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Dermatophytic Onychomycosis (DO) – US Drug Forecast and Market Analysis to 2022 © GlobalData. This report is a licensed product and is not to be copied, reproduced, shared or resold in any form.

REFERENCE CODE GDHC101PIDR | PUBLICAT ION DATE JUNE 2013

DERMATOPHYTIC ONYCHOMYCOSIS (DO) – US DRUG FORECAST AND MARKET ANALYSIS TO

2022

Dermatophytic Onychomycosis (DO) – US Drug Forecast and Market Analysis to 2022 2 © GlobalData. This report is a licensed product and is not to be copied, reproduced, shared or resold in any form.


2022

Executive Summary

Dermatophytic Onychomycosis (DO): Key Metrics in the US Market

2012 Epidemiology

Prevalent population 32.23 million

Treated population 1.88 million

2012 Market Sales

US $548.44m

Pipeline Assessment

Number of drugs in Phase IIb–III 5

Number of first-in-class drugs 3

Most Promising Pipeline Drugs Peak-Year Sales

Efinaconazole $406.98m

Tavaborole $105.10m

TDT-067 $277.3 0m

Key events (2012–2022) Level of Impact

Efinaconazole launch ↑↑↑

Tavaborole launch ↑↑

TDT-067 launch ↑↑↑

2022 Market Sales

US $3,258.94m

Source: GlobalData

Sales for the US Dermatophytic Onychomycosis Market are Estimated to Grow at a 19.5% CAGR for 2012–2022

The US DO market generated approximately

$548.44m from the sales of generic oral therapies

in 2012. Over the next 10 years, GlobalData

expects this market to grow at a Compound Annual

Growth Rate (CAGR) of 19.5% to reach total

revenue sales of $3.26 billion in 2022. These sales

are expected to be driven by:

New topical therapies that have efficacy rates

comparable to the existing systemic oral drugs

and very mild side effects that warrant a

premium price

An overall growth in the size of the elderly

population

Increasing drug treatment rates based on the

availability of safer treatment options — that is,

more patients are expected to adopt drug

therapy than to forego treatment because of

concerns about hepatotoxicity.

The barriers limiting the growth of the US DO

market include:

Generic oral therapies, such as the “gold

standard,” terbinafine, that still garner favor

with prescribing physicians because of their

strong efficacy profile and shorter treatment

duration compared with generic topical

regimens.



2022

Executive Summary

The longer duration of therapy associated with

topical treatments is expected to limit

compliance and decrease potential revenue

generation from new pipeline products.

Sales for DO by Route of Administration, 2012–2022

97%

3%2012

Total: 0.55bn

Oral Topical

48%52%

2022Total: 3.26bn

Oral Topical

Source: GlobalData

Drug Manufacturers Embrace Safer Topical Therapies to Combat Existing Systemic Oral Therapies

The current market for DO in the US is driven by

generic therapies consisting of first- and second-

generation antifungals. Terbinafine, originally

marketed as Lamisil by Novartis in the US, showed

the best efficacy profile and was quickly

established as a first-line treatment of choice by

high-prescribing physicians. Since the loss of its

patent, generic terbinafine has maintained a

stronghold on the market in the face of other

generic antifungals with poor safety profiles that

include black box warnings associated with

hepatotoxicity.

During the forecast period, GlobalData believes

that new players, such as Valeant

Pharmaceuticals, Anacor Pharmaceuticals, Celtic

Pharma and Palau Pharma, will harness the use of

new novel technologies to develop safer products

to gain inroads into the US market. Most of the

players in this market are new to the space, with

Valeant being the strongest contender because of

the sheer size of the company, the strength of its

product, and its first-mover advantage. The other

companies in this space are smaller biotechnology

firms without the financial capital of Valeant.

Nevertheless, the strength of the products makes

them prime candidates for in-licensing

opportunities by larger companies that are eager to

acquire a piece of the DO market in the US.



