Onychomycosis Market Assessment, By Treatment Type [Drugs, Laser Therapy, Photodynamic Therapy], By Indication [Distal Subungual Onychomycosis, White Superficial Onychomycosis, Proximal Subungual Onychomycosis, Candidal Onychomycosis, Total Dystrophic Ony

Onychomycosis Market Assessment, By Treatment Type [Drugs, Laser Therapy, Photodynamic Therapy], By Indication [Distal Subungual Onychomycosis, White Superficial Onychomycosis, Proximal Subungual Onychomycosis, Candidal Onychomycosis, Total Dystrophic Onychomycosis], By Distribution Channel [Hospitals, Dermatology Clinics, Retail Pharmacies, Online Pharmacies], By Region, Opportunities and Forecast, 2017-2031F

Global onychomycosis market is projected to witness a CAGR of 5.53% during the forecast period 2024-2031, growing from USD 4.01 billion in 2023 to USD 6.17 billion in 2031. Onychomycosis market is majorly driven by the high prevalence of onychomycosis, increasing geriatric population that is more prone to such disorders due to the weakened immune system, significant developments in the healthcare infrastructure, and increasing approvals of novel products in the industry. Antifungal preparations like tablets, creams, sprays, and injections, along with other drug classes like steroids and antibiotics, are used for the treatment of onychomycosis. The ability of fungal species to spread quickly through various means like air, water, touch, sharing personal belongings, and using public spaces like swimming pools is the major concern for widespread onychomycosis infection. However, post-COVID awareness about social distancing and growing hygienic practices reduces the risk of onychomycosis and further limit the growth of the market. Additionally, side effects associated with these drugs and therapies and growing antifungal resistance are some major restraints for the market.

In January 2024, Vanda Pharmaceuticals announced that it had received US FDA approval to begin with an investigational new drug (IND) VTR-297, which is a topical antifungal drug candidate for the treatment of onychomycosis. VTR-297 is a histone deacetylase (HDAC) inhibitor with promising antifungal activity against dermatophytes and other fungi. This molecule was originally isolated from the yeast species Streptomyces hygroscopicus as an antifungal antibiotic.

Growing Prevalence of Onychomycosis

The global prevalence of onychomycosis is steadily increasing due to factors such as age, poor peripheral circulation, diabetes, inactivity, and the inability to maintain good foot care. Recurrent nail trauma, longer exposure to pathogenic fungi, suboptimal immune function, and shared bathing facilities are some other reasons for the spread of onychomycosis. Additionally, fungal nail infections are more common in toenails than fingernails due to their slower growth, reduced blood supply, and frequent confinement in dark, moist environments. While onychomycosis is not life-threatening, it can cause pain and potentially undermine work and social lives, making it an important public health problem. The rising prevalence of the disease drives the demand for relevant products and services in the market.

As per an article published in the Journal of Fungi, in May 2023, the global prevalence of onychomycosis was somewhere around 10% and this infection accounted for up to 50% of all nail diseases. Dermatophytes species Trichophyton rubrum and Trichophyton mentagrophytes are common causative agents of onychomycosis, responsible for 60-70% of infections. While yeasts are responsible for approximately 20% of onychomycosis, non-dermatophytes cause the remaining 10%.

Aging Population and Diabetic Disease Burden

The occurrence of onychomycosis is very common in the geriatric population, the reason being the weakened immune system. Diabetic patients present several clinical conditions that favor the development of onychomycosis, including high levels of glycated hemoglobin (HbA1C) and prolonged diabetic status leading to nail thickness and acceleration of nail plate involvement. As the global geriatric population and diabetic disease both are rising significantly, the market demand for onychomycosis is expected to rise as well, further expanding the market growth.

As per the National Diabetes Statistics Report published by the CDC, the prevalence of diabetes in adults increases with age, reaching about 29.2% among those aged 65 years or older. Nearly 20% of the population suffering from onychomycosis is aged above 60 years. Around one-third of diabetic patients are likely to suffer from onychomycosis.

