Primary Biliary Cholangitis Market Report 2025

This 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 primary biliary cholangitis market size has grown rapidly in recent years. It will grow from $0.98 billion in 2024 to $1.09 billion in 2025 at a compound annual growth rate (CAGR) of 11.8%. 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 $1.6 billion in 2029 at a compound annual growth rate (CAGR) of 9.9%. 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 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.

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.

The primary biliary cholangitis market research report is one of a series of new reports 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 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.

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