Commercial Insight Infectious Diseases Overview

CHAPTER 1 EXECUTIVE SUMMARY 3
Scope of the analysis 3
Datamonitor insight into the Infectious Disease market 4
Related reports 9
Upcoming reports 9
CHAPTER 2 MARKET DEFINITIONS 11
Anatomical Therapeutic Classifications 11
Antibacterials 11
Antifungals 12
Antivirals excluding HIV 13
HIV 13
Geographic coverage 13
License status 14
CHAPTER 3 BACKGROUND AND OVERVIEW 15
Infectious Disease market performance 16
Volume sales are showing a nominal decline in both the medium and short term 17
Volume sales are relatively low by comparison to other ATCs 17
Sharp decline in value growth 18
Infectious Disease sector comparison 21
Sector key metrics 21
Market attractiveness 24
Leading molecules 27
Top 10 company involvement 29
Market leader performance and portfolio composition 29
Sector reliance 35
Geographic orientation 38
CHAPTER 4 ANTIBACTERIALS 42
Disease background 43
Pathogen and pathogen type 45
Antibiotic classes 49
Penicillins 52
Cephalosporins 53
Fluoroquinolones 54
Macrolides and ketolides 55
Other significant classes 56
Site of infection 57
Hospital versus community markets 58
Commercial analysis 62
Market size and structure 63
Geographic focus 68
Brand and company focus 70
Top five company analysis 74
Pfizer - success through accession, but will the formula work again? 77
Johnson & Johnson - cornering the market ahead of time 80
Abbott - will the last one out, turn off the lights? 83
Novartis - the best of both worlds: mixing high value brands with a generic assault 85
Sanofi-Aventis - what will you be remembered for: Tavanic and Claforan, or Synercid and Ketek? 89
Key portfolio management strategies - Antibiotics: Pfizer 92
Softening the blow of Zithromax 94
Zyvox and Zeven: creating a unified front 96
CHAPTER 5 ANTIFUNGALS 98
Disease background 98
Unmet need - driving product development of premium products 100
Changing patient populations 103
Transplant patients 104
Cancer 104
HIV 105
Children and neonates 106
The antifungal drug explosion 106
Class overviews 109
The shifting spectrum of causative pathogens 113
Linking patients to pathogens 115
From Candida to Aspergillus and beyond - changing fungal epidemiology 116
Diagnostic capabilities 118
Commercial analysis 120
Market size and structure 122
J2A0 and Azole market devaluation pulls market down 122
Echinocandins - a price war beckons 126
Polyenes - liposomal formulations sidelined 127
Others 128
Geographic focus 128
Brand and company focus 131
Top five company analysis 133
Novartis - one hit wonder? 137
Pfizer - the best of the rest 141
Merck & Co - the Cancidas honeymoon is over 144
Johnson & Johnson - let down by licensing opportunities? 147
Astellas Pharma - a simple value proposition in a costly market 150
CHAPTER 6 ANTIVIRALS 153
Disease background 156
Hepatitis 157
HCV management 158
HBV management 160
Respiratory viruses 161
Influenza 162
Respiratory syncytial virus (RSV) 164
HSV, CMV and similar viruses 166
Herpes simplex virus (HSV) 167
Varicella zoster virus (VZV) 170
Cytomegalovirus (CMV) 172
Commercial analysis 174
Market size and structure 176
Hepatitis 179
Respiratory viruses 181
HSV, CMV and similar viruses 183
Geographic focus 184
US 185
M5EU 187
Japan 187
Brand and company focus 188
Top five company analysis 189
GSK - opting for a biological future 192
Roche - the need for sector dominance 195
Schering-Plough - back-footed, but fighting on 203
Novartis - would generics be a better option? 206
Gilead - can leveraging portfolios yield sustainable growth? 209
CHAPTER 7 HIV 212
Disease background 213
Patient population 215
Drug class overviews 218
Nucleoside reverse transcriptase inhibitors 218
Non-nucleotide reverse transcriptase inhibitors 219
Protease inhibitors 219
Entry inhibitors 220
Commercial analysis 221
Market size and structure 222
Geographic focus 224
Brand and company focus 225
Top five HIV company analysis 228
GSK - a behemoth with an ageing proposition 232
Gilead - young turk or smooth operator? 237
BMS - all about timing 240
Abbott - can in-licensing be relied on? 242
Roche - going for broke 246
Key portfolio management strategies - HIV FDC Case Study 248
GSK - plugging the pipeline let-down gap 253
