Dermatophytic Onychomycosis: US Drug Forecast and Market Analysis to 2028
Summary
Onychomycosis (tinea unguium) of the toenail is a fungal infection of the nail by dermatophytic, nondermatophytic, or yeast species. Infection can occur in the nail matrix, nail bed, or nail plate. While dermatophytic onychomycosis (DO) is not considered life-threatening, it can cause discomfort, pain, and physical and occupational limitations. Onychomycosis patients can be identified as having thick or brittle nails, along with discoloration (white and opaque) and inflammation of the skin underneath the nail.
The publisher estimates that sales of drugs in the US DO market were approximately $208.8M in 2018, not taking into account over-the-counter (OTC) treatments for the disease. As one of the largest onychomycosis markets in the world, the US is expected to see the market grow to $676.5M by 2028, at a Compound Annual Growth Rate (CAGR) of 12.5% from 2018-2028. This growth will be mainly driven by the launche of several new topical therapies. However, the publisher expects the patents of Jublia and Kerydin, the only branded marketed products, to expire over the forecast and thus face generic competition.
The DO pipeline consists entirely of topicals, accounting for the moderate growth of the market over the next ten years. The three pipeline agents are Moberg Pharma's MOB-015, Blueberry therapeutics' BB2603-om, and Hallux Inc.'s HTS-519
Key Highlights
Key Questions Answered
Scope
Reasons to buy
The report will enable you to:
Summary
Onychomycosis (tinea unguium) of the toenail is a fungal infection of the nail by dermatophytic, nondermatophytic, or yeast species. Infection can occur in the nail matrix, nail bed, or nail plate. While dermatophytic onychomycosis (DO) is not considered life-threatening, it can cause discomfort, pain, and physical and occupational limitations. Onychomycosis patients can be identified as having thick or brittle nails, along with discoloration (white and opaque) and inflammation of the skin underneath the nail.
The publisher estimates that sales of drugs in the US DO market were approximately $208.8M in 2018, not taking into account over-the-counter (OTC) treatments for the disease. As one of the largest onychomycosis markets in the world, the US is expected to see the market grow to $676.5M by 2028, at a Compound Annual Growth Rate (CAGR) of 12.5% from 2018-2028. This growth will be mainly driven by the launche of several new topical therapies. However, the publisher expects the patents of Jublia and Kerydin, the only branded marketed products, to expire over the forecast and thus face generic competition.
The DO pipeline consists entirely of topicals, accounting for the moderate growth of the market over the next ten years. The three pipeline agents are Moberg Pharma's MOB-015, Blueberry therapeutics' BB2603-om, and Hallux Inc.'s HTS-519
Key Highlights
- The epidemiology team forecast an increasing prevalence of DO, representing one of the main drivers for market growth.
- Pipeline topical agents need to demonstrate efficacy on par with oral treatments through novel mechanisms of action.
- Highly efficacious, yet safe therapy remains the highest unmet need of DO treatment.
- Opportunities are expected in patients who prefer topical treatments in order to avoid any side effects and prevent drug-drug interactions with other medications.
Key Questions Answered
- What are the key drivers behind the increasing uptake of both oral and topical DO drugs, and which drug class is expected to see greater gains over the forecast period?
- When will the key patents of Jublia and Kerydin expire, and how will it affect drug sales and the overall DO market in the US?
- What are the struggles for pipeline drug development in the DO market? Why does the publisher expect the pipeline drugs to have a substantial impact on the marketspace during the forecast period?
Scope
- Overview of DO, including epidemiology, etiology, pathophysiology, symptoms, diagnosis, and disease management.
- Annualized DO therapeutics market revenue, cost of therapy per patient, and treatment usage patterns, with the forecast covering 2018 to 2028.
- Key topics covered include strategic competitor assessment, market characterization, unmet needs, clinical trial mapping and implications for the DO therapeutics market
- Pipeline analysis: comprehensive data assessing emerging trends and mechanisms of action under development for DO therapy.
- Analysis of the current and future market competition in the US DO therapeutics market. Insightful review of the key industry drivers, restraints and challenges. Each trend is independently researched to provide qualitative analysis of its implications.
Reasons to buy
The report will enable you to:
- Develop and design your in-licensing and out-licensing strategies through a review of pipeline products and technologies, and by identifying the companies with the most robust pipeline.
- Develop business strategies by understanding the trends shaping and driving the US therapeutics market.
- Drive revenues by understanding the key trends, innovative products and technologies, market segments, and companies likely to impact the US DO therapeutics market in the future.
- Formulate effective sales and marketing strategies by understanding the competitive landscape and by analysing the performance of various competitors.
- Identify emerging players with potentially strong product portfolios and create effective counter-strategies to gain a competitive advantage.
- Organize your sales and marketing efforts by identifying the market categories and segments that present maximum opportunities for consolidations, investments and strategic partnerships.
