PharmaPoint: Dermatophytic Onychomycosis (DO) - US Drug Forecast and Market Analysis to 2022

Date: June 27, 2013
Pages: 146
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PharmaPoint: Dermatophytic Onychomycosis (DO) - US Drug Forecast and Market Analysis to 2022
Summary

Dermatophytic onychomycosis (DO) is characterized as being a fungal infection of the nail. Infection can involve the nail unit (nail matrix, nail bed, or nail plate). DO isn’t considered life-threatening, however can cause patients to experience discomfort, pain, and may cause physical and occupational limitations. DO patients can be identified as having thick or brittle nails along with discoloration (white and opaque). Physicians currently use direct microscopy and fungal culture tests to ensure correct diagnosis and treatment are achieved. Risk factors such as advanced age, pre-existing diabetes, or immunocompromised systems can increase the incidence of DO in patients. Current therapies consist of generics that offer substantial efficacy but sub-par safety profiles. A new wave of therapies is expected to offer topical options for patients who are unable to withstand existing generic options. These therapies are also expected to drive an increase in total drug treatment rates in the US market.

Highlights

Key Questions Answered
  • How big of an impact will topical agents have on the DO market? What do key opinion leaders think of this paradigm shift?
  • What new product is expected to become the market leader during the forecast period? How will this impact the existing generic therapies?
  • How will a change in the route of administration change the uptake of drugs in the US market?
  • What are the primary unmet needs that exist in the market according to key opinion leaders?
  • What alliance opportunities exist in this market for a company looking to tap into the DO market?
Key Findings
  • Generic therapies are expected to pose as a considerable threat to upcoming topical therapies because of their shorter treatment duration.
  • The first wave of new pipeline candidates will increase drug treatment rates as physicians begin to opt for more safer options for treatment.
  • Individual compliance, patient co-morbidities, and insurance payers function as important considerations in assessing the treatment algorithm for every patient.
Scope
  • Overview of DO, including epidemiology, etiology, general symptoms from infection, and disease management recommendations and guidelines.
  • Annualized DO market revenue, annual cost of therapy and treatment usage pattern data from 2012 and forecast for ten years to 2022.
  • Key topics covered include strategic competitor assessment, market characterization, unmet needs, clinical trial mapping and implications for the DO market.
  • Pipeline analysis: comprehensive data split across different phases, and emerging trends, specifically new therapies with novel routes of administration.
  • Analysis of the current and future market competition in the US DO market. Insightful review of the key industry and governmental drivers, restraints and challenges. Each trend is independently researched to provide qualitative analysis of its implications.
Key Benefits
  • 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 DO market.
  • Drive revenues by understanding the key trends, innovative products and technologies, market segments, and companies likely to impact the US DO market in future.
  • Formulate effective sales and marketing strategies by understanding the competitive landscape and by analyzing the performance of various competitors.
  • Identify emerging players with potentially strong product portfolios and create effective counter-strategies to gain a competitive advantage.
  • Track drug sales in the US DO market from 2012-2022.
  • 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 INTRODUCTION

2.1 Catalyst
2.2 Related Reports
2.3 Upcoming Related Reports

3 DISEASE OVERVIEW

3.1 Etiology and Pathophysiology
  3.1.1 Etiology
  3.1.2 Pathophysiology
  3.1.3 Prognosis
  3.1.4 Quality of Life
3.2 Symptoms

4 EPIDEMIOLOGY

4.1 Risk Factors and Comorbidities
  4.1.1 Poor peripheral circulation is greater in older men
  4.1.2 Household contact with other DO patients increases risk of infection 2.5 times
  4.1.3 Immunosuppression increases susceptibility to DO infections
  4.1.4 Prevalence of dermatophytic onychomycosis is higher in diabetics than in non-diabetics
4.2 Global Trends
4.3 Forecast Methodology
  4.3.1 Sources Used
  4.3.2 Forecast Assumptions and Methods
  4.3.3 Sources Not Used
4.4 Epidemiology Forecast (2012–2022)
  4.4.1 Prevalent Cases of Dermatophytic Onychomycosis
  4.4.2 Age-Specific Prevalent Cases of Dermatophytic Onychomycosis
  4.4.3 Sex-Specific Prevalent Cases of Dermatophytic Onychomycosis
4.5 Discussion
  4.5.1 Epidemiological Trends
  4.5.2 Limitations of the Analysis
  4.5.3 Strengths of the Analysis

