Onychomycosis - Market Insight, Epidemiology And Market Forecast - 2032

Onychomycosis - Market Insight, Epidemiology And Market Forecast - 2032

DelveInsight’s ‘Onychomycosis – Market Insights, Epidemiology, and Market Forecast – 2032’ report delivers an in-depth understanding of the historical and forecasted epidemiology as well as the market trends of onychomycosis in the United States, EU5 (Germany, Spain, Italy, France, and United Kingdom), Japan and China.

The onychomycosis market report provides current treatment practices, emerging drugs, market share of the individual therapies, and current, and forecasted onychomycosis market size from 2019–2032 segmented by 7MM + China. The report also covers the current onychomycosis treatment practice/algorithm, market drivers, market barriers, and unmet medical needs to curate the best opportunities and assesses the underlying market potential.

Geographies Covered

  • The United States
  • EU5 (Germany, France, Italy, Spain, and the United Kingdom)
  • Japan
  • China
Study Period: 2019–2032

Onychomycosis: Disease Understanding and Treatment Algorithm

Onychomycosis Overview

Onychomycosis is a fungal nail infection that causes discoloration and thickening of the affected nail plate. It was initially caused by dermatophytes predominantly; however, new research has revealed that mixed infections and those caused by non-dermatophyte molds (NDMs) are more prevalent, especially in warmer climates. Onychomycosis caused by dermatophytes is called tinea unguium. The term Onychomycosis encompasses not only dermatophytes but also yeasts and saprophytic mold infections. It can infect both fingernails and toenails, Onychomycosis of the toenail is more prevalent.

Onychomycosis is classified into subtypes based on the invasion pattern. Distal subungual onychomycosis (DSO) is the most common subtype and occurs when the fungus invades the distal aspect of the nail plate. In superficial white onychomycosis (SWO), fungi invade the most superficial layers of the nail plate. Proximal subungual onychomycosis (PSO) is caused by the infecting organism invading from the undersurface of the proximal nail fold, and the infection then progresses distally. Endonyx onychomycosis (EO) occurs with the fungal invasion of the nail plate without infection of the nail bed. Total dystrophic onychomycosis (TDO) represents end-stage onychomycosis and may follow any other subtypes. Secondary onychomycosis (SO) is a non-fungal nail condition (i.e., psoriasis) with a secondary fungal infection, clinically approximating both the fungal and non-fungal nail conditions.

The treatment of onychomycosis involves the usage of oral antifungals, topical antifungals, and devices. Oral antifungals have higher cure rates than topical treatments but have adverse side effects such as hepatotoxicity and drug interactions. Topical treatments have less serious side effects but generally result in lower cure rates and longer treatment regimens.

Hence, treatment aims to prevent drug interactions and potential hepatotoxicity. The prime focus in the treatment of onychomycosis is to achieve superior efficacy and less time-consuming therapies with better nail bed penetration.

Onychomycosis Diagnosis and Treatment

It covers the details of conventional and current medical therapies and diagnoses available in the onychomycosis market to treat the condition. It also provides country-wise treatment guidelines and algorithms across the United States, Europe, Japan, and China.

Onychomycosis Epidemiology

The onychomycosis epidemiology division provides insights into the historical and current patient pool and the forecasted trend for every 7MM and China. It helps recognize the causes of current and forecasted trends by exploring numerous studies and views of KOL. The report also provides the diagnosed prevalent patient pool, trends, and assumptions.

Key Findings

The disease epidemiology covered in the report provides historical and forecasted onychomycosis epidemiology segmented as the diagnosed prevalent cases of onychomycosis, Gender-specific cases of onychomycosis, Age-specific cases of onychomycosis, Type-specific cases of onychomycosis and Severity-specific cases of onychomycosis. The report includes the diagnosed prevalent scenario of onychomycosis symptoms covering the United States, EU5 countries (Germany, France, Italy, Spain, and the United Kingdom), Japan, and China from 2019–2032.

Country-wise onychomycosis Epidemiology

The epidemiology segment also provides the onychomycosis epidemiology data and findings across the United States, EU5 (Germany, France, Italy, Spain, and the United Kingdom), Japan, and China.

The diagnosed prevalence of onychomycosis population in the United States, EU5 (Germany, France, Italy, Spain, and the United Kingdom), Japan, and China was estimated to be close to 121,608,000 cases in 2021.

