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    US Onychomycosis Market

    ID: MRFR/Pharma/1895-CR
    30 Pages
    Rahul Gotadki
    April 2017

    US Onychomycosis Market Research Report Information By Type (Distal Subungual Onychomycosis (DSO), White Superficial Onychomycosis (WSO), Proximal Subungual Onychomycosis (PSO), Endonyx Onychomycosis (EO), And Others), By Treatment (Oral And Topical) And By Region (US) –Market Forecast Till 2035

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    US Onychomycosis Market Infographic
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    US Onychomycosis Market Summary

    The United States Onychomycosis market is projected to grow from 1.75 USD billion in 2024 to 3.85 USD billion by 2035.

    Key Market Trends & Highlights

    US Onychomycosis Key Trends and Highlights

    • The market is expected to experience a compound annual growth rate of 7.48 percent from 2025 to 2035.
    • By 2035, the market valuation is anticipated to reach 3.87 USD billion, indicating robust growth.
    • in 2024, the market is valued at 1.75 USD billion, reflecting the current demand for onychomycosis treatments.
    • Growing adoption of advanced antifungal therapies due to increasing prevalence of onychomycosis is a major market driver.

    Market Size & Forecast

    2024 Market Size 1.75 (USD Million)
    2035 Market Size 3.85 (USD Million)
    CAGR (2025-2035) 7.44%

    Major Players

    Pfizer, Johnson & Johnson, Novartis AG, Valeant Pharmaceuticals, Anacor Pharmaceuticals, Galderma S.A., Moberg Pharma AB, Bayer AG, Dr. Reddy’s Laboratories Ltd., Cipla Ltd., Medimetriks Pharmaceuticals, Inc.

    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.

    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) 

    Get more detailed insights about US Onychomycosis Market

    Key Players and 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 US Onychomycosis Market market include

    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%.

    Future Outlook

    US Onychomycosis Market Future Outlook

    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

    Report Scope

    Attribute/MetricDetails
    Market Size 2024USD 1.75 Billion
    Market Size 20353.85 (Value (USD Billion))
    Compound Annual Growth Rate (CAGR)7.44% (2025 - 2035)
    Base Year2024
    Market Forecast Period2025 - 2035
    Historical Data2018- 2022
    Market Forecast UnitsValue (USD Billion)
    Report CoverageRevenue Forecast, Market Competitive Landscape, Growth Factors, and Trends
    Segments CoveredType, Treatment, and Region
    Countries CoveredThe US
    Key Companies ProfiledJohnson & 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.
    Key Market OpportunitiesJoint ventures, strategic alliances, mergers and acquisitions, new product developments along with research and developments
    Key Market DynamicsTechnological advancement
    Market Size 20251.88 (Value (USD Billion))

    Market Highlights

    Author
    Rahul Gotadki
    Assistant Manager

    He holds an experience of about 7+ years in Market Research and Business Consulting, working under the spectrum of Life Sciences and Healthcare domains. Rahul conceptualizes and implements a scalable business strategy and provides strategic leadership to the clients. His expertise lies in market estimation, competitive intelligence, pipeline analysis, customer assessment, etc. In addition to the above, his other responsibility includes strategic tracking of high growth markets & advising clients on the potential areas of focus they could direct their business initiatives

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    FAQs

    What is the projected growth of the US Onychomycosis market?

    The US Onychomycosis market is the expected increase in total market value of 3.85 USD billion over a defined forecast period 2025–2035. It is driven by factors such as demand trends, technological advances, regulatory changes, and geographic expansion.

    What is the size of the US Onychomycosis market?

    US Onychomycosis market size was valued at approximately 1.75 billion USD in 2024. This figure will reach 3.85 billion USD covering all regions (America, Europe, Asia, MEA and ROW), focusing its segments / services / distribution channels till 2035.

    What is the CAGR of the US Onychomycosis market?

    US Onychomycosis market is expected to grow at a CAGR of 7.44% between 2025 and 2035.

    How much will the US Onychomycosis market be worth by 2035?

    US Onychomycosis market is expected to be worth of 3.85 billion USD, reflecting growth driven by usage, technology and global demands by the end of 2035.

    How will the US Onychomycosis market perform over the next 10 years?

    Over the next 10 years the US Onychomycosis market is expected to shift from usd billion 1.75 to 3.85 billion USD, led by adoption of advanced tech, demographic trends, regulatory approvals, with potential headwinds from 2025 to 2035.

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