bullous pemphigoid market insight

DelveInsight’s ‘Bullous Pemphigoid-Market Insights, Epidemiology, and Market Forecast–2030’ report deliver an in-depth understanding of the Bullous Pemphigoid historical and forecasted epidemiology as well as the Bullous Pemphigoid market trends in the United States, EU5 (Germany, France, Italy, Spain, and the United Kingdom), and Japan.

The Bullous Pemphigoid market report provides current treatment practices, emerging drugs, and market share of the individual therapies, current and forecasted 7MM Bullous Pemphigoid market size from 2021 to 2030. The Report also covers current Bullous Pemphigoid treatment practice, market drivers, market barriers, SWOT analysis, and unmet medical needs to curate the best of the opportunities and assesses the underlying potential of the market.

Geography Covered

• The United States
• EU5 (Germany, France, Italy, Spain, and the United Kingdom)
• Japan

Study Period: 2018–2030

Bullous Pemphigoid Disease Understanding and Treatment Algorithm

Bullous Pemphigoid Overview

Bullous Pemphigoid (BP) is an acquired autoimmune subepidermal bullous disease in which autoantibodies are directed against the skin’s basement membrane zone components. Mainly IgG (rarely IgA, IgM, and IgE) autoantibodies bind to components of the hemidesmosome adhesion complex, the BP230, and BP180 antigens.

It is characterized by blistering, urticarial lesions (hives), and itching. Less commonly, these blisters can involve the mucous membranes, including the eyes, oral mucosa, esophagus, and genital mucosa. It typically presents in older adults as a generalized intensely itchy blistering skin condition.

Bullous Pemphigoid Diagnosis

The initial evaluation of a patient with bullous pemphigoid includes medical history, physical examination, and clinical symptoms, including affected area and number of blisters per day. Direct and Indirect Immunofluorescence microscopy tests and ELISA are some of the most common diagnostic techniques. Diagnostic delay is quite common as the usual delay is ~6 months.

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Bullous Pemphigoid Treatment

Bullous pemphigoid is usually a self‐limiting disease with a clinical course that may last from months to years. During the active stage, the disease is associated with significant morbidity and mortality twice that of the general elderly population. Older age at onset and frail general condition are poor prognostic factors. Many available treatments are associated with toxicity and may be poorly tolerated in patients with bullous pemphigoid. During the first year, mortality is significantly higher in patients treated with high doses of systemic corticosteroids (prednisolone equivalent >40 mg daily). Treatment should aim to control symptoms with minimum adverse effects where possible.

The therapeutic options for bullous pemphigoid are divided into anti-inflammatory drugs, immunosuppressive or immunomodulatory drugs, and procedures to remove circulating pathogenic antibodies or inflammatory mediators. The choice of treatment depends on the individual patient’s circumstances, especially the severity of the bullous pemphigoid and the presence of comorbidities.

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Bullous Pemphigoid Epidemiology  

The disease epidemiology covered in the report provides historical as well as forecasted epidemiology segmented by Diagnosed Prevalent Cases of Bullous Pemphigoid, Gender-specific Diagnosed Prevalent Cases of Bullous Pemphigoid, Age-specific Diagnosed Prevalent Cases of Bullous Pemphigoid, and Severity-specific Diagnosed Prevalent Cases of Bullous Pemphigoid scenario in the 7MM covering the United States, EU5 countries (Germany, France, Italy, Spain, and the United Kingdom), and Japan from 2018 to 2030.

Key Findings

• In 2020, the total diagnosed prevalent cases of bullous pemphigoid in the 7MM were 124,517 which is likely to increase by 2030 at a CAGR of 0.96% for the study period (2018–2030).
• In 2020, there were 25,041 diagnosed prevalent cases of bullous pemphigoid in the United States, these cases are expected to increase at a CAGR of 1.26% for the study period of 2018–2030.
• Assessments as per DelveInsight's analysts showed that there were 13,772 cases of the mild-moderate form of bullous pemphigoid and 11,268 cases of the severe form of bullous pemphigoid in the United States in 2020.
• Assessments as per DelveInsight analysts showed that 47% of total cases of bullous pemphigoid in the United States in 2020 were from the age group above 80 years.
• In 2020, males and females contributed to 44% and 56% of the total diagnosed prevalent cases of Bullous Pemphigoid in the United States, respectively.
• Among the European countries, the UK had the highest diagnosed prevalent population of bullous pemphigoid with 24,644 cases, followed by France which had 23,843 diagnosed prevalent cases in 2020. On the other hand, Spain had the lowest diagnosed prevalent population of 10,920 in 2020.
• In 2020, Japan accounted for 8,619 diagnosed prevalent cases of bullous pemphigoid which is the least cases among 7MM countries.

