Onychomycosis Market Analysis

Global Onychomycosis Market Overview

Onychomycosis Market Size was valued at USD 3.98 Billion in 2023. The Global Onychomycosis industry is projected to grow from USD 4.17 Billion in 2024 to USD 6.07 Billion by 2032, exhibiting a compound annual growth rate (CAGR) of 5.20% during the forecast period (2024 - 2032).

Increasing R&D for the creation of novel medications and rising chronic disease and onychomycosis incidence are the key market drivers propelling the market growth.

Source: Secondary Research, Primary Research, MRFR Database and Analyst Review

Almirall S.A., a global biopharmaceutical company that specializes in skin health, and Kaken Pharmaceutical (KKPCF) have announced today that they have entered into a license and distribution agreement. Under the agreement, Kaken Pharmaceutical has granted Almirall the exclusive right to develop and commercialize the topical formulation of efinaconazole in Europe. This active principle, a triazole antifungal compound discovered by Kaken Pharmaceutical, is prescribed for the treatment of onychomycosis, a fungal infection of the nail. It possesses exceptional nail-penetrating properties due to its low binding affinity with keratin, the primary component of nails.

Onychomycosis is estimated to be present in approximately 5.5% of the global population and accounts for 50% of all nail disorder consultations. Kaken Pharmaceutical is entitled to an initial cash payment and the potential to receive milestone payments and royalties on the product's net sales under the terms of the agreement. Almirall intends to conduct a pre-submission meeting with regulatory authorities within the next year to facilitate the product's approval in Europe.

Lupin announced the US launch of Tavaborole Topical Solution, 5% in July 2021, following its approval by the United States Food and Drug Administration (FDA). The substance will be produced at Lupin's facility in Pithampur, India. Tavaborole Topical Solution, 5%, is the generic equivalent of Kerydin® Topical Solution, 5%, of Anacor Pharmaceuticals, Inc. It is an oxaborole antifungal that is authorized for the topical treatment of onychomycosis of the toenails caused by Trichophyton rubrum or Trichophyton mentagrophytes.

Historically, onychomycosis was used to describe a non-dermatophytic nail infection, but it is now a catch-all word for any fungal nail infection. White to yellow-brown nail discoloration, nail shape distortion, and ragged, crumbly nail texture are some of the disease's symptoms. Laser therapy and photodynamic therapies are typically used to treat it. It is typically identified through oxygen, potassium, hydrogen analysis, culture, and histological investigations of nail clippings and biopsies. The increased incidence of chronic diseases, such as onychomycosis, type 2 diabetes, and peripheral artery disease, is one of the major factors driving the market's rise during the forecast period.

Additionally, it is anticipated that during the projection period, there will be a rise in demand for medications due to an aging population that will be more susceptible to particular diseases due to a weakened immune system. Onychomycosis can take many different forms; however, it only causes around fifty percent of nail dystrophies while accounting for a third of skin fungal infections. Due to the rising prevalence of onychomycosis and chronic diseases, increased R&D for the creation of novel medications, and the rise in elderly and diabetic people, the onychomycosis market is expanding.

Numerous variables, such as recurrent nail trauma, poor peripheral circulation, type 2 diabetes, impaired immune function, prolonged exposure to pathogenic fungus, The age-associated increase in onychomycosis is caused by a variety of factors, including recurrent nail trauma, impoverished circulation to the extremities, type 2 diabetes, compromised immune function, long-term contact with the pathogenic fungus, idleness, or incapacity to trim toenails or preserve proper foot hygiene. Domestic businesses are utilizing various strategies, including product launches, acquisitions and mergers, and research and development, to strengthen their market positions. 

Since most antifungal drugs have minimal potency, it is challenging to treat. Since nondermatophyte molds and mixed infections, onychomycosis is usually underdiagnosed and ignored, contributing to the rise in antifungal resistance. Because onychomycosis infections are so common worldwide, the necessity for treatments is widely acknowledged. Small research-based biotechnology and pharmaceutical businesses are frequently in charge of R&D, while larger players are frequently concentrated on more lucrative goods. Due to their consistently high success rate, medications remain the first-line therapeutic choice for treating onychomycosis and account for a sizeable market share. As we age, the immune system slowly decreases in effectiveness. Therefore, physical and cognitive changes often render elderly persons more prone to contracting diseases like onychomycosis. The number of elderly people worldwide is growing.

Onychomycosis Market Trends

• Growing Prevalence of dermatophytic onychomycosis to boost market growth

Onychomycosis' increasing incidence is one of the major factors propelling the market's expansion. Infection of the toenail onychomycosis is far more common than that of the fingernails. The market is anticipated to be driven by the rising prevalence of dermatophyte-caused nail fungal infections and a significant rise in prescriptions. Over 10% of the world's population has onychomycosis, with 35–40 million Americans suffering nail fungus, according to a press release from Moberg Pharma AB. Throughout the anticipated period, this is anticipated to boost demand for the market for treating dermatophytic onychomycosis. A further factor contributing to the rise in dermatophytic infection is the rising incidence of diabetes. The World Diabetes Federation estimates that 463 million people worldwide will have diabetes in 2019, which will help the industry grow.

