Ursodeoxycholic Acid Market - by Dosage Form (Solid Dosage Form and Liquid Dosage Form), by Mode of Extraction (Synthetic and Biological), by Application (Gallstones, Cystic Fibrosis, Liver Cirrhosis and Others) and by Region (North America, Latin America, Europe, Asia Pacific, Middle East, and Africa) - Size, Share, Outlook, and Opportunity Analysis, 2018 – 2026

  • Published On : Jun 2018 |
  • Pages : 160 Pages |
  • Format : CMI Insight PPT Format CMI Insight PDF Format

Global Ursodeoxycholic Acid Market – Market Insights

Ursodeoxycholic acid (UDCA) is a bile acid taken as either a tablet or liquid to treat gallstones and to treat and prevent progression of cystic fibrosis-related liver disorders. UDCA modifies the bile acid pool by decreasing levels of hydrophobic bile acids while increasing proportion of nontoxic hydrophilic bile acids. UDCA can delay development of gastroesophageal varices and progression to cirrhosis. Moreover, it can improve long-term survival in patients with primary biliary cirrhosis.

Significant improvement in liver health can be achieved through UDCA therapy in patients with intrahepatic cholestasis of pregnancy, primary sclerosing cholangitis, nonalcoholic fatty liver disease, cystic fibrosis-associated liver disease, total parenteral nutrition-induced cholestasis, graft related liver disease, and in some pediatric cholestatic liver diseases.

The global ursodeoxycholic acid market size was valued at US$ 457.3 million in 2017 and is expected to exhibit a CAGR of 10.1% over the forecast period (2018 – 2026).

Figure 1. Global Ursodeoxycholic Acid Market Value (US$ Mn), by Region, 2018

                                                                      Source: Coherent Market Insights Analysis (2019)

Increasing prevalence of gall stones and cystic fibrosis to propel the ursodeoxycholic acid market growth

Ursodeoxycholic acid is being increasingly used for treatment of chronic cholestatic liver diseases. Increasing prevalence of cystic fibrosis and gall stones is the major factor driving growth of the global ursodeoxycholic acid market during the forecast period. According to the Cystic Fibrosis Foundation 2015 data, around 30,000 people suffered from cystic fibrosis in the U.S. Moreover, around 1,000 new cases of cystic fibrosis are diagnosed in the country, annually. According to the American Gastroenterological Association 2017 report, gallstones is affecting 10-15% of the U.S. population annually, which accounts for around 25 million people.

Women are more likely to develop gallstones in comparison to men. High estrogen levels during pregnancy, birth control pills or hormone replacement therapy are the major factors that produce gallstones in women. Moreover, occurrence of gallstones is also high in older adults and individuals with a family history of gallstones. Surgery is the usual treatment for symptomatic gallstones, however, treatment with ursodeoxycholic acid can dissolve smaller stones, which are made mainly of cholesterol.

However, drawbacks such as low efficacy (around 40%), slowness in action, and possibility of stone recurrence are expected to hinder the market growth.

Figure 2. Global Ursodeoxycholic Acid Market Share (%), by Dosage Form, 2026

     

                                                                        Source: Coherent Market Insights Analysis (2019)

Increasing research studies on ursodeoxycholic acid to bolster the market growth

Increasing research studies conducted on application of ursodeoxycholic acid (UDCA) in other disease indications is expected to fuel growth of the global ursodeoxycholic acid market. According to the University of Sheffield August 2018 study, UDCA improves mitochondrial dysfunction, which is known to be a causative factor for both sporadic and familial Alzheimer’s disease.

According to the Cure Parkinson’s Trust, U.K. 2018 article, researchers demonstrated that UDCA could protect dopamine cells grown in culture from apoptosis, or programmed cell death, by regulating a specific cell survival pathway.

According to a study published by National Center for Biotechnology Information (NCBI) in 2016, UDCA can be introduced as a novel approach for management of Parkinson's disease through anti-apoptotic and anti-inflammatory mechanisms.

Moreover, UDCA can reduce the rotenone-induced nuclear factor-κB expression and tumor necrosis factor alpha level with its anti-inflammatory properties.

Key Players

Major players operating in the global ursodeoxycholic acid market include Dipharma Francis Srl, ERREGIERRE S.p.A., Grindeks, Industria Chimica Emiliana, Mitsubishi Tanabe Pharma Corporation, Zhongshan Belling Biotechnology Co., Glenmark Pharmaceutical Limited, Abil Chempharma Private Limited, Biotavia Labs Pvt Ltd, Daewoong Bio Inc., PharmaZell GmbH, and Suzhou Tianlu Bio-pharmaceutical Co., Ltd.

