Biliary Atresia - Market Insights, Epidemiology, and Market Forecast - 2030

DelveInsight’s ‘Biliary Atresia– Market Insights, Epidemiology, and Market Forecast—2030’ report delivers an in-depth understanding of the Biliary Atresia, historical and forecasted epidemiology as well as the market trends in the United States, EU5 (Germany, Spain, Italy, France, and United Kingdom) and Japan.
The Biliary Atresia market report provides current treatment practices, emerging drugs and their market share of the individual therapies, current and forecasted Biliary Atresia market size from 2017 to 2030 segmented by seven major markets. The Report also covers current Biliary Atresia symptoms treatment practice/algorithm, market drivers, market barriers and unmet medical needs to curate the best of the opportunities and assesses the underlying potential of the market.
Geographies Covered
• The United States
• EU5 (Germany, France, Italy, Spain, and the United Kingdom)
• Japan

Study Period: 2017–2030
Biliary Atresia Disease Understanding and Treatment Algorithm
Biliary Atresia Overview
Biliary Atresia is a neonatal liver disease characterized by progressive obstruction and fibrosis of the extrahepatic biliary tree along with fibrosis and inflammation of the liver parenchyma. The etiology and pathogenesis of BA remain unknown. Recent studies are examining potential pathogenetic mechanisms of BA, including genetic susceptibility, the involvement of the immune system, and environmental insults such as viruses and toxins. It is possible that there is not a single etiological agent but rather a large group of injurious insults that might result in a final common pathway of extrahepatic bile duct obstruction and liver fibrosis.
The symptoms of Biliary Atresia usually appear by the age of 2–6 weeks. They include a yellowish coloration of the skin and whites of the eyes (jaundice), abnormally pale stools, and dark urine. Infants may also have swollen (distended) stomach and/or abnormal enlargement of the liver (hepatomegaly). The pathway from clinical suspicion to establishing the diagnosis of Biliary Atresia in a child with jaundice is a daunting task—however, investigations available help point the correct diagnosis in a reasonable time frame.Imaging by sonography has identified several parameters which can be of help in the diagnostic workup. Comparison of sonography with imaging by nuclear medicine can bring out significant differences and also avoid inappropriate imaging. The battery of biochemical tests, available currently, enable a better understanding of the line-up of investigations in a given child with neonatal cholestasis. Untreated, Biliary Atresia remains a fatal condition of the newborn. Most present within 4–6 weeks of conjugated jaundice and acholic stools, and although still a challenging diagnosis to make, therein lies the opportunity of changing the course of this otherwise inexorable disease.
 
