Commercial Insight: Community Antibacterials - Pipelines wither as generic tidal wave takes its toll

CHAPTER 1 EXECUTIVE SUMMARY 3
Strategic scoping and focus 3
Datamonitor insight into the disease market 3
Related reports 5

CHAPTER 2 MARKET DEFINITION 7
Market definition for this report 7
Geographic coverage 7
Defining the community setting 7
Anatomical therapy classes 8

CHAPTER 3 MARKET OVERVIEW 10
Seven major markets 10
Regional variations 19
Opportunities and threats 24
Opportunity 1: Adjusting the financial risks of drug development 25
Opportunity 2: Accommodating alternative business models 27
Opportunity 3: Aim for higher value ground 29
Threat 1: Better opportunities elsewhere - the demise of the community pipeline 32
Threat 2: Increased generic attentions on existing brands 35
US 36
Market assessment 37
Opportunities and threats 45
The Food & Drug Administration 45
Japan 47
Market assessment 47
Opportunities and threats 55
Regulation, tradition and reform 55
Five major European markets (5EU) 56
Market assessment 56
Country variations 64
Opportunities and threats 71
Time to cut back, but how and where? 72
France 75
Current market assessment 75
Germany 83
Current market assessment 83
Italy 91
Current market assessment 91
Spain 99
Current market assessment 99
UK 107
Current market assessment 108

CHAPTER 4 BRAND DYNAMICS 115
Overview of competitive landscape 115
Patient acquisition process 118
Introduction 118
Patient care path 118
Influences on patient behavior 120
Influences on physician behavior 121
US formulary status for leading brands 129
Cephalosporins 131
Cefzon (cefdinir) 132
Drug profile 133
Product positioning 134
Brand forecast to 2017 134
Spectracef (cefditoren pivoxil) 136
Drug profile 136
Product positioning 138
Brand forecast to 2017 138
Maxipime (cefepime) 141
Drug profile 142
Product positioning 143
Brand forecasts to 2017 144
Fluoroquinolones 146
Cravit (levofloxacin) 147
Drug profile 148
Product positioning 149
Brand forecasts to 2017 150
Avelox (moxifloxacin) 153
Drug profile 154
Product positioning 155
Brand forecasts to 2017 156
Macrolides and similars 159
Biaxin (clarithromycin) 160
Drug profile 162
Product positioning 163
Brand forecasts to 2017 164
Ketek (telithromycin) 166
Drug profile 166
Product positioning 167
Brand forecasts to 2017 168
Other classes 170
Cubicin (daptomycin) 171
Drug profile 172
Product positioning 173
Brand forecasts to 2017 174
Primaxin (imipenem and cilastatin) 176
Drug profile 177
Product positioning 178
Brand forecasts to 2017 178
Zyvox (linezolid) 180
Drug profile 181
Product positioning 182
Brand forecasts to 2017 182
Merrem (meropenem) 184
Drug profile 185
Product positioning 186
Brand forecasts to 2017 186
Tazocin (piperacillin and tazobactam) 188
Drug profile 188
Product positioning 190
Brand forecasts to 2017 190

BIBLIOGRAPHY 194
Journal papers 194
Presentations 196
Websites 196
Books 197
Datamonitor reports 198

APPENDIX A - MARKET ASSUMPTIONS 199
Patent expiries 199
Data definitions, limitations and assumptions 199
Standard units 199
Japanese market data 200
Derivation of sales forecasts and pricing trends 202
Forecast methodology 203

APPENDIX B 204
Contributing experts 204
Report methodology 204
About Datamonitor 205
About Datamonitor Healthcare 205
About the Infectious Disease analysis team 206
Disclaimer 207

