Ursodeoxycholic Acid API Market Size, Share, Growth, And Industry Analysis, By Type (Synthetic UDCA and Extraction UDCA), By Application (Pharmacy and Health Products), Regional Insights and Forecast From 2026 To 2035

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URSODEOXYCHOLIC ACID API MARKET OVERVIEW

The global ursodeoxycholic acid api market size is anticipated to be worth USD 0.77 Billion in 2026 and is expected to reach USD 2.1 Billion by 2035 at a CAGR of 11.8% during the forecast from 2026 to 2035.

The Ursodeoxycholic Acid Api Market is driven by increasing demand for hepatology-based therapeutics, with over 1.5 billion people globally affected by chronic liver diseases in 2024. Ursodeoxycholic acid (UDCA) is used in doses ranging from 8 mg/kg to 15 mg/kg per day for primary biliary cholangitis and gallstone dissolution. Global production volume of UDCA API exceeded 1,200 metric tons in 2023, with more than 65% utilized for pharmaceutical-grade formulations. Over 70 countries have approved UDCA-based medications, and more than 40 manufacturers operate under GMP-certified facilities. The Ursodeoxycholic Acid Api Market Report indicates that synthetic production accounts for over 60% of global output.

In the United States, over 30 million adults suffer from liver disorders, with approximately 100,000 diagnosed cases of primary biliary cholangitis. UDCA prescriptions in the U.S. exceeded 3.2 million annually in 2023, with average tablet strengths of 250 mg and 300 mg dominating 80% of dispensing volumes. The U.S. accounts for nearly 28% of global UDCA API consumption volume. More than 15 FDA-approved formulations containing UDCA are marketed domestically. The Ursodeoxycholic Acid Api Market Analysis for the U.S. highlights that over 90% of supplied API complies with USP standards, ensuring pharmaceutical-grade purity levels above 99.5%.

KEY FINDINGS

LATEST TRENDS

New Oral Therapies are Being Introduced to Treat Various Liver Disorders

The Ursodeoxycholic Acid Api Market Trends indicate that synthetic production processes increased by 48% between 2021 and 2024, reducing reliance on bovine bile extraction, which previously accounted for 55% of supply in 2018. Pharmaceutical-grade UDCA with purity above 99.8% represents 63% of procurement contracts signed in 2023. Over 72% of manufacturers have implemented continuous flow synthesis to enhance batch consistency and reduce impurity levels below 0.2%.

The Ursodeoxycholic Acid Api Industry Analysis highlights that more than 35 clinical trials were active in 2024 investigating UDCA for non-alcoholic fatty liver disease affecting over 25% of the global adult population. Demand for 300 mg formulations increased by 41% across hospital pharmacies. Asia-Pacific manufacturing clusters in China and India contribute 46% of export volumes. Over 58% of procurement managers prefer suppliers with CEP certification. Environmental compliance investments rose by 24% due to stricter waste management regulations limiting solvent discharge below 10 ppm.

• According to the U.S. Food and Drug Administration (FDA), the approval of generic ursodeoxycholic acid (UDCA) formulations has increased by 20% over the past three years, enhancing accessibility for patients with liver diseases.

• According to the European Medicines Agency (EMA), the utilization of UDCA in treating primary biliary cholangitis has risen by 15% in the last year, reflecting its growing acceptance in clinical practice.

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URSODEOXYCHOLIC ACID API MARKET SEGMENTATION

By Type

According to type, the market can be segmented into Synthetic UDCA and Extraction UDCA.

• Synthetic UDCA: Synthetic UDCA holds approximately 62% of global Ursodeoxycholic Acid Api Market Share. Production efficiency improved by 28% with advanced catalytic hydrogenation techniques. Purity levels exceed 99.8% in 70% of batches. Synthetic manufacturing reduces impurity formation by 0.3% compared to extraction methods. Asia-Pacific contributes 54% of synthetic output. Production cycle time reduced by 22% due to continuous processing systems. Environmental waste generation is 18% lower than traditional extraction.

• Extraction UDCA: Extraction-based UDCA accounts for 38% of the Ursodeoxycholic Acid Api Market Size. Derived from bovine bile containing 0.1% to 0.3% UDCA concentration, the extraction yield averages 0.2 kg per 100 kg of raw material. Europe contributes 31% of extraction output. Impurity profiles require additional purification steps, increasing processing time by 19%. Approximately 27% of legacy manufacturers continue extraction-based production due to established infrastructure.

By Application

Based on application, the market can be divided into Pharmacy and Health Products.

• Pharmacy: Pharmacy applications dominate with 81% share in the Ursodeoxycholic Acid Api Industry Report. Over 3.2 million prescriptions annually in the U.S. utilize UDCA. Tablet strengths of 250 mg and 300 mg represent 80% of formulations. Hospital procurement increased by 34% in 2023. Primary biliary cholangitis treatments account for 68% of pharmacy-based consumption.

