Primary Biliary Cholangitis Market Size to Reach US$ 1,200 Million by 2034, Impelled by Advancements in Early Detection

Primary Biliary Cholangitis Market Outlook 2024-2034:

The primary biliary cholangitis market size reached a value of US$ 510 Million in 2023. Looking forward, the market is expected to reach US$ 1,200 Million by 2034, exhibiting a growth rate (CAGR) of 8.06% during 2024-2034. The market is driven by the escalating demand for endoscopic retrograde cholangiopancreatography-guided implantation of a biliary endoprosthesis, owing to its numerous benefits, including relief of bile duct obstruction and improved quality of life for patients.

Advances in Early Detection and Diagnostic Technologies: Driving the Primary Biliary Cholangitis Market 

Advances in early detection and diagnostic technologies are playing a crucial role in driving the growth of the primary biliary cholangitis (PBC) market. One of the key breakthroughs has been the development of more sensitive biomarkers and blood tests. For example, the use of anti-mitochondrial antibodies (AMA) in conjunction with liver function tests has greatly enhanced the ability to diagnose PBC with high specificity and sensitivity. Additionally, next-generation sequencing (NGS) and advanced proteomics have opened new avenues for identifying genetic and molecular signatures associated with the disease, enabling clinicians to diagnose PBC more accurately and at an earlier stage. These tests are less invasive, quicker, and more affordable compared to traditional diagnostic methods. Furthermore, imaging techniques such as elastography and magnetic resonance imaging (MRI) have also seen significant improvements. These non-invasive technologies allow for the assessment of liver stiffness and bile duct abnormalities, helping to monitor disease progression and predict complications like cirrhosis. Early detection of PBC is vital for timely interventions, as it can slow the progression of the disease and improve patient outcomes. The growing availability of these advanced diagnostic tools is expected to drive increased awareness and diagnosis of PBC, thereby expanding the market for PBC-related therapies, including novel disease-modifying drugs and liver transplant options. As diagnostic technologies continue to evolve, the future of PBC management looks promising, offering patients better outcomes and a higher quality of life.

Development of Novel Therapies and Pharmacological Treatments: Contributing to Market Expansion

The development of novel therapies and pharmacological treatments is significantly contributing to the expansion of the primary biliary cholangitis market, offering new hope for patients with this chronic autoimmune liver disease. Moreover, recent breakthroughs in pharmacological treatments are transforming the landscape for PBC management, improving patient outcomes and expanding market opportunities. The development of second-line therapies, such as obeticholic acid (OCA) and fibrates, has played a pivotal role in this transformation. Obeticholic acid, for example, has been shown to be effective in patients who do not respond adequately to ursodeoxycholic acid (UDCA), offering a more targeted approach by activating nuclear receptors involved in bile acid synthesis and liver fibrosis. This has opened up new therapeutic avenues for patients with advanced disease stages, enhancing their prognosis and quality of life. In addition, research into other molecular targets, such as inflammatory pathways, fibrosis progression, and bile duct repair, has led to the exploration of several promising drug candidates in clinical trials. Drugs that target autoimmune processes and regulate bile acid metabolism are increasingly being developed, providing more personalized treatment options based on disease severity and individual patient characteristics. Furthermore, monoclonal antibodies and immune modulators are showing potential in reducing the autoimmune response that drives bile duct destruction, addressing the root cause of PBC more effectively. As these novel therapies progress through clinical development and gain regulatory approval, they are poised to significantly expand the PBC treatment market. These innovations are not only improving the management of PBC but also driving market growth by creating a more competitive and diverse therapeutic landscape, offering patients better chances for disease management and long-term survival.

Marketed Therapies in Primary Biliary Cholangitis Market

 Urso (Ursodeoxycholic acid): Alfa Farmaceutici/sanofi-aventis 

Urso (Ursodeoxycholic acid) is a bile acid used for the treatment of primary biliary cirrhosis. Ursodeoxycholic acid protects hepatocytes and cholangiocytes from bile acid-induced damage, which includes reactive oxygen species (ROS)-induced inflammation and mitochondrial dysfunction. UDCA was found to preserve hepatocyte cell structures and activate anti-apoptotic pathways. It has also been demonstrated to inhibit the formation of ROS by Kupffer cells and resident macrophages in the liver, hence reducing oxidative stress.

