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Bullous Pemphigoid Market Insight, Epidemiology And Market Forecast - 2034

Published Date : 2025
Pages : 175
Region : United States, Japan, EU4 & UK
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Bullous Pemphigoid Market

  • Bullous Pemphigoid is known to be quite a prevalent autoimmune bullous disease, and it is known for its distinctive features, including erythema, tense blisters, and intense itching.
  • Its onset in older individuals, who represent the majority of cases, is associated with a poorer prognosis in this rare condition.
  • The United States accounted for the highest number of prevalent cases of atopic dermatitis in the 7MM.
  • Of the total diagnosed patients from bullous pemphigoid, more than 50% are females.
  • Approximately half of the population affected by bullous pemphigoid is over 80 years old, while less than 5% experience an early onset, occurring between the ages of 18 and 40 years.
  • As of now, there is no approved therapy for treating bullous pemphigoid, highlighting a significant gap in addressing this condition. However, a potential upcoming treatment by Regeneron and Sanofi, dupilumab is currently undergoing Phase III clinical trials. Data from these trials suggests that dupilumab shows promising efficacy and safety in patients with bullous pemphigoid, although there are some specific concerns regarding the risk of infection and eosinophilia associated with its use.
  • Expected launch of potential therapies by key Bullous Pemphigoid Companies such as Regeneron/ Sanofi, argenx, and others may increase the market size in the coming years, assisted by an increase in the prevalent population of Bullous Pemphigoid. It is expected that these therapies will help thrive the market of Bullous Pemphigoid post-launch, in the United States. Furthermore, these novel therapies will mark there entry in EU4 and the UK and Japan in subsequent years.

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Bullous Pemphigoid Market

DelveInsight's “Bullous Pemphigoid Market Insights, Epidemiology and Market Forecast – 2034” report delivers an in-depth understanding of Bullous Pemphigoid, historical and forecasted epidemiology as well as the Bullous Pemphigoid market trends in the United States, EU4 (Germany, Spain, Italy, and France) and the United Kingdom, and Japan.

Bullous Pemphigoid Treatment Market Report provides real-world prescription pattern analysis, emerging drugs, market share of individual therapies, and historical and forecasted 7MM Bullous Pemphigoid market size from 2020 to 2034. The report also covers current Bullous Pemphigoid treatment market practices/algorithms and unmet medical needs to curate the best opportunities and assess the market’s underlying potential.

Report Metrics

Details

Study Period

2020 to 2034

Forecast Period

2024 to 2034

Geographies Covered

The US, EU4 (Germany, France, Italy, and Spain) and UK, and Japan

Bullous Pemphigoid Epidemiology

  • Diagnosed Prevalent Cases of Bullous Pemphigoid
  • Gender-specific Diagnosed Prevalent Cases of Bullous Pemphigoid
  • Age-specific Diagnosed Prevalent Cases of Bullous Pemphigoid
  • Severity-specific Diagnosed Prevalent Cases of Bullous Pemphigoid
  • Total Treated Cases of Bullous Pemphigoid

Bullous Pemphigoid Drugs Market

  • Bullous Pemphigoid Market Size by Region
  • Bullous Pemphigoid Market Size by Therapies

Bullous Pemphigoid Market Analysis

  • KOL Views
  • SWOT Analysis
  • Reimbursement
  • Conjoint Analysis
  • Unmet needs

Bullous Pemphigoid Companies

  • Nihon Pharmaceutical/ Takeda
  • AstraZeneca/ Kyowa Kirin
  • Regeneron/ Sanofi
  • Argenx

Bullous Pemphigoid Therapies

  • Kenketu Glovenin-I
  • DUPIXENT (dupilumab)
  • VYVGART (efgartigimod PH20 SC)

Bullous Pemphigoid Treatment Market: Understanding and Algorithm

Overview, Country-Specific Treatment Guidelines and Diagnosis

Bullous pemphigoid is an autoimmune cutaneous blistering disease characterized by autoantibody deposition at the epithelial basement membrane zone. The disorder is a rare skin condition that mainly affects older people and classically presents with generalized, pruritic, urticarial plaques and tense, subepithelial blisters. 