5 DISEASE MANAGEMENT

5.1 Treatment Overview
  5.1.1 Diagnosis
  5.1.2 Clinical Practice

6 COMPETITIVE ASSESSMENT

6.1 Overview
6.2 Strategic Competitor Assessment
6.3 Product Profiles
  6.3.1 Terbinafine
  6.3.2 Itraconazole
  6.3.3 Fluconazole
  6.3.4 Ketoconazole
  6.3.5 Griseofulvin
  6.3.6 Ciclopirox

7 OPPORTUNITY AND UNMET NEED

7.1 Overview
7.2 Unmet Needs
  7.2.1 Unmet Need: Efficacious Oral and Topical Treatments
  7.2.2 Unmet Need: Clinical Safety
  7.2.3 Unmet Need: Patient Awareness
  7.2.4 Unmet Need: Shorter Treatment Duration
  7.2.5 Unmet Need: Higher Treatment Rates
  7.2.6 Unmet Need: Prescribing Guidelines
  7.2.7 Unmet Need: Differential Diagnosis
7.3 Unmet Needs Gap Analysis
7.4 Opportunities
  7.4.1 Opportunity: Decreased Frequency of Dosing
  7.4.2 Opportunity: Combinatorial Approaches to Treatment

8 CLINICAL PIPELINE ASSESSMENT

8.1 Overview
8.2 Clinical Trials by Phase and Trial Status
8.3 Promising Drugs in Clinical Development
  8.3.1 Efinaconazole
  8.3.2 Tavaborole
  8.3.3 TDT-067
  8.3.4 Luliconazole
  8.3.5 Albaconazole

9 CURRENT AND FUTURE PLAYERS

9.1 Overview
9.2 Trends in Corporate Strategy
9.3 Company Profiles
  9.3.1 Valeant Pharmaceuticals International
  9.3.2 Topica Pharmaceuticals
  9.3.3 Anacor Pharmaceuticals
9.4 Late-Stage Competition
  9.4.1 Celtic Pharmaceutical Holdings
  9.4.2 Palau Pharma
9.5 Early-Stage Competition
  9.5.1 Merck
  9.5.2 Apricus Biosciences

10 MARKET OUTLOOK

10.1 United States
  10.1.1 Forecast
  10.1.2 Key Events
  10.1.3 Drivers and Barriers

11 APPENDIX

11.1 Bibliography
11.2 Abbreviations
11.3 Methodology
11.4 Forecasting Methodology
  11.4.1 Diagnosed DO patients
  11.4.2 Percent Drug-Treated Patients
  11.4.3 Drugs Included in Each Therapeutic Class
  11.4.4 Launch and Patent Expiry Dates
  11.4.5 General Pricing Assumptions
  11.4.6 Individual Drug Assumptions
  11.4.7 Pricing of Pipeline Agents
11.5 Physicians and Specialists Included in this Study
11.6 About the Authors
  11.6.1 Author
  11.6.2 Reviewer
  11.6.3 Epidemiologist
  11.6.4 Global Head of Healthcare
11.7 About GlobalData
11.8 Disclaimer

