DelveInsight’s “Primary Sclerosing Cholangitis Market Insights, Epidemiology, and Market Forecast 2032” report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the Primary Sclerosing Cholangitis market size, share, trends, and growth opportunities in the seven major markets (7MM) (i.e., the United States, EU4 (Germany, Spain, Italy, France), the United Kingdom and Japan).
The report covers emerging Primary Sclerosing Cholangitis drugs, current treatment practices, market share of individual therapies, and current & forecasted market size from 2019 to 2032. It also evaluates the current Primary Sclerosing Cholangitis treatment practice/algorithm, key drivers & barriers impacting the market growth, and unmet medical needs to curate the best of the opportunities and assess the underlying potential of the market.
Primary Sclerosing Cholangitis: An Overview
According to the American Liver Foundation, primary sclerosing cholangitis (PSC) is a chronic or long-term disease that slowly damages the bile ducts. In PSC patients, the bile ducts are blocked due to inflammation and scarring or fibrosis, leading to the accumulation of bile in the liver, which gradually damages liver cells and causes cirrhosis or fibrosis of the liver. As cirrhosis progresses and the amount of scar tissue in the liver increases, the liver slowly loses its ability to function. The scar tissue may block the drainage of the bile ducts leading to bile infection.
Mostly, PSC is genetically predisposed following exposure to environmental triggers. These might create complicated immune system interactions, culminating in lymphocyte migration, cholangiocyte destruction, and progressive fibrosis.
Sclerosing cholangitis is classified into a primary type of unknown origins, such as PSC or IgG4-SC, and a secondary type with obvious pathogenesis (e.g., common bile duct [CBD] stone, cholangiocarcinoma, trauma, operation of the biliary tract, congenital biliary anatomy, corrosive cholangitis, ischemic bile duct stenosis, AIDS-related cholangitis, or biliary injury of intra-arterial chemotherapy).
Despite clinical trials of numerous pharmacotherapies over several decades, safe and effective medical therapy remains to be established. High-dose ursodeoxycholic acid is used to treat PSC patients as there is a trend toward increased survival. Dominant bile duct stenoses should be treated endoscopically; however, liver transplantation is the only therapeutic option for patients with advanced disease.
Primary Sclerosing Cholangitis Market Key Facts
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The total Primary Sclerosing Cholangitis market size in the 7MM is approximately USD 113 million in 2022 and is projected to increase during the forecast period (2023-2032).
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In 2022, the market size of PSC was highest in the US among the 7MM, accounting for approximately USD 78 Million, which is further expected to increase by 2032.
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Among EU countries, Germany and the UK account for the maximum market size of USD 8 million in 2022 while Spain occupies the bottom of the ladder in the same year with USD 0.2 million.
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Japan accounts for a market size of USD 4 million in 2022, but these dynamics are expected to change in the forecasted years.
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There were 53,081 diagnosed prevalent cases of Primary Sclerosing Cholangitis estimated to have occurred in the 7MM in 2022 of which 30,429 of the accounted cases were estimated to be from the US alone and these cases are anticipated to grow in the foreseeable future during the study period.
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The diagnosed prevalent population of Primary Sclerosing Cholangitis can be divided into two types symptomatic and asymptomatic. The diagnosed prevalent cases of Asymptomatic Primary Sclerosing Cholangitis in 2022 in the 7MM was nearly 27,726 cases.
Primary Sclerosing Cholangitis Market
The market outlook section of the report helps to build a detailed comprehension of the historical, current, and forecasted market size by analyzing the impact of current and emerging Primary Sclerosing Cholangitis pipeline therapies. It also thoroughly assesses the Primary Sclerosing Cholangitis market drivers & barriers, unmet needs, and emerging technologies set to impact the market dynamics.
The report gives complete details of the market trend for each marketed Primary Sclerosing Cholangitis drug and mid & late-stage pipeline therapies by evaluating their impact based on the annual cost of therapy, their Mechanism of Action (MOA), Route of Administration (ROA), molecule types, competition with other therapies, brand value, and their impact on the market.
Primary Sclerosing Cholangitis Epidemiology Assessment
The epidemiology section provides insights into the historical, current, and forecasted Primary Sclerosing Cholangitis epidemiology trends in the seven major countries (7MM) from 2019 to 2032. It helps to recognize the causes of current and forecasted Primary Sclerosing Cholangitis epidemiology trends by exploring numerous studies and research. The epidemiology section also provides a detailed analysis of diagnosed and prevalent patient pools, future trends, and views of key opinion leaders.