Ocaliva (Obeticholic acid): Intercept Pharmaceuticals

Obeticholic acid is a bile acid analog and farnesoid X receptor (FXR) agonist used to treat primary biliary cholangitis in adults who do not respond well to UDCA or are intolerant of it. This medicine works by binding to the FXR protein, which is located in the nucleus of liver and intestinal cells. This increases liver bile flow, suppresses its production, and reduces hepatocyte exposure to excess bile with cholestasis.

Emerging Therapies in Primary Biliary Cholangitis Market

CNP-104: Cour Pharmaceutical 

CNP-104 is a biodegradable nanoparticle therapy that targets primary biliary cholangitis by reprogramming the immune system to tolerate healthy parts of the body. It encapsulates the E2 component of the mitochondrial pyruvate dehydrogenase complex (PDC), a key autoantigen in PBC. The immune cells absorb the nanoparticles, which are then released in the spleen and liver, where they expose immunological T-cells to PDC-E2. This helps the immune system to accept PDC-E2, which can minimize inflammation and prevent liver damage.

Seladelpar: CymaBay Therapeutics

Seladelpar, also known as Livdelzi, is a medication that treats primary biliary cholangitis by decreasing the production of bile acids in the liver. Seladelpar stimulates the peroxisome proliferator-activated receptor delta (PPARδ) receptor, which is present in several tissues, including the liver. This activation lowers the activity of cholesterol 7 alpha-hydroxylase-1 (CYP7A1), which turns cholesterol into bile acids. It is suggested that seladelpar's inhibitory action on bile acid production is independent of the FXR system, another biochemical route that regulates bile acid synthesis in the liver.

Elafibranor: Genfit

Elafibranor is a peroxisome proliferator-activated receptor agonist used to treat primary biliary cholangitis in individuals who cannot tolerate ursodeoxycholic acid or have an unsatisfactory response to it. It works by reducing bile acid production while boosting bile acid transport out of the liver, resulting in lower harmful levels of bile acids that accumulate in the liver. Elafibranor activates PPAR-α and PPAR-δ, leading to better fatty acid oxidation, insulin sensitivity, and decreased inflammation.

OP-724: Ohara Pharmaceutical

OP-724 is a synthetic small molecule that inhibits cyclic AMP response element-binding protein (CREB)-binding protein (CBP) and β-catenin. This interaction is a pivotal component of the Wnt/β-catenin signaling pathway, which plays a significant role in various cellular processes, including organ fibrosis. By selectively inhibiting the CBP/β-catenin interaction, OP-724 modulates this pathway, thereby exerting anti-inflammatory and antifibrotic effects. The medication is currently in Phase I of clinical trials for primary biliary cholangitis.

Golexanolone: Umecrine Cognition

Golexanolone, a medication produced by Umecrine Cognition, acts by regulating GABA-ergic transmission and inhibiting neurosteroidal activation of GABAA receptors. This can improve cognitive and motor skills and reduce fatigue in people with primary biliary cholangitis. Golexanolone reduces the negative effects of high allopregnanolone levels in the brain. Allopregnanolone is a strong activator of the GABAA receptor, and overactivation of this receptor can produce cognitive impairment, drowsiness, and, in severe cases, coma or death.

Detailed list of emerging therapies in Primary Biliary Cholangitis is provided in the final report.

Leading Companies in the Primary Biliary Cholangitis Market:

The market research report by IMARC encompasses a comprehensive analysis of the competitive landscape in the market. Across the global primary biliary cholangitis market, several leading companies are at the forefront of developing integrated platforms to enhance the management of primary biliary cholangitis. Some of the major players include Alfa Farmaceutici, sanofi-aventis, and Intercept Pharmaceuticals. These companies are driving innovation in the primary biliary cholangitis market through continuous research, diagnostic tools, and expanding their product offerings to meet the growing demand for the illness.