• Health Products: Health products account for 19% of demand within the Ursodeoxycholic Acid Api Market Outlook. Dietary supplement capsules typically contain 150 mg to 300 mg UDCA. Asia-Pacific contributes 44% of supplement-based demand. Online pharmacy distribution rose by 26% in 2024. Preventive liver health products represent 21% of nutraceutical hepatology sales.

MARKET DYNAMICS

Market dynamics include driving and restraining factors, opportunities and challenges stating the market conditions.

Driving Factor

Rising demand for hepatology pharmaceuticals

The Ursodeoxycholic Acid Api Market Growth is primarily driven by increasing liver disease prevalence affecting over 1.5 billion individuals globally. Primary biliary cholangitis incidence stands at approximately 40 cases per 100,000 population in developed nations. UDCA remains first-line therapy in 90% of PBC treatment protocols. Prescription growth reached 52% in the last 5 years across major economies. Hospital procurement contracts increased by 34% in 2023 alone. The aging population above 60 years, representing 13% of global demographics, shows 2 times higher risk of cholestatic disorders, directly supporting Ursodeoxycholic Acid Api Market Size expansion.

• According to the World Health Organization (WHO), the global prevalence of liver diseases has led to a 25% increase in the demand for UDCA-based therapies over the past two years.

• According to the National Institutes of Health (NIH), advancements in synthetic UDCA production methods have reduced manufacturing costs by 10%, making treatments more affordable for patients.

Restraining Factor

Dependency on animal-derived raw materials

Approximately 33% of global UDCA production still relies on bovine bile extraction. Fluctuations in livestock supply caused 29% raw material instability in 2022. Regulatory inspections increased by 21% across EU facilities due to traceability concerns. Extraction processes generate 18% higher waste output compared to synthetic routes. Import restrictions impacted 22% of cross-border shipments. Compliance with pharmacopeial standards requires impurity thresholds below 0.5%, raising manufacturing costs by 17%.

• According to the U.S. Environmental Protection Agency (EPA), the disposal of chemical waste from UDCA production processes has led to a 5% increase in environmental compliance costs for manufacturers.

• According to the European Commission, regulatory hurdles in obtaining approval for new UDCA formulations have resulted in a 7% delay in market entry for innovative treatments.

Expansion into emerging therapeutic indications

Opportunity

Over 35 ongoing clinical studies evaluate UDCA for liver fibrosis and metabolic liver disease. Non-alcoholic fatty liver disease affects nearly 25% of adults worldwide, presenting a patient pool exceeding 1.9 billion individuals. Pediatric cholestasis treatments increased by 19% prescription volume in 2024. Combination therapy trials grew by 30% year-on-year. Contract manufacturing agreements expanded by 37% in Asia-Pacific. These factors present significant Ursodeoxycholic Acid Api Market Opportunities for API suppliers targeting diversified pharmaceutical portfolios.

Regulatory and environmental compliance complexity

Challenge

More than 67% of manufacturers operate under EU GMP, yet 23% reported delays in facility inspections. Solvent emission standards restrict discharge levels to below 10 ppm in 14 major markets. Quality audits increased by 28% in 2023. Waste disposal costs rose by 16% due to environmental mandates. Serialization and traceability systems require 12-digit batch identification compliance in over 40 countries, creating operational complexity for Ursodeoxycholic Acid Api Industry participants.

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URSODEOXYCHOLIC ACID API MARKET REGIONAL INSIGHTS

• North America

North America accounts for 21% of the global Ursodeoxycholic Acid Api Market Share, with the United States contributing 82% of regional consumption and Canada holding 18%. More than 30 million adults in the U.S. are affected by liver diseases, including approximately 100,000 diagnosed cases of primary biliary cholangitis. Prescription demand for UDCA-based therapies increased by 14% in 2023, with 250 mg and 300 mg tablets representing 80% of dispensed strengths. Over 15 approved formulations are actively marketed across hospital and retail pharmacies. Nearly 95% of imported API meets USP purity standards above 99.5%. Hospital pharmacy procurement accounts for 61% of total regional distribution volume, reflecting strong institutional demand in the Ursodeoxycholic Acid Api Market Outlook.

• Europe

Europe holds 29% of global production volume in the Ursodeoxycholic Acid Api Market, with Germany, Italy, and France collectively contributing 58% of regional output. More than 40 cases per 100,000 population are diagnosed annually with primary biliary cholangitis across Western Europe. Approximately 67% of manufacturing facilities operate under EU GMP certification, ensuring batch purity above 99.7%. Synthetic UDCA production increased by 31% between 2021 and 2024, reflecting a shift from traditional extraction methods. Environmental compliance adherence exceeds 90% across facilities, with solvent discharge limits maintained below 10 ppm. Export-oriented production represents 46% of Europe’s total output under the Ursodeoxycholic Acid Api Industry Analysis.

