Primary Sclerosing Cholangitis (PSC) - Market Insight, Epidemiology And Market Forecast - 2032

Primary Sclerosing Cholangitis (PSC) - Market Insight, Epidemiology And Market Forecast - 2032

DelveInsight’s ‘Primary Sclerosing Cholangitis (PSC) – Market Insights, Epidemiology, and Market Forecast – 2032’ report deliver an in-depth understanding of the Primary Sclerosing Cholangitis (PSC), historical and forecasted epidemiology as well as the market trends in the United States, the EU-5 (Germany, Spain, Italy, France, and United Kingdom), Nordic countries (Sweden, Finland, Denmark, and Norway), and Japan.

The Primary Sclerosing Cholangitis (PSC) market report provides current treatment practices, emerging drugs, and their market share of the individual therapies, current and forecasted Primary Sclerosing Cholangitis (PSC) symptoms market size from 2019 to 2032 segmented by the seven major markets + Nordic countries. The report also covers current Primary Sclerosing Cholangitis (PSC) symptoms, diagnostic and treatment practice guidelines/algorithms and unmet medical needs to curate the best opportunities. It assesses the underlying potential of the market.

Geography Covered

• The United States
• The EU-5 (Germany, France, Italy, Spain, and the United Kingdom)
• Nordic countries (Sweden, Finland, Denmark, and Norway)
• Japan

Study Period: 2019–2032

Primary Sclerosing Cholangitis (PSC) Disease Background and Treatment Algorithm

Primary Sclerosing Cholangitis (PSC) Overview

Primary sclerosing cholangitis (PSC) is a rare progressive disorder characterized by inflammation, thickening, and abnormal formation of fibrous tissue (fibrosis) within the passages that carry bile from the liver (bile ducts). Both the bile ducts within the liver (intrahepatic) and outside the liver (extrahepatic) are affected, resulting in the obstruction or interruption of bile flow from the liver (cholestasis).

Primary Sclerosing Cholangitis (PSC) Diagnosis and Treatment

This section covers the details of conventional and current medical therapies and diagnoses available in the Primary Sclerosing Cholangitis (PSC) market to treat the condition. It also provides the country-wise treatment guidelines and algorithms across the United States, the EU-5, Nordic countries, and Japan.

DelveInsight’s Primary Sclerosing Cholangitis (PSC) market report thoroughly understands Primary Sclerosing Cholangitis (PSC) symptoms by including disease definition, symptoms, causes, physiology, and diagnosis. It also provides Primary Sclerosing Cholangitis (PSC) treatment algorithms and treatment guidelines for Primary Sclerosing Cholangitis (PSC) symptoms in the US, the EU-5, Nordic countries, and Japan.

High-dose ursodeoxycholic acid is used to treat PSC patients with 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.

A few major unmet needs in the market include lack of effective therapies, lack of proven surveillance strategies, lack of tools for early detection of malignancies, impact on quality of life (QoL), and lack of surrogate endpoints in clinical trials, among others.

Primary Sclerosing Cholangitis (PSC) Epidemiology

The Primary Sclerosing Cholangitis (PSC) symptoms epidemiology division provides insights into the historical and current patient pool and the forecasted trend for every seven major countries + Nordic countries. It helps recognize the causes of current and forecasted trends by exploring numerous studies and views of KOL. This part of the DelveInsight report also provides the diagnosed patient pool and their trends and assumptions.

Key Findings

The total diagnosed prevalent cases of Primary Sclerosing Cholangitis (PSC) patients in the 7MM + Nordic countries are increasing during the study period, i.e., 2019–2032.

The disease epidemiology covered in the report provides historical as well as forecasted Primary Sclerosing Cholangitis (PSC) epidemiology segmented as the total diagnosed prevalent cases of Primary Sclerosing Cholangitis (PSC), gender-specific cases of Primary Sclerosing Cholangitis (PSC), comorbidity-specific cases of Primary Sclerosing Cholangitis (PSC), and symptom-specific cases of Primary Sclerosing Cholangitis (PSC). The report includes the diagnosed prevalent cases scenario of Primary Sclerosing Cholangitis (PSC) in the 7MM + Nordic countries covering the United States, the EU-5 countries (Germany, France, Italy, Spain, and the United Kingdom), Nordic countries (Sweden, Finland, Denmark, and Norway), and Japan from 2019 to 2032.