Gilead - keeping options open - balancing FDCs with new product 254
BMS - what is there to lose? 255
FDCs from generics - Waiting in the wings 256
BIBLIOGRAPHY 258
Literature 258
Websites and similar 260
Other sources 260
Datamonitor sources 261
APPENDIX A 262
CHAPTER 8 APPENDIX B 269
About Datamonitor 269
About Datamonitor Healthcare 269
About the Infectious & Respiratory Disease analysis team 270
Key therapy team members 271
Holger Rovini, Head of Respiratory and Infectious Diseases 271
Disclaimer 272
List of Tables
Table 1: Key dynamics - Infectious Disease versus other key therapeutic sectors, 7MM, 2002-06 19
Table 2: Infectious disease sector dynamic comparisons - key volume and value metrics, 7MM, 2002-06 22
Table 3: Market attractiveness - product, company and generic dominance by sector, 7MM, 2006 25
Table 4: Top selling molecules across the antibiotic, antifungal, antiviral and HIV sectors, 7MM, 2006 27
Table 5: Top 10 companies by revenue across the antibiotic, antifungal, antiviral and HIV sectors, 7MM, 2006 30
Table 6: Top 10 company portfolio bias - percentage value sales across the antibiotic, antifungal, antiviral and HIV sectors, 7MM, 2006 36
Table 7: Regional revenues - top 10 companies, rest of market and total market sales across the antibiotic, antifungal, antiviral and HIV sectors, 7MM, 2006 41
Table 8: Examples of clinically significant pathogens by Gram stain 46
Table 9: Key pathogens targeted by marketed or developmental vaccines 49
Table 10: Cephalosporins' spectrum of activity by generation 50
Table 11: Antibiotic class sales by volume and value, 7MM, 2006 52
Table 12: Late-stage pipeline antibiotic products by trial phase, indication and grouping, 2007 61
Table 13: Top five Antibacterial companies by 2006 revenues versus rest of market 70
Table 14: Top five antibacterial companies by 2006 revenues versus rest of market 75
Table 15: Pfizer SWOT analysis for the antibacterials market 77
Table 16: Pfizer antibiotics portfolio overview, 2002-06 78
Table 17: Johnson & Johnson SWOT analysis for the antibacterials market 80
Table 18: Johnson & Johnson antibiotics portfolio overview, 2002-06 81
Table 19: Abbott SWOT analysis for the antibacterials market 83
Table 20: Abbott antibiotics portfolio overview, 2002-06 84
Table 21: Novartis SWOT analysis for the antibacterials market 85
Table 22: Novartis antibiotics portfolio overview, 2002-06 86
Table 23: Sanofi-Aventis SWOT analysis for the antibacterials market 89
Table 24: Sanofi-Aventis antibiotics portfolio overview, 2002-06 90
Table 25: Systemic antifungals versus other antifungal sales, 2006 99
Table 26: Mortality due to invasive mycoses 100
Table 27: Nosocomial bloodstream infection organism distribution in the US, 2004 102
Table 28: Predominant and emerging opportunistic fungal pathogens of clinical significance, 2007 114
Table 29: Types of immunocompromise, causes and associated fungal pathogens 115
Table 30: Indexed 7MM antifungal sales by ATC - indexed volume and value sales, 2002-06, actual sales (SUm and $m) 2006, and CAGR (%) 2002-06 123
Table 31: Indexed 7MM J2A0 ATC antifungal sales by class - Indexed volume and value sales, 2002-06, actual sales (SUm and $m) 2006, and CAGR 2002-06% 124
Table 32: 7MM antifungal market key volume and value sales dynamics by region - US, M5EU, Japan, 2002-06 130
Table 33: Top five Antifungal companies by 2006 revenues versus rest of market 131
Table 34: Top five antifungal companies by 2006 revenues versus rest of market 135
Table 35: Novartis SWOT analysis for the antifungals market 137
Table 36: Novartis antifungals portfolio overview, 2002-06 138
Table 37: Pfizer SWOT analysis for the antifungals market 141
Table 38: Pfizer antifungals portfolio overview , 2002-06 142
Table 39: Merck & Co SWOT analysis for the antifungals market 144
Table 40: Merck & Co antifungals portfolio overview, 2002-06 145
Table 41: Johnson & Johnson SWOT analysis for the antifungals market 147
Table 42: Johnson & Johnson antifungals portfolio overview, 2002-06 148
Table 43: Astellas SWOT analysis for the antifungals market 150
Table 44: Astellas Pharma antifungals portfolio overview, 2002-06 151
Table 45: HCV - treatment options, 2007 159