2022

Executive Summary

Company Portfolio Gap Analysis in DO, 2012–2022

Strength of Pipeline

Low High

Hig

hLo

wS

treng

th o

f Mar

kete

d Pr

oduc

ts

Current and Future Players

Future Players

Current Players

Source: GlobalData

A Need for Safer Therapy Options Drives Market Away from Generic Therapies

The current landscape of DO consists of a range of

first-and second-generation antifungals that have

serious safety effects. While the new upcoming

therapies eliminate these safety concerns, certain

outstanding unmet needs remain. Since most of

the new therapies are formulated as topical

treatments, patients can expect to use them for as

long as 48 weeks in order to achieve a mycological

cure. Given that the majority of patients who suffer

from DO tend to be older and also suffer from other

comorbidities, compliance rates can drop with

therapies that require a longer duration. Palau

Pharma’s albaconazole, the latecomer to the

market, is expected to differentiate itself by offering

a much shorter treatment duration, with a safety

profile that is milder than those of the existing

generic therapies. The combination of an improved

safety profile and a shorter treatment regimen is

likely to increase its market adoption and drive

sales.

Therapy Options with Shorter Treatment Durations Likely to Blow Past Upcoming Competition

With the late-stage pipeline agents meeting the

need for safer treatments, the early-stage products

in development are mostly focused on novel

delivery mechanisms that go beyond the traditional

topical and oral routes of administration. This type

of administration requires developing products with

unique chemistries that allow the active ingredient

to have high pharmacokinetic properties that are

targeted towards the site of infection. Secondly, a

therapy with a shorter duration, such as Palau

Pharma’s albaconazole, is expected to overcome

the competition with not only its safety and efficacy

profile, but also its predicted shorter therapy

regimen. Furthermore, medical procedures, like

laser treatment of the fungal infection, are also

growing among infected patients, which can

ultimately compete with the uptake of these newer

drug-based therapies if they are able to show

substantial increases in their mycological cure

rates. Other outstanding needs in the market

revolve around increasing the diagnosis and drug-

treatment rates, which are markedly low as a result

of poor therapy options and low patient awareness.

Quicker diagnostic measures are expected to



2022

Executive Summary

increase the overall market size of the DO market

in the US.

Valeant’s Topical Therapy to Usher in Trend of Topical Therapies with Favorable Side Effect Profiles

The DO market is poised to see a great influx of

new products that boast better efficacy and safety

profiles than those of the existing therapies. The

current generic therapies suffer from exceptionally

poor safety profiles, and in some cases include

black-box warnings regarding their side effects,

such as hepatotoxicity. However, new products,

like Valeant Pharmaceutical’s efinaconazole, are

expected to leverage their first-mover advantage in

the current landscape and steal patient share away

from other less efficacious first-generation

antifungals, as well as the market standard,

terbinafine. GlobalData predicts that the new

pipeline products, like Valeant’s efinaconazole,

Anacor Pharmaceuticals’ tavaborole, and Celtic

Pharma’s TDT-067, will all enjoy first-in-class

status, given the differences in their primary active

ingredients and their mechanisms of action. All

three drugs are expected to grab a spot as a first-

line therapy, while slowly stealing share from

subpar generic options, such as griseofulvin,

fluconazole, ketoconazole, and ciclopirox.

GlobalData predicts peak-year sales of $406.98m

for efinaconazole in 2022, $105.10m for tavaborole

in 2021, and $277.34m for TDT-067 in 2021.

Competitive Assessment of Late-Stage Pipeline Agents in DO, 2012–2022

Clinical AttributesLow High

Hig

hLo

wCom

mer

cial

Attr

ibut

esNote: Bubble size represents approximate peak-year sales of pipeline drug

Valeant’sefinaconazole

Celtic Pharma’sTDT-067

Palau Pharma’s

albaconazole

Anacor’stavaborole

Topica’sluliconazole

Source: GlobalData

What Do the Physicians Think?

The key opinion leaders (KOLs) interviewed for this

report shared their insight on current and future

market and clinical trends within the US DO

market. They indicated that the primary concerns

within this market remain for safer and more

efficacious therapies, shorter treatment durations,

and better differential diagnostic tests.

“Oral medication requires lab monitoring and [is]

associated with severe liver reactions. So, when

most patients hear that they say, ‘I don’t want to

risk my liver or dying for my nail problems.’ Oral

medication works only on two or three patients and

have [sic] pretty low efficacy. Those patients on

whom it works well, they will get re-infected.

