Primary Biliary Cholangitis Treatment Market, by Treatment Type by Treatment Type (Ursodeoxycholic acid (UDCA), and Obeticholic acid (Ocaliva)), by Distribution Channels (Hospital Pharmacies, Retail Pharmacies, and Online Pharmacies) - Size, Share, Outlook, and Opportunity Analysis, 2018-2026

  • Published On : Mar 2019 |
  • Pages : 143 Pages |
  • Format : CMI Insight PPT Format CMI Insight PDF Format

Primary Biliary Cholangitis Treatment Market Insights

Primary biliary cirrhosis, also 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 include 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.

The global primary biliary cholangitis treatment market size was valued at US$ 526.4 million in 2017, and is expected to witness a CAGR of 36.3% during the forecast period (2018 – 2026).

Figure 1. Global Primary Biliary Cholangitis Treatment Market Value Analysis (US$ Mn) and Forecast and Absolute $ Opportunity

Source: Coherent Market Insights Analysis (2019)

Increasing number of pipeline studies is expected to drive the primary biliary cholangitis treatment market growth

Increasing pipeline studies to develop prominent treatments for rare diseases such as primary biliary cholangitis are expected to boost the primary biliary cholangitis treatment market size. For instance, in October 2018, CymaBay Therapeutics, Inc., initiated placebo-controlled and randomized phase 3 clinical trial for seladelpar 5-10mg. The aim of the study was to evaluate safety and efficacy of seladelpar in patients with primary biliary cholangitis (PBC) and to determine inadequate response or intolerance to ursodeoxycholic acid (UDCA). The study is estimated to complete in December 2021.

Moreover, in January 2017, GlaxoSmithKline (GSK) initiated phase 2 clinical trial to study the efficacy, safety, and tolerability of GSK2330672 administration for the treatment of pruritus (itch) in participants with primary biliary cholangitis (PBC). GSK2330672 is a selective inhibitor of human ileal bile acid transporter (IBAT). The study is estimated to complete in April 2020.

Primary Biliary Cholangitis Treatment Market- Regional Analysis

Regional segmentation of the global primary biliary cholangitis treatment market comprises North America, Latin America, Europe, Asia Pacific, Middle East, and Africa.

North America is anticipated to witness lucrative primary biliary cholangitis treatment market growth, owing to growing initiatives by market players to develop advance treatment options for PBC. For instance, in October 2016, TARGET PharmaSolutions, Inc., U.S.-based Company, in collaboration with Intercept Pharmaceuticals, Inc., launched its TARGET-PBC (Primary Biliary Cholangitis) platform. TARGET-PBC platform has been created to improve the understanding of real world treatment patterns in PBC.

Asia Pacific is also expected to witness significant growth in the primary biliary cholangitis treatment market. For instance, in 2017, the Japanese Biliary Association (JBA) and the Intractable Hepatobiliary Disease Study Group of Japan estimated that there were 2,000 to 3,000 patients with PBC in Japan. Also, in 2017, Japanese researchers planned to collect DNAs from Japanese PSC patients, to examine difference in genetic background between the East and the West of Japan.

Europe is expected to witness significant market share in the market, owing to rising initiative by professional organizations to create awareness among the healthcare professionals to treat the patients suffering from rare diseases such as primary biliary cholangitis. For instance, April 2018, the British Society of Gastroenterology and UK-PBC entered into strategic partnership to develop a comprehensive guidelines for the treatment of primary biliary cholangitis. The guidelines are mainly designed for gastroenterologists and herpetologists engaged in providing treatment to the patients with PBC.

Figure 2: Global Primary Biliary Cholangitis Treatment Market Value (US$ Mn), By Region, 2017

Source: Coherent Market Insights Analysis (2019)

Primary Biliary Cholangitis Treatment Market - Competitive Landscape

Key players operating in the primary biliary cholangitis treatment market include Novartis AG, Bristol-Myers Squibb, NGM Biopharmaceuticals, Lumena Pharmaceuticals, Inc., TARGET PharmaSolutions, Inc., Intercept Pharmaceuticals, Inc., Teva Pharmaceutical Industries Ltd, Retrophin, Inc., Calliditas Therapeutics AB., and GlaxoSmithKline (GSK) pharmaceutical.

