The Primary Sclerosing Cholangitis (PSC) Market is estimated to be valued at USD 174.9 million in 2025 and is projected to reach USD 363.9 million by 2035, registering a compound annual growth rate (CAGR) of 7.6% over the forecast period.
-market-market-value-analysis.webp "Primary Sclerosing Cholangitis (psc) Market Market Value Analysis")
| Metric | Value |
|---|---|
| Primary Sclerosing Cholangitis (PSC) Market Estimated Value in (2025 E) | USD 174.9 million |
| Primary Sclerosing Cholangitis (PSC) Market Forecast Value in (2035 F) | USD 363.9 million |
| Forecast CAGR (2025 to 2035) | 7.6% |
The primary sclerosing cholangitis market is witnessing a gradual yet significant transformation, influenced by increasing disease awareness, advances in diagnostic methods, and sustained research and development efforts. The unmet medical need in this rare cholestatic liver disease has driven pharmaceutical innovation and fostered collaborations between academia and industry to accelerate novel drug development.
Rising incidence rates and growing clinical trial activity have further contributed to the momentum. The future outlook remains positive, with pipeline therapies showing promising mechanisms of action and an emphasis on addressing both inflammatory and fibrotic components of the disease.
Strategic focus on orphan drug designations, patient-centric trial designs, and regulatory incentives are paving the path for faster approvals and wider adoption of effective therapies. These drivers collectively are expected to open avenues for improved clinical outcomes and market growth in the coming years.
The market is segmented by Drug and region. By Drug, the market is divided into BTT1023, GS-9674, NGM282, OCA, Cenicriviroc, LUM001, DUR928, norUDCA, HTD1801, IDN-7314, and STP705. Regionally, the market is classified into North America, Latin America, Western Europe, Eastern Europe, Balkan & Baltic Countries, Russia & Belarus, Central Asia, East Asia, South Asia & Pacific, and the Middle East & Africa.
-market-analysis-by-drug.webp "Primary Sclerosing Cholangitis (psc) Market Analysis By Drug")
When segmented by drug, BTT1023 is anticipated to capture 18∙5% of the total market revenue in 2025, establishing itself as a leading therapy in the primary sclerosing cholangitis market. This leadership has been attributed to its differentiated mechanism targeting vascular adhesion protein 1 which plays a pivotal role in the pathogenesis of the disease.
Its progression through late-stage clinical trials has been marked by favorable safety and efficacy profiles which have positioned it as a strong contender in addressing the significant unmet need. Additionally, the drug has benefited from orphan drug incentives and accelerated regulatory pathways which have enhanced its visibility and appeal among prescribers and stakeholders.
Investments in manufacturing scale-up and physician education initiatives have also strengthened its market readiness. The growing confidence among hepatologists and specialists regarding its potential to modify disease progression rather than merely manage symptoms has further reinforced its prominence within the therapeutic landscape.
The global demand for Primary Sclerosing Cholangitis (PSC) is projected to increase at a CAGR of 7.6% during the forecast period between 2025 and 2035, reaching a total of USD 363.9 Million in 2035, according to a report from Future Market Insights (FMI). From 2020 to 2025, sales witnessed significant growth, registering a CAGR of 2.8%.
According to Future Market Insights, a market research and competitive intelligence provider, the Primary Sclerosing Cholangitis (PSC) market was valued at USD 174.9 Million in 2025.
As per the report of NCBI, in 2020, there were approximately 0.2-1.2 million people having primary sclerosing cholangitis, in Northern European countries and North America, where the disease is most common, and almost more than half of these cases could have been avoided with the availability of proper medical treatment.
Thus, factors such as a rise in the number of cholangitis cases and an increase in product approvals by several regulatory authorities globally are projected to fuel the revenue share of the market in the forthcoming years. Hence, increasing prevalence, as well as incidence rates of liver failure, and bile cancer associated with cholangitis, is one of the major factors that are likely to escalate the demand for PSC over the forecast period.
Affordable Treatment Options to Fuel the Market Growth
Currently, a liver transplant is one of the major causes of liver transplantation in the USA and is the only known cure for primary sclerosing cholangitis. However, according to a February 2020 survey by Mayo Clinic, the disease is projected to recur in the transplanted liver in 27.2% of the patients, thereby demanding efficient as well as affordable therapeutic solutions to cater to unmet patient needs. As per the United Network for Organ Sharing (UNOS), 2020, the estimated bill charges for a liver transplant procedure are around USD 577,100 in the USA.
