Onychomycosis Market Size, Share & Trends Analysis Report By Type (Distal Subungual Onychomycosis, White Superficial Onychomycosis, Proximal Subungual Onychomycosis), By Treatment (Oral, Topical), By Region, And Segment Forecasts, 2023 - 2030

Report Overview

The global onychomycosis market size was estimated at USD 3.44 billion in 2022 and is expected to expand at a compound annual growth rate (CAGR) of 4.56% by 2030. The onychomycosis market is witnessing growth due to factors such as the rising incidence of onychomycosis and chronic disease, rising R&D pertaining to the development of novel drugs, and the growing geriatric population and diabetic population.

The need for therapies is globally accepted owing to the high prevalence of onychomycosis infections worldwide. The R&D is widely led by small research-based pharmaceutical and biotechnology companies and bigger players are widely focused on more lucrative products. Furthermore, bigger players are using acquisition strategies to enhance their pipeline for antifungals. For instance, in November 2021, Pfizer announced making strategic investments in antibacterial and antifungal R&D to get new products to market. Such investments are expected to propel R&D initiatives.

A significantly large range of antifungal preparations, both oral and topical agents such as tablets, creams, sprays, and injections are commercially available for the treatment. High demand for these products resulting in increased adoption is anticipated to support therapies market growth during the forecast period. The rising adoption of immunosuppressive & antineoplastic agents, broad-spectrum antibiotics, and prosthetic devices, has resulted in an increased incidence of fungal infections.

Aging causes a gradual decrease in the functionality of the immune system. Therefore, cognitive and physical changes usually make elderly people more susceptible to acquiring infections such as onychomycosis. The global geriatric population is rising. According to the WHO, 1 in every 6 people in the world is expected to be over 60 years by 2030, which equals 1 billion in 2020 increasing to 1.4 billion in 2030. The number of elderly people is expected to grow at the fastest rate in Eastern and South-Eastern Asia with a two-fold increase estimated in a population aged 65 & above, followed by Central and Southern Asia, reaching 328.1 million by 2050.

However, the market growth is being restrained due to the growing resistance to antifungal drugs becoming an issue at the global level. Onychomycosis is becoming more prevalent, especially among at-risk populations. It is difficult to cure since most antifungal medications have low efficacy. Nondermatophyte molds and mixed infection onychomycosis are leading to the growth in antifungal resistance since they are frequently underestimated and disregarded due to misdiagnosis. Moreover, the advent of generic competitors in the market is further restraining the growth of the market. For instance, in July 2021, Lupin received U.S. FDA approval for Tavaborole Topical Solution, 5%, a generic version of an oxaborole antifungal, Kerydin Topical Solution, 5%, developed by Anacor Pharmaceuticals.

Type Insights

Distal subungual onychomycosis (DSO) segment held the largest share of 42.14% of the market in 2022. The dominance of the segment is attributed to the increasing prevalence and number of generic approvals by the FDA to meet the rising demands. In addition, rising number of pipeline products to meet the heightened demands for effective drugs. For instance, in March 2020, NovaBiotics Ltd., a U.K.-based, clinical-stage biotechnology company, presented new clinical data on Novexatin's safety and efficacy. The developed NP213 (Novexatin), is a new antifungal peptide to treat patients with severe DSO. In Feb 2021, in Japan and Europe, NP213 has been licensed to an undisclosed company. In 2022, the firm expects to market its product with the support of its partner through direct-to-consumer healthcare channels such as retail pharmacies

White superficial onychomycosis segment is expected to show the fastest growth rate in the forecast period. This is due to it being a less prevalent type of nail fungal infection. It only affects toenails, and the fungus colonizes the nail plate's surface, resulting in many white friable patches of the nail plate. Treatment for white superficial onychomycosis always necessitates a systemic approach. T. mentagrophytes causes superficial white onychomycosis, which is a dermatophyte infection. It affects the surface of the nail plate instead of the nail bed and is far less prevalent than distal and lateral subungual onychomycosis.

