US Onychomycosis Market Trends

US Onychomycosis Market Overview

US Onychomycosis Market Size was valued at USD 1.62 Billion in 2023. The Onychomycosis market industry is projected to grow from USD 1.75 Billion in 2024 to USD 3.12 Billion by 2032, exhibiting a compound annual growth rate (CAGR) of 7.44% during the forecast period (2024 - 2032).

Increasing prevalence of onychomycosis and chronic illness, increased R&D for the discovery of innovative medications are the key market drivers enhancing the market growth.

Source: Secondary Research, Primary Research, MRFR Database and Analyst Review

Lupin announced the US launch of Tavaborole Topical Solution, 5% in July 2021, following its approval by the United States Food and Drug Administration (FDA). The substance will be produced at Lupin's facility in Pithampur, India. Tavaborole Topical Solution, 5%, is the generic equivalent of Kerydin® Topical Solution, 5%, of Anacor Pharmaceuticals, Inc. It is an oxaborole antifungal that is authorized for the topical treatment of onychomycosis of the toenails caused by Trichophyton rubrum or Trichophyton mentagrophytes. The estimated annual sales of Tavaborole Topical Solution (RLD: Kerydin®), 5% in the United States are $53 million (IQVIA MAT May 2021).

US Onychomycosis Market Trends

• Growing prevalence for onychomycosis is driving the market growth

Market CAGR for onychomycosis is being driven by the rising cases for onychomycosis. Onychomycosis is becoming more common. Toenail onychomycosis infection is far more common than infection in fingernails. The rising prevalence of dermatophyte-caused nail fungal infection and a large increase in the number of prescriptions are likely to drive the market. Onychomycosis is growing increasingly common, particularly among vulnerable groups. It is difficult to treat since most antifungal drugs are ineffective. Nondermatophyte molds and mixed infection onychomycosis increase antifungal resistance because they are usually underestimated and ignored due to misdiagnosis. Furthermore, the entry of generic rivals into the market stifles market growth. 

This is likely to boost demand for dermatophytic onychomycosis therapy during the projected period. Furthermore, the increased incidence of diabetes contributes to an increase in the prevalence of dermatophytic infection. The rising inclination for topical treatment solutions is a primary dermatophytic onychomycosis treatment market trend. Because oral antifungal medications have been linked to liver damage, they are not recommended for individuals suffering from liver or heart problems. 

According to a 2017 poll of dermatologists and podiatrists in the United States performed by Moberg Pharma AB, 7 out of 10 clinicians avoid prescription oral terbinafine due to the risk of liver damage. Furthermore, dermatologists and podiatrists throughout the world believe that better topical therapies than those now available are desperately needed. A progressive move towards topical solutions has resulted in huge market prospects for topical medications and active R&D for the creation of effective nail lacquers.

The Onychomycosis Market in the United States is expanding as individuals become more health-conscious and have more disposable income. However, a lack of knowledge and pharmaceutical side effects are possible hurdles to expanding the US Onychomycosis Market. The need for medicines is well recognized because of the high incidence of onychomycosis infections worldwide. Small research-based pharmaceutical and biotechnology businesses are broadly leading R&D, while larger players are increasingly focused on more lucrative goods. Furthermore, larger businesses are utilizing acquisition techniques to expand their antifungal pipeline. 

During the projected period, the treatments market is expected to develop due to high demand for these goods and rising usage. The growing use of immunosuppressive and antineoplastic drugs, broad-spectrum antibiotics, and prosthetic devices has resulted in a rise in fungal infections.

Other variables influencing sales include fewer visits to healthcare facilities to reduce cross-contamination and fewer visits to pharmacies. Furthermore, compared to other chronic disorders, onychomycosis receives far less attention than it deserves. Market sales have fallen even further as the disease's severity has decreased over the year covid-19. The oral treatment of onychomycosis is a market growth accelerator in the United States. Thus, driving the Onychomycosis market revenue.

US Onychomycosis Market Segment Insights

US Onychomycosis Type Insights

The US Onychomycosis market segmentation, based on type includes distal subungual onychomycosis (DSO), white superficial onychomycosis (WSO), proximal subungual onychomycosis (PSO), endonyx onychomycosis (EO), and others. The distal subungual onychomycosis (DSO) segment dominated the market, accounting for 35% of market revenue. The segment's dominance is linked to the FDA's increasing prevalence and quantity of generic approvals to fulfil rising demand. Furthermore, the number of pipeline items is increasing to match the increased need for effective treatments. The most prevalent kind of fungal nail infection is distal lateral subungual onychomycosis (DLSO). The fungus in DLSO usually spreads from the epidermis to the underside of the nail, where the nail meets the nail bed. The symptoms of DLSO are caused by inflammation in certain sections of the nail.