Country Wise- Bullous Pemphigoid Epidemiology

The epidemiology segment also provides the bullous pemphigoid epidemiology data and findings across the United States, EU5 (Germany, France, Italy, Spain, and the United Kingdom), and Japan.

Bullous Pemphigoid Drug Chapters

Bullous Pemphigoid Marketed Drug

Kenketu Glovenin-I (NPB-01): Nihon Pharmaceutical

Kenketu Glovenin-I for IV injection (“Kenketu Glovenin-I”) is a lyophilized powder for solution for injection containing freeze-dried polyethylene glycol-treated human normal immunoglobulin G as the active ingredient. Kenketu Glovenin-I was approved in Japan in October 1984 for the indications of agammaglobulinemia or hypogammaglobulinemia and coadministration with antibiotics for the treatment of severe infection.

The Pharmaceuticals and Medical Devices Agency (PMDA) concluded that the efficacy of the product in treating patients with bullous pemphigoid (BP) who have not sufficiently responded to corticosteroids had been demonstrated, and its safety is acceptable given its observed benefits. In November 2015, as a result of its regulatory review, PMDA concluded that the product may be approved for the indication.

Products detail in the report…

Bullous Pemphigoid Emerging Drugs

Dupilumab (Dupixent): Regeneron Pharmaceuticals/Sanofi

Dupilumab (Dupixent) is a monoclonal antibody targeting the α 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. The company is currently evaluating dupilumab in Phase II/III clinical trial to evaluate its efficacy and safety in adult patients with bullous pemphigoid. The pivotal Phase III trial has been initiated, and regulatory filings are planned for 2023+. The safety and efficacy of dupilumab were also evaluated in a case series of 13 patients with bullous pemphigoid. In August 2019, the US FDA granted Orphan Drug Designation to Dupilumab for the treatment of bullous pemphigoid.

Products detail in the report…

Nomacopan: Akari Therapeutics

Nomacopan is a small recombinant protein (16,740 Da) that acts on complement component-C5, preventing the release of C5a and formation of C5b–9 (also known as the membrane attack complex, or MAC). Also, it independently inhibits leukotriene B4, or LTB4, activity, both elements that are collocated as part of the immune/inflammatory response. Nomacopan is currently clinically evaluated in four indications, bullous pemphigoid, atopic keratoconjunctivitis (AKC), thrombotic microangiopathies (TMA) including atypical hemolytic uremic syndrome (aHUS) and hematopoietic stem cell transplant-associated thrombotic microangiopathy (HSCT TMA), and paroxysmal nocturnal hemoglobinuria (PNH). The Phase II study has been completed for bullous pemphigoid and planned to initiate the Phase III study in the first half of 2021. In September 2019, the US FDA granted Orphan Drug Designation to Nomacopan for the treatment of bullous pemphigoid.

Products detail in the report…

List to be continued in the report…

Bullous Pemphigoid Market Outlook

Bullous pemphigoid is a chronic disease characterized by spontaneous exacerbations. It is a self-limiting disease that may last from several months to years. Approximately 30% of bullous pemphigoid patients show a relapse during the first year of treatment with extensive disease and associated dementia as independent risk factors for relapse. Furthermore, after cessation of therapy, approximately half of the patients show a relapse, which most frequently occurs within the first 3 months. Therefore, dealing with treatments for bullous pemphigoid is based more on clinical experience or national or international guidelines than on controlled studies. While the optimal duration of therapy has not been established, patients with bullous pemphigoid usually need to be treated for approximately 6–12 months according to the presence of either mild or generalized disease.

The treatment includes anti-inflammatory drugs, immunosuppressive or immunomodulatory drugs, and procedures to remove circulating pathogenic antibodies or inflammatory mediators.

For decades, systemic corticosteroids have been used and considered as the gold standard for the treatment of the disease, especially for generalized bullous pemphigoid. This therapy was demonstrated to be effective in BP in uncontrolled clinical studies during the 1950s and has become established as the mainstay of treatment. In most cases, the effect is rapid, with suppression of inflammation and blistering achieved typically within 1–4 weeks, after which the dose is gradually reduced. The most commonly used drugs are prednisone and prednisolone, which are assumed to be bioequivalent.

