United States Onychomycosis Treatment Market 2031 | Growth Drivers, Key Players & Investment Opportunities

Market Size and Growth

The global Onychomycosis Treatment Market is projected to experience steady growth during the forecast period from 2024 to 2031. Onychomycosis, a common fungal infection affecting toenails and fingernails, is primarily caused by dermatophytes such as Trichophyton rubrum, along with non-dermatophyte molds and yeasts. As awareness of the condition improves and diagnostic capabilities advance, the demand for effective treatments continues to rise worldwide, driving market expansion.

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Recent Developments

United States: Recent Onychomycosis Treatment Developments

✅ In November 2025, a post‐hoc analysis confirmed that Efinaconazole 10% topical solution remains effective and safe for adults (18-70 yrs) with mild-to-moderate toenail onychomycosis, achieving consistent complete‐ and mycological‐cure rates across diverse patient subgroups.

✅ In 2025, a review of onychomycosis therapies underscored next‐generation topical agents and alternative delivery methods as promising noting that newer agents like Luliconazole (pending US approval for nail solution) have strong antifungal activity in preclinical models.

✅ In 2025, experts highlighted personalized treatment for high-risk groups (e.g., diabetes, older adults), suggesting that topical regimens such as Efinaconazole 10% may offer a safer profile compared to systemic therapy expanding treatment accessibility.

✅ In 2024-2025, there is growing clinical and regulatory interest in alternative systemic and topical agents beyond traditional oral drugs reflecting a shift toward treatments with better safety, fewer interactions, and easier use for mild/moderate onychomycosis.

Japan: Recent Onychomycosis Treatment Developments

✅ In September 2025, a real‐world study of 477 culture‐positive onychomycosis patients reported rising cases of resistance to conventional oral antifungals (e.g., terbinafine, itraconazole), and identified that resistant strains were still sensitive to agents such as Fosravuconazole, Efinaconazole, and Luliconazole supporting their continued use.

✅ In 2025, updated real‐world evidence shows increased prescriptions of Fosravuconazole for onychomycosis in Japan, particularly among older adults and those refractory to topical therapy demonstrating its growing role as a preferred oral antifungal option.

✅ In early 2025, an ultrastructural study reported that Luliconazole 5% nail‐solution achieves effective penetration and antifungal action in infected nails, reinforcing the rationale for topical therapy in Japan.

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Market Overview

Onychomycosis manifests clinically through several subtypes including distal and lateral subungual onychomycosis (DLSO), superficial white onychomycosis (SWO), proximal subungual onychomycosis (PSO), candidial onychomycosis, and total dystrophic onychomycosis. The infection leads to nail discoloration, thickening, deformation, and can cause discomfort and secondary infections if untreated. Treatment options primarily include oral and topical antifungal agents, with oral therapy commanding a significant share of the market due to its higher efficacy despite longer treatment durations and potential side effects.

Market Drivers

A primary factor propelling market growth is the rising prevalence of diabetes globally. Diabetic patients are more susceptible to fungal infections like onychomycosis and face higher risks of severe complications. According to the International Diabetes Federation, approximately 537 million adults aged 20-79 were living with diabetes in 2021, a number expected to rise substantially, thereby increasing the patient pool requiring onychomycosis treatment. Moreover, advancement in therapeutic options, including newer antifungal agents and improved formulations, is continuously expanding the treatment landscape.

Increasing awareness about the infection and its complications among patients and healthcare providers also bolsters market demand. Improved diagnostics enable earlier detection, facilitating timely treatment initiation to reduce disease burden. Additionally, demographic factors such as aging populations susceptible to fungal infections support the sustained market growth.

Competitive Landscape

Major players leading the onychomycosis treatment market include Bausch Health Companies Inc., Novartis AG, Pfizer Inc., Moberg Pharma AB, Bayer AG, Dr. Reddy's Laboratories Ltd., Gladerma, Medimetriks Pharmaceuticals Inc., Kaken Pharmaceuticals, and Hahn Medical Systems, among others. These companies focus on developing innovative formulations, expanding geographic presence, and engaging in clinical trials to enhance their product portfolios and market penetration.

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Market Restraints

Despite the growth prospects, the market faces some restraints. A significant challenge is the lack of awareness about onychomycosis in several regions, which leads to underdiagnosis and undertreatment. Many individuals ignore symptoms such as nail discoloration or thickening, delaying medical consultation. Furthermore, side effects associated with antifungal medications, particularly oral therapies like terbinafine, which can cause gastrointestinal disturbances, rash, and elevated liver enzymes, may hinder patient compliance and impact market growth.

Market Segment Analysis

The market segmentation includes type, treatment type, end user, and region. Oral therapy accounts for a significant portion, approximately 41.3% of the total market share, as it provides superior efficacy compared to topical treatments. Common oral antifungal agents include griseofulvin, terbinafine, and itraconazole, often prescribed for extended durations required to fully eradicate the infection. Topical treatments, although less effective in severe cases, offer advantages of localized application and reduced systemic side effects, making them suitable for mild infections and patients with contraindications to oral drugs.

End users of onychomycosis treatments include hospitals, dermatology clinics, and outpatient care facilities, with hospitals holding the majority share due to availability of comprehensive diagnostic and treatment services.

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Geographical Insights

North America is estimated to hold about 40.4% of the global onychomycosis treatment market share throughout the forecast period. The region's dominance is attributed to a high prevalence of fungal infections among adults, robust healthcare infrastructure, advanced diagnostic methodologies, and increased patient awareness. Ongoing clinical trials and novel product launches further stimulate market growth. For instance, in January 2024, Vanda Pharmaceuticals announced FDA approval to investigate VTR-297 for onychomycosis treatment, reflecting active research initiatives in the region.

Asia-Pacific, while currently smaller than North America in market size, is a fast-growing region driven by rising healthcare access, increasing diabetic population, and awareness campaigns. Governments and healthcare providers in key countries like India, China, and Japan are progressively promoting early diagnosis and treatment programs, expanding the addressable patient base.

COVID-19 Impact Analysis

The COVID-19 pandemic significantly impacted the onychomycosis treatment market primarily due to disruptions in healthcare access and changes in patient visit patterns. Clinical examinations and diagnostic tests were deferred, and telemedicine became a prevalent alternative for diagnosis and management. While this shift initially slowed traditional treatment uptake, the pandemic also accelerated digital health adoption, potentially facilitating long-term patient engagement and monitoring improvements.

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Why Purchase the Report?

Comprehensive segmentation analysis based on type, treatment type, end-user, and regional markets offering valuable insights. Identification of commercial opportunities via trend analysis and potential co-development strategies. Access to detailed Excel data sheets encompassing multiple market points with exhaustive qualitative and quantitative research. Extensive competitive landscape profiling including mergers and acquisitions, growth strategies, and product mapping. Detailed documentation of regulatory frameworks, pricing models, supply chain analysis, and emerging market trends to support strategic decisions.

DataM Intelligence's onychomycosis treatment market report equips manufacturers, investors, healthcare professionals, and stakeholders with actionable insights to capitalize on growth opportunities and navigate challenges.

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