Table of Contents

Commercial Insight: Antifungals - More Data, More Prescriptions - Examination of the impact of key events in the systemic antifungal market, such as the patent expiries of leading products and the launch of several pipeline drugs, with recommendations for effective portfolio and lifecycle management

Product Code: DMHC1972

Publication Date: 24-May-2004

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Overview

Introduction

The launch of Vfend and Cancidas has created increased competition within a sector traditionally dominated by a limited number of products. As patent expiries and new product launches increase competition further, market penetration and product success will increasingly depend on effective positioning strategies and appropriate targeting of niche patient groups and pathogen types.

Scope

· The market for systemic antifungals is analyzed in detail on a country basis, with historic and forecast sales from 1999 to 2014 provided

· Detailed product profiles for selected leading drugs, incorporating strategic recommendations and forecasted regional sales to 2014

· The major players' antifungal portfolios are examined, with recommendations for future development and product positioning included

· Various lifecycle management strategies are analyzed, using case studies, and their applicability for the future is determined

Highlights

Novel antifungals, such as Vfend and Cancidas, have experienced relatively slow initial uptake, as physicians are reluctant to use them without detailed, peer reviewed data. However, 2003 sales were significantly stronger than 2002 for both products, demonstrating an acceptance of their role in antifungal therapy.

Targeted promotion and marketing activities facilitate rapid physician switching, with patient and physician needs and demands varying widely between specialties. Sales forces with a strong presence and reputation should be built up to ensure access to the optimum number of prescribing physicians.

Launching a product in countries where treatment options are limited will guarantee greater uptake than in those countries where physicians have a wider choice of efficacious drugs. Subsequent launches in these countries can, therefore, be supplemented by data gathered from the first markets of launch.

Reasons to Purchase

· Understand the impact of imminent patent expiries of leading antifungal products on market dynamics

· Devise lifecycle management strategies to counter generic competition or expand commercial potential, and identify best practice pricing policies

· Prioritize antifungal development programs and sales and marketing efforts to effectively counter competitive threats