In patients who respond only partially to corticosteroid therapy or who develop adverse effects, non-immunosuppressive agents such as tetracyclines, erythromycin, nicotinamide, and sulfone are used as adjuvant therapy, especially in patients with mild or moderate disease. Tetracyclines and nicotinamide are also considered as treatment in adults, in combination with topical corticosteroids.

There are currently no approved drugs for bullous pemphigoid in the United States. However, in November 2015, the PMDA approved Kenketu Glovenin-I for bullous pemphigoid. The corticosteroid prednisolone was authorized in some EU countries for the treatment of bullous pemphigoid. Patients were also given medicines to suppress the immune system, such as azathioprine, to allow lower doses of corticosteroids to be used.

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Key Findings

• The market size of bullous pemphigoid in the 7MM is estimated to be USD 151 million in 2020, which is further expected to increase by 2030 with a CAGR of 17.70%.
• The United States holds the largest market share of the bullous pemphigoid among the 7MM countries. In 2020, the market size of bullous pemphigoid in the US was USD 63 million.
• In 2020, among the EU-5 countries, the UK had the highest market share, followed by France and Germany.
• Japan holds the smallest share of the 7MM bullous pemphigoid market with a market size of USD 7 million in 2020 that is expected to increase by 2030.

The United States Market Outlook

This section provides the total Bullous Pemphigoid market size and; market size by therapies in the United States.

EU-5 Market Outlook

The total Bullous Pemphigoid market size and market size by therapies in Germany, France, Italy, Spain, and the United Kingdom are provided in this section.

Japan Market Outlook

The total Bullous Pemphigoid market size and market size by therapies in Japan are provided.

Bullous Pemphigoid Drugs Uptake

This section focuses on the rate of uptake of the potential drugs recently launched in the Bullous Pemphigoid market or expected to get launched in the market during the study period 2018–2030. The analysis covers the Bullous Pemphigoid market uptake by drugs; patient uptake by therapies; and sales of each drug. 

This helps in understanding the drugs with the most rapid uptake, reasons behind the maximal use of new drugs, and allows the comparison of the drugs based on market share and size which again will be useful in investigating factors important in market uptake and in making financial and regulatory decisions.

Bullous Pemphigoid Development Activities

The report provides insights into different therapeutic candidates in phase II, and phase III stage. It also analyzes key players involved in developing targeted therapeutics.

Pipeline Development Activities

The report covers the detailed information of collaborations, acquisition, and merger, licensing, and patent details for Bullous Pemphigoid emerging therapies.

Reimbursement Scenario in Bullous Pemphigoid

Approaching reimbursement proactively can have a positive impact both during the late stages of product development and well after product launch. In the report, we consider reimbursement to identify economically attractive indications and market opportunities. When working with finite resources, the ability to select the markets with the fewest reimbursement barriers can be a critical business and price strategy.

Competitive Intelligence Analysis

We perform competitive market Intelligence analysis of the Bullous Pemphigoid market by using various competitive intelligence tools that include–SWOT analysis, PESTLE analysis, Porter’s five forces, BCG Matrix, Market entry strategies, etc. The inclusion of the analysis entirely depends upon the data availability.

Scope of the Report

• The report covers the descriptive overview of Bullous Pemphigoid, explaining its causes, symptoms, pathophysiology, genetic basis, and currently available therapies.
• Comprehensive insight has been provided into the Bullous Pemphigoid epidemiology and treatment.
• Additionally, an all-inclusive account of both the current and emerging therapies for Bullous Pemphigoid is provided, along with the assessment of new therapies, which will have an impact on the current treatment landscape.
• A detailed review of the Bullous Pemphigoid market; historical and forecasted is included in the report, covering the 7MM drug outreach.
• The report provides an edge while developing business strategies, by understanding trends shaping and driving the 7MM Bullous Pemphigoid market.