Topical therapies don’t work at all.”

US Key Opinion Leader, September 2012



2022

Executive Summary

“I cannot treat DO patients very much because

patients are concerned about the risk of treatment.

I see 300 to 400 of DO patients, from which I treat

only 15 to 20 because of the side effects of

available treatment.”

US Key Opinion Leader, August 2012

“I don’t think treatment rates will change because

we don’t have any good treatment [options]

currently available.”

US Key Opinion Leader, September 2013

“The cure rate is very low, even with the effective

treatments. With oral treatment we might have a

cure rate ranging from 60-80%. So we still have

20-40% of patients that do not respond to

treatment. I am talking about systemic antifungals.

So I think that there is a lot of space for

improvement. This is a situation where I would like

to have more effective treatments.”

US Key Opinion Leader, March 2013



2022

Table of Contents

1 Table of Contents

1 Table of Contents .......................................................................................................................... 7

1.1 List of Tables ........................................................................................................................ 11

1.2 List of Figures ....................................................................................................................... 14

2 Introduction ................................................................................................................................. 15

2.1 Catalyst ................................................................................................................................ 15

2.2 Related Reports ................................................................................................................... 15

2.3 Upcoming Related Reports ................................................................................................... 16

3 Disease Overview ....................................................................................................................... 17

3.1 Etiology and Pathophysiology ............................................................................................... 17

3.1.1 Etiology ........................................................................................................................... 17

3.1.2 Pathophysiology ............................................................................................................. 18

3.1.3 Prognosis ....................................................................................................................... 20

3.1.4 Quality of Life .................................................................................................................. 21

3.2 Symptoms ............................................................................................................................ 21

4 Epidemiology ............................................................................................................................... 23

4.1 Risk Factors and Comorbidities ............................................................................................ 23

4.1.1 Poor peripheral circulation is greater in older men .......................................................... 24

4.1.2 Household contact with other DO patients increases risk of infection 2.5 times .............. 24

4.1.3 Immunosuppression increases susceptibility to DO infections ........................................ 25

4.1.4 Prevalence of dermatophytic onychomycosis is higher in diabetics than in non-diabetics ....................................................................................................................................... 26

4.2 Global Trends ....................................................................................................................... 27

4.3 Forecast Methodology .......................................................................................................... 28

4.3.1 Sources Used ................................................................................................................. 28

4.3.2 Forecast Assumptions and Methods ............................................................................... 28

4.3.3 Sources Not Used........................................................................................................... 29



2022

Table of Contents

4.4 Epidemiology Forecast (2012–2022) .................................................................................... 30

4.4.1 Prevalent Cases of Dermatophytic Onychomycosis ........................................................ 30

4.4.2 Age-Specific Prevalent Cases of Dermatophytic Onychomycosis ................................... 31

4.4.3 Sex-Specific Prevalent Cases of Dermatophytic Onychomycosis ................................... 32

4.5 Discussion ............................................................................................................................ 33

4.5.1 Epidemiological Trends................................................................................................... 33

4.5.2 Limitations of the Analysis .............................................................................................. 34

4.5.3 Strengths of the Analysis ................................................................................................ 34

5 Disease Management.................................................................................................................. 35

5.1 Treatment Overview ............................................................................................................. 35

5.1.1 Diagnosis ........................................................................................................................ 37

5.1.2 Clinical Practice .............................................................................................................. 38

6 Competitive Assessment ............................................................................................................. 43

6.1 Overview .............................................................................................................................. 43

6.2 Strategic Competitor Assessment ......................................................................................... 44

6.3 Product Profiles .................................................................................................................... 45

6.3.1 Terbinafine...................................................................................................................... 45

6.3.2 Itraconazole .................................................................................................................... 49

6.3.3 Fluconazole .................................................................................................................... 52

6.3.4 Ketoconazole .................................................................................................................. 55

6.3.5 Griseofulvin..................................................................................................................... 58

6.3.6 Ciclopirox ........................................................................................................................ 61

7 Opportunity and Unmet Need ...................................................................................................... 64