Market players are focused on strategies such as acquisition, in order to expand their offerings and strengthen their market presence in the U.S. For instance, in May 2018, Dipharma Francis Srl acquired Kalexsyn, Inc., a contract research organization (CRO) that provides chemistry services to the biotechnology and pharmaceutical industry. Such strategic moves will strengthen the company’s technical competency in the development of industrial manufacturing processes for active pharmaceutical ingredients (API).

Ursodeoxycholic acid (UDCA) is a naturally occurring bile acid and is used for dissolving gallstones that are rich in cholesterol. It is also used to improve the flow of bile in primary biliary cirrhosis. UDCA solubilizes cholesterol gallstones, and improves liver function in case of cholestatic diseases. UDCA can be obtained from cholic acid, which is the most abundant and least expensive bile acid available.

Market Dynamics

Factors such as increasing prevalence of gallstones and cystic fibrosis, combined with approval for new indications, is expected to drive market growth over the forecast period. For instance, according to the American Gastroenterological Association 2017 report, gallstones affects 10-15% of the U.S. population annually, which accounts for around 25 million people. In May 2017, IntraBio Ltd. received orphan designation from the European Commission, for ursodeoxycholic acid for the treatment of Niemann-Pick disease. However, the occurrence of possible side effects including nausea, vomiting, itching or dry skin, headache, and sleep disturbances are factors restricting growth of the market.

Key features of the study:

  • This report provides in-depth analysis of the ursodeoxycholic acid market and provides market size (US$ Mn) and Compound Annual Growth Rate (CAGR %) for the forecast period (2018 – 2026), considering 2017 as the base year
  • It elucidates potential revenue 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 approvals, market trends,  regional outlook, and competitive strategies adopted by key players
  • It profiles key players in the global ursodeoxycholic acid 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 part of this study include Dipharma Francis Srl, ERREGIERRE S.p.A., Grindeks, Industria Chimica Emiliana, Mitsubishi Tanabe Pharma Corporation, Zhongshan Belling Biotechnology Co., Glenmark Pharmaceutical Limited, Abil Chempharma Private Limited, Biotavia Labs Pvt Ltd, Daewoong Bio Inc., PharmaZell GmbH, and Suzhou Tianlu Bio-pharmaceutical Co., Ltd.
  • Insights from this report would allow marketers and management authorities of companies to make informed decisions regarding their future product launches, technology up-gradation, market expansion, and marketing tactics
  • The global ursodeoxycholic acid 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 ursodeoxycholic acid market

Detailed Segmentation:

  • Global Ursodeoxycholic Acid Market, By Dosage Form:
    • Solid Dosage Form
    • Liquid Dosage Form
  • Global Ursodeoxycholic Acid Market, By Mode of Extraction:
    • Synthetic
    • Biological
  • Global Ursodeoxycholic Acid Market, By Application:
    • Gallstones
    • Cystic Fibrosis
    • Liver Cirrhosis
    • Others
  • Global Ursodeoxycholic Acid Market, By Region:
    • North America
      • By Dosage Form:
        • Solid Dosage Form
        • Liquid Dosage Form
      • By Mode of Extraction:
        • Synthetic
        • Biological
      • By Application:
        • Gallstones
        • Cystic Fibrosis
        • Liver Cirrhosis
        • Others
      • By Country:
        • U.S.
        • Canada
    • Latin America
      • By Dosage Form:
        • Solid Dosage Form
        • Liquid Dosage Form
      • By Mode of Extraction:
        • Synthetic
        • Biological
      • By Application:
        • Gallstones
        • Cystic Fibrosis
        • Liver Cirrhosis
        • Others
      • By Country:
        • Brazil
        • Mexico
        • Argentina
        • Rest of Latin America
    • Europe
      • By Dosage Form:
        • Solid Dosage Form
        • Liquid Dosage Form
      • By Mode of Extraction:
        • Synthetic
        • Biological
      • By Application:
        • Gallstones
        • Cystic Fibrosis
        • Liver Cirrhosis
        • Others
      • By Country:
        • Germany
        • U.K.
        • France
        • Italy
        • Spain
        • Russia
        • Rest of Europe
    • Asia Pacific
      • By Dosage Form:
        • Solid Dosage Form
        • Liquid Dosage Form
      • By Mode of Extraction:
        • Synthetic
        • Biological
      • By Application:
        • Gallstones
        • Cystic Fibrosis
        • Liver Cirrhosis
        • Others
      • By Country:
        • China
        • India
        • Japan
        • Australia
        • South Korea
        • ASEAN
        • Rest of Asia Pacific
    • Middle East
      • By Dosage Form:
        • Solid Dosage Form
        • Liquid Dosage Form
      • By Mode of Extraction:
        • Synthetic
        • Biological
      • By Application:
        • Gallstones
        • Cystic Fibrosis
        • Liver Cirrhosis
        • Others
      • By Country:
        • GCC
        • Israel
        • Rest of Middle East
    • Africa
      • By Dosage Form:
        • Solid Dosage Form
        • Liquid Dosage Form
      • By Mode of Extraction:
        • Synthetic
        • Biological
      • By Application:
        • Gallstones
        • Cystic Fibrosis
        • Liver Cirrhosis
        • Others
      • By Country:
        • South Africa
        • Central Africa
        • North Africa
  • Company Profiles
    • Dipharma Francis Srl*
      • Company Overview
      • Material Portfolio
      • Financial Performance
      • Key Highlights
      • Market Strategies
    • ERREGIERRE S.p.A.
    • Grindeks
    • Industria Chimica Emiliana
    • Mitsubishi Tanabe Pharma Corporation
    • Zhongshan Belling Biotechnology Co.
    • Glenmark Pharmaceutical Limited
    • Abil Chempharma Private Limited
    • Biotavia Labs Pvt Ltd
    • Daewoong Bio Inc.
    • PharmaZell GmbH
    • Suzhou Tianlu Bio-pharmaceutical Co., Ltd.

