원발성 담즙성 담관염 : 시장 전망, 역학, 경쟁 구도, 시장 예측 보고서(2025-2035년)

Primary Biliary Cholangitis (PBC) Market Outlook

Thelansis's "Primary Biliary Cholangitis (PBC) Market Outlook, Epidemiology, Competitive Landscape, and Market Forecast Report - 2025 To 2035" covers disease overview, epidemiology, drug utilization, prescription share analysis, competitive landscape, clinical practice, regulatory landscape, patient share, market uptake, market forecast, and key market insights under the potential Primary Biliary Cholangitis treatment modalities options for eight major markets (USA, Germany, France, Italy, Spain, UK, Japan, and China).

Primary Biliary Cholangitis (PBC) Overview

Primary biliary cholangitis (PBC) is a chronic, progressive autoimmune cholestatic liver disease characterized by immune-mediated destruction of small intrahepatic bile ducts, leading to impaired bile flow, chronic cholestasis, fibrosis, and eventual cirrhosis in advanced stages. The disease predominantly affects middle-aged women and is strongly associated with antimitochondrial antibodies (AMA), which serve as the hallmark diagnostic biomarker in the majority of patients. Common clinical manifestations include fatigue, pruritus, and elevated cholestatic liver enzymes, while advanced disease may lead to portal hypertension, hepatic insufficiency, and liver failure.

Diagnosis is based on cholestatic liver biochemistry, AMA positivity, and histological findings in select cases. Ursodeoxycholic acid (UDCA) remains the standard first-line therapy and significantly improves transplant-free survival; however, a substantial proportion of patients demonstrate inadequate biochemical response or persistent disease progression. Second-line treatment options include obeticholic acid and fibrates, while recently approved PPAR agonists such as elafibranor and seladelpar are expanding the therapeutic landscape.

Despite therapeutic advances, unmet needs persist in patients with incomplete treatment response, progressive fibrosis, and persistent symptom burden, particularly fatigue and pruritus, which significantly impact quality of life. The evolving treatment landscape is increasingly focused on novel targeted therapies, improved risk stratification, and personalized disease management approaches aimed at delaying progression and reducing the need for liver transplantation.

Key Highlights

• In France, diagnosed PBC cases are projected to increase from approximately 18,716 in 2025 to nearly 20,069 by 2035, reflecting a gradual rise in diagnosed prevalence.
• PBC predominantly affects women and remains associated with substantial long-term morbidity due to progressive cholestatic liver damage.
• A considerable proportion of patients exhibit inadequate biochemical response to UDCA, driving demand for second-line and combination therapies.
• Recently approved PPAR agonists are significantly expanding treatment options for patients with persistent disease activity.
• Persistent fatigue and pruritus continue to represent major unmet clinical needs impacting patient quality of life.

Market Overview

• The Germany PBC market is projected to grow from approximately $54 MN to $145 MN, reflecting significant market expansion.
• Market growth is supported by:
• Increasing adoption of second-line and novel targeted therapies
• Expanding use of PPAR agonists and combination treatment strategies
• Improved diagnosis, earlier intervention, and enhanced disease awareness are contributing to increased treatment uptake.
• Future market growth will depend on next-generation targeted therapies, improved long-term disease control, and expanded personalized treatment approaches.

Insights driven by robust research, including:

• In-depth interviews with leading KOLs and payers
• Physician surveys
• RWE analysis for claims and EHR datasets
• Secondary research (e.g., peer-reviewed journal articles, third-party research databases)

Deliverables format and updates*:

• Detailed Report (PDF)
• Market Forecast Model (MS Excel-based automated dashboard)
• Epidemiology (MS Excel; interactive tool)
• Executive Insights (PowerPoint presentation)
• Others: regular updates, customizations, consultant support
• As per Thelansis's policy, we ensure that we include all the recent updates before releasing the report content and market model.

Salient features of Market Forecast model:

• 10-year market forecast (2025-2035)
• Bottom-up patient-based market forecasts validated through the top-down sales methodology
• Covers clinically and commercially-relevant patient populations/ line of therapies
• Annualized drug-level sales and patient share projections
• Utilizes our proprietary Epilansis and Analog tool (e.g., drug uptake and erosion) datasets and conjoint analysis approach
• Detailed methodology/sources & assumptions
• Graphical and tabular outputs
• Users can customize the model based on requirements

Key business questions answered:

• How can drug development and lifecycle management strategies be optimized across G8 markets (US, EU5, Japan, and China)?
• How large is the patient population in terms of incidence, prevalence, segments, and those receiving drug treatments?
• What is the 10-year market outlook for sales and patient share?
• Which events will have the greatest impact on the market's trajectory?
• What insights do interviewed experts provide on current and emerging treatments?
• Which pipeline products show the most promise, and what is their potential for launch and future positioning?
• What are the key unmet needs and KOL expectations for target profiles?
• What key regulatory and payer requirements must be met to secure drug approval and favorable market access?

Countries Covered

• G8
  • United States
  • EU5
    • France
    • Germany
    • Italy
    • Spain
    • U.K.
  • Japan
  • China

Apart from the G8 Market, adding any additional country data to the dashboard will cost USD 1,750 per country

Companies Mentioned

• Zydus Therapeutics Inc.
• Gilead Sciences
• Ipsen
• Intercept Pharmaceuticals
• COUR Pharmaceutical Development Company, Inc.
• Tharimmune Inc.
• Mirum Pharmaceuticals, Inc.
• Umecrine Cognition AB
• Parvus Therapeutics, Inc.
• Calliditas Therapeutics Suisse SA

Table of Contents

1. Key Findings and Analyst Commentary

• Key trends: market snapshots, SWOT analysis, commercial benefits and risks, etc.

2. Disease Context

• Disease definition, classification, etiology and pathophysiology, drug targets, etc.

3. Epidemiology

• Key takeaways
• Incidence / Prevalence
• Diagnosed and Drug-Treated populations
• Comorbidities
• Other relevant patient segments

4. Market Size and Forecast

• Key takeaways
• Market drivers and constraints
• Drug-class specific trends
• Country-specific trends

5. Competitive Landscape

• Current therapies
• Key takeaways
• Dx and Tx journey/algorithm
• Key current therapies - profiles and KOL insights
• Emerging therapies
• Key takeaways
• Notable late-phase emerging therapies - profiles, launch expectations, KOL insights
• Notable early-phase pipeline

6. Unmet Need and TPP Analysis

• Top unmet needs and future attainment by emerging therapies
• TPP analysis and KOL expectations

7. Regulatory and Reimbursement Environments (by country and payer insights)

8. Appendix (e.g., bibliography, methodology)