Country-wise Primary Sclerosing Cholangitis (PSC) Epidemiology

The epidemiology segment also provides the Primary Sclerosing Cholangitis (PSC) epidemiology data and findings across the United States, the EU-5 (Germany, France, Italy, Spain, and the United Kingdom), and Nordic countries (Sweden, Finland, Denmark, and Norway), and Japan.

The total number of diagnosed prevalent cases of Primary Sclerosing Cholangitis (PSC) associated in the 7MM countries + Nordic countries was approximately 59,000 in 2021.

Primary Sclerosing Cholangitis (PSC) Drug Chapters

The Primary Sclerosing Cholangitis (PSC) report’s drug chapter segment encloses the detailed analysis of Primary Sclerosing Cholangitis (PSC) early-stage (Phase I, II, and III) pipeline drugs. It also helps understand the Primary Sclerosing Cholangitis (PSC) 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.

Primary Sclerosing Cholangitis (PSC) Emerging Drugs

Cilofexor: Gilead Sciences/Phenex Pharmaceuticals

Cilofexor (GS-9674) is a potent, selective, orally active, nonsteroidal FXR agonist. It is an investigational agent to treat primary sclerosing cholangitis (PSC), a chronic cholestatic liver disease with limited treatment options for patients and significant unmet needs. Synthetic FXR agonists reduce potentially toxic levels of bile acids in the liver and enterohepatic circulation, display anti-inflammatory properties, reduce portal hypertension, and diminish gut permeability.

Currently, Cilofexor is undergoing evaluation in the Phase III PRIMIS study to evaluate the safety, tolerability, and efficacy of Cilofexor in non-cirrhotic subjects with PSC at multiple locations worldwide.

HTD 1801: HighTide Therapeutics

HTD1801 is a first-in-class new molecular entity and is an ionic salt of two active moieties, berberine and ursodeoxycholic acid. It is administered orally, acts as a lipid modulator, and significantly reduces liver fat.

It has completed a Phase II trial to treat PSC and is currently under Phase II trials for other chronic disorders.

Other Products detailed in the report…

Primary Sclerosing Cholangitis (PSC) Market Outlook

The report’s Primary Sclerosing Cholangitis (PSC) market outlook helps understand historic, current, and forecasted Primary Sclerosing Cholangitis (PSC) market trends by analyzing the impact of current therapies on the market, unmet needs, drivers and barriers, and demand for better technology.

This segment gives a thorough detail of the Primary Sclerosing Cholangitis (PSC) market trend of each marketed drug and early-stage pipeline therapy by evaluating their impact based on the annual cost of therapy, inclusion and exclusion criteria, 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 KOL. The calculated market data are presented with relevant tables and graphs to glance the market at first sight.

According to DelveInsight, Primary Sclerosing Cholangitis (PSC) market in the 7MM + Nordic countries is expected to grow steadily during the study period (2019–2032).

High-dose ursodeoxycholic acid is used to treat PSC patients due to 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. Patients have significant unmet needs due to limited therapeutic options and a lack of proven surveillance strategies.

The major market players in the Primary Sclerosing Cholangitis (PSC) therapeutic market are Dr. Falk Pharma, HighTide Biopharma, and Gilead Sciences, among others.

Key Findings

This section includes a glimpse of the Primary Sclerosing Cholangitis (PSC) market in the 7MM + Nordic countries. The primary Sclerosing Cholangitis (PSC) market size in the seven major markets + Nordic countries was approximately USD 900 million in 2021.

The United States Market Outlook

This section provides the total Primary Sclerosing Cholangitis (PSC) market size and market size by therapies in the United States.

The United States accounts for the largest market size of Primary Sclerosing Cholangitis (PSC) compared to the EU-5 (the United Kingdom, Germany, Italy, France, and Spain), Nordic countries (Sweden, Finland, Denmark, and Norway), and Japan.

The EU-5 Countries: Market Outlook

The total Primary Sclerosing Cholangitis (PSC) market size and market size by therapies in Germany, France, Italy, Spain, and the United Kingdom are provided in this section.

Nordic Countries: Market Outlook

The total Primary Sclerosing Cholangitis (PSC) market size and market size by therapies in Sweden, Finland, Denmark, and Norway are provided in this section.

Japan Market Outlook

The total Primary Sclerosing Cholangitis (PSC) market size and market size by therapies in Japan are also mentioned.

Primary Sclerosing Cholangitis (PSC) Drugs Uptake

This section focuses on the uptake of the potential drugs recently launched or expected to be launched in the market during 2019–2032. The analysis covers the Primary Sclerosing Cholangitis (PSC) market uptake by drugs, patient uptake by therapies, and sales of each drug.

