(Albany, US) On November 06, 2026, DelveInsight’s “Pemphigus Vulgaris Market Insights, Epidemiology and Market Forecast – 2036” report provides comprehensive insights into the Pemphigus Vulgaris (PV) market and pipeline landscape across the 7MM. It covers marketed and emerging drug profiles, including clinical and nonclinical stage products. It also covers the therapeutics assessment by product type, stage, route of administration, and molecule type, and examines the market drivers and barriers shaping the space.
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Key Takeaways from the Pemphigus Vulgaris Report
In April 2026, Cabaletta Bio announced multiple upcoming presentations, including manufacturing, translational, and clinical data on rese-cel, at the American Society of Gene & Cell Therapy (ASGCT) 2026 Annual Meeting.
In January 2026, Ono Pharmaceutical announced INDa clearance for rese-cel to be manufactured using an automated manufacturing platform, the Cell Shuttle from Cellares, offering the potential to scale production to thousands of patients per year with minimal capital investment.
Tirabrutinib (ONO-4059/VELEXBRU), an oral BTK inhibitor from Ono Pharmaceutical, is in Phase III development in Japan for steroid-resistant pemphigus.
Resecabtagene autoleucel (rese-cel/CABA-201), a CD19-directed CAR-T therapy from Cabaletta Bio, is being evaluated in the Phase I/II RESET-PV trial. Longer-term data from the evaluation of rese-cel without preconditioning is expected in the second half of 2026.
Pemphigus vulgaris occurs at a rate of 0.1 to 2.7 per 100,000 people per year, and is estimated at about 10–20 cases per million population in the US. It is most commonly diagnosed between ages 40 and 60.
DelveInsight’s report depicts a space where rituximab remains the cornerstone targeted therapy, corticosteroids and off-label immunosuppressants are widely used, and BTK inhibitors and CAR-T cell therapies are expanding options.
Leading Pemphigus Vulgaris companies include Ono Pharmaceutical, Cabaletta Bio, Artiva Biotherapeutics, and others.
Promising therapies include Tirabrutinib Hydrochloride (ONO-4059/VELEXBRU), Resecabtagene Autoleucel (rese-cel/CABA-201), AB-101 (AlloNK), and others.
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Pemphigus Vulgaris Overview
Pemphigus vulgaris is a rare, chronic, life-threatening autoimmune blistering disease characterized by pathogenic autoantibodies against desmoglein-3 (DSG3) and, in many cases, desmoglein-1 (DSG1). These autoantibodies disrupt cell-to-cell adhesion between keratinocytes, resulting in fragile blisters and painful erosions of the mucous membranes and skin. PV most commonly presents with persistent oral ulcers followed by cutaneous blistering and, if left untreated, can lead to severe infections, fluid loss, and significant morbidity. Genetic susceptibility and environmental triggers are believed to contribute to disease development. Diagnosis combines clinical presentation, histopathology, immunopathology, and serological testing, with direct immunofluorescence considered the diagnostic gold standard. Treatment relies on systemic corticosteroids, rituximab, off-label immunosuppressants such as azathioprine, mycophenolate mofetil, methotrexate, and cyclophosphamide, and, in severe cases, IVIG and plasmapheresis/immunoadsorption.
Common features include:
Persistent oral ulcers, often the first sign
Fragile skin blisters and painful erosions
Involvement of mucous membranes and skin
Chronic disease course with frequent relapses
Risk of severe infections and fluid loss if untreated
Need for long-term follow-up and monitoring
Pemphigus Vulgaris Emerging Drugs Profile
Tirabrutinib Hydrochloride (ONO-4059/VELEXBRU): Ono Pharmaceutical Tirabrutinib hydrochloride is an oral, highly selective Bruton’s tyrosine kinase (BTK) inhibitor being developed for steroid-resistant pemphigus. By suppressing B-cell activation and autoantibody production against desmogleins, it aims to provide an effective oral steroid-sparing option. Currently, the drug is in Phase III (NCT06696716) in Japan.