Biliary Atresia Diagnosis and Treatment
It covers the details of conventional and current medical therapies and diagnosis available in the Biliary Atresia market for the treatment of the condition. It also provides the country-wise treatment guidelines and algorithms across the United States, Europe, and Japan.
The DelveInsight Biliary Atresia market report gives a thorough understanding of Biliary Atresia by including details such as disease definition, symptoms, causes, pathophysiology, and diagnosis. It also provides Biliary Atresia treatment algorithms and treatment guidelines for Biliary Atresia in the US, Europe, and Japan.
Biliary Atresia Epidemiology
The Biliary Atresia epidemiology division provides insights about the historical and current patient pool along with the forecasted trend for every seven major countries. It helps to recognize the causes of current and forecasted trends by exploring numerous studies and views of key opinion leaders. This part of the DelveInsight report also provides the diagnosed patient pool and their trends along with assumptions undertaken.
Key Findings
The disease epidemiology covered in the report provides historical as well as forecasted Biliary Atresia epidemiology segmented as the Total Incident Cases of Biliary Atresia, Gender-specific Cases of Biliary Atresia, and Type-specific Cases of Biliary Atresia. The report includes the Incident scenario of Biliary Atresia in 7MM covering the United States, EU5 countries (Germany, France, Italy, Spain, and the United Kingdom), and Japan from 2017 to 2030.
Country Wise- Biliary Atresia Epidemiology
The epidemiology segment also provides the Biliary Atresia epidemiology data and findings across the United States, EU5 (Germany, France, Italy, Spain, and the United Kingdom) and Japan.
The total Incident population of Biliary Atresiain 7MM countries was estimated to be 613 cases in 2017.
Biliary Atresia Drug Chapters
The drug chapter segment of the Biliary Atresia report encloses the detailed analysis of Biliary Atresia marketed drugs and late stage (Phase-III and Phase-II) pipeline drugs. It also helps to understand the Biliary Atresia clinical trial details, expressive pharmacological action, agreements and collaborations, approval and patent details, advantages and disadvantages of each included drug and the latest news and press releases.
There is no FDA approved therapy for treatment of Biliary Atresia. The therapeutic market size of Biliary Atresia in the US is mainly accounted for off label treatment options including choleretics such as ursodeoxycholic acid (UDCA), anti-inflammatory medications, steroids, nutritional rehabilitation, and fat-soluble vitamin supplementation
Products detail in the report…
Biliary Atresia Emerging Drugs
Odevixibat (Albireo) 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. Therefore, Odevixibat works by decreasing the reabsorption of bile acids from the small intestine to the liver, which reduces the toxic levels of bile acids during the progression of the disease. It exhibits therapeutic intervention by checking the transport of bile acids.
The company presented the data from phase II trial in pediatric cholestasis that supports the potential of odevixibat in Biliary Atresia and Alagille syndrome at the European Association for the Study of the Liver (EASL) annual conference.
Currently, the company is conducting the phase III trial for the treatment of Biliary Atresia. Both FDA and EMA also have granted Orphan Drug Designation to Odevixibat for the treatment of Biliary Atresia.
Products detail in the report…
Biliary Atresia Market Outlook
The Biliary Atresia market outlook of the report helps to build the detailed comprehension of the historic, current and forecasted Biliary Atresia market trends by analyzing the impact of current therapies on the market, unmet needs, drivers and barriers and demand of better technology.
This segment gives a thorough detail of Biliary Atresia market trend of each marketed drug and late-stage pipeline therapy by evaluating their impact based on annual cost of therapy, inclusion and exclusion criteria’s, mechanism of action, compliance rate, growing need of the market, increasing patient pool, covered patient segment, expected launch year, competition with other therapies, brand value, their impact on the market and view of the key opinion leaders. The calculated market data are presented with relevant tables and graphs to give a clear view of the market at first sight.
According to DelveInsight, Biliary Atresia market in 7MM is expected to change in the study period 2017–2030.
The management and diagnosis of BA have not advanced significantly in the past decade, but given recent advances in understanding the timing and potential pathogenesis of BA, it is hopeful that the next decade will bring early diagnostics and novel therapeutics.
Key Findings
This section includes a glimpse of the Biliary Atresia market in 7MM. The market size of Biliary Atresia in the seven major markets was found to be USD 2.9 million, in 2017.

