Primary Sclerosing Cholangitis Market, by Drug (BT1023, GS-9674, NGM282, OCA, LUM001, and Others) and by Region (North America, Latin America, Europe, Asia Pacific, Middle East, and Africa) - Size, Share, Trends, and Forecast to 2023

  • Published On : Jul 2018 |
  • Pages : 134 Pages |
  • Format : CMI Insight PPT Format CMI Insight PDF Format

Global Primary Sclerosing Cholangitis Market – Efficient Treatment Targeting Orphan Disease

Primary sclerosing cholangitis (PSC) is a condition causing long-term inflammation and scarring (fibrosis) of bile ducts in the liver. These ducts are tubes that allow the liquid (bile) produced by the liver to pass through the intestine allowing fat digestion. This disease predominantly affects men between the age of 25 and 40 years. The damage to the ducts causes accumulation of bile acids, essential components of bile to build up in the liver leading to liver tissue damage, portal hypertension (high blood pressure in the vessels connecting the liver and the gut), and liver failure, and may increase the risk of liver cancer.

Figure 1. Global Primary Sclerosing Cholangitis Market, by Drug

Global Primary Sclerosing Cholangitis Market- Optimistic Scenario:

Currently, over five products are in clinical trials Phase 2 and some of them have shown good results in Phase 2. For instance, ASEOP trial, testing Obeticholic acid (OCA) for primary sclerosing cholangitis, is being conducted by Intercept Pharmaceuticals, Inc. Also, Shire Plc. completed Phase 2 clinical trial for the drug candidate LUM001 in February, 2016.

If these potential molecules pass through the advanced clinical trials phase (i.e. Phase 3) and secure regulatory approval, these would be among the first-to-get-approval for this disease.

Moreover, most of the patients are in developed economies such as Europe and North America where diagnosis percentage and affordability is generally higher compared to emerging economies in regions such as Asia Pacific, which would result in higher adoption rate of novel products with significantly high yearly cost (i.e. more than US$ 50,000 for orphan drugs). Due to the above mentioned factors, the global primary sclerosing cholangitis market is expected to reach US$ 140.4 Mn by 2023.

However, withdrawal of potential therapeutic molecules from late-stage clinical trials have limited the availability of efficient treatment, thus compelling the patient pool to adopt alternative treatment therapies such as bile acid sequestrants, antibiotics, antihistamines, opioid antagonists, and ursodeoxycholic acid (UDCA).

According to a study published by Gastroenterology and Hepatology Journal, 2016, current medical therapies such as ursodeoxycholic acid improves liver enzymes. However, it does not prevent the progression of PSC or reduce the risk of recurrence. Thus, unavailability of approved drugs targeting the condition in practical medical use is a factor hindering growth of the global primary sclerosing cholangitis market.

Increasing incidence of liver failure and bile cancer associated with PSC

Increasing prevalence of diseases associated with PSC such as liver cancer and inflammatory bowel disease is expected to enhance the therapeutic adoption of efficient drugs to manage the condition, thus driving growth of the primary sclerosing cholangitis market. According to the World Journal of Gastroenterology, 2017, inflammatory bowel disease (IBD) is diagnosed in around 50-80% of the patients with PSC, with ulcerative colitis (UC) comprising around 80-90% of these cases.

Furthermore, individuals with PSC are at a greater risk of developing cancer in bile ducts called cholangiocarcinoma, as compared to general populace. According to the National Organization for Rare Disorders (NORD), 2016, around 8-15% of the PSC affected individuals eventually develop cholangiocarcinoma and have enhanced risk of developing gall bladder cancer. Moreover, NORD states that patients with PSC are at a greater risk of developing Crohn’s disease, colon cancer, and immune-mediated disorders such as thyroid disease, Peyronie’s disease, retroperitoneal fibrosis, psoriasis, rheumatoid arthritis, Celiac disease, and others.

