Primary Biliary Cholangitis Global Market Report 2025

Primary biliary cholangitis (PBC) is a chronic autoimmune liver disease characterized by the progressive inflammation and destruction of the small bile ducts within the liver. This condition can lead to impaired bile flow, liver damage, and various related complications. PBC primarily affects middle-aged women and is often associated with symptoms such as fatigue, itching, and abdominal discomfort.

The main types of treatment for primary biliary cholangitis are drugs and liver transplantation. A drug is any chemical substance that causes a change in an organism's physiology or psychology when consumed, and ursodeoxycholic acid (UDCA) is the standard first-line treatment for PBC. UDCA helps improve liver function, reduce liver inflammation, and slow down disease progression. Primary biliary cholangitis is diagnosed through various imaging tests such as magnetic resonance elastography (MRE), magnetic resonance cholangiopancreatography (MRCP), ultrasound, fibroscan, as well as blood tests including cholesterol tests, antibody tests, and liver function tests. These diagnostic methods are employed by end-users such as specialty clinics, homecare services, and other healthcare facilities.

Note that the outlook for this market is being affected by rapid changes in trade relations and tariffs globally. The report will be updated prior to delivery to reflect the latest status, including revised forecasts and quantified impact analysis. The report's Recommendations and Conclusions sections will be updated to give strategies for entities dealing with the fast-moving international environment.

The sharp rise in U.S. tariffs and the resulting trade tensions in spring 2025 are having a significant impact on the healthcare sector, especially in the supply of essential medical devices, diagnostic equipment, and pharmaceuticals. Hospitals and healthcare providers are grappling with higher costs for imported surgical tools, imaging systems, and consumables like syringes and catheters, many of which have limited domestic substitutes. These escalating expenses are putting pressure on healthcare budgets, prompting some providers to delay equipment upgrades or pass increased costs on to patients. Furthermore, tariffs on raw materials and components are disrupting the manufacturing of vital drugs and devices, leading to supply chain delays. In response, the industry is adopting diversified sourcing strategies, expanding local production where feasible, and pushing for tariff exemptions on critical medical products.

The primary biliary cholangitis market research report is one of a series of new reports from The Business Research Company that provides primary biliary cholangitis market statistics, including primary biliary cholangitis industry global market size, regional shares, competitors with a primary biliary cholangitis market share, detailed primary biliary cholangitis market segments, market trends and opportunities, and any further data you may need to thrive in the primary biliary cholangitis industry. This primary biliary cholangitis market research report delivers a complete perspective of everything you need, with an in-depth analysis of the current and future scenario of the industry.

The primary biliary cholangitis market size has grown strongly in recent years. It will grow from $0.98 billion in 2024 to $1.06 billion in 2025 at a compound annual growth rate (CAGR) of 7.9%. The growth in the historic period can be attributed to increased disease awareness, rising global healthcare expenditure, strategic collaborations in the healthcare sector, focus on patient advocacy, government initiatives for liver health.

The primary biliary cholangitis market size is expected to see strong growth in the next few years. It will grow to $1.47 billion in 2029 at a compound annual growth rate (CAGR) of 8.6%. The growth in the forecast period can be attributed to expansion of biomarker research, global efforts in rare disease management, increased collaboration in clinical trials, patient-centric healthcare approaches, rising demand for liver transplants. Major trends in the forecast period include advancements in biomarker research, growing emphasis on non-invasive diagnostic techniques, research focus on immunomodulatory therapies, integration of artificial intelligence (AI), patient-reported outcomes in clinical trials, telemedicine for patient management, focus on combination therapies, emerging therapies targeting fibrosis.

The forecast of 8.6% growth over the next five years reflects a modest reduction of 0.3% from the previous estimate for this market. This reduction is primarily due to the impact of tariffs between the US and other countries. The imposition of tariffs may disrupt U.S. treatment access by increasing costs for ursodeoxycholic acid (UDCA) and obeticholic acid imported from Spain and Poland, potentially delaying therapy initiation and raising hepatology clinic expenses. The effect will also be felt more widely due to reciprocal tariffs and the negative effect on the global economy and trade due to increased trade tensions and restrictions.

The anticipated rise in smoking is poised to drive the expansion of the primary biliary cholangitis market in the coming years. Smoking involves the inhalation and exhalation of smoke generated by burning tobacco or other substances. It is a recognized risk factor for liver diseases, including PBC, and elevated smoking rates may result in an increased number of individuals seeking medical attention for liver-related issues. As an illustration, in July 2023, Statistics Canada reported a 2.2% increase in cigarette production compared to June 2023, with a corresponding 2.6% rise in cigarette sales, reaching 1.4 billion units in June compared to May. Consequently, the upswing in smoking is expected to propel the primary biliary cholangitis market's growth.