Primary Biliary Cholangitis (PBC) is a rare disease characterized by chronic progressive liver disorder. It majorly affects women and usually occurs in middle age ranging between 30 to 60 years. It is also called as biliary cirrhosis. PBC tends to affect the small bile duct present in the liver. Primary biliary cholangitis is divided into four stages including stage 1 with no significant scarring to stage 4 known as cirrhosis. PBC is triggered by the combination of factors such as autoimmune, genetic, and environmental factors.

Market Dynamics

Increasing number of Food and Drug Administration (FDA) approvals for the drugs to treat PBC is contributing to the market growth. For instance, in May 2016, the U.S. Food and Drug Administration (FDA) approved Ocaliva (obeticholic acid) in combination with ursodeoxycholic acid (UDCA) for the treatment of Primary Biliary Cholangitis (PBC) in adults with an inadequate response to UDCA. Furthermore, in 2016, Ocaliva was assigned fast track designation and orphan drug designation by the U.S. FDA.

Moreover, in February 2018, U.S.FDA granted orphan drug designation (ODD) to Calliditas Therapeutics AB, specialty pharmaceutical company engaged in development of high quality pharmaceutical products for patients with a significant unmet medical need in niche indications, in Stockholm, Sweden, for the treatment of Primary biliary cholangitis (PBC).

Furthermore, key players are engaged in conducting clinical trial to develop treatment for primary biliary cholangitis. For instance, in February 2017, Zydus Cadila received the US Food and Drug Administration (USFDA) approval to initiate a Phase-2 clinical trial of Saroglitazar Magnesium (Mg) in patients with Primary Biliary Cholangitis of the liver.

Key features of the study:

  • This report provides in-depth analysis of the primary biliary cholangitis treatment market size (US$ Mn), and cumulative annual growth rate (CAGR (%)) for the forecast period: 2018 – 2026, considering 2017, as the base year
  • It elucidates potential revenue opportunity across different segments and explains attractive investment proposition matrix for this market
  • This study also provides key insights about market drivers, restraints, opportunities, new product launches or approval, market trends, regional outlook, and competitive strategies adopted by the leading players
  • It profiles leading players in the global Primary Biliary Cholangitis Treatment Market based on the following parameters – company overview, financial performance, product portfolio, geographical presence, distribution strategies, key developments, and strategies
  • Key players covered as a part of this study include Novartis AG, Bristol-Myers Squibb, NGM Biopharmaceuticals, Lumena Pharmaceuticals, Inc., TARGET PharmaSolutions, Inc., Intercept Pharmaceuticals, Inc., Teva Pharmaceutical Industries Ltd., Retrophin, Inc., Calliditas Therapeutics AB, and GlaxoSmithKline (GSK) pharmaceuticals.
  • Insights from this report would allow marketers and management authorities of companies to make informed decision with respect to their future product launch, governmental initiatives, technological up-gradation, market expansion, and marketing tactics
  • The global Primary Biliary Cholangitis Treatment Market report caters to various stakeholders in this industry, including investors, product manufacturers, distributors and suppliers for Primary Biliary Cholangitis Treatment Market, research and consulting firms, new entrants, and financial analysts 

Detailed Segmentation:

  • Global  Primary Biliary Cholangitis Treatment Market, By Treatment Type
    • Ursodeoxycholic acid (UDCA)
    • Obeticholic acid (Ocaliva)
  • Global  Primary Biliary Cholangitis Treatment Market, By Distribution Channel:
    • Hospital Pharmacies
    • Retail Pharmacies
    • Online Pharmacies
  • Global  Primary Biliary Cholangitis Treatment Market, By Region:
    • North America
      • By Country:
        • U.S.
        • Canada
      • By Treatment Type:
        • Ursodeoxycholic acid (UDCA)
        • Obeticholic acid (Ocaliva)
      • By Distribution Channel:
        • Hospital Pharmacies
        • Retail Pharmacies
        • Online Pharmacies
    • Europe
      • By Country:
        • U.K.
        • Germany
        • Italy
        • Spain
        • France
        • Russia
        • Rest of Europe
      • By Treatment Type:
        • Ursodeoxycholic acid (UDCA)
        • Obeticholic acid (Ocaliva)
      • By Distribution Channel:
        • Hospital Pharmacies
        • Retail Pharmacies
        • Online Pharmacies
    • Asia Pacific
      • By Country:
        • Australia
        • India
        • China
        • Japan
        • ASEAN
        • South Korea
        • Rest of Asia Pacific
      • By Treatment Type:
        • Ursodeoxycholic acid (UDCA)
        • Obeticholic acid (Ocaliva)
      • By Distribution Channel:
        • Hospital Pharmacies
        • Retail Pharmacies
        • Online Pharmacies
    • Latin America
      • By Country:
        • Brazil
        • Mexico
        • Argentina
        • Rest of Latin America
      • By Treatment Type:
        • Ursodeoxycholic acid (UDCA)
        • Obeticholic acid (Ocaliva)
      • By Distribution Channel:
        • Hospital Pharmacies
        • Retail Pharmacies
        • Online Pharmacies
    • Middle East
      • By Country:
        • GCC
        • Israel
        • Rest of Middle East
      • By Treatment Type:
        • Ursodeoxycholic acid (UDCA)
        • Obeticholic acid (Ocaliva)
      • By Distribution Channel:
        • Hospital Pharmacies
        • Retail Pharmacies
        • Online Pharmacies
    • Africa
      • By Country:
        • South Africa
        • Central Africa
        • North Africa
      • By Treatment Type:
        • Ursodeoxycholic acid (UDCA)
        • Obeticholic acid (Ocaliva)
      • By Distribution Channel:
        • Hospital Pharmacies
        • Retail Pharmacies
        • Online Pharmacies
  • Company Profiles
    • Novartis AG,*
      • Company Overview
      • Product Portfolio
      • Financial Performance
      • Recent Highlights
      • Strategies
    • Bristol-Myers Squibb.
    • NGM Biopharmaceuticals
    • Lumena Pharmaceuticals, Inc.
    • TARGET PharmaSolutions, Inc
    • Intercept Pharmaceuticals, Inc
    • Teva Pharmaceutical Industries Ltd
    • Retrophin, Inc.
    • Calliditas Therapeutics AB.
    • GlaxoSmithKline (GSK) pharmaceuticals

“*” marked represents similar segmentation in other categories in the respective section.

