Global Primary Biliary Cirrhosis Market – Industry Trends and Forecast to 2029

Global Primary Biliary Cirrhosis Market, By Drug Type (Ursodeoxycholic acid (USDA), Obeticholic acid), Stages (Portal, Periportal, Septal, Cirrhotic, Others), Treatment Indication (Cirrhosis, Itching, Dry Eye, Dry Mouth, Others), Treatment Type (Medication, Surgery, Others), Route of Administration (Oral, Parenteral, Others), End-Users (Hospitals, Homecare, Specialty Clinics, Others), Distribution Channel (Hospital Pharmacy, Retail Pharmacy, online Pharmacies and Others) – Industry Trends and Forecast to 2029.

Primary Biliary Cirrhosis Market Analysis and Size

The global primary biliary cirrhosis market is expected to witness significant growth during the forecast period. The total diagnosed prevalent cases of Primary biliary cholangitis (PBC) was around 253,146 in 2020. According to National Center for Biotechnology Information (NCBI) data, the occurrence of primary biliary cirrhosis from 2006 through 2016, rise from 21.7 to 39.2 per 100,000 persons in the U.S. There are increased acquisitions and initiatives by government that are helping in the market expansion. North America is expected to witness profitable market share in primary biliary cirrhosis market, due to rising initiatives by major market players to develop advance treatment options for primary biliary cirrhosis. Sudden outbreak of the COVID-19 pandemic imposed stringent lockdown regulations globally, causing interruptions in import and export activities of primary biliary cirrhosis market.

Data Bridge Market Research analyses a growth rate in the global primary biliary cirrhosis market in the forecast period 2022-2029. In addition to the market insights such as market value, growth rate, market segments, geographical coverage, market players, and market scenario, the market report curated by the Data Bridge Market Research team also includes in-depth expert analysis, patient epidemiology, pipeline analysis, pricing analysis, and regulatory framework.

Market Definition

Primary biliary cirrhosis is a kind of progressive autoimmune disease of the biliary system with a chronic course, which eventually worsens with time. When body’s own immune system attack the healthy cells and tissue of bile duct and liver, it leads to slow damage of the interlobular bile ducts. This condition causes intrahepatic cholestasis which damages cells and tissue leading to scarring, fibrosis and ultimately cirrhosis. As per the WHO statistics, liver cirrhosis is most common in Northern Europe and North America. This disease prevalence is rising and important diagnostic procedures and treatments will boost the growth of the market.

Primary Biliary Cirrhosis Market Scope and Segmentation

Global Primary Biliary Cirrhosis Market Dynamics

Drivers

• Availability of Advanced Treatment Procedures

With each decade, varied treatment methods are available to help the patients' faster recovery. Development of diverse advanced devices are providing high output, carrying out several tests in a very short duration of time, and reducing weight time significantly. Thus, it acts as a major driver in the market growth.

• Huge Number of Pipeline Studies

Growing pipeline studies to develop prominent treatments for several rare diseases such as primary biliary cirrhosis are expected to increase the primary biliary cirrhosis market size. For instance, in October 2018, CymaBay Therapeutics, Inc., started placebo-controlled and randomized phase 3 clinical trial for seladelpar 5-10mg. The primary goal was to assess safety and efficacy of seladelpar in patients with primary biliary cirrhosis and to determine inadequate response or intolerance to ursodeoxycholic acid (UDCA). The study is projected to complete in December 2021. Thus, this studies are contributing to the market growth.

• Increase in the number of research and development activities       

The market growth is boosted by a rise in the number of R&D activities. This will provide beneficial opportunities for the global biliary atresia treatment market. The government is funding research and development (R&D) initiatives to encourage researchers and pharmaceutical companies to develop novel medicines.

Opportunities

• Strategic Initiatives and Collaborations

Increasing initiatives such as acquisitions by major market players is predicted to boost the market size. For instance, in June 2016, Retrophin, Inc. attained ownership of a liquid formulation of ursodeoxycholic acid from Asklepion Pharmaceuticals, LLC. Ursodeoxycholic acid is a naturally occurring bile acid that liquefies gall stone which is rich in cholesterol and increases the flow of bile in primary biliary cirrhosis. All these factors are also contributing in the growth of the market.  

• Increasing Drug Approvals from Authorizations

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

Restraints/Challenges

• Complications of Primary Biliary cirrhosis Drugs

Common complications of Primary Biliary cirrhosis might hamper the market growth. For instance, the FDA approved drug called ursodeoxycholic acid for this disease is associated with complications such as difficulty in breathing, itchy skin, swollen face or lips. This restrict the market growth.

• Unavailability of Appropriate Treatments

To treat rare conditions, all treatments are not available, especially in the under-developed countries. The severe patients’ needs to be treated with the advanced techniques but at times, these are not available in the hospitals and clinics. Thus, it hampers the market growth.

This global primary biliary cirrhosis market report provides details of new recent developments, trade regulations, import-export analysis, production analysis, value chain optimization, market share, impact of domestic and localized market players, analyses opportunities in terms of emerging revenue pockets, changes in market regulations, strategic market growth analysis, market size, category market growths, application niches and dominance, product approvals, product launches, geographic expansions, technological innovations in the market. To gain more info on the global primary biliary cirrhosis market contact Data Bridge Market Research for an Analyst Brief, our team will help you take an informed market decision to achieve market growth.

