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How Has the Obeticholic Acid Market Grown from 2024 to 2025?

In recent years, there has been a significant surge in the obeticholic acid market size. Expected to expand from $0.90 billion in 2024 to about $1.02 billion in 2025, the market anticipates a compound annual growth rate (CAGR) of 13.4%. The growth during the historical period is ascribed to several factors. These include the escalating prevalence of primary biliary cholangitis (PBC) and non-alcoholic steatohepatitis (NASH), the expansion of healthcare infrastructures in burgeoning markets, the amplification in liver disease diagnostic practices and screening rates, increased healthcare spending, and substantial investment in liver disease studies.

What Growth Rate Is Anticipated for the Obeticholic Acid Market in the Coming Years?

The anticipated growth of the obeticholic acid market size is set to be significant in the upcoming years, with an expected valuation of $1.67 billion in 2029, a 13.1% compound annual growth rate (CAGR). Factors contributing to the predicted growth during this forecast period include an increasing incidence of both primary biliary cholangitis (PBC) and non-alcoholic steatohepatitis (NASH), a growing demand for innovative treatments for liver disease, heightened awareness of liver diseases and the available remedies, improved access to healthcare globally in emerging markets, along with an increased consciousness regarding liver diseases and potential treatments. Heightened use for NASH treatment, collaborative efforts for continued development, the integration of digital health mechanisms for monitoring and patient adherence, a moving focus towards non-alcoholic fatty liver disease (NAFLD) treatment, improvements in liver disease biomarkers, and advancements in diagnostic technology are amongst the major trends expected in the forecast period.

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Who Are the Leading Companies in the Obeticholic Acid Market?

Major companies operating in the obeticholic acid market are Pfizer Inc., GlaxoSmithKline (GSK), Gilead Sciences Inc., Amgen Inc., Genfit, Teva Pharmaceutical Industries Ltd., Regeneron Pharmaceuticals, WuXi AppTec, Bayer AG, Sumitomo Dainippon Pharma Co. Ltd., Horizon Therapeutics, Dr. Reddy’s Laboratories, Lupin Limited, Hepalink Pharmaceutical Group5, Alembic Pharmaceuticals, Intercept Pharmaceuticals Inc., Enanta Pharmaceuticals, Viva Life sciences, Omgene Life Sciences Pvt. Ltd., Zydus Cadila

What Are the Key Drivers of the Obeticholic Acid Market?

The increasing incidence of liver diseases is anticipated to fuel the expansion of the obeticholic acid market in the future. Liver diseases impair the healthy functioning of the liver. The upsurge in liver diseases can be attributed to excessive alcohol intake, which can induce liver inflammation, cirrhosis, and liver failure by damaging liver cells and inhibiting the organ’s healthy operations. Obeticholic acid aids those suffering from liver disease by activating the farnesoid X receptor (FXR). This leads to a reduction in bile acid build-up, a decrease in liver inflammation, and a slowing down of fibrosis progression, ultimately leading to an improvement in liver functionality. For example, the Office for Health Improvement and Disparities, a government department in the UK, stated that in December 2024, premature fatalities due to alcoholic liver disease increased by 3.6% in 2023, amounting to 5,984 compared to 5,776 in 2022. Thus, the escalating incidence of liver diseases is stimulating the growth of the obeticholic acid market.

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What Are the Key Market Segments in the Obeticholic Acid Industry?

The obeticholic acid market covered in this report is segmented –

1) By Product Type: Tablets, Capsules, Other Product Types

2) By Distribution Channel: Hospital Pharmacies, Retail Pharmacies, Online Pharmacies

3) By Application: Primary Biliary Cholangitis, Nonalcoholic Steatohepatitis, Other Applications

Subsegmentss:

1) By Tablets: Immediate-Release Tablets, Extended-Release Tablets

2) By Capsules: Soft Gelatin Capsules, Hard Gelatin Capsules

3) By Other Product Types: Oral Suspensions, Injectable Formulations

What Are the Latest Trends in the Obeticholic Acid Market?

Leading businesses in the obeticholic acid market are investing in the innovation of products such as the Farnesoid X receptor (FXR) agonist, aimed to improve liver disease treatments and patient outcomes. An FXR agonist is a compound that triggers the FXR, a nuclear receptor that plays a significant role in moderating the metabolism of bile acid, liver inflammation, and fibrosis. Utilizing FXR agonists enhances liver functionality and they are applied in treating conditions such as primary biliary cholangitis (PBC) and nonalcoholic steatohepatitis (NASH). For instance, in February 2024, Intercept Pharmaceuticals Inc., an American biopharmaceutical firm, revealed the U.S. Food and Drug Administration’s (FDA) acceptance of its supplemental New Drug Application (sNDA) for the use of Ocaliva in treating individuals with primary biliary cholangitis (PBC). The FDA’s authorization of the sNDA for obeticholic acid (Ocaliva) represents a regulatory step towards affirming its therapeutic advantages in the treatment of PBC.

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What Are the Key Regional Markets in the Obeticholic Acid Industry?

North America was the largest region in the Obeticholic Acid market in 2024. Asia-Pacific is expected to be the fastest-growing region in the forecast period. The regions covered in the obeticholic acid market report are Asia-Pacific, Western Europe, Eastern Europe, North America, South America, Middle East, Africa.

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This Report Delivers Insight On:

1. How big is the obeticholic acid market, and how is it changing globally?

2. Who are the major companies in the obeticholic acid market, and how are they performing?

3. What are the key opportunities and risks in the obeticholic acid market right now?

4. Which products or customer segments are growing the most in the obeticholic acid market?

5. What factors are helping or slowing down the growth of the obeticholic acid market?

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