Market Report Source

Overview

Introduction
The systemic antifungals market accounts for $3.1bn of the total $41bn anti-infectives market. A wave of new products coinciding with patent expiry of two widely used compounds will shake up the market for systemic infections, further polarizing between winners and losers. Key changes are forcing a rethink of management strategies and clinical trial design.

Scope

• In-depth analysis of the market for systemic antifungals covering Japan, US, France, Italy, Germany, Spain and the UK
• Product by product analysis of the key marketed and pipeline brands that will determine the market’s evolution
• An assessment of key unmet needs and the opportunities they offer for new product development
• Key considerations for trial design as pre-emptive and targeted strategies replace prophylactic and empiric strategies

Highlights
Over the 2002 to 2006 period, the market for systemic antifungals has risen by a moderate 3.3% from $2.7billion to $3.1 billion; however, its value has dropped by 7.4% between 2005 and 2006. The US and M5EU launch of the next wave of echinocandins (Eraxis and Mycamine) and the next generation azoles (Vfend and Noxafil) will shorten the current period of devaluation of the market caused by widespread uptake of generic fluconazole and itraconazole. New diagnostic technology promises to offer clinicians far better decision making tools, emphasizing the need for a rethink of antifungal clinical trial design. Innovative approaches will be needed to ensure that already costly trials do not become prohibitively expensive, while remaining clinically relevant.

Reasons to Purchase

• Understand clinical and commercial impact of key marketed and pipeline products on the future shape of the systemic fungal infections market
• Understand the key clinical analysis that will be essential to cater to clinicians’ information needs and gain widespread use
• Review the impacts of new diagnostic techniques on antifungal treatment strategies

Table of Contents

CHAPTER 1 EXECUTIVE SUMMARY 3
Objective of the analysis 3
Datamonitor insight into the systemic fungal infection market 4
Predictable, heavy losses continue but rejuvenation in sight 4
Patients, drugs, diagnostics and pathogens change market focus 4
Unmet need will require more inventive trial design to fulfil 5
Changing spectrum of clinical attractiveness 6
New blood in top ranks, but Pfizer will increase its lead 7
Contributing experts 8
Related reports 9
Upcoming related reports 9

CHAPTER 2 MARKET DEFINITION AND OVERVIEW 11
Market definition for this report 11
Current market situation 13
Geographical bias 16
High market concentration of brand sales 17
Key companies, strategies and approaches 19
Disease background 22
The fungal family tree – a history of succession 23
Pathogens and patients – linking immunocompromise to species 25
From Candida to Aspergillus and beyond – changing fungal epidemiology 27
The pathogens of the future: Fusarium and Scedosporium 29
Patients – drivers of demand 30
Transplant patients – driving the need for patient and pathogen-specific drug indications 33
Cancer – a core sector for years to come 35
HIV – HAART reducing demand, but facing increased azole resistance 37
Children and neonates – a dearth of basic information 38
The antifungal drug explosion – new challenges, new opportunities 40
Amphotericin B – saving lives 40
Ketoconazole – oral opportunities 41
Fluconazole – a pharmacological revolution 41
Caspofungin – a new class and a sign of things to come 42
Lipid amphotericins – setting the pharmacoeconomic standard 43
Diagnostics – shaping new management strategies 44
Conventional technologies – still invaluable tools 46
Molecular diagnostics: changing the outlook for drug use 48
Changing treatment paradigms: towards pre-emptive and targeted therapy 53
Prophylaxis – an indication under threat 53
Pre-emptive therapy – led by diagnostic advance 56
Empiric therapy – not enough any more 58
Directed therapy – the importance of specific and costly indications 59
Current unmet need – significant, numerous, and specific 60
Mortality 60
Pediatric data 62
More specific data and indications 62
Clinical trial design 63
Dealing with limited patient populations 64
Finding other ways of growing the sample size 64
Making sure the right patients are included 65
Confounding underlying disease 68
Making sure the group is comparable 68
Avoiding mortality (in all its forms) as an endpoint 69
Reconsidering trial duration: too short, or too long? 70
Adequately measuring diagnosis and response 71
Staying with the times: get molecular 72

