Biliary Atresia Market Analysis 2034 - Competitive Landscape, Clinical Trials, Market Size, Medication, Prevalence, Companies by DelveInsight

Biliary Atresia Market Summary
The Biliary Atresia market is projected to grow at a steady CAGR of 7.7% between 2024 and 2034, fueled by rising incidence, improved diagnostic methods, and broader adoption of treatment strategies. In 2023, the 7MM recorded approximately 609 new cases, with the US accounting for 56%, EU4 and the UK for 28%, and Japan for 16%. Despite this, therapeutic options remain limited, with surgery, such as the Kasai procedure and liver transplantation, serving as the mainstay. To address unmet needs, promising investigational drugs like odevixibat and obeticholic acid are under development.

DelveInsight's report, "Biliary Atresia Market Insights, Epidemiology, and Market Forecast - 2034", provides an in-depth analysis of Biliary Atresia, including historical data, projected epidemiology, and market dynamics across the US, EU4 (Germany, France, Italy, and Spain), the UK, and Japan. The Biliary Atresia market is emerging as a critical segment in healthcare, driven by increasing prevalence and ongoing innovation in treatment approaches. The report covers multiple therapeutic areas, including adjunctive therapies and investigational treatments, highlighting existing practices, pipeline drugs, therapy-wise market share, and market forecasts from 2020 to 2034 across the seven major markets. It also explores treatment algorithms, key drivers and restraints, unmet medical needs, and growth opportunities, offering a comprehensive outlook.

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Key Takeaways from the Biliary Atresia Market Report
• In March 2025, Mirum Pharmaceuticals, Inc announced results of a Randomized Double-Blind Placebo-Controlled Phase 3 Study to Evaluate the Efficacy and Safety of Maralixibat in the Treatment of Participants with Cholestatic Pruritus
• In November 2024, Intercept Pharmaceuticals announced results of a Randomized, Double-blind, Placebo-controlled, Phase 2/3 Study to Assess the Efficacy, Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Obeticholic Acid Compared to Placebo in Pediatric Subjects With Biliary Atresia, Post-hepatoportoenterostomy
• In October 2024:- Mirum Pharmaceuticals Inc.- The purpose of this study is to determine whether the investigational treatment (maralixibat) is safe and effective in pediatric and adult participants who have cholestatic liver disease with pruritus that has been refractory to other therapies, and who have no other treatment options.
• In October 2024:- Albireo, an Ipsen Company- A Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Odevixibat (A4250) in Children With Biliary Atresia Who Have Undergone a Kasai Hepatoportoenterostomy. Double-blind, randomized, placebo-controlled, Phase 3 study to investigate the efficacy and safety of odevixibat compared to placebo in children with biliary atresia who have undergone a Kasai hepatoportoenterostomy.
• According to DelveInsight's epidemiology model, in 2023, the Incident cases of biliary atresia in the US was found to be approximately 338, these case are expected to increase by 2034.
• In 2023, there were nearly 17 cases of Type I, 7 cases of Type II and 315 cases for Type III. Our estimates suggest that these cases will change during the forecast period (2024-2034).
• In 2023, Germany saw approximately 34 cases of biliary atresia, with around 17 cases in males and 18 in females.
• In 2023, in the UK there were approximately 19 cases of biliary atresia in males and 25 cases in females. Assessments as per DelveInsight's analysts show that the overall cases of biliary atresia in both the genders is subjected to decrease in the coming years directly attributed to the country population that is decreasing by 2034, in males and females, respectively.
• In 2023, in Japan there were 11 cases of Type I and 2 cases of Type II. Assessments as per DelveInsight's analysts show that the overall incidence of biliary atresia is maximum for type III with 80 cases.
• The leading Biliary Atresia Companies working in the market include Mirium Pharmaceuticals, Albireo, Intercept Pharmaceuticals, Ipsen and others.
• Promising Biliary Atresia Therapies in the various stages of development include BYLVAY, LIVMARLI, and others.

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Biliary Atresia Overview
Biliary Atresia is a rare, serious liver disorder in infants characterized by blocked or absent bile ducts, leading to liver damage and scarring. Symptoms usually appear within the first weeks of life, including jaundice, dark urine, pale stools, and poor growth. Diagnosis involves blood tests, imaging, and sometimes biopsy. Treatment primarily includes the Kasai procedure, ideally within the first two months of life, with liver transplantation as a secondary option. Early intervention improves prognosis, though many children eventually require transplantation. Research and awareness are essential for early detection, better management, and improved outcomes.

