| REPORT ATTRIBUTE |
DETAILS |
| Historical Period |
2019-2022 |
| Base Year |
2023 |
| Forecast Period |
2024-2032 |
| Primary Sclerosing Cholangitis Market Size 2024 |
USD 171.2 million |
| Primary Sclerosing Cholangitis Market, CAGR |
7.5% |
| Primary Sclerosing Cholangitis Market Size 2032 |
USD 305.33 million |
Market Overview:
The Primary Sclerosing Cholangitis Market is projected to grow from USD 171.2 million in 2024 to an estimated USD 305.33 million by 2032, with a compound annual growth rate (CAGR) of 7.5% from 2024 to 2032.
Several key drivers are propelling the growth of the PSC market. First, there is an increasing prevalence of liver-related diseases globally, with PSC being one of the rare but serious conditions. The development of novel therapeutics and improved diagnostic technologies has enabled earlier detection and more targeted treatment options, which is boosting market growth. Additionally, advancements in biotechnology and the introduction of new treatment methods, including biologics and small molecule therapies, are expected to further fuel market expansion. The growing awareness among healthcare providers and patients regarding the severity of PSC and its potential progression to liver cirrhosis or cancer is also fostering early diagnosis and treatment, driving the demand for effective therapeutic solutions.
Lastly, increased R&D activities, alongside supportive regulatory frameworks, are fostering innovation in drug discovery for PSC.Regionally, North America dominates the PSC market, driven by the high prevalence of liver diseases, advanced healthcare infrastructure, and significant investment in research and development. The United States leads in terms of market share due to its robust healthcare system and numerous ongoing clinical trials for PSC treatments. Europe follows, with countries such as the UK and Germany focusing on research and improving patient access to innovative treatments. Asia-Pacific is expected to witness the fastest growth due to increasing healthcare expenditure, rising awareness of rare diseases, and improvements in diagnostic capabilities. Moreover, favorable government initiatives to support orphan drug development and treatment availability in regions such as Japan and China are likely to boost the market.
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Market Drivers:
Increasing Prevalence of Liver Diseases and PSC:
One of the primary drivers of the Primary Sclerosing Cholangitis (PSC) market is the rising prevalence of liver diseases globally. While PSC is a relatively rare condition, its incidence has increased over the years, particularly in regions with higher rates of inflammatory bowel diseases (IBD), such as ulcerative colitis and Crohn’s disease, which are commonly associated with PSC. For instance, in the United States, approximately 4.5 million adults have been diagnosed with liver disease. As awareness of liver diseases improves, more patients are being diagnosed with PSC at earlier stages, creating a larger patient pool requiring specialized treatments. The chronic and progressive nature of PSC, which can lead to liver cirrhosis and bile duct cancer, further underscores the demand for effective treatment options, driving the market’s growth.
Advancements in Diagnostic Technologies:
Another key factor contributing to the growth of the PSC market is the advancement in diagnostic technologies. Improved imaging techniques, such as magnetic resonance cholangiopancreatography (MRCP) and liver biopsy, have significantly enhanced the ability to diagnose PSC more accurately and earlier in the disease progression. Early diagnosis is critical because it allows for timely medical interventions, which can slow disease progression and improve patient outcomes. These diagnostic innovations, coupled with growing investments in research and development to identify biomarkers for PSC, are enabling clinicians to make more precise diagnoses. This, in turn, drives demand for specific therapeutics tailored to the individual patient’s disease stage, contributing to the overall expansion of the PSC market.
Expanding Therapeutic Pipeline and Drug Development:
The development of new therapeutic options is a major driver of the PSC market. Currently, there is no FDA-approved treatment specifically for PSC, and many patients rely on off-label use of drugs meant for other liver conditions. However, there is significant research underway aimed at discovering targeted therapies for PSC, including biologics, small molecule inhibitors, and antifibrotic agents. Clinical trials exploring various novel treatment approaches are creating optimism within the market. For instance, more than 25 companies are involved in product development for PSC, including Gilead Sciences, Pliant Therapeutics, and Mirum Pharmaceuticals. As more drugs progress through late-stage clinical trials, the approval of new, effective treatments for PSC could revolutionize the market. Pharmaceutical companies are heavily investing in R&D to tap into the potential of these novel treatments, which is expected to stimulate further market growth.
