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DelveInsight’s “Onychomycosis Market Insights, Epidemiology, and Market Forecast – 2034” report delivers an in-depth understanding of Onychomycosis, historical and forecasted epidemiology, as well as the Onychomycosis market trends in the United States, EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan.

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Key Takeaways from the Onychomycosis Market Report

• In January 2026, Hallux Inc. received FDA approval to initiate a Phase 2b clinical trial for its Hallux Subungual Gel 42% (HSG 42), a treatment for toenail fungus. The trial will enroll approximately 134 participants to evaluate the safety and efficacy of HSG 42.

• In November 2025, Moberg Pharma signed an exclusive licensing agreement with Karo Healthcare for the commercialization of MOB-015 (Terclara®) in Europe. Under the agreement, Karo Healthcare obtained the exclusive rights to market and distribute MOB-015 across 19 European countries.

• The leading Onychomycosis companies include Blueberry Therapeutics, Mycovia Pharmaceuticals, Pfizer, Bausch Health, Valeant Pharmaceuticals, and others.

• Rising prevalence of Onychomycosis globally, driven by aging populations, poor foot hygiene, tight footwear, and frequent exposure to communal areas such as swimming pools, is accelerating demand for advanced antifungal therapies offering effective and durable treatment outcomes.

• Breakthroughs in nanotechnology-based topical delivery platforms, selective fungal CYP51 inhibitors, and novel oral antifungal formulations are expanding therapeutic applications and improving clinical efficacy.

• The Onychomycosis market in the 7MM is expected to witness major change during the study period 2020–2034, with the United States accounting for approximately 61% of the total 7MM market size.

• In 2023, approximately 83,553 thousand diagnosed prevalent cases of Onychomycosis existed across the 7MM, with the US alone recording approximately 37,250 thousand total prevalent cases.

• Key subtypes currently driving clinical classification and treatment decisions include Distal Subungual Onychomycosis (DSO), Superficial White Onychomycosis (SWO), Proximal Subungual Onychomycosis (PSO), Endonyx Onychomycosis (EO), Total Dystrophic Onychomycosis (TDO), and Secondary Onychomycosis (SO), among others.

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Onychomycosis Epidemiology Segmentation in the 7MM

• Total Prevalent Cases of Onychomycosis

• Total Diagnosed Prevalent Cases of Onychomycosis

• Subtype-specific Diagnosed Prevalent Cases of Onychomycosis

• Severity-specific Diagnosed Prevalent Cases of Onychomycosis

Onychomycosis Treatment Market

Onychomycosis Pipeline Analysis

BB2603: Blueberry Therapeutics

BB2603 is a squalene epoxidase inhibitor formulated as a spray, leveraging nanotechnology to deliver terbinafine through the nail plate and into the skin to treat fungal infections. It maintains the potency of the oral gold standard at a lower dose through targeted nail-bed delivery, reducing systemic side effects. In November 2023, BB2603 met the primary endpoint in its Phase IIb trial (BBTAF202) with high statistical significance, demonstrating superiority over placebo in onychomycosis patients. BB2603 is expected to achieve a probability-adjusted peak market share of approximately 6% in the US, with a medium uptake trajectory and an estimated five years to peak from the year of launch.

VT-1161: Mycovia Pharmaceuticals

VT-1161 is a potent, selective, and orally available inhibitor of fungal CYP51, demonstrating broad-spectrum activity against Candida species and dermatophytes, including Trichophyton rubrum and Trichophyton mentagrophytes — the two most common dermatophyte species responsible for onychomycosis. Its high selectivity for fungal CYP51 is designed to avoid the hepatotoxicity and drug interactions that limit the use of currently approved antifungals such as fluconazole, itraconazole, and terbinafine, positioning it as a fierce competitor to current standard-of-care agents.

KERYDIN (tavaborole): Pfizer

KERYDIN is an oxaborole antifungal topical solution (5% w/w) that inhibits fungal protein synthesis by blocking aminoacyl-tRNA synthetase (AARS). Its small molecular weight enables penetration through the nail plate to interfere with protein synthesis in fungal cells. Approved by the US FDA in July 2014 for the treatment of onychomycosis of the toenails caused by Trichophyton rubrum or Trichophyton mentagrophytes.

