In 2023, the Primary Sclerosing Cholangitis market size was highest in the US among the 7MM, accounting for approximately USD 80 million which is further expected to increase by 2034.
DelveInsight projects that in 2023, there were approximately 54,400 thousand diagnosed cases of Primary Sclerosing Cholangitis across the 7MM. This number is anticipated to rise by 2034.
Some of the major Primary Sclerosing Cholangitis drugs that are likely to hit the market during our forecast period 2024–2034 include PLN-74809/bexotegrast (Pliant Therapeutics, Inc.) and HTD1801 (HighTide Therapeutics).
In July 2024, Pliant Therapeutics, Inc. reported positive 24-week data from the 320 mg cohort of INTEGRIS-PSC, a multinational, randomized, double-blind, placebo-controlled Phase IIa Primary Sclerosing Cholangitis clinical trial of bexotegrast in patients with Primary Sclerosing Cholangitis and suspected moderate to severe liver fibrosis. The 320 mg treatment group achieved its primary endpoint of safety, demonstrating that bexotegrast was well tolerated up to 40 weeks of treatment. Incidences of pruritus and cholangitis were lower in the bexotegrast group compared to the placebo group, consistent with previous findings.
The emerging Primary Sclerosing Cholangitis drug HTD1801 is expected to launch in the US by 2027, in EU4 and the UK by 2028 and in Japan by 2029, which has the potential to reduce the disease burden of Primary Sclerosing Cholangitis treatment market in the forecasted years.

DelveInsight’s “Primary Sclerosing Cholangitis Market Insights, Epidemiology, and Market Forecast – 2034” report deliver an in-depth understanding of the Primary Sclerosing Cholangitis, historical and forecasted epidemiology as well as the Primary Sclerosing Cholangitis therapeutics market trends in the United States, EU4 and the UK (Germany, France, Italy, Spain) and the United Kingdom, and Japan.

The Primary Sclerosing Cholangitis market report provides current Primary Sclerosing Cholangitis treatment practices, emerging drugs, and market share of the individual Primary Sclerosing Cholangitis therapies, current and forecasted 7MM Primary Sclerosing Cholangitis market size from 2020 to 2034. The Report also covers current Primary Sclerosing Cholangitis therapeutics market, market drivers, market barriers, SWOT analysis, reimbursement and market access, and unmet medical needs to curate the best of the opportunities and assesses the underlying potential of the Primary Sclerosing Cholangitis market.

Study Period	2020 to 2034
Forecast Period	2024-2034
Geographies Covered	The US, EU4 (Germany, France, Italy, and Spain) and UK, Japan
Primary Sclerosing Cholangitis Market	Total Market Size Market Size by Therapies Market Size by Class
Primary Sclerosing Cholangitiss Market Size	USD XX Million by 2034
Primary Sclerosing Cholangitis Companies	Gilead Sciences, Phenex Pharmaceuticals, HighTide Therapeutics, Dr. Falk Pharma, Mirum Pharmaceuticals, Pliant Therapeutics, Inc, NGM Biopharmaceuticals, CymaBay Therapeutics, Chemomab Therapeutics, and others.
Primary Sclerosing Cholangitis Epidemiology Segmentation	Diagnosed Primary Sclerosing Cholangitis Prevalent Cases in the 7MM Gender-specific Diagnosed Primary Sclerosing Cholangitis Prevalent Cases in the 7MM Symptom-specific Diagnosed Primary Sclerosing Cholangitis Prevalent cases in the 7MM Comorbidity-specific Diagnosed Primary Sclerosing Cholangitis Prevalent cases in the 7MM

Primary Sclerosing Cholangitis Treatment Market

According to the American Liver Foundation, Primary Sclerosing Cholangitis 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.

Common initial primary sclerosing cholangitis symptoms are fatigue, abdominal discomfort, itching (pruritus), and obstructive jaundice. Additional primary sclerosing cholangitis symptoms include malaise, abdominal pain, nausea, dark urine, light-colored stools, unintended weight loss, and/or hepatomegaly and/or splenomegaly.

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).

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.

Primary Sclerosing Cholangitis Diagnosis

The Primary Sclerosing Cholangitis diagnosis includes evaluation of patient history, clinical features, liver function tests (ALP, γGT, ALT, bilirubin, albumin), blood tests, and the exclusion of differential diagnoses. Hepatobiliary system imaging techniques such as ultrasonography, ERCP, MRCP, MRC, and ultrasound are also employed. Sometimes, a liver biopsy is also required.

