DelveInsight’s “Primary Biliary Cholangitis Market Insight, Epidemiology, and Market Forecast – 2034” report delivers comprehensive insights into the PBC market, including historical and forecasted epidemiology as well as market trends across the US, EU4 (Germany, France, Italy, and Spain), the UK, and Japan.
The primary biliary cholangitis market size was USD 1.2 billion across the 7MM in 2023, which is forecasted to increase steadily from 2024 to 2034. Furthermore, the US accounted for the largest PBC market share. This trend is expected to continue in the forecasted period, due to a larger patient pool, better disease awareness, and favourable reimbursement policies.
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The report provides detailed epidemiological data segmentation covering total diagnosed prevalent cases, gender-specific diagnosed prevalent cases, and age-specific diagnosed prevalent cases of primary biliary cholangitis across the 7MM during the study period (2020-2034).
According to the primary biliary cholangitis epidemiology contained in the report, the US accounted for the largest proportion of diagnosed prevalent PBC cases among the 7MM in 2023. Furthermore, the epidemiology model reveals a significantly higher prevalence among females compared to males across all markets, attributable to genetic predisposition, hormonal influences, and environmental factors. Among European nations, Germany reported the highest burden, followed by Italy and the UK. The data also indicates that PBC predominantly affects individuals aged 40-70 years, reinforcing the importance of age-targeted screening and treatment strategies.
Discover evolving trends in the Primary Biliary Cholangitis patient pool forecasts @ Primary Biliary Cholangitis Epidemiological Analysis.
The current primary biliary cholangitis treatment landscape has been historically dominated by ursodeoxycholic acid (UDCA) as the cornerstone first-line therapy, with obeticholic acid (OCALIVA) from Intercept Pharmaceuticals serving as the second-line option for patients with inadequate response to or intolerance of UDCA. However, the therapeutic paradigm has experienced significant evolution in 2024 with the FDA granting accelerated approvals to two novel treatments: Elafibranor (IQIRVO) in June 2024 by Genfit/Ipsen and Seladelpar (LIVDELZI) in August 2024 by Gilead Sciences. Both therapeutics represent innovative approaches targeting peroxisome proliferator-activated receptors, offering new mechanisms to address the complex primary biliary cholangitis pathophysiology.
The primary biliary cholangitis clinical trials market is demonstrating robust activity, with several promising candidates advancing through the development pipeline. Saroglitazar Magnesium by Zydus Therapeutics, a dual PPAR alpha/gamma agonist with the FDA Fast Track and Orphan Drug designations, shows substantial potential in addressing both cholestasis and metabolic aspects of PBC. A Phase IIb/III trial (NCT05133336) is ongoing to further evaluate its dual PPAR alpha/gamma agonism targeting metabolic and inflammatory pathways.
GlaxoSmithKline’s Linerixibat, an IBAT inhibitor currently in Phase III trials, targets the debilitating pruritus associated with PBC. Additionally, COUR Pharmaceuticals’ CNP-104 secured FDA Orphan Drug Designation in January 2025, positioning it as potentially the first disease-modifying treatment for PBC by inducing tolerance to pathogenic activated PDC-E2 T-cells that drive bile duct inflammation.
Discover evolving trends in the Primary Biliary Cholangitis treatment landscape @ Primary Biliary Cholangitis Recent Developments.
Despite these significant advancements, the PBC market faces several challenges, including insufficient disease awareness among healthcare providers and patients, complex diagnostic processes resulting in under-recognition, and affordability barriers to innovative treatments. Addressing these obstacles will require comprehensive educational initiatives, streamlined diagnostic pathways, and creative pricing strategies to improve treatment accessibility.
Furthermore, safety concerns continue to emerge, as evidenced by the FDA’s recent identification of serious liver injury cases in non-cirrhotic PBC patients treated with obeticholic acid. This new safety concern was announced in a Drug Safety Communication in December 2024, following a review of postmarket clinical trial data, highlighting the ongoing need for vigilant safety monitoring of both established and emerging therapies.
The primary biliary cholangitis competitive landscape is evolving rapidly, with several key players actively involved in therapeutic development and commercialization. Some of the pharmaceutical companies active in this landscape include Gilead Sciences (NASDAQ: GILD), Intercept Pharmaceuticals (NASDAQ: ICPT), CymaBay Therapeutics (NASDAQ: CBAY), COUR Pharmaceuticals, Teva Pharmaceutical (NYSE: TEVA), Mylan, AbbVie (NYSE: ABBV), Glenmark Pharmaceuticals (NSE: GLENMARK), Allergan, Eli Lilly (NYSE: LLY), Novartis (NYSE: NVS), Pfizer (NYSE: PFE), Roche (SWX: ROG), Merck (NYSE: MRK), Bristol-Myers Squibb (NYSE: BMY), AstraZeneca (NASDAQ: AZN), GlaxoSmithKline (NYSE: GSK), Takeda (NYSE: TAK), Amgen (NASDAQ: AMGN), Boehringer Ingelheim, Dr. Reddy’s (NYSE: RDY), Amneal (NASDAQ: AMRX), Alnylam (NASDAQ: ALNY), Ionis (NASDAQ: IONS), Arrowhead (NASDAQ: ARWR), CureVac (NASDAQ: CVAC), Sangamo (NASDAQ: SGMO), Calliditas Therapeutics (NASDAQ: CALT), NGM Biopharmaceuticals (NASDAQ: NGM), Bluebird Bio (NASDAQ: BLUE), Intellia (NASDAQ: NTLA), Albireo, TARGET PharmaSolutions, Genfit (NASDAQ: GNFT), and Ascletis Pharma, among others.
Looking ahead, DelveInsight forecasts the primary biliary cholangitis market will witness accelerated growth driven by the continued uptake of newly approved therapies and the potential introduction of pipeline candidates addressing unmet needs. The integration of biomarker-guided treatment approaches and combination regimens is anticipated to optimize therapeutic outcomes, while ongoing research into disease-modifying interventions may fundamentally transform the treatment paradigm. As the understanding of PBC pathophysiology advances, the market is poised for further innovation, with the ultimate goal of improving quality of life and long-term outcomes for patients living with this challenging autoimmune liver condition.
Table of Contents
1. Key Insights
2. Executive Summary of Primary Biliary Cholangitis
3. Primary Biliary Cholangitis Competitive Intelligence
4. Primary Biliary Cholangitis: Market Overview at a Glance
5. Primary Biliary Cholangitis: Disease Background and Overview
6. Patient Journey
7. Primary Biliary Cholangitis Epidemiology and Patient Population
8. Treatment Algorithm, Current Treatment, and Medical Practices
9. Primary Biliary Cholangitis Unmet Needs
10. Key Endpoints of Primary Biliary Cholangitis Treatment
11. Primary Biliary Cholangitis Marketed Products
12. Primary Biliary Cholangitis Emerging Therapies
13. Primary Biliary Cholangitis: Seven Major Market Analysis
14. Attribute analysis
15. 7MM: Market Outlook
16. Access and Reimbursement Overview of Primary Biliary Cholangitis
17. KOL Views
18. Primary Biliary Cholangitis Market Drivers
19. Primary Biliary Cholangitis Market Barriers
20. Appendix
21. DelveInsight Capabilities
22. Disclaimer
23. About DelveInsight
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About DelveInsight
DelveInsight is a leading market research and consulting firm specializing in disease-specific insights and therapeutic market analysis. Their reports integrate real-world data, clinical trial findings, and expert interviews to deliver comprehensive industry intelligence.
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