Commercial Insight: Antibacterials

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Publication Date: 2005-08-03

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Rapid uptake of products focused on drug-resistant infections, such as Pfizer's Zyvox (linezolid), has been driven by the increasing numbers of immunocompromised patients in hospitals. Despite these pockets of strong growth, the market for antibacterials, valued at $24 billion in the seven major markets, still faces significant revenue loss in the period 2005-2007 due to major patent expiries.

Scope

Highlights epidemiological trends in bacterial infections across the major Western markets

In-depth value analysis per product, class and country, with an assessment of underlying commercial and clinical influencers

Case study analysis of Pfizer's Zmax single dose formulation for respiratory tract infections, including the impact of generic azithromycin

Examines the outlook for branded Rocephin in the key US market discussion of Sandoz, Lupin, and Hospira strategies for generic ceftriaxone

Report Highlights
In 2004 the global antibacterial market was valued at approximately $24 billion with modest growth on 2000 (CAGR 4.4%). The fastest growing classes during this period were the carbapenems and others with notable products such as Pfizer's Zyvox (linezolid).

Although drug resistant infections such as MRSA have been a key focus over recent years, Datamonitor's opinion leader research reveals new concerns with Gram negative organisms such as actineobacter, pseudomonas and ESBL producing strains.

Pfizer's acquisition of Vircuron's dalbavancin and Johnson's and Johnson's investment in both doripenem and ceftobipole brings much need reinvestment to the antibacterial sector and a commitment to combating serious hospital infections.

Reasons to Purchase

Review the clinical and commercial factors driving new product decisions in antibacterials, and the opportunities and threats facing the market

Gain insight into the product lifecycle management strategies of the top antibacterial players through real case study analyses

Understand why 2005 has brought new investment to a previously neglected therapeutic sector

ABOUT DATAMONITOR HEALTHCARE - page 2
- About the Infectious Disease pharmaceutical analysis team - page 2
CHAPTER 1 EXECUTIVE SUMMARY - page 3
- Objective of the analysis - page 3
- Datamonitor insight into the antibacterials market - page 3
CHAPTER 2 MARKET DEFINITION AND OVERVIEW - page 11
- Market definition for this report - page 11
  - ATC classes covered - page 11
  - Classification of pathogens and sites of infection - page 14
    - The hospital versus the community market - page 15
- Current market situation - page 16
  - Despite being highly mature, the antibacterial market is still growing - page 16
  - Injectable antibacterials and those with activity against resistant strains are the main growth drivers - page 18
  - Four classes with sales over $4 billion dominate the antibacterial market - page 20
    - Cephalosporins - page 21
    - Fluoroquinolones - page 23
    - Macrolides and ketolides - page 24
    - Penicillins - page 25
  - The cephalosporins generate the highest sales in terms of value - page 26
    - The penicillins remain the most widely used class - page 29
  - The impact of patent expiry and genericization - page 31
    - While the UK antibacterial market is highly genericized, in Italy, generic incursion represents only 10% of yearly sales - page 31
  - The US is the largest market in terms of value - page 35
  - The antibacterial market is highly segmented - page 37
    - Leading antibacterial products - page 38
    - Leading antibacterial players with sales over $1 billion in 2004 - page 40
- Strategic scoping and focus - page 41
CHAPTER 3 COUNTRY MARKET ASSESSMENTS - page 42
- Current and future opportunities and threats in the antibacterial market - page 42
  - Global opportunities and threats - page 42
    - Opportunities - page 42
    - Threats - page 50
  - US: opportunities and threats - page 58
    - Antibacterial market overview - page 58
    - Opportunities - page 61
    - Threats - page 64
  - Japan: opportunities and threats - page 67
    - Antibacterial market overview: Pacific Rim - page 67
    - Opportunities - page 70
    - Threats - page 74
  - France: opportunities and threats - page 78
    - Antibacterial market overview - page 78
    - Opportunities - page 80
    - Threats - page 83
  - Germany: opportunities and threats - page 85
    - Antibacterial market overview - page 85
    - Opportunities - page 87
    - Threats - page 89
  - Italy: opportunities and threats - page 92
    - Antibacterial market overview - page 92
    - Opportunities - page 94
    - Threats - page 97
  - Spain: opportunities and threats - page 100
    - Antibacterial market overview - page 100
    - Opportunities - page 102
    - Threats - page 104
  - UK: opportunities and threats - page 106
    - Antibacterial market overview - page 106
    - Opportunities - page 108
    - Threats - page 111
- Summary of environmental issues affecting antibacterial market size - page 114
CHAPTER 4 FORECAST ANALYSIS - page 116
- Assumptions and events - page 116
  - Events excluded from the forecast - page 116
  - Product-specific events - page 116
    - Study shows efficacy of Avelox for the treatment of pneumonia in the elderly - page 116
    - Avelox demonstrates faster symptom relief and hospital discharge for pneumonia patients - page 117
    - Study shows Avelox is better than comparators for IAIs - page 118
    - Antibacterial patent expiries - page 118
    - Launch of new drugs with activity against resistant bacterial strains - page 130
  - Country-specific events - page 134
    - US - page 134
    - Japan - page 137
- Limitations of data - page 138
  - Standard units - page 138
  - Japanese market data - page 139
  - Regional launch dates for new products - page 139
- Forecasts - page 139
CHAPTER 5 CASE STUDIES - page 140
- Product lifecycle management strategies can delay or limit generic incursion - page 140
  - Line extension is a popular LCM strategy to minimize generic incursion - page 142
    - Augmentin - generic incursion still driving down sales - page 144
    - Cipro - alliance with a generics manufacturer fails to achieve the desired result - page 151
    - Biaxin - will Biaxin XL withstand generic clarithromycin? - page 159
  - Are line extensions worth the effort? - page 162
  - Zithromax and Zmax - single hope in a single dose? - page 164
    - Zithromax - pending patent expiry - page 166
    - Zithromax - possible revenue scenarios - page 175
  - Rocephin - a giant falls in 2005 - page 177
    - US brand value dominance to disappear - page 179
    - Generic ceftazidime - slow on the uptake - page 185
- Portfolio management of the top antibacterial players - page 187
  - Antibacterial market dynamics - sales trends shift market share - page 188
    - Pfizer is currently market leader - page 188
    - 2005 - a year of change - page 189
  - Antibacterial portfolio analysis - a variety of management tools are being employed - page 191
    - Pfizer - strong presence in the community, niche in the hospital - page 191
    - Is GSK giving up on antibacterials? - page 194
    - Johnson & Johnson - planning ahead - page 197
    - Abbott - an overcast outlook - page 202
    - Roche - it's all about injectables - page 204
- Niche markets: the only money spinners left? - page 207
  - The community treatment market - is there any value left? - page 208
  - Drug-resistance sparks developmental activity - page 212
APPENDIX A - MARKET DATA AND MAJOR BRAND KEY FACTS - page 223
- Definition of the Pacific Rim - page 223
- Global antibacterial market data - page 224
- CEPHALOSPORINS (J1D1, J1D2) market data - page 226
- FLUOROQUINOLONES (J1G1) market data - page 239
- MACROLIDES (J1F0) market data - page 245
- PENICILLINS (J1C1, J1C2, J1H1) market data - page 251
- CARBAPENEMS (J1P2) market data - page 254
- GLYCOPEPTIDES (J1X1) market data - page 258
- AMINOGLYCOSIDES (J1K0) market data - page 260
- TETRACYCLINES (J1A0) market data - page 263
- ALL OTHERS (J1X market data) - page 266
APPENDIX B - page 270
- Bibliography - page 270
  - Journals - page 270
  - Epidemiology - page 271
  - Press releases - page 271
  - Datamonitor - page 273
  - Miscellaneous - page 273
  - Websites - page 274
- Report methodology - page 274
- About Datamonitor - page 275
  - About Datamonitor Healthcare - page 275
  - About the Infectious Disease analysis team - page 276
- Disclaimer - page 277