Rising Awareness and Supportive Regulatory Environment:
Increased awareness about PSC among healthcare professionals and patients is also driving market growth. Educational initiatives by medical associations, patient advocacy groups, and research institutions have contributed to a better understanding of PSC as a severe, chronic condition. As awareness grows, more patients seek diagnosis and treatment earlier, leading to higher demand for therapeutic options. Additionally, the regulatory environment in key regions such as North America and Europe has become increasingly supportive of orphan drug development, with incentives such as fast-track designations and market exclusivity for companies developing treatments for rare diseases like PSC. This regulatory support encourages pharmaceutical companies to invest in PSC drug development, further driving market growth.
Market Trends:
Rising Focus on Orphan Drug Development:
A prominent trend in the Primary Sclerosing Cholangitis (PSC) market is the increasing emphasis on orphan drug development. As PSC is classified as a rare disease, pharmaceutical companies are actively exploring the benefits of orphan drug status, which provides significant incentives such as tax credits, reduced regulatory fees, and extended market exclusivity. These incentives are driving investments in research and development aimed at finding targeted therapies for PSC, an area that has long been underserved. This focus on orphan drugs is creating new opportunities for companies to develop innovative treatments for PSC, with several promising candidates in the clinical trial pipeline. As more therapies receive orphan designation, the market is expected to see significant growth driven by the introduction of specialized treatments.
Advancements in Biomarker Research:
Another important trend in the PSC market is the growing focus on biomarker research. Researchers are increasingly looking for biomarkers that can help predict disease progression, aid in early diagnosis, and serve as targets for therapeutic intervention. Identifying reliable biomarkers for PSC has the potential to transform patient care by enabling more personalized treatment approaches. Several research efforts are underway to develop non-invasive biomarker tests that could replace or complement traditional diagnostic methods such as liver biopsies and imaging. The study titled “PR3-ANCA: A Promising Biomarker in Primary Sclerosing Cholangitis (PSC)” published in PLOS ONE confirms that PR3-ANCA was detected in 94 out of 244 PSC patients compared to 27 out of 254 controls1. As biomarker research advances, it is expected to drive both the diagnostic and therapeutic segments of the PSC market by allowing for earlier detection, better patient stratification, and the development of more targeted therapies.
Increasing Collaborations and Partnerships:
Strategic collaborations and partnerships between pharmaceutical companies, research institutions, and patient advocacy groups are becoming increasingly common in the PSC market. These collaborations are essential for pooling resources, expertise, and funding to accelerate the development of new treatments. In recent years, several large pharmaceutical companies have partnered with smaller biotech firms that specialize in rare liver diseases, allowing them to expand their pipeline of potential PSC treatments. For instance, PSC Partners Seeking a Cure has collaborated with various organizations to support the development of new treatments for PSC. Academic institutions and research organizations are also playing a key role in advancing understanding of PSC, conducting clinical trials, and identifying potential therapeutic targets. These partnerships not only enhance innovation in drug development but also streamline the clinical trial process, making it faster and more efficient. The study titled “PRIMIS: design of a pivotal, randomized, phase 3 study evaluating the safety and efficacy of the nonsteroidal farnesoid X receptor agonist cilofexor in noncirrhotic patients with primary sclerosing cholangitis” published in BMC Gastroenterology provides insights into such collaborations. For example, PSC Partners Seeking a Cure has funded over $6 million in research grants to date.