The United States Market Outlook
This section provides the total Biliary Atresia market size and market size by therapies in the United States.
The United States accounts for the highest market size of Biliary Atresia in comparison to the EU5 (the United Kingdom, Germany, Italy, France, and Spain) and Japan.
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 indications for liver transplantation depend on the success of the Kasai portoenterostomy and the rate of development of complications. In those infants in whom bile drainage is not achieved, transplantation is usually indicated within the first year or life. In children with a successful Kasai portoenterostomy, liver transplantation should be considered if there is persistent or progressive cholestasis, development of cirrhosis with hepatic dysfunction, or development of portal hypertension with ascites and variceal bleeding unresponsive to endoscopic management.
In the Postoperative Management, medical care following HPE consists of interventions such as Choleretics and possible use of anti-inflammatory medications, Nutritional rehabilitation, Fat-soluble vitamin supplementation, Prevention of cholangitis, management of portal hypertension and its sequel.
Despite these measures, many infants and children with BA require supplemental feeding by nasogastric tube because they are unable to take enough energy by mouth to meet their increased nutritional needs.
Deficiencies of fat-soluble vitamins are common in patients with BA. Vitamin deficiencies occur despite recommended supplementation and are particularly common among patients with residual cholestasis after Kasai HPE. Therefore, vitamin levels should be monitored frequently. Infants with BA and prolonged jaundice may especially be deficient in vitamin K.
EU-5 Countries: Market Outlook
The total Biliary Atresia market size and market size by therapies in Germany, France, Italy, Spain, and the United Kingdom are provided in this section.
The treatment regime for most children with diagnosed BA include surgery, whereby an attempt is made to preserve the infant's liver. Kasai operation is performed which essentially excises all extrahepatic biliary remnants leaving a transected portal plate, followed by biliary reconstruction using a Roux loop onto that plate as a Hepatoportoenterostomy. However, liver transplantation is indicated in BA in three different clinical settings. It may be necessary for infants who have a delayed diagnosis of BA and hence have not been subjected to a KPE. These children usually present within 1 year of age with intense jaundice, synthetic liver dysfunction, and failure to thrive. The second group of children is those who undergo a KPE but do not overcome synthetic failure. These children need transplantation in the first 2 years of life. The indications in this group include jaundice, portal hypertension, and failure to thrive. The third group of children (or adults) is those who have successfully cleared jaundice after the KPE but have recurrent cholangitis, portal hypertension, or hepatopulmonary syndrome.
Furthermore, surgical treatment essentially involves post operative management regime which mainly consists of antibiotics, ursodeoxycholic acid to encourage bile flow, fat-soluble vitamin supplementation, and nutritional support.
Japan Market Outlook
The total Biliary Atresiamarket size and market size by therapies in Japan are also mentioned.
Biliary Atresia Drugs Uptake
This section focusses on the rate of uptake of the potential drugs recently launched or expected to get launched in the market during the study period 2017–2030. The analysis covers Biliary Atresia market uptake by drugs; patient uptake by therapies; and sales of each drug.
This helps in understanding the drugs with the most rapid uptake, reasons behind the maximal use of new drugs and allow the comparison of the drugs on the basis of market share and size which again will be useful in investigating factors important in the market uptake and in making financial and regulatory decisions.
Biliary Atresia Pipeline Development Activities
The report provides insights into different therapeutic candidates in Phase II, and Phase III stage. It also analyses Biliary Atresia key players involved in developing targeted therapeutics.
Major players include Intercept Pharmaceuticals, Albireo etc. which are expected to get launched in the US market by 20XX.
Pipeline Development Activities
The report covers the detailed information of collaborations, acquisition, and merger, licensing and patent details for Biliary Atresia emerging therapies.
KOL- Views
To keep up with current market trends, we take KOLs and SME’s opinion working in Biliary Atresiadomain through primary research to fill the data gaps and validate our secondary research. Their opinion helps to understand and validate current and emerging therapies treatment patterns or Biliary Atresia market trend. This will support the clients in potential upcoming novel treatment by identifying the overall scenario of the market and the unmet needs.
Competitive Intelligence Analysis
We perform Competitive & Market Intelligence analysis of the Biliary Atresia Market by using various Competitive Intelligence tools that includes – SWOT analysis, PESTLE analysis, Porter’s five forces, BCG Matrix, Market entry strategies, etc. The inclusion of the analysis entirely depends upon the data availability.
Scope of the Report
• The report covers the descriptive overview of Biliary Atresia, explaining its causes, signs and symptoms, pathophysiology and currently available therapies
• Comprehensive insight has been provided into the Biliary Atresia epidemiology and treatment in the 7MM
• Additionally, an all-inclusive account of both the current and emerging therapies for Biliary Atresia is provided, along with the assessment of new therapies, which will have an impact on the current treatment landscape
• A detailed review of Biliary Atresia market; historical and forecasted is included in the report, covering drug outreach in the 7MM
• The report provides an edge while developing business strategies, by understanding trends shaping and driving the global Biliary Atresia market
Report Highlights
• In the coming years, Biliary Atresia market is set to change due to the rising awareness of the disease, and incremental healthcare spending across the world; which would expand the size of the market to enable the drug manufacturers to penetrate more into the market
• The companies and academics are working to assess challenges and seek opportunities that could influence Biliary Atresia R&D. The therapies under development are focused on novel approaches to treat/improve the disease condition
• Major players are involved in developing therapies for Biliary Atresia. Launch of emerging therapies will significantly impact the Biliary Atresia market
• A better understanding of disease pathogenesis will also contribute to the development of novel therapeutics for Biliary Atresia.
• Our in-depth analysis of the pipeline assets across different stages of development (Phase III and Phase II), different emerging trends and comparative analysis of pipeline products with detailed clinical profiles, key cross-competition, launch date along with product development activities will support the clients in the decision-making process regarding their therapeutic portfolio by identifying the overall scenario of the research and development activities
Biliary Atresia Report Insights
• Patient Population
• Therapeutic Approaches
• Biliary Atresia Pipeline Analysis
• Biliary Atresia Market Size and Trends
• Market Opportunities
• Impact of upcoming Therapies

