Onychomycosis Treatment Market

Global Onychomycosis Treatment Market:

The global onychomycosis treatment market size reached USD 3.6 Billion in 2024. Looking forward, IMARC Group expects the market to reach USD 5.4 Billion by 2033, exhibiting a growth rate (CAGR) of 4.5% during 2025-2033. The rising prevalence of this fungal infection among adults and millennials due to the increased exposure to public swimming pools and the use of tight, contaminated, or soiled clothes, shoes, socks, etc., is primarily driving the market.

Onychomycosis Treatment Market Analysis:

• Major Market Drivers: The increasing incidences of chronic medical ailments, such as human immunodeficiency virus (HIV), onychomycosis, diabetes, peripheral artery disease (PAD), etc., are among the primary drivers bolstering the market. Moreover, the rising geriatric population, which is highly prone to weakened immune systems and circulatory disorders, is also acting as another significant growth-inducing factor.
• Key Market Trends: The introduction of water-soluble antifungal treatment solutions that can be administered orally is catalyzing the market. In line with this, they aid in preventing secondary bacterial infections and prevent the growth of fungus, which is positively influencing the market.
• Competitive Landscape: Some of the prominent companies in the global market include Bausch Health Companies Inc., Cipla Limited, Dr. Reddy's Laboratories, Galderma SA, GlaxoSmithKline PLC, Kaken Pharmaceutical Co. Ltd, Lumenis Ltd, Moberg Pharma AB, Novartis AG, Pfizer Inc., and The OTC Lab B.V., among many others.
• Geographical Trends: North America exhibits a clear dominance in the market, owing to the improvements in the healthcare infrastructure. Additionally, the elevating usage of topical nail lacquers and ointments to maintain nail hygiene is further contributing to the regional market.
• Challenges and Opportunities: The limited efficacy of existing therapies is one of the primary challenges hindering the market. However, the growing investments in more effective antifungal medications and improving patient adherence to treatment protocols are expected to fuel the market over the forecasted period.

Onychomycosis Treatment Market Trends:

Adoption of Topical Treatments

The inflating usage of topical treatments, owing to their fewer systemic side effects and non-invasive nature as compared to oral medications, is primarily driving the market. For example, in May 2022, the Consumer Health division of Bayer announced the introduction of the new and improved range of Canesten, their antifungal treatment solution in India that provides fungal nail infection. Moreover, it is an easy-to-use solution with a full-cycle skin infection control formulation that not only offers relief from itching but also halts the spread of infection. Besides this, in July 2022, Zydus Lifesciences received approval from the U.S. Food and Drug Administration (USFDA) to market an antifungal efinaconazole topical solution for onychomycosis. Additionally, prominent companies are investing in new drug formulations, thereby increasing the success rate of these treatments. For instance, in June 2024, Renata commercialized terbinafine 250 mg tablets under a facility that was approved by the UK's Medicines and Healthcare Products Regulatory Agency (MHRA). Additionally, they are extensively used for the treatment of onychomycosis of the fingernail or toenail due to dermatophytes.

Demand for Combination Therapies

The inflating popularity of strategies to enhance treatment outcomes for onychomycosis is bolstering the onychomycosis treatment market growth. For example, in January 2024, Medexus announced that Health Canada recently accepted for review Medexus’s new drug submission, or NDS, for terbinafine hydrochloride nail lacquer to treat fungal nail infections. Moreover, combining topical and oral antifungal agents or integrating traditional treatments with laser therapy can address the limitations of single-modality treatments. For instance, in August 2023, the government in Odisha, India, launched a 10-day program for mass drug administration with a view to eradicating lymphatic filariasis by regulating a combination of three drugs, namely DEC, ivermectin, and Albendazole. Besides this, the rising occurrence of fungal infection that occurs in the fingernails and toenails is also catalyzing the market. In January 2024, the U.S. Centers for Disease Control and Prevention (CDC) assessed prescription rates, volumes, and costs for topical antifungal medications in the context of the recent emergence of severe antimicrobial-resistant superficial fungal infections in the United States.

Rising Focus on Personalized Medicine

The increasing emphasis on tailored treatment plans based on individual patient characteristics is propelling the market. In February 2024, TheOTCLab, one of the Dutch foot-care specialists, introduced its latest addition to the FungeX range of innovative nail fungus treatments in Denmark, Sweden, Netherlands, and Norway. Apart from this, government bodies across countries are offering comprehensive policies to make healthcare accessible to all, which is acting as another significant growth-inducing factor. For instance, in February 2024, Community Pharmacy North East London (CPNEL) launched a self-care scheme funded by the local integrated care board to allow patients who cannot afford OT medicines to access them for free. Additionally, the increasing number of clinical trials that are done to identify the specific type of fungal infection and its resistance patterns will continue to bolster the market in the coming years. For example, in September 2023, Alkem Laboratories and Biosergen partnered to launch Phase II and Phase III clinical trials of the BSG005 drug for the treatment of invasive fungal diseases in India.

