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.
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.
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.
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.
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.
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.
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.
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…
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.
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.
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.
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.
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.
Market Insights:
Epidemiology Insights:
1. Key Insights
2. Biliary Atresia: Market Overview at a Glance
2.1. Market Share (%) Distribution of Biliary Atresia in 2017
2.2. Market Share (%) Distribution of Biliary Atresia in 2030
3. Executive summary
4. Organizations
5. Disease Overview: Biliary Atresia
5.1. Introduction
5.2. Signs and Symptoms
5.3. Classification of Biliary Atresia
5.4. Anatomical forms
5.5. Clinical phenotypes of Biliary Atresia
5.6. Kasai classification
5.7. Etiology and Pathogenesis
5.8. Pathogenesis
5.9. Diagnosis
5.10. Differential Diagnosis
6. Epidemiology and Patient Population
6.1. Key Findings
6.2. 7MM Total Incident Patient Population of Biliary Atresia
6.3. United States
6.4. Assumptions and Rationale
6.5. Total Incident Cases of Biliary Atresia in the United States
6.6. Type-specific Cases of Biliary Atresia in the United States
6.7. Gender-specific Cases of Biliary Atresia in the United States
6.8. EU-5
6.9. Assumptions and Rationale
6.10. Germany
6.11. Total Incident Cases of Biliary Atresia in Germany
6.12. Type-specific Cases of Biliary Atresia in Germany
6.13. Gender-specific Cases of Biliary Atresia in Germany
6.14. France
6.15. Total Incident Cases of Biliary Atresia in France
6.16. Type-specific Cases of Biliary Atresia in France
6.17. Gender-specific Cases of Biliary Atresia in France
6.18. Italy
6.19. Total Incident Cases of Biliary Atresia in Italy
6.20. Type-specific Cases of Biliary Atresia in Italy
6.21. Gender-specific Cases of Biliary Atresia in Italy
6.22. Spain
6.23. Total Incident Cases of Biliary Atresia in Spain
6.24. Type-specific Cases of Biliary Atresia in Spain
6.25. Gender-specific Cases of Biliary Atresia in Spain
6.26. UK
6.27. Total Incident Cases of Biliary Atresia in the UK
6.28. Type-specific Cases of Biliary Atresia in the UK
6.29. Gender-specific Cases of Biliary Atresia in the UK
6.30. Japan
6.31. Assumptions and Rationale
6.32. Total Incident Cases of Biliary Atresia in Japan
6.33. Type-specific Cases of Biliary Atresia in Japan
6.34. Gender-specific Cases of Biliary Atresia in Japan
7. Treatment and Management
7.1. Surgical Management
7.2. Liver Transplantation
7.3. Medical management
8. Unmet needs
9. Emerging Therapies
9.1. Key cross competition
9.2. Odevixibat: Albireo
9.2.1. Drug Description
9.2.2. Other Developmental Activities
9.2.3. Clinical Development
9.2.4. Clinical trial information
9.2.5. Safety and Efficacy
9.2.6. Product Profile
9.3. Obeticholic Acid: Intercept Pharmaceuticals
9.3.1. Drug Description
9.3.2. Other Developmental Activities
9.3.3. Clinical Development
9.3.4. Clinical Trial Information
9.3.5. Product Profile
10. Biliary Atresia: 7 Major Market Analysis
10.1. Key Findings
10.2. Market Size of Biliary Atresia in 7MM
10.3. Market Outlook
10.4. United States Market Size
10.4.1. The total market size of Biliary Atresia in the United States
10.4.2. Therapy Based Market Size of Biliary Atresia in the United States
10.5. Germany Market Size
10.5.1. The total market size of Biliary Atresia in Germany
10.5.2. Therapy Based Market Size of Biliary Atresia in Germany
10.6. France Market Size
10.6.1. The total market size of Biliary Atresia in France
