Product Code: GDHC190PIDR
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.
GlobalData 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, GlobalData 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
- GlobalData's 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 GlobalData expect the pipeline drugs to have a substantial impact on the marketspace during the forecast period?
- 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.
1 Table of Contents
- 1.1 List of Tables
- 1.2 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?
- 3.1 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
- 5.1 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
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
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 GlobalData Expects