Dominance of Orally Administered Drugs Segment

One of the major onychomycosis market trends is the rising dominance of orally administered drugs over other routes of administration. Orally administered drugs are highly preferred due to their better effectiveness and shorter treatment duration compared to topically applied drugs. Oral antifungal medications like terbinafine and azoles are highly effective treatments for the clinical cure of onychomycosis. They have been found to have higher cure rates compared to topical preparations, which traditionally have low success rates due to the physical hindrance of the nail. Most of the marketed formulations are meant for oral administration only, although a few topical formulations like nail lacquer and sprays also hit the market in recent times.

For instance, in February 2024, Moberg Pharma AB launched MOB-015 under the Terclara brand in partnership with Allderma AB in the Swedish market. The launched drug is witnessing significant traction from the market as it is highly effective against nail fungus and conditions such as onychomycosis. Moberg Pharma estimated the sales potential of MOB-015 at the global level to be around USD 250-500 million.

The Popularity of Distal Subungual Onychomycosis as the Leading Type

Distal subungual onychomycosis is anticipated to be the leading type of onychomycosis occurring among individuals globally since it is the most diagnosed type of onychomycosis. Distal subungual initiates under the edge of the nail or alongside the lateral edges. It is further characterized by the accumulation of debris under the nail, resulting in yellowish, thickened, and brittle toenails. Around 90% of the onychomycosis cases are comprised of distal subungual onychomycosis. Market players are actively designing efficient products for its treatment.

For instance, in November 2023, Blueberry Therapeutics Limited reported that BB2603, a novel topical terbinafine antifungal medication, has demonstrated superiority over placebo (vehicle) with a high degree of statistical significance in the Phase 2b trial (BBTAF202) in patients with onychomycosis, meeting the primary endpoint. 111 participants with mild to moderate distal subungual onychomycosis of the toenail were included in the BBTAF202 European trial. This study evaluated the pharmacokinetics, safety, and effectiveness of BB2603-10 twice daily for three months in comparison to a vehicle, as well as two lower formulation strengths of BB2603-3 and BB2603-1. Successful completion of this trial is anticipated to add another promising product to the market.

Asia-Pacific to be the Fastest-Growing Region

Asia-Pacific is expected to be the fastest-growing region for the onychomycosis market. This is due to factors such as the increasing geriatric population, rising prevalence of diabetes and other risk factors associated with fungal infections, improving healthcare infrastructure, and growing awareness about nail health and fungal infections in the region. The expansion of pharmaceutical companies in the region and the availability of cost-effective treatment options also contribute to the market growth in Asia Pacific. According to Blueberry Therapeutics, the prevalence of onychomycosis in Asia Pacific is around 20%, while in North America, the prevalence of onychomycosis is around 14%.

Future Market Scenario

Terbinafine resistance being the major concern related to onychomycosis treatment needs to be addressed through a shift towards azole-based formulations, which may drive innovation in the future of onychomycosis treatment. Market approval and good marketing strategy for azole-based drugs like Fosravuconazole, Posaconazole, Oteseconazole, and other related compounds is anticipated to expand the market further.

The growing popularity of photodynamic therapy and laser-assisted drug delivery methods have shown high efficacy in the treatment of onychomycosis. The future of the onychomycosis market has promising scope for these treatment options. For instance, according to an article published by ‘Mycoses’ journal in October 2023, with excellent performance, safety, and tolerability, photodynamic therapy, which uses a cream combining 0.1% w/w FMN or 2% w/w MB with 40% w/w urea, can be a very promising new topical treatment for toenail onychomycosis.

Key Players Landscape and Outlook

Bausch Health Companies Inc., Abbott Laboratories, Pfizer Inc., Bayer AG, Teva Pharmaceutical Industries Ltd., Cipla Inc., Merck & Co., Inc., Novartis AG, Sun Pharmaceutical Industries Ltd., and GlaxoSmithKline plc. are some of the leading players in the onychomycosis market with years of experience and trust. These companies are involved in the development and marketing of drugs, laser therapy, and photodynamic therapy for the treatment of onychomycosis. The key players have active involvement in intellectual property filings and clinical trials, which seems promising for the expansion of the market size.

In October 2023, Bausch Health filed a new patent for the treatment method for nail fungal onychomycosis. The method comprises the application of 10% efinaconazole formulation once a day for 36 weeks without removing the formulation from the nail. The formulation contains ingredients like alcohol, water, and citric acid.