This helps understand the drugs with the most rapid uptake, the reasons behind the maximal use of new drugs, and the comparison of the drugs based on market share and size, which will again be useful in investigating factors important in the market uptake and in making financial and regulatory decisions.

Primary Sclerosing Cholangitis (PSC) Pipeline Development Activities

The report provides insights into the therapeutic candidate in Phase I, II, and III stages. It also analyses Primary Sclerosing Cholangitis (PSC) key players in developing targeted therapeutics.

Major market players include Dr. Falk Pharma, HighTide Biopharma, and Gilead Sciences, among others.

Pipeline Development Activities

The report covers detailed information on collaborations, acquisitions, mergers, licensing, and patent details for Primary Sclerosing Cholangitis (PSC) emerging therapies.

In October 2018, Gilead Sciences announced that the US FDA had granted Orphan Drug Designation to Cilofexor to treat PSC.

Reimbursement Scenario in Primary Sclerosing Cholangitis (PSC)

Proactively approaching reimbursement can positively impact both during the early stages of product development and after product launch. The report considers reimbursement to identify economically attractive indications and market opportunities. When working with finite resources, the ability to select the markets with better market access can be a critical business and price strategy.

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 continues to be the only therapeutic option for patients with advanced disease.

Besides this, immunosuppressive-based therapies such as glucocorticoids, azathioprine, tacrolimus, and a few others are in use, especially in patients with additional autoimmune hepatitis (AIH) or IgG4-related sclerosing cholangitis (IgG4-SC).

Liver transplants in the UK are much more affordable than in the US. As the healthcare sector is highly regulated, most transplants are successful. Most patients spend at least 2 weeks in the hospital after the operation. Private health plans do not pay for transplants, but it costs the NHS up to 80,000 USD plus several thousand extras, depending on the stability of the recovery period.

KOL Views

To keep up with current market trends, we take KOLs and SMEs’ opinions working in the Primary Sclerosing Cholangitis (PSC) domain through primary research to fill the data gaps and validate our secondary research. Their opinion helps understand and validate current and emerging therapies treatment patterns or Primary Sclerosing Cholangitis (PSC) market trends. This will support the clients in potential novel treatments by identifying the overall scenario of the market and the unmet needs.

Competitive Intelligence Analysis

We perform a competitive and market intelligence analysis of the Primary Sclerosing Cholangitis (PSC) Market using various competitive intelligence tools: SWOT analysis, PESTLE analysis, Porter’s five forces, BCG Matrix, and 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 Primary Sclerosing Cholangitis (PSC), explaining its causes, signs and symptoms, physiology, and currently available therapies
• Comprehensive insight has been provided into the Primary Sclerosing Cholangitis (PSC) epidemiology and treatment in the 7MM + Nordic countries
• Additionally, an all-inclusive account of the current and emerging therapies for Primary Sclerosing Cholangitis (PSC) is provided, along with the assessment of new therapies which will impact the current treatment landscape
• A detailed review of the Primary Sclerosing Cholangitis (PSC) market, historical and forecasted, is included in the report, covering drug outreach in the 7MM + Nordic countries
• The report provides an edge while developing business strategies by understanding trends shaping and driving the global Primary Sclerosing Cholangitis (PSC) market

Report Highlights

• In the coming years, the Primary Sclerosing Cholangitis (PSC) market is set to change due to the rising awareness of the disease, the development of diagnostic techniques, and the favorable environment from regulators for innovative first-in-class curative drugs, which are likely to expand the market’s size and 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 Primary Sclerosing Cholangitis (PSC) 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 Primary Sclerosing Cholangitis (PSC). Launching emerging therapies will significantly impact the Primary Sclerosing Cholangitis (PSC) market
• Our in-depth analysis of the pipeline assets across different stages of development (Phase I, II, and III), other emerging trends, and comparative analysis of pipeline products with detailed clinical profiles, key cross-competition, and 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.

