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Onychomycosis Treatment Market: Growing Prevalence Globally and Expected Entry of New Therapies Shall Drive the Market at a 4.22% CAGR During the Study Period [2018-2030], Analyses DelveInsight
By: PR Newswire Association LLC. - 22 Jul 2021Back to overview list

Moberg Pharma is developing MOB-015, which is believed to be the most successful therapy amongst all the other expected drug candidates and shall account for the highest Onychomycosis market revenue in the coming years

LAS VEGAS, July 22, 2021 /PRNewswire/ -- DelveInsight's "Onychomycosis Market" report provides a thorough comprehension of the Onychomycosis historical and forecasted epidemiology and the Onychomycosis market trends in the 7MM [the United States, EU5 (Germany, Spain, Italy, France, and United Kingdom) and Japan]. The Onychomycosis market report also proffers an analysis of the current Onychomycosis treatment algorithm/practice, market drivers, market barriers, and unmet medical needs. 

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Some of the necessary takeaways from the Onychomycosis Market Research Report  

  • Several key pharmaceutical companies include Pfizer, Bausch Health, Sato Pharmaceutical, Eisai, Moberg Pharma, Blueberry Therapeutics, Mycovia Pharmaceuticals, Meiji Seika Pharma, NovaBiotics, Hallux, and others, are developing novel products to improve the Onychomycosis treatment outlook. 
  • In July 2014, the FDA approved Kerydin (Tavaborole) to treat Onychomycosis of the toenails due to Trichophyton rubrum or Trichophyton mentagrophytes. Tavaborole prohibits protein synthesis by inhibition of an aminoacyl-transfer ribonucleic acid (tRNA) synthetase (AARS). 
  • The FDA approved Jublia in July 2014 for the Onychomycosis treatment due to Trichophyton rubrum or Trichophyton mentagrophytes. Jublia has been marketed under the brand name Clenafin (Kaken Pharmaceuticals) in Japan since 2014. 
  • A luliconazole 5% solution (Luconac R) was developed by Pola Pharma and Sato Pharmaceutical and launched in Japan in 2016 after securing approval from PMDA.
  • The Onychomycosis market to be driven by the factors such as advancements in clinical trials, promising results of emerging therapies, and wide acceptance of topical therapies. However, the long duration of Onychomycosis treatment, discontinuation of drug developments, and underdiagnosis of the disease may impede the Onychomycosis market growth.

For further information on Market Impact by Therapies, visit: Onychomycosis Drugs Market Analysis 

Onychomycosis is a fungal infection of the nail, causing discoloration and thickening of the affected nail plate. The disease is the most common nail infection worldwide. 

DelveInsight estimates that the Onychomycosis prevalent population in the United States was found to be 36,500,979 cases in 2020, whereas the total prevalent cases in the 7MM was 82,830,728. 

The Onychomycosis Market Analysis Report provides historical as well as forecasted epidemiological analysis segmented into: 

  • Diagnosed Onychomycosis prevalent cases 
  • Prevalent cases of Onychomycosis by subtype
  • Onychomycosis Prevalence by Severity

Get a complete epidemiological segmentation breakdown @ Onychomycosis Epidemiological Analysis 

Onychomycosis Treatment Market 

Several Onychomycosis treatment options are available, including oral antifungals, topical antifungals, and devices. Oral antifungals have higher treatment cure rates and shorter treatment periods than topical treatments but have severe side effects such as hepatotoxicity and drug interactions. Topical treatments have less serious side effects but result in lower cure rates generally and much longer treatment regimens. Besides, new topical formulations are being investigated as faster-acting alternatives to the currently available topical treatments.

Currently, oral Terbinafine hydrochloride (Lamisil) is the most common treatment for Onychomycosis. It was approved by the US FDA and has been the mainstay with all its generic versions marketed since the patent expiry in 2007. Oral terbinafine is associated with safety issues, including drug interactions and liver damage. 

A luliconazole 5% solution (Luconac R), which Pola Pharma and Sato Pharmaceutical developed, is an antifungal that belongs to the azole class. The other recently approved drug in Japan is NAILIN (fosravuconazole), currently marketed and manufactured by Sato Pharmaceutical Co., Ltd. This is the first new treatment for Onychomycosis that has improved bioavailability as compared to ravuconazole. In the process, Sato Pharma has attained the ability to provide externally and internally administered medicines as options for the Onychomycosis treatment.

Numerous attempts have been made to develop remedies for toenail fungus. Still, to date, the few products the FDA approved are currently dominating the Onychomycosis market are considered as a poor treatment option primarily for two significant reasons. Topical formulations deliver low cure rates and suboptimal efficacy. They cannot penetrate the nail plate to reach the infected nail bed in adequate concentrations to kill the fungus and may require debridement of the nail plate before application.