Further details related to diagnosis are provided in the report…

Primary Sclerosing Cholangitis Treatment

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 Primary Sclerosing Cholangitis 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.

It is estimated that the Primary Sclerosing Cholangitis treatment market will experience significant changes during the forecast period (2024–2034), owing to the launch of novel Primary Sclerosing Cholangitis therapies in Primary Sclerosing Cholangitis clinical trials to manage PSC. Many molecules are in the pipeline to treat PSC patients across the 7MM to cater to their needs.

Further details related to treatment are provided in the report…

Primary Sclerosing Cholangitis Epidemiology

As the Primary Sclerosing Cholangitis market is derived using a patient-based model, the Primary Sclerosing Cholangitis epidemiology chapter in the report provides historical as well as forecasted epidemiology segmented by, Diagnosed Prevalent Cases of Primary Sclerosing Cholangitis, Gender-specific Diagnosed Primary Sclerosing Cholangitis prevalence, Symptoms-specific Diagnosed Primary Sclerosing Cholangitis prevalence, and Comorbidity (IBD)-specific Diagnosed Prevalent Cases of Primary Sclerosing Cholangitis, in the 7MM covering, the United States, EU4 countries (Germany, France, Italy, and Spain), United Kingdom, and Japan from 2020 to 2034.

The highest diagnosed Primary Sclerosing Cholangitis prevalence were accounted by the US in 2023 (~31 thousand), which are expected to show a rise in the future.
Among the European countries, Germany had the highest diagnosed Primary Sclerosing Cholangitis prevalence with ~5 thousand cases, followed by the UK in 2023. On the other hand, Spain had the lowest prevalent population (~0.1 thousand cases).
Japan had ~3 thousand total diagnosed prevalent cases of Primary Sclerosing Cholangitis in 2023, accounting for approximately 5% in 7MM.
In 2023, in the US, the gender-specific diagnosed Primary Sclerosing Cholangitis prevalence were highest for male (~21 thousand) and female (~10 thousand).
In 2023, 62% of diagnosed Primary Sclerosing Cholangitis prevalence in Japan were asymptomatic, while 38% were symptomatic.
The major comorbidity associated with Primary Sclerosing Cholangitis is IBD. As per our estimates, in 2023, ~23 thousand cases belonged to IBD in the US, and is expected to increase during the forecast period.

Primary Sclerosing Cholangitis Drugs

The Primary Sclerosing Cholangitis drugs chapter segment of the Primary Sclerosing Cholangitis report encloses a detailed analysis of Primary Sclerosing Cholangitis off-label drug and late-stage (Phase-III and Phase-II) pipeline drug. It also helps to understand the Primary Sclerosing Cholangitis clinical trials 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 Emerging Drugs

HTD 1801: HighTide Biopharma

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. The drug has received ODD and FTD. In June 2021, HighTide Therapeutics Inc. announced the topline results of the study of HTD1801 in Primary Sclerosing Cholangitis were presented at the International Liver Congress 2021.

Further detail in the report…

PLN-74809 (bexotegrast): Pliant Therapeutics, Inc.

PLN-74809 is an oral, small molecule, a dual-selective inhibitor of αvβ6 and αvβ1 being developed to treat PSC. While present at very low levels in healthy tissues, these integrins are upregulated in the lungs of IPF patients and the bile ducts of PSC patients where they activate TGF-β, a key driver of the fibrotic process. Blocking these integrins is designed to stop TGF-β activation, potentially halting the growth of scar tissue. In July 2022, Pliant Therapeutics recieved received FTD from the US FDA for the Primary Sclerosing Cholangitis treatment market.

Further detail in the report…

Drug	MoA	RoA	Company	Phase
HTD 1801	Lipid modulators	Oral	HighTide Therapeutics, Inc.	II
XXX	XX	XXX	XXX	II

Note: Detailed emerging therapies assessment will be provided in the final report of Primary Sclerosing Cholangitis.

Primary Sclerosing Cholangitis Market Outlook

Primary Sclerosing Cholangitis treatment market is multimodality based and requires a specialist team with varying skills. The absence of definitive evidence implies that practice is based on expert opinion and local expertise. PSC can be unpredictable; therefore, periodic follow-up in specialist centers is often helpful for patients, as is involvement with support groups. Despite clinical trials of numerous pharmacotherapies over several decades, safe and effective medical therapy remains to be established. Liver transplantation is an option for selected patients with severe complications of PSC, and its outcomes are generally favorable. Treatment is directed toward the specific symptoms that are apparent in each individual and at slowing the progression of the disorder.