List of Tables
Table 1: Key events impacting the community antibacterials market, 1991-2019 11
Table 2: Sales forecasts for community antibiotics in the seven major markets ($m), 2007-2017 16
Table 3: Summary of opportunities and threats in the community antibacterials market across the seven major markets, 2007 25
Table 4: Key pathogens targeted by marketed or developmental vaccines, 2008 28
Table 5: Drivers of outpatient parenteral antibiotic therapy use 31
Table 6: New antibacterials approved since 1998 35
Table 7: Community antibacterial class sales dynamics in the US, 2007 and 2017 39
Table 8: Leading branded community antibacterial sales ($m) in the US, 2007-2017 41
Table 9: Sales forecasts for community antibiotics in the US ($m), 2007-2017 42
Table 10: Summary of opportunities and threats in the community antibacterial market in the US, 2007 47
Table 11: Community antibacterial class sales dynamics in Japan, 2007 and 2017 49
Table 12: Leading branded community antibacterial sales ($m) in Japan, 2007-2017 51
Table 13: Sales forecasts for community antibiotics in Japan ($m), 2007-2017 52
Table 14: Summary of opportunities and threats in the community antibacterials market in Japan, 2007 56
Table 15: Community antibacterial class sales dynamics in the 5EU, 2007 and 2017 58
Table 16: Leading branded community antibacterial sales ($m) in the 5EU, 2007-2017 59
Table 17: Sales forecasts for community antibiotics in the 5EU ($m), 2007-2017 61
Table 18: Differences in community sales presence for featured antibacterial products across the 5EU, 2007 64
Table 19: Summary of opportunities and threats in the European market, 2008 74
Table 20: Community antibacterial class sales dynamics in France, 2007 and 2017 77
Table 21: Leading branded community antibacterial sales ($m) in France, 2007-2017 79
Table 22: Sales forecasts for community antibiotics in France ($m), 2007-2017 80
Table 23: Community antibacterial class sales dynamics in Germany, 2007 and 2017 85
Table 24: Leading branded community antibacterial sales ($m) in Germany, 2007-2017 87
Table 25: Sales forecasts for community antibiotics in Germany ($m), 2007-2017 88
Table 26: Community antibacterial class sales dynamics in Italy, 2007 and 2017 93
Table 27: Leading branded community antibacterial sales ($m) in Italy, 2007-2017 95
Table 28: Sales forecasts for community antibiotics in Italy ($m), 2007-2017 96
Table 29: Community antibacterial class sales dynamics in Spain, 2007 and 2017 101
Table 30: Leading branded community antibacterial sales ($m) in Spain, 2007-2017 103
Table 31: Sales forecasts for community antibiotics in Spain ($m), 2007-2017 104
Table 32: Community antibacterial class sales dynamics in the UK, 2007 and 2017 109
Table 33: Leading branded community antibacterial sales ($m) in the UK, 2007-2017 111
Table 34: Sales forecasts for community antibiotics in the UK ($m), 2007-2017 112
Table 35: Leading branded community antibacterial sales ($m) in the seven major markets, 2007-2017 116
Table 36: Representative formulary tier status in the US for leading community antibiotic brands, 2008 130
Table 37: Critical recent cephalosporin patent expiries in the seven major markets, 2008 131
Table 38: Cefzon - drug profile, 2008 133
Table 39: Cefzon sales ($m) in the community antibiotics market by country in the seven major markets, 2007 2017 135
Table 40: Spectracef - drug profile, 2008 137
Table 41: Spectracef sales ($m) in the community antibiotics market by country in the seven major markets, 2007 2017 140
Table 42: Maxipime - drug profile, 2008 142
Table 43: Maxipime sales ($m) in the community antibiotics market by country in the seven major markets, 2007 2017 145
Table 44: Cravit - drug profile, 2008 148
Table 45: Cravit sales ($m) in the community antibiotics market by country in the seven major markets, 2007 2017 152
Table 46: Avelox - drug profile, 2008 154
Table 47: US approved indications for moxifloxacin, ciprofloxacin and levofloxacin 156
Table 48: Avelox sales ($m) in the community antibiotics market by country in the seven major markets, 2007 2017 158
Table 49: Biaxin - drug profile, 2008 162
Table 50: US approved indications for azithromycin and clarithromycin, 2008 164
Table 51: Biaxin sales ($m) in the community antibiotics market by country in the seven major markets, 2007 2017 165
Table 52: Ketek - drug profile, 2008 167
Table 53: Ketek sales ($m) in the community antibiotics market by country in the seven major markets, 2007 2017 169
Table 54: Cubicin - drug profile, 2008 172
Table 55: Cubicin sales ($m) in the community antibiotics market by country in the seven major markets, 2007 2017 175
Table 56: Primaxin - drug profile, 2008 177
Table 57: Primaxin sales ($m) in the community antibiotics market by country in the seven major markets, 2007 2017 179
Table 58: Zyvox - drug profile, 2008 181
Table 59: Zyvox sales ($m) in the community antibiotics market by country in the seven major markets, 2007 2017 183
Table 60: Merrem - drug profile, 2008 185
Table 61: Merrem sales ($m) in the community antibiotics market by country in the seven major markets, 2007 2017 187
Table 62: Tazocin - drug profile, 2008 189
Table 63: Tazocin sales ($m) in the community antibiotics market by country in the seven major markets, 2007 2017 192
Table 64: Patent expiry dates for key community antibiotic brands in the seven major markets, 2007-2016 199
Table 65: Proportion of product used in the retail environment by volume in the US and 5EU, 2003 07 201
Table 66: Proportion of product used in the retail environment by value in the US and 5EU, 2003 07 202