The rise in liver cancer is expected to drive the growth of the primary biliary cholangitis market in the future. Liver cancer, also known as hepatocellular carcinoma, is a type of cancer that begins in the liver cells. Primary biliary cholangitis plays a significant role in liver cancer due to the increased risk of various malignancies, including cholangiocarcinoma and hepatocellular carcinoma. The growing prevalence of this disease and its potential complications are contributing to the expansion of the primary biliary cholangitis market. For example, in January 2024, the American Cancer Society, a leading professional organization in the U.S., projected approximately 41,630 new cases of liver cancer in the country, with 28,000 cases in men and 13,630 in women. Additionally, about 29,840 individuals (19,120 men and 10,720 women) are expected to die from the disease. As a result, the increase in liver cancer cases is driving the growth of the primary biliary cholangitis market.

Major companies operating in the primary biliary cholangitis market are directing their efforts towards the development of innovative and specialized treatments. This includes the creation of orphan drugs featuring a combination of obeticholic acid (OCA) and bezafibrates for the treatment of primary biliary cholangitis (PBC), aiming to secure market exclusivity. The combination of OCA and bezafibrate, with an orphan drug designation, seeks to provide a more comprehensive and effective approach to managing PBC treatment, potentially enhancing the quality of life for individuals affected by this rare condition. For example, in May 2023, Intercept Pharmaceuticals, Inc., a US-based biopharmaceutical company, obtained orphan drug designation from the FDA for the combination of obeticholic acid (OCA) and bezafibrate as a potential treatment for PBC, a progressive liver disease, with OCA already approved for PBC in the US.

In March 2023, Ipsen SA, a France-based pharmaceutical company, completed the acquisition of Albireo Pharma, Inc. for an undisclosed amount. This strategic move by Ipsen aims to broaden its rare disease portfolio by incorporating novel pipeline prospects, promising therapies for rare cholestatic liver diseases in both children and adults, and leveraging strong scientific and commercial capabilities. Albireo Pharma Inc., a US-based biopharmaceutical company, is actively developing A3907 therapy for primary biliary cholangitis (PBC), contributing to Ipsen's expansion in the rare disease segment.

Major companies operating in the primary biliary cholangitis market report are Pfizer Inc., F. Hoffmann-La Roche Ltd., Merck And Co. Inc., Novartis AG, Bristol-Myers Squibb Company, AstraZeneca PLC, GlaxoSmithKline PLC, Takeda Pharmaceutical Company, Amgen Inc., Boehringer Ingelheim International GmbH., Gilead Sciences Inc., Vertex Pharmaceuticals, Dr. Reddy's Laboratories Ltd., Amneal Pharmaceuticals LLC, Alnylam Pharmaceuticals Inc., Ionis Pharmaceuticals Inc., Intercept Pharmaceuticals Inc., Arrowhead Pharmaceuticals Inc., CureVac N.V., Sangamo Therapeutics Inc., Calliditas Therapeutics AB, NGM Biopharmaceuticals Inc., Bluebird Bio Inc., Intellia Therapeutics Inc., Albireo Pharma Inc., TARGET PharmaSolutions Inc., Genfit S.A., Editas Medicine Inc., CymaBay Therapeutics Inc., Ascletis Pharma Inc.

North America was the largest region in the primary biliary cholangitis market in 2024. Asia-Pacific is expected to be the fastest-growing region in the forecast period. The regions covered in the primary biliary cholangitis market report are Asia-Pacific, Western Europe, Eastern Europe, North America, South America, Middle East, Africa.

The countries covered in the primary biliary cholangitis market report are Australia, Brazil, China, France, Germany, India, Indonesia, Japan, Russia, South Korea, UK, USA, Canada, Italy, Spain.

The primary biliary cholangitis market includes revenues earned by entities by providing services such as psychosocial support services, nutritional guidance services, medical diagnosis, and specialized medical care services. The market value includes the value of related goods sold by the service provider or included within the service offering. The primary biliary cholangitis market also includes sales of products such as fat-soluble vitamins, anti-itch medications, and imaging equipment. Values in this market are 'factory gate' values, that is the value of goods sold by the manufacturers or creators of the goods, whether to other entities (including downstream manufacturers, wholesalers, distributors, and retailers) or directly to end customers. The value of goods in this market includes related services sold by the creators of the goods.

