• Report Number: 180910900

Reports Overview

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.

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.

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.

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.

The report offers a comprehensive evaluation of the market. It does so via in-depth insights, understanding market evolution by tracking historical developments, and analyzing the present scenario and future projections based on optimistic and likely scenarios. Each research report serves as a repository of analysis and information for every facet of the market, including but not limited to: Regional markets, technology developments, types, applications, and the competitive landscape.

The study is a source of reliable data on:

  • Key market segments and sub-segments
  • Evolving market trends and dynamics
  • Changing supply and demand scenarios
  • Quantifying market opportunities through market sizing and market forecasting
  • Tracking current trends/opportunities/challenges
  • Competitive insights
  • Opportunity mapping in terms of technological breakthroughs 

The regional analysis covers:

  • North America (U.S. and Canada)
  • Latin America (Mexico, Brazil, Peru, Chile, and others)
  • Western Europe (Germany, U.K., France, Spain, Italy, Nordic countries, Belgium, Netherlands, Luxembourg)
  • Eastern Europe (Poland, Russia)
  • Asia Pacific (China, India, Japan, ASEAN, Australia and New Zealand)
  • Middle East and Africa (GCC, Southern Africa, North Africa)

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FII regularly interviews technology and business professionals as an ongoing effort to track the latest developments within each sector. These continuous surveys are stratified by company size and industry segment and weighted to reflect the global market place.  All data are collected on an ongoing effort through a structured questionnaire rolled over the web or conducted via telephones. This provides the FII team opportunities to request for detailed question sets, complex skip patterns, and real-time calculations, which assists respondents in answering questions involving numbers and percentages. Respondents, who are interviewed as experts, are screened and qualified based on certain criteria in addition to their decision-making authority and the scope of activity within their organizations.

Analyst Review

With collective industry experience of about 200 years of its analysts and experts, Future Industry Insight (FII) encompasses most infallible research methodology for its market intelligence and industry analysis. We do not only engrave the deepest levels of markets but also sneak through its slimmest details for the purpose of our market estimates and forecasts. Our approach helps in building greater market consensus view for size, shape and industry trends within each industry segment. We carefully factor in industry trends and real developments for identifying key growth factors and future course of the market. Our research proceeds are the resultant of high quality data, expert views and analysis and high value independent opinions. Our research process is designed to deliver balanced view of the global markets and allow stakeholders to make informed decisions.

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With a strong methodology we are, therefore, confident that our research and analysis are most reliable and guarantees sound business planning.

Secondary research
We refer a broad array of industry sources for our secondary, which typically include; however, not limited to: Company SEC filings, annual reports, company websites, broker & financial reports and investor presentations for competitive scenario and shape of the industry

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Our primary research efforts include reaching out participants through mail, tele-conversations, referrals, professional networks and face-to-face interactions. We are also in professional corporate relations with various companies that allow us greater flexibility for reaching out industry participants and commentators for interviews and discussions, fulfilling following functions:

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Our primary research interview and discussion panels are typically composed of most experienced industry members. These participants include; however, not limited to:

  • Chief executives and VPs of leading corporations specific to industry
  • Product and sales managers or country heads; channel partners and top level distributors; banking, investments and valuation experts Key opinion leaders (KOLs)

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