The complete cure rates are meager in the treatment modalities, and hepatotoxicity is a common side effect associated with prolonged usage. Onychomycosis patients must undertake periodic lab tests to ensure that their liver is functioning correctly while on the product. The numerous pharma players such as Moberg Pharma, Meiji Seika Pharma Co., Ltd., NovaBiotics, Hallux, and others have targeted this high unmet need to tap the Onychomycosis market and move forward towards overcoming the unmet needs.

The drug candidate MOB-015 by Moberg Pharma is a new topical treatment for Onychomycosis with fungicidal, keratolytic, and emollient properties. It is an internally developed topical formulation of terbinafine based on its experience from previously developed and commercialized OTC products for Onychomycosis. 

Another candidate, ME1111, being developed by Meiji Seika Pharma Co., Ltd., is a topical formulation based on a novel class of compounds with a unique mode of action. 

NP213 (Novexatin) by NovaBiotics is a unique compound for the treatment of Onychomycosis that addresses both the clinical and cosmetic issues associated with Onychomycosis. It rapidly kills fungi causative of nail infections by perturbing and lysing their outer membrane. 

HTS-519 micro-insert being developed by Hallux, which can deliver high concentrations of terbinafine directly to the site of infection.

As many potential therapies are being investigated for Onychomycosis management, the treatment space will experience significant reconstitution during the forecast period of 2020-2030. Lack of awareness among the patient population leads to lower diagnosis and higher treatment duration, leading to low adherence. Improved safety and efficacy remain a major challenge, though emerging players have reported improved results. Currently approved therapies have very low mycological as well as clinical cure rates, thereby presenting the emerging players with a highly untapped market.

Scope of the Onychomycosis Market Insight Report 

  • Onychomycosis Market Segmentation report provides detailed information about each region: The United States, EU5 (Germany, France, Italy, Spain, and the United Kingdom), and Japan, and how numerous factors of that particular region affect the growth of the Onychomycosis market. 
  • Study Period: 3-year historical and 11-year forecasted analysis (2017-2030).
  • Onychomycosis Markets Segmentation proffers in the report as: By Geographies and By Onychomycosis Therapies (Historical and Forecasted, Current and Upcoming) 
  • Dominant Market Companies investigate its candidates for Onychomycosis: Pfizer, Bausch Health, Sato Pharmaceutical, Eisai, Moberg Pharma, Blueberry Therapeutics, Mycovia Pharmaceuticals, Meiji Seika Pharma, NovaBiotics, Hallux, and several others. 
  • Onychomycosis Pipeline Analysis provides a comparative and conjoint analysis of emerging therapies. 
  • The report includes KOLs and SME's opinions working in the Onychomycosis domain through primary research to fill the data gaps and validate the secondary research to keep up with current Onychomycosis market trends, along with Case Studies and Analyst's Views. 
  • Competitive and Market Intelligence analysis of the Onychomycosis Market is evaluated by using various Competitive Intelligence tools: SWOT analysis, PESTLE analysis, Porter's five forces, BCG Matrix, Market entry strategies, and others.

Request for a Webex demo of the report @ Onychomycosis Therapeutics Market

Table of Contents 


Onychomycosis Key Insights


Executive Summary of Onychomycosis 


SWOT Analysis for Onychomycosis 


Onychomycosis Market Overview at a Glance 


Onychomycosis Disease Background and Overview 


Onychomycosis Epidemiology and Patient Population 


Country Wise-Epidemiology of Onychomycosis 


The United States


EU5 Countries










The United Kingdom




Onychomycosis Treatment and Management 


Onychomycosis  Patient Journey 


Onychomycosis  Unmet Needs 


Onychomycosis Marketed Products


Kerydin (tavaborole): Pfizer 


Jublia/Clenafin (efinaconazole): Bausch Health 


Luliconazole: Sato Pharmaceutical/Bausch Health


Nialin: Sato Pharmaceutical/ Eisai


Onychomycosis Emerging Therapies


 MOB015: Moberg Pharma


 BB2603: Blueberry Therapeutics


 VT-1161: Mycovia Pharmaceuticals


Other Onychomycosis Promising Candidates


ME1111: Meiji Seika Pharma


NP213 (Novexatin): NovaBiotics


HTS-519: Hallux


Onychomycosis Discontinued Products


P3058: Almirall


Onychomycosis 7MM Market Analysis


The United States Onychomycosis Market Size


EU-5 Onychomycosis Market Size


Germany Market Size


France Market Size


Italy Market Size


Spain Market Size


The United Kingdom Market Size


Japan Onychomycosis Market Size


Onychomycosis Case Reports


Onychomycosis Market Drivers


Onychomycosis Market Barriers




DelveInsight Capabilities




About DelveInsight

Browse full report with detailed TOC with charts, figures, tables @ Onychomycosis Diagnostics Market Report

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