LIST OF TABLES

Table 1: Symptoms of DO
Table 2: Risk Factors and Comorbidities for DO
Table 3: Sources of DO Prevalence Data
Table 4: Total Prevalent Cases of DO, Ages ?15 Years, Men and Women, Selected Years, 2012–2022
Table 5: Total Prevalent Cases of DO, by Age, Men and Women, N = Millions (Row %), 2012
Table 6: Total Prevalent Cases of DO, by Sex, Ages ? 15 Years, N=Millions, (Row %), 2012
Table 7: Treatment Guidelines for DO
Table 8: Most Prescribed Drugs for DO by Class in the US Market, 2012
Table 9: Leading Treatments for DO in the US, 2012
Table 10: Terbinafine SWOT Analysis, 2012
Table 11: United States Sales Forecasts ($m) for Terbinafine, 2012–2022
Table 12: Itraconazole SWOT Analysis, 2012
Table 13: United States Sales Forecasts ($m) for Itraconazole, 2012-2022
Table 14: Fluconazole SWOT Analysis, 2012
Table 15: United States Sales Forecasts ($m) for Fluconazole, 2012–2022
Table 16: Ketoconazole SWOT Analysis, 2012
Table 17: United States Sales Forecasts ($m) for Ketoconazole, 2012–2022
Table 18: Griseofulvin SWOT Analysis, 2012
Table 19: United States Sales Forecasts ($m) for Griseofulvin, 2012–2022
Table 20: Ciclopirox SWOT Analysis, 2012
Table 21: United States Sales Forecasts ($m) for Ciclopirox, 2012-2022
Table 22: Overall Unmet Needs – Current Level of Attainment
Table 23: Clinical Unmet Needs – Gap Analysis, 2012
Table 24: DO – Clinical Trials by Phase and Status in the US, 2012
Table 25: DO – Phase Pipeline, 2012
Table 26: Product Profile – Efinaconazole
Table 27: Efinaconazole SWOT Analysis, 2012
Table 28: United States Sales Forecasts ($m) for Efinaconazole, 2012–2022
Table 29: Product Profile – Tavaborole
Table 30: Tavaborole Phase III Clinical Efficacy Results
Table 31: Tavaborole SWOT Analysis, 2012
Table 32: United States Sales Forecasts ($m) for Tavaborole, 2012–2022
Table 33: Product Profile – TDT-067
Table 34: TDT-067 SWOT Analysis, 2012
Table 35: United States Sales Forecasts ($m) for TDT-067, 2012–2022
Table 36: Product Profile – Luliconazole
Table 37: Luliconazole SWOT Analysis, 2012
Table 38: United States Sales Forecasts ($m) for Luliconazole, 2012–2022
Table 39: Product Profile – Albaconazole
Table 40: Results of Phase IIb Multi-Arm Clinical Trial of Albaconazole
Table 41: Albaconazole SWOT Analysis, 2012
Table 42: United States Sales Forecasts ($m) for Albaconazole, 2012–2022
Table 43: Key Companies in the DO Market, 2012
Table 44: Valeant Pharmaceuticals International DO Therapy Portfolio Assessment, 2012
Table 45: Valeant Pharmaceuticals SWOT Analysis, 2012
Table 46: Topica Pharmaceuticals DO Therapy Portfolio Assessment, 2012
Table 47: Topica Pharmaceuticals SWOT Analysis, 2012
Table 48: Anacor Pharmaceuticals DO Therapy Portfolio Assessment, 2012
Table 49: Anacor Pharmaceuticals SWOT Analysis, 2012
Table 50: Sales Forecasts ($m) for DO in the United States, 2012–2022
Table 51: Key Events Impacting Sales for DO in the United States, 2012–2022
Table 52: United States DO Market – Drivers and Barriers, 2012–2022
Table 53: Key Launch Dates

LIST OF FIGURES

Figure 1: Structure of Human Nail
Figure 2: Total Prevalent Cases of DO, Ages ?15 Years, Men and Women, Selected Years, 2012–2022
Figure 3: Total Prevalent Cases of DO, by Age, Men and Women, N = Millions, 2012
Figure 4: Total Prevalent Cases of DO, by Sex, Ages ? 15 Years, N = Millions, 2012
Figure 5: Competitive Assessment of Late-Stage Pipeline Agents in DO , 2012–2022
Figure 6: Company Portfolio Gap Analysis in DO, 2012–2022
Figure 7: Sales for DO in the United States by Route of Administration, 2012–2022

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