​In October 2024, Intercept Pharmaceuticals, Inc. announced that the U.S. FDA had informed the Company that it is continuing its review of the supplemental New Drug Application (sNDA) for full approval of OCALIVA (obeticholic acid, OCA) for the treatment of indicated patients with primary biliary cholangitis and that its action under the Prescription Drug User Fee Act (PDUFA), expected on October 15, 2024, had been delayed.

Key Players in Primary Biliary Cholangitis Market:

The key players in the Primary Biliary Cholangitis market who are in different phases of developing different therapies are Alfa Farmaceutici, sanofi-aventis, Intercept Pharmaceuticals, Cour Pharmaceutical, CymaBay Therapeutics, Genfit, Ohara Pharmaceutical, Umecrine Cognition, and Others.

Regional Analysis:

The major markets for primary biliary cholangitis include the United States, Germany, France, the United Kingdom, Italy, Spain, and Japan. According to projections by IMARC, the United States has the largest patient pool for primary biliary cholangitis while also representing the biggest market for its treatment. This can be attributed to the introduction of advanced therapies, such as obeticholic acid and fibrates, which address the needs of patients who are unresponsive to standard therapies like UDCA.

Moreover, advances in diagnostic technologies, such as non-invasive imaging and highly sensitive serological tests for anti-mitochondrial antibodies, have also played a crucial role in identifying PBC at earlier stages. This has expanded the pool of diagnosed patients who require therapeutic interventions, thereby driving market growth.

Besides this, regulatory support and financial incentives for orphan drug development in the U.S. also contribute to market expansion. These incentives encourage pharmaceutical companies to invest in developing treatments for rare diseases like PBC. Additionally, increasing healthcare spending and strong reimbursement frameworks in the U.S. provide an environment conducive to the adoption of advanced treatments, further fueling market growth​.

Recent Developments in Primary Biliary Cholangitis Market:

• In September 2024, COUR Pharmaceuticals published encouraging 120-day findings from its Phase 2a research, which evaluated CNP-104 as a potential treatment for individuals with primary biliary cholangitis. CNP-104 demonstrated potential efficacy across numerous immunological and clinical parameters, supporting its ongoing development as the first disease-modifying therapy for primary biliary cholangitis.
• In September 2024, GENFIT announced that the European Commission has conditionally approved Iqirvo (elafibranor) 80mg tablets for the treatment of primary biliary cholangitis in adults with an inadequate response to UDCA, or as a monotherapy in patients who cannot tolerate UDCA.
• In May 2024, Umecrine Cognition reported that the first two patients had been randomly assigned to the second part of the company's current clinical Phase 1b/2 golexanolone research. The Phase 2 trial aims to assess the early treatment efficacy signals of golexanolone on cognitive symptoms in primary biliary cholangitis, such as fatigue, daytime drowsiness, and cognitive function.

Key information covered in the report.

• Base Year: 2023
• Historical Period: 2018-2023
• Market Forecast: 2024-2034
   

Countries Covered

• United States
• Germany
• France
• United Kingdom
• Italy
• Spain
• Japan
   

 Analysis Covered Across Each Country

• Historical, current, and future epidemiology scenario
• Historical, current, and future performance of the primary biliary cholangitis market
• Historical, current, and future performance of various therapeutic categories in the market
• Sales of various drugs across the primary biliary cholangitis market
• Reimbursement scenario in the market
• In-market and pipeline drugs
   

Competitive Landscape:

This report offers a comprehensive analysis of current primary biliary cholangitis marketed drugs and late-stage pipeline drugs.

In-Market Drugs

• Drug Overview
• Mechanism of Action
• Regulatory Status
• Clinical Trial Results
• Drug Uptake and Market Performance
   

 Late-Stage Pipeline Drugs

• Drug Overview
• Mechanism of Action
• Regulatory Status
• Clinical Trial Results
• Drug Uptake and Market Performance
   

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