Affordable options in comparison with the currently available treatments is expected to increase the adoption of PSC drugs

Currently, liver transplant is the only known cure for primary sclerosing cholangitis and is one of the major causes for liver transplantation in the U.S. However, as per the survey by Mayo Clinic, the disease is expected to recur in the transplanted liver in 27.2% of the patients, thereby demanding efficient and affordable therapeutic solutions to cater to unmet patient needs. According to the United Network for Organ Sharing (UNOS), 2011, estimated bill charges of a liver transplant procedure is around US$ 577,100 in the U.S.

Thus, requirement of providing affordable treatment, owing to high costs associated with liver transplantation coupled with increasing risk factors resulting in the development of serious disorders are major factors that are expected to increase the adoption of PSC drugs, in turn favoring market growth in the near future.

Major players operating in the global primary sclerosing cholangitis market include Acorda Therapeutics, Inc., Gilead Sciences, Inc., NGM Biopharmaceuticals, Inc., Intercept Pharmaceuticals, Inc., Dr. Falk Pharma GmbH, Allergan Plc., Shire Plc., Durect Corporation, Conatus Pharmaceuticals, Inc., Sirnaomics, Inc., and Shenzhen HighTide Biopharmaceutical Ltd.

Primary sclerosing cholangitis market report provides detailed information about various candidates that are presently in the preclinical and clinical trials by the manufacturers and research organizations. The drug segment will provide quick snapshot about the clinical phase of the study, study outcomes, estimated launch date, and the upcoming drug molecules. Moreover, the report entails information regarding the major events taking place in the global market, thereby gaining insights about drug approvals, merger agreements, and acquisitions undertaken by the manufacturing companies. Also, incidence and prevalence of PSC and its associated conditions at regional as well as global level are provided in the report, thereby indicating the total number of addressable patient pool in the respective regions and market opportunity for the same.

Market Dynamics

Major factors that are expected to augment growth of the primary sclerosing cholangitis market include increasing number of organizations focusing on clinical innovation and scientific progress on understanding the mechanisms and risk factors for primary sclerosing cholangitis (PSC). For instance, the International PSC study group (IPSCSG), founded in 2010, aims to coordinate PSC research projects between leading institutions worldwide, thereby allowing feasible translational research and advancing efficient research. Also, increasing number of clinical and preclinical trials conducted by the research universities and pharmaceuticals companies is expected to favor market growth over the forecast period.

However, failure of drug candidates to provide desired study outcomes and the withdrawal of late phase clinical trials of potential drug molecules are factors hindering the market growth.

Key features of the study:

  • This report provides in-depth analysis of primary sclerosing cholangitis market and provides pipeline analysis for the same
  • It elucidates potential opportunities across different segments and explains attractive investment proposition matrices 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 sclerosing cholangitis market based on the following parameters – company overview, financial performance, product portfolio, market presence, distribution strategies, key developments, strategies, and future plans
  • Key companies covered as a part of this study include Acorda Therapeutics, Inc., Gilead Sciences, Inc., NGM Biopharmaceuticals, Inc., Intercept Pharmaceuticals, Inc., Dr. Falk Pharma GmbH, Allergan Plc., Shire Plc., Durect Corporation, Conatus Pharmaceuticals, Inc., Sirnaomics, Inc., and Shenzhen HighTide Biopharmaceutical Ltd.
  • Insights from this report would allow marketers and the management authorities of the companies to make informed decisions regarding their future product launches, technology up-gradation, market expansion, and marketing tactics
  • The global primary sclerosing cholangitis market report caters to various stakeholders in this industry including investors, suppliers, product manufacturers, distributors, new entrants, and financial analysts
  • Stakeholders would have ease in decision-making through various strategy matrices used in analyzing the primary sclerosing cholangitis market

Detailed Segmentation:

