Pemphigus Vulgaris (U.S.), January 2023
The MarketVue®: Pemphigus Vulgaris 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®: Pemphigus Vulgaris report is supported by 4 qualitative interviews with key opinion leaders, a quantitative survey with 20 U.S. physicians and secondary research.
Geographies covered:
United States plus epidemiology for EU5 (France, Germany, Italy, Spain, United Kingdom)
Key companies mentioned:
- argenx
- Cabaletta Bio
- National Institute of Allergy and Infectious Diseases (NIAID)
Key drugs mentioned:
- Rituximab
- Mycophenolate
- Azathioprine
- Cyclophosphamide
- Methotrexate
- Cyclosporine
- Tetracycline
- Dapsone
- Efgartigimod (Vyvgart)
- DSG3-CAART
- Regulatory T Cells
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 pemphigus by region in 2021
Table 2.1 Diagnosed incident, prevalent, and drug-treated patients in the US and EU5
3. DIAGNOSIS & CURRENT TREATMENT
Overview
Figure 3.1. Diagnostic pathway for pemphigus patients
Once patients reach a physician familiar with pemphigus, diagnostic testing for auto-antibodies is standard
Figure 3.2. Dermatologist-reported percentage of pemphigus patients misdiagnosed/not diagnosed in a timely manner
Table 3.1. Pemphigus severity classification used in clinical practice according to interviewed dermatologists
Figure 3.3. Percentage of pemphigus patients in each PDAI severity category used in clinical trials
Achieving complete response off long-term corticosteroid treatment is the ultimate goal
Figure 3.4. Dermatologist-reported proportion of pemphigus patients currently treated with drug therapy
Table 3.2. Key terms to know for pemphigus
Table 3.3. Treatment goals for pemphigus
Treatment flow for pemphigus
While there is no standard approach to treatment; FDA approval of rituximab has replaced use of steroid-sparing immunosuppressants for many physicians
Figure 3.5. Dermatologist-reported current treatment share for newly diagnosed PV and PF patients
Figure 3.6. Dermatologist-reported proportion of pemphigus patients achieving different disease response
Upsides and downsides of current pemphigus treatments
Comparison of published regimens for pemphigus
Table 3.4. Comparison of available clinical trial data for current pemphigus treatment regimens
Physician perspectives on current treatment regimens
Table 3.5. KOL insights on current regimens
Upsides and downsides of rituximab
Figure 3.7. Rituximab – upside and downside
Figure 3.8. Dermatologist-reported % of pemphigus patients not well-managed by current treatments
Physician perspectives on rituximab product attributes
Key treatment dynamics that will shape disease management and drug use in pemphigus
Figure 3.9. Important dynamics of pemphigus market evolution
4. UNMET NEED
Overview
Figure 4.1. Dermatologist-reported unmet needs in pemphigus
The need for new PV treatments is high compared to other dermatologic conditions
Figure 4.2. U.S. dermatologists’ rating of the need for new treatments in dermatologic conditions
Physician insights on the most urgent unmet needs for pemphigus
5. PIPELINE ANALYSIS
Overview
Figure 5.1. Current vs future therapeutic goals for pemphigus
Comparison of ongoing trials of emerging pemphigus therapies
Table 5.1. Comparison of ongoing trials of therapies for pemphigus
Efgartigimod is poised to be the next entrant to the pemphigus market; well-ahead of any competitors
Figure 5.2. Phase 2 results for argenx’s efgartigimod
Figure 5.3. Percentage of dermatologists rating CROT as “important” in a pivotal trial for a novel PV therapy
Figure 5.4. Efgartigimod- upside and downside
Dermatologists’ opinions on the PV pipeline
6. VALUE & ACCESS
Overview
Table 6.1. Pemphigus therapy pricing, U.S.
Table 6.2. Typical U.S. commercial payer coverage of rituximab and IVIg for pemphigus patients (Aetna, BCBS, Cigna, United)
Key market access dynamics that will continue to shape treatment use
Figure 6.1. Pemphigus patients by insurance type
Genetech and argenx utilize patient support programs to expand access
Figure 6.2. Strategies that could be used by Efgartigimod (SC) to compete with Rituximab (IV)
7. METHODOLOGY
Primary market research approach
Epidemiology methodology
Appendix: List of abbreviations used in pemphigus report
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