10.6.2. Therapy Based Market Size of Biliary Atresia in France
10.7. Italy Market Size
10.7.1. The total Market size of Biliary Atresia in the Italy
10.7.2. Therapy Based Market Size of Biliary Atresia in Italy
10.8. Spain Market Size
10.8.1. The total market size of Biliary Atresia in Spain
10.8.2. Therapy Based Market Size of Biliary Atresia in Spain
10.9. UK Market Size
10.9.1. The total market size of Biliary Atresia in the UK
10.9.2. Therapy Based Market Size of Biliary Atresia in the UK
10.10. Japan Market Size
10.10.1. The total market size of Biliary Atresia in Japan
10.10.2. Therapy Based Market Size of Biliary Atresia in Japan
11. Market Drivers
12. Market Barriers
13. SWOT Analysis
14. Case studies
14.1. A Case of Biliary Atresia with Pancreaticobiliary Maljunction
14.2. Case study: Biliary Atresia: A Case Report
14.3. Case study: Clinical and Pathological Challenges in the Diagnosis of Late-Onset Biliary Atresia: Four Case Studies
15. KOL Views
16. Bibliography
17. Appendix
18. Report Methodology
18.1. DelveInsight Capabilities
19. Disclaimer
20. About DelveInsight
List of Tables
Table 1: Anatomical types of biliary atresia (BA)
Table 2: Clinical phenotypes of Biliary Atresia
Table 3: Total Incident Patient Population of Biliary Atresia in 7MM (2017-2030)
Table 4: Total Incident cases of Biliary Atresia in the United States (2017-2030)
Table 5: Type-specific cases of Biliary Atresia in the United States (2017-2030)
Table 6: Gender-specific cases of Biliary Atresia in the United States (2017-2030)
Table 7: Total Incident cases of Biliary Atresia in Germany (2017-2030)
Table 8: Type-specific cases of Biliary Atresia in Germany (2017-2030)
Table 9: Gender-specific cases of Biliary Atresia in Germany (2017-2030)
Table 10: Total Incident cases of Biliary Atresia in France (2017-2030)
Table 11: Type-specific cases of Biliary Atresia in France (2017-2030)
Table 12: Gender-specific cases of Biliary Atresia in the France (2017-2030)
Table 13: Total Incident cases of Biliary Atresia in Italy (2017-2030)
Table 14: Type-specific cases of Biliary Atresia in Italy (2017-2030)
Table 15: Gender-specific cases of Biliary Atresia in Italy (2017-2030)
Table 16: Total Incident cases of Biliary Atresia in Spain (2017-2030)
Table 17: Type-specific cases of Biliary Atresia in Spain (2017-2030)
Table 18: Gender-specific cases of Biliary Atresia in Spain (2017-2030)
Table 19: Total Incident cases of Biliary Atresia in the UK (2017-2030)
Table 20: Type-specific cases of Biliary Atresia in the UK (2017-2030)
Table 21: Gender-specific cases of Biliary Atresia in the UK (2017-2030)
Table 22: Total Incident cases of Biliary Atresia in Japan (2017-2030)
Table 23: Type-specific cases of Biliary Atresia in Japan (2017-2030)
Table 24: Gender-specific cases of Biliary Atresia in Japan (2017-2030)
Table 25: Key cross competition
Table 26: Key cross competition, Academics Trial
Table 27: Odevixibat, Clinical Trial Description, 2020
Table 28: Obeticholic acid, Clinical Trial Description, 2020
Table 29: 7 Major Market Size of Biliary Atresia in USD Million (2017-2030)
Table 30: United States Market Size of Biliary Atresia in USD Million (2017-2030)
Table 31: Therapy Based Market Size of Biliary Atresia in the US in USD Million (2017-2030)
Table 32: Germany Market Size of Biliary Atresia in USD Million (2017-2030)
Table 33: Therapy Based Market Size of Biliary Atresia in Germany in USD Million (2017-2030)
Table 34: France Market Size of Biliary Atresia in USD Million (2017-2030)
Table 35: Therapy Based Market Size of Biliary Atresia in France in USD Million (2017-2030)
Table 36: Italy Market Size of Biliary Atresia in USD Million (2017-2030)
Table 37: Therapy Based Market Size of Biliary Atresia in Italy in USD Million (2017-2030)
Table 38: Spain Market Size of Biliary Atresia in USD Million (2017-2030)
Table 39: Therapy Based Market Size of Biliary Atresia in Spain in USD Million (2017-2030)