Table of Contents

  1. Research Objective and Assumption
    • Research Objectives
    • Assumptions
    • Abbreviations
  2. Market Overview
    • Report Description
      • Market Definition and Scope
    • Executive Summary
      • Market Snippet, By Treatment Type
      • Market Snippet, By Distribution Channel
      • Market Snippet, By Region
    • Coherent Opportunity Map (COM)
  3. Market Dynamics, Regulations, and Trends Analysis
    • Market Dynamics
      • Drivers
      • Restraints
      • Market Opportunities
    • Impact Analysis
    • Market Trends
    • Key Developments
    • Technology Advancements
    • Pipeline Analysis
    • Epidemiology
    • Merger and Acquisition
    • Regulatory Scenario
    • Government Initiatives
    • PEST Analysis
  4. Global Primary Biliary Cholangitis Treatment Market, By Treatment Type, 2018 – 2026, (US$ Million)
    • Introduction
      • Market Share Analysis, 2018 and 2026 (%)
      • Y-o-Y Growth Analysis, 2017 – 2026
      • Segment Trends
    • Ursodeoxycholic acid (UDCA)
      • Introduction
      • Market Size and Forecast, and Y-o-Y Growth, 2016 – 2026, (US$ Million)
    • Obeticholic acid (Ocaliva)
      • Introduction
      • Market Size and Forecast, and Y-o-Y Growth, 2016 – 2026, (US$ Million)
  5. Global Primary Biliary Cholangitis Treatment Market, By Distribution Channel, 2018 – 2026, (US$ Million)
    • Introduction
      • Market Share Analysis, 2018 and 2026 (%)
      • Y-o-Y Growth Analysis, 2017 – 2026
      • Segment Trends
    • Hospital Pharmacies
      • Introduction
      • Market Size and Forecast, and Y-o-Y Growth, 2016 – 2026, (US$ Million)
    • Retail Pharmacies
      • Introduction
      • Market Size and Forecast, and Y-o-Y Growth, 2016 – 2026, (US$ Million)
    • Online Pharmacies
      • Introduction
      • Market Size and Forecast, and Y-o-Y Growth, 2016 – 2026, (US$ Million)
  6. Global Primary Biliary Cholangitis Treatment Market, By Region, 2018 – 2026, (US$ Million)
    • Introduction
      • Market Share Analysis, By Region, 2018 and 2026 (%)
      • Y-o-Y Growth Analysis, By Region, 2017 – 2026
      • Regional Trends
    • North America
      • Market Size and Forecast, By Treatment Type, 2016 – 2026, (US$ Million)
      • Market Size and Forecast, By Distribution Channel, 2016 – 2026, (US$ Million)
      • Market Size and Forecast, By Country, 2016 – 2026, (US$ Million)
        • U.S.
        • Canada
    • Europe
      • Market Size and Forecast, By Treatment Type, 2016 – 2026, (US$ Million)
      • Market Size and Forecast, By Distribution Channel, 2016 – 2026, (US$ Million)
      • Market Size and Forecast, By Country, 2016 – 2026, (US$ Million)
        • U.K.
        • Germany
        • Italy
        • France
        • Spain
        • Russia
        • Rest of Europe
    • Asia Pacific
      • Market Size and Forecast, By Treatment Type, 2016 – 2026, (US$ Million)
      • Market Size and Forecast, By Distribution Channel, 2016 – 2026, (US$ Million)
      • Market Size and Forecast, By Country, 2016 – 2026, (US$ Million)
        • China
        • Japan
        • India
        • ASEAN
        • Australia
        • South Korea
        • Rest of Asia Pacific
    • Latin America
      • Market Size and Forecast, By Treatment Type, 2016 – 2026, (US$ Million)
      • Market Size and Forecast, By Distribution Channel, 2016 – 2026, (US$ Million)
      • Market Size and Forecast, By Country, 2016 – 2026, (US$ Million)
        • Brazil
        • Mexico
        • Argentina
        • Rest of Latin America
    • Africa
      • Market Size and Forecast, By Treatment Type, 2016 – 2026, (US$ Million)
      • Market Size and Forecast, By Distribution Channel, 2016 – 2026, (US$ Million)
      • Market Size and Forecast, By Country, 2016 – 2026, (US$ Million)
        • North Africa
        • Central Africa
        • South Africa
    • Middle East
      • Market Size and Forecast, By Treatment Type, 2016 – 2026, (US$ Million)
      • Market Size and Forecast, By Distribution Channel, 2016 – 2026, (US$ Million)
      • Market Size and Forecast, By Country, 2016 – 2026, (US$ Million)
        • GCC Countries
        • Israel
        • Rest of Middle East
  7. Competitive Landscape
    • Heat Map Analysis
    • Company Profiles
      • Novartis AG
        • Company Overview
        • Product Portfolio
        • Financial Performance
        • Recent Highlights
        • Strategies
      • Bristol-Myers Squibb.
        • Company Overview
        • Product Portfolio
        • Financial Performance
        • Recent Highlights
        • Strategies
      • NGM Biopharmaceuticals.
        • Company Overview
        • Product Portfolio
        • Financial Performance
        • Recent Highlights
        • Strategies
      • Lumena Pharmaceuticals, Inc,
        • Company Overview
        • Product Portfolio
        • Financial Performance
        • Recent Highlights
        • Strategies
      • TARGET PharmaSolutions,  
        • Company Overview
        • Product Portfolio
        • Financial Performance
        • Recent Highlights
        • Strategies
      • Intercept Pharmaceuticals, Inc
        • Company Overview
        • Product Portfolio
        • Financial Performance
        • Recent Highlights
        • Strategies
      • Teva Pharmaceutical Industries Ltd.
        • Company Overview
        • Product Portfolio
        • Financial Performance
        • Recent Highlights
        • Strategies
      • Retrophin, Inc.
        • Company Overview
        • Product Portfolio
        • Financial Performance
        • Recent Highlights
        • Strategies
      • Calliditas Therapeutics AB.
        • Company Overview
        • Product Portfolio
        • Financial Performance
        • Recent Highlights
      • GlaxoSmithKline (GSK) pharmaceuticals.
        • Company Overview
        • Product Portfolio
        • Financial Performance
        • Recent Highlights
    • Analyst Views
  8. Section
    • References
    • Research Methodology
    • About us and Sales Contact