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

Table of Contents

  1. Research Objectives and Assumptions
    • Research Objectives
    • Assumptions
    • Abbreviations
  2. Market Purview
    • Report Description
      • Market Definition and Scope
    • Executive Summary
      • Market Snippet, By Dosage Form
      • Market Snippet, By Mode of Extraction
      • Market Snippet, By Application
      • 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
    • PORTER’s Analysis
    • Epidemiology
    • Pipeline Analysis
  4. Global Ursodeoxycholic Acid Market, By Dosage Form, 2016 – 2026, (US$ Mn)
    • Introduction
      • Market Share Analysis, 2016 and 2026 (%)
      • Y-o-Y Growth Analysis, 2017 – 2026
      • Segment Trends
    • Solid Dosage Form
      • Introduction
      • Market Size and Forecast, and Y-o-Y Growth, 2016 – 2026, (US$ Mn)
    • Liquid Dosage Form
      • Introduction
      • Market Size and Forecast, and Y-o-Y Growth, 2016 – 2026, (US$ Mn)
  5. Global Ursodeoxycholic Acid Market, By Mode of Extraction, 2016 – 2026, (US$ Mn)
    • Introduction
      • Market Share Analysis, 2016 and 2026 (%)
      • Y-o-Y Growth Analysis, 2017 – 2026
      • Segment Trends
    • Synthetic
      • Introduction
      • Market Size and Forecast, and Y-o-Y Growth, 2016 – 2026, (US$ Mn)
    • Biological     
      • Introduction
      • Market Size and Forecast, and Y-o-Y Growth, 2016 – 2026, (US$ Mn)
  6. Global Ursodeoxycholic Acid Market, By Application, 2016 – 2026, (US$ Mn)
    • Introduction
      • Market Share Analysis, 2016 and 2026 (%)
      • Y-o-Y Growth Analysis, 2017 – 2026
      • Segment Trends
    • Gallstones
      • Introduction
      • Market Size and Forecast, and Y-o-Y Growth, 2016 – 2026, (US$ Mn)
    • Cystic Fibrosis
      • Introduction
      • Market Size and Forecast, and Y-o-Y Growth, 2016 – 2026, (US$ Mn)
    • Liver Cirrhosis
      • Introduction
      • Market Size and Forecast, and Y-o-Y Growth, 2016 – 2026, (US$ Mn)
    • Others
      • Introduction
      • Market Size and Forecast, and Y-o-Y Growth, 2016 – 2026, (US$ Mn)
  7. Global Ursodeoxycholic Acid Market, By Region, 2016 – 2026, (US$ Mn)
    • Introduction
      • Market Share Analysis, By Region, 2016 and 2026 (%)
      • Y-o-Y Growth Analysis, For Regions, 2017–2026
    • North America
      • Market Size and Forecast, By Dosage Form, 2016 – 2026, (US$ Mn)
      • Market Size and Forecast, By Mode of Extraction, 2016 – 2026, (US$ Mn)
      • Market Size and Forecast, By Application, 2016 – 2026, (US$ Mn)
      • Market Size and Forecast, By Country, 2016 – 2026, (US$ Mn)
        • U.S.
        • Canada
    • Latin America
      • Market Size and Forecast, By Dosage Form, 2016 – 2026, (US$ Mn)
      • Market Size and Forecast, By Mode of Extraction, 2016 – 2026, (US$ Mn)
      • Market Size and Forecast, By Application, 2016 – 2026, (US$ Mn)
      • Market Size and Forecast, By Country, 2016 – 2026, (US$ Mn)
        • Brazil
        • Mexico
        • Argentina
        • Rest of Latin America
    • Europe
      • Market Size and Forecast, By Dosage Form, 2016 – 2026, (US$ Mn)
      • Market Size and Forecast, By Mode of Extraction, 2016 – 2026, (US$ Mn)
      • Market Size and Forecast, By Application, 2016 – 2026, (US$ Mn)
      • Market Size and Forecast, By Country, 2016 – 2026, (US$ Mn)
        • Germany
        • U.K.
        • France
        • Italy
        • Spain
        • Russia
        • Rest of Europe
    • Asia Pacific
      • Market Size and Forecast, By Dosage Form, 2016 – 2026, (US$ Mn)
      • Market Size and Forecast, By Mode of Extraction, 2016 – 2026, (US$ Mn)
      • Market Size and Forecast, By Application, 2016 – 2026, (US$ Mn)
      • Market Size and Forecast, By Country, 2016 – 2026, (US$ Mn)
        • China
        • India
        • Japan
