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Market Opportunity

Onychomycosis is notoriously difficult to treat and cosmetically distressing. One in 4 patients don’t respond to therapy, and up to half of patients will experience relapse.Beyond efficacy issues, treatment options for onychomycosis come with certain risks. A 3- to 6-month regimen of oral antifungals comes with hepatotoxicity risk and a host of drug interaction possibilities. Most notably, the azole antifungals inhibit the most prevalent and critical hepatic enzyme (CYP3A4) in drug metabolism.  Despite these interaction risks, oral therapy is more effective and takes up to 75% less time to complete than topical therapy. Cure rates for oral therapy fall between 45% to 70%, and total remission occurs for 35% to 80% of patients.
Onychomycosis Treatment: Are Topical Therapies Worthwhile?
Daniel Holland, PharmD
The global dermatophytic onychomycosis (DO) therapeutics market was valued at US$ 3.1 billion in 2015, of which North America was the largest market accounting for over 43% revenue share and expected to a compound annual growth rate (CAGR) of 9.2% until 2021. In Asia Pacific, this market is projected to expand at the highest CAGR of 5.1% during the forecast period.
By product, revenue from the tablet segment is projected to rise at the highest CAGR of 5.2% during the forecast period. The nail paint segment is expected to dominate the market, accounting for a maximum share of the overall market by 2021. The nail paint segment revenue is projected to rise at a CAGR of 8.3% during the forecast period (2015–2021).
By treatment, the topical segment is estimated to dominate the dermatophytic onychomycosis therapeutics market, accounting for a maximum share of the overall market by 2015 end. Revenue from the topical segment is projected to increase at a CAGR of 8.3% during the forecast period.
Source:  Global Market Study on Dermatophytic Onychomycosis Therapeutics (DOT): North America Expected to Account for Maximum Market Share by 2021, Due to Increasing Prevalence of Fungal Toe Nail Infections
Competition in this space includes oral anti-fungal treatments, laser treatment and topical anti-fungal treatments.  The ToeFX solution is low-cost, safe and shows high efficacy in preliminary studies.