respective CAGRs during 2016-2023
- Qualitative assessment tools such as market drivers, challenges, and opportunities
- Market competition scrutiny tools such as market share analysis, fractal map assessment, and Porter’s Five Forces model
- Focus on each level of market segmentation based on product approvals, launches, and current and anticipated market dynamics.
- A general overview of the industry structure
- Company profiles highlight key information about the major players operating in the primary biliary cholangitis treatment market.
