우르소데옥시콜산 시장 : 점유율 분석, 업계 동향과 통계, 성장 예측(2026-2031년)

According to Mordor Intelligence, the ursodeoxycholic acid market size was valued at USD 620.10 million in 2025 and is estimated to grow from USD 660.40 million in 2026 to reach USD 986.90 million by 2031, at a CAGR of 7.74% during the forecast period (2026-2031).

This report is Segmented by Indication (Primary Biliary Cholangitis, Gallstone Dissolution and Prophylaxis, Cholestatic Liver Diseases (non-PBC), and More), Dosage Form (Tablets, Capsules, Oral Suspension), Distribution Channel (Hospital Pharmacies, Retail Pharmacies & Drug Stores, and Online Pharmacies), and Geography (North America and More). The Market Forecasts are Provided in Terms of Value (USD).

Global Ursodeoxycholic Acid Market Trends and Insights

First-line Therapy Status in PBC Under AASLD/EASL

UDCA remains the recommended first-line therapy for PBC at 13-15 mg/kg/day, which locks in consistent treatment volumes and provides a durable base for the ursodeoxycholic acid market across major regions. Longstanding clinical evidence shows that UDCA improves liver biochemistry and transplant-free survival when initiated early in the disease course, which sustains physician confidence and adherence to guidelines. The 2024 approvals of seladelpar and elafibranor did not alter the standard of care because both are used alongside UDCA for inadequate responders rather than as replacements, reinforcing UDCA's backbone role. The 2025 U.S. withdrawal of obeticholic acid further strengthened UDCA positioning since a second-line competitor exited the market, which redirected escalation pathways toward PPAR agonists added to UDCA. As a result, the ursodeoxycholic acid market is anchored by guideline-backed use and reinforced by add-on strategies for partial responders. This combination of guidelines and label positioning helps stabilize core demand for UDCA through the forecast period.

Rising Diagnosed Prevalence of PBC and Cholestatic Liver Diseases

Better awareness and serologic testing have increased diagnosed PBC prevalence, which steadily expands the patient pool eligible for UDCA. Clinicians rely on established guideline frameworks that endorse UDCA as lifelong therapy in PBC, which supports a sustained prescription base as more cases are detected at earlier stages. A considerable share of patients do not fully respond biochemically to UDCA alone, which concentrates add-on use for that cohort while preserving UDCA in the regimen. Additional cholestatic conditions also contribute to volumes in specialist practice, particularly where clinical guidance supports UDCA use to improve cholestatic parameters.

The direction of travel favors earlier diagnosis and sustained therapy durations, which underpins growth in the ursodeoxycholic acid market as treated prevalence rises. These patterns are most visible in health systems with screening infrastructure and specialist access in place.

Generic Pricing Pressure Compressing Branded Margins

Broader generic participation shifts price competition from brand value to supply chain efficiency, which compresses margins for finished-dose manufacturers. In this environment, the locus of profitability often moves upstream to API producers with cost advantages and secure feedstock, while finished-dose players differentiate through distribution execution. Mature labeling across presentations and strengths evidences the depth of generic availability, which makes sustained price premiums difficult to defend in pharmacy channels. For the ursodeoxycholic acid market, this pressure can flatten average selling prices even as total prescriptions rise. The net effect is top-line growth that relies more on volumes than on price realization in many geographies. In regions with public reimbursement and tendering, this restraint is more pronounced as procurement favors lowest bids.

Other drivers and restraints analyzed in the detailed report include:

1. Increasing Gallstone Disease and Non-surgical Management Cohorts
2. Expansion of Generics and API Capacity Improving Affordability
3. Limited Efficacy/Non-response in Subsets

For complete list of drivers and restraints, kindly check the Table Of Contents.

Segment Analysis

PBC captured 59.23% of the ursodeoxycholic acid market share in 2025, reflecting entrenched first-line use and guideline continuity that stabilizes long-term therapy. Combination regimens in partial responders extend UDCA duration and keep the base in place while add-on agents target more ambitious biochemical endpoints, which supports the ursodeoxycholic acid market in core hepatology practices. Gallstone dissolution and prophylaxis are projected to grow at 9.54% CAGR between 2026 and 2031, which is higher than the overall trajectory and signals a more dynamic secondary use case. The ursodeoxycholic acid market benefits as bariatric programs scale and as clinicians standardize prevention protocols for high-risk postoperative periods, where UDCA has shown meaningful reductions in gallstone formation. Cholestatic liver diseases outside PBC contribute steady volumes where laboratory improvements are clinically valued, and safety is well characterized in long-term use. In PSC, adoption is limited by a lack of impact on progression endpoints in recent overviews, which restricts UDCA mainly to selected biochemical management strategies.