Biliary Atresia Epidemiology
In 2023, the US reported approximately 338 incident cases of biliary atresia, projected to rise by 2034, with Type III being the most common (315 cases). Germany recorded 34 cases (17 males, 18 females), while the UK had 44 cases (19 males, 25 females), with a declining trend expected due to population decrease. In Japan, Type III was the most prevalent with 80 cases, compared to 11 cases of Type I and 2 cases of Type II.

Download the report to understand which factors are driving Biliary Atresia epidemiology trends @ Biliary Atresia Patient Pool Forecasting and Prevalence - https://www.delveinsight.com/report-store/biliary-atresia-market?utm_source=openpr&utm_medium=pressrelease&utm_campaign=apr

Biliary Atresia Epidemiology Segmentation in the 7MM
• Total Biliary Atresia Incident cases
• Biliary Atresia Type-specific cases
• Biliary Atresia Gender-specific cases
• Biliary Atresia Treated cases

Biliary Atresia Market Outlook
Biliary Atresia management involves early Kasai procedure followed by liver transplantation if required. Postoperative care includes choleretic agents, nutritional optimization, and management of complications. The market is influenced by rising incidence, diagnostic advancements, surgical innovations, emerging drug pipelines, and increased awareness and research funding.

Biliary Atresia Market Drivers
• Rising incidence and prevalence in the US, EU4+UK, and Japan.
• Improved neonatal screening and imaging techniques.
• Advances in surgical and transplantation outcomes.
• Emerging therapeutics like odevixibat and obeticholic acid.
• Increased research focus and funding.

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Biliary Atresia Market Barriers
• Lack of approved pharmacological therapies.
• Dependence on invasive procedures with high risk and cost.
• Variable treatment outcomes depending on timing and expertise.
• Low awareness in regions with fewer cases.
• Regulatory challenges due to rare disease status and small patient population.

Biliary Atresia Emerging Drugs
• BYLVAY (odevixibat): Ipsen
Odevixibat (A-4250), a potent and selective inhibitor of the ileal bile acid transporter (IBAT), also known as apical sodium-dependent bile acid transporter (ASBT), acts locally in the gut, and has minimal systemic exposure at the therapeutic dose. IBAT initiates the transport of bile acids, which flow through the portal vein back to the liver in a process known as enterohepatic circulation. Approximately 95% of bile acids are recirculated via the IBAT to the liver. Accordingly, a product capable of inhibiting the IBAT could lead to a reduction in bile acids returning to the liver and may represent a promising approach for treating cholestatic liver diseases. Odevixibat is being developed by Ipsen that completed acquisition of Albireo, expanding the scope of its rare disease portfolio.

• Obeticholic Acid: Intercept Pharmaceuticals
Obeticholic acid (OCA) is a first-in-class agonist that selectively binds to the farnesoid X receptor (FXR), a nuclear receptor expressed in the liver and intestine. FXR is a key regulator of bile acid, inflammatory, fibrotic, and metabolic pathways. FXR activation decreases the intracellular hepatocyte concentrations of bile acids by suppressing de novo synthesis from cholesterol as well as by increased transport of bile acids out of the hepatocytes. These mechanisms limit the overall size of the circulating bile acid pool while promoting choleresis, thus reducing hepatic exposure to bile acids.

Unlock Strategic Insights with DelveInsight's Comprehensive Biliary Atresia Market Report @ Biliary Atresia Clinical Trials and FDA Approvals - https://www.delveinsight.com/sample-request/biliary-atresia-market?utm_source=openpr&utm_medium=pressrelease&utm_campaign=apr

Scope of the Biliary Atresia Market Report
• Coverage- 7MM
• Biliary Atresia Companies- Mirum Pharmaceuticals (NASDAQ: MIRM), Albireo Pharma (NASDAQ: ALBO), Intercept Pharmaceuticals (NASDAQ: ICPT), Ipsen (EPA: IPN), and others.
• Biliary Atresia Therapies- BYLVAY, LIVMARLI, and others.
• Biliary Atresia Market Dynamics: Biliary Atresia Market Drivers and Barriers
• Biliary Atresia Market Access and Reimbursement, Unmet Needs and Future Perspectives

Contact Us:
Ankit Nigam
Manager Marketing
info@delveinsight.com
+14699457679

About DelveInsight
DelveInsight is a leading Life Science market research and business consulting company recognized for its off-the-shelf syndicated market research reports and customized solutions to firms in the healthcare sector.

This release was published on openPR.