US Onychomycosis Treatment Insights

The US Onychomycosis market segmentation, based on treatment, includes oral and topical. The oral category generated the most income (70.4%). The segment's rise is linked to higher cure rates and shorter treatment periods than topical antifungals, although they have major side effects such as hepatotoxicity and drug interactions. Terbinafine hydrochloride (Lamisil) is the most often used treatment for onychomycosis. To address the increased occurrence of onychomycosis, several generic manufacturers are releasing oral treatments.Because oral medications have negative side effects such as liver damage, many dermatologists and podiatrists prefer to prescribe topical treatments. This, together with increased research for topical medicine development, is likely to promote the growth of the tablets market.

Figure 1: US Onychomycosis Market, by Treatment, 2022 & 2032 (USD Billion) 

Source: Secondary Research, Primary Research, MRFR Database and Analyst Review

US Onychomycosis Key Market Players & Competitive Insights

Leading market companies are extensively spending R&D on increasing their product lines, which will help the Onychomycosis market grow even more. Important market developments include new product releases, contractual agreements, acquisitions and mergers, greater investments, and collaboration with other organizations. The Onychomycosis industry must produce cost-effective merchandise to flourish and thrive in a more competitive and increasing market climate.

Manufacturing locally to reduce operating costs is an effective business strategy manufacturers use in the worldwide Onychomycosis industry to serve clients and expand the market sector. The Onychomycosis industry has provided some of the most important benefits recently. Major players in the Onychomycosis market, including Pfizer, and others, are attempting to increase market demand by investing in research and development operations.

Their global portfolio comprises pharmaceuticals, vaccines, and several of the most well-known consumer healthcare goods on the market. Every day, Pfizer associates work in established and emerging markets to promote wellness, prevention, treatments, and cures for today's most dreaded illnesses. Pfizer before making an employment offer. In October 2020, Pfizer Inc. announced the start of clinical trials for onychomycosis. The first entailed investigating if the AN2690 topical solution is an effective therapy for toenail onychomycosis. The second was an open-label trial to assess the safety and pharmacokinetics of tavaborole 5% topical solution in children and adolescents with distal subungual onychomycosis of the toe.

Almirall is a multinational biopharmaceutical firm specializing in skin care. They work with scientists and healthcare experts to answer patients' needs with science to enhance their lives. Their Noble Purpose is at the heart of their work: "Transform the patients' world by assisting them in realizing their hopes and dreams for a healthy life." They invest in distinctive and ground-breaking medical dermatological products to deliver creative solutions to needy people. Throughout its 77-year existence, Almirall has maintained a strong focus on patient requirements. Almirall has a direct presence in 21 countries and strategic relationships in over 70 more, with about 1,800 workers across 13 companies. 

In 2020, total revenues were 814.5 million euros. In July 2020, Almirall S.A. and Kaken Pharmaceutical (KKPCF) announced signing a license and distribution agreement. Kaken Pharmaceutical granted Almirall the exclusive right to develop and commercialize an efinaconazole topical formulation. This active principle, a triazole antifungal chemical developed by Kaken Pharmaceutical, treats onychomycosis, a fungal nail infection. It possesses exceptional nail-penetrating characteristics due to its low binding affinity for keratin, the primary component of nails.

Key Companies in the Onychomycosis market include

• Johnson & Johnson


• Novartis AG


• Valeant Pharmaceuticals


• Pfizer Inc.


• Anacor Pharmaceuticals


• Galderma S.A.


• Moberg Pharma AB


• Bayer AG


• Dr. Reddy’s Laboratories Ltd.


• Cipla Ltd.


• Medimetriks Pharmaceuticals, Inc.

US Onychomycosis Industry Developments

July 2021: Alembic announced that its joint venture Aleor Dermaceuticals Limited (Aleor) took tentative approval from the US Food & Drug Administration (US FDA) for an abbreviated new drug application (ANDA) for Efinaconazole Topical Solution for the medical management of this condition in toenail.

April 2021: Lupin Limited (Lupin) announced today that the US Food and Drug Administration had approved its Tavaborole Topical Solution, 5%, to market as a generic counterpart of Anacor Pharmaceuticals, Inc.'s Kerydin Topical Solution, 5%.

US Onychomycosis Market Segmentation

US Onychomycosis Type Outlook

• Distal Subungual Onychomycosis (DSO)


• White Superficial Onychomycosis (WSO)


• Proximal Subungual Onychomycosis (PSO)


• Endonyx Onychomycosis (EO)


• Others

US Onychomycosis Treatment Outlook

• Oral


• Topical