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.

Symptomatic management involves using antihistamines to reduce pruritic symptoms, which, if left untreated, can be detrimental to a patient’s quality of life, leading to depression and sleep deprivation. More severe pruritus is managed with bile acid sequestrants, such as cholestyramine.

Cholestyramine, a bile acid-binding resin, is the recommended first-line therapy for moderate-severe cholestatic pruritus in several countries, despite a limited evidence base. It is the only medication with an indication for the relief of pruritus associated with partial biliary obstruction in the US (approved December 1966) and for the relief of pruritus associated with partial biliary obstruction and primary biliary cirrhosis in Europe (approved July 1988).

Off-label options recommended for treating cholestatic pruritus include the antibiotic rifampicin, which targets the pregnane X receptor, opioid antagonists (naltrexone, naloxone), and the selective serotonin reuptake inhibitor (SSRI) sertraline.

Keeping in mind, the current strategies which are insufficient to manage the disease burden there is an urgent need for development of novel therapy. The market awaits the launch of the potential entities such as HTD1801, and others that would be a helpful in the reduction of affected population accomplishing a critical global public health need, if proved to be efficacious.

According to DelveInsight, the Primary Sclerosing Cholangitis market in 7MM is expected to change in the study period 2020–2034.

The United States accounted for the highest Primary Sclerosing Cholangitis market size is approximately 69% of the total Primary Sclerosing Cholangitis market size in 7MM in 2023, in comparison to the other major markets i.e., EU4 countries (Germany, France, Italy, and Spain), and the United Kingdom, and Japan.
Among the European countries, Germany had the highest Primary Sclerosing Cholangitis market size with nearly USD 8 million in 2023, while Spain had the lowest Primary Sclerosing Cholangitis market size of Primary Sclerosing Cholangitis with USD 0.2 million in 2023.
The Primary Sclerosing Cholangitis market size in Japan was estimated to be USD 4 million in 2023, which accounts for 4% of the total 7MM market.
With the expected launch of upcoming Primary Sclerosing Cholangitis therapies, such as HTD1801 the total Primary Sclerosing Cholangitis market size is expected to show change in the upcoming years.

Primary Sclerosing Cholangitis Drugs Uptake

This section focuses on the uptake rate of potential Primary Sclerosing Cholangitis drugs expected to launch in the market during 2020–2034. For example, HTD1801 in the US is expected to be launched by 2027 with a peak shared of 15%. HTD1801 is anticipated to take 7 years to peak with a medium uptake.

Further detailed analysis of emerging therapies drug uptake in the report…

Primary Sclerosing Cholangitis Pipeline Development Activities

The report provides insights into Primary Sclerosing Cholangitis clinical trials within Phase III, Phase II, and Phase I stage. It also analyzes key players involved in developing targeted therapeutics.

Pipeline Development Activities

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

KOL Views

To keep up with current market trends, we take KOLs and SMEs’ opinions working in the domain through primary research to fill the data gaps and validate the secondary research. Industry Experts were contacted for insights on Primary Sclerosing Cholangitis evolving treatment landscape, patient reliance on conventional therapies, patient therapy switching acceptability, and drug uptake along with challenges related to accessibility, including KOL from University of Miami, USA; David Geffen School of Medicine, USA, University Hospital Aachen, Germany; , CHU Saint-Antoine, France, Autonomous University of Madrid, Spain, Tohoku University Hospital, Sendai, Japan, and Others.

Delveinsight’s analysts connected with 50+ KOLs to gather insights; however, interviews were conducted with 15+ KOLs in the 7MM. Their opinion helps understand and validate current and emerging therapies, treatment patterns, or Primary Sclerosing Cholangitis market trends. This will support the clients in potential upcoming novel treatments by identifying the overall scenario of the market and the unmet needs.

Qualitative Analysis

We perform Qualitative and market Intelligence analysis using various approaches, such as SWOT and Conjoint Analysis. In the SWOT analysis, strengths, weaknesses, opportunities, and threats in terms of disease diagnosis, patient awareness, patient burden, competitive analysis, cost-effectiveness, and geographical accessibility of therapies are provided. These pointers are based on the Analyst’s discretion and assessment of the patient burden, cost analysis, and existing and evolving treatment landscape.