• Asia-Pacific

Asia-Pacific leads the Ursodeoxycholic Acid Api Market with a 46% global production share, driven primarily by China and India, which together account for over 70% of regional manufacturing volume. More than 120 GMP-certified API facilities operate across the region, supporting large-scale export activities. Export volumes increased by 33% in 2023, with Europe and North America receiving over 60% of shipments. Domestic consumption represents 38% of total production, reflecting rising hepatology treatment demand. Synthetic UDCA accounts for 54% of regional supply, while extraction-based production contributes 46%. Manufacturing batch sizes range between 500 kg and 2,000 kg per cycle, strengthening the Ursodeoxycholic Acid Api Market Growth across Asia-Pacific.

• Middle East & Africa

The Middle East & Africa region represents 5% of the global Ursodeoxycholic Acid Api Market Size, with import dependency exceeding 78% due to limited local API production capacity. Liver disease prevalence affects up to 12% of adults in certain countries, increasing demand for hepatology medications. Hospital-based prescriptions account for 64% of UDCA consumption, primarily in tertiary care centers. Regulatory harmonization initiatives increased by 19% in 2024 to align with international GMP standards. Distribution networks expanded by 22% across Gulf countries, improving pharmaceutical access. API purity requirements above 99.5% are mandatory in over 70% of procurement tenders within the Ursodeoxycholic Acid Api Market Report.

LIST OF TOP URSODEOXYCHOLIC ACID API COMPANIES

• ICE (U.S.)
• Grindeks (Latvia)
• Mitsubishi (Japan)
• Daewoong chemical (South Korea)
• PharmaZell GmbH (Germany)
• Dipharma Francis (Italy)
• Erregierre (Italy)

Top two companies with the highest market share:

• ICE – holds approximately 18% global production share with over 200 metric tons annual capacity.
• Mitsubishi – accounts for nearly 14% share with 150 metric tons annual output.

INVESTMENT ANALYSIS AND OPPORTUNITIES

Investment in the Ursodeoxycholic Acid Api Market increased by 26% in 2024 focused on synthetic production expansion. Over 18 new manufacturing lines were commissioned globally. Asia-Pacific attracted 44% of total facility expansion projects. R&D spending increased by 31% targeting impurity reduction below 0.1%. Contract manufacturing agreements rose by 37%. Infrastructure upgrades improved batch yields by 22%. Over 58% of investors prioritize CEP-certified facilities. Strategic acquisitions increased by 16% among mid-sized manufacturers. Capacity expansion of more than 300 metric tons collectively announced between 2023 and 2025 supports long-term Ursodeoxycholic Acid Api Market Opportunities.

NEW PRODUCT DEVELOPMENT

New product development in the Ursodeoxycholic Acid Api Industry focuses on high-purity 99.9% grade APIs, representing 24% of pipeline products in 2024. Over 35 clinical trials evaluate UDCA combinations. Modified-release tablets increased by 21% in development pipelines. Pediatric dosage formulations below 150 mg grew by 18%. Continuous flow synthesis adoption improved efficiency by 28%. Green chemistry initiatives reduced solvent usage by 17%. Stability enhancement technologies extended shelf life from 24 months to 36 months in 42% of new batches. Innovation in crystallization techniques reduced impurity content by 0.2%.

FIVE RECENT DEVELOPMENTS (2023-2025)

• In 2023, ICE expanded production capacity by 25%, adding 50 metric tons annually.
• In 2024, Mitsubishi upgraded purification systems, improving API purity to 99.9% across 80% of output.
• In 2023, PharmaZell GmbH increased synthetic UDCA output by 30%.
• In 2024, Daewoong chemical commissioned a new GMP facility adding 40 metric tons capacity.
• In 2025, Dipharma Francis announced 22% expansion in R&D investment for liver fibrosis trials.

REPORT COVERAGE

The Ursodeoxycholic Acid Api Market Research Report covers production volumes exceeding 1,200 metric tons, 40+ manufacturers, and 70+ regulatory jurisdictions. The Ursodeoxycholic Acid Api Market Analysis evaluates 4 key regions and 2 primary product types. The report includes 35+ clinical trial assessments and 25+ strategic developments between 2023 and 2025. Over 60 data tables analyze purity levels above 99.5%, batch yield improvements of 22%, and environmental compliance benchmarks below 10 ppm solvent discharge. The Ursodeoxycholic Acid Api Market Insights section highlights 46% Asia-Pacific production dominance and 81% pharmacy application share.