7.1 Overview .............................................................................................................................. 64

7.2 Unmet Needs ....................................................................................................................... 65

7.2.1 Unmet Need: Efficacious Oral and Topical Treatments ................................................... 65

7.2.2 Unmet Need: Clinical Safety ........................................................................................... 66



2022

Table of Contents

7.2.3 Unmet Need: Patient Awareness .................................................................................... 67

7.2.4 Unmet Need: Shorter Treatment Duration ...................................................................... 68

7.2.5 Unmet Need: Higher Treatment Rates ............................................................................ 68

7.2.6 Unmet Need: Prescribing Guidelines .............................................................................. 69

7.2.7 Unmet Need: Differential Diagnosis ................................................................................ 69

7.3 Unmet Needs Gap Analysis .................................................................................................. 70

7.4 Opportunities ........................................................................................................................ 71

7.4.1 Opportunity: Decreased Frequency of Dosing ................................................................ 71

7.4.2 Opportunity: Combinatorial Approaches to Treatment .................................................... 71

8 Clinical Pipeline Assessment ....................................................................................................... 72

8.1 Overview .............................................................................................................................. 72

8.2 Clinical Trials by Phase and Trial Status ............................................................................... 73

8.3 Promising Drugs in Clinical Development ............................................................................. 74

8.3.1 Efinaconazole ................................................................................................................. 76

8.3.2 Tavaborole...................................................................................................................... 81

8.3.3 TDT-067 ......................................................................................................................... 86

8.3.4 Luliconazole.................................................................................................................... 91

8.3.5 Albaconazole .................................................................................................................. 97

9 Current and Future Players ....................................................................................................... 103

9.1 Overview ............................................................................................................................ 103

9.2 Trends in Corporate Strategy ............................................................................................. 105

9.3 Company Profiles ............................................................................................................... 106

9.3.1 Valeant Pharmaceuticals International .......................................................................... 106

9.3.2 Topica Pharmaceuticals................................................................................................ 109

9.3.3 Anacor Pharmaceuticals ............................................................................................... 111

9.4 Late-Stage Competition ...................................................................................................... 113

9.4.1 Celtic Pharmaceutical Holdings .................................................................................... 113



2022

Table of Contents

9.4.2 Palau Pharma ............................................................................................................... 114

9.5 Early-Stage Competition ..................................................................................................... 115

9.5.1 Merck............................................................................................................................ 115

9.5.2 Apricus Biosciences ...................................................................................................... 115

10 Market Outlook .......................................................................................................................... 117

10.1 United States ...................................................................................................................... 117

10.1.1 Forecast ....................................................................................................................... 117

10.1.2 Key Events ................................................................................................................... 121

10.1.3 Drivers and Barriers ...................................................................................................... 122

11 Appendix ................................................................................................................................... 125

11.1 Bibliography........................................................................................................................ 125

11.2 Abbreviations...................................................................................................................... 136

11.3 Methodology ....................................................................................................................... 138

11.4 Forecasting Methodology ................................................................................................... 138

11.4.1 Diagnosed DO patients ................................................................................................. 139

11.4.2 Percent Drug-Treated Patients ..................................................................................... 139

11.4.3 Drugs Included in Each Therapeutic Class ................................................................... 139

11.4.4 Launch and Patent Expiry Dates ................................................................................... 140

11.4.5 General Pricing Assumptions ........................................................................................ 140

11.4.6 Individual Drug Assumptions ........................................................................................ 140

11.4.7 Pricing of Pipeline Agents ............................................................................................. 143

11.5 Physicians and Specialists Included in this Study ............................................................... 145

11.6 About the Authors ............................................................................................................... 146

11.6.1 Author ........................................................................................................................... 146

11.6.2 Reviewer ...................................................................................................................... 146

11.6.3 Epidemiologist .............................................................................................................. 147

11.6.4 Global Head of Healthcare ............................................................................................ 147



2022

Table of Contents

11.7 About GlobalData ............................................................................................................... 148

11.8 Disclaimer .......................................................................................................................... 148

1.1 List of Tables

Table 1: Symptoms of DO .............................................................................................................................. 22

