Biliary Atresia Market Size to Grow at a CAGR of 5.64% during 2024-2034, Impelled by Advancements in Early Detection

December 03, 2024 | Healthcare


Biliary Atresia Market Outlook 2024-2034:

The biliary atresia market size is expected to exhibit a CAGR of 5.64% during 2024-2034. The market is driven by the escalating application of gene therapy approaches focused on rectifying or replacing defective genes that may be contributing to the pathogenesis of the underlying illness. Additionally, the development of targeted therapies and innovative treatments is further propelling the market growth.

Advances in Early Detection and Diagnostic Technologies: Driving the Biliary Atresia Market 

Advances in early detection and diagnostic technologies are significantly driving growth in the biliary atresia market by improving patient outcomes and enabling timely interventions. Moreover, neonatal screening programs have increasingly incorporated innovative diagnostic tools, such as direct bilirubin testing, to detect signs of cholestasis in newborns. This simple yet effective method has been instrumental in identifying biliary atresia earlier, enabling prompt referral for further evaluation. Additionally, the use of high-resolution ultrasonography and contrast-enhanced imaging has improved the visualization of bile duct abnormalities, facilitating more accurate and non-invasive diagnoses. Besides this, molecular and genetic testing technologies have also emerged as game-changers. Studies identifying genetic markers and molecular pathways associated with biliary atresia are paving the way for precision medicine approaches. These advancements not only enhance early detection but also provide insights into potential therapeutic targets, broadening the scope of treatment options. Moreover, as these diagnostic technologies continue to evolve, they are driving demand for earlier intervention strategies, such as the Kasai procedure, which is most effective when performed within the first few months of life. The integration of these cutting-edge tools into clinical practice is transforming the biliary atresia landscape, fostering market growth while improving outcomes for affected infants.

Development of Novel Therapies and Pharmacological Treatments: Contributing to Market Expansion

The development of novel therapies and pharmacological treatments is playing a pivotal role in the expansion of the biliary atresia market, addressing unmet medical needs, and transforming the management of this rare and severe pediatric liver disease. Emerging therapeutic innovations are reshaping the landscape, offering hope for improved outcomes and expanding the market. Moreover, pharmacological advancements have focused on reducing liver inflammation and fibrosis, two major contributors to disease progression in biliary atresia. Anti-fibrotic drugs and bile acid modulators, such as ursodeoxycholic acid, are being optimized to preserve liver function post-surgery. Additionally, immunomodulatory therapies targeting the immune dysregulation implicated in biliary atresia pathogenesis are showing promise in clinical trials. These therapies aim to slow disease progression and extend the time before liver transplantation becomes necessary. Regenerative medicine is another exciting frontier. Research on cell-based therapies, including stem cell transplantation and liver organoids, seeks to repair damaged liver tissue and restore bile flow. These approaches have the potential to revolutionize treatment by reducing dependence on transplantation. Gene therapy is also emerging as a potential game-changer, particularly for cases linked to genetic mutations. Advances in gene-editing technologies, such as CRISPR-Cas9, are paving the way for correcting the underlying genetic defects driving the disease. The introduction of these novel treatments, combined with continued surgical advancements and supportive care, is bolstering the growth of the market.

Emerging Therapies in Biliary Atresia Market

Maralixibat: Mirum Pharmaceuticals

Maralixibat is an oral, minimally absorbed ileal bile acid transporter (IBAT) inhibitor. It works by inhibiting the apical sodium-dependent bile acid transporter (ASBT) in the small intestine. This prevents bile acids from being reabsorbed into the blood and liver, increasing the amount eliminated in the stool. This lowers bile acid levels in the body, potentially decreasing bile acid-related liver damage and consequences.

Drug Name Company Name MOA ROA
Maralixibat Mirum Pharmaceuticals Sodium-bile acid cotransporter inhibitors Oral


Detailed list of emerging therapies in Biliary Atresia is provided in the final report.

Key Players in Biliary Atresia Market:

The key players in the Biliary Atresia market who are in different phases of developing different therapies are Mirum Pharmaceuticals and Others.

Key Players

Regional Analysis:

The major markets for biliary atresia include the United States, Germany, France, the United Kingdom, Italy, Spain, and Japan. According to projections by IMARC, the United States has the largest patient pool for biliary atresia while also representing the biggest market for its treatment. This can be attributed to the growing use of direct bilirubin testing in newborns as part of routine screening, which has significantly improved early detection rates, enabling timely surgical interventions such as the Kasai procedure.

Moreover, pharmaceutical companies and academic institutions are actively exploring novel therapies, including anti-fibrotic drugs, bile acid modulators, and immunomodulatory agents, which aim to slow disease progression and improve long-term outcomes. Furthermore, regenerative medicine and gene therapy research, supported by substantial funding and favorable regulatory frameworks, are paving the way for groundbreaking treatments.

Besides this, patient advocacy and awareness campaigns have also contributed to the market’s growth by educating healthcare professionals and families about the importance of early diagnosis and available treatment options​.

Recent Developments in Biliary Atresia Market:

  • In December 2023, Mirum Pharmaceuticals, Inc. published top-line results from the Phase 2 EMBARK study, which compared LIVMARLI (maralixibat) oral solution to placebo as an adjuvant therapy following Kasai surgery in patients with biliary atresia.
     

Key information covered in the report.

  • Base Year: 2023
  • Historical Period: 2018-2023
  • Market Forecast: 2024-2034
     

Countries Covered

  • United States
  • Germany
  • France
  • United Kingdom
  • Italy
  • Spain
  • Japan
     

 Analysis Covered Across Each Country

  • Historical, current, and future epidemiology scenario
  • Historical, current, and future performance of the biliary atresia market
  • Historical, current, and future performance of various therapeutic categories in the market
  • Sales of various drugs across the biliary atresia market
  • Reimbursement scenario in the market
  • In-market and pipeline drugs
     

Competitive Landscape:

This report offers a comprehensive analysis of current biliary atresia marketed drugs and late-stage pipeline drugs.

In-Market Drugs

  • Drug Overview
  • Mechanism of Action
  • Regulatory Status
  • Clinical Trial Results
  • Drug Uptake and Market Performance
     

 Late-Stage Pipeline Drugs

  • Drug Overview
  • Mechanism of Action
  • Regulatory Status
  • Clinical Trial Results
  • Drug Uptake and Market Performance
     

About Us:

IMARC Group is a global management consulting firm that helps the world’s most ambitious changemakers to create a lasting impact. Across the six major continents and 100+ countries, we work alongside our business partners as one team with a common ambition to achieve unparallelled results, gain a competitive edge, and transform industries. IMARC Group excels in understanding its clients’ business priorities and delivering tailored solutions that drive meaningful outcomes. Our client base spans over 3,000 organizations in the private, public, and social sectors, ranging from high-growth startups to Fortune 500 companies.

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