The MarketVue®: Frontal Fibrosing Alopecia 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.
An analyst from the research firm, stated: 'With very few therapies in development for FFA, dermatologists will continue to rely upon off-label treatments. Although the first approved therapy will likely be a JAK inhibitor, dermatologists agree they would like to see more research into the pathophysiology of the disease to identify more druggable targets such as the IL-17/23 pathway, interferon gamma, and retinoic acid receptors.'
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: Review the evidence needed to assess and communicate value to key stakeholders (e.g., providers, payers, regulators) and learn what competitors have done or are doing
Methodology:
Research for the MarketVue®: Frontal Fibrosing Alopecia report is supported by 6 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:
- LEO Pharma
- Pfizer
Key drugs mentioned:
- Finasteride
- Dutasteride
- Tacrolimus
- Pimecrolimus
- Hydroxychloroquine
- Tetracycline
- Minoxidil
- Methotrexate
- Mycophenolate mofetil
- Pioglitazone
- Naltrexone
- Apremilast
- Baricitinib (Olumiant)
- Delgoticinib
- Ritlecitinib
Key takeaways from the report:
Since the June 2022 approval of Eli Lilly’s Olumiant (baricitinib), the AA market landscape has been dynamic with two more oral JAK inhibitors (e.g., Pfizer’s ritlecitinib and SUN/Concert Pharmaceutical’s deuruxolitinib) likely to be approved in the next year. In contrast, there is no FDA-approved treatment for FFA, a rare hair loss condition with a high clinical and psychosocial burden marked by frontal hairline recession and inflammation causing itching, pain, and burning.Currently, FFA patients are managed primarily with off-label:
- Corticosteroids
- JAK inhibitors
- Non-steroidal immunosuppressants
Despite the high unmet need for effective treatments, the FFA pipeline is sparse, with few options under investigation including:
- LEO Pharma’s topical pan-JAK delgocitinib
- Pfizer’s TEC/JAK3 ritlecitinib through an investigator-initiated study
An analyst from the research firm, stated: 'With very few therapies in development for FFA, dermatologists will continue to rely upon off-label treatments. Although the first approved therapy will likely be a JAK inhibitor, dermatologists agree they would like to see more research into the pathophysiology of the disease to identify more druggable targets such as the IL-17/23 pathway, interferon gamma, and retinoic acid receptors.'
Table of Contents
1. DISEASE OVERVIEW- A slow, chronic inflammatory, hormonal disorder causing hair loss
- Figure 1.1. Hair loss in scarring alopecias
- Figure 1.2. Key differences between AA and FFA
- Disease definition
- Figure 2.1. G6 prevalent cases of FFA by region
- Table 2.1 Diagnosed prevalent and drug-treated populations of FFA in the U.S. and EU5
- Diagnosis overview
- Figure 3.1. Diagnostic journey for frontal fibrosing alopecia patients
- Figure 3.2. American Academy of Dermatology proposed diagnostic criteria
- Since no laboratory tests are necessary, physicians rely on clinical signs and symptoms for diagnosis
- Figure 3.3. Dermatologist-reported percentage of frontal fibrosing alopecia patients misdiagnosed/not diagnosed in a timely manner
- Dermatologists’ opinions on misdiagnosis
- Stopping the inflammatory process and further hair loss are the ultimate goals of treatment
- Figure 3.4. Surveyed U.S. dermatologist frontal fibrosing alopecia patient load
- Figure 3.5. Treatment goals for frontal fibrosing alopecia
- Figure 3.6. Dermatologist-reported proportion of frontal fibrosing alopecia patients currently treated with drug therapy
- Treatment flow for frontal fibrosing alopecia
- Figure 3.7. Treatment algorithm for the management of frontal fibrosing alopecia
- While there is no standard approach to treatment, most FFA patients are on some form of steroid medication
- Figure 3.8. Dermatologist-Reported Current Treatment Patient Shares in Frontal Fibrosing Alopecia
- Standard of care (SOC)
- Physicians have different opinions on what remission means for frontal fibrosing alopecia
- Figure 3.9. Dermatologist-reported FFA patients’ response to treatment
- Figure 3.10. Dermatologist-reported proportion of frontal fibrosing alopecia patients achieving different degrees of disease response
- Upsides and downsides of all current off-label FFA treatments
- Physician perspectives on current treatment regimens
- Figure 3.11. Dermatologist-reported % of frontal fibrosing alopecia patients not well-managed by current treatments1
- Key treatment dynamics that shape disease management in FFA
- Figure 3.12. U.S. dermatologists ranking of attribute importance when selecting treatments
- Table 3.1. Must-know frontal fibrosing alopecia treatment dynamics
- Alopecia areata vs. frontal fibrosing alopecia: different treatment goals, but some physicians are using JAK inhibitors off-label
- Figure 3.13. U.S. dermatologists view on select attributes of frontal fibrosing alopecia (FFA) as compared to alopecia areata (AA)
- Physician perspectives on the use of JAK inhibitors in FFA
- FFA has a severe psychosocial and quality of life impact on patients
- Figure 3.14. Dermatologists’ rating of frontal fibrosing alopecia impact on patients1
- First approved therapies for frontal fibrosing alopecia likely to be JAK inhibitors
- Figure 3.15. Important dynamics of frontal fibrosing alopecia market evolution
- Overview
- Figure 4.1. Top unmet needs in FFA
- Figure 4.2. Dermatologist-reported unmet needs in FFA
- Physician insights on unmet needs in frontal fibrosing alopecia
- Overview
- Table 5.1. Comparison of ongoing clinical trials for FFA
- Opinions are mixed on which MOA is the most promising and which clinical outcomes are most relevant
- Overview
- Table 6.1. Current therapy pricing, U.S. 2022
- Lack of a clear ICD-10 code for FFA may impede therapy approval efforts
- Figure 6.1. Reimbursement and Access Considerations for Emerging Therapies in FFA
- Figure 6.2. FFA patients by insurance type in the U.S.
- Insurers coverage of baricitinib in AA could be an indicator of future access criteria for FFA
- Table 6.2. Typical U.S. commercial payer coverage of baricitinib for AA patients in 2022 (United, Aetna, Cigna, BCBS)
- Primary market research approach
- Epidemiology methodology
Samples
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Companies Mentioned
- LEO Pharma
- Pfizer
