Primary Biliary Cholangitis Market Expected to Gain Momentum Through 2034, According to DelveInsight

DelveInsight's "Primary Biliary Cholangitis Market Insights, Epidemiology, and Market Forecast-2034′′ report offers an in-depth understanding of the Primary Biliary Cholangitis, historical and forecasted epidemiology as well as the Primary Biliary Cholangitis market trends in the United States, EU4 (Germany, Spain, Italy, France) the United Kingdom and Japan.

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Some of the key facts of the Primary Biliary Cholangitis Market Report:
• The Primary Biliary Cholangitis market size was approximately USD 1,150 million in 2023 and is anticipated to grow with a significant CAGR during the study period (2020-2034).
• In September 2025, Intercept Pharmaceuticals has voluntarily withdrawn Ocaliva (obeticholic acid), an oral treatment for certain adults with primary biliary cholangitis (PBC), from the U.S. market following a request from the U.S. Food and Drug Administration (FDA). The FDA has also placed a clinical hold on all Intercept-sponsored Ocaliva trials currently underway in the U.S., the company reported. These actions follow emerging safety concerns, as the FDA noted late last year that Ocaliva posed a risk of serious liver injury in PBC patients, including those without pre-existing cirrhosis at the start of therapy.
• In May 2025, Dr. Falk Pharma's norucholic acid (NCA) demonstrated encouraging outcomes in a Phase III trial for primary sclerosing cholangitis (PSC). In the pivotal NUC-5 study (NCT03872921), NCA achieved statistically significant improvements over placebo in meeting the combined primary endpoints of partially normalizing alkaline phosphatase levels-a key liver enzyme linked to PSC-and slowing disease progression as shown in histology. The therapy also showed meaningful benefits across multiple secondary endpoints, while maintaining a safety and tolerability profile comparable to placebo.
• In May 2025, Galmed Pharmaceuticals Ltd. (NASDAQ: GLMD), a clinical-stage biopharmaceutical company specializing in cardiometabolic and gastrointestinal oncology diseases, reported encouraging preclinical data for Aramchol in models of primary sclerosing cholangitis (PSC). Fibroinflammatory cholangiopathies such as PSC and primary biliary cholangitis (PBC) are characterized by cholestatic injury, inflammation, and fibrosis-induced bile duct obstruction, driving disease progression. Aramchol, a stearoyl-CoA desaturase 1 (SCD-1) inhibitor, showed both preventive and therapeutic activity against biliary fibrosis in mouse PSC models. The therapy dose-dependently lowered fibrotic marker expression, including plasminogen activator inhibitor-1 and critical hepatic stellate cell activation genes (VEGFA and PDGFB) in TGFβ-stimulated human cholangiocyte (H69) and mouse biliary epithelial cells (MLEs). Moreover, Aramchol significantly blocked TGFβ-induced hepatic fibrosis pathways while promoting PPAR signaling activity.
• In March 2025, Chemomab Therapeutics, Ltd. (Nasdaq: CMMB), a clinical-stage biotechnology company developing innovative therapies for fibro-inflammatory diseases with high unmet need, recently announced positive results from the Open Label Extension (OLE) of its Phase 2 SPRING trial evaluating nebokitug in patients with primary sclerosing cholangitis (PSC). More than 90% of eligible participants from the SPRING trial chose to continue into the OLE. In this extension, patients who had previously received nebokitug during the 15-week double-blind phase were given an additional 33 weeks of treatment, totaling up to 48 weeks, while participants originally on placebo transitioned to receive 33 weeks of nebokitug therapy.
• In January 2025, COUR Pharmaceuticals, a clinical-stage biotech company focused on developing disease-modifying therapies for immune-mediated diseases, has received Orphan Drug Designation (ODD) from the FDA for CNP-104, a treatment for primary biliary cholangitis (PBC).
