Bullous Pemphigoid Drugs Market 2034: Clinical Trials, EMA, PDMA, FDA Approvals, Medication, Therapies, MOA, ROA, NDA Approval, Treatment and Companies by DelveInsight

Bullous Pemphigoid Drugs Market

[Albany, United States] – DelveInsight’s “Bullous Pemphigoid Market Insights, Epidemiology, and Market Forecast 2034” report offers a detailed examination of Bullous Pemphigoid, covering historical and predicted epidemiology, market trends, and treatment scenarios in the United States, EU4 (Germany, Spain, Italy, France), the United Kingdom, and Japan.

The Bullous Pemphigoid market size is expected to increase during the forecast period with the increasing prevalence, disease awareness, and promising emerging treatment options by leading companies such as AstraZeneca, Kyowa Kirin, Regeneron,Sanofi, Argenx, Innate Pharma, ARTham Therapeutics, Kaken Pharmaceutical, Mayo Clinic, Nihon Pharmaceutical Co., Ltd, Immune Pharmaceuticals, AKARI Therapeutics and others.

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Key Findings from the Bullous Pemphigoid Market Report:

• The Bullous Pemphigoid market size is poised for significant growth, with an anticipated Compound Annual Growth Rate (CAGR) during the study period (2020-2034).
• In February 2025, The US Food and Drug Administration (FDA) has accepted for priority review the supplemental biologics license application (sBLA) for Sanofi’s Dupixent (dupilumab) to treat adults with bullous pemphigoid (BP).
• In December 2024, Chugai Pharmaceutical announced results of a Phase 1b Open-label Basket Trial of RAY121 to Inhibit Classical Complement Pathway in Immunological Diseases (RAINBOW Trial)
• In September, 2024: Regeneron Pharmaceuticals announced that the maine purpose of their study is to investigate whether dupilumab is effective and safe for the treatment of bullous pemphigoid. Dupilumab is a type of drug called a “monoclonal antibody”. An antibody is a special kind of protein that the immune (defense) system normally makes to fight bacteria and viruses.
• In July, 2024: Investigación Sanitaria de la Fundación Jiménez Díaz announced that a phase IIa, open label, non controlled clinical trial to assess the feasibility and safety of allogeneic adipose-derived mesenchymal stem cells (ASC) in the treatment of cicatricial conjunctivitis associated with Lyell’s syndrome, Stevens-Johnson’s syndrome and mucous membrane pemphigoid with ocular involvement
• In January, 2024: argenx announced that ARGX-113-2009 is an operationally seamless 2-part, phase 2/3, prospective, global, multicenter, randomized, double-blinded, placebo-controlled study to investigate the efficacy, safety, tolerability, immunogenicity, participant-reported outcome measures (including those assessing participant QoL), PK, and PD of efgartigimod PH20 SC administered via subcutaneous (SC) injection in adult participants with moderate to severe BP.
• According to the recent cross-sectional analysis conducted Wertenteil et al. (2018), titled “Prevalence estimates for pemphigoid in the US: A gender-adjusted an age-adjusted population analysis” the overall prevalence of pemphigoid was 0.012%, or 12 pemphigoid patients/100,000 adults in the US.
• According to the study conducted by Persson et al. (2020), in the UK, the prevalence of BP was 26.82 (95% CI 23.83-30.19) per 100,000 people in 1998 and increased to 47.99 (95% CI 43.09-53.46) per 100,000 in 2017.
• According to “Japan Intractable diseases,” approximately 6,850 patients with pemphigoid, including both bullous and non bullous pemphigoid, with the majority considered to be the elderly.
• Key Bullous Pemphigoid Companies are as follows: AstraZeneca, Kyowa Kirin, Regeneron,Sanofi, Argenx, Innate Pharma, ARTham Therapeutics, Kaken Pharmaceutical, Mayo Clinic, Nihon Pharmaceutical Co., Ltd, Immune Pharmaceuticals, AKARI Therapeutics
• Key Bullous Pemphigoid Therapies are as follow: DUPIXENT (dupilumab), Kenketu Glovenin-I (NPB-01), VYVGART (efgartigimod PH20 SC), Ixekizumab, Prednisone, dupilumab, NPB-01, Bertilimumab, rVA576
• Launching multiple stage Bullous Pemphigoid pipeline products is expected to revolutionize market dynamics, further propelling market growth.

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Bullous Pemphigoid Overview:

Bullous pemphigoid (BP) is a chronic autoimmune blistering disorder that primarily affects the elderly, typically over 60 years of age. It is caused by autoantibodies targeting hemidesmosomal proteins, particularly BP180 and BP230, which are essential for epidermal-dermal adhesion. The resulting immune response leads to subepidermal blister formation.

Bullous pemphigoid often presents with pruritic, tense blisters on normal or erythematous skin, predominantly on the trunk, limbs, and flexural areas. Early stages may resemble eczema or urticaria, making diagnosis challenging. Mucosal involvement is less common compared to other autoimmune blistering diseases, such as pemphigus vulgaris.

Bullous pemphigoid Diagnosis is confirmed through a combination of clinical findings, histopathology, direct immunofluorescence (showing linear IgG and C3 deposition along the basement membrane), and serological tests detecting circulating autoantibodies.

Bullous pemphigoid Treatment aims to control inflammation and prevent blister formation. First-line therapy includes high-potency topical corticosteroids or systemic corticosteroids for severe cases. Immunosuppressive agents like azathioprine or mycophenolate mofetil and biologics, such as rituximab, are considered in refractory cases. Nonsteroidal treatments, including doxycycline, are also effective with fewer side effects.

Although Bullous pemphigoid can significantly impact quality of life, prompt diagnosis and appropriate management often lead to remission, reducing morbidity and improving patient outcomes.