Bullous pemphigoid is a condition characterized by large, fluid-filled blisters typically found on the arms, legs, or torso, with possible involvement of the mouth or genital areas in some cases. These blisters can rupture, leading to the formation of ulcers or open sores. Symptoms may include itching skin, which can precede blister formation by weeks or months, large blisters that are resistant to breaking when touched, often appearing in skin creases or folds, and manifestations such as eczema or a rash resembling hives. Additionally, small blisters or sores may occur in the mouth or other mucous membranes, a variant known as benign mucous membrane pemphigoid. Symptoms may fluctuate over time, and while bullous pemphigoid often resolves on its own within several months, complete resolution may take up to five years.

The diagnosis of Bullous Pemphigoid is based on a combination of clinical features, positive direct immunofluorescence (IF) microscopy of perilesional skin, and the detection of specific circulating IgG anti-basement membrane autoantibodies by either indirect IF microscopy studies or by enzyme-linked immunosorbent assay (ELISA). In most cases, the latter tests are sufficient for a correct diagnosis.

Bullous pemphigoid is usually a chronic disease with spontaneous exacerbations and remissions, which may be accompanied by significant morbidity. The therapeutic options for Bullous Pemphigoid include topical or systemic corticosteroids and immunosuppressive or immunomodulatory drugs in severe or relapsing cases. In the past decade, potent topical corticosteroids have emerged as an effective and safe first-line treatment for Bullous Pemphigoid, but their long-term feasibility is still controversial. Newer therapeutic agents targeting molecules involved in the inflammatory cascade associated with Bullous Pemphigoid represent future alternatives to classical immunosuppressant drugs for maintenance therapy

Further details related to country-based variations in diagnosis are provided in the report

Bullous Pemphigoid Treatment

Bullous Pemphigoid typically follows a self-limiting course, lasting from months to years. However, during active phases, it can lead to significant morbidity and mortality, with a risk twice that of the general elderly population. Older age at onset and overall frailty are indicators of poor prognosis. Many available treatments for Bullous Pemphigoid carry toxicity risks and may be poorly tolerated by patients. High doses of systemic corticosteroids (equivalent to prednisolone >40 mg daily) in the initial year of treatment are associated with increased mortality rates. 

Treatment strategies should prioritize symptom control while minimizing adverse effects. Therapeutic options include anti-inflammatory drugs, immunosuppressants, immunomodulators, and procedures to eliminate circulating pathogenic antibodies or inflammatory agents. The choice of treatment depends on individual patient factors, particularly the severity of Bullous Pemphigoid and the presence of other medical conditions.

Bullous Pemphigoid Epidemiology

The Bullous Pemphigoid epidemiology chapter in the report provides historical as well as forecasted in the 7MM covering the United States, EU4 countries (Germany, France, Italy, and Spain), the United Kingdom, and Japan from 2024 to 2034. The Bullous Pemphigoid epidemiology is segmented with detailed insights into Diagnosed Prevalent Cases, Gender-specific Diagnosed Prevalent Cases, Age-specific Diagnosed Prevalent Cases, Severity-specific Diagnosed Prevalent Cases, and Total Treated Cases of Bullous Pemphigoid.

  • According to findings, bullous pemphigoid, a rare skin disorder, accounted for nearly 135,000 cases in the 7MM in 2023.
  • In the EU4 and the UK, Spain had the smallest number of patients, while the UK had the highest, representing nearly 25% of all cases in the EU4 and the UK in 2023.
  • Bullous Pemphigoid is frequently observed in older individuals, consistent with our research findings indicating that nearly half of prevalent patients in the United States are aged 80 years or above.
  • According to DelveInsight, in gender-specific contexts, over half of the patients are females, suggesting a higher prevalence among women.

Unlock comprehensive insights! Click Here to Purchase the Full Epidemiology Report @ Bullous Pemphigoid Prevalence

Bullous Pemphigoid Recent Developments

  • In February 2025, Sanofi announced that the FDA has accepted the supplemental biologics license application for Dupixent, seeking priority review for the treatment of bullous pemphigoid in adults.

Bullous Pemphigoid Drug Chapters

The drug chapter segment of the Bullous Pemphigoid treatment market report encloses a detailed analysis of Bullous Pemphigoid marketed drugs and late-stage (Phase III and Phase II) pipeline drugs. It also deep dives into the pivotal Bullous Pemphigoid clinical trials details; recent and expected market approvals, patent details, the latest news, and recent deals and collaborations. 