• In December 2024, Gilead Sciences, Inc. (Nasdaq: GILD) announced that the CHMP of the EMA has issued a positive opinion recommending seladelpar for treating primary biliary cholangitis (PBC). The therapy is intended for use with ursodeoxycholic acid (UDCA) in adults who show an inadequate response to UDCA alone or as a monotherapy for those unable to tolerate UDCA. A final European Commission decision is expected in Q1 2025.
• In November 2024, Gilead Sciences, Inc. (Nasdaq: GILD) released interim data from its ongoing Phase 3 ASSURE study, revealing that 81% (30 of 37) of primary biliary cholangitis (PBC) patients treated with Livdelzi® (seladelpar) achieved a composite biochemical response (CBR), indicating notable improvements in PBC progression markers. Additionally, 41% (15 of 37) of participants achieved normalization of alkaline phosphatase (ALP) levels, a crucial liver function biomarker.
• In September 2024, Ipsen received conditional approval from the European Commission for Iqirvo® (elafibranor) 80 mg tablets, a treatment for primary biliary cholangitis (PBC) in adults who either do not respond well to ursodeoxycholic acid (UDCA) or cannot tolerate it. Iqirvo is a first-in-class oral peroxisome proliferator-activated receptor (PPAR) agonist that targets PPARα and PPARδ, which are thought to play key roles in regulating bile acid, inflammation, and fibrosis.
• In August 2024, The FDA granted accelerated approval for Livdelzi® (seladelpar) for the treatment of primary biliary cholangitis (PBC). Livdelzi can be used alongside ursodeoxycholic acid (UDCA) in adults who do not respond adequately to UDCA, or as a monotherapy for those who are intolerant to UDCA. It is not recommended for patients with decompensated cirrhosis.
• According to our analysis, the US reported the highest number of diagnosed prevalent cases of PBC in 2023, and these cases are anticipated to grow at a strong CAGR during the forecast period (2024-2034).
• In 2023, Germany had the highest number of diagnosed prevalent cases of PBC among the EU4 countries (Germany, France, Italy, and Spain) and the United Kingdom, with approximately 34 thousand cases, and this number is expected to grow by 2034.
• The incidence of PBC increases with age, peaking between 40 and 70 years. In 2023, our estimates show around 14 thousand cases in individuals under 40, with numbers rising steadily as age increases. The largest group, with 87 thousand cases, was in the 40-70 age range, while 43 thousand cases were reported in those aged 70 and above in the US.
• Our analysis shows a higher prevalence of PBC in females than in males, with distribution rates of 82% for females and 18% for males in the US in 2023.
• Key Primary Biliary Cholangitis Companies: CymaBay Therapeutics, Inc., Zydus Therapeutics Inc., Gannex Pharma Co., Ltd., Nanjing Chia-tai Tianqing Pharma, Intercept Pharmaceuticals, Enanta Pharmaceuticals, COUR Pharmaceutical, Novartis, Merck Sharp & Dohme LLC, Mirum Pharmaceuticals, Inc., Genfit, CymaBay Therapeutics, Inc., Calliditas Therapeutics, HighTide Biopharma Pty Ltd, Albireo, Curome Biosciences, Tobira Therapeutics, Inc., Pliant Therapeutics, Inc., Biotie Therapies Corp., and others
• Key Primary Biliary Cholangitis Therapies: Seladelpar, Saroglitazar, ASC42, Obeticholic, Bezafibrate, EDP-305, CNP-104, LJN452, Emtricitabine (FTC)/Tenofovir Disoproxil (TDF), Volixibat, Elafibranor, MBX-8025, Setanaxib, HTD1801 (BUDCA), A3907, HK-660S, Cenicriviroc, PLN-74809, BTT1023, and others
• The Primary Biliary Cholangitis epidemiology based on gender analyzed that Primary Biliary Cholangitis (PBC) is seen more among females than in males
• The Primary Biliary Cholangitis market is expected to surge due to the disease's increasing prevalence and awareness during the forecast period. Furthermore, launching various multiple-stage Primary Biliary Cholangitis pipeline products will significantly revolutionize the Primary Biliary Cholangitis market dynamics.