Primary Sclerosing Cholangitis (PSC) Report Insights

• Patient Population
• Therapeutic Approaches
• Primary Sclerosing Cholangitis (PSC) Pipeline Analysis
• Primary Sclerosing Cholangitis (PSC) Market Size and Trends
• Market Opportunities
• Impact of upcoming Therapies

Primary Sclerosing Cholangitis (PSC) Report Key Strengths

• 11-Year Forecast
• 7MM + Nordic Countries Coverage
• Primary Sclerosing Cholangitis (PSC) Epidemiology Segmentation
• Key Cross Competition
• Highly Analyzed Market
• Drugs Uptake

Primary Sclerosing Cholangitis (PSC) Report Assessment

• Current Treatment Practices
• Unmet Needs
• Pipeline Product Profiles
• Market Attractiveness

Key Questions

Market Insights:

• What was the Primary Sclerosing Cholangitis (PSC) market share percentage distribution in 2019, and how would it look by 2032?
• What would be the Primary Sclerosing Cholangitis (PSC) total market size and market size by therapies across the 7MM + Nordic countries during the forecast period (2019–2032)?
• What are the key findings of the market across the 7MM + Nordic countries, and which country will have the largest Primary Sclerosing Cholangitis (PSC) market size during the forecast period (2019–2032)?
• At what CAGR the Primary Sclerosing Cholangitis (PSC) market is expected to grow in the 7MM + Nordic countries during the forecast period (2019–2032)?
• What would be the Primary Sclerosing Cholangitis (PSC) market outlook across the 7MM + Nordic countries during the forecast period (2019–2032)?
• What would be the Primary Sclerosing Cholangitis (PSC) market growth till 2032, and what will be the resultant market size by 2032?

Epidemiology Insights:

• What are the disease risk, burden, and unmet needs of Primary Sclerosing Cholangitis (PSC)?
• What is the historical Primary Sclerosing Cholangitis (PSC) patient pool in the 7MM + Nordic countries covering the United States, the EU5 (Germany, Spain, France, Italy, the UK), Nordic countries (Sweden, Finland, Denmark, and Norway), and Japan?
• What would be the forecasted patient pool of Primary Sclerosing Cholangitis (PSC) in the 7MM + Nordic countries covering the United States, the EU5 (Germany, Spain, France, Italy, the UK), Nordic countries (Sweden, Finland, Denmark, and Norway), and Japan?
• What will be the growth opportunities in the 7MM + Nordic countries concerning the patient population for Primary Sclerosing Cholangitis (PSC)?
• Among the 7MM + Nordic countries, which country would have the largest diagnosed prevalent population of Primary Sclerosing Cholangitis (PSC) during the forecast period (2019–2032)?
• At what CAGR is the population expected to grow in the 7MM + Nordic countries during the forecast period (2019–2032)?

Current Treatment Scenario, Marketed Drugs, and Emerging Therapies:

• What are the current options for treating Primary Sclerosing Cholangitis (PSC) along with the approved therapy?
• What are the current treatment guidelines for treating Primary Sclerosing Cholangitis (PSC) in the US, the EU5, Nordic countries, and Japan?
• What are the Primary Sclerosing Cholangitis (PSC) marketed drugs and their MOA, regulatory milestones, product development activities, advantages, disadvantages, safety, efficacy, etc.?
• How many companies are developing therapies for treating Primary Sclerosing Cholangitis (PSC)?
• How many therapies are developed by each company to treat Primary Sclerosing Cholangitis (PSC)?
• How many emerging therapies are in the mid-stage and late stages of development to treat Primary Sclerosing Cholangitis (PSC)?
• What are the key collaborations (Industry–Industry, Industry–Academia), Mergers and acquisitions, and licensing activities related to Primary Sclerosing Cholangitis (PSC) therapies?
• What are the recent novel therapies, targets, mechanisms of action, and technologies developed to overcome the limitation of existing therapies?
• What are the clinical studies going on for Primary Sclerosing Cholangitis (PSC) and their status?
• What key designations have been granted for the emerging therapies for Primary Sclerosing Cholangitis (PSC)?
• What are the global historical and forecasted markets for Primary Sclerosing Cholangitis (PSC)?

Reasons to buy

• The report will help develop business strategies by understanding trends shaping and driving the Primary Sclerosing Cholangitis (PSC) market
• To understand the future market competition in the Primary Sclerosing Cholangitis (PSC) market and an Insightful review of the key market drivers and barriers
• Organize sales and marketing efforts by identifying the best opportunities for Primary Sclerosing Cholangitis (PSC) in the US, the EU5 (Germany, Spain, Italy, France, and the United Kingdom), and Nordic countries (Sweden, Finland, Denmark, and Norway), and Japan
• Identifying strong upcoming players in the market will help devise strategies that will help get ahead of competitors
• Organize sales and marketing efforts by identifying the best opportunities for the Primary Sclerosing Cholangitis (PSC) market
• To understand the future market competition in the Primary Sclerosing Cholangitis (PSC) market