원발성 담즙성 담관염(PBC) : 세계 시장 전망, 역학, 경쟁 구도, 시장 예측 리포트(주요 32 시장), 2025-2035년

Global Primary Biliary Cholangitis (PBC) Market Outlook

Thelansis's "Global Primary Biliary Cholangitis (PBC) Market Outlook, Epidemiology, Competitive Landscape, and Market Forecast Report (Top 32 Markets) - 2025 To 2035" covers disease overview, epidemiology, kidney biopsy cases, 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 the 32 markets (North America, Europe, Middle East, Asia Pacific, Africa, South / Latin America).

Primary Biliary Cholangitis (PBC) Overview

Primary biliary cholangitis (PBC) is a chronic, progressive autoimmune cholestatic liver disease characterised by immune-mediated destruction of small intrahepatic bile ducts, driven by autoreactive T-cell targeting of mitochondrial antigens - predominantly the pyruvate dehydrogenase complex E2 subunit - in genetically susceptible individuals, with antimitochondrial antibodies (AMA) serving as the hallmark diagnostic biomarker present in over 90% of patients. Predominantly affecting middle-aged women, patients may present insidiously with fatigue and pruritus - often preceding overt cholestasis - or be identified incidentally through elevated alkaline phosphatase and GGT on routine biochemistry. Diagnosis integrates AMA positivity, cholestatic liver biochemistry, and - in AMA-negative cases - liver biopsy demonstrating florid bile duct lesions. Risk stratification employs validated scores including GLOBE and UK-PBC to identify inadequate biochemical responders at greatest cirrhosis progression risk. Ursodeoxycholic acid (UDCA) remains first-line therapy, improving bile flow and transplant-free survival; obeticholic acid, an FXR agonist, and bezafibrate provide second-line options for inadequate UDCA responders. Elafibranor and seladelpar, novel PPAR agonists, represent recently approved therapeutic advances expanding the management landscape. Prognosis is favourable with early treatment and biochemical response; liver transplantation remains definitive therapy for end-stage disease, with patient-centred symptom management - particularly pruritus and fatigue - integral to quality-of-life optimisation.

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.

Market Definition:

• North America (United States, Canada)
• Europe (Austria, Belgium, Czech Republic, Denmark, Finland, France, Germany, Greece, Italy, Netherlands, Norway, Poland, Portugal, Russia, Spain, Sweden, Switzerland, United Kingdom)
• Middle East (Saudi Arabia, UAE, Kuwait, Turkey)
• Asia Pacific (Australia, China, Hong Kong, India, Indonesia, Japan, Malaysia, New Zealand, Philippines, Singapore, South Korea, Taiwan, Thailand, Vietnam)
• Africa (Egypt, Nigeria, South Africa, Morocco)
• South / Latin America (Argentina, Brazil, Chile, Colombia, Mexico, Peru)

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 the 32 markets (North America, Europe, Middle East, Asia Pacific, Africa, South / Latin America)?
• 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

• North America (United States, Canada)
• Europe (Austria, Belgium, Czech Republic, Denmark, Finland, France, Germany, Greece, Italy, Netherlands, Norway, Poland, Portugal, Russia, Spain, Sweden, Switzerland, United Kingdom)
• Middle East (Saudi Arabia, UAE, Kuwait, Turkey)
• Asia Pacific (Australia, China, Hong Kong, India, Indonesia, Japan, Malaysia, New Zealand, Philippines, Singapore, South Korea, Taiwan, Thailand, Vietnam)
• Africa (Egypt, Nigeria, South Africa, Morocco)
• South / Latin America (Argentina, Brazil, Chile, Colombia, Mexico, Peru)

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)