Primary Biliary Cholangitis Overview
Primary Biliary Cholangitis (PBC), previously known as Primary Biliary Cirrhosis, is a chronic autoimmune liver disease that primarily affects the small bile ducts within the liver. Over time, these ducts become damaged and inflamed, leading to the buildup of bile (a digestive fluid) in the liver, which can subsequently cause liver damage and scarring (cirrhosis).

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Primary Biliary Cholangitis Epidemiology
The epidemiology section provides insights into the historical, current, and forecasted epidemiology trends in the seven major countries (7MM) from 2020 to 2034. It helps to recognize the causes of current and forecasted trends by exploring numerous studies and views of key opinion leaders. The epidemiology section also provides a detailed analysis of the diagnosed patient pool and future trends.

Primary Biliary Cholangitis Epidemiology Segmentation:
The Primary Biliary Cholangitis market report proffers epidemiological analysis for the study period 2020-2034 in the 7MM segmented into:
• Total Prevalence of Primary Biliary Cholangitis
• Prevalent Cases of Primary Biliary Cholangitis by severity
• Gender-specific Prevalence of Primary Biliary Cholangitis
• Diagnosed Cases of Episodic and Chronic Primary Biliary Cholangitis

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Primary Biliary Cholangitis Drugs Uptake and Pipeline Development Activities
The drugs uptake section focuses on the rate of uptake of the potential drugs recently launched in the Primary Biliary Cholangitis market or expected to get launched during the study period. The analysis covers Primary Biliary Cholangitis market uptake by drugs, patient uptake by therapies, and sales of each drug.
Moreover, the therapeutics assessment section helps understand the drugs with the most rapid uptake and the reasons behind the maximal use of the drugs. Additionally, it compares the drugs based on market share.
The report also covers the Primary Biliary Cholangitis Pipeline Development Activities. It provides valuable insights about different therapeutic candidates in various stages and the key companies involved in developing targeted therapeutics. It also analyzes recent developments such as collaborations, acquisitions, mergers, licensing patent details, and other information for emerging therapies.

Primary Biliary Cholangitis Therapies and Key Companies
• Seladelpar: CymaBay Therapeutics, Inc.
• Saroglitazar: Zydus Therapeutics Inc.
• ASC42: Gannex Pharma Co., Ltd.
• Obeticholic: Nanjing Chia-tai Tianqing Pharma
• Bezafibrate: Intercept Pharmaceuticals
• EDP-305: Enanta Pharmaceuticals
• CNP-104: COUR Pharmaceutical
• LJN452: Novartis
• Emtricitabine (FTC)/Tenofovir Disoproxil (TDF): Merck Sharp & Dohme LLC
• Volixibat: Mirum Pharmaceuticals, Inc.
• Elafibranor: Genfit
• MBX-8025: CymaBay Therapeutics, Inc.
• Setanaxib: Calliditas Therapeutics
• HTD1801 (BUDCA): HighTide Biopharma Pty Ltd
• A3907: Albireo
• HK-660S: Curome Biosciences
• Cenicriviroc: Tobira Therapeutics, Inc.
• Volixibat: Mirum Pharmaceuticals
• PLN-74809: Pliant Therapeutics, Inc.
• BTT1023: Biotie Therapies Corp.

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Primary Biliary Cholangitis Market Drivers
• The rise in prevalence of PBC with an increase in IBD cases, geriatric population, increase in elderly age group, and advancement in diagnostic technology such as ERCP and MBCP
• Research and development are increasing the demand for better diagnosis and treatment options for Primary Biliary Cholangitis

Primary Biliary Cholangitis Market Barriers
• As there is only one approved treatment for UDCAresistant Primary Biliary Cholangitis, the first drug approved in the pipeline will have a significant advantage over the others
• The development of potential biomarkers such as miRNA for the diagnosis of Primary Biliary Cholangitis may improve the screening of Primary Biliary Cholangitis patients

Scope of the Primary Biliary Cholangitis Market Report
• Study Period: 2020-2034
• Coverage: 7MM [The United States, EU5 (Germany, France, Italy, Spain, and the United Kingdom), and Japan]
• Key Primary Biliary Cholangitis Companies: CymaBay Therapeutics, Inc., Zydus Therapeutics Inc., Gannex Pharma Co., Ltd., Nanjing Chia-tai Tianqing Pharma, Intercept Pharmaceuticals, Enanta Pharmaceuticals, COUR Pharmaceutical, Novartis, Merck Sharp & Dohme LLC, Mirum Pharmaceuticals, Inc., Genfit, CymaBay Therapeutics, Inc., Calliditas Therapeutics, HighTide Biopharma Pty Ltd, Albireo, Curome Biosciences, Tobira Therapeutics, Inc., Pliant Therapeutics, Inc., Biotie Therapies Corp., and others
• Key Primary Biliary Cholangitis Therapies: Seladelpar, Saroglitazar, ASC42, Obeticholic, Bezafibrate, EDP-305, CNP-104, LJN452, Emtricitabine (FTC)/Tenofovir Disoproxil (TDF), Volixibat, Elafibranor, MBX-8025, Setanaxib, HTD1801 (BUDCA), A3907, HK-660S, Cenicriviroc, PLN-74809, BTT1023, and others
• Primary Biliary Cholangitis Therapeutic Assessment: Primary Biliary Cholangitis current marketed and Primary Biliary Cholangitis emerging therapies
• Primary Biliary Cholangitis Market Dynamics: Primary Biliary Cholangitis market drivers and Primary Biliary Cholangitis market barriers
• Competitive Intelligence Analysis: SWOT analysis, PESTLE analysis, Porter's five forces, BCG Matrix, Market entry strategies
• Primary Biliary Cholangitis Unmet Needs, KOL's views, Analyst's views, Primary Biliary Cholangitis Market Access and Reimbursement

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