COVID-19 Impact on Global Primary Biliary Cirrhosis Market

COVID-19 has left a major global public health crisis impacting practically every business and a heavy impact on the global biliary atresia treatment market. The COVID-19 pandemic has really had a great impact on research and clinical trials of primary biliary cirrhosis. They have been extremely impacted due to the immense lack of new sample collections. Furthermore, as per the article published by American Association for the Study of Liver Diseases, a considerable decline in donations with unparalleled financial challenges and the cancellation of all fundraising events, will definitely impact liver research funding. Histopathological signs of autoimmune reactions have been observed analyzing autopsies from patients deceased from COVID-19. Several studies conducted on telemedicine in many parts of the country during the COVID-19 pandemic in patients with autoimmune liver disease exhibited quite low rates of symptomatic SARS CoV-2 infection, with total favourable outcomes.

Many hospitals have decided to cancel or postpone other procedures during the pandemic. The situation improved a bit after the pandemic, and doctors and physicians could focus on the other syndromes, including these rare ones. Travel restrictions has uplifted and treatments are expanding at a high pace. In terms of genetic counselling, telemedicine is also on the rise and is really helpful, especially for treating these diseases.

Global Primary Biliary Cirrhosis Market Scope

The global primary biliary cirrhosis market is segmented on the basis of stages, treatment indication, treatment type, route of administration, distribution channel, end users. The growth amongst these segments will help you analyze meagre growth segments in the industries and provide the users with a valuable market overview and market insights to help them make strategic decisions for identifying core market applications.

Drug Type

• Ursodeoxycholic acid (USDA)

Ursodiol

• Obeticholic acid
• Ocaliva

Stages

• Portal
• Periportal
• Septal
• Cirrhotic
• Others  

Treatment Indication

• Cirrhosis
• Itching
• Dry Eye
• Dry Mouth
• Others

Treatment Type

• Medication
• Surgery
• Others

Route of Administration

• Oral
• Parenteral
• Others

End-Users

• Hospitals
• Homecare
• Specialty Clinics
• Others

Distribution Channel

• Hospital Pharmacy
• Retail Pharmacy
• Online Pharmacies
• Others

Primary Biliary Cirrhosis Market Regional Analysis/Insights

The global primary biliary cirrhosis market is analysed and market size insights and trends are provided by stages, treatment indication, treatment type, route of administration,  distribution channel, end users as referenced above.

The major countries covered in the global primary biliary cirrhosis market report are the U.S., Canada and Mexico in North America, Germany, France, U.K., Netherlands, Switzerland, Belgium, Russia, Italy, Spain, Turkey, Rest of Europe in Europe, China, Japan, India, South Korea, Singapore, Malaysia, Australia, Thailand, Indonesia, Philippines, Rest of Asia-Pacific (APAC) in the Asia-Pacific (APAC), Saudi Arabia, U.A.E, South Africa, Egypt, Israel, Rest of Middle East and Africa (MEA) as a part of Middle East and Africa (MEA), Brazil, Argentina and Rest of South America as part of South America.

North America is dominating the market due to increased investment by pharmaceutical industries for the advancement in the treatment and favourable reimbursement scenario.

Asia-Pacific is considered to have the most lucrative period due to increased liver diseases such as hepatitis, liver failure, and rapidly improving health care infrastructure in the region.

The country section of the report also provides individual market impacting factors and changes in regulation in the market domestically that impacts the current and future trends of the market. Also, the presence and availability of global brands and their challenges faced due to large or scarce competition from local and domestic brands, impact of domestic tariffs and trade routes are considered while providing forecast analysis of the country data.   

Competitive Landscape and Global Primary Biliary Cirrhosis Market Share Analysis

The global primary biliary cirrhosis market competitive landscape provides details by competitor. Details included are company overview, company financials, revenue generated, market potential, investment in research and development, new market initiatives, global presence, production sites and facilities, production capacities, company strengths and weaknesses, product launch, product width and breadth, application dominance. The above data points provided are only related to the companies' focus related to global primary biliary cirrhosis market

Key players operating in the global primary biliary cirrhosis market include:

• F. Hoffmann-La Roche Ltd. (Switzerland)
• Mylan N.V. (U.S.)
• Pfizer Inc. (U.S.)
• Novartis AG (Switzerland)
• AstraZeneca (U.K.)
• Johnson & Johnson Private Limited (U.S.)
• Sun Pharmaceutical Industries Ltd. (India)
• Bristol-Myers Squibb Company (U.S.)
• Lilly (U.S.)
• Amgen Inc. (U.S.)
• Glenmark Pharmaceuticals Inc (India)
• Amneal Pharmaceuticals LLC. (U.K.)
• Intercept Pharmaceuticals, Inc (U.K.)
• Emcure Pharmaceuticals Limited(India)
• Takeda Pharmaceutical Company Limited (Japan)
• Teva Pharmaceutical Industries Ltd (Israel)