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CHAPTER 1 EXECUTIVE SUMMARY	3
Scope of the analysis	3
Datamonitor insight into the antifungal market	4
The systemic antifungal market has experienced strong growth since 1999, increasing in value from $2.1 billion to $3.3 billion in 2003, representing a CAGR of 11.4%. An increased incidence and severity of invasive fungal infections, combined with the launch of novel, premium priced antifungal products, have been the main drivers of growth and this is expected to continue to 2014, with Datamonitor forecasting a CAGR of 4.5% (2004-2014)	5
Although the azoles dominate the systemic antifungal market, accounting for 52% of total sales in 2003, the novel echinocandin class has been the key growth driver, boosting the value of the sector by 22% between 2002 and 2003. With the market leading azole, Diflucan, expected to lose final patent protection in July 2004, and the imminent launch of anidulafungin and micafungin, Datamonitor expects the echinocandin class to become increasingly predominant.	6
One of the main factors deterring physician switching from older, traditional therapies is the lack of exhaustive clinical trial data and peer experience in using newer antifungals. Compounds with known side effects, drug interactions and a proven history are still favored. Phase IV trials, 'on-the-ground' experience and niche clinical studies are key to ensuring maximum product uptake.	8
The increasing competitiveness of the systemic antifungals market necessitates a larger commitment of pre-launch resources, with a lengthening payback period. Niche indications offer key opportunities for companies seeking to establish their products, while providing the potential for targeted co-promotion of antifungals with other products frequently used in at-risk groups. Micafungin's rapid uptake in Japan provides a good case-study.	9
Summary	11
Key metrics	11
TABLE OF CONTENTS	13
CHAPTER 2 ANTIFUNGAL MARKET DEFINITION	24
Strategic scoping and focus	24
Market definition	25
A gold standard in antifungals?	25
Associated pharmaceutical markets and indications	28
HIV	28
Cancer	28
Transplant	29
Others	29
CHAPTER 3 GLOBAL MARKET OVERVIEW	30
Key findings	30
Global antifungal market analysis	30
Superficial antifungal market analysis	32
Systemic antifungal market analysis	36
Global market forecast	44
Class analysis	50
Azole overview	50
Polyene overview	58
Echinocandin overview	65
Allylamine analysis	72
CHAPTER 4 PRODUCT ANALYSIS	78
Key findings	78
Introduction	79
Brand analysis	80
Diflucan analysis	80
Lamisil	90
Sporanox analysis	94
Cancidas	101
AmBisome	107
Vfend analysis	113
Nizoral analysis	121
Abelcet	125
Fungard	131
Amphotec	136
CHAPTER 5 PORTFOLIO ANALYSIS AND STRATEGIC PRODUCT POSITIONING	138
Key findings	138
Positioning of the major antifungals players	139
Antifungals portfolio analysis	141
Portfolio development	149
Sales by indication	150
Sales by patient group	153
Antifungal prophylaxis - the untapped patient population	156
Strategic product positioning	159
Patient targeting and influence	159
Physician targeting and influence	162
Physician focused product positioning	167
CHAPTER 6 ANTIFUNGAL LIFECYCLE MANAGEMENT	170
Key findings	170
Lifecycle management in antifungals	170
The systemic antifungal product lifecycle	171
The superficial antifungal product lifecycle	172
Launch strategy and market penetration	172
Optimizing peak systemic antifungal sales	182
Revenue protection strategies	192
Antifungal pricing analysis	204
Invasive fungal infections - disease description	212
Aspergillosis	212
Blastomycosis	212
Candidiasis	212
Coccidioidomycosis	213
Cryptococcosis	213
Histoplasmosis	213
Others	213
Global forecasts - analyst consensus	214
Opinion leader 1 - US infectious disease physician	217
Section 1 - Product prescription process	217
Section 2 - Product prescription choices	220
Section 3 - Clinical trials	225
Section 4 - Dissemination of data	228
Opinion leader 2 - Italian ID physician	230
Section 1 - Product prescription process	230
Section 2 - Product prescription choices	232
Section 3 - Clinical trials	236
Section 4 - Dissemination of data	237