Because onychomycosis infections are so common worldwide, the necessity for treatments is widely acknowledged. Small research-based pharmaceutical and biotechnology companies are frequently in charge of R&D, while more prominent players are commonly concentrated on more lucrative goods. Also, larger businesses are expanding their antifungal drug portfolio through acquisition tactics. For instance, Pfizer said in November 2021 that it would be making significant expenditures in R&D for antibacterial and antifungal medications to bring new products to market. R&D initiatives are predicted to be accelerated by such spending. Commercially accessible antifungal medicines include a sizable variety of tablets, creams, sprays, injections, and oral and topical medications. High demand for these goods and higher acceptance are expected throughout the projected period to promote market expansion for therapies. Therefore, such medical condition has enhanced the market CAGR of Onychomycosis across the globe in the recent years.

However, increasing understanding of the possible risks posed by onychomycosis is another factor driving the growth of the Onychomycosis market revenue.

Onychomycosis Market Segment Insights

Onychomycosis Type Insights

The Market segments of Onychomycosis, based on Type, includes distal subungual onychomycosis (DSO), white superficial onychomycosis (WSO), proximal subungual onychomycosis (PSO), candida onychomycosis, and others. The distal subungual onychomycosis (DSO) segment held the majority share in 2022, contributing to around ~40% of the Onychomycosis Market revenue. The segment's dominance is linked to the FDA's clearance of more generic drugs due to rising demand and rising generic prevalence. Additionally, more pharmaceuticals are in the pipeline to address the increased demand for effective medications. For instance, in March 2020, NovaBiotics Ltd., a clinical-stage biotechnology business based in the United Kingdom, provided updated clinical information on the safety and effectiveness of Novexatin. A novel antifungal peptide called NP213 (Novexatin) was discovered to treat individuals with severe DSO. An unnamed business has been granted a license to use NP213 throughout Europe and Japan as of February 2021. The company anticipates that in 2022, with the assistance of its partner, it will advertise its product through direct-to-consumer healthcare channels, including retail pharmacies.

Onychomycosis Treatment Type Insights

The Onychomycosis Market data has been bifurcated by treatment type into drug treatment, topical therapy, and others. The Drug Treatment segment dominated the market in 2022 and is projected to be the faster-growing segment during the forecast period, 2024-2032. Terbinafine, ciclopirox, Jublia, Fluconazole, Penlac, ciclodan, ketoconazole, Sporanox, Itraconazole, Kerydin, efinaconazole, griseofulvin, and others are some of the medications that can be used to treat onychomycosis. Drugs continue to be the first-line therapeutic option for onychomycosis treatment and hold a significant market share due to a continuously high success rate.

Figure 1: Onychomycosis Market, by Treatment Type, 2022 & 2032 (USD billion)

Source: Secondary Research, Primary Research, MRFR Database and Analyst Review

Topical treatments require substantially longer treatment times but have less effective cure rates and less severe side effects. Moreover, new topical formulations that respond more quickly than currently existing topical medicines are being studied. Topical formulations, on the other hand, have low cure rates and are useless because they can't get through the nail plate to the infected nail bed in sufficient concentration to kill the fungus, necessitating debridement of the nail plate before administration. 

Onychomycosis End User Insights

Based on End Users, the global Onychomycosis industry has been divided into retail pharmacies, hospital pharmacies, and others. Retail Pharmacies held the most significant segment share in 2022, Due to rising OTC drug sales, rising diabetes and fungal nail infection rates, and increasing OTC drug sales.

The fastest-growing segment in the Onychomycosis industry is hospital pharmacies due to the rise in privately operated clinics and the growing number of dermatologists and podiatrists.The Swift device from Emblation will be used in the trial in Canada, which MediProbe is running. Onychomycosis, sometimes known as toenail fungus, is being treated in a clinical trial in Canada launched by the Scottish medical technology company Emblation. Three patient groups will participate in the experiment being run by MediProbe Research with Emblation as a collaborator. Each group will get a different course of treatment. Antifungal lotions are currently the mainstay therapies. According to Emblation, there are worries that some fungal strains are becoming resistant to treatments that are already being employed.

Onychomycosis Regional Insights

The analysis provides market information for North America, Asia-Pacific, Europe, and the rest of the world, organised by region. The North America Onychomycosis market is expected to exhibit a significant CAGR growth during the study period. Due to the region's increased senior population, high cost of medications, and rising rates of onychomycosis and diabetes in the patient population. In 2020, the Census Bureau projected that more than 55 million Americans are 65 or older, with one-fourth of them residing in one of the three states of California, Florida, or Texas. The remaining seven states—Georgia, Illinois, Michigan, and New York—represent another quarter of the population 65 and over.

Further, the significant countries studied in the market report are The U.S., Italy, Canada, Germany, France, the UK, Spain, China, Japan, India, Australia, South Korea, and Brazil.