Onychomycosis Drug Chapters

The drug chapter segment of the onychomycosis report encloses the detailed analysis of onychomycosis marketed drugs and late-stage (Phase III, Phase II/III, Phase II, and Phase I/II) pipeline drugs. It also helps understand the onychomycosis clinical trial details, expressive pharmacological action, agreements and collaborations, approval and patent details, advantages and disadvantages of each included drug, and the latest news and press releases.

The current standard of care lacks efficiency in treating onychomycosis and demands prolonged treatment, calling for better and more effective therapies. Although some broad-spectrum antifungals show superior efficacy in vitro, they achieve less than expected results. The reasons are numerous, depending on the biology of the fungus, the intrinsic properties of the nail, the chemical properties of the antifungal agent, and the treatment regimen. Despite these modalities producing success for most patients with onychomycosis, there remains a need for more effective topical agents with greater nail penetration and more effective oral antifungal agents with fewer adverse effects and fewer drug–drug interactions.

Products detail in the report…

Onychomycosis Emerging Drugs

Drug developers are gradually shifting their attention toward onychomycosis to meet the patient pool's current demands and counter the unmet needs of the therapeutic market.

Several companies are working robustly on many new therapies, such as MOB-015 (Moberg Pharma), BB2603 (Blueberry Therapeutics), and Hallux Terbinafine Subungual Gel (Hallux).

MOB-015 (Moberg Pharma) is a next-generation nail fungus treatment targeting over-the-counter (OTC) and prescription markets worldwide. The company’s patented formulation technology facilitates the delivery of high concentrations of a proven antifungal substance (terbinafine) into and through the nail. It has emollient and keratolytic properties that contribute to rapid, visible improvement.

MOB-015 is developed to meet this need and is patent protected by 2032 in most major markets, including the US, EU, Japan, and China.

The drug is currently being evaluated in Phase III to measure the complete cure and adverse events of the target toenail.

Products detail in the report…

Onychomycosis Market Outlook

The onychomycosis market outlook of the report builds a detailed comprehension of the historical, current, and forecasted onychomycosis market trends by analyzing the impact of current therapies on the market, unmet needs, and demand for better technology.

This segment gives a thorough detail of the onychomycosis market trend of each marketed drug and late-stage pipeline therapy by evaluating their impact based on the annual cost of therapy, inclusion and exclusion criteria, mechanism of action, compliance rate, growing need for the market, increasing patient pool, covered patient segment, expected launch year, competition with other therapies, brand value, their impact on the market, and KOL view. The calculated market data are presented with relevant tables and graphs to give a clear view of the market at first sight.

As per DelveInsight, the onychomycosis market in 7MM + China is expected to change in the study period 2019–2032.

Key Findings

This section includes a glimpse of the onychomycosis market in 7MM + China. In the 7MM and China, the onychomycosis market size was approximately USD 2,900 million in 2021.

The United States: Market Outlook

This section provides the total onychomycosis market size and market size by onychomycosis therapies in the United States.

The United States accounts for the highest market size of onychomycosis than the EU5 (the United Kingdom, Germany, Italy, France, and Spain), Japan, and China.

EU-5 Countries: Market Outlook

The total onychomycosis market size and market size by therapies in Germany, France, Italy, Spain, and the United Kingdom are also mentioned.

Japan Market Outlook

The total onychomycosis market size and market size by therapies of onychomycosis in Japan are also mentioned.

China Market Outlook

The total Onychomycosis market size and market size by therapies of onychomycosis in China are also mentioned.

Onychomycosis Drugs Uptake

This section focuses on the rate of uptake of the potential drugs recently launched or expected to get launched in the market during the study period 2019–2032. The analysis covers onychomycosis market uptake by drugs, patient uptake by therapies, and sales of each drug.

This helps in understanding the drugs with the most rapid uptake and the reasons behind the maximal use of new drugs and allows the comparison of the drugs based on market share and size, which again will be useful in investigating factors important in the market uptake and in making financial and regulatory decisions.

Onychomycosis Pipeline Development Activities

The report provides insights into different therapeutic candidates in Phase III, Phase II/III, Phase II, and Phase I/II stages. It also analyses onychomycosis’s key players involved in developing targeted therapeutics.

Major players include Moberg Pharma, Blueberry Therapeutics, Hallux, and others whose key products are expected to get launched in the US market by 20XX.

Pipeline Development Activities

The report covers information on collaborations, acquisitions, mergers, licensing, and patent details for emerging onychomycosis therapies.