The Report Covers the Primary Sclerosing Cholangitis Epidemiology, Segmented as –
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Diagnosed Prevalent Cases of Primary Sclerosing Cholangitis
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Symptom-specific Diagnosed Prevalent cases of Primary Sclerosing Cholangitis
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Comorbidity-specific Diagnosed Prevalent cases of Primary Sclerosing Cholangitis
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Gender-specific Diagnosed Prevalent Cases of Primary Sclerosing Cholangitis
Primary Sclerosing Cholangitis Drugs Uptake and Pipeline Development Activities
The drug uptake section focuses on the uptake rate of potential drugs recently launched in the Primary Sclerosing Cholangitis market or expected to be launched during the study period. The analysis covers the Primary Sclerosing Cholangitis market uptake by drugs, patient uptake by therapies, and sales of each drug. Moreover, the therapeutics assessment section helps understand the market dynamics by drug sales, the most rapid drug uptake, and the reasons behind the maximal use of particular drugs. Additionally, it compares the Primary Sclerosing Cholangitis drugs based on their sale and market share.
The report also covers the Primary Sclerosing Cholangitis pipeline development activities. It provides valuable insights about different therapeutic candidates in various stages and the key Primary Sclerosing Cholangitis companies involved in developing targeted therapeutics. It also analyzes recent developments such as collaborations, acquisitions, mergers, licensing patent details, and other information for emerging therapies.
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Primary Sclerosing Cholangitis Therapeutics Analysis
High-dose ursodeoxycholic acid is used to treat PSC patients because of a trend toward increased survival. Dominant bile duct stenosis should be treated endoscopically. However, liver transplantation remains the only therapeutic option for patients with advanced disease.
Apart from this, Immunosuppressive-based therapies such as glucocorticoids, azathioprine, tacrolimus, and a few others are in use, especially in those patients with additional features of autoimmune hepatitis (AIH) or IgG4-related sclerosing cholangitis (IgG4-SC). Although they had shown improvements in liver biochemistry, these effects were not sustained and did not show clinical benefit. The outcomes were not assessed over prolonged periods to determine the progression to cirrhosis. This makes their inclusion in daily practice all the more difficult.
Antibiotics, such as vancomycin, metronidazole, and tetracycline, were investigated to assess the interrelationship between systemic and mucosal inflammation. However, limited evidence does not support vancomycin (or other antibiotics) for treating PSC liver disease without cholangitis. Several antimicrobial agents have been used and studied in treating PSC, including rifaximin, tetracycline, minocycline, metronidazole, and OVT, with mixed results.
Several major pharma and biotech companies are developing therapies for Primary Sclerosing Cholangitis. Currently, Gilead Sciences is leading the therapeutics market with its Primary Sclerosing Cholangitis drug candidates in the most advanced stage of clinical development.
Primary Sclerosing Cholangitis Companies Actively Working in the Therapeutics Market Include
Albireo Pharma, CymaBay Therapeutics, Dr. Falk Pharma, Genfit, Gilead Sciences, HighTide Biopharma, Immunic, Ipsen, Mirum Pharmaceuticals, Morphic Therapeutic, Pliant Therapeutics, SCOHIA PHARMA, Sirnaomics, and many others.
Emerging and Marketed Primary Sclerosing Cholangitis Therapies Covered in the Report Include:
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GS-9674: Gilead Sciences
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IMU-838: Immunic
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HTD 1801: HighTide Biopharma
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Norursodeoxycholic acid (norUDCA): Dr. Falk Pharma
And Many Others
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Table of Content (TOC)
1. Key Insights
2. Executive Summary
3. Primary Sclerosing Cholangitis Competitive Intelligence Analysis
4. Primary Sclerosing Cholangitis Market Overview at a Glance
5. Primary Sclerosing Cholangitis Disease Background and Overview
6. Primary Sclerosing Cholangitis Patient Journey
7. Primary Sclerosing Cholangitis Patient Population and Epidemiology Trends (In the US, EU5, and Japan)
8. Primary Sclerosing Cholangitis Treatment Algorithm, Current Treatment, and Medical Practices
9. Primary Sclerosing Cholangitis Unmet Needs
10. Key Endpoints of Primary Sclerosing Cholangitis Treatment
11. Primary Sclerosing Cholangitis Marketed Therapies
12. Primary Sclerosing Cholangitis Emerging Drugs and Latest Therapeutic Advances
13. Primary Sclerosing Cholangitis Seven Major Market Analysis
14. Attribute Analysis
15. Primary Sclerosing Cholangitis Market Outlook (In US, EU5, and Japan)
16. Primary Sclerosing Cholangitis Companies Active in the Market
17. Primary Sclerosing Cholangitis Access and Reimbursement Overview
18. KOL Views on the Primary Sclerosing Cholangitis Market
19. Primary Sclerosing Cholangitis Market Drivers
20. Primary Sclerosing Cholangitis Market Barriers
21. Appendix
22. DelveInsight Capabilities
23. Disclaimer
*The Table of Contents (TOC) is not exhaustive; the final content may vary. Refer to the sample report for the complete table of contents.
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About DelveInsight
DelveInsight is a leading Business Consultant and Market Research Firm focused exclusively on life sciences. It supports pharma companies by providing comprehensive end-to-end solutions to improve their performance.
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