China Ursodeoxvcholic Acid (UDCA) Market Size & Share Growth Forecast Report (2026-2035)

China Ursodeoxvcholic Acid (UDCA) Market Overview

The China Ursodeoxycholic Acid (UDCA) Market was estimated at USD 360 Million in 2025 and is projected to reach USD 390 Million in 2026 and USD 870 Million by 2035, expanding at a 9.3% CAGR from 2026 to 2035.

Ursodeoxycholic acid refers to the hydrophilic bile acid that dissolves cholesterol gallstones and remedies cholestatic liver disorders. It is also used to make medicines and liquid suspension. It is prescribed to treat patients with gallstones, cholestatic liver diseases, primary biliary cholangitis, and also for patients with biliary reflux gastritis. Children and patients not able to take the regular form of dose can be given ursodeoxycholic acid oral suspension. In China, UDCA is an established prescription medicinal product with a strong presence in the market due to the availability of local manufacturing companies.

The market includes UDCA formulations used for gallstone dissolution, cholestatic liver diseases, primary biliary cholangitis, biliary reflux gastritis and other approved hepatobiliary indications. Recent Chinese industry data indicates that UDCA remains one of the leading medicines within the domestic biliary disease treatment category, supported by broad product availability, generic competition and increasing treatment accessibility.

The Chinese Society of Hepatology considers UDCA as the treatment of choice for primary biliary cholangitis, while the National Health Commission featured the disease among the cases covered by its 2025 diagnostic and treatment guidelines. China has a significant gallstone disease burden as the nationwide study revealed the age- and gender-standardized prevalence of 5.13% among adults.

Research Methodology

VynZ Research’s approach to analyzing the China Ursodeoxycholic Acid market embraces a combination of the secondary research, primary industry evaluation, company disclosures, regulatory data, clinical guidelines, pharmaceutical industry publications and market data. As for the country specific analysis of the market, it incorporates domestic formulation sales, approved products, manufacturer participation, centralized procurement, treatment indications, prevalence of disease, dosage-form development and regional healthcare infrastructure. The company’s analysts utilize the data from the National Medical Products Administration, National Health Commission, Chinese Society of Hepatology and relevant pharmaceutical industry publications. Triangulation with the company information and historical market indicators enables to estimate the China Ursodeoxycholic Acid market and verify the figures with the comparative analysis and analytical modelling in order to determine the 2025 base year and 2026 to 2035 forecast period.

Research Highlights

Tablets accounted for approximately 54% of the China UDCA market in 2025, supported by established prescribing practices, convenient oral administration and broad availability of 250 mg and 500 mg strengths.

Primary biliary cholangitis accounted for approximately 43% of the China UDCA market in 2025, due to clinical guidelines recommending UDCA as the standard first-line treatment for the condition.

Hospital pharmacies accounted for approximately 55% of the China UDCA market in 2025, because of the prescription-based nature of UDCA treatment and strong hospital procurement channels.

The oral suspension segment is projected to register approximately 11.2% CAGR from 2026 to 2035, driven by increasing adoption among pediatric patients and individuals with difficulty swallowing conventional solid formulations.

East China accounted for approximately 35% of the China UDCA market in 2025, owing to its concentration of hospitals, pharmaceutical manufacturers, specialist healthcare services and established distribution networks.

China Ursodeoxvcholic Acid Market Dynamics

Market Trends

China Ursodeoxycholic Acid (UDCA) Market is gradually dominated by the development of homemade generic drugs, dosage forms and increased competition after the expiration of product patent protection period. Capsules and tablets are the main dosage forms, while oral suspension is rising for its value for children and people who have difficulty swallowing. Oral suspension for the treatment of cystic fibrosis associated liver disease was approved for sale in 2025. At the same time, centralized procurement has an impact on prices, manufacturers' participation and transaction volume in the hospital channel.

Growth Drivers

The improvement in the diagnosis and treatment of hepatobiliary diseases is one of the main drivers for market growth. China has a large number of gallstones, and primary biliary cholangitis is increasingly recognized and standardized in diagnosis and treatment. The expert consensus of the Chinese Society of Hepatology recommends the use of UDCA as the first-line treatment for primary biliary cholangitis. With the improvement of accessibility of medical care, the development of hospital hepatology and the popularization of generic drugs, the treatment rate of hepatobiliary diseases has been greatly improved. In addition, the inclusion of products in the national medical insurance directory and centralized procurement directory also promotes the increase of market size.