Global Onychomycosis Treatment Industry Segmentation:

IMARC Group provides an analysis of the key trends in each segment of the market, along with the onychomycosis treatment market forecast at the global, regional, and country levels for 2025-2033. Our report has categorized the market based on the disease type, treatment type, drug class, and distribution channel.

Breakup by Disease Type:

• Distal Subungual Onychomycosis
• Proximal Subungual Onychomycosis
• White Superficial Onychomycosis
• Candidal Onychomycosis
• Others
   

Distal subungual onychomycosis currently exhibits a clear dominance in the market

The report has provided a detailed breakup and analysis of the market based on the disease type. This includes distal subungual onychomycosis, proximal subungual onychomycosis, white superficial onychomycosis, candidal onychomycosis, and others. According to the report, distal subungual onychomycosis represented the largest market segmentation.

Distal subungual onychomycosis (DSO) is the most common form of fungal nail infection, characterized by the invasion of the nail bed and underside of the nail plate, leading to discoloration, thickening, and detachment of the nail. Recent advancements in the treatment of DSO have seen the launch of several innovative therapies aimed at improving patient outcomes. Topical antifungal solutions with enhanced nail penetration capabilities, such as efinaconazole and tavaborole, have been introduced, providing effective alternatives to oral medications. Additionally, the advent of laser treatments specifically designed for DSO has gained traction, offering a non-invasive and painless option that targets the fungal pathogens directly. New combination therapies, integrating both topical and oral agents, have also been launched to tackle the persistent nature of DSO by employing a multifaceted approach. In November 2023, Blueberry Therapeutics Limited, one of the pharmaceutical companies focused on developing innovative nanomedicines to treat dermatological conditions, introduced BB2603, a novel topical terbinafine antifungal product to treat distal subungual onychomycosis.

Breakup by Treatment Type:

• Laser Therapy
• Photodynamic Therapy
• Drug Treatment
   

Currently, drug treatment holds the largest market share

The report has provided a detailed breakup and analysis of the market based on the treatment type. This includes laser therapy, photodynamic therapy, and drug treatment. According to the report, drug treatment represented the largest market segmentation.

Drug treatment for onychomycosis mainly involves oral and topical antifungal medications, each with distinct examples of efficacy in treating the condition. Oral antifungals like terbinafine (Lamisil) and itraconazole are commonly prescribed due to their ability to reach the nail bed through the bloodstream, effectively targeting the fungal infection from within. On the other hand, topical treatments, such as ciclopirox and efinaconazole, offer non-invasive options that are applied directly to the affected nail. Ciclopirox is a nail lacquer that is applied daily and gradually penetrates the nail to eradicate the fungus. For example, in July 2022, Zydus Lifesciences received approval from the U.S. Food and Drug Administration (USFDA) to market an antifungal efinaconazole topical solution for onychomycosis.

Breakup by Drug Class:

• Allylamine
• Azole
• Griseofulvin
• Others
   

The report has provided a detailed breakup and analysis of the market based on the drug class. This includes allylamine, azole, griseofulvin, and others.

Allylamines, such as terbinafine, are prominently featured due to their high efficacy and relatively short treatment duration, making them a preferred choice for both patients and healthcare providers. Azoles, including itraconazole and fluconazole, are also thoroughly examined, highlighting their broad-spectrum antifungal activity and flexibility in dosing regimens, which cater to patients requiring alternative treatment options. Griseofulvin, an older antifungal, is analyzed for its continued use in cases where other treatments are contraindicated. The report further explores other emerging drug classes and novel antifungal agents that are being developed to address the limitations of existing therapies, which is propelling the onychomycosis treatment market share. This analysis not only informs about the market dynamics but also aids in understanding the evolving preferences and trends in antifungal treatments.

Breakup by Distribution Channel:

• Hospitals and Clinics
• Online Stores
• Retail Pharmacies
• Others
   

Retail pharmacies account for the majority of the total market share

The report has provided a detailed breakup and analysis of the market based on the distribution channel. This includes hospitals and clinics, online stores, retail pharmacies, and others. According to the report, retail pharmacies represented the largest market segmentation.