  • Global Primary Sclerosing Cholangitis Market, By Drug:
    • BTT1023
    • GS-9674
    • NGM282
    • OCA
    • Cenicriviroc
    • LUM001
    • DUR928
    • norUDCA
    • HTD1801
    • IDN-7314
    • STP705
  • Global Primary Sclerosing Cholangitis Market, By Region:
    • North America
      • Regional Overview
    • Latin America
      • Regional Overview
    • Europe
      • Regional Overview
    • Asia Pacific
      • Regional Overview
    • Middle East
      • Regional Overview
    • Africa
      • Regional Overview
  • Company Profiles
    • Acorda Therapeutics, Inc.*
      • Company Overview
      • Product Portfolio
      • Financial Performance
      • Key Strategies
      • Recent Developments
    • Gilead Sciences, Inc.
    • NGM Biopharmaceuticals, Inc.
    • Intercept Pharmaceuticals, Inc.
    • Dr. Falk Pharma GmbH
    • Allergan Plc.
    • Shire Plc.
    • Durect Corporation
    • Conatus Pharmaceuticals, Inc.
    • Sirnaomics, Inc.
    • Shenzhen HighTide Biopharmaceuticals Ltd.

*” 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 Purview
    • Report Description
      • Market Definition and Scope
    • Executive Summary
      • Market Overview
      • Optimistic, Likely and Pessimistic Overview
  3. Market Dynamics, Pipeline, and PEST Analysis
    • Market Dynamics
      • Drivers
      • Restraints
      • Market Opportunities
    • Impact Analysis
    • PEST Analysis
    • Pipeline Analysis
    • Initiatives Focusing On PSC Support And Research
    • Reason For Phase 3 Drug Withdrawal
    • Challenges Faced by Orphan Drug Candidates
    • Epidemiology
  4. Global Primary Sclerosing Cholangitis Market, By Drug
    • Introduction
    • BTT1023
      • Research Details
    • GS-9674
      • Research Details
    • NGM282
      • Research Details
    • OCA
      • Research Details
    • Cenicriviroc
      • Research Details
    • LUM001
      • Research Details
    • DUR928
      • Research Details
    • norUDCA
      • Research Details
    • HTD1801
      • Research Details
    • IDN-7314
      • Research Details
    • STP705
      • Research Details
  5. Global Primary Sclerosing Cholangitis Market, By Region
    • Introduction
    • North America
      • Regional Overview
    • Latin America
      • Regional Overview
    • Europe
      • Regional Overview
    • Asia Pacific
      • Regional Overview
    • Middle East
      • Regional Overview
    • Africa
      • Regional Overview
  6. Competitive Landscape
    • Company Profiles
      • Acorda Therapeutics, Inc.
        • Company Overview
        • Product Portfolio
        • Financial Overview
        • Key Highlights
        • Market Strategies
      • Gilead Sciences, Inc.
        • Company Overview
        • Product Portfolio
        • Financial Overview
        • Key Highlights
        • Market Strategies
      • NGM Biopharmaceuticals, Inc.
        • Company Overview
        • Product Portfolio
        • Financial Overview
        • Key Highlights
        • Market Strategies
      • Intercept Pharmaceuticals, Inc.
        • Company Overview
        • Product Portfolio
        • Financial Overview
        • Key Highlights
        • Market Strategies
      • Dr. Falk Pharma GmbH
        • Company Overview
        • Product Portfolio
        • Financial Overview
        • Key Highlights
        • Market Strategies
      • Allergan Plc.
        • Company Overview
        • Product Portfolio
        • Financial Overview
        • Key Highlights
        • Market Strategies
      • Shire Plc.
        • Company Overview
        • Product Portfolio
        • Financial Overview
        • Key Highlights
        • Market Strategies
      • Durect Corporation
        • Company Overview
        • Product Portfolio
        • Financial Overview
        • Key Highlights
        • Market Strategies
      • Conatus Pharmaceuticals, Inc.
        • Company Overview
        • Product Portfolio
        • Financial Overview
        • Key Highlights
        • Market Strategies
      • Sirnaomics, Inc.
        • Company Overview
        • Product Portfolio
        • Financial Overview
        • Key Highlights
        • Market Strategies
      • Shenzhen HighTide Biopharmaceutical Ltd.
        • Company Overview
        • Product Portfolio
        • Financial Overview
        • Key Highlights
        • Market Strategies
    • Analyst Views
  7. Section
    • References
    • Research Methodology
    • About us and Sales Contact

Research Methodology

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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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  • National level desk research: It Includes research analysis of regional players, regional regulatory bodies, regional trade associations, and regional organization.
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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:

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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
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  • Environmental indicators
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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:

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  • 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:

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