U.S. Dermatophytic Onychomycosis Treatment Market Size, Share & COVID-19 Impact Analysis, By Product Type (Tablets, and Nail Paints), By Route of Administration (Oral, and Topical), By Type (Prescription, and Over-the-Counter (OTC)), By Distribution Channel (Hospital Pharmacies, Retail Pharmacies, and Online Channels), and Country Forecast, 2023-2030

The U.S. dermatophytic onychomycosis treatment market size was worth USD 1.89 billion in 2022 and is projected to grow at a CAGR of 8.1% during the forecast period.

Onychomycosis is a common fungal nail disease affecting the general population of the U.S. Most infections are caused by dermatophytes. Furthermore, various studies have shown that the risk of developing onychomycosis increases with age. Additionally, people suffering from diabetes and immunosuppression are at great risk of developing nail infections.

• According to the Centers for Disease Control and Prevention (CDC) data, onychomycosis affects approximately 14% of the general population of the country.

Thus, the rising prevalence of onychomycosis infections, a surge in the geriatric population, an increase in the diabetic population, and other factors supporting the U.S. dermatophytic onychomycosis treatment market growth. However, due to the COVID-19 pandemic, there was a reduction in patient visits. Moreover, the temporary closure of dermatology clinics during the pandemic resulted in delayed diagnosis, thus negatively impacting the market.

LATEST TRENDS

Rising Preference for Topical Solutions is a Prominent Trend in the Market  

At present, patients are gradually shifting their preference toward topical treatment solutions. Oral antifungal drugs for onychomycosis treatment are accompanied by systemic side effects and hepato-toxicity, and other side effects. The rising preference for topical solutions created significant market opportunities for manufacturers to increase R&D for developing and launching effective nail lacquers and topical drugs.

• For instance, in April 2020, Bausch Health Companies Inc. received approval from the U.S. FDA for its efinaconazole topical solution 10%, “Jublia,” for treating fungal infections of toenails.

DRIVING FACTORS

Growing Prevalence of Dermatophytic Onychomycosis to Propel the Demand  for the Treatment

The rising prevalence of dermatophytic onychomycosis in the country is one of the prominent factors increasing the demand for effective treatment and management of the condition. According to various research studies, it has been demonstrated that the risk of developing onychomycosis increases with age.

• According to a study published by National Centers for Biotechnology Information (NCBI) in 2022, the prevalence of onychomycosis is more than 20% in people aged 60 years and above and more than 50% in adults aged 70 years and above.

Further, as per the data published by the World Bank Group, approximately 17.0% of the U.S. population is aged 65 years and above. Thus, the presence of a large target population is projected to augment the market growth.

According to the research articles published in the National Institute of Health, the prevalence of onychomycosis among the U.S. population is approximately 3.0%. The disease is more prevalent in men compared to women. The prevalence of onychomycosis (tines unguium) is 4.0% in male and around 1.7% in female.

RESTRAINING FACTORS

Low Awareness Coupled with Side Effects Associated with Medications to Hamper the Market Growth 

Most people affected with onychomycosis infection are unaware of the condition and do not take treatment as the condition is not severe and life-threatening. Moreover, the drugs are associated with various side effects, such as headache, itching, diarrhea, skin blisters, and others.

• According to the FDA data, the side effects of Jublia occurred in 1%-2% of the patients and comprised inflammation, skin rash, ingrown toenails, itchy skin, and pain.

Thus, the above-mentioned factors are likely to hamper the adoption of drugs for dermatophytic onychomycosis treatment, thereby impeding the market growth.

SEGMENTATION

By Product Type Analysis

Based on product type, the market is segmented into tablets, and nail paints. The tablets segment is anticipated to grow at a significant CAGR during the forecast period. The higher efficacy of tablets dermatophytic onchomycosis treatment, is one of the key factors promoting the segment’s growth in the forthcoming years.

• According to an article published in NCBI in 2022, tablets are intended for use in moderate to severe fungal diseases and exhibit a high cure rate. As per the article, Terbinafine (Lamisil) is 70% -79% effective in treating fingernail and toenail onychomycosis.

By Route of Administration Analysis

Based on route of administration, the market is categorized into oral and topical. The topical segment accounted for the largest U.S. dermatophytic onychomycosis treatment market share in 2022. Topical drugs are cost-effective and associated with fewer side effects, thus, increasing their adoption for the treatment of dermatophytic onychomycosis. Moreover, growing research for developing novel topical drugs is anticipated to bolster the market growth. 

• For instance, NovaBiotics Inc., a clinical-stage biotechnology company, is developing a topical NP213 solution for nail disorders such as onychomycosis. NP213 (Novexatin) is a novel peptide developed from the company’s proprietary technology platform.

By Type Analysis

Based on type, the market is categorized into prescription, and over-the-counter (OTC). The OTC segment accounted for the highest market in 2022. The wide availability of the onychomycosis drug over the counter, sifting preferences towards nail lacquers, increasing OTC drug sales, and easy access to essential medication from the OTC are a few factors supporting the segment’s growth.

• According to the Consumer Healthcare Products Association, in 2022, over-the-counter drug retail sales were about USD 41.2 billion.

By Distribution Channel Analysis

Based on distribution channel, the market is divided into hospital pharmacies, retail pharmacies, and online channels. The retail pharmacies segment held the largest share in 2022, owing to the increase in the sales of OTC onychomycosis medications. Furthermore, expanding retail pharmacies in the country is contributing to the market's growth.

• For instance, in May 2021, Amazon announced opening its brick-mortar retail pharmacy in the U.S. Through this inorganic activity, the company is expanding its services in the physical pharmacy business segment.

KEY INDUSTRY PLAYERS

This market is fragmented, with various players operating in the market. Bausch Health is one of the major players. The company has launched Jubila, a topical solution for toenail fungal infection. The cure rate of the product is about 15.0% -18.0%, which increased its adoption and increased the sales of the company.

Furthermore, other factors, such as the company's strong presence in the country and increasing R&D activities to develop novel drugs, among others, also strengthen the company’s market share. Some other companies operating in the market are, Pfizer, Inc., Johnson & Johnson Services, Inc., and others.

LIST OF KEY COMPANIES PROFILED:

• Bausch Health Companies Inc. (Canada)


• Pfizer Inc. (U.S.)


• Galderma (Switzerland)


• Johnson & Johnson Services, Inc. (U.S.)


• Lupin Pharmaceuticals, Inc. (India)


• Zydus Pharmaceuticals, Inc. (India)

KEY INDUSTRY DEVELOPMENTS:

• December 2021- American Podiatric Medical Association (APMA) approved Jublia developed by Bausch Health Companies Inc. The drug also received extended FDA clearance in 2020 for treating pediatric and adult patients suffering from onychomycosis.


• July 2021- Lupin launched a generic topical solution, Tavaborole, in the U.S. The topical solution is equivalent to topical Kerydin intended for treating onychomycosis of toenails caused due to trichophyton rubrum or trichophyton mentagrophytes.


• April 2021 - Aleor Dermaceuticals received the FDA clearance for efinaconazole topical solution for treating fungal toenail infections.

REPORT COVERAGE

The market report provides a detailed analysis of the market. It focuses on key aspects such as leading companies, competitive landscape, product type, and application. Besides this, it offers insights into the market trends and highlights key industry developments. In addition to the factors mentioned above, the report encompasses several factors that have contributed to the growth of the market over recent years.

Report Scope & Segmentation