Treatment Insights

Topical segment held the largest share of 31.67% of the market in 2022. Topical treatments have fewer severe side effects, but they also have lower cure rates and require much longer treatment periods. New topical formulations are also being researched as faster-acting alternatives to already available topical therapies. However, topical formulations have low cure rates and are ineffective since they are unable to penetrate the nail plate to reach the diseased nail bed in adequate concentration to kill the fungus, thus debridement of the nail plate may be required before administration. For instance, in December 2021, Bausch Health Companies Inc. received the American Podiatric Medical Association (APMA) seal of approval for JUBLIA, a topical solution of efinaconazole for the treatment of onychomycosis.

Oral segment is expected to show the fastest growth over the forecast period. The growth of the segment is attributed to better treatment cure rates and shorter treatment times than topical antifungals, but they come with serious adverse effects such as hepatotoxicity and medication interactions. The most common therapy for onychomycosis is oral Terbinafine hydrochloride (Lamisil). Several generic manufacturers are launching oral therapies to address the growing prevalence of onychomycosis. For instance, in June 2021, Glenmark Pharmaceuticals received the U.S. FDA approval for their bioequivalent and therapeutically equivalent, Theophylline extended-release tablets, 300 mg, and 450 mg, of Alembic Pharmaceuticals.

Regional Insights

North America held the largest share of 41.52% of the market in 2022 and is expected to maintain its dominant position, in terms of share, throughout the forecast period. This can be attributed to the rising prevalence of onychomycosis and favorable government initiatives in the region. North America is one of the developed regions with high healthcare expenditures. Moreover, the prevalence rate of onychomycosis in North America was estimated to be up to 14%. This high prevalence rate is inducing demand for efficient onychomycosis therapies in disease management. This region held a major market share, particularly the U.S., due to an increase in understanding of the enormous potential of onychomycosis drugs. This has driven U.S.-based firms to make considerable investments in the development of these drugs.

Asia Pacific is estimated to show the fastest growth in onychomycosis market over the forecast period. The growth of the market in the region is due to the high incidence of onychomycosis. This can be attributed to various factors such as poor access to healthcare facilities, a growing geriatric population, lack of hygiene, and large urbanization. Asia Pacific has a high incidence of onychomycosis which can be attributed to the humid and warm climate, promoting the growth of onychomycosis. Moreover, key players in the market are focusing on developing new products. For instance, in March 2021, HUYABIO International in collaboration with its joint venture Tianjin Institute of Pharmaceutical Research submitted NDA for Jublia, efinaconazole for the treatment of onychomycosis.

Onychomycosis Market Share Insights

The key players operating in the market are constantly focusing on introducing and changing existing technologies that enhance patient outcomes and significantly increase the effectiveness and efficiency of healthcare. For Instance, in July 2021, Almirall S.A. entered into licensing and distribution agreement with Kaken Pharmaceutical for the development and commercialization of Efinaconazole, a topical formulation. Some of the key players in the global onychomycosis market include:

• Bausch Health Companies Inc.

• GSK plc

• Abbott

• Pfizer Inc.

• Bayer AG

• Teva Pharmaceutical Industries Ltd.

• Cipla Inc.

• Merck & Co., Inc.

• Novartis AG

• Sun Pharmaceutical Industries Ltd.

Onychomycosis Market Report Scope

Global Onychomycosis Market Segmentation

This report forecasts revenue growth and provides an analysis of the latest trends in each of the sub-segments from 2018 to 2030. For this study, Grand View Research has segmented the onychomycosis market report based on the type, treatment, and region.

• Type Outlook (Revenue, USD Million, 2018 - 2030)

  • Distal Subungual Onychomycosis

  • White Superficial Onychomycosis

  • Proximal Subungual Onychomycosis

  • Other Types

• Treatment Outlook (Revenue, USD Million, 2018 - 2030)

  • Oral

  • Topical

  • Others

• Regional Outlook (Revenue, USD Million, 2018 - 2030)

  • North America

    • U.S.

    • Canada

  • Europe

    • U.K.

    • Germany

    • France

    • Italy

    • Spain

    • Italy

    • Denmark

    • Sweden

    • Norway

    • Rest of Europe

  • Asia Pacific

    • Japan

    • China

    • India

    • Australia

    • South Korea

    • Thailand

    • Rest of Asia Pacific

  • Latin America

    • Brazil

    • Mexico

    • Argentina

    • Rest of Latin America

  • Middle East and Africa

    • South Africa

    • Saudi Arabia

    • UAE

    • Kuwait

    • Rest of Middle East and Africa