Market Restraints / Challenges

Price pressure remains a major challenge because multiple domestic manufacturers compete in a mature generic-drug market. Centralized procurement can increase prescription volumes but simultaneously reduce unit prices and limit revenue growth. The market also faces competition from alternative treatments for patients who show an inadequate biochemical response to UDCA. Chinese clinical guidance notes the need for additional treatment strategies in patients who respond incompletely to UDCA. Regulatory requirements covering pharmaceutical quality, consistency evaluation, manufacturing standards and drug registration further increase compliance costs for manufacturers.

Market Opportunities

Opportunities are emerging from improved diagnosis of rare hepatobiliary disorders, pediatric formulations and continued development of higher-accessibility dosage forms. The introduction of oral UDCA suspension products creates additional opportunities in pediatric and swallowing-difficulty patient populations. The 2025 national guidance for primary biliary cholangitis also supports more standardized diagnosis and treatment, which can improve patient identification and long-term prescription demand. Further opportunities exist in biotechnology-based UDCA manufacturing, process optimization and higher-purity pharmaceutical-grade active ingredients as manufacturers seek to improve production efficiency and quality consistency.

China Ursodeoxvcholic Acid (UDCA) Market Report Coverage

China Ursodeoxvcholic Acid Market Segmentation

By Formulation Type

In 2025, tablets are anticipated to constitute the largest segment, registering for about 54% of the overall market value. This can be attributed to the well-established prescribing habits, convenience of the oral route of administration, and the easy availability of the most prevalent dosage forms. Oral suspension is anticipated to experience the highest growth from 2026 to 2035, registering a CAGR of about 11.2%. This is primarily attributed to the medication’s availability in a form that is more convenient for patients with swallowing difficulties and those who cannot take standard dosage forms.

By Application

Primary biliary cholangitis is anticipated to remain the largest application segment in 2025, accounting for about 43% of the overall market value. This is mainly due to the well-established use of UDCA in the treatment of this particular indication. On the other hand, gallstone dissolution and prophylaxis are anticipated to experience the highest growth from 2026 to 2035, registering a CAGR of about 10.4%. This trend is explained by the high prevalence of gallstone disease and the continuous use of UDCA in appropriate clinical settings.

By Distribution Channel

Hospital pharmacies are projected to remain the largest distribution channel in 2025, accounting for about 55% of the overall market value. This is primarily attributed to the prevalent use of the prescription-based treatment and the presence of hepatobiliary disease diagnosis in hospital settings. In contrast, online pharmacies are anticipated to experience the highest growth from 2026 to 2035, registering a CAGR of about 12%. The key reason for this trend is the growing accessibility to digital healthcare services and the increased use of online prescriptions.

By End User

Hospitals are anticipated to remain the largest end-user segment in 2025, registering about 58% of the overall market value. This is mainly attributed to the high prevalence of diagnoses that require specific treatments, such as hepatobiliary disease, and the convenience of the oral dosage form that is prescribed in hospital settings. On the other hand, home care is anticipated to experience the highest growth from 2026 to 2035, registering a CAGR of about 10.6%. The main reason for this trend is the increasing need for oral treatment for chronically ill patients and the growing availability of outpatient prescriptions.

Regional Insights

East China

East China accounted for approximately 35% of the China Ursodeoxycholic Acid market in 2025, representing the largest regional share. The region benefits from a dense concentration of hospitals, specialist medical institutions, pharmaceutical manufacturers and established distribution networks. Provinces and major cities across the region also have relatively developed hepatology and gastroenterology services, supporting diagnosis and long-term treatment of hepatobiliary disorders. Strong pharmaceutical manufacturing activity further improves product availability and supply reliability.

South Central China

South Central China accounted for approximately 23% of the market in 2025, supported by a large population base, expanding hospital infrastructure and increasing access to prescription medicines. The region includes several major pharmaceutical manufacturing and commercial centers, strengthening distribution coverage. Rising healthcare utilization and greater availability of generic UDCA formulations are expected to support steady regional demand during the forecast period.

North China

North China accounted for approximately 18% of the market in 2025, supported by major healthcare institutions, specialist hospitals and pharmaceutical distribution networks. Beijing and surrounding provinces contribute significantly to demand through advanced diagnostic facilities and specialist hepatobiliary services. The region is also important for pharmaceutical procurement and clinical research, supporting continued use of UDCA across established indications.

