Bullous Pemphigoid (U.S.), February 2023
The MarketVue®: Bullous Pemphigoid market landscape report combines primary (KOL interviews and survey data) and secondary market research to empower strategic decision-making and provide a complete view of the market.
Every MarketVue® includes a disease overview, epidemiology (US and EU5), current treatment, unmet needs, pipeline and access and reimbursement chapter.
Topics covered in this report:
- Disease overview: Review the disease pathophysiology and potential druggable targets
- Epidemiology: Understand prevalence, diagnosed and drug-treated prevalence of the population and key market segments
- Current treatment: Understand the treatment decision tree and strengths and weaknesses of current on-label and off-label treatment
- Unmet needs: Identify opportunities to address treatment or disease management gaps
- Pipeline analysis: Compare current and emerging therapy clinical development strategy; their performance on efficacy, safety, and delivery metrics; and their potential to address unmet needs
- Value and access: Gain insights into the drug pricing landscape and payer controls within the disease market or analogous markets
Methodology:
Research for the MarketVue®: Bullous Pemphigoid report is supported by 4 qualitative interviews with key opinion leaders, a quantitative survey with 25 U.S. physicians and secondary research.
Geographies covered:
United States plus epidemiology for EU5 (France, Germany, Italy, Spain, United Kingdom)
Key companies mentioned:
- Regeneron
- Sanofi
- AstraZeneca
- argenx
- AKARI Therapeutics
- Immune Pharmaceuticals
Key drugs mentioned:
- Corticosteroids
- Tetracycline
- Rituximab (Rituxan)
- Omalizumab (Xolair)
- Dupilumab (Dupixent)
- Benralizumab (Fasenra)
- Doxycycline
- Dapsone+J17
- Niacinamide
- Minocycline
- Azathioprine
- Cyclophosphamide
- Methotrexate
- Cyclosporine
- IVIg (Panzyga)
- Efgartigimod
- Nomacopan
- Prednisone
- Bertilimumab
- Mycophenolate mofetil
Key takeaways from the report:
Bullous pemphigoid (BP) is a rare, autoimmune, blistering disease for which there are no approved therapies. BP is associated with significant morbidities such as:
- Subepidermal blistering
- Severe pruritis
- Infection
- Diminished quality of life
In the absence of approved treatments, physicians utilize oral corticosteroids as first-line treatment to quickly eliminate pruritus and stop further blistering in the acute phase of BP. However, chronic use of corticosteroids can lead to life-threatening side effects; therefore, physicians assert that improving the time between relapses without long-term reliance on corticosteroids is a significant unmet need in the treatment of BP. Furthermore, nearly three-quarters of surveyed dermatologists rated therapies that can minimize corticosteroid exposure in the acute setting as an “important” unmet need in the treatment landscape, according to REACH Market Research’s MarketVue® assessment.
Dermatologist, U.S.: I’m most optimistic for the biologics. I think there’s enough in the pipeline that something will hopefully get an on-label indication, and that’ll improve accessibility for patients to these treatments. Being able to give somebody something that’s not increasing their risk of infection and death, but rather helping their symptoms without increasing those risks would be nice and seems attainable.
The BP pipeline contains a number of biologics, including:
- argenx’s FcRn inhibitor – efgartigimod
- Regeneron/Sanofi’s IL-4/IL-13 inhibitor – dupilumab
- AstraZeneca’s IL-5 inhibitor – benralizumab
Dermatologists report that preliminary results from clinical trials of biologics such as FcRn and IL-4 inhibitors look promising, although some express doubts that they would be efficacious enough to eliminate the need for corticosteroids.
Tyler Jakab, Analyst at REACH: “Physicians seem to agree that emerging therapies like FcRn inhibitors hold promise in reducing the circulating autoantibodies that drive autoimmune diseases like bullous pemphigoid. However, BP is also characterized by complement and eosinophil activity, so we’ll have to await clinical trial results to see if these therapies measure up to steroids in terms of efficacy and speed in controlling the inflammation found in the acute phase of the disease.”
1. DISEASE OVERVIEW
A rare, progressive autoimmune disease causing blistering of the skin and mucous membranes
Table 1.1. Select diagnostic features of patients presenting with Pemphigus Vulgaris and Pemphigus Foliaceus
Underlying pathophysiology dictates current and future targets for therapy
Figure 1.1. The pathophysiology of pemphigus
2. EPIDEMIOLOGY & PATIENT POPULATIONS
Disease definition
Figure 2.1. Diagnosed prevalent cases of BP by region
Table 2.1 Diagnosed incident, prevalent, and drug-treated patients in the US and EU5
3. DIAGNOSIS & CURRENT TREATMENT
Diagnosis overview
Figure 3.1. Diagnostic pathway for bullous pemphigoid patients
Once patients reach a physician familiar with bullous pemphigoid, diagnostic testing for auto-antibodies is standard
Figure 3.2. Dermatologist-reported percentage of bullous pemphigoid patients misdiagnosed/not diagnosed in a timely manner
Figure 3.3. Percentage of bullous pemphigoid patients in each severity category
Figure 3.4. Percentage of bullous pemphigoid patients in each age category (years)
Achieving complete response off long-term corticosteroid treatment is the ultimate goal
Figure 3.5. Surveyed U.S. dermatologist bullous pemphigoid patient load
Table 3.2. Treatment goals for bullous pemphigoid
Figure 3.6. Dermatologist-reported proportion of bullous pemphigoid patients currently treated with drug therapy
Treatment flow for bullous pemphigoid
While there is no standard approach to treatment, corticosteroids are the mainstay of treatment
Figure 3.7. Dermatologist-reported current treatment share for
bullous pemphigoid
Figure 3.8. Dermatologist-reported BP patients’ response to treatment
Bullous pemphigoid has periods of higher activity and remission that wax and wane
Table 3.3. Key terms to know for bullous pemphigoid
Figure 3.9. Dermatologist-reported proportion of BP patients achieving different disease responses
Upsides and downsides of current bullous pemphigoid treatments
Physician perspectives on current treatment regimens
Table 3.4. KOL insights on current regimens
Key treatment dynamics that shape disease management and drug use in bullous pemphigoid
Figure 3.10. Dermatologist-reported % of BP patients not well-managed by current treatments
Table 3.5. Must-know bullous pemphigoid treatment dynamics
Figure 3.11. Dermatologist ranking of attribute importance as an outcome in a pivotal trial
Key treatment dynamics that shape disease management and drug use in bullous pemphigoid
Figure 3.12. Dermatologists’ perceptions of aspects of bullous pemphigoid treatment versus pemphigus
There is large opportunity for corticosteroid-sparing therapies that are just as effective as prednisone
Figure 3.13. Important dynamics of bullous pemphigoid market evolution
4. UNMET NEED
Overview
Figure 4.1. Dermatologist-reported unmet needs in bullous pemphigoid
Physician insights on the most urgent unmet needs for pemphigoid
5. PIPELINE ANALYSIS
Overview
Figure 5.1. Key differences in efgartigimod trials in pemphigus vulgaris/foliaceus and bullous pemphigoid
Table 5.1. Comparison of ongoing trials of therapies for bullous pemphigoid
Physician insights on the pemphigoid pipeline
6. VALUE & ACCESS
Overview
Table 6.1. Bullous pemphigoid therapy pricing, U.S.
Figure 6.1. Bullous pemphigoid patients by insurance type
Table 6.2. Typical U.S. commercial payer coverage of Rituximab for pemphigus patients (United Healthcare, Aetna, BlueCross BlueShield, Cigna)
7. METHODOLOGY
Primary market research approach
Epidemiology methodology
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