North America Pemphigus Vulgaris Market Size, Share, and Trends Analysis Report – Industry Overview and Forecast to 2032

North America Pemphigus Vulgaris Market Segmentation, By Diagnosis and Treatment (Diagnosis and  Treatment), Population Type (Pediatric, Adults, and Geriatric), End User (Hospitals, Specialty Clinics, Research Institutes, and Others), Distribution Channel (Hospitals Pharmacy, Retail Pharmacy, and Online Pharmacy) - Industry Trends and Forecast to 2032

Pemphigus Vulgaris Market Size

• The North America pemphigus vulgaris market size was valued at USD  192.28  million in 2024 and is expected to reach USD  376.35  million by 2032, at a CAGR of 8.9% during the forecast period
• The market growth is largely fueled by rising prevalence of pemphigus vulgaris, increasing awareness about autoimmune skin diseases, advancements in diagnostic techniques, and growing investments in research and development for effective treatment options.
• Furthermore, the market is expected to witness continued expansion due to improved healthcare infrastructure, increasing patient access to advanced therapies, supportive government initiatives, and a growing focus on biologics and targeted treatments for managing pemphigus vulgaris more effectively.

Pemphigus Vulgaris Market Analysis

• The market is driven by the rising incidence of pemphigus vulgaris, growing awareness of autoimmune diseases, and advancements in biologic therapies, leading to increased demand for effective treatment options and improved patient outcomes North Americaly.
• Key factors influencing market growth include expanding healthcare infrastructure, rising healthcare expenditure, government support for rare disease research, and ongoing clinical trials focused on novel therapeutics targeting pemphigus vulgaris management.
• U.S. dominates the Pemphigus Vulgaris market with a 82.78% revenue share in 2025, supported by advanced healthcare infrastructure, high patient awareness, robust research and development activities, widespread availability of biologic therapies, and strong government initiatives promoting rare disease treatment.
• U.S.  is expected to be the fastest-growing  in the Pemphigus Vulgaris market during the forecast period, fueled by increasing healthcare investments, growing patient population, rising awareness, improved diagnostic facilities, and expanding access to advanced treatments across emerging economies.
• The treatment segment is expected to dominate the Pemphigus Vulgaris market with a 63.22% share in 2025, driven by increasing demand for biologic therapies, rising prevalence of autoimmune diseases, advancements in treatment options, and growing patient preference for effective, targeted therapies.

Report Scope and Pemphigus Vulgaris Market Segmentation

Pemphigus Vulgaris Market Trends

“RISING PREVALENCE OF AUTOIMMUNE DISORDERS”

• The increasing incidence of autoimmune disorders is expanding the patient base, driving higher demand for diagnostics, therapies, and healthcare services, thereby significantly fueling market growth North Americaly.
• Market players are investing heavily in research and development to create innovative biologic and targeted treatments, responding to the growing autoimmune disease burden.
• Rising awareness and improved diagnostic capabilities are boosting early detection, leading to increased treatment adoption and expanding the overall market size.
• The expanding autoimmune disorder market attracts substantial investments from pharmaceutical companies and governments, supporting infrastructure and new product launches that enhance market competitiveness.
• Increasing prevalence in emerging economies opens new growth opportunities, prompting market expansion through improved healthcare access and rising healthcare expenditure in these regions. sustainability

Pemphigus Vulgaris Market Dynamics

Driver

“EMERGING TREATMENT OPTIONS FOR PEMPHIGUS VULGARIS”

• Traditional corticosteroid-based therapies, while effective, are associated with significant side effects and long-term health risks. This has created a strong demand for safer and more targeted alternatives. Biologic therapies, particularly anti-CD20 monoclonal antibodies such as rituximab, have shown substantial promise by offering improved remission rates and a reduced need for steroids.
• For instance, According to a 2022 article published in Frontiers in Medicine, immunotherapy has shown promise for the prevention or treatment of disease. Studies have shown the significance of T cells in pemphigus, and the function of Dsg3-specific CD4+ T cells has been elegantly demonstrated in an animal model by inducing a phenotype of interface dermatitis and PV. Defective regulatory T (Treg) cells may also contribute to the onset of pemphigus by modulating the production of anti-Dsg3 autoantibodies. It has been shown that the main cause of humoral autoimmunity was the interaction of autoreactive T cells and B cells. As a result, the T and B immunological axis, which are implicated in the immune mechanisms of pemphigus, the primary therapeutic target for pemphigus patients
• Additionally, novel pipeline candidates like neonatal Fc receptor (FcRn) inhibitors and Bruton’s Tyrosine Kinase (BTK) inhibitors are advancing through clinical trials, aiming to further improve efficacy and patient safety. These innovative approaches are expanding the therapeutic arsenal and attracting significant investment from pharmaceutical companies. \
• Regulatory approvals in key markets, increasing disease awareness, and greater physician acceptance of biologics are further accelerating market penetration. As research continues, these emerging therapies are expected to reshape the treatment landscape and sustain long-term market growth.
• The landscape of pemphigus vulgaris treatment is undergoing a pivotal transformation driven by biologics and precision medicine. As the demand for safer and more effective therapies grows, the North America market is expected to expand significantly. Innovations such as FcRn inhibitors and B-cell targeted therapies offer renewed hope for patients and new revenue streams for pharmaceutical companies.