KOL Views

To keep up with current market trends, we take KOLs and SMEs’ opinions working in the onychomycosis domain through primary research to fill the data gaps and validate our secondary research. Their opinion helps understand and validate current and emerging therapies treatment patterns or onychomycosis market trends. This will support the clients in potential upcoming novel treatments by identifying the overall scenario of the market and the unmet needs.

Competitive Intelligence Analysis

We perform a competitive and market intelligence analysis of the onychomycosis market using various competitive intelligence tools: SWOT analysis, PESTLE analysis, Porter’s five forces, BCG Matrix, Market entry strategies, etc. The inclusion of the analysis entirely depends upon the data availability.

Scope of the Report
  • The report covers the descriptive overview of onychomycosis, explaining its causes, signs and symptoms, pathophysiology, and currently available therapies
  • Comprehensive insight is provided into the onychomycosis epidemiology and treatment in the 7MM + China
  • Additionally, an all-inclusive account of both the current and emerging therapies for onychomycosis is provided, along with the assessment of new therapies that will impact the current treatment landscape
  • A detailed review of the onychomycosis market; historical and forecasted, is included in the report, covering drug outreach in the 7MM + China
  • The report provides an edge while developing business strategies by understanding trends shaping and driving the global onychomycosis market
Report Highlights
  • Recently, the onychomycosis market is set to change due to the rising awareness of the disease and incremental healthcare spending across the world; which would expand the size of the market to enable the drug manufacturers to penetrate more into the market
  • The companies and academics are working to assess challenges and seek opportunities that could influence onychomycosis R&D. The therapies under development are focused on novel approaches to treat/improve the disease condition
  • Major players are involved in developing therapies for onychomycosis. The launch of emerging therapies will significantly impact the onychomycosis market
  • For onychomycosis, a better understanding of disease pathogenesis will also contribute to developing novel therapeutics
  • Our in-depth analysis of the pipeline assets across different stages of development (Phase III and Phase II), different emerging trends, and comparative analysis of pipeline products with detailed clinical profiles, key cross-competitor, launch date along with product development activities will support the clients in the decision-making process regarding their therapeutic portfolio by identifying the overall scenario of the R&D activities
Onychomycosis Report Insights
  • Patient Population
  • Therapeutic Approaches
  • Onychomycosis Pipeline Analysis
  • Onychomycosis Market Size and Trends
  • Market Opportunities
  • Impact of upcoming Therapies
Onychomycosis Report Key Strengths
  • 11-year Forecast
  • 7MM + China Coverage
  • Onychomycosis Epidemiology Segmentation
  • Key Competitors
  • Highly Analyzed Market
  • Drugs Uptake
Onychomycosis Report Assessment
  • Current Treatment Practices
  • Unmet Needs
  • Pipeline Product Profiles
  • Market Attractiveness
Key Questions

Market Insights:
  • What was the market share percentage distribution, and how would it look by 2032?
  • What would be the total market size and market size of onychomycosis by therapies across the 7MM + China forecast period (2019–2032)?
  • What are the key findings about the market across 7MM + China, and which country will have the largest onychomycosis market size during the forecast period (2019–2032)?
  • At what CAGR is the onychomycosis market expected to grow in the 7MM + China forecast period (2019–2032)?
  • What would be the onychomycosis market outlook across the 7MM + China forecast period (2019–2032)?
  • What would be the onychomycosis market growth until 2032 and the resultant market size by 2032?
  • How would future opportunities affect the market dynamics and subsequent analysis of the associated trends?
Epidemiology Insights:
  • What are the disease risk, burdens, and unmet needs of onychomycosis?
  • What is the historical patient pool of onychomycosis covering the United States, EU5 (Germany, Spain, France, Italy, UK), Japan, and China?
  • What would be the forecasted patient pool of onychomycosis covering the United States, EU5 (Germany, Spain, France, Italy, UK), Japan, and China?
  • What will be the growth opportunities in 7MM + China concerning the patient population of onychomycosis?
  • Out of all 7MM + China, which country would have the highest diagnosed prevalence of onychomycosis during the forecast period (2019–2032)?
  • At what CAGR is the population expected to grow in 7MM + China during the forecast period (2019–2032)?
Current Treatment Scenario, Marketed Drugs, and Emerging Therapies:
  • What are the current options to treat onychomycosis?
  • What are the current treatment guidelines for treating onychomycosis in the US, Europe, Japan, and China?
  • What are the onychomycosis marketed drugs and their MOA, regulatory milestones, product development activities, advantages, disadvantages, safety, efficacy, etc.?
  • How many companies are developing therapies to treat onychomycosis?
  • How many therapies are developed by each company to treat onychomycosis?
  • How many emerging therapies are in the mid-stage and late stages of development to treat onychomycosis?
  • What are the key collaborations (Industry–Industry, Industry-Academia), Mergers and acquisitions, and licensing activities related to the onychomycosis therapies?
  • What are the recent novel therapies, targets, mechanisms of action, and technologies developed to overcome the limitation of existing therapies?
  • What are the clinical studies for onychomycosis and its status?
  • Which key designations have been granted for the emerging therapies for onychomycosis?
  • What are the global historical and forecasted onychomycosis markets?
Reasons to buy
  • The report will help in developing business strategies by understanding trends shaping and driving the onychomycosis market
  • To understand the future market competition in the onychomycosis market and an Insightful review of the key market drivers and barriers.
  • Organize sales and marketing efforts by identifying the best opportunities for onychomycosis in the US, Europe (Germany, Spain, Italy, France, and the United Kingdom), Japan, and China
  • Identifying upcoming solid players in the market will help devise strategies that will help get ahead of competitors
  • Organize sales and marketing efforts by identifying the best opportunities for the onychomycosis market
  • To understand the future market competition in the onychomycosis market