Growing Use of Precision Medicine:
The trend toward precision medicine is gaining momentum in the PSC market. With the increased understanding of the genetic and molecular factors underlying PSC, there is a growing push toward developing treatments that are tailored to individual patients based on their genetic profiles and disease characteristics. Precision medicine aims to provide more effective, personalized care by targeting specific pathways involved in disease progression. This approach has the potential to significantly improve treatment outcomes for PSC patients, who currently have limited therapeutic options. As precision medicine continues to evolve, it is likely to play a critical role in shaping the future of the PSC market by offering more tailored, effective therapies for patients.
Market Restraints and Challenges:
Lack of Approved Therapies:
One of the primary restraints in the Primary Sclerosing Cholangitis (PSC) market is the lack of approved therapies specifically designed for the condition. Currently, there is no FDA-approved treatment available for PSC, and patients often rely on off-label use of drugs that are primarily intended for other liver conditions. This lack of targeted treatment options not only limits the effectiveness of current interventions but also discourages some healthcare providers and patients from pursuing aggressive treatment approaches. The absence of approved therapies has created a significant gap in the market, stalling its growth potential and leaving a large unmet medical need.
High Cost of Drug Development:
The cost of developing treatments for rare diseases like PSC presents another key challenge for the market. Orphan drug development, while incentivized by regulatory bodies, still requires substantial financial resources, including extensive clinical trials and long-term research to ensure safety and efficacy. For smaller biotech companies in particular, these high development costs can be a barrier to bringing new treatments to market. The long lead time for clinical trials and regulatory approvals further compounds the issue, delaying potential treatments from reaching patients and limiting market expansion.
Limited Awareness and Diagnostic Challenges:
Despite growing awareness, PSC remains a rare disease, and many healthcare professionals are still not fully equipped to diagnose and manage the condition effectively. The complexity of PSC, combined with its association with other diseases like inflammatory bowel disease (IBD), can lead to delayed or misdiagnosis. This delay in diagnosis can result in patients not receiving timely treatment, thus worsening disease outcomes. The limited understanding of PSC among some healthcare providers and patients remains a challenge, hindering early intervention and the overall growth of the PSC market.
Market Segmentation Analysis:
By Drug Class, Ursodeoxycholic acid (UDCA) remains one of the most commonly prescribed drugs for PSC, although its efficacy in improving long-term outcomes is limited. Other drug classes, such as corticosteroids, azathioprine, mercaptopurine, and budesonide, are used to manage symptoms and associated conditions like inflammatory bowel disease. Obeticholic acid and monoclonal antibodies represent newer, promising treatments that are in various stages of clinical development, with a focus on targeting the underlying mechanisms of PSC. These innovative therapies are expected to drive significant market growth over the forecast period.
By Route of Administration, oral administration dominates the market due to the convenience and accessibility of oral medications such as UDCA and corticosteroids. However, parenteral administration, which includes intravenous delivery of newer biologic therapies, is expected to grow as targeted treatments become available.
By Distribution Channel, hospital pharmacies account for the largest share, given the complexity of PSC treatment and the need for specialist care. Retail pharmacies also play a key role, particularly for patients using long-term maintenance therapies like UDCA. Online pharmacies are gaining traction due to the increasing demand for convenience and accessibility, particularly for patients requiring chronic medication management.
Segmentation:
By Drug Class
- Ursodeoxycholic acid (UDCA)
- Corticosteroids
- Azathioprine
- Mercaptopurine
- Budesonide
- Obeticholic acid
- Monoclonal antibody
- Others
By Route of Administration:
By Distribution Channel:
- Hospital Pharmacies,
- Retail Pharmacies,
- Online Pharmacies
By Region
- North America
- Latin America
- Brazil
- Argentina
- Mexico
- Rest of Latin America
- Europe
- Germany
- UK
- Spain
- France
- Italy
- Russia
- Rest of Europe
- Asia Pacific
- China
- India
- Japan
- Australia
- South Korea
- ASEAN
- Rest of Asia Pacific
- Middle East
- GCC
- Israel
- Rest of Middle East
- Africa
- South Africa
- North Africa
- Central Africa
Regional Analysis:
North America
North America holds the largest market share in the Primary Sclerosing Cholangitis (PSC) market, accounting for approximately 40% of the global market. The region’s dominance can be attributed to its advanced healthcare infrastructure, high awareness of liver diseases, and strong emphasis on research and development activities. The United States, in particular, is a key player due to its well-established healthcare system, significant investment in PSC-related research, and the presence of several leading pharmaceutical companies conducting clinical trials for PSC treatments. The region also benefits from a supportive regulatory environment that encourages orphan drug development, offering incentives such as fast-track approvals and market exclusivity. Canada, although a smaller market compared to the U.S., has also seen increasing demand for improved diagnostics and treatments for PSC, contributing to the overall growth in North America.