Figure 2: ONYCHOMYCOSIS MARKET SHARE BY REGION 2022 (%)

Source: Secondary Research, Primary Research, MRFR Database and Analyst Review

Europe's Onychomycosis market accounts for the second-largest market share. Due to the rising incidence of onychomycosis, favorable health reimbursement policies, and enhanced distribution of OTC medications through partnerships with retail pharmacies like Walmart, Walgreens, and others, the need for dermatophytic onychomycosis therapy is projected to increase. Further, the Germany market of Onychomycosis held the largest market share, and the UK market of Onychomycosis was the fastest-growing market in the European region

From 2024 to 2032, the fastest CAGR is anticipated to be seen in the Asia-Pacific Onychomycosis Market. This is proliferating due to new product introductions, an increase in diabetes incidence, and a rise in the number of older adults. Jublia will be made available as a treatment for dermatophytic onychomycosis in Hong Kong starting in March 2020, according to Kaken Pharmaceuticals Co., Ltd. This is anticipated to stimulate the Asia Pacific market. The market in the rest of the globe is being driven by factors such as expanding distribution networks, growing patient awareness, and rising health spending. Moreover, the China market of Onychomycosis held the largest market share, and the India market of Onychomycosis was the fastest-growing market in the Asia-Pacific region.

Onychomycosis Key Market Players & Competitive Insights

Top market companies are investing a lot of money in R&D to expand their product offerings, which will spur further growth in the onychomycosis industry.  With significant market developments like new product releases, mutual arrangements, mergers and acquisitions, more significant investment, and partnerships with other companies, market participants are also undertaking various strategic activities to expand their global presence. To grow and compete in a more cutthroat and competitive market climate, Onychomycosis business competitors must provide affordable products.

Manufacturing locally to cut operational costs is one of the leading business tactics companies use in the global onychomycosis industry to benefit customers and expand the market sector. In recent years, Onychomycosis industry has provided medicine with some of the most significant benefits. Major players in the onychomycosis industry, including Almirall S.A., HUYABIO International, and others, are attempting to increase market demand by funding R&D initiatives.

Founded in 1943, the Spanish pharmaceutical company Almirall, S.A. has its main office in Barcelona. It had a total revenue of €859.3 million in 2016, making it Spain's top pharmaceutical business in terms of R&D investment. In September 2021, Alembic Pharmaceuticals Limited (Alembic) announced that its joint venture Aleor Dermaceuticals Limited (Aleor) had received tentative approval from the US Food & Drug Administration (US FDA) for its abbreviated new drug application (ANDA) for Efinaconazole Topical Solution for the treatment of onychomycosis in the toenail.

Also, HUYABIO has developed into a pioneer in bringing China's pharmaceutical innovation abroad. Using the skills of Chinese researchers and advancing their discoveries is necessary to meet the problem of unmet medical needs in the future.  In September 2021, For the treatment of onychomycosis, HUYABIO International and its joint venture, Tianjin Institute of Pharmaceutical Research, submitted an NDA for Jublia, which contains the drug efinaconazole.

Key Companies in the market of Onychomycosis includes

• Novartis AG (Switzerland)


• Pfizer, Inc. (the US)


• Galderma Laboratories (Switzerland)


• Bausch Health Sciences (Canada)


• Moberg Pharma AB (Sweden)


• Reddy’s Laboratories Ltd (India)


• Medimetriks Pharmaceuticals, Inc. (US)


• Merz Pharma (Germany)


• Kaken Pharmaceutical Co., Ltd (Japan)


• Johnson & Johnson Services, Inc. (US)


• GlaxoSmithKline plc (UK)


• Taro Pharmaceuticals Industries Ltd (Israel), among others

Onychomycosis Industry Developments

July 2021: Tavaborole Topical Solution, 5%, a generic version of the oxaborole antifungal Kerydin Topical Solution, 5% created by Anacor Pharmaceuticals, has been approved by the U.S. FDA.

April 2021: The Tavaborole Topical Solution from Lupin Limited has been given the thumbs-up by the US Food and Drug Administration for treating onychomycosis.

Onychomycosis Market Segmentation

Onychomycosis Type Outlook

• Distal Subungual Onychomycosis (DSO)


• White Superficial Onychomycosis (WSO)


• Proximal Subungual Onychomycosis (PSO)


• Candida Onychomycosis


• Others

Onychomycosis Treatment Type Outlook

• Drug Treatment


• Topical Therapy Others

Onychomycosis End User Outlook

• Hospital Pharmacies


• Retail Pharmacies


• Others

Onychomycosis Regional Outlook

• North America
  
  
  
  • US
  
  
  • Canada
  
  
  
  


• Europe
  
  
  
  • Germany
  
  
  • France
  
  
  • UK
  
  
  • Italy
  
  
  • Spain
  
  
  • Rest of Europe
  
  
  
  


• Asia-Pacific
  
  
  
  • China
  
  
  • Japan
  
  
  • India
  
  
  • Australia
  
  
  • South Korea
  
  
  • Australia
  
  
  • Rest of Asia-Pacific
  
  
  
  


• Rest of the World
  
  
  
  • Middle East
  
  
  • Africa
  
  
  • Latin America