1. Key Insights
2. Report Introduction
3. Onychomycosis Market Overview at a Glance
3.1. Market Share Percentage Distribution of Onychomycosis in 2019
3.2. Market Share Percentage Distribution of Onychomycosis by 2032
4. Executive Summary of Onychomycosis
5. Disease Background and Overview
5.1. Introduction
5.2. Etiology and Risk Factors
5.3. Pathophysiology
5.4. Types
5.5. Clinical Aspects
5.6. Clinical Presentation and Diagnosis
5.7. Treatment and Management
5.7.1. Treatment algorithm
5.7.2. Management of onychomycosis
5.7.3. Resistance of dermatophytes to standard treatments
5.8. Treatment Guidelines
5.8.1. British Association of Dermatologists (BAD) Guidelines for the management of onychomycosis
6. Patient Journey
7. Epidemiology and Patient Population
7.1. Key Findings
7.2. Total Prevalence of Onychomycosis in 7MM + China
7.3. Assumption and Rationale
7.4. The United States
7.4.1. Diagnosed Cases of Onychomycosis in the United States
7.4.2. Gender-specific Cases of Onychomycosis in the United States
7.4.3. Age-specific Cases of Onychomycosis in the United States
7.4.4. Type-specific Cases of Onychomycosis in the United States
7.4.5. Severity-specific Cases of Onychomycosis in the United States
7.5. The EU5
7.5.1. Total Diagnosed Cases of Onychomycosis in the EU5
7.5.2. Germany
7.5.2.1. Gender-specific Cases of Onychomycosis in Germany
7.5.2.2. Age-specific cases of Onychomycosis in Germany
7.5.2.3. Type-specific Cases of Onychomycosis in Germany
7.5.2.4. Severity-specific Cases of Onychomycosis in Germany
7.5.3. France
7.5.3.1. Gender-specific Cases of Onychomycosis in France
7.5.3.2. Age-specific Cases of Onychomycosis in France
7.5.3.3. Type-specific Cases of Onychomycosis France
7.5.3.4. Severity-specific cases of Onychomycosis in France
7.5.4. Italy
7.5.4.1. Gender-specific Cases of onychomycosis in Italy
7.5.4.2. Age-specific Cases of Onychomycosis in Italy
7.5.4.3. Type-specific cases of Onychomycosis Italy
7.5.4.4. Severity-specific Cases of Onychomycosis in Italy
7.5.5. Spain
7.5.5.1. Gender-specific Cases of Onychomycosis in Spain
7.5.5.2. Age-specific Cases of Onychomycosis in Spain
7.5.5.3. Type-specific Cases of Onychomycosis in Spain
7.5.5.4. Severity-specific Cases of Onychomycosis in Spain
7.5.6. The United Kingdom
7.5.6.1. Gender-specific Cases of Onychomycosis in the United Kingdom
7.5.6.2. Age-specific cases of onychomycosis in the United Kingdom
7.5.6.3. Type-specific cases of onychomycosis in the United Kingdom
7.5.6.4. Severity-specific Cases of Onychomycosis in the United Kingdom
7.6. Japan
7.6.1. Diagnosed Cases of Onychomycosis in Japan
7.6.2. Gender-specific Cases of Onychomycosis in Japan
7.6.3. Age-specific Cases of Onychomycosis in Japan
7.6.4. Type-specific Cases of Onychomycosis in Japan
7.6.5. Severity-specific Cases of Onychomycosis in Japan
7.7. China
7.7.1. Diagnosed Cases of Onychomycosis in China
7.7.2. Gender-specific Cases of Onychomycosis in China
7.7.3. Age-specific Cases of Onychomycosis in China
7.7.4. Type-specific Cases of Onychomycosis in China
7.7.5. Severity-specific Cases of Onychomycosis in China
8. Marketed Therapies
8.1. KERYDIN (tavaborole): Pfizer