The ursodeoxycholic acid market size for gallstone prevention is aligned with bariatric program growth because the risk of postoperative stone formation is highest in the first postoperative year, and clinical guidance supports prophylactic use in defined cohorts. For small, cholesterol-rich stones in functioning gallbladders, medical management remains a targeted option in patients where surgery is delayed or contraindicated, and this use preserves continuity across surgical pathways.

In PBC, stable long-term prescribing anchors base volumes that extend across primary and specialty care, which is central to the consistency of the ursodeoxycholic acid market. Across indications, add-on labels for second-line PBC therapies sustain UDCA's role rather than displacing it, which lowers substitution risk and supports long-range planning for supply chains. These patterns keep PBC as the largest contributor, while gallstone prevention and selected cholestatic uses provide higher incremental growth. The balance yields a portfolio effect that underpins resilient revenue for the ursodeoxycholic acid market through 2031.

Geography Analysis

North America held 41.32% of the ursodeoxycholic acid market share in 2025, led by the United States, where guideline-backed first-line use in PBC is firmly established, and coverage policies support long-term therapy. The U.S. withdrawal of obeticholic acid in 2025 removed a second-line option and reinforced the pairing of UDCA with PPAR agonists for inadequate responders, which kept UDCA volumes intact at escalation. Canada and Mexico contribute additional volumes through public and private coverage frameworks that tend to favor cost-effective generics, which stabilizes uptake where hepatology centers coordinate care. Specialist networks and transplant programs also support the use of UDCA in defined protocols, while bariatric surgery programs add demand through preventive use in high-risk cohorts. The overall picture in North America is one of maturity in share but resilient volume based on long-term therapy behaviors.

Europe accounts for the second-largest regional base, driven by adherence to EASL-aligned guidance and robust reimbursement across major markets. National health systems in Germany, the United Kingdom, France, Italy, and Spain have established pathways for UDCA access and for escalation to second-line therapies where criteria are met. Physician familiarity with long-term safety and dosing consistency supports stable demand, while demographic aging increases the share of patients under chronic care. Tendering structures and public procurement in the European Union tilt toward low-cost generics, which benefits the ursodeoxycholic acid market in terms of volume but caps pricing power. Variations in bariatric surgery uptake across Europe also influence the pace of growth in gallstone prophylaxis. Overall, Europe shows steady expansion driven by clinical continuity and payer support.

Asia-Pacific is set to grow at 10.45% CAGR through 2031, which positions the region as the fastest-growing engine for the ursodeoxycholic acid market. Rising hepatitis B prevalence in some countries, a growing burden of metabolic liver disease, and fast-expanding bariatric surgery programs drive incremental demand. Local API expansions in India and strong manufacturing ecosystems in China increase supply security and support affordability, which broadens access to UDCA. Japan and Australia provide steady demand based on established care pathways, while China and India produce the largest incremental gains due to scale and improving reimbursement coverage. In Southeast Asia, policy initiatives to improve viral hepatitis screening and metabolic disease management are likely to lift diagnosed prevalence and treatment initiation. The ursodeoxycholic acid market size in Asia-Pacific is therefore set to expand in line with clinical infrastructure and payer policies through the forecast horizon.

1. Alkem Laboratories Ltd.
2. Apotex
3. Aurobindo Pharma
4. Cipla
5. Daewoong Pharmaceutical (INDIA) Pvt. Ltd.
6. Dr. Falk Pharma GmbH
7. Epic Pharma
8. Glenmark Pharmaceuticals
9. Grindeks
10. Lannett
11. Lupin
12. Strides Pharma
13. Sun Pharmaceuticals Industries
14. Teva Pharmaceutical Industries
15. Torrent Pharmaceuticals
16. Viatris
17. Wockhardt
18. Zydus Group

Additional Benefits:

• The market estimate (ME) sheet in Excel format
• 3 months of analyst support

TABLE OF CONTENTS

1 Introduction

• 1.1 Study Assumptions & Market Definition
• 1.2 Scope of the Study

2 Research Methodology

3 Executive Summary

4 Market Landscape

• 4.1 Market Overview
• 4.2 Market Drivers
  • 4.2.1 First-line Therapy Status in PBC Under AASLD/EASL
  • 4.2.2 Rising Diagnosed Prevalence of PBC and Cholestatic Liver Diseases
  • 4.2.3 Increasing Gallstone Disease and Non-surgical Management Cohorts
  • 4.2.4 Expansion of Generics and API Capacity Improving Affordability
  • 4.2.5 Vertically Integrated Bile-acid Supply Chains Stabilizing UDCA Output
  • 4.2.6 Pipeline of Second-line PBC Agents Preserves UDCA as Backbone
• 4.3 Market Restraints
  • 4.3.1 Generic Pricing Pressure Compressing Branded Margins
  • 4.3.2 Limited Efficacy/Non-response in Subsets (e.g., PSC; ~40% PBC Non-responders)
  • 4.3.3 Feedstock Exposure to Cholic-acid/Bovine Bile Supply Risks
  • 4.3.4 New PBC Agents Competing for Non-responder Share
• 4.4 Supply-Chain Analysis
• 4.5 Regulatory Landscape
• 4.6 Technological Outlook
• 4.7 Porter's Five Forces
  • 4.7.1 Threat of New Entrants
  • 4.7.2 Bargaining Power of Suppliers
  • 4.7.3 Bargaining Power of Buyers
  • 4.7.4 Threat of Substitutes
  • 4.7.5 Industry Rivalry

5 Market Size & Growth Forecasts (Value, USD)

• 5.1 By Indication
  • 5.1.1 Primary Biliary Cholangitis (PBC)
  • 5.1.2 Gallstone Dissolution and Prophylaxis
  • 5.1.3 Cholestatic Liver Diseases (non-PBC)
  • 5.1.4 Primary Sclerosing Cholangitis (PSC)
  • 5.1.5 Other Indications
• 5.2 By Dosage Form
  • 5.2.1 Tablets
  • 5.2.2 Capsules
  • 5.2.3 Oral Suspension
• 5.3 By Distribution Channel
  • 5.3.1 Hospital Pharmacies
  • 5.3.2 Retail Pharmacies & Drug Stores
  • 5.3.3 Online Pharmacies
• 5.4 By Geography
  • 5.4.1 North America
    • 5.4.1.1 United States
    • 5.4.1.2 Canada
    • 5.4.1.3 Mexico
  • 5.4.2 Europe
    • 5.4.2.1 Germany
    • 5.4.2.2 United Kingdom
    • 5.4.2.3 France
    • 5.4.2.4 Italy
    • 5.4.2.5 Spain
    • 5.4.2.6 Rest of Europe
  • 5.4.3 Asia-Pacific
    • 5.4.3.1 China
    • 5.4.3.2 India
    • 5.4.3.3 Japan
    • 5.4.3.4 Australia
    • 5.4.3.5 South Korea
    • 5.4.3.6 Rest of Asia-Pacific
  • 5.4.4 Middle East and Africa
    • 5.4.4.1 GCC
    • 5.4.4.2 South Africa
    • 5.4.4.3 Rest of Middle East and Africa
  • 5.4.5 South America
    • 5.4.5.1 Brazil
    • 5.4.5.2 Argentina
    • 5.4.5.3 Rest of South America

6 Competitive Landscape

• 6.1 Market Concentration
• 6.2 Market Share Analysis
• 6.3 Company Profiles {(includes Global level Overview, Market level overview, Core Segments, Financials as available, Strategic Information, Market Rank/Share for key companies, Products & Services, and Recent Developments)}
  • 6.3.1 Alkem Laboratories Ltd.
  • 6.3.2 Apotex Inc.
  • 6.3.3 Aurobindo Pharma Limited
  • 6.3.4 Cipla
  • 6.3.5 Daewoong Pharmaceutical (INDIA) Pvt. Ltd.
  • 6.3.6 Dr. Falk Pharma GmbH
  • 6.3.7 Epic Pharma
  • 6.3.8 Glenmark Pharmaceuticals
  • 6.3.9 Grindeks
  • 6.3.10 Lannett
  • 6.3.11 Lupin
  • 6.3.12 Strides Pharma
  • 6.3.13 Sun Pharmaceutical Industries Ltd.
  • 6.3.14 Teva Pharmaceutical Industries Ltd.
  • 6.3.15 Torrent Pharmaceuticals Ltd.
  • 6.3.16 Viatris Inc.
  • 6.3.17 Wockhardt
  • 6.3.18 Zydus Group

7 Market Opportunities & Future Outlook

• 7.1 White-space & Unmet-need Assessment