Europe
Europe holds the second-largest share in the PSC market, representing approximately 30% of the global market. Countries such as the United Kingdom, Germany, and France are at the forefront of research and development in PSC, with several academic institutions and pharmaceutical companies actively involved in clinical trials and drug development. The European healthcare system, with its focus on patient access to innovative treatments, has supported the growth of the PSC market in the region. The European Medicines Agency (EMA) also provides incentives for orphan drug development, similar to the U.S. Food and Drug Administration (FDA), which encourages pharmaceutical companies to invest in rare disease treatments. In addition, growing awareness of PSC and related liver diseases among healthcare providers and patients has driven demand for better diagnostic tools and therapeutic options, supporting market growth across Europe.
Asia-Pacific
The Asia-Pacific region is expected to witness the fastest growth in the PSC market, with an increasing market share projected to reach approximately 20% by 2032. The region’s growth can be attributed to rising healthcare expenditures, improved diagnostic capabilities, and greater awareness of rare liver diseases. Countries like Japan, China, and South Korea are investing heavily in healthcare infrastructure and research, which has led to the development of advanced diagnostic technologies and treatments for liver diseases. Japan, in particular, has a strong focus on orphan drug development, supported by government initiatives aimed at improving access to treatments for rare diseases like PSC. The growing adoption of Western medical practices and the increasing prevalence of inflammatory bowel disease, which is closely linked to PSC, are also driving market expansion in this region.
Rest of the World
The Rest of the World, including regions such as Latin America, the Middle East, and Africa, holds a smaller share of the global PSC market, accounting for approximately 10%. These regions are experiencing slower growth due to limited healthcare infrastructure and lower awareness of PSC. However, increasing healthcare investments and improvements in diagnostic capabilities are expected to drive modest growth in these regions over the next decade. Countries like Brazil and Saudi Arabia are emerging as potential markets for PSC treatments, with governments focusing on improving access to healthcare and rare disease treatments.
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Key Player Analysis:
- Acorda Therapeutics
- Allergan Plc.
- Conatus Pharmaceuticals
- Cymabay Therapeutics
- Falk Pharma GmbH
- Durect Corporation
- Gilead Sciences
- Immunic AG
- Intercept Pharmaceuticals
- NGM Biopharmaceuticals
- Pliant Therapeutics
- Shenzhen High Tide Biopharmaceutical Ltd.
- Shire Plc.
- Sirnaomics
Competitive Analysis:
The Primary Sclerosing Cholangitis (PSC) market is characterized by increasing competition among pharmaceutical companies, driven by the high unmet need for effective treatments. Major players in the market include companies like Gilead Sciences, Dr. Falk Pharma, and Intercept Pharmaceuticals, which are actively involved in developing novel therapies for PSC. These companies are focusing on research and development, with several promising candidates in late-stage clinical trials. Additionally, smaller biotech firms are entering the market, leveraging advancements in biologics and precision medicine to develop targeted treatments. The competitive landscape is further shaped by the race for orphan drug designation, which provides companies with market exclusivity and regulatory incentives. Collaborations and partnerships between larger pharmaceutical companies and smaller biotech firms are common, allowing for pooled resources and accelerated drug development. As more therapies approach regulatory approval, competition is expected to intensify, particularly in North America and Europe.
