Onychomycosis Affects Clinical, as well as Psychological Health of Infected Adult Population
Fungal infection of nails known as tinea unguium, more popularly onychomycosis. Toenails or fingernails, both can be affected but the infection of the former is more commonly seen. The nail fungi dermatophytes cause onychomycosis, and a weakened immune system, excess sweating, diabetes, blood circulation problems, and psoriasis can be some other prominent reasons that cause onychomycosis. The infection may cause nails to become discoloured, more likely to crack and break, and distorted, which ultimately results in degraded quality of life, and self-esteem of patients. The annual global onychomycosis prevalence among adults is estimated between ~7-10% and the prevalence of the nail fungus infection increases with the increasing incidence of chronic diseases such as diabetes mellitus, psoriasis, and peripheral vascular diseases. Moreover, the risk is high in patients with genetic predisposition, athlete’s foot, and those suffering from acquired immunodeficiency syndrome (AIDS). This continues to generate the demand for effective onychomycosis treatment worldwide.
Ageing Population, and High Prevalence of Chronic Conditions Drive Onychomycosis Treatment Market Growth
In the US, onychomycosis of the toenail is estimated to affect ~10-14% of the population. The primary growth driver for this market is the growing geriatric population. Changing consumer preference towards maintaining the aesthetic appeal of their nails is on the rise, which is also one of the key factors attracting nail fungi causing infections, thus fueling growth of the onychomycosis treatment market. Besides this, the risk of dermatophytic onychomycosis is 1.9–2.8 times higher in patients suffering from diabetes vis-à-vis general population. The prevalence of dermatophytic onychomycosis varies by region, which is between 10% and 14% in North America, 4% and 5% in the tropical Asian countries, and up to 17% in European countries. The rising prevalence of onychomycosis will create tremendous growth opportunities to the onychomycosis treatment providers during the forecast period.
Unmet Need for a Safer, More Effective, and Convenient Topical Product Exists in Market
Currently, there are topical, and oral treatment options available on the market and the former is strongly preferred over the latter. Nail lacquers are also getting preferred for toenail onychomycosis treatment as they are convenient to use, and stay on nails for a longer time. Onychomycosis patients are reluctant to use oral drugs because of potential toxicity. Moreover, many patients often discontinue their treatment because the appearance of the nail does not improve for many months. However, it takes time. Research findings indicate that a larger patient base (between 50% and 90%) with fungal nail infections is not even seeking/receiving the onychomycosis treatment. There are clear shortcomings of the current treatment regimen. Topical drugs come with a long course of treatment and limited efficacy, while oral drugs accompany with a risk of toxic side effects. Both clinicians, and patients are thus in the pursuit of a safe topical product with better efficacy, and a more convenient, shorter course of therapy.
Growing Demand for Combination Therapies to Treat Onychomycosis, Coupled with a Strong Product Pipeline, Boosts Market Growth
At present, there are four key topical products in the US market - Loceryl (5% Amorolfine), Penlac/Rejuvenail/Ciclodan/Penlac Nail Lacquer (8% Ciclopirox), Kerydin/ Tavaborole (5% Tavaborole), and Jublia (10% Efinaconazole). Jublia is currently the bestseller topical product in terms of revenue. In the oral drugs category, LamISIL/Terbinex (terbinafine), Onmel/Sporanox/Sporanox/PulsePak/Tolsura (itraconazole), and Grifulvin V/Gris-PEG (griseofulvin) are approved globally. Recently, the combination therapy has gained recognition as a prominent treatment option. As it combines the oral, and topical antifungal treatments to gain higher efficacy, and faster results in addition to avoiding the re-occurrence of the disease. Moreover, multiple promising topical drug agents are in their advanced phases of product development pipeline, which have the disease-modifying properties, and a better efficacy and safety profile.
Hexima Limited is developing a novel topical therapeutic (HXP124) for the treatment of fungal nail infections. Moberg Pharma has developed MOB-015, which is a topical formulation. It has showed positive outcomes in phase 3 clinical trials recently. Moberg Pharma estimates the annual worldwide peak sales potential for MOB-015 to be in the range of $250-500 Mn.
North America, and Europe Prominent; Asia Pacific Exhibits Strong Growth Potential
The US, and European countries are dominating the global onychomycosis treatment market. As per Diabates.org, ~34 million US citizens had undiagnosed diabetes in 2018. Moreover, the expanding elderly population in Europe is leading to the increasing demand for onychomycosis treatment in the region. People from these regions are also more cautious to physical appearance, which is an indirect booster to market growth.
In Asia Pacific, the demand from developing countries such as China is anticipated to soar during the forecast period along, with some economies in the Southeast Asia. A recent research study in China revealed that onychomycosis is widespread across the country with ~2% of the adult population suffering with nail infection(s). In South Korea, a disturbing ~10% of the population suffers from onychomycosis, and a majority of those afflicted go untreated. As per Moberg Pharma AB, the Korean market for topical drugs for onychomycosis roughly amounts to US$40 Mn.
Companies Explore Strategic Collaborations to Gain a Competitive Edge in Onychomycosis Treatment Market
Key companies are actively seeking opportunities to collaborate in an effort to consolidate market positions, and thereby increase market penetration. A Swedish company Moberg Pharma AB has signed a distribution agreement with DongKoo Bio & Pharma Co., Ltd. for MOB-015 in the Republic of Korea. Some of the important players in the onychomycosis treatment market are Hexima Limited, Teva Pharmaceutical Industries Ltd., Sanofi S.A., Valent Pharmaceutical, Galderma, Johnson & Johnson, Novartis AG, Moberg Pharma AB, Cardinal Health, Inc, Pfizer Inc., Almirall, S.A., Bayer AG, Viatris Inc., GlaxoSmithKline plc, Cipla Ltd., and Dr. Reddy’s Laboratories Ltd.