List of Figures
Figure 1: Defining the community setting - acquisition, onset and treatment 8
Figure 2: Community antibiotic sales ($ billion) by class in the seven major markets, 2003 2017 13
Figure 3: Regional variations in antibiotic value sales by drug class/category and region in the US, Japan and 5EU, 2007 19
Figure 4: Regional variations in antibiotic volume sales by drug class/category and region in the US, Japan and 5EU, 2007 20
Figure 5: Regional variations in antibiotic value sales per capita by drug class/category and region in the US, Japan and 5EU, 2007 21
Figure 6: Regional variations in antibiotic volume sales per capita by drug class/category and region in the US, Japan and 5EU, 2007 22
Figure 7: Regional variations in antibiotic value sales per capita, branded versus generic product averages, 2007 23
Figure 8: Regional variations in antibiotic volume sales per capita, branded versus generic product averages, 2007 24
Figure 9: Incentives for antibacterial investment 26
Figure 10: Antibacterial drug approvals in the US, 1983 2008 34
Figure 11: Timeline of antibiotic class discovery, 1930s 2000s 34
Figure 12: Community antibacterial class sales dynamics in the US, 2007 and 2017 37
Figure 13: Leading branded community antibacterial sales, other brands and generics ($m) in the US, 2007-2017 40
Figure 14: Community antibacterial class sales dynamics in Japan, 2007 and 2017 48
Figure 15: Leading branded community antibacterial sales, other brands and generics ($m) Japan, 2007-2017 50
Figure 16: Community antibacterial class sales dynamics in the 5EU, 2007 and 2017 57
Figure 17: Leading branded community antibacterial sales, other brands and generics ($m) in the 5EU, 2007-2017 60
Figure 18: Country level variations in antibiotic value sales by drug class/category in the 5EU, 2007 65
Figure 19: Country level variations in antibiotic value sales by drug class/category in the 5EU, 2007 66
Figure 20: Country level variations in antibiotic value sales per capita by drug class/category and region in the 5EU, 2007 68
Figure 21: Country level variations in antibiotic volume sales per capita by drug class/category and region in the 5EU, 2007 69
Figure 22: Country level variations in antibiotic value sales per capita, branded versus generic product averages in the 5EU, 2007 70
Figure 23: Country level variations in antibiotic volume sales per capita, branded versus generic product averages in the 5EU, 2007 71
Figure 24: Community antibacterial class sales dynamics in France, 2007 and 2017 76
Figure 25: Leading branded community antibacterial sales, other brands and generics ($m) in France, 2007-2017 78
Figure 26: Community antibacterial class sales dynamics in Germany, 2007 and 2017 84
Figure 27: Leading branded community antibacterial sales, other brands and generics ($m) in Germany, 2007-2017 86
Figure 28: Community antibacterial class sales dynamics in Italy, 2007 and 2017 92
Figure 29: Leading branded community antibacterial sales, other brands and generics ($m) in Italy, 2007-2017 94
Figure 30: Community antibacterial class sales dynamics in Spain, 2007 and 2017 100
Figure 31: Leading branded community antibacterial sales, other brands and generics ($m) in Spain, 2007-2017 102
Figure 32: Community antibacterial class sales dynamics in the UK, 2007 and 2017 108
Figure 33: Leading branded community antibacterial sales, other brands and generics ($m) in the UK, 2007-2017 110
Figure 34: Leading branded community antibacterial sales ($m) in the seven major markets, 2003-07 117
Figure 35: Leading branded community antibacterial sales ($m) in the seven major markets, 2007-2017 117
Figure 36: Patient care pathways in community bacterial infections, 2008 119
Figure 37: Correlations between antibacterial consumption and resistance 125
Figure 38: Site of infection, source of infection and antibiotic choices 128
Figure 39: Community antibiotic sales ($m) of key branded and generic cephalosporins in the seven major markets, 2003 2017 132
Figure 40: Cefzon sales ($m) in the community antibiotics market by country in the seven major markets, 2007 2017 136
Figure 41: Spectracef sales ($m) in the community antibiotics market by country in the seven major markets, 2007 2017 141
Figure 42: Maxipime sales ($m) in the community antibiotics market by country in the seven major markets, 2007 2017 146
Figure 43: Community antibiotic sales ($m) of key branded and generic fluoroquinolones in the seven major markets, 2003 2017 147
Figure 44: Cravit sales ($m) in the community antibiotics market by country in the seven major markets, 2007 2017 153
Figure 45: Avelox sales ($m) in the community antibiotics market by country in the seven major markets, 2007 2017 159
Figure 46: Community antibiotic sales ($m) of key branded and generic macrolides and similar antibiotics in the seven major markets, 2003 2017 160
Figure 47: Biaxin sales ($m) in the community antibiotics market by country in the seven major markets, 2007 2017 166
Figure 48: Ketek sales ($m) in the community antibiotics market by country in the seven major markets, 2007 2017 170
Figure 49: Community antibiotic sales ($m) of key branded and generic antibiotics from other classes in the seven major markets, 2003 2017 171
Figure 50: Cubicin sales ($m) in the community antibiotics market by country in the seven major markets, 2007 2017 176
Figure 51: Primaxin sales ($m) in the community antibiotics market by country in the seven major markets, 2007 2017 180
Figure 52: Zyvox sales ($m) in the community antibiotics market by country in the seven major markets, 2007 2017 184
Figure 53: Merrem sales ($m) in the community antibiotics market by country in the seven major markets, 2007 2017 188
Figure 54: Tazocin sales ($m) in the community antibiotics market by country in the seven major markets, 2007 2017 193