Table 40: UK Market Size of Biliary Atresia in USD Million (2017-2030)
Table 41: Therapy Based Market Size of Biliary Atresia in the UK in USD Million (2017-2030)
Table 42: Japan Market Size of Biliary Atresia in USD Million (2017-2030)
Table 43:Therapy Based Market Size of Biliary Atresia in Japan in USD Million (2017-2030)
List of Figures
Figure 1: Signs and Symptoms
Figure 2: Clincal Phenotypes of BA
Figure 3: Classification of biliary atresia according to Kasai classification system
Figure 4: Schematic of the hypothesis of biliary atresia etiology
Figure 5: Etiology and Pathogenesis
Figure 6: Innate immune receptors present in Cholangiocytes
Figure 7: Mechanism of obstruction in biliary atresia
Figure 8: Disease progression mechanisms after bile duct obstruction
Figure 9: Total Incident Patient Population of Biliary Atresia in 7MM (2017-2030)
Figure 10: Total Incident cases of Biliary Atresia in the United States (2017–2030)
Figure 11: Type-specific cases of Biliary Atresia in the US (2017-2030)
Figure 12: Gender-specific cases of Biliary Atresia in the United States (2017-2030)
Figure 13: Total Incident cases of Biliary Atresia in Germany (2017–2030)
Figure 14: Type-specific cases of Biliary Atresia in the Germany 2017-2030)
Figure 15: Gender-specific cases of Biliary Atresia in Germany (2017-2030)
Figure 16: Total Incident cases of Biliary Atresia in France (2017–2030)
Figure 17: Type-specific cases of Biliary Atresia in the France 2017-2030)
Figure 18: Gender-specific cases of Biliary Atresia in France (2017-2030)
Figure 19: Total Incident cases of Biliary Atresia in Italy (2017–2030)
Figure 20: Type-specific cases of Biliary Atresia in the Italy 2017-2030)
Figure 21: Gender-specific cases of Biliary Atresia in Italy (2017-2030)
Figure 22: Total Incident cases of Biliary Atresia in Spain (2017–2030)
Figure 23: Type-specific cases of Biliary Atresia in the Spain 2017-2030)
Figure 24: Gender-specific cases of Biliary Atresia in Spain (2017-2030)
Figure 25: Total Incident cases of Biliary Atresia in the UK (2017–2030)
Figure 26: Type-specific cases of Biliary Atresia in the UK 2017-2030)
Figure 27: Gender-specific cases of Biliary Atresia in the UK (2017-2030)
Figure 28: Total Incident cases of Biliary Atresia in Japan (2017–2030)
Figure 29: Type-specific cases of Biliary Atresia in the Japan 2017-2030)
Figure 30: Gender-specific cases of Biliary Atresia in Japan (2017-2030)
Figure 31: Management of children with Biliary Atresia.
Figure 32: Unmet Needs of Biliary Atresia
Figure 33: 7 Major Market Size of Biliary Atresia in USD Million (2017-2030)
Figure 34: Market Size of Biliary Atresia in the United States, USD Millions (2017-2030)
Figure 35: Therapy Based Market Size of Biliary Atresia in the US in USD Million (2017-2030)
Figure 36: Market Size of Biliary Atresia in Germany, USD Millions (2017-2030)
Figure 37: Therapy Based Market Size of Biliary Atresia in Germany in USD Million (2017-2030)
Figure 38: Market Size of Biliary Atresia in France, USD Millions (2017-2030)
Figure 39: Therapy Based Market Size of Biliary Atresia in France in USD Million (2017-2030)
Figure 40: Market Size of Biliary Atresia in Italy, USD Millions (2017-2030)
Figure 41: Therapy Based Market Size of Biliary Atresia in Italy in USD Million (2017-2030)
Figure 42: Market Size of Biliary Atresia in Spain, USD Millions (2017-2030)
Figure 43: Therapy Based Market Size of Biliary Atresia in Spain in USD Million (2017-2030)
Figure 44: Market Size of Biliary Atresia in the UK, USD Millions (2017-2030)
Figure 45: Therapy Based Market Size of Biliary Atresia in the UK in USD Million (2017-2030)
Figure 46: Market Size of Biliary Atresia in Japan, USD Millions (2017-2030)
Figure 47:Therapy Based Market Size of Biliary Atresia in Japan in USD Million (2017-2030)
Figure 48: Market Drivers
Figure 49: Market Barriers
Odevixibat
Obeticholic Acid
And Many Others