Retail pharmacies represented the largest segment in the onychomycosis treatment market, reflecting their pivotal role in the distribution and accessibility of antifungal medications. This dominance is attributed to the convenience and widespread availability of retail pharmacies, making it easier for patients to obtain both prescription and over-the-counter treatments. For example, widely used oral antifungals like terbinafine (Lamisil) and itraconazole (Sporanox) are commonly dispensed through retail pharmacies, allowing for prompt initiation of treatment following a diagnosis. Additionally, popular, topical solutions such as ciclopirox (Penlac) and efinaconazole (Jublia) are readily accessible at these outlets, providing non-invasive treatment options for patients. The extensive reach of retail pharmacies, often supplemented by in-store pharmacist consultations, supports patient adherence to treatment regimens, thereby enhancing the effectiveness of therapy. This segment's growth is further bolstered by the increasing availability of online pharmacy services, which offer added convenience and discreet purchasing options, catering to the evolving preferences of consumers seeking onychomycosis treatments.

Breakup by Region:

• North America
  • United States
  • Canada
• Asia-Pacific
  • China
  • Japan
  • India
  • South Korea
  • Australia
  • Indonesia
  • Others
• Europe
  • Germany
  • France
  • United Kingdom
  • Italy
  • Spain
  • Russia
  • Others
• Latin America
  • Brazil
  • Mexico
  • Others
• Middle East and Africa
   

North America currently dominates the market

The market research report has also provided a comprehensive analysis of all the major regional markets, which include North America (the United States and Canada); Asia Pacific (China, Japan, India, South Korea, Australia, Indonesia, and others); Europe (Germany, France, the United Kingdom, Italy, Spain, Russia, and others); Latin America (Brazil, Mexico, and others); and the Middle East and Africa. According to the report, North America accounted for the largest market share. 

The expanding geriatric population is primarily driving the market. The Census Bureau estimated that more than 55 million individuals in the U.S. are aged 65 years or older, out of which one-fourth live in one of three states, namely Florida, California, and Texas. Besides this, the rising number of regulatory approvals is also acting as another significant growth-inducing factor. For example, in April 2021, Alembic Pharmaceuticals Limited (Alembic) announced that its joint venture Aleor Dermaceuticals Limited (Aleor) received tentative approval from the U.S. Food & Drug Administration (US FDA) for its abbreviated new drug application (ANDA) for the treatment of onychomycosis in the toenail. Similarly, in February 2021, Lupin Limited received the U.S. Food and Drug Administration's approval for its tavaborole topical solution for onychomycosis.

Competitive Landscape:

The market research report has provided a comprehensive analysis of the competitive landscape. Detailed profiles of all major market companies have also been provided. Some of the key players in the market include:

• Bausch Health Companies Inc.
• Cipla Limited
• Dr. Reddy's Laboratories
• Galderma SA
• GlaxoSmithKline PLC
• Kaken Pharmaceutical Co. Ltd
• Lumenis Ltd
• Moberg Pharma AB
• Novartis AG
• Pfizer Inc.
• The OTC Lab B.V.
   

 (Please note that this is only a partial list of the key players, and the complete list is provided in the report.)

 Onychomycosis Treatment Market Recent Developments:

• June 2024: Renata commercialized terbinafine 250 mg tablets under a facility that was approved by the UK's Medicines and Healthcare Products Regulatory Agency (MHRA) for the onychomycosis treatment.
• February 2024: TheOTCLab, one of the Dutch foot-care specialists, introduced its latest addition to the FungeX range of innovative nail fungus treatments in Denmark, Sweden, Netherlands, and Norway.
• January 2024: The U.S. Centers for Disease Control and Prevention (CDC) assessed prescription rates, volumes, and costs for topical antifungal medications in the context of the recent emergence of severe antimicrobial-resistant superficial fungal infections in the United States.

Onychomycosis Treatment Market Report Scope:

Key Benefits for Stakeholders:

• IMARC’s industry report offers a comprehensive quantitative analysis of various market segments, historical and current market trends, market forecasts, and dynamics of the onychomycosis treatment market from 2019-2033.
• The research report provides the latest information on the market drivers, challenges, and opportunities in the global onychomycosis treatment market.
• The study maps the leading, as well as the fastest-growing, regional markets. It further enables stakeholders to identify the key country-level markets within each region.
• Porter's five forces analysis assists stakeholders in assessing the impact of new entrants, competitive rivalry, supplier power, buyer power, and the threat of substitution. It helps stakeholders to analyze the level of competition within the onychomycosis treatment industry and its attractiveness.
• The competitive landscape allows stakeholders to understand their competitive environment and provides insight into the current positions of key players in the market.