Restraint/Challenge

“STRINGENT REGULATORY GUIDELINES FOR PEMPHIGUS VULGARIS DRUG APPROVAL”

• Strict regulatory guidelines refer to the rigorous standards set by North America health authorities—such as the U.S. FDA, EMA, and others—for the development, approval, and commercialization of drugs. In the context of Pemphigus Vulgaris (PV), these regulations are crucial due to the disease’s rarity and the complexity of its treatment.
• For instance, In November 2024, an article by Oxford University Press highlighted that strict regulatory guidelines, such as those outlined by the U.S. FDA and EMA, ensure that therapies for pemphigus vulgaris undergo rigorous clinical testing to confirm their safety and efficacy. While these measures are essential for patient safety, they can delay the approval and availability of new treatments. For instance, the FDA’s 21 CFR 312 regulations and EMA’s Committee for Medicinal Products for Human Use (CHMP) guidelines necessitate extensive phase trials before new therapies can be approved, potentially limiting patient access to promising treatments. This thorough process, while protective, can restrict treatment options in the interim
• Strict regulatory guidelines, while essential for patient safety, present both challenges and opportunities within the North America pemphigus vulgaris market. On one hand, they ensure that only safe and effective therapies reach patients, reinforcing confidence in approved treatments. On the other hand, lengthy approval processes and high compliance costs can delay innovation and restrict market access.

Pemphigus Vulgaris Market Scope

The market is segmented on the basis of diagnosis & treatment, population type, end-user and distribution channel.

• By Diagnosis & Treatment

On the basis of diagnosis & treatment, the market is segmented into diagnosis, treatment. In 2025, the treatment segment will dominate the market with a market share of 63.22% in 2025, driven by advancements in diagnostic technologies, increasing demand for early and accurate detection, rising awareness, and growing adoption of innovative diagnostic tools for effective management of pemphigus vulgaris.

The treatment segment is anticipated to witness the fastest growth rate of 9.3% from 2025 to 2032, fueled by technological advancements in diagnostic tools, increasing prevalence of pemphigus vulgaris, rising awareness about early detection, growing healthcare infrastructure, and expanding adoption of non-invasive and accurate diagnostic methods worldwide.

• By Population Type

On the basis of population type, the market is segmented into pediatric, adults and geriatric. The adults segment is expected to hold the largest market revenue share of 60.15% in 2025, driven by increasing diagnosis of pemphigus vulgaris in children, rising awareness among caregivers, advancements in pediatric-specific treatments, growing focus on early intervention, and enhanced healthcare access for the pediatric population in both developed and emerging regions.

The adults segment is expected to witness the fastest CAGR of 9.3% from 2025 to 2032, driven by increasing prevalence of autoimmune disorders in children, rising parental awareness, advancements in child-friendly therapies, improved diagnostic accuracy, and expanding healthcare infrastructure focused on pediatric care across both developed and emerging markets.

• By End-User

On the basis of end-user, the market is segmented into hospitals, specialty clinics, research institutes and others. The hospitals segment held the largest market revenue share in 2025, driven by advanced healthcare facilities, availability of specialized medical professionals, comprehensive treatment options, higher patient footfall, growing adoption of innovative therapies, and increased government funding supporting hospital infrastructure for managing pemphigus vulgaris effectively.

The hospitals segment is expected to witness the fastest CAGR from 2025 to 2032, favored for its well-equipped infrastructure, availability of multidisciplinary specialists, advanced diagnostic and treatment facilities, increasing patient preference for hospital care, and expanding healthcare investments supporting better management of complex autoimmune conditions like pemphigus

By Distribution Channel

On the basis of distribution Channel, the market is segmented into hospitals pharmacy, retail pharmacy and online pharmacy. The hospitals pharmacy segment accounted for the largest market revenue share in 2025, driven by direct access to prescribed medications, strong hospital partnerships, higher patient trust, availability of specialized drugs, streamlined supply chains, and the ability to provide integrated care and counseling for patients with pemphigus vulgaris.

The hospitals pharmacy segment is expected to witness the fastest CAGR from 2025 to 2032, driven by increasing hospital admissions, growing demand for specialized medications, enhanced supply chain efficiency, and rising preference for in-hospital medication dispensing for pemphigus vulgaris patients.

