United States Primary Sclerosing Cholangitis Market 2031 | Growth Drivers, Key Players & Investment Opportunities

Market Size and Growth

The global critical infrastructure protection market is growing at a high CAGR during the forecast period (2024-2031).

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Key Development:

United States

✅ In December 2025, Chemomab Therapeutics published peer‐reviewed Phase 2 trial results for Nebokitug showing that 48‐week treatment in PSC patients was generally safe, well tolerated and produced sustained improvements in biomarkers linked to inflammation and fibrosis supporting a Phase 3 registration trial.

✅ In June 2025, Ipsen initiated a clinical study evaluating Elafibranor for safety and efficacy in PSC patients, expanding the therapeutic pipeline for this rare disease.

✅ In June 2025, Mirum Pharmaceuticals announced a study of Volixibat to assess its potential to treat PSC-associated pruritus and possibly impact disease progression further diversifying investigational treatment options.

✅ In June 2025, NGM Biopharmaceuticals launched a Phase 2, randomized, placebo-controlled trial of NGM282 in PSC patients to evaluate safety, tolerability, and preliminary efficacy, reflecting ongoing broad efforts to develop disease‐modifying therapies.

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Japan

✅ In October 2025, researchers at Kyoto University identified specific HLA alleles including HLA-C07:02, HLA-B07:02, HLA-DQB105:01 and HLA-DRB101:01 that are significantly associated with PSC susceptibility in a Japanese cohort, shedding light on genetic predisposition in Japan.

✅ In October 2025, the same study also reported that 15 amino acid variants in the HLA‐C molecule significantly correlated with disease susceptibility, offering new clues for the immunogenetic mechanisms underlying PSC in Japanese patients.

✅ In June 2025, through the efforts of PSC Partners Seeking a Cure's international initiative, the first project under its ICRN (International Collaborative Research Network) was funded a study to validate candidate blood biomarkers for detecting bile duct cancer (CCA) in PSC patients, potentially enabling earlier and less invasive cancer screening.

Key Players:

=> Intercept Pharmaceuticals, Gilead Sciences, Bristol Myers Squibb, Takeda Pharmaceutical Company Limited, Johnson & Johnson, Allergan, Genfit, Pliant Therapeutics, ChemomAb Therapeutics Ltd., and Dr. Falk Pharma among others.

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Key Segments:

By Treatment

Medication-based Therapies dominate with 45%, focusing on immunosuppressants, anti-fibrotic agents, and symptom management. Bile Duct Blockages interventions account for 30%, including stenting and endoscopic procedures, primarily addressing cholestasis and disease complications. Liver Transplantation represents 25%, reserved for advanced-stage PSC patients, driven by limited donor availability and specialized care requirements.

By Disease Stage

Early-stage PSC contributes 35%, with patients largely managed via medication and monitoring. Moderate-stage PSC represents 40%, requiring a combination of interventions such as bile duct procedures alongside medications. Advanced-stage PSC accounts for 25%, where liver transplantation and complex interventions become critical, reflecting higher treatment complexity and healthcare resource utilization.

By Patient Age

Adult patients (18 and above) account for 70%, reflecting the higher prevalence of PSC in adult populations. Children (0-18) represent 30%, focusing on pediatric care, early diagnosis, and disease management strategies suitable for growth and development considerations.

By End-User

Hospitals hold 50%, serving as the primary treatment centers for all PSC stages, offering advanced therapies, surgical interventions, and transplantation services. Specialty Clinics contribute 35%, focusing on outpatient management, early-stage interventions, and patient monitoring programs. Others (including academic centers and research hospitals) account for 15%, providing clinical trials, experimental therapies, and specialized patient care services.

By Region

North America - 40% Share
North America dominates due to established healthcare infrastructure, advanced liver disease management programs, and high awareness of PSC.

Europe - 30% Share
Europe accounts for 30%, supported by specialized hepatology centers, reimbursement policies, and growing adoption of minimally invasive procedures.

Asia Pacific - 15% Share
Asia Pacific represents 15%, with emerging liver disease awareness, expanding healthcare facilities, and increasing access to diagnostic and therapeutic interventions.

Latin America - 10% Share
Latin America holds 10%, driven by improving healthcare infrastructure, specialized clinics, and growing medical tourism for advanced procedures.

Middle East & Africa - 5% Share
Middle East & Africa contribute 5%, with opportunities in establishing specialized hepatology centers, awareness programs, and access to liver transplantation services.

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