Biliary Atresia Drugs Market 2034: Clinical Trials, EMA, PDMA, FDA Approval, Medication, Prevalence, NICE Approvals, Revenue, Statistics and Companies by DelveInsight

(Albany, USA) DelveInsight's "Biliary Atresia Market Insights, Epidemiology, and Market Forecast - 2034" report delivers an in-depth understanding, historical and forecasted epidemiology, as well as the Biliary Atresia market trends in the United States, EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan.

The Biliary Atresia Market is an evolving segment of the global healthcare landscape, driven by the increasing Biliary Atresia prevalence of the disorder and the continuous development of innovative treatment options. The Biliary Atresia market encompasses various therapeutic categories, including antipsychotics, adjunctive therapies, and emerging treatment modalities.

The Biliary Atresia market report provides current treatment practices, emerging drugs, the market share of the individual therapies, and the current and forecasted Biliary Atresia market size from 2020 to 2034, segmented by seven major markets. The Report also covers current Biliary Atresia treatment practice/algorithm, market drivers, market barriers, and unmet medical needs to curate the best opportunities and assesses the underlying potential of the Biliary Atresia market.

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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.

Biliary Atresia Overview
Biliary Atresia is a rare but serious liver condition that affects infants, characterized by the blockage or absence of bile ducts. Biliary Atresia prevents bile from flowing from the liver to the gallbladder, leading to liver damage and scarring. Biliary Atresia symptoms typically appear within the first few weeks of life and may include jaundice, dark urine, pale stools, and poor weight gain.

Biliary Atresia diagnosis involves a combination of blood tests, imaging studies, and sometimes a liver biopsy. Biliary Atresia treatment primarily includes surgery, known as the Kasai procedure, which aims to restore bile flow. Biliary Atresia surgery is most effective when performed early, ideally within two months of birth. Biliary Atresia prognosis improves with timely intervention, though many children may eventually require a liver transplant. Biliary Atresia research is ongoing to better understand its causes and develop more effective treatments.

Biliary Atresia awareness is crucial for early detection and management. Biliary Atresia support groups and medical teams play a key role in helping families navigate the condition. Biliary Atresia outcomes vary, but early diagnosis and appropriate care can significantly improve quality of life. Biliary Atresia remains a leading cause of pediatric liver transplants worldwide.

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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

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

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.

Biliary Atresia Market Outlook
Biliary atresia is characterized by a fibro proliferative obliteration of the biliary tree that progresses toward hepatic fibrosis, cirrhosis, and end-stage liver failure. The treatment of BA is surgical and currently recommended as a sequence of, eventually, two interventions. During the first months of life, a Hepatoportoenterostomy (a "Kasai," modifications) should be performed, to restore the biliary flow to the intestine and lessen further damage to the liver. If this fails or the disease progresses towards biliary cirrhosis and life-threatening complications, then liver transplantation is indicated, for which biliary atresia represents the most frequent pediatric indication.

The Biliary Atresia market is driven by several key factors, including the increasing awareness of rare pediatric liver disorders, advancements in diagnostic techniques, and improvements in surgical procedures such as the Kasai portoenterostomy. The rising number of liver transplants in infants and growing investments in pediatric healthcare infrastructure also contribute to market growth. Additionally, ongoing research and clinical trials targeting the underlying causes of Biliary Atresia are opening new avenues for treatment and innovation. However, the Biliary Atresia market faces significant barriers such as delayed diagnosis due to the rarity and nonspecific early symptoms of the disease. Limited access to specialized healthcare in low- and middle-income countries further hinders timely treatment. The high cost of surgical procedures and liver transplants, coupled with the lack of curative therapies beyond transplantation, also poses challenges.

Moreover, the small patient population restricts large-scale clinical research, impacting the development of targeted therapies. Despite these challenges, continued collaboration among healthcare providers, researchers, and patient advocacy groups is essential to overcome the current limitations in the Biliary Atresia market.

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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

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

Table of Content
1 Key Insights
2 Report Introduction
3 Market Overview at a Glance
4 Epidemiology and Market Forecast Methodology
5 Executive Summary
6 Key Events
7 Disease Background and Overview
8 Patient Journey
9 Epidemiology and Patient Population
10 Emerging Drugs
11 Biliary atresia: Market Analysis
12 Key Opinion Leaders' Views
13 SWOT Analysis
14 Unmet Needs
15 Market Access and Reimbursement
16 Appendix
17 DelveInsight Capabilities
18 Disclaimer
19 About DelveInsight

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