Pemphigus Vulgaris Market Regional Analysis

• U.S. dominates the Pemphigus Vulgaris market with a 82.78% revenue share in 2025, supported by advanced healthcare infrastructure, high patient awareness, robust research and development activities, widespread availability of biologic therapies, and strong government initiatives promoting rare disease treatment.
• U.S. dominance is strengthened by significant healthcare investments, a well-established pharmaceutical industry, and comprehensive insurance coverage, ensuring patient access to cutting-edge pemphigus vulgaris treatments and diagnostics.
• Additionally, active collaborations between government agencies, research institutions, and biotech companies accelerate innovation and approval of novel therapies, further driving market growth in the region.

U.S. Pemphigus Vulgaris Market Insight

U.S.accounted for the largest market revenue share in the North America region in 2025, attributed to advanced healthcare infrastructure, increasing awareness, rising prevalence of autoimmune disorders, and growing adoption of novel therapies. Additionally, strong government support and ongoing research boosted market growth in the region.

U.S.Pemphigus Vulgaris Market Insight

U.S. is expected to register the fastest CAGR in the region from 2025 to 2032, driven by increasing investments in biomedical research, rising incidence of pemphigus vulgaris, advanced healthcare facilities, growing patient awareness, and the introduction of innovative treatments. Strong regulatory support further accelerates market expansion in the region.

Pemphigus Vulgaris Market Share

The Pemphigus Vulgaris industry is primarily led by well-established companies, including:

• Merck & Co., Inc. (U.S.)
• Regeneron Pharmaceuticals Inc. (U.S.)
• Johnson & Johnson Services, Inc. (U.S.)
• Lilly (U.S.)
• Pfizer Inc. (U.S.)
• Abbvie Inc. (U.S.)
• Amgen Inc (U.S.)
• Artiva Biotherapeutics, Inc. (U.S.)
• Cabaletta Bio Inc. (U.S.)
• Incyte (U.S.)
• Baxter (U.S.)
• Sanofi (France)
• GSK plc. (U.K.)
• AstraZeneca (U.K.)
• Novartis AG (Switzerland)
• F. Hoffmann-La Roche Ltd (Switzerland)
• Boehringer Ingelheim International GmbH (Germany)
• Teva Pharmaceutical Industries Ltd. (Israel)
• CSL (Australia)
• Fresenius Kabi AG (Germany)

Latest Developments in North America Pemphigus Vulgaris Market

• In September 2021, the Phase 3 PEGASUS trial evaluated rilzabrutinib in adults with moderate-to-severe pemphigus vulgaris or foliaceus, a rare autoimmune skin disorder. Although rilzabrutinib showed a consistent safety profile with no new concerns, the study did not meet its primary or key secondary endpoints. The primary goal—complete remission between weeks 29 and 37 with low-dose corticosteroids—was not significantly different from placebo. This was the first placebo-controlled trial of a BTK inhibitor in pemphigus, highlighting the challenge of treating this complex condition.
• In February 2025, Regeneron and Sanofi submitted a supplemental Biologics License Application (sBLA) to the U.S. FDA for Dupixent to treat adults with Bullous Pemphigoid (BP), a rare autoimmune blistering disorder. This submission is based on positive data from the ADEPT Phase 2/3 trial, which showed that Dupixent significantly improved disease remission, reduced disease severity, and alleviated itch in BP patients. The FDA accepted the application for Priority Review, with a decision expected by June 20, 2025. This collaboration aims to provide a new treatment option for patients with BP, further expanding Dupixent’s role in autoimmune blistering diseases.
• In March 2025, Regeneron expanded its research into Dupixent’s potential for treating Pemphigus Vulgaris (PV), following its success in Bullous Pemphigoid (BP). Both BP and PV share underlying type 2 inflammation mechanisms, positioning Dupixent as a promising candidate for PV treatment. Ongoing studies are evaluating Dupixent’s efficacy in PV, with early results suggesting potential benefits. This exploration aims to provide a new treatment option for patients with PV, further expanding Dupixent’s application in autoimmune blistering diseases
• In April 2025, the company announced that groundbreaking of a cutting-edge biologics center of excellence in Wilmington, Delaware, spanning 470,000 square feet and representing a USD 1 billion investment.efficiency.
• In September 2024, Sanofi biologics Dupixent demonstrated significant improvements in disease remission and symptoms in both bullous pemphigoid (BP) and pemphigus vulgaris (PV), rare and life-threatening autoimmune skin diseases. In the ADEPT Phase 3 trial, five times more patients with BP on Dupixent achieved sustained remission compared to those on placebo. The study met its primary and all key secondary endpoints, showing a strong steroid-sparing effect. Dupixent is poised to become the first targeted treatment for BP and PV in the U.S. and EU, pending regulatory approval.

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