Bullous Pemphigoid Marketed Drugs

  • Kenketu Glovenin-I (NPB-01): Nihon Pharmaceutical/ Takeda

Kenketu Glovenin-I for IV injection is a lyophilized powder for solution containing freeze-dried polyethylene glycol-treated human normal immunoglobulin G as the active ingredient. The mechanism of action of Kenketu Glovenin-I against Bullous Pemphigoid has not been elucidated. However, given that Bullous Pemphigoid is an autoimmune bullous disease with subepidermal blisters caused by the autoantibody in the epidermal basement membrane with BP180 as the primary antigen, Kenketu Glovenin-I is considered to exhibit its effect by a similar mechanism found in other autoimmune diseases.

Note: Detailed current therapies assessment will be provided in the full report of Bullous Pemphigoid

Bullous Pemphigoid Emerging Drugs

DUPIXENT (dupilumab): Regeneron/ Sanofi

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. In August 2019, the US FDA granted Orphan Drug Designation to dupilumab for the treatment of Bullous Pemphigoid. Currently, the drug is being investigated in a Phase III trial. 

VYVGART (efgartigimod PH20 SC) 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. It is being investigated in several autoimmune diseases mediated by disease-causing IgG antibodies, including neuromuscular disorders, blood disorders, and skin-blistering diseases. Currently, the drug is being investigated in Phase II/III trial (NCT05267600) to investigate the efficacy, safety, tolerability, immunogenicity, and participant-reported outcome measures, in patients with symptomatic Bullous Pemphigoid.

Note: Detailed emerging therapies assessment will be provided in the final report.

Therapy Name

Company Name

ROA

Molecule Type

Phases

Any Special Status

DUPIXENT (dupilumab)

Regeneron/Sanofi

SC injection

Monoclonal antibody

III

NA

VYVGART (efgartigimod PH20 SC)

argenx

SC injection

Monoclonal antibody

II/III

Orphan Drug Designation

Bullous Pemphigoid Market Outlook

Bullous Pemphigoid Market Outlook

  • Key Bullous Pemphigoid Companies such as Regeneron/ Sanofi, argenx, and others are evaluating their lead candidates in different stages of clinical development, respectively. They aim to investigate their products for the treatment of Bullous Pemphigoid.
  • The United States accounts for the largest Bullous Pemphigoid Market Size, in comparison to EU4 (Germany, Spain, Italy, France), the United Kingdom, and Japan.
  • There are emerging drugs in the pipeline but the rate of discontinuation is high due to which the bullous pemphigoid market is underserved and there is a scarcity of approved drugs in the market.
  • Among EU4 and the UK, Germany had the highest Bullous Pemphigoid Market Size.
  •  

Bullous Pemphigoid Drugs Uptake

This section focuses on the uptake rate of potential Bullous Pemphigoid drugs expected to be launched in the market during 2024–2034, which depends on the competitive landscape, safety, and efficacy data along with order of entry. It is important to understand that the key players evaluating their novel therapies in the pivotal and confirmatory trials should remain vigilant when selecting appropriate comparators to stand the greatest chance of a positive opinion from regulatory bodies, leading to approval, smooth launch, and rapid uptake. 

Further detailed analysis of emerging therapies drug uptake in the report…

Bullous Pemphigoid Pipeline Development Activities

The Bullous Pemphigoid therapeutics market report provides insights into different therapeutic candidates in Phase III and Phase II stages. It also analyzes key Bullous Pemphigoid Companies involved in developing targeted therapeutics. 

Pipeline Development Activities

The Bullous Pemphigoid therapeutics market report covers information on collaborations, acquisitions and mergers, licensing, and patent details for Bullous Pemphigoid emerging therapies. 

Take Your Research to the Next Level! Click Here to Get Access to the Full Pipeline Report @ Bullous Pemphigoid Treatment Drugs

KOL Views

To keep up with the real-world scenario in current and emerging market trends, we take opinions from Key Industry leaders working in the domain through primary research to fill the data gaps and validate our secondary research. Industry Experts were contacted for insights on the evolving treatment landscape, patient reliance on conventional therapies, patient therapy switching acceptability, and drug uptake along with challenges related to accessibility.