Report Highlights

• The robust pipeline with novel MOA and oral ROA, increasing prevalence, effectiveness of drugs as both mono and combination therapy will positively drive the Bullous Pemphigoid market.
• The companies and academics are working to assess challenges and seek opportunities that could influence Bullous Pemphigoid R&D. The therapies under development are focused on novel approaches to treat/improve the disease condition.
• Major players are involved in developing therapies for Bullous Pemphigoid. The launch of emerging therapies will significantly impact the Bullous Pemphigoid market.
• Our in-depth analysis of the pipeline assets across different stages of development (phase III and phase II), different emerging trends and comparative analysis of pipeline products with detailed clinical profiles, key cross-competition, launch date along with product development activities will support the clients in the decision-making process regarding their therapeutic portfolio by identifying the overall scenario of the research and development activities.

Bullous Pemphigoid Report Insights

• Patient Population
• Therapeutic Approaches
• Bullous Pemphigoid Pipeline Analysis
• Bullous Pemphigoid Market Size and Trends
• Market Opportunities
• Impact of upcoming Therapies

Bullous Pemphigoid Report Key Strengths

• 10 Years Forecast
• 7MM Coverage
• Bullous Pemphigoid Epidemiology Segmentation
• Key Cross Competition
• Highly Analyzed Market
• Drugs Uptake

Bullous Pemphigoid Report Assessment

• Current Treatment Practices
• Unmet Needs
• Pipeline Product Profiles
• Market Attractiveness
• Market Drivers and Barriers
• SWOT analysis

Key Questions

Market Insights:

• What was the Bullous Pemphigoid market share (%) distribution in 2018 and how it would look like in 2030?
• What would be the Bullous Pemphigoid total market size as well as market size by therapies across the 7MM during the forecast period (2021–2030)?
• What are the key findings pertaining to the market across the 7MM and which country will have the largest Bullous Pemphigoid market size during the forecast period (2021–2030)?
• At what CAGR, the Bullous Pemphigoidmarket is expected to grow at the 7MM level during the forecast period (2021–2030)?
• What would be the Bullous Pemphigoid market outlook across the 7MM during the forecast period (2021–2030)?
• What would be the Bullous Pemphigoid market growth till 2030 and what will be the resultant market size in the year 2030?
• How would the market drivers, barriers, and future opportunities affect the market dynamics and subsequent analysis of the associated trends?

Epidemiology Insights:

• What are the disease risk, burdens, and unmet needs of Bullous Pemphigoid?
• What is the historical Bullous Pemphigoid patient population in the United States, EU5 (Germany, France, Italy, Spain, and the UK), and Japan?
• What would be the forecasted patient population of Bullous Pemphigoid at the 7MM level?
• What will be the growth opportunities across the 7MM with respect to the patient population pertaining to Bullous Pemphigoid?
• Out of the above-mentioned countries, which country would have the highest population of Bullous Pemphigoid during the forecast period (2021–2030)?
• At what CAGR the population is expected to grow across the 7MM during the forecast period (2021–2030)?

Current Treatment Scenario, Marketed Drugs, and Emerging Therapies:

• What are the current options for the treatment of Bullous Pemphigoid along with the approved therapy?
• What are the current treatment guidelines for the treatment of Bullous Pemphigoid in the US and Europe?
• What are the Bullous Pemphigoid marketed drugs and their MOA, regulatory milestones, product development activities, advantages, disadvantages, safety, and efficacy, etc.?
• How many companies are developing therapies for the treatment of Bullous Pemphigoid?
• How many emerging therapies are in the mid-stage and late stages of development for the treatment of Bullous Pemphigoid?
• What are the key collaborations (Industry–Industry, Industry-Academia), Mergers and acquisitions, licensing activities related to the Bullous Pemphigoid therapies?
• What are the recent novel therapies, targets, mechanisms of action, and technologies developed to overcome the limitation of existing therapies?
• What are the clinical studies going on for Bullous Pemphigoid and their status?
• What are the key designations that have been granted for the emerging therapies for Bullous Pemphigoid?
• What are the 7MM historical and forecasted market of Bullous Pemphigoid?

Reasons to buy

• The report will help in developing business strategies by understanding trends shaping and driving Bullous Pemphigoid.
• To understand the future market competition in the Bullous Pemphigoid market and Insightful review of the key market drivers and barriers.
• Organize sales and marketing efforts by identifying the best opportunities for Bullous Pemphigoid in the US, Europe (Germany, Spain, Italy, France, and the United Kingdom), and Japan.
• Identification of strong upcoming players in the market will help in devising strategies that will help in getting ahead of competitors.
• Organize sales and marketing efforts by identifying the best opportunities for the Bullous Pemphigoid market.
• To understand the future market competition in the Bullous Pemphigoid market.