Table 2: Risk Factors and Comorbidities for DO ............................................................................................. 23

Table 3: Sources of DO Prevalence Data ....................................................................................................... 28

Table 4: Total Prevalent Cases of DO, Ages ≥15 Years, Men and Women, Selected Years, 2012–2022 ...... 30

Table 5: Total Prevalent Cases of DO, by Age, Men and Women, N = Millions (Row %), 2012 ....................... 31

Table 6: Total Prevalent Cases of DO, by Sex, Ages ≥ 15 Years, N=Millions, (Row %), 2012 ......................... 32

Table 7: Treatment Guidelines for DO ............................................................................................................ 36

Table 8: Most Prescribed Drugs for DO by Class in the US Market, 2012 ....................................................... 36

Table 9: Leading Treatments for DO in the US, 2012 ..................................................................................... 45

Table 10: Terbinafine SWOT Analysis, 2012 .................................................................................................. 47

Table 11: United States Sales Forecasts ($m) for Terbinafine, 2012–2022 .................................................... 48

Table 12: Itraconazole SWOT Analysis, 2012 ................................................................................................ 51

Table 13: United States Sales Forecasts ($m) for Itraconazole, 2012-2022 .................................................... 52

Table 14: Fluconazole SWOT Analysis, 2012 ................................................................................................ 54

Table 15: United States Sales Forecasts ($m) for Fluconazole, 2012–2022 ................................................... 54

Table 16: Ketoconazole SWOT Analysis, 2012 .............................................................................................. 57

Table 17: United States Sales Forecasts ($m) for Ketoconazole, 2012–2022 ................................................. 58

Table 18: Griseofulvin SWOT Analysis, 2012 ................................................................................................. 60

Table 19: United States Sales Forecasts ($m) for Griseofulvin, 2012–2022 .................................................... 60

Table 20: Ciclopirox SWOT Analysis, 2012 .................................................................................................... 63



2022

Table of Contents

Table 21: United States Sales Forecasts ($m) for Ciclopirox, 2012-2022........................................................ 63

Table 22: Overall Unmet Needs – Current Level of Attainment ....................................................................... 64

Table 23: Clinical Unmet Needs – Gap Analysis, 2012 ................................................................................... 70

Table 24: DO – Clinical Trials by Phase and Status in the US, 2012 ............................................................. 73

Table 25: DO – Phase Pipeline, 2012 ............................................................................................................ 74

Table 26: Product Profile – Efinaconazole ...................................................................................................... 77

Table 27: Efinaconazole SWOT Analysis, 2012 ............................................................................................. 80

Table 28: United States Sales Forecasts ($m) for Efinaconazole, 2012–2022 ................................................ 81

Table 29: Product Profile – Tavaborole .......................................................................................................... 82

Table 30: Tavaborole Phase III Clinical Efficacy Results ................................................................................ 83

Table 31: Tavaborole SWOT Analysis, 2012 .................................................................................................. 85

Table 32: United States Sales Forecasts ($m) for Tavaborole, 2012–2022 ..................................................... 86

Table 33: Product Profile – TDT-067 .............................................................................................................. 87

Table 34: TDT-067 SWOT Analysis, 2012 ..................................................................................................... 90

Table 35: United States Sales Forecasts ($m) for TDT-067, 2012–2022 ........................................................ 91

Table 36: Product Profile – Luliconazole ........................................................................................................ 92

Table 37: Luliconazole SWOT Analysis, 2012 ................................................................................................ 96

Table 38: United States Sales Forecasts ($m) for Luliconazole, 2012–2022 ................................................... 97

Table 39: Product Profile – Albaconazole ....................................................................................................... 98

Table 40: Results of Phase IIb Multi-Arm Clinical Trial of Albaconazole .......................................................... 99

Table 41: Albaconazole SWOT Analysis, 2012 ............................................................................................ 101

Table 42: United States Sales Forecasts ($m) for Albaconazole, 2012–2022 ............................................... 102

Table 43: Key Companies in the DO Market, 2012 ....................................................................................... 103

Table 44: Valeant Pharmaceuticals International DO Therapy Portfolio Assessment, 2012........................... 108