Southwest China

Southwest China accounted for approximately 12% of the market in 2025 and is expected to record comparatively faster growth through 2035. Increasing healthcare investment, improving specialist access and the expansion of domestic pharmaceutical companies are supporting market development. The region is also gaining importance through the development and commercialization of newer UDCA formulations, including pediatric oral suspension products.

Northeast and Northwest China

Northeast and Northwest China together accounted for the remaining approximately 12% of the market in 2025. Demand in these regions is supported by hospital-based treatment, retail pharmaceutical distribution and the continuing diagnosis of gallstone and cholestatic disorders. Market penetration is expected to improve gradually as healthcare infrastructure and pharmaceutical access continue to develop.

Competitive Landscape / Company Insights

The China Ursodeoxycholic Acid market is highly competitive, with domestic generic manufacturers increasingly gaining share against established imported products. Competition is centered on formulation approvals, consistency evaluation, centralized procurement participation, manufacturing efficiency and distribution coverage. Recent Chinese industry data indicates a concentrated formulation market, with the leading five participants accounting for more than 99% of reported public-hospital sales in 2025. Domestic companies are also expanding dosage-form options, particularly capsules and oral suspensions, while established manufacturers continue to compete through production scale and market access.

Mini Profiles

Anshi Pharmaceutical (Zhongshan) Co Ltd. develops and manufactures pharmaceutical products including UDCA capsules. Its 250 mg UDCA capsule has passed consistency evaluation and is included in China's medical insurance system.

Chengdu Saijing Biopharmaceutical Technology Co Ltd. focuses on hepatobiliary, oncology and musculoskeletal medicines. Its UDCA capsule and oral suspension portfolio strengthens its position in conventional and pediatric hepatobiliary treatment.

Dr. Falk Pharma GmbH is the originator of UDCA products marketed in China and remains a major participant in the domestic market. Its UDCA capsule has long been used for gallstones and cholestatic liver diseases.

Fujian Guangshengtang Pharmaceutical Co Ltd. expanded its hepatoprotective medicine portfolio with an approved UDCA capsule. The product received its Chinese drug registration certificate in 2024 for established hepatobiliary indications.

Wuhan Puyuan Pharmaceutical Co Ltd. is a major domestic UDCA manufacturer with an established tablet product. Its UDCA product participated in national centralized procurement, supporting significant domestic market penetration.

Key Players

• Anshi Pharmaceutical (Zhongshan) Co Ltd.
• Changzhou Pharmaceutical Factory Co Ltd.
• Chengdu Saijing Biopharmaceutical Technology Co Ltd.
• Dr. Falk Pharma GmbH
• Fujian Guangshengtang Pharmaceutical Co Ltd.
• Jiangsu Xuantai Pharmaceutical Co Ltd.
• Shandong Zibo Xinda Pharmaceutical Co Ltd.
• Sunflower Pharmaceutical Group Co Ltd.
• Wuhan Puyuan Pharmaceutical Co Ltd.
• Zhejiang Ruixin Pharmaceutical Co Ltd.

Recent Developments

Changzhou Pharmaceutical Factory Co Ltd. received approval from the National Medical Products Administration for its 250 mg UDCA capsule. The approval expanded domestic generic competition and added another qualified manufacturer to the Chinese market.

Chengdu Saijing Biopharmaceutical Technology Co Ltd. received approval for its UDCA oral suspension as a domestic first generic 3.1-category product. The formulation expanded treatment availability for pediatric patients and patients with swallowing difficulties, including children with cystic-fibrosis-associated liver disease.

Shandong Zibo Xinda Pharmaceutical Co Ltd. received approval for its UDCA capsule, regarded as passing consistency evaluation under China's generic-drug framework. The approval strengthened domestic manufacturer participation in the established capsule segment.

Jiangsu Xuantai Pharmaceutical Co Ltd. received recognition for its UDCA capsule formulation and industrialization project developed jointly with East China University of Science and Technology. The project was nominated for the 2025 Shanghai Industry-University-Research Cooperation Excellence Award.

Sunflower Pharmaceutical Group Co Ltd. received NMPA registration approval for its 250 mg UDCA capsule through a subsidiary. The approval enabled the company to enter a large domestic hepatobiliary medicine category and broaden its digestive-system product portfolio.