Additionally, there are major risk factors associated with liver transplantation that causes the death of the patient. For instance, in May 2020, as per the data published by the National Center for Biotechnology Information, pre-transplant malignancies were identified as those malignancies known prior to the transplant and those found only on pathologic evaluation of the explant. In addition, as per the data published by Mayo Clinic in March 2025, about 75% of people who undergo liver transplants live for at least five years. This means that for every 100 people who receive a liver transplant for any reason, about 75 will live for five years and 25 will die within five years.
Hence, the requirement of providing affordable treatment, due to increasing risk factors resulting in the development of serious disorders, and high costs associated with liver transplantation are major factors that are anticipated to fuel the adoption of primary sclerosing cholangitis drugs, which in turn are likely to boost the market growth over the analysis period.
Rise in Prevalence of Liver Failure & Bile Cancer to Accelerate the Market Growth
The rising incidence of diseases associated with primary sclerosing cholangitis, including liver cancer and inflammatory bowel disease, is expected to boost the therapeutic adoption of efficient drugs to manage the condition, thus accelerating the growth of the primary sclerosing cholangitis market.
For instance, in May 2024, as per an article published by Springer Nature Limited, a diagnosis of primary sclerosing cholangitis (PSC) has been associated with the increased risk of colorectal cancer, hepatobiliary cancers, and all-cause mortality in several studies, while associations with cardiovascular disease have been inconsistent. In addition, an incidence of 0.4-0.7 cases per 100,000 in the UK, and a prevalence of 3.9-16.2 per 100,000 of liver failure were reported.
Stringent Government Regulations to Restrain the Market Growth
The withdrawal of novel molecules from late-stage clinical trials, coupled with stringent regulations for the approval of the drugs are the major factors that are anticipated to hamper the market growth in the coming years. For instance, approval of Ursodeoxycholic acid (UDCA) by the US Food and Drug Administration (FDA) for the treatment of Primary Biliary Cholangitis (PBC) required overcoming several barriers to drug development, and these barriers continue to pose challenges for current as well as the future drug development.
As cholangitis is a rare disease, the recruitment of adequate numbers of PBC patients to power clinical trials requires many participating sites. Moreover, clinical outcomes, including liver transplantation and survival, occur at a low rate, particularly in patients with early-stage disease. Hence, the timeframe for a clinical trial to demonstrate clinical benefits is not practical, especially for therapies that may be most effective in early-stage disease. Thus, these challenges are projected to limit the market growth in the near future.
High Cost of Drug Development to Limit the Market Growth
The high cost associated with drug development is one of the major factors that is anticipated to restrain the growth of the primary sclerosing cholangitis market during the forecast period. In addition, the withdrawal of molecules from late clinical stages is another factor that will hinder market growth.
Factors such as development activities in this direction, as well as a lack of initiatives by the government to spread awareness and undertake research, will further impede market growth in the near future. Also, the lack of skilled professionals or trained expertise in this area in low-and-middle class economies will further hamper in the way of growth over the analysis period.
Increase in R&D Proficiencies in the Region to Fuel the Market Growth
The Primary Sclerosing Cholangitis (PSC) Market in North America is expected to accumulate the highest market share of 42% in 2025.
Factors such as higher healthcare spending as well as favorable reimbursement scenario are expected to fuel the regional market growth during the forecast period. In addition, a developed regulatory framework, and a rise in awareness about new treatment options are other factors driving the market growth in the region.
Other factors including the rise in the research and development proficiencies by the pharmaceutical companies, rapid adoption of new and better healthcare technologies, and prevalence of sophisticated healthcare infrastructure are also likely to stimulate the demand for primary sclerosing cholangitis drugs, which in turn will boost the revenue share of the market. Favorable reimbursement policies are also inducing the dominance of the region.
North America dominated the global primary sclerosing cholangitis market in terms of revenue share in 2020. The region is expected to continue its dominance over the forecast period. This can be attributed to a rise in awareness about PSC, the availability of effective treatment methods, and the presence of well-established healthcare facilities. In addition, the increasing prevalence of diabetes and hypertension is also anticipated to drive regional growth during the forecast period.
In 2020, there were an estimated 83,081 people living with liver and intrahepatic bile duct cancer in the USA. Thus, rising bile duct cancer is another factor that is boosting the market growth in the region. The region is expected to hold the highest CAGR of 7.5% during the forecast period.
Growing Medical Tourism Industry in the Region to Fuel the Market Growth
The Primary Sclerosing Cholangitis (PSC) Market in Asia Pacific is expected to accumulate the highest market share of 40% in 2025.