DelveInsight’s analysts connected with 10+ KOLs to gather insights; however, interviews were conducted with 5+ KOLs in the 7MM. Their opinion helps understand and validate current and emerging treatment patterns of Bullous Pemphigoid. This will support the clients in potential upcoming novel treatments by identifying the overall scenario of the market and the unmet needs.

Bullous Pemphigoid Therapeutics Market: Qualitative Analysis

We perform Qualitative and market Intelligence analysis using various approaches, such as SWOT analysis and Conjoint Analysis. In the SWOT analysis, strengths, weaknesses, opportunities, and threats in terms of gaps in disease diagnosis, patient awareness, physician acceptability, competitive landscape, cost-effectiveness, and geographical accessibility of therapies are provided. 

Conjoint Analysis analyzes multiple approved and emerging therapies based on relevant attributes such as safety, efficacy, frequency of administration, route of administration, and order of entry. Scoring is given based on these parameters to analyze the effectiveness of therapy. In efficacy, the trial’s primary and secondary outcome measures are evaluated; for instance, in event-free survival, one of the most important primary outcome measures is event-free survival and overall survival. 

Further, the therapies’ safety is evaluated wherein the acceptability, tolerability, and adverse events are majorly observed, and it sets a clear understanding of the side effects posed by the drug in the trials. In addition, the scoring is also based on the probability of success, and the addressable patient pool for each therapy. According to these parameters, the final weightage score and the ranking of the emerging therapies are decided. 

Bullous Pemphigoid Therapeutics Market Access and Reimbursement

Reimbursement of rare disease therapies can be limited due to lack of supporting policies and funding, challenges of high prices, lack of specific approaches to evaluating rare disease drugs given limited evidence, and payers’ concerns about budget impact. The high cost of rare disease drugs usually has a limited effect on the budget due to the small number of eligible patients being prescribed the drug. The US FDA has approved several rare disease therapies in recent years. From a patient perspective, health insurance and payer coverage guidelines surrounding rare disease treatments restrict broad access to these treatments, leaving only a small number of patients who can bypass insurance and pay for products independently. 

The report further provides detailed insights on the country-wise accessibility and reimbursement scenarios, cost-effectiveness scenario of currently used therapies, programs making accessibility easier and out-of-pocket costs more affordable, insights on patients insured under federal or state government prescription drug programs, etc.

Bullous Pemphigoid Therapeutics Market Report Scope

  • The Bullous Pemphigoid therapeutics market report covers a segment of key events, an executive summary, descriptive overview, explaining its causes, signs and symptoms, pathogenesis, and currently available therapies.
  • Comprehensive insight has been provided into the epidemiology segments and forecasts, the future growth potential of diagnosis rate, and disease progression along with country specific treatment guidelines.
  • Additionally, an all-inclusive account of both the current and emerging therapies, along with the elaborative profiles of late-stage and prominent therapies, will have an impact on the current Bullous Pemphigoid treatment market landscape.
  • A detailed review of the Bullous Pemphigoid treatment market, historical and forecasted Bullous Pemphigoid treatment market size, Bullous Pemphigoid drugs market share by therapies, detailed assumptions, and rationale behind our approach is included in the report, covering the 7MM drug outreach.
  • The Bullous Pemphigoid therapeutics market report provides an edge while developing business strategies, by understanding trends, through SWOT analysis and expert insights/KOL views, patient journey, and treatment preferences that help in shaping and driving the 7MM Bullous Pemphigoid drugs market.