Biliary Atresia Report Key Strengths
• 11 Years Forecast
• 7MM Coverage
• Biliary Atresia Epidemiology Segmentation
• Key Cross Competition
• Highly Analyzed Market
• Drugs Uptake

Biliary Atresia Report Assessment
• Current Treatment Practices
• Unmet Needs
• Pipeline Product Profiles
• Market Attractiveness
• Market Drivers and Barriers
Key Questions
Market Insights:
• What were the Biliary Atresia Market share (%) distribution in 2017 and how it would look like in 2030?
• What would be the Biliary Atresia total market Size as well as market Size by therapies across the 7MM during the forecast period (2017–2030)?
• What are the key findings pertaining to the market across 7MM and which country will have the largest Biliary Atresiamarket Size during the forecast period (2017–2030)?
• At what CAGR, the Biliary Atresia market is expected to grow in 7MM during the forecast period (2017–2030)?
• What would be the Biliary Atresia market outlook across the 7MM during the forecast period (2017–2030)?
• What would be the Biliary Atresia market growth till 2030 and what will be the resultant market Size in the year 2030?
• How would the market drivers, barriers and future opportunities affect the market dynamics and subsequent analysis of the associated trends?
 
Epidemiology Insights:
• What is the disease risk, burden and unmet needs of the Biliary Atresia?
• What is the historical Biliary Atresia patient pool in seven major markets covering the United States, EU5 (Germany, Spain, France, Italy, UK) & Japan?
• What would be the forecasted patient pool of Biliary Atresia in 7 major markets covering the United States, EU5 (Germany, Spain, France, Italy, UK) & Japan?
• What will be the growth opportunities in the 7MM with respect to the patient population pertaining to Biliary Atresia?
• Out of all 7MM countries, which country would have the highest Incident population of Biliary Atresia during the forecast period (2017–2030)?
• At what CAGR the population is expected to grow in 7MM during the forecast period (2017–2030)?
Current Treatment Scenario, Marketed Drugs, and Emerging Therapies:
• What are the current options for the treatment of Biliary Atresia?
• What are the current treatment guidelines for the treatment of Biliary Atresia in the USA, Europe, and Japan?
• What are the Biliary Atresia marketed drugs and their MOA, regulatory milestones, product development activities, advantages, disadvantages, safety, and efficacy, etc.?
• How many companies are developing therapies for the treatment of Biliary Atresia?
• How many therapies are develop by each company for the treatment of Biliary Atresia?
• How many emerging therapies are in the mid-stage and late stages of development for the treatment of Biliary Atresia?
• What are the key collaborations (Industry–Industry, Industry-Academia), Mergers and acquisitions, licensing activities related to the Biliary Atresia therapies?
• What are the recent novel therapies, targets, mechanisms of action and technologies develop to overcome the limitation of existing therapies?
• What are the clinical studies going on for Biliary Atresia and their status?
• What are the key designations that have been granted for the emerging therapies for Biliary Atresia?
• What are the global historical and forecasted market of Biliary Atresia?
Reasons to buy
• The report will help in developing business strategies by understanding trends shaping and driving the Biliary Atresia market,
• To understand the future market competition in the Biliary Atresia market and Insightful review of the key market drivers and barriers.
• Organize sales and marketing efforts by identifying the best opportunities for Biliary Atresia in the US, Europe (Germany, Spain, Italy, France, and the United Kingdom) and Japan.
• Identification of strong upcoming players in the market will help in devising strategies that will help in getting ahead of competitors.
• Organize sales and marketing efforts by identifying the best opportunities for Biliary Atresia market.
• To understand the future market competition in the Biliary Atresia market.