Primary Sclerosing Cholangitis (PSC) Market Snapshot (2023 to 2033)

The global Primary Sclerosing Cholangitis (PSC) market size is expected to be valued at USD 151.07 Million in 2023. With the increasing alcohol consumption among people, the overall demand for Primary Sclerosing Cholangitis (PSC) is projected to grow at a CAGR of 7.6% between 2023 and 2033, totaling around USD 314.26 Million by 2033.

Data Points Key Statistics
Primary Sclerosing Cholangitis (PSC) Market Value 2023 USD 151.07 Million
Primary Sclerosing Cholangitis (PSC) Market Projected Value (2033) USD 314.26 Million
Primary Sclerosing Cholangitis (PSC) Market CAGR (2023 to 2033) 7.6%

According to the analysis of Future Market Insights, the Primary Sclerosing Cholangitis (PSC) market is expected to fuel over the analysis period, attributed to the factors such as the rise in the incidences of liver diseases, as well as the rise in alcohol consumption. As per the Centers for Disease Control and Prevention, the global incidence of liver disease was 3.9 million in 2016. As per the World Health Organization (WHO), the prevalence of liver cirrhosis is increasing in European countries, due to the high consumption of alcohol. Furthermore, rising awareness programs and an upsurge in Research and Development investment for the development of new drug molecules are other factors that are expected to augment the growth of the primary sclerosing cholangitis market during the forecast period.

The rising frequency of disorders linked to PSC, such as liver cancer and inflammatory bowel disease, is another factor that is anticipated to fuel the therapeutic acceptance of effective pharmaceuticals to treat the condition, which in turn is expected to accelerate the market growth. As per the World Journal of Gastroenterology, Inflammatory bowel disease (IBD) is detected in 50-80 percent of patients with PSC, with ulcerative colitis (UC) accounting for 80-90 percent of these instances.

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Primary Sclerosing Cholangitis (PSC) Demand Analysis (2018 to 2022) Vs Market Outlook (2023 to 2033)

The global demand for Primary Sclerosing Cholangitis (PSC) is projected to increase at a CAGR of 7.6% during the forecast period between 2023 and 2033, reaching a total of USD 314.26 Million in 2033, according to a report from Future Market Insights (FMI). From 2018 to 2022, 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 140.4 Million in 2022.

As per the report of NCBI, in 2018, 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.

Which Drivers underpin Primary Sclerosing Cholangitis (PSC) Industry Expansion?

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 2018 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), 2018, 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 2019, 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 2022, 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 2021, 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.

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Which Factors are limiting the Growth of Primary Sclerosing Cholangitis (PSC) Market?

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.

Region-wise Insights

Will North America Continue Dominance in the Global Primary Sclerosing Cholangitis (PSC) Market?

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 2023.

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 2019. 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 2016, 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.

How Will the Growth of the Primary Sclerosing Cholangitis (PSC) Market unfold in Asia Pacific?

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 2023.

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.

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Category-wise Insights

By Type, which Primary Sclerosing Cholangitis (PSC) Category will remain prominent?

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.

By Application, which Primary Sclerosing Cholangitis (PSC) Category dominates?

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 2022, 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.

The Start-up Ecosystem: How key Players are opening Frontiers for Future Growth?

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,

  • Founded in 2014, PBC is a provider of an application for monitoring primary biliary cholangitis (PBC). The company offers an app for tracking and monitoring all aspects of primary biliary cholangitis (PBC). Its features include tracking Liver markers to input alkaline phosphatase (ALP) and bilirubin levels.
  • Hepagene, a start-up established in 2016, is a developer of therapeutics for liver diseases and other life-threatening diseases. The products pipeline includes HPG1860 for the treatment of non-alcoholic steatohepatitis (NASH), primary biliary cholangitis (IND completed), primary sclerosing cholangitis (IND), HPG2746 for NASH, HPG2466 for Hepatitis B infection (HBV), and HPG4980 for Hepatocellular Carcinoma (HCC).
  • Started in 2015, Qing Bile Therapeutics is a developer of bile acid-based therapeutics to treat liver diseases. The company has identified and developed tetrahydroxylated bile acids (THBAs) to treat cholestatic and metabolic diseases. Moreover, the company identified the bile acid in Bsep -/- mice (a model of human progressive familial intrahepatic cholestasis type II (PFIC2)) having normal levels of liver indicators and normal hepatocyte morphology even in the diseased condition due to high levels of TBHA.

Who are the Leading Players in the Primary Sclerosing Cholangitis (PSC) Market? 