Opinion leader 3 - Canadian ID physician	238
Section 1 - Product prescription process	238
Section 2 - Product prescription choices	239
Section 3 - Clinical trials	243
Section 4 - Dissemination of data	246
Opinion leader 4 - German ID physician	248
Section 1 - Product prescription process	248
Section 2 - Product prescription choices	249
Section 3 - Clinical trials	252
Section 4 - Dissemination of data	253
Opinion leader 5 - French ID physician	255
Section 1 - Treatment rates and prophylaxis	255
Section 2 - Treatment options	259
Section 3 - Prescription decisions	261
Section 4 - Unmet needs	262
Opinion leader 6 - UK ICU physician	264
Section 1 - Treatment rates and prophylaxis	264
Section 2 - Treatment options	269
Section 3 - Prescription practices	270
Section 4 - Unmet needs	271
Opinion leader 7 - US ID physician	274
Section 1 - Treatment rates and prophylaxis	274
Section 2 - Treatment options	278
Section 3 - Prescription practices	280
Section 4 - Unmet needs	282
Opinion leader 8 - Italian ID physician	284
Section 1 - Treatment rates and prophylaxis	284
Section 2 - Treatment options	288
Section 3 - Prescription decisions	289
Section 4 - Unmet needs	291
Opinion leader 9 - Spanish ID physician	293
Section 1 - Treatment rates and prophylaxis	293
Section 2 - Treatment options	296
Section 3 - Prescription decisions	297
Section 4 - Unmet needs	299
Opinion leader 10 - US ID physician	301
Section 1 - Treatment rates and prophylaxis	301
Section 2 - Treatment options	305
Section 3 - Prescription decisions	307
Section 4 - Unmet needs	309
Opinion leader 11 - Canadian ID physician	311
Section 1 - Treatment rates and prophylaxis	311
Section 2 - Treatment options	315
Section 3 - Prescription decisions	316
Section 4 - Unmet needs	318
Opinion leader 12 - US transplant physician	320
Section 1 - Treatment rates and prophylaxis	320
Section 2 - Treatment options	324
Section 3 - Prescription decisions.	326
Section 4 - Unmet needs	328
Bibliography	330
Journal articles	330
Press releases	337
Product labeling	341
National formularies	341
Websites	342
Key associations and conferences	343
Report methodology	343
Standard units	343
Japanese market data	344
Regional launch dates for new products	344
Stakeholder Insight: Invasive Fungal Infections (DMHC1957)	344
About Datamonitor	347
About Datamonitor Healthcare	347
Datamonitor Healthcare's research and analysis methodologies	348
Disclaimer	349
List of Tables
Table 1: Systemic antifungal sales to 2014, seven markets	12
Table 2: Key antifungal product sales forecasts, seven major markets, 2004-14	12
Table 3: Examples of comparator trials for recently launched or pipeline antifungal products	27
Table 4: Superficial antifungal sales by class ($m), seven markets, 1999-2003	33
Table 5: Antifungal usage (number of doses), seven markets, 1999-2003 (SU* millions)	35
Table 6: Antifungal market forecasts, seven markets, 2004-14	46
Table 7: Systemic antifungal sales by country, 2004-14	46
Table 8: Overview of the azole class of antifungals	51
Table 9: Global azole forecast by leading brand, 2004-14	57
Table 10: R&D included in azoles forecast, 2004-14	58
Table 11: Overview of the polyene class of antifungals	59
Table 12: Comparative volume usage (number of doses) in the polyene class, seven markets, 1999-2003 (SU millions)	62
Table 13: Price per gram of amphotericin B products in the UK, 2004	62
Table 14: Global polyene forecast by leading brand, 2004-14	65
Table 15: Overview of the echinocandin class of antifungals	66
Table 16: Global echinocandin forecast by leading brand, 2004-14	71
Table 17: R&D included in echinocandins forecast, 2004-14	72
Table 18: Overview of the allylamine class of antifungals	73
Table 19: Lamisil sales in the seven major markets, 1999-2003	75
Table 20: Global allylamine forecast by leading brand, 2004-14	77
Table 21: Overview of key antifungal products, 2003	79
Table 22: Diflucan: key facts	80
Table 23: Diflucan spectrum of activity and indications	81
Table 24: Diflucan geographic sales profile	82
Table 25: Key Diflucan events, 2003-04	83
Table 26: Price of fluconazole in the UK and US, 2003	88
Table 27: Lamisil : key facts	90