The market value is defined as the revenues that enterprises gain from the sale of goods and/or services within the specified market and geography through sales, grants, or donations in terms of the currency (in USD, unless otherwise specified).

The revenues for a specified geography are consumption values that are revenues generated by organizations in the specified geography within the market, irrespective of where they are produced. It does not include revenues from resales along the supply chain, either further along the supply chain or as part of other products.

Primary Biliary Cholangitis Global Market Report 2025 from The Business Research Company provides strategists, marketers and senior management with the critical information they need to assess the market.

This report focuses on primary biliary cholangitis market which is experiencing strong growth. The report gives a guide to the trends which will be shaping the market over the next ten years and beyond.

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Where is the largest and fastest growing market for primary biliary cholangitis ? How does the market relate to the overall economy, demography and other similar markets? What forces will shape the market going forward, including technological disruption, regulatory shifts, and changing consumer preferences? The primary biliary cholangitis market global report from the Business Research Company answers all these questions and many more.

The report covers market characteristics, size and growth, segmentation, regional and country breakdowns, competitive landscape, market shares, trends and strategies for this market. It traces the market's historic and forecast market growth by geography.

• The market characteristics section of the report defines and explains the market.
• The market size section gives the market size ($b) covering both the historic growth of the market, and forecasting its development.
• The forecasts are made after considering the major factors currently impacting the market. These include:

The forecasts are made after considering the major factors currently impacting the market. These include the technological advancements such as AI and automation, Russia-Ukraine war, trade tariffs (government-imposed import/export duties), elevated inflation and interest rates.

• Market segmentations break down the market into sub markets.
• The regional and country breakdowns section gives an analysis of the market in each geography and the size of the market by geography and compares their historic and forecast growth.
• The competitive landscape chapter gives a description of the competitive nature of the market, market shares, and a description of the leading companies. Key financial deals which have shaped the market in recent years are identified.
• The trends and strategies section analyses the shape of the market as it emerges from the crisis and suggests how companies can grow as the market recovers.

Scope

• Markets Covered:1) By Treatment Type: Drugs; Liver Transplantation
• 2) By Diagnosis: Imaging Tests; Magnetic Resonance Elastography (MRE); Magnetic Resonance Cholangiopancreatography (MRCP); Ultrasound; Fibroscan; Blood Tests; Cholesterol Test; Antibody Tests; Liver Tests; Other Diagnoses
• 3) By End-Users: Specialty Clinics; Homecare; Other End-Users
• Subsegments:
• 1) By Drugs: Ursodeoxycholic Acid (UDCA); Obeticholic Acid (OCA); Fibrates; Immunosuppressive Drugs; Other Targeted Therapies
• 2) By Liver Transplantation: Orthotopic Liver Transplantation (OLT); Living Donor Liver Transplantation; Hepatobiliary Surgery For Liver Transplant
• Companies Mentioned: Pfizer Inc.; F. Hoffmann-La Roche Ltd.; Merck And Co. Inc.; Novartis AG; Bristol-Myers Squibb Company; AstraZeneca plc; GlaxoSmithKline plc; Takeda Pharmaceutical Company; Amgen Inc.; Boehringer Ingelheim International GmbH.; Gilead Sciences Inc.; Vertex Pharmaceuticals; Dr. Reddy's Laboratories Ltd.; Amneal Pharmaceuticals LLC; Alnylam Pharmaceuticals Inc.; Ionis Pharmaceuticals Inc.; Intercept Pharmaceuticals Inc; Arrowhead Pharmaceuticals Inc.; CureVac N.V.; Sangamo Therapeutics Inc.; Calliditas Therapeutics AB; NGM Biopharmaceuticals Inc.; Bluebird Bio Inc.; Intellia Therapeutics Inc.; Albireo Pharma Inc; TARGET PharmaSolutions Inc.; Genfit S.A.; Editas Medicine Inc.; CymaBay Therapeutics Inc.; Ascletis Pharma Inc.
• Countries: Australia; Brazil; China; France; Germany; India; Indonesia; Japan; Russia; South Korea; UK; USA; Canada; Italy; Spain.
• Regions: Asia-Pacific; Western Europe; Eastern Europe; North America; South America; Middle East; Africa
• Time Series: Five years historic and ten years forecast.
• Data: Ratios of market size and growth to related markets, GDP proportions, expenditure per capita,
• Data Segmentations: country and regional historic and forecast data, market share of competitors, market segments.
• Sourcing and Referencing: Data and analysis throughout the report is sourced using end notes.
• Delivery Format: PDF, Word and Excel Data Dashboard.