Bullous Pemphigoid Therapeutics Market Report Insights

  • Patient-based Bullous Pemphigoid Market Forecasting
  • Therapeutic Approaches
  • Bullous Pemphigoid Pipeline Drugs Analysis
  • Bullous Pemphigoid Market Size and Trends
  • Existing and future Bullous Pemphigoid Drugs Market Opportunity 

Bullous Pemphigoid Therapeutics Market Report Key Strengths

  • 10 Years Bullous Pemphigoid Market Forecast
  • 7MM Coverage 
  • Bullous Pemphigoid Epidemiology Segmentation
  • Inclusion of Country specific treatment guidelines
  • KOL’s feedback on approved and emerging therapies 
  • Key Cross Competition 
  • Conjoint analysis
  • Bullous Pemphigoid Drugs Uptake
  • Key Bullous Pemphigoid Market Forecast Assumptions

Bullous Pemphigoid Therapeutics Market Report Assessment

  • Current Bullous Pemphigoid Treatment Market Practices
  • Bullous Pemphigoid Unmet Needs
  • Bullous Pemphigoid Pipeline Drugs Profiles
  • Bullous Pemphigoid Drugs Market Attractiveness
  • Qualitative Analysis (SWOT and Conjoint Analysis)

FAQs

  • What is the growth rate of the 7MM Bullous Pemphigoid treatment market?
  • What was the Bullous Pemphigoid treatment market size, the market size by therapies, market share (%) distribution in 2023, and what would it look like in 2034? What are the contributing factors/key catalysts for this growth?
  • Is there any unexplored patient setting that can open the window for growth in the future?
  • What are the pricing variations among different geographies for approved and off-label therapies?
  • How would the market drivers, barriers, and future opportunities affect the market dynamics and subsequent analysis of the associated trends? Although multiple expert guidelines recommend testing for targetable mutations before therapy initiation, why do barriers to testing remain high?
  • What are the current and emerging options for the treatment of Bullous Pemphigoid? 
  • How many companies are developing therapies for the treatment of Bullous Pemphigoid?
  • What are the recent novel therapies, targets, mechanisms of action, and technologies developed to overcome the limitations of existing therapies? 
  • What are the country-specific accessibility issues of expensive, recently approved therapies? 

Reasons to buy

  • The Bullous Pemphigoid drugs market report will help in developing business strategies by understanding the latest trends and changing treatment dynamics driving the Bullous Pemphigoid Drugs Market.
  • Insights on patient burden/disease Bullous Pemphigoid Prevalence, evolution in diagnosis, and factors contributing to the change in the epidemiology of the disease during the forecast years
  • Understand the existing market opportunities in varying geographies and the growth potential over the coming years.
  • Distribution of historical and current patient share based on real-world prescription data along with reported sales of approved products in the US, EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan.
  • Identifying strong upcoming players in the market will help devise strategies to help get ahead of competitors.
  • Detailed analysis and ranking of class-wise potential current and emerging therapies under the conjoint analysis section to provide visibility around leading classes.
  • Highlights of access and reimbursement policies of approved therapies, barriers to accessibility of expensive off-label therapies, and patient assistance programs.
  • To understand Key Opinion Leaders’ perspectives around the accessibility, acceptability, and compliance-related challenges of existing treatment to overcome barriers in the future.
  • Detailed insights on the unmet needs of the existing market so that the upcoming players can strengthen their development and launch strategy.

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Frequently Asked Questions

Bullous Pemphigoid is a rare skin condition that mainly affects older people. It usually starts with an itchy, raised rash. As the condition develops, large blisters can form on the skin. It is characterized by a poor prognosis due to its high mortality rate and the tendency to relapse. The relapse rate of BP ranges from 27.87% to 53% after disease remission, while the majority of relapses occur early (within 6 months) during remission. Treatment usually helps heal the blisters and ease any itching.
Bullous Pemphigoid epidemiology is segmented as Bullous Pemphigoid Total Incident Cases, Age-specific Bullous Pemphigoid cases, Gender-specific Bullous Pemphigoid Cases, Stage-specific Bullous Pemphigoid incident cases, Type-specific Bullous Pemphigoid incident cases, and Total Treated Bullous Pemphigoid Cases.
The Bullous Pemphigoid market size is USD 171.25 million in 2021 and is expected to grow owing to the launch of emerging therapies by 2032.
The Bullous Pemphigoid Market is expected to grow at a moderate CAGR during the study period 2019–2032.
The United States is expected to account for the highest prevalent Bullous Pemphigoid prevalent cases.
Some of the key Bullous Pemphigoid companies working in the Bullous Pemphigoid market are AstraZeneca, Kyowa Kirin, Regeneron, Sanofi, Argenx, Innate Pharma, ARTham Therapeutics, Kaken Pharmaceutical, and others.

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