Table 28: Lamisil geographical sales profile	91
Table 29: Key Lamisil events, 2002-04	91
Table 30: Sporanox: key facts	94
Table 31: Sporanox spectrum of activity and indications	95
Table 32: Sporanox geographic sales profile	96
Table 33: Cancidas: key facts	101
Table 34: Cancidas spectrum of activity and indications	102
Table 35: Cancidas geographical sales profile	102
Table 36: Key Cancidas events, 2002-04	103
Table 37: AmBisome: key facts	107
Table 38: AmBisome spectrum of activity and indications	108
Table 39: AmBisome geographical sales profile	109
Table 40: Vfend: key facts	113
Table 41: Vfend spectrum of activity and indications	114
Table 42: Vfend geographic sales profile	115
Table 43: Key Vfend events, 2002-04	115
Table 44: Nizoral: key facts	121
Table 45: Nizoral spectrum of activity and indications	122
Table 46: Nizoral geographic sales profile	123
Table 47: Key Nizoral events, 2002-04	123
Table 48: Abelcet: key facts	125
Table 49: Abelcet geographical sales profile	126
Table 50: Key Abelcet events, 2002-04	127
Table 51: Price ($/g) of selected IV antifungal products, 2003	128
Table 52: Fungard: key facts	131
Table 53: Fungard's spectrum of activity and indications	132
Table 54: Key Fungard events, 2002-04	133
Table 55: Amphotec: key facts	136
Table 56: Total, infectious disease and antifungal performance of the antifungal market leaders, 2003	140
Table 57: Total number of patients acquiring an invasive fungal infection per year, seven markets	183
Table 58: Potential patient pool for clinical trials, seven markets	184
Table 59: Total number of products available for the treatment of fungal infections, seven markets, 2004	188
Table 60: Selected key patent expiries in antifungals	193
Table 61: Total number of generics currently available, 2003	200
Table 62: Selected antifungal pricing data ($/g)	204
Table 63: Comparison of selected brand and generic antifungal prices	207
Table 64: Estimated cost per therapeutic regime for invasive fungal infections ($), 2003	209
Table 65: Estimated cost per day of antifungal prophylaxis as recommended by the guidelines of the AGIHO of the DGHO	210
Table 66: Median costs in each service category ($)	211
Table 67: Datamonitor and analyst sales forecasts for Diflucan	214
Table 68: Datamonitor and analyst sales forecasts for Sporanox	215
Table 69: Datamonitor and analyst sales forecasts for Vfend	215
Table 70: Datamonitor and analyst sales forecasts for Cancidas	216
Table 71: Datamonitor and analyst sales forecasts for AmBisome	216
List of Figures
Figure 1: Key drivers and resistors of the antifungal market to 2014	11
Figure 2: Timeline of the introduction of key antifungal drugs	31
Figure 3: Annual systemic and superficial antifungal sales, 1999-2003	32
Figure 4: Comparative class contribution to superficial antifungal sales, seven markets, 1999-2003	34
Figure 5: Comparative volume (number of doses) in each superficial antifungal class, seven markets, 1999-2003	36
Figure 6: Total systemic antifungal sales ($ billion) by class, seven markets, 1999-2003	37
Figure 7: Relative contribution of each class to total systemic antifungal sales, seven markets, 1999-2003	38
Figure 8: Systemic antifungal sales by country, 1999-2003	39
Figure 9: Systemic antifungal volume (number of doses), seven markets, 1999-2003	41
Figure 10: Quarterly antifungal sales and volume usage, seven markets, 1999-2003	42
Figure 11: Quarterly antifungal sales by country, 1999-2003	43
Figure 12: Vfend quarterly sales, 2002-03	44
Figure 13: Global antifungal market forecast, seven markets, 2004-14	45
Figure 14: Systemic antifungal volume (number of doses), seven markets, 2004-14	47
Figure 15: Systemic antifungal sales by country, 2004-14	49
Figure 16: Azole sales by molecule, seven markets, 1999-2003	52
Figure 17: Genericization in the azole class, seven markets, 1999-03	53
Figure 18: Comparative volume usage (number of doses) in the azole class, seven markets, 1999-2003	54
Figure 19: Key drivers and resistors of azole growth, 2004-14	55
Figure 20: Azole market concentration, 2004-14	56
Figure 21: Polyene sales, seven markets, 1999-2003	60