Conjoint Analysis analyzes multiple approved and emerging therapies based on relevant attributes such as safety, efficacy, frequency of administration, route of administration, and order of entry. Scoring is given based on these parameters to analyze the effectiveness of therapy.

Further, the therapies’ safety is evaluated wherein the acceptability, tolerability, and adverse events are majorly observed, and it sets a clear understanding of the side effects posed by the drug in the trials. In addition, the scoring is also based on the route of administration, order of entry and designation, probability of success, and the addressable patient pool for each therapy. According to these parameters, the final weightage score and the ranking of the emerging therapies are decided.

Market Access and Reimbursement

The high cost of therapies for the treatment is a major factor restraining the growth of the global drug market. Because of the high cost, the economic burden is increasing, leading the patient to escape from proper treatment.

The report further provides detailed insights on the country-wise accessibility and reimbursement scenarios, cost-effectiveness scenario of approved therapies, programs making accessibility easier and out-of-pocket costs more affordable, insights on patients insured under federal or state government prescription drug programs, etc.

Scope of the Primary Sclerosing Cholangitis Market Report

The report covers a segment of key events, an executive summary, descriptive overview of Primary Sclerosing Cholangitis, explaining its causes, signs and symptoms, and currently available therapies.
Comprehensive insight has been provided into the epidemiology segments and forecasts, the future growth potential of diagnosis rate, disease progression, and Primary Sclerosing Cholangitis treatment guidelines.
Additionally, an all-inclusive account of the current and emerging therapies and the elaborative profiles of late-stage and prominent therapies will impact the current treatment landscape.
A detailed review of the Primary Sclerosing Cholangitis market, historical and forecasted market size, market share by therapies, detailed assumptions, and rationale behind the approach is included in the report covering the 7MM drug outreach.
The report provides an edge while developing business strategies, by understanding trends, through SWOT analysis and expert insights/KOL views, patient journey, and treatment preferences that help shape and drive the 7MM Primary Sclerosing Cholangitis market.

Primary Sclerosing Cholangitis Report Insights

Primary Sclerosing Cholangitis Patient Population
Primary Sclerosing Cholangitis Therapeutic Approaches
Primary Sclerosing Cholangitis Pipeline Analysis
Primary Sclerosing Cholangitis Market Size and Trends
Existing and Future Market Opportunity

Primary Sclerosing Cholangitis Report Key Strengths

11 years Forecast
The 7MM Coverage
Primary Sclerosing Cholangitis Epidemiology Segmentation
Key Cross Competition
Conjoint Analysis
Primary Sclerosing Cholangitis Drugs Uptake
Key Primary Sclerosing Cholangitis Market Forecast Assumptions

Primary Sclerosing Cholangitis Report Assessment

Current Primary Sclerosing Cholangitis Treatment Practices
Primary Sclerosing Cholangitis Unmet Needs
Primary Sclerosing Cholangitis Pipeline Product Profiles
Primary Sclerosing Cholangitis Market Attractiveness
Qualitative Analysis (SWOT and Conjoint Analysis)
Primary Sclerosing Cholangitis Market Drivers
Primary Sclerosing Cholangitis Market Barriers

Key Questions Answered In The Primary Sclerosing Cholangitis Market Report:

Primary Sclerosing Cholangitis Market Insights

What was the Primary Sclerosing Cholangitis market share (%) distribution in 2020 and how it would look like in 2034?
What would be the Primary Sclerosing Cholangitis total market size as well as market size by therapies across the 7MM during the forecast period (2024–2034)?
What are the key findings pertaining to the market across the 7MM and which country will have the largest Primary Sclerosing Cholangitis market size during the forecast period (2024–2034)?
At what CAGR, the Primary Sclerosing Cholangitis market is expected to grow at the 7MM level during the forecast period (2024–2034)?
What would be the Primary Sclerosing Cholangitis market outlook across the 7MM during the forecast period (2024–2034)?
What would be the Primary Sclerosing Cholangitis market growth till 2034 and what will be the resultant market size in the year 2034?
How would the market drivers, barriers, and future opportunities affect the market dynamics and subsequent analysis of the associated trends?

Primary Sclerosing Cholangitis Epidemiology Insights

What is the disease risk, burden, and unmet needs of Primary Sclerosing Cholangitis?
What is the historical Primary Sclerosing Cholangitis patient population in the United States, EU4 (Germany, France, Italy, Spain) and the UK, and Japan?
What would be the forecasted patient population of Primary Sclerosing Cholangitis at the 7MM level?
What will be the growth opportunities across the 7MM with respect to the patient population pertaining to Primary Sclerosing Cholangitis?
Out of the above-mentioned countries, which country would have the highest prevalent population of Primary Sclerosing Cholangitis during the forecast period (2024–2034)?
At what CAGR the population is expected to grow across the 7MM during the forecast period (2024–2034)?

