Frontal Fibrosing Alopecia (U.S.), January 2023
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.
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®: 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
However, JAK inhibitor use is not widespread (<10% of patients) mostly due to insurance restrictions. Physicians are eager for treatment options indicated specifically for FFA able to achieve complete response defined as stopping hair loss and inflammatory progression of the disease. Currently, about half of all patients achieve this goal, as one interviewed dermatologist states: “The condition will eventually burn out spontaneously, so we are preventing follicular loss in patients who are going to otherwise lose a lot of their hair permanently.”
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
With no indication that Pfizer plans to apply for a label extension, there is opportunity for other pharmaceutical companies to develop treatments for FFA and own a significant share of the market.
Pooja Patel, Analyst at REACH: “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.”
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
2. EPIDEMIOLOGY & PATIENT POPULATIONS
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
3. DIAGNOSIS AND CURRENT TREATMENT
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
4. UNMET NEED
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
5. PIPELINE ANALYSIS
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
6. VALUE & ACCESS
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)
7. METHODOLOGY
Primary market research approach
Epidemiology methodology
What is the difference between purchasing a published report and requesting a new report?
Published reports have been pre-produced on the specified date and can be delivered immediately. If you prefer to refresh an existing report or request an entirely new disease, REACH can create and deliver any new report within 15 business days.
How does REACH produce new primary market research reports in 15 business days?
By deploying our senior team to each of our reports, we can begin insight generation on day 1. The REACH team also recruits Key Opinion Leaders from our internal panel rather than outsourcing recruitment which enables us to quickly begin primary market research interviews.
Who writes REACH reports?
Each REACH report is produced by one of our senior US-based team members with 10+ years of experience in life sciences market research. We are deeply committed to ensuring REACH reports are high quality and strategic to enable informed decision-making for our clients.
Does REACH cover both rare and non-rare diseases?
REACH specializes in covering diseases and subpopulations that are not addressed by traditional market research reports. As such, we focus on rare diseases and niche subpopulations of more common conditions (e.g., Dupixent-refractory atopic dermatitis). Our flexible model enables in-depth assessments across all disease types, allowing us to support research for non-rare conditions as well.
Can I meet with the team to discuss the report?
Contact us to set up a call directly with the analyst who has written the report to answer any questions and discuss the key takeaways.
Published Report
New Report
Undecided about purchasing this report?
Reach out to learn more about report bundle discounts