Figure 22: Generic incursion in amphotericin B and nystatin sales, seven markets, 1999-2003	61
Figure 23: Key drivers and resistors of polyene growth, 2004-14	63
Figure 24: Polyene market concentration, 2004-14	64
Figure 25: Echinocandins quarterly sales, seven markets, 2001-03	66
Figure 26: Regional contribution to echinocandin sales, 2001-03	68
Figure 27: Comparative value and volume usage (number of doses) in the echinocandin class, seven markets, 2003	69
Figure 28: Key drivers and resistors of echinocandin growth, 2004-14	70
Figure 29: Allylamine sales by molecule, seven markets, 1999-2003	74
Figure 30: Comparative volume usage (number of doses) in the allylamine class, seven markets, 1999-2003	76
Figure 31: SWOT analysis for Diflucan	84
Figure 32: Global sales forecasts for Diflucan, 2004-14	87
Figure 33: Global sales forecasts for Lamisil, 2004-14	92
Figure 34: SWOT analysis for Sporanox	97
Figure 35: Global sales forecasts for Sporanox, 2004-14	99
Figure 36: SWOT analysis for Cancidas	104
Figure 37: Global sales forecasts for Cancidas, 2004-14	105
Figure 38: SWOT analysis for AmBisome	110
Figure 39: Global sales forecasts for AmBisome, 2004-14	112
Figure 40: SWOT analysis for Vfend	116
Figure 41: Global sales forecasts for Vfend, 2004-14	119
Figure 42: Global sales forecasts for Nizoral, 2004-14	124
Figure 43: SWOT analysis for Abelcet	127
Figure 44: Global sales forecasts for Abelcet, 2004-14	130
Figure 45: Global sales forecasts for Fungard, 2004-14	134
Figure 46: Global sales forecasts for Amphotec, 2004-14	137
Figure 47: Antifungal market share, seven markets, 1999 and 2003	139
Figure 48: Antifungal portfolio coverage	141
Figure 49: Pfizer's antifungal portfolio coverage	142
Figure 50: J&J's antifungal portfolio coverage	144
Figure 51: Annual sales of other antifungals in the J&J portfolio, 2003	145
Figure 52: Fujisawa's antifungal portfolio coverage	147
Figure 53: Total invasive fungal infections and annual systemic antifungal sales attributable to each infection (%), seven markets, 2003	151
Figure 54: Analysis of unmet therapeutic needs by infection in the systemic antifungal market	152
Figure 55: Overview of the most common infections and key needs for the at-risk patient populations	154
Figure 56: Total invasive fungal infections and annual systemic antifungal sales attributable to each patient group (%)	155
Figure 57: Percentage of at-risk patients receiving antifungal prophylaxis in the US, EU and Japan, 2003	157
Figure 58: Total at-risk patients not receiving antifungal prophylaxis in the US, EU and Japan, 2003	158
Figure 59: Diflucan website product positioning	160
Figure 60: Lamisil website product positioning (1)	161
Figure 61: Lamisil website product positioning (2)	162
Figure 62: Physician interaction in the treatment of invasive fungal infections in the hospital	163
Figure 63: Physician interaction with the pharmacist in the antifungal prescription process	165
Figure 64: Vfend website product positioning (1)	168
Figure 65: Vfend website product positioning (2)	169
Figure 66: Sporanox lifecycle, 1990-2014	171
Figure 67: Market penetration of Diflucan and Sporanox	173
Figure 68: Impact of new product launches on selected antifungal sales	174
Figure 69: Antifungal players portfolios	177
Figure 70: Quarterly sales of Cancidas and Fungard in the first year following launch in the domestic markets	181
Figure 71: Cancidas quarterly sales, US, 2001-03	182
Figure 72: Sporanox sales and indication expansion, 1989-99	185
Figure 73: Impact of genericization on Nizoral sales, seven markets, 1999-2003	194
Figure 74: Factors affecting generic incursion in the antifungal markets	196
Figure 75: Branded and generic antifungals sales, seven markets 1998-2003	197
Figure 76: Branded and generic sales in the superficial* antifungal market, seven markets, 1999-2003	198
Figure 77: Branded and generics sales for selected molecules, seven markets, 2003	199
Figure 78: Canesten products and indications	203
Figure 79: Total Cancidas and Vfend sales and number of doses used, seven markets, 2001-03	206
Figure 80: Spanish ketoconazole sales, 1999-2003	208

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