Table of Contents
1.1 List of Tables1.2 List of Figures
2 Dermatophytic Onychomycosis: Executive Summary
2.1 Dermatophytic Onychomycosis Market to Experience Mild Growth from 2018-2028
2.2 Early and Late-Stage Pipeline Product Launches Will Result in New Players Establishing Themselves
2.3 Persistent Unmet Needs Will Be Partially Addressed Over the Forecast Period
2.4 Topicals Dominate the Dermatophytic Onychomycosis Pipeline
2.5 What Do Physicians Think?
3 Introduction
3.1 Catalyst
3.2 Related Reports
3.3 Upcoming Related Reports
4 Disease Overview
4.1 Etiology and Pathophysiology
4.1.1 Etiology
4.1.2 Pathophysiology
4.2 Classification or Staging Systems
5 Epidemiology
5.1 Disease Background
5.2 Risk Factors and Comorbidities
5.3 Historical Trends
5.4 Forecast Methodology
5.4.1 Sources Used
5.4.2 Forecast Assumptions and Methods
5.5 Epidemiological Forecast for Dermatophytic Onychomycosis (2018-2020)
5.5.1 Total Prevalent Cases of Dermatophytic Onychomycosis
5.5.2 Diagnosed Prevalent Cases of Dermatophytic Onychomycosis
5.5.3 Sex-Specific Diagnosed Prevalent Cases of Dermatophytic Onychomycosis
5.5.4 Age-Specific Diagnosed Prevalent Cases of Dermatophytic Onychomycosis
5.6 Discussion
5.6.1 Epidemiological Forecast Insight
5.6.2 Limitations of the Analysis
6 Disease Management
6.1 Diagnosis and Treatment Overview
6.1.1 Diagnosis
6.1.2 Clinical Practice
7 Competitive Assessment
7.1 Overview
8 Unmet Needs and Opportunity Assessment
8.1 Overview
8.2 Greater Cure Rates and Long-Term Relapse Prevention
8.3 Cheaper, More Efficacious Topical Treatments with Shorter Treatment Periods
8.4 Safer Systemic Treatments
8.5 Updated Guidelines for the Treatment of Onychomycosis
9 Pipeline Assessment
9.1 Overview
9.2 Promising Drugs in Clinical Development
10 Current and Future Players
10.1 Overview
10.2 Trends in Corporate Strategy
10.3 Bausch Health's Portfolio Assessment
10.4 Sandoz's Portfolio Assessment
10.5 Moberg Pharma's Portfolio Assessment
10.6 Blueberry Therapeutics' Portfolio Assessment
10.7 Hallux Inc.'s Portfolio Assessment
11 Market Outlook
11.1 US
11.1.1 Forecast
11.1.2 Key Events
11.1.3 Drivers and Barriers
12 Appendix
List of Tables
Table 1: Dermatophytic Onychomycosis: Key Metrics in the US
Table 2: Risk Factors and Comorbidities for DO
Table 3: Treatment Guidelines for DO
Table 4: Approved Onychomycosis Drug Cure Rates in Toenails
Table 5: Disease Management Criteria in the US
Table 6: Leading Treatments for DO, 2018
Table 7: Comparison of Therapeutic Classes in Development for Dermatophytic Onychomycosis, 2018-2028
Table 8: Bausch Health's DO Portfolio Assessment, 2019
Table 9: Sandoz's DO Portfolio Assessment, 2019
Table 10: Moberg Pharma's DO Portfolio Assessment, 2019
Table 11: Blueberry Therapeutics' DO Portfolio Assessment, 2019
Table 12: Hallux Inc.'s DO Portfolio Assessment, 2019
Table 13: Key Events Impacting US Sales for DO, 2018-2028
Table 14: DO Market - Drivers and Barriers in the US, 2018-2028
Table 15: Key Historical and Projected Launch Dates for DO
Table 16: Key Historical and Projected Patent Expiry Dates for DO
Table 17: High-Prescribing Physicians (non-KOLs) Surveyed
List of Figures
Figure 1: Sales Forecast by Class for DO in the US in 2018 and 2028
Figure 2: Analysis of the Company Portfolio Gap in DO During the Forecast Period
Figure 3: Competitive Assessment of the Late-Stage Pipeline Agents that the Publisher Expects to Be Licensed for the Treatment of DO During the Forecast Period
Figure 4: Etiology of Onychomycosis
Figure 5: US, Total Prevalent Cases of DO, Men and Women, All Ages, 2018-2028
Figure 6: US, Diagnosed Prevalent Cases of DO, Men and Women, All Ages, 2018-2028
Figure 7: US, Diagnosed Prevalent Cases of DO, by Sex, All Ages, 2018
Figure 8: US, Diagnosed Prevalent Cases of DO, by Age, Men and Women, 2018
Figure 9: Onychomycosis Diagnostic Algorithm
Figure 10: Unmet Needs and Opportunities in DO
Figure 11: Overview of the US Development Pipeline in DO
Figure 12: Key Phase II/III Trials for the Promising Pipeline Agents that the Publisher Expects to Be Licensed for DO in the US During the Forecast Period
Figure 13: Competitive Assessment of the Late-Stage Pipeline Agents that the Publisher Expects to Be Licensed for the Treatment of DO During the Forecast Period
Figure 14: Analysis of the Company Portfolio Gap in DO During the Forecast Period
Figure 15: Sales Forecast by Class for DO in the US in 2018 and 2028
Companies Mentioned (Partial List)
A selection of companies mentioned in this report includes, but is not limited to:
- Actavis
- Allergan
- Anacor
- Aventis
- Bausch Health
- Blueberry Therapeutics
- Hallux Inc.
- Merck & Co.
- Moberg Pharma
- Novartis
- Pfizer
- Sandoz
- Topica Pharmaceuticals