Recent Developments:
- In June 2024, Pliant Therapeutics, a clinical-stage biopharmaceutical company focused on treatments for cholangiopathies, announced positive results from its Phase 2a clinical trial of bexotegrast (formerly PLN-74809) in treating Primary Sclerosing Cholangitis (PSC). The trial demonstrated that bexotegrast was well-tolerated and safe, with promising activity signals reflected in improvements in liver function markers for PSC patients.
- In April 2024, the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), part of the National Institutes of Health (NIH), increased its funding for research on cholangiopathies, including PSC. This enhanced support aims to advance understanding of PSC’s causes and accelerate the development of novel therapeutic approaches.
- In April 2022, Sirnaomics, a clinical-stage RNA therapeutics company, conducted a Phase I clinical trial in the U.S. to assess the potential of STP707 for treating liver fibrosis in PSC. STP707, a systemic small interfering RNA (siRNA) therapy, targets TGF-β1 and COX-2 mRNA to address liver fibrosis in PSC.
- In February 2022, Sirnaomics received approval from the U.S. Food and Drug Administration (FDA) for its Investigational New Drug (IND) application for STP707 in PSC. A Phase I trial to evaluate the safety, tolerability, and pharmacokinetics of STP707 was planned to begin in the second quarter of 2022.
- In January 2022, Engitix raised €48M in a Series A funding round to advance its liver disease pipeline, including drug discovery efforts in partnership with Dompé Farmaceutici. The investment will support the preclinical development of treatments for PSC and liver cancer, with the first candidate expected to enter Phase I trials by 2025.
Market Concentration & Characteristics:
The Primary Sclerosing Cholangitis (PSC) market is characterized by moderate market concentration, with a few key players dominating the landscape due to the rarity of the disease and the high barriers to entry for new competitors. Major pharmaceutical companies like Gilead Sciences, Pliant Therapeutics, and Sirnaomics are leading the development of novel therapies, leveraging their resources and expertise in rare liver diseases. These companies benefit from orphan drug incentives, including market exclusivity and regulatory support, which further consolidates their position in the market. The PSC market is also marked by high research and development intensity, as the current lack of approved therapies drives innovation. Clinical trials are the primary focus, with several promising drugs in the pipeline. Collaborations between larger pharmaceutical firms and biotech companies are common, fostering a competitive yet collaborative environment aimed at addressing the significant unmet medical needs in this market.
Report Coverage:
The research report offers an in-depth analysis based on By Drug Class, By Route of Administration and By Distribution Channel. It details leading market players, providing an overview of their business, product offerings, investments, revenue streams, and key applications. Additionally, the report includes insights into the competitive environment, SWOT analysis, current market trends, as well as the primary drivers and constraints. Furthermore, it discusses various factors that have driven market expansion in recent years. The report also explores market dynamics, regulatory scenarios, and technological advancements that are shaping the industry. It assesses the impact of external factors and global economic changes on market growth. Lastly, it provides strategic recommendations for new entrants and established companies to navigate the complexities of the market.
Future Outlook:
- The PSC market is expected to witness steady growth driven by ongoing research into novel therapies and increased understanding of the disease.
- New drug approvals, particularly those targeting specific pathways involved in PSC, will significantly enhance treatment options.
- Advancements in precision medicine and biomarker research are likely to lead to more personalized treatment approaches for PSC patients.
- The rising prevalence of liver-related diseases, especially in Western countries, will increase demand for PSC therapies.
- Regulatory incentives, including orphan drug designations, will encourage more pharmaceutical companies to invest in PSC drug development.
- Increased awareness among healthcare professionals and patients will contribute to earlier diagnosis and treatment of PSC, expanding the patient pool.
- Collaborative efforts between biotech companies, research institutions, and pharmaceutical firms will accelerate the development of novel treatments.
- The Asia-Pacific region is expected to experience the fastest growth due to rising healthcare investments and improving diagnostic capabilities.
- The high cost of clinical trials and R&D may pose challenges for smaller biotech firms, though partnerships can alleviate this.
- The market’s focus on addressing the unmet medical need for effective PSC therapies will remain a key driver of future growth