CHAPTER 3 COUNTRY MARKET ASSESSMENTS 74
Seven major markets 74
Key facts 74
Opportunities and threats 78
Genericization of the first wave of safer drugs 79
Pharmacoeconomic analysis: influencing key decision makers 79
Which pathogen to look for next? 84
The commercial flipside: are antifungals worth it? 86
New treatment guidelines: The IDSA guidelines go international 89
United States 90
Key facts 90
Opportunities and threats 93
Broader FDA initiatives decrease time to market, but antibiotic scrutiny increases 94
DTC advertising – ideal for the acute sector, but not for antifungals 95
Pricing and reimbursement 96
Japan 100
Key facts 100
Opportunities and threats 104
The threat of foreign competition: enough to force domestic change? 105
Price cuts – still dominating pricing and reimbursement in Japan 106
Increasing uptake of generics 107
Lengthy approval process slows down access to the Japanese market 108
5EU 109
Key facts 109
Opportunities and threats 112
EMEA drug approval process harmonization 112
Smaller companies helped by European regulators 114
France 115
Opportunities and threats 117
Germany 119
Opportunities and threats 121
Italy 124
Opportunities and threats 126
Spain 129
Opportunities and threats 131
UK 134
Opportunities and threats 135

CHAPTER 4 DRUG ANALYSES AND FORECASTS 141
7MM overview 141
Regional contributions 141
Corporate performance 151
Pfizer to remain the leader of the pack 153
Merck and Johnson and Johnson need new options 154
Astellas and Schering Plough: On the way up with simple propositions 155
Azoles 156
Key impact summary 157
Azole analysis – historical and future outlook and comparative forecasts 159
Azoles as a proportion of total market value 160
Regional variations: azole value slump limited to US 164
Class composition – currently marketed products, new and recent launches and generics 169
Textbook generic displacement 171
Generic incursion beginning to stabilize 175
Marketed product overviews 180
Diflucan (fluconazole) 181
Prodif (fosfluconazole) 185
Sporanox (itraconazole) 190
Nizoral (ketoconazole) 196
Noxafil (posaconazole) 201
Vfend (voriconazole) 212
Pipeline products 218
Isavuconazonium chloride (BAL8557) 218
Others [not forecast] 223
Echinocandins 229
Key impact summary 230
Echinocandin analysis – historical and future outlook 231
Echinocandins as a proportion of total market value 233
Class composition – new launches detract from the incumbent 237
Regional variations: Japan leads the way 239
Brand overview – a tale of two territories 243
Marketed product overviews 247
Cancidas (caspofungin) 247
Mycamine (micafungin) 256
Eraxis (anidulafungin) 263
Pipeline products [not forecast] 270
HMR-3270 (aminocandin) 271
Polyenes 272
Key impact summary 273
Polyene analysis – historical and future outlook 274
Polyenes as a proportion of total market value 276
Regional variations 279
Class composition 283
Brand overview 285
Marketed product overviews 290
Abelcet (Amphotericin B Lipid Complex) 290
AmBisome (liposomal AmB) 294
Other branded polyenes [not forecast] 300
Pipeline products 303
SinuNase & BiOral Amphotericin B (AmB Oral and Nasal cochleates) 303
NKTR-024 (amphotericin B inhalation powder) 306
Discontinued/withdrawn products 308
Others 309
Group overview 310
Others as a proportion of total market value 310
Regional sales composition 311
Branded versus generic and new launch composition 313
Pipeline products 316
Mycograb (efungumab) 316
Others [not forecast] 319
Forecast methodology 320

CHAPTER 5 FORECAST ASSUMPTIONS 321
Patent expiries and generic incursion 321
Approvals and launches 327
Other studies 332
New guidelines 339
BIBLIOGRAPHY 343
Presentations 343
Books 343
Journal papers 344
Epidemiology 344
Trial design and data 345
Cost efficacy 349
Diagnosis and Diagnostics 350
Presentations 353
Websites 354
Datamonitor reports 354

APPENDIX A – MARKET DATA AND MAJOR BRAND KEY FACTS 355
Summary systemic fungal disease market data 355

APPENDIX B – MARKET FORECAST DATA 357
Seven major markets 357
M5EU 361
US 364
Japan 366
France 368
Germany 371
Italy 373
Spain 376
UK 378

APPENDIX C 381
Contributing experts 381
Report methodology 381
About Datamonitor 381
About Datamonitor Healthcare 381
About the Infectious & Respiratory Disease analysis team 382
About the Antibacterials analysis team 383
Key therapy team members 384
Holger Rovini, Head of Respiratory and Infectious Diseases 384
Disclaimer 385