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:

  • In April 2022, Sirnaomics, a clinical-stage RNA therapeutics biopharmaceutical company, carried out a Phase I clinical trial analyzing the potential of STP707 to treat liver fibrosis in primary sclerosing cholangitis in the USA A systemic small interfering ribonucleic acid (siRNA) therapy STP707 comprises two siRNA oligonucleotides that act on TGF-β1 and COX-2 mRNA, respectively.
  • In February 2022, Siranomics received the safe-to-proceed approval letter from the US Food and Drug Administration (FDA) for the Company's investigational new drug (IND) application for STP707, it's lead siRNA (small interfering RNA) drug candidate in Primary Sclerosing Cholangitis. The Company anticipates initiating a Phase I study in the second quarter of 2022, to evaluate the safety, tolerability, and pharmacokinetics of STP707, administered intravenously in healthy volunteers.
  • In January 2022, Engitix built a Liver Disease Pipeline with €48M Series A round and a drug discovery partnership with the Milan-based Dompé Farmaceutici. The proceeds from Engitix’s Series A round will bankroll the development of the company’s tissue models for use in drug discovery. Moreover, the investment will fuel the preclinical development of Engitix’s drug pipeline, with a focus on treating liver diseases including primary sclerosing cholangitis and liver cancer. The first candidate is expected to reach phase I testing by 2025.

Report Scope

Report Attribute Details
Growth Rate CAGR of 7.6% from 2023 to 2033
Market Value in 2023 USD 151.07 Million
Market Value in 2033 USD 314.26 Million
Base Year for Estimation 2022
Historical Data 2018 to 2022
Forecast Period 2023 to 2033
Quantitative Units Revenue in USD Million and CAGR from 2023 to 2033
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.

Key Segments Covered in the Primary Sclerosing Cholangitis (PSC) Industry Analysis

Primary Sclerosing Cholangitis (PSC) Market by Drug:

  • BTT1023
  • GS-9674
  • NGM282
  • OCA
  • Cenicriviroc
  • LUM001
  • DUR928
  • norUDCA
  • HTD1801
  • IDN-7314
  • STP705

Primary Sclerosing Cholangitis (PSC) Market by Region:

  • North America
  • Europe
  • Asia Pacific
  • Latin America
  • Middle East & Africa

Frequently Asked Questions

What was the market value for Primary Sclerosing Cholangitis (PSC) in 2022?

As of 2022, the market for Primary Sclerosing Cholangitis (PSC) was valued at USD 140.4 Million, as per FMI.

At what value did the Primary Sclerosing Cholangitis (PSC) Market close in 2023?

By 2023-end, sales of Primary Sclerosing Cholangitis (PSC) closed at a value of USD 151.07 Million.

What was the last 4 years value CAGR for Primary Sclerosing Cholangitis (PSC)?

From 2018 to 2022, Primary Sclerosing Cholangitis (PSC) demand expanded at a CAGR of 2.8%

What is the projected forecast CAGR for the Primary Sclerosing Cholangitis (PSC) Industry from 2023 to 2033?

From 2023 to 2033, Primary Sclerosing Cholangitis (PSC) sales are expected to flourish at a CAGR of 7.6%

According to FMI, what is the anticipated market value for Primary Sclerosing Cholangitis (PSC) in 2033?

By 2033, the market value of Primary Sclerosing Cholangitis (PSC) is expected to reach USD 314.26 Million.

By Type, which category ranks first with regard to Primary Sclerosing Cholangitis (PSC)?

By Type, the Primary Sclerosing Cholangitis segment constitutes the bulk of market share of 45% in 2022.

By Application, which category ranks first with regard to Primary Sclerosing Cholangitis (PSC)?

By Application, the Hospitals segment dominates the market with a share of 62% in 2022.

Table of Content
	1. Executive Summary | Primary Sclerosing Cholangitis (PSC) Market
	2. Market Overview
	3. Market Background
	4. Global Market Analysis 2018 to 2022 and Forecast, 2023 to 2033
	5. Global Market Analysis 2018 to 2022 and Forecast 2023 to 2033, By Drug
		5.1. BTT1023
		5.2. GS-9674
		5.3. NGM282
		5.4. OCA
		5.5. Cenicriviroc
		5.6. LUM001
		5.7. DUR928
		5.8. norUDCA
		5.9. HTD1801
		5.10. IDN-7314
		5.11. STP705
	6. Global Market Analysis 2018 to 2022 and Forecast 2023 to 2033, By Region
		6.1. North America
		6.2. Latin America
		6.3. Europe
		6.4. Asia Pacific
		6.5. Middle East and Africa
	7. North America Market Analysis 2018 to 2022 and Forecast 2023 to 2033, By Country
	8. Latin America Market Analysis 2018 to 2022 and Forecast 2023 to 2033, By Country
	9. Europe Market Analysis 2018 to 2022 and Forecast 2023 to 2033, By Country
	10. Asia Pacific Market Analysis 2018 to 2022 and Forecast 2023 to 2033, By Country
	11. Middle East and Africa Market Analysis 2018 to 2022 and Forecast 2023 to 2033, By Country
	12. Key Countries Market Analysis
	13. Market Structure Analysis
	14. Competition Analysis
		14.1. Acorda Therapeutics, Inc.
		14.2. Gilead Sciences, Inc.
		14.3. NGM Biopharmaceuticals, Inc.
		14.4. Intercept Pharmaceuticals, Inc.
		14.5. Falk Pharma GmbH
		14.6. Allergan Plc.
		14.7. Takeda Pharmaceutical Company
		14.8. Durect Corporation
		14.9. Conatus Pharmaceuticals, Inc.
		14.10. Sirnaomics, Inc.
	15. Assumptions & Acronyms Used
	16. Research Methodology
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