Current Primary Sclerosing Cholangitis Treatment Scenario, Marketed Drugs, and Emerging Therapies

What are the current options for the treatment of Primary Sclerosing Cholangitis along with the approved therapy?
What are the current treatment guidelines for the treatment of Primary Sclerosing Cholangitis in the US, EU4 and the UK, And Japan?
What are the Primary Sclerosing Cholangitis marketed Primary Sclerosing Cholangitis drugs and their Primary Sclerosing Cholangitis MOA, regulatory milestones, product development activities, advantages, disadvantages, safety, and efficacy, etc.?
How many Primary Sclerosing Cholangitis companies are developing Primary Sclerosing Cholangitis drugs for the treatment of Primary Sclerosing Cholangitis?
How many emerging therapies are in the mid-stage and late stages of development for the treatment of Primary Sclerosing Cholangitis?
What are the key collaborations (Industry–Industry, Industry-Academia), Mergers and acquisitions, licensing activities related to the Primary Sclerosing Cholangitis therapies?
What are the recent therapies, targets, Primary Sclerosing Cholangitis mechanisms of action and technologies developed to overcome the limitation of existing therapies?
What are the Primary Sclerosing Cholangitis clinical trials going on for Primary Sclerosing Cholangitis and their status?
What are the key designations that have been granted for the emerging therapies for Primary Sclerosing Cholangitis?
What are the 7MM historical and forecasted market of Primary Sclerosing Cholangitis?

Reasons to Buy our Primary Sclerosing Cholangitis Market Report:

The report will help in developing business strategies by understanding the latest trends and changing treatment dynamics driving the Primary Sclerosing Cholangitis Market.
Insights on patient burden/disease incidence, evolution in diagnosis, and factors contributing to the change in the epidemiology of the disease during the forecast years.
To understand the existing market opportunity in varying geographies and the growth potential over the coming years.
Distribution of historical and current patient share based on real-world prescription data along with reported sales of approved products in the US, EU4 (Germany, France, Italy, and Spain), 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.
Detailed analysis and potential of current and emerging therapies under the conjoint analysis section to provide visibility around leading emerging drugs.
Highlights of Access and Reimbursement policies of approved therapies, barriers to accessibility of off-label expensive therapies, and patient assistance programs.
To understand the perspective of Key Opinion Leaders around the accessibility, acceptability, and compliance-related challenges of existing treatment to overcome barriers in future.
Detailed insights on the unmet need of the existing market so that the upcoming players can strengthen their development and launch strategy.

Frequently Asked Questions

1. What is the forecast period covered in the report?

The Primary Sclerosing Cholangitis Epidemiology and Market Insight report for the 7MM covers the forecast period from 2024 to 2034, providing a projection of market dynamics and trends during this timeframe.

2. Who are the key players in the Primary Sclerosing Cholangitis market?

The Primary Sclerosing Cholangitis market quite sparse. The major layers are HighTide Biopharma, Pliant Therapeutics, Inc., and others which are currently developing drugs for the treatment of Primary Sclerosing Cholangitis.

3. How is the market size estimated in the forecast report?

The market size is estimated through data analysis, statistical modeling, and expert opinions. It may consider factors such as incident cases, treatment costs, revenue generated, and market trends.

4. What is the key driver of the Primary Sclerosing Cholangitis market?

The increase in diagnosed prevalent cases of Primary Sclerosing Cholangitis and the launch of emerging therapies are attributed to be the key drivers for increasing Primary Sclerosing Cholangitis market.

5. What is the expected impact of emerging therapies or advancements in Primary Sclerosing Cholangitis treatment on the market?

Introducing new therapies, advancements in diagnostic techniques, and innovations in treatment approaches can significantly impact the Primary Sclerosing Cholangitis treatment market. Market forecast reports may provide analysis and predictions regarding the potential impact of these developments.

6. Does the report provide insights into the competitive landscape of the market?

The market forecast report may include information on the competitive landscape, profiling key market players, their product offerings, partnerships, and strategies, and helping stakeholders understand the competitive analysisPrimary Sclerosing Cholangitis market.

Read our blog on "Novel Insights of Primary Sclerosing Cholangitis Treatment Market"

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