        • Australia
        • South Korea
        • ASEAN
        • Rest of Asia Pacific
    • Middle East
      • Market Size and Forecast, By Dosage Form, 2016 – 2026, (US$ Mn)
      • Market Size and Forecast, By Mode of Extraction, 2016 – 2026, (US$ Mn)
      • Market Size and Forecast, By Application, 2016 – 2026, (US$ Mn)
      • Market Size and Forecast, By Country, 2016 – 2026, (US$ Mn)
        • GCC
        • Israel
        • Rest of Middle East
    • Africa
      • Market Size and Forecast, By Dosage Form, 2016 – 2026, (US$ Mn)
      • Market Size and Forecast, By Mode of Extraction, 2016 – 2026, (US$ Mn)
      • Market Size and Forecast, By Application, 2016 – 2026, (US$ Mn)
      • Market Size and Forecast, By Country/Region, 2016 – 2026, (US$ Mn)
        • South Africa
        • Central Africa
        • North Africa
  8. Competitive Landscape
    • Heat Map Analysis
    • Market Share Analysis
      • Dipharma Francis Srl*
        • Company Overview
        • Dosage Form Portfolio
        • Financial Overview
        • Key Highlights
        • Market Strategies
      • ERREGIERRE S.p.A.
        • Company Overview
        • Dosage Form Portfolio
        • Financial Overview
        • Key Highlights
        • Market Strategies
      • Grindeks
        • Company Overview
        • Dosage Form Portfolio
        • Financial Overview
        • Key Highlights
        • Market Strategies
      • Industria Chimica Emiliana
        • Company Overview
        • Dosage Form Portfolio
        • Financial Overview
        • Key Highlights
        • Market Strategies
      • Mitsubishi Tanabe Pharma Corporation
        • Company Overview
        • Dosage Form Portfolio
        • Financial Overview
        • Key Highlights
        • Market Strategies
      • Zhongshan Belling Biotechnology Co.
        • Company Overview
        • Dosage Form Portfolio
        • Financial Overview
        • Key Highlights
        • Market Strategies
      • Glenmark Pharmaceutical Limited
        • Company Overview
        • Dosage Form Portfolio
        • Financial Overview
        • Key Highlights
        • Market Strategies
      • Abil Chempharma Private Limited
        • Company Overview
        • Dosage Form Portfolio
        • Financial Overview
        • Key Highlights
        • Market Strategies
      • Biotavia Labs Pvt Ltd
        • Company Overview
        • Dosage Form Portfolio
        • Financial Overview
        • Key Highlights
        • Market Strategies
      • Daewoong Bio Inc.
        • Company Overview
        • Dosage Form Portfolio
        • Financial Overview
        • Key Highlights
        • Market Strategies
      • PharmaZell GmbH
        • Company Overview
        • Dosage Form Portfolio
        • Financial Overview
        • Key Highlights
        • Market Strategies
      • Suzhou Tianlu Bio-pharmaceutical Co., Ltd.
        • Company Overview
        • Dosage Form Portfolio
        • Financial Overview
        • Key Highlights
        • Market Strategies
    • Analyst Views
  9. Section
    • References
    • Research Methodology
    • About Us and Sales Contact

*Browse 32 market data tables and 22 figures on "Ursodeoxycholic Acid Market - Global forecast to 2026”.

Research Methodology

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  • 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.
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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:

  • Governmental bodies, National and international social welfare institutions, and organizations creating economic policies among others.
  • Trade association, National and international media and trade press.
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  • 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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