Enhanced healthcare infrastructure and reimbursement policies across emerging economies including India and China, coupled with increasing incidence rates associated with PSC are the major factors that are driving the market growth in Asia Pacific.
In addition, the surging medical tourism industry, due to its low-cost burden, and enhanced healthcare services are the other key factors that are projected to contribute to regional market demand over the analysis period. Additionally, the market is expected to be driven by factors such as rising incidences of liver diseases and disorders. The region is expected to hold the highest CAGR of 7.4% during the forecast period.
Primary Sclerosing Cholangitis Segment to beat Competition in Untiring Market
On the basis of type, the global Primary Sclerosing Cholangitis (PSC) market is dominated by the Primary Sclerosing Cholangitis Segment, which accounts for a share of 45%. The segment is expected to hold a CAGR of 7.5% over the analysis period.
The segment’s growth is attributed to the factors such as the growing research & development activities for the treatment. Primary sclerosing cholangitis is a progressive, rare, and chronic cholestatic liver disorder that is characterized by thickening, inflammation, and fibrosis of the bile ducts. Both intra- and extra-hepatic bile ducts are affected. This generally leads to cholestasis, liver cirrhosis, and eventually liver failure.
Hospitals Segment to Drive the Primary Sclerosing Cholangitis (PSC) Market
Based on the Application, the hospital's segment is expected to witness a significant growth of 62% in 2025, and the trend is expected to continue during the forecast period, expanding at a rapid rate of 7.4% CAGR over the analysis period.
This growth is attributed to rising incidence rates of MPSC among hospitalized patients across the globe. Hospital-based clinics have been found most effective in diagnosing and treating primary sclerosing cholangitis due to their access to advanced healthcare facilities, along with experienced medical professionals, which has led them to be considered one of the best treatment centers for this disease.
Primary Sclerosing Cholangitis (PSC) Market start-up players are adopting various marketing strategies such as new product launches, geographical expansion, mergers and acquisitions, partnerships, and collaboration to identify the interest of potential patients and create a larger customer base. For instance,
Prominent players in the Primary Sclerosing Cholangitis (PSC) market are Acorda Therapeutics, Inc., Gilead Sciences, Inc., NGM Biopharmaceuticals, Inc., Intercept Pharmaceuticals, Inc., Dr. Falk Pharma GmbH, Allergan Plc., Shire Plc., Durect Corporation, Conatus Pharmaceuticals, Inc., Sirnaomics, Inc., and Shenzhen HighTide Biopharmaceutical Ltd., among others.
Recent Developments:
| Report Attribute | Details |
|---|---|
| Growth Rate | CAGR of 7.6% from 2025 to 2035 |
| Market Value in 2025 | USD 174.9 million |
| Market Value in 2035 | USD 363.9 million |
| Base Year for Estimation | 2025 |
| Historical Data | 2020 to 2025 |
| Forecast Period | 2025 to 2035 |
| Quantitative Units | Revenue in USD Million and CAGR from 2025 to 2035 |
| Report Coverage | Revenue Forecast, Company Ranking, Competitive Landscape, Growth Factors, Trends, and Pricing Analysis |
| Segments Covered | Drug, Region |
| Regions Covered | North America; Europe; Asia Pacific; Latin America; Middle East & Africa |
| Key Countries Profiled | USA, Canada, Brazil, Mexico, Germany, UK, France, Spain, Italy, China, Japan, South Korea, Malaysia, Singapore, Australia, New Zealand, GCC Countries, South Africa, Israel |
| Key Companies Profiled | Acorda Therapeutics, Inc.; Gilead Sciences, Inc.; NGM Biopharmaceuticals, Inc.; Intercept Pharmaceuticals, Inc.; Dr. Falk Pharma GmbH; Allergan Plc.; Shire Plc.; Durect Corporation; Conatus Pharmaceuticals, Inc.; Sirnaomics, Inc.; Shenzhen HighTide Biopharmaceutical Ltd. |
The global primary sclerosing cholangitis (PSC) market is estimated to be valued at USD 174.9 million in 2025.
The market size for the primary sclerosing cholangitis (PSC) market is projected to reach USD 363.9 million by 2035.
The primary sclerosing cholangitis (PSC) market is expected to grow at a 7.6% CAGR between 2025 and 2035.
The key product types in primary sclerosing cholangitis (PSC) market are btt1023, gs-9674, ngm282, oca, cenicriviroc, lum001, dur928, norudca, htd1801, idn-7314 and stp705.
In terms of , segment to command 0.0% share in the primary sclerosing cholangitis (PSC) market in 2025.
Primary Sclerosing Cholangitis (PSC) Market
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