2022

Table of Contents

Table 45: Valeant Pharmaceuticals SWOT Analysis, 2012 ........................................................................... 108

Table 46: Topica Pharmaceuticals DO Therapy Portfolio Assessment, 2012 ................................................ 110

Table 47: Topica Pharmaceuticals SWOT Analysis, 2012 ............................................................................ 110

Table 48: Anacor Pharmaceuticals DO Therapy Portfolio Assessment, 2012 ............................................... 112

Table 49: Anacor Pharmaceuticals SWOT Analysis, 2012............................................................................ 113

Table 50: Sales Forecasts ($m) for DO in the United States, 2012–2022 ..................................................... 119

Table 51: Key Events Impacting Sales for DO in the United States, 2012–2022 ........................................... 121

Table 52: United States DO Market – Drivers and Barriers, 2012–2022 ....................................................... 122

Table 53: Key Launch Dates ........................................................................................................................ 140



2022

Table of Contents

1.2 List of Figures

Figure 1: Structure of Human Nail .................................................................................................................. 18

Figure 2: Total Prevalent Cases of DO, Ages ≥15 Years, Men and Women, Selected Years, 2012–2022 ..... 30

Figure 3: Total Prevalent Cases of DO, by Age, Men and Women, N = Millions, 2012 .................................... 31

Figure 4: Total Prevalent Cases of DO, by Sex, Ages ≥ 15 Years, N = Millions, 2012 ..................................... 32

Figure 5: Competitive Assessment of Late-Stage Pipeline Agents in DO , 2012–2022 .................................... 75

Figure 6: Company Portfolio Gap Analysis in DO, 2012–2022 ...................................................................... 104

Figure 7: Sales for DO in the United States by Route of Administration, 2012–2022 ..................................... 120



2022

Introduction

2 Introduction

2.1 Catalyst

The generically-driven US dermatophytic onychomycosis (DO) toenail market has experienced a

period of stagnation stemming from the lapse of the patent life on many highly-prescribed systemic

therapies, such as terbinafine and itraconazole. However, the introduction of new therapies that

offer better safety profiles and a topical route of administration is likely to cause waves in the DO

market and increase the market size by introducing patent-protected therapies for the first time in

more than six years.

The launch of topical agents, such as Valeant Pharmaceuticals’ efinaconazole, Celtic Pharma’s

TDT-067, and Anacor Pharmaceuticals’ tavaborole, is expected to provide the market with new

mechanisms of action in topical treatments, which is a marked change from the systemic

therapies that currently prevail in the market.

The growth of the elderly population, who are at an elevated risk of developing DO, functions

as a driver for the development of new products that are effective and have better safety

profiles.

Laser treatments for DO are seeing a surge in terms of development and adoption as a method

to treat infections, with minimal patient compliance concerns. While this movement is likely to

increase patient awareness, GlobalData expects it to pose a small barrier to the growth of the

new therapeutic regimens, which require prolonged treatment durations.

2.2 Related Reports

GlobalData (2013). PharmaFocus: Vaccine Adjuvants in Infectious Disease, March, 2013,

GDHC001PFR



2022

Introduction

2.3 Upcoming Related Reports

GlobalData (2013). PharmaFocus: Research and Development Strategies in HIV, July, 2013,

GDHC003PFR

GlobalData (2013). PharmaFocus: Market Access Strategies for Gram-Negative Nosocomial

Infections, August, 2013, GDHC004PFR



2022

Appendix

11.7 About GlobalData

GlobalData is a leading global provider of business intelligence in the healthcare industry.

GlobalData provides its clients with up-to-date information and analysis on the latest developments

in drug research, disease analysis, and clinical research and development. Our integrated business

intelligence solutions include a range of interactive online databases, analytical tools, reports, and

forecasts. Our analysis is supported by a 24/7 client support and analyst team.

GlobalData has offices in New York, Boston, London, India, and Singapore.

11.8 Disclaimer

All Rights Reserved.

No part of this publication may be reproduced, stored in a retrieval system, or transmitted in any

form by any means, electronic, mechanical, photocopying, recording, or otherwise, without the prior

permission of the publisher, GlobalData.

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