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

ABOUT DATAMONITOR HEALTHCARE 2

About the Infectious Diseases and Respiratory pharmaceutical analysis team 2

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