Resecabtagene Autoleucel (rese-cel/CABA-201): Cabaletta Bio Rese-cel is a fully human CD19-CAR T construct with a 4-1BB co-stimulatory domain, designed to deplete CD19-positive B cells and reset the aberrant immune response in a broad range of autoimmune diseases. The FDA has granted Orphan Drug Designation for DSG3-CAART for the treatment of pemphigus vulgaris. Currently, the drug is in Phase I/II (RESET-PV).
AB-101 (AlloNK): Artiva Biotherapeutics AB-101 is an intravenously administered cell therapy that works through immunologic cytotoxicity. Currently, the drug is in Phase I.
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Pemphigus Vulgaris Market Drivers
Growing adoption of rituximab biosimilars: Greater affordability improves access to B-cell-depleting therapy and is expected to expand biologic use, particularly in cost-sensitive healthcare systems.
Favorable rare disease development environment: Orphan drug incentives, regulatory support, and rising investment in autoimmune disease research encourage innovation.
Unmet need for steroid-sparing therapies: Long-term corticosteroid toxicity and variable outcomes with off-label immunosuppressants drive demand for safer, targeted therapies.
Targeted therapy advances: BTK inhibitors and CAR-T cell therapies aim to deliver more durable, disease-modifying options.
Demand for durable remission: Frequent relapses keep the focus on therapies with sustained efficacy.
Pemphigus Vulgaris Market Barriers
Rarity of the disease: A small patient population limits clinical trial recruitment and commercial opportunities.
Limited pipeline: Only a few late-stage or innovative candidates are in development, sparse compared with other autoimmune disorders.
Entrenched standard of care: Generic corticosteroids, off-label immunosuppressants, and rituximab biosimilars set a high bar for new entrants.
Early-stage candidates: Emerging therapies are expected to have limited near-term market impact, with adoption dependent on efficacy, safety, and durability of response.
Delayed diagnosis and misdiagnosis: Late recognition of the disease can hinder timely treatment.
Reimbursement pressure: Payers weigh the price of high-cost therapies against the benefit produced in treated patients.
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Scope of the Pemphigus Vulgaris Report
Coverage: 7MM (US, EU4, UK, Japan)
Companies: Ono Pharmaceutical, Cabaletta Bio, Artiva Biotherapeutics, and others
Therapies: Tirabrutinib Hydrochloride (ONO-4059/VELEXBRU), Resecabtagene Autoleucel (rese-cel/CABA-201), AB-101 (AlloNK), and others
Study Period: 2022–2036 (Forecast: 2026–2036)
Analysis: Epidemiology segmentation, market size by therapy, drug uptake, peak patient share, price analogues, country-specific treatment guidelines, KOL views, SWOT, conjoint analysis, market access and reimbursement, unmet needs
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Table of Contents
Introduction
Executive Summary
Pemphigus Vulgaris: Overview
Pipeline Therapeutics
Therapeutic Assessment
DelveInsight’s Analytical Perspective
Late Stage Products (Phase III): Tirabrutinib Hydrochloride (Ono Pharmaceutical)
Mid Stage Products (Phase I/II): Resecabtagene Autoleucel (Cabaletta Bio)
Early Stage Products (Phase I): AB-101 (Artiva Biotherapeutics)
Preclinical and Discovery Stage Products
Inactive Products
Key Companies
Key Products
Unmet Needs
Market Drivers and Barriers
Future Perspectives and Conclusion
Analyst Views
Appendix
About Us
About DelveInsight
DelveInsight is a leading healthcare-focused market research and consulting firm that provides clients with high-quality market intelligence and analysis to support informed business decisions. With a team of experienced industry experts and a deep understanding of the life sciences and healthcare sectors, we offer customized research solutions and insights to clients across the globe.
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