JUBLIA/CLENAFIN (efinaconazole): Bausch Health

JUBLIA is a topical triazole antifungal (10% nail solution) with lower minimum inhibitory concentrations than terbinafine, ciclopirox, itraconazole, and amorolfine in key dermatophyte and Candida species. Its solution-based formula features low surface tension and low keratin binding, enhancing nail plate penetrance. Approved by the US FDA in June 2014 and by Japan’s PMDA in July 2014 (as CLENAFIN), it has been established as a key topical treatment option for distal and lateral subungual onychomycosis.

Onychomycosis Market Insights

The current treatment landscape is divided into systemic (oral) and topical pharmacotherapy routes. Oral antifungals — including terbinafine (Lamisil), itraconazole, fluconazole, griseofulvin, and ketoconazole — deliver higher cure rates but carry risks of hepatotoxicity and drug interactions, requiring periodic liver function monitoring. Topical treatments, including efinaconazole, tavaborole, ciclopirox, and amorolfine, offer a more favorable side-effect profile but generally achieve lower cure rates and require substantially longer treatment regimens.

Among the currently approved treatments, Topical Pharmacotherapy is expected to garner the highest market size by 2034 in the US, driven by the anticipated entry of next-generation topical formulations offering faster action and improved nail penetration.

Among the EU4 and the UK, France accounted for the highest number of diagnosed prevalent Onychomycosis cases (approximately 2,046 thousand in 2023) and the highest market size (approximately USD 123 million in 2023).

The competitive landscape is innovation-driven, with leading players advancing nanotechnology-based delivery platforms and highly selective oral antifungal agents to overcome the key limitations of existing therapies — low cure rates, long treatment duration, and systemic side effects.

Growth of the Onychomycosis market is expected to be mainly driven by improved diagnostic approaches, an upsurge in the launch of products, and increasing research in pharmaceutical treatment, alongside a rising diagnosed patient pool across the 7MM through 2034.

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Onychomycosis Market Outlook

Onychomycosis is the most common nail infection worldwide, commonly referred to as “toenail fungus” given that toenail infections constitute the majority of cases. Estimated to affect nearly 3% of the general adult population — with approximately 20% prevalence among individuals aged 40 to 60 years — it is one of the most prevalent foot complaints for which adults seek both over-the-counter and prescription treatment. Traditionally thought to be caused predominantly by dermatophytes, newer research has revealed that mixed infections and those caused by nondermatophyte molds are more prevalent than previously understood, particularly in warmer climates. The Onychomycosis pipeline is increasingly robust with promising Phase II and III candidates, and the treatment space is expected to undergo a significant positive shift during the forecast period. Market growth may be offset by high recurrence rates, inadequate penetration of existing topical formulations, suboptimal cure rates, hepatotoxicity concerns with oral agents, and reimbursement challenges for newer therapies.

Scope of the Onychomycosis Market Report

• Coverage: 7MM

• Study Period: 2020–2034

• Forecast Period: 2024–2034

• Onychomycosis Companies: Blueberry Therapeutics, Mycovia Pharmaceuticals, Pfizer, Bausch Health, Valeant Pharmaceuticals, and others

• Onychomycosis Therapies: BB2603, VT-1161, KERYDIN (tavaborole), JUBLIA/CLENAFIN (efinaconazole), Terbinafine (Lamisil), and others

• Onychomycosis Market Access & Reimbursements, Unmet Needs and Perspectives

• Onychomycosis SWOT Analysis and KOL Views

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Table of Contents

1. Key Insights

2. Report Introduction

3. Onychomycosis Market Overview at a Glance

4. Executive Summary of Onychomycosis

5. Disease Background and Overview

6. Treatment of Onychomycosis

7. Management of Onychomycosis

8. Guidelines

9. Epidemiology and Patient Population

10. Patient Journey

11. Marketed Products

12. Emerging Therapies

13. Onychomycosis: Seven Major Market

14. Key Opinion Leaders’ Views

15. SWOT Analysis

16. Unmet Needs

17. Market Access and Reimbursement

18. Appendix

19. DelveInsight Capabilities

20. Disclaimer

21. About DelveInsight

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