Table of Contents for China Ursodeoxvcholic Acid (UDCA) Market Report

1.    Research Overview

        1.1.    The Report Offers
        1.2.    Market Coverage
        1.3.    Research Phases
        1.4.    Limitations
        1.5.    Market Methodology
                  1.5.1.  Data Sources
                             1.5.1.1. Primary Research
                             1.5.1.2. Secondary Research
                  1.5.2.  Methodology
                             1.5.2.1. Data Exploration
                             1.5.2.2. Forecast Parameters
                             1.5.2.3. Data Validation
                             1.5.2.4. Assumptions
                  1.5.3.  Study Period & Data Reporting Unit

2.    Executive Summary

3.    Industry Overview

       3.1.    Industry Dynamics
                 3.1.1.    Market Growth Drivers
                 3.1.2.    Market Restraints
                 3.1.3.    Key Market Trends
                 3.1.4.    Major Opportunities
       3.2.    Industry Ecosystem
                 3.2.1.    Porter’s Five Forces Analysis
                 3.2.2.    Recent Development Analysis
                 3.2.3.    Value Chain Analysis
       3.3.    Competitive Insight
                 3.3.1.    Competitive Position of Industry Players
                 3.3.2.    Market Attractive Analysis
                 3.3.3.    Market Share Analysis

4.    China Market Estimate and Forecast

       4.1.    China Market Overview
       4.2.    China Market Estimate and Forecast to 2035

5.    Market Segmentation Estimate and Forecast

6.   East China Market Estimate and Forecast

7.   South Central China Market Estimate and Forecast

8.   North China Market Estimate and Forecast

9.   Southwest China Market Estimate and Forecast

10.   Northeast and Northwest China Market Estimate and Forecast

11.  Company Profiles

       11.1.   Anshi Pharmaceutical (Zhongshan) Co., Ltd.
                  11.1.1.    Snapshot
                  11.1.2.    Overview
                  11.1.3.    Offerings
                  11.1.4.    Financial Insight
                  11.1.5.    Recent Developments
       11.2.   Changzhou Pharmaceutical Factory Co., Ltd.
                  11.2.1.    Snapshot
                  11.2.2.    Overview
                  11.2.3.    Offerings
                  11.2.4.    Financial Insight
                  11.2.5.    Recent Developments
       11.3.   Chengdu Saijing Biopharmaceutical Technology Co., Ltd.
                  11.3.1.    Snapshot
                  11.3.2.    Overview
                  11.3.3.    Offerings
                  11.3.4.    Financial Insight
                  11.3.5.    Recent Developments
       11.4.   Dr. Falk Pharma GmbH
                  11.4.1.    Snapshot
                  11.4.2.    Overview
                  11.4.3.    Offerings
                  11.4.4.    Financial Insight
                  11.4.5.    Recent Developments
       11.5.   Fujian Guangshengtang Pharmaceutical Co., Ltd.
                  11.5.1.    Snapshot
                  11.5.2.    Overview
                  11.5.3.    Offerings
                  11.5.4.    Financial Insight
                  11.5.5.    Recent Developments
       11.6.   Jiangsu Xuantai Pharmaceutical Co., Ltd.
                  11.6.1.    Snapshot
                  11.6.2.    Overview
                  11.6.3.    Offerings
                  11.6.4.    Financial Insight
                  11.6.5.    Recent Developments
       11.7.   Shandong Zibo Xinda Pharmaceutical Co., Ltd.
                  11.7.1.    Snapshot
                  11.7.2.    Overview
                  11.7.3.    Offerings
                  11.7.4.    Financial Insight
                  11.7.5.    Recent Developments
       11.8.   Sunflower Pharmaceutical Group Co., Ltd.
                  11.8.1.    Snapshot
                  11.8.2.    Overview
                  11.8.3.    Offerings
                  11.8.4.    Financial Insight
                  11.8.5.    Recent Developments
       11.9.   Wuhan Puyuan Pharmaceutical Co., Ltd.
                  11.9.1.    Snapshot
                  11.9.2.    Overview
                  11.9.3.    Offerings
                  11.9.4.    Financial Insight
                  11.9.5.    Recent Developments
       11.10.   Zhejiang Ruixin Pharmaceutical Co., Ltd.
                  11.10.1.    Snapshot
                  11.10.2.    Overview
                  11.10.3.    Offerings
                  11.10.4.    Financial Insight
                  11.10.5.    Recent Developments

12.    Appendix

         12.1.    Exchange Rates
         12.2.    Abbreviations

Note: Financial insight and recent developments of different companies are subject to the availability of information in the secondary domain.