List of Tables
Table 1: Datamonitor product groupings for the systemic fungal infections market 12
Table 2: 7MM antifungal sales by region by volume and value (%), 2006 17
Table 3: Key players in the market for systemic fungal infection, 2007 19
Table 4: Antifungal volume sales leader board by rank, sales and share, 2006 21
Table 5: Antifungal value sales leader board by rank, sales and share, 2006 22
Table 6: Predominant and emerging opportunistic fungal pathogens of clinical significance, 2007 25
Table 7: Types of immunocompromise, causes and associated fungal pathogens 26
Table 8: Stratified risk groups for invasive Aspergillosis 30
Table 9: Examples of risk factors associated with invasive fungal infections 32
Table 10: Galactomannan testing for invasive aspergillosis in hematologic malignancy and allogeneic bone marrow transplant patients 49
Table 11: Nosocomial bloodstream infection organism distribution in the US, 2004 61
Table 12: Mortality due to invasive mycoses 61
Table 13: 7MM antifungal leading brands by value sales ($m), 2006 and CAGR growth, 2002-06 77
Table 14: 7MM leading antifungal brands by volume sales (SUm), 2006 and CAGR growth, 2002-06 77
Table 15: 7MM pportunities and threats in the antifungals market, 2007 78
Figure 23: Healthcare spending as a proportion of GDP in the 7MM, 2004 81
Table 16: The pharmacoeconomics of prophylaxis 83
Table 17: Definition for Immune Reconstitution Inflammatory Response in Mycoses 86
Table 18: US leading antifungal brands by value sales ($m), 2006 and CAGR growth, 2002-06 92
Table 19: US leading brands by volume sales (SUm), 2006 and CAGR growth, 2002-06 92
Table 20: United States: summary of opportunities and threats in the antifungals market, 2007 93
Table 21: Japan leading brands by value sales ($m), 2006 and CAGR growth, 2002-06 103
Table 22: Japan leading brands by volume sales 2006 (SUm) and CAGR growth, 2002-06 103
Table 23: Japan: summary of opportunities and threats in the antifungals market, 2007 104
Table 24: 5EU leading antifungal brands by value sales ($m), 2006 and CAGR growth, 2002-06 111
Table 25: 5EU leading antifungal brands by volume sales (SUm), 2006 111
Table 26: 5EU Opportunities and Threats in the antifungals market, 2007 112
Table 27: France leading antifungal brands by value sales ($m), 2006 and CAGR growth, 2002-06 115
Table 28: France leading antifungal brands by volume sales (SUm), 2006 116
Table 29: France: opportunities and threats in the antifungals market, 2007 117
Table 30: Germany leading antifungal brands by value sales ($m), 2006 and CAGR growth, 2002-06 120
Table 31: Germany leading antifungal brands by volume sales (SUm), 2006 and CAGR growth, 2002-06 120
Table 32: Germany: opportunities and threats in the antifungals market. 2007 121
Table 33: Italy leading antifungal brands by value sales ($m), 2006 and CAGR growth, 2002-06 125
Table 34: Italy leading brands by volume sales 2006 (SUm) and CAGR growth, 2002-06 125
Table 35: Italy: opportunities and threats in the antifungal market, 2007 126
Table 36: Spain leading brands by value sales ($m), 2006 and CAGR growth, 2002-06 129
Table 37: Spain leading brands by volume sales (SUm), 2006 and CAGR growth, 2002-06 130
Table 38: Spain: opportunities and threats in the antifungal market, 2007 131
Table 39: UK leading brands by value sales ($m), 2006 and CAGR growth, 2002-06 134
Table 40: UK leading brands by volume sales (SUm), 2006 and CAGR growth, 2002-06 134
Table 41: UK opportunities and threats in the antifungal market, 2007 135
Table 42: 7MM antifungal sales – indexed volume and value sales and average pricing, 2002-06 143
Table 43: Forecast 7MM antifungal sales by volume, value and region, 2006-2016 145
Table 44: Forecast new launches, existing products and generics by regional contribution, and CAGR (2006-16) 147
Table 45: Forecast regional sales by new launch, existing product and generic contribution, and CAGR (2006-16) 150
Table 46: Ranking and shares 2006/16 – Key players by volume and value 152
Table 47: Market growth by key player, volume and value sales, 2006-16 153
Table 48: Indexed 7MM azole class sales versus rest of antifungal market, 2002-06 162
Table 49: Forecast 7MM azole class sales versus rest of antifungal market sales, 2006-2016 164
Table 50: Indexed azole class sales by region, 2002-06 167
Table 51: Forecast azole class sales by region, 2006-2016 169
Table 52: Forecast 7MM azole sales – new launches, existing products and generics, 2006-2016 171
Table 53: Indexed 7MM azole class sales – key brands and generics, 2002-06 173
Table 54: Forecast 7MM azole class sales – key brands and generics, 2006-2016 175
Table 55: Indexed 7MM generic azole volume and value sales, 2002-06 178
Table 56: Forecast 7MM azole generic sales by molecule and combined brands, 2006-2016 180
Table 57: Diflucan: Key facts 181
Table 62: Noxafil (posaconazole) trial data overview, 2007 210