*Browse 20 market data tables and 17 figures on “Primary Biliary Cholangitis Treatment Market” - Global forecast to 2026”.

Research Methodology

Coherent Market Insights followsa comprehensive research methodology focused on providing the most precise market analysis. The company leverages a data triangulation model which helps company to gauge the market dynamics and provide accurate estimates. Key components of the research methodologies followed for all our market reports include:

  • Primary Research (Trade Surveys and Experts Interviews)
  • Desk Research
  • Proprietor Data Analytics Model

In addition to this, Coherent Market Insights has access to a wide range of the regional and global reputed paid data bases, which helps the company to figure out the regional and global market trends and dynamics. The company analyses the industry from the 360 Degree Perspective i.e. from the Supply Side and Demand Side which enables us to provide granular details of the entire ecosystem for each study. Finally, a Top-Down approach and Bottom-Up approach is followed to arrive at ultimate research findings.


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Coherent Market Insights desk research is based on a principle set of research techniques:

  • National level desk research: It Includes research analysis of regional players, regional regulatory bodies, regional trade associations, and regional organization.
  • Multinational level desk research: The research team keeps a track of multinational players, global regulatory bodies, global trade associations, and global organization.

Coherent Market Insights has a large amount of in-house repository of industry database. This is leveraged as a burner for initiating a new research study. Key secondary sources include:

  • Governmental bodies, National and international social welfare institutions, and organizations creating economic policies among others.
  • Trade association, National and international media and trade press.
  • Company Annual reports, SEC filings, Corporate Presentations, press release, news, and specification sheet of manufacturers, system integrators, brick and mortar - distributors and retailers, and third party online commerce players.
  • Scientific journals, and other technical magazines and whitepapers.

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Preliminary Data Mining

The raw data is obtained through the secondary findings, in house repositories, and trade surveys. It is then filtered to ensure that the relevant information including industry dynamics, trends, and outlook is retained for further research process.

Data Standardization:

Holistic approach is used to ensure that the granular and uncommon parameters are taken into consideration to ensure accurate results. The information from the paid databases are further combined to the raw data in order to standardize it.

Coherent Statistical model

We arrive at our final research findings through simulation models. Coherent Data Analytics Model is a statistical tool that helps company to forecast market estimates. Few of the parameters considered as a part of the statistical model include:

  • Micro-economic indicators
  • Macro-economic indicators
  • Environmental indicators
  • Socio-political indicators
  • Technology indicators

Data Processing

Once the findings are derived from the statistical model, large volume of data is process to confirm accurate research results. Data analytics and processing tools are adopted to process large chunk of collected informative data. In case, a client customizes the study during the process, the research finding till then are benchmarked, and the process for new research requirement is initiated again.

Data Validation

This is the most crucial stage of the research process. Primary Interviews are conducted to validate the data and analysis. This helps in achieving the following purposes:

  • It provides first-hand information on the market dynamics, outlook, and growth parameters.
  • Industry experts validates the estimates which helps the company to cement the on-going research study.
  • Primary research includes online surveys, face-to face interviews, and telephonic interviews.

The primary research is conducted with the ecosystem players including, but not limited to:

  • Raw Material Suppliers
  • Manufacturers
  • System Integrators
  • Distributors
  • End-users

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