Table 46: HBV - treatment options, 2007 161
Table 47: Populations targeted for influenza vaccination, US, 2003 163
Table 48: Marketed influenza antivirals, 7MM, 2007 163
Table 49: Marketed RSV antiviral 165
Table 50: The human herpesviruses (HHV) fall into three sub-families 166
Table 51: Marketed HSV antivirals, 7MM, 2007 170
Table 52: Marketed VZV antivirals, 7MM, 2007 172
Table 53: Marketed CMV antivirals, 7MM, 2007 173
Table 54: 7MM antiviral sales by subsector - HSV, CMV and similar, hepatitis, respiratory and other molecule sales dynamics by volume and value (%), 2002-06 177
Table 55: Indexed 7MM antivirals market by sector - hepatitis, HSV CMV and similar, respiratory and other antivirals, 2002-06 and CAGR 179
Table 56: 7MM indexed respiratory virus drug sales 2002-06 183
Table 57: 7MM antiviral sales by geographic region, 2002-06 185
Table 58: Top five antiviral companies by 2006 revenues versus rest of market, 2002-06 188
Table 59: Top five antifungal companies by 2006 revenues versus rest of market 191
Table 60: GSK SWOT analysis for the antivirals sector 192
Table 61: GSK antivirals portfolio overview 193
Table 62: Roche SWOT analysis for the antivirals sector 195
Table 63: Roche antivirals portfolio overview, 2002-06 196
Table 64: Ribavirin, interferons and pegylated interferons - milestones in the Schering Plough/Roche HCV battle 200
Table 65: Schering-Plough SWOT analysis for the antivirals sector 203
Table 66: Schering Plough antivirals portfolio overview, 2002-06 204
Table 67: Novartis SWOT analysis for the antivirals sector 206
Table 68: Novartis antivirals portfolio overview, 2002-06 207
Table 69: Gilead SWOT analysis for the antivirals sector 209
Table 70: Gilead antivirals portfolio overview, 2002-06 210
Table 71: Changing drivers of demand in HIV, 2007 217
Table 72: 7MM HIV sales by class and product line composition, 2006 223
Table 73: Regional HIV sales dynamics, 7MM, 2006 225
Table 74: Top five HIV companies by combined revenues versus rest of market, 7MM, 2006 226
Table 75: Top five HIV companies by company revenues versus rest of market, 7MM, 2006 229
Table 76: GSK SWOT analysis for the HIV market 232
Table 77: GSK - HIV portfolio overview, 2007 233
Table 78: Agenerase and Lexiva background 235
Table 79: Gilead SWOT analysis for the HIV market 237
Table 80: Gilead - HIV portfolio overview, 2007 238
Table 81: BMS SWOT analysis for the HIV market 240
Table 82: BMS - HIV portfolio overview, 2007 241
Table 83: Abbott SWOT analysis for the HIV market 242
Table 84: Abbott -HIV portfolio overview, 2007 244
Table 85: Roche SWOT analysis for the HIV market 246
Table 86: Roche - HIV portfolio overview, 2007 247
Table 87: FDCs and original brands - overlaps in market exclusivity and potential revenue extension periods, 2007 252
Table 88: HIV FDCs currently available in India 257
Table 89: Antiviral market subdivisions by molecule 262
Table 90: US antiviral volume and value sales dynamics by therapeutic area 263
Table 91: M5EU antiviral volume and value sales dynamics by therapeutic area 264
Table 92: Japan antiviral volume and value sales dynamics by therapeutic area 265
Table 93: Hepatitis antiviral volume and value sales dynamics by geographic area 266
Table 94: HSV, CMV and similar antivirals volume and value sales dynamics by geographic area 267
Table 95: Respiratory antivirals volume and value sales dynamics by geographic area 268
List of Figures
Figure 1: Key dynamics - Infectious disease versus other key therapeutic sectors, 7MM, 2002-06 20
Figure 2: Infectious disease overview - key volume and value sales dynamics by sector, 7MM, 2002-06 23
Figure 3: Infectious disease overview - market attractiveness by sector, 7MM, 2006 26
Figure 4: Leading original and branded molecule sales versus rest of market, 7MM, 2006 28
Figure 5: Top 10 companies by revenue across the antibiotic, antifungal, antiviral and HIV sectors, 7MM, 2006 33
Figure 6: Top 10 players' infectious disease portfolio characteristics, 7MM, 2006 34
Figure 7: Top 10 company portfolio sector bias across the antibiotic, antifungal, antiviral and HIV sectors, 7MM, 2006 35
Figure 8: Top 10 players - Portfolio bias, performance and market attractiveness, 7MM, 2006 38