Bullous Pemphigoid Epidemiology Segmentation:

The Bullous Pemphigoid market report proffers epidemiological analysis for the study period 2020-2034 in the 7MM segmented into:

• Bullous Pemphigoid Diagnosed prevalent
• Bullous Pemphigoid Gender-specific diagnosed prevalent cases
• Bullous Pemphigoid Age-specific diagnosed prevalent cases
• Bullous Pemphigoid Diagnosed Total treated cases

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Bullous Pemphigoid Market Insights

Bullous pemphigoid is an uncommon autoimmune subepidermal blistering disease that accounts for about 70% of subepidermal bullous diseases, mainly affecting the elderly.

Treatment of Bullous pemphigoid aims to arrest the development of new lesions and enable cutaneous healing and control of pruritus. As Bullous pemphigoid mainly affects elderly individuals, the choice of therapy has to be tailored according to the patient’s comorbidities and ability to self care to avoid potential complications and increased morbidity and mortality.

Currently there is no FDA approved therapy for Bullous pemphigoid in the 7MM, but pharmaceutical companies are constantly working to bring innovative treatments soon into the market which could meet the unmet demands of Bullous pemphigoid patients. efgartigimod, developed argenx, and dupilumab developed by Regeneron/Sanofi are in the Phase III clinical development.

Bullous Pemphigoid Drugs Uptake

• FASENRA (benralizumab) is a monoclonal antibody that binds directly to IL-5 receptor alpha on eosinophils. It attracts natural killer (NK) cells to induce rapid and near-complete depletion of blood and tissue eosinophils in most patients via apoptosis (programmed cell death).
• DUPIXENT (dupilumab) is a monoclonal antibody targeting the chain of the interleukin (IL)-4 receptor. It inhibits the biological effects of the cytokines IL-4 and IL-13, which are key drivers in the TH2 response.
• VYVGART (efgartigimod PH20 SC) developed by Argenx is an antibody fragment designed to reduce pathogenic immunoglobulin G (IgG) antibodies by binding to the neonatal Fc receptor and blocking the IgG recycling process.

Bullous Pemphigoid Therapies and Key Companies:

• DUPIXENT (dupilumab): Regeneron/ Sanofi
• Kenketu Glovenin-I (NPB-01): Nihon Pharmaceutical/ Takeda
• VYVGART (efgartigimod PH20 SC): Argenx
• Ixekizumab: Mayo Clinic
• Prednisone: argenx
• dupilumab: Regeneron Pharmaceuticals
• NPB-01: Nihon Pharmaceutical Co., Ltd
• Bertilimumab: Immune Pharmaceuticals
• rVA576: AKARI Therapeutics

Bullous Pemphigoid Epidemiology:

Bullous pemphigoid is considered a rare disease, with its incidence estimated at 2.5-42.8 cases per million annually, depending on the region. Studies show that the prevalence of BP is higher in Europe and North America compared to other parts of the world. However, the condition is becoming more recognized, and the incidence is rising due to better diagnostic tools and increasing awareness.

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Bullous Pemphigoid Market Drivers:

• Rising Incidence in Aging Population
• Advances in Immunotherapy and Targeted Therapies
• Increased Awareness and Early Diagnosis
• Development of Novel Therapeutics and Pipeline Drugs

Bullous Pemphigoid Market Barriers:

• Limited Awareness and Misdiagnosis
• Adverse Side Effects of Existing Treatments
• Regulatory Challenges and Slow Approvals
• Limited Patient Pool

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Scope of the Bullous Pemphigoid Market Report:

• Study Period: 2020-2034
• Coverage: 7MM (The United States, EU5, and Japan)
• Key Bullous Pemphigoid Companies: AstraZeneca, Kyowa Kirin, Regeneron,Sanofi, Argenx, Innate Pharma, ARTham Therapeutics, Kaken Pharmaceutical, Mayo Clinic, Nihon Pharmaceutical Co., Ltd, Immune Pharmaceuticals, AKARI Therapeutics
• Key Bullous Pemphigoid Therapies: DUPIXENT (dupilumab), Kenketu Glovenin-I (NPB-01), VYVGART (efgartigimod PH20 SC), Ixekizumab, Prednisone, dupilumab, NPB-01, Bertilimumab, rVA576
• Bullous Pemphigoid Therapeutic Assessment: Current marketed and emerging therapies
• Bullous Pemphigoid Market Dynamics: Bullous Pemphigoid Market drivers and Bullous Pemphigoid barriers
• Competitive Intelligence Analysis: SWOT analysis, PESTLE analysis, Porter’s five forces, BCG Matrix, Market entry strategies
• Bullous Pemphigoid Unmet Needs: Insights into unmet needs, KOL’s views, Analyst’s views, Market Access, and Reimbursement.

Table of Content:

1 Key Insights

2 Report Introduction

3 Bullous Pemphigoid Market Overview at a Glance

4 Executive Summary of Bullous Pemphigoid

5 Epidemiology and Market Methodology

6 Disease Background and Overview

7 Diagnosis of Bullous Pemphigoid

8 Treatment and Management

9 Conclusion

10 Epidemiology and Patient Population

11 Patient Journey

12 Key Endpoints in Bullous Pemphigoid clinical trials

13 Marketed Therapies

14 Emerging Therapies

15 Bullous Pemphigoid: The 7MM Analysis

16 KOL Views

17 SWOT Analysis

18 Unmet Needs

19 Appendix

20 DelveInsight Capabilities

21 Disclaimer

22 About DelveInsight

About DelveInsight:

DelveInsight is a leading market research firm providing insightful solutions and services to pharmaceutical and life sciences companies. With a commitment to delivering accurate and comprehensive reports, DelveInsight empowers businesses to make informed decisions and navigate the complexities of the healthcare industry.

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