8.1.1. Product Description
8.1.2. Mechanism of action
8.1.3. Regulatory Milestones
8.1.4. Safety and Efficacy
8.1.5. Product Profile
8.2. JUBLIA/CLENAFIN (efinaconazole): Bausch Health
8.2.1. Product Description
8.2.2. Mechanism of action
8.2.3. Regulatory Milestones
8.2.4. Safety and Efficacy
8.2.5. Product Profile
8.3. Luliconazole: Sato Pharmaceutical/Bausch Health
8.3.1. Product Description
8.3.2. Mechanism of Action
8.3.3. Regulatory Milestones
8.3.4. Safety and Efficacy
8.3.5. Product Profile
8.4. Nialin: Sato Pharmaceutical/Eisai
8.4.1. Product Description
8.4.2. Mechanism of Action
8.4.3. Regulatory Milestones
8.4.4. Safety and Efficacy
8.4.5. Product Profile
9. Emerging Therapies
9.1. Key cross
9.2. MOB-015: Moberg Pharma
9.2.1. Drug description
9.2.2. Other development activities
9.2.3. Clinical development
9.2.4. Clinical trials information
9.2.5. Safety and efficacy
9.2.6. Product profile
9.2.7. Analyst Comment
9.3. BB2603: Blueberry Therapeutics
9.3.1. Drug description
9.3.2. Other development activities
9.3.3. Clinical development
9.3.3.1. Clinical trials information
9.3.4. Safety and efficacy
9.3.5. Product profile
9.3.6. Analyst Comment
9.4. Hallux Terbinafine Subungual Gel (HSG): Hallux
9.4.1. Drug description
9.4.2. Clinical development
9.4.2.1. Clinical trials information
9.4.3. Product profile
9.4.4. Analyst comment
10. No Development Assets
10.1. Key cross
10.2. VT-1161: Mycovia Pharmaceuticals
10.2.1. Drug description
10.2.2. Other development activities
10.2.3. Clinical development
10.2.3.1. Clinical trials information
10.2.4. Safety and efficacy
10.2.5. Product profile
10.3. P-3058: Almirall
10.3.1. Drug description
10.3.2. Other developmental activities
10.3.3. Clinical development
10.3.3.1. Clinical trials information
10.3.4. Safety and efficacy
10.3.5. Product profile
10.4. PD P 506 A: Photonamic
10.4.1. Drug description
10.4.2. Clinical development
10.4.2.1. Clinical trials information
10.4.3. Product profile
11. Onychomycosis: 7MM + China Analysis
11.1. Key Findings
11.2. Market Size of Onychomycosis in 7MM + China
11.3. Market Outlook
11.4. Attribute Analysis
11.5. The United States Market Size
11.5.1. Total Market Size of Onychomycosis in the United States
11.5.2. Market Size of Onychomycosis by Therapies in the United States
11.6. Market Size of Onychomycosis in the EU5
11.6.1. Market Size of Onychomycosis by Therapies in Germany
11.6.2. Market Size of Onychomycosis by Therapies in France
11.6.3. Market Size of Onychomycosis by Therapies in Italy
11.6.4. Market Size of Onychomycosis by Therapies in Spain
11.6.5. Market Size of Onychomycosis by Therapies in the United Kingdom
11.7. Japan Market Size
11.7.1. Total Market Size of Onychomycosis in Japan
11.7.2. Market Size of Onychomycosis by Therapies in Japan
11.8. China Market Size
11.8.1. Total Market Size of Onychomycosis in China
11.8.2. Market Size of Onychomycosis by Therapies in China
12. KOL Views
13. SWOT Analysis
14. Unmet Needs
15. Market Access and Reimbursement
16. Appendix
16.1. Bibliography
17. Report Methodology
18. DelveInsight Capabilities
19. Disclaimer
20. About DelveInsight

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