List of Tables
Table 1: Definition of combined antibacterial classes used throughout the report - page 13
Table 2: Four antibacterial classes with the highest growth between 2000 and 2004, seven major markets - page 19
Table 3: Antibacterial sales across the seven major markets by class, 2000-04 - page 28
Table 4: Sales and growth rates of the top ten branded parenteral cephalosporins across the seven major markets, 2000-04 - page 29
Table 5: Combined annual growth rates (CAGRs) across the seven major antibacterial markets, 2000-04 - page 37
Table 6: Key players in the antibacterial market - page 39
Table 7: Several bestselling drugs are expected to experience patent expiry in the US, 2005-07 - page 51
Table 8: Antibacterial vaccines in advanced clinical development - page 54
Table 9: Antibacterial market in the US by class, 2000-04 - page 59
Table 10: Antibacterial market in the Pacific Rim by class, 2000-04 - page 68
Table 11: The five leading brands in the Pacific Rim were originally developed by Japanese companies - page 70
Table 12: The number of beds in hospitals is significantly higher than in GP clinics, 2001 - page 74
Table 13: Antibacterial market in France by class, 2000-04 - page 78
Table 14: French healthcare funding, 2002 - page 81
Table 15: Antibacterial market in Germany by class, 2000-04 - page 86
Table 16: Antibacterial market in Italy by class, 2000-04 - page 93
Table 17: Number of private and public hospital beds - page 95
Table 18: Drivers and resistors for genericization in the Italian pharmaceutical market - page 99
Table 19: Antibacterial market in Spain by class, 2000-04 - page 101
Table 20: Antibacterial market the UK by class, 2000-04 - page 107
Table 21: Developmental antibacterials in Phase II or higher - page 131
Table 22: Overview of 2004 sales for original brands and their follow-up products in the US - page 143
Table 23: Augmentin, Augmentin ES-600 and Augmentin XR prescription summary - page 145
Table 24: Price per unit for original Augmentin and follow-up products, US, 2000-2004 - page 148
Table 25: Price per unit for branded versus generic amoxicillin/clavulanic acid, in the US, 2004 - page 149
Table 26: Price per standards unit for branded versus generic ciprofloxacin - page 156
Table 27: Despite decreasing sales due to generic incursion, Bayer did not reduce Cipro's price in the US - page 157
Table 28: Cipro and follow-up product sales, US, 2000-04 - page 158
Table 29: Impact of generic incursion following loss of patent protection on brand sales for brands with and without follow-up products - page 162
Table 30: Revenue scenarios for Zithromax, sales for 2005-08 - page 176
Table 31: Major acquisitions by Novartis/Sandoz generics, 2001-05 - page 184
Table 32: Total, infectious disease and antibacterial portfolio performance of the antibacterial market leaders, seven major markets, 2004 - page 190
Table 33: Since it was first approved in the US in 1996, Levaquin has been extensively lifecycle managed through various indication expansions - page 199
Table 34: Price per gram of key hospital and community antibacterials, 2004 - page 212
Table 35: Antibacterial compounds in development for the treatment of drug-resistant bacterial infections - page 214
Table 36: Zyvox is more cost-effective than Synercid - page 219
Table 37: Definition of the Pacific Rim in terms of countries and channels included - page 223
Table 38: Historical sales data used for the forecasts, seven major markets, 2001-04 - page 224
Table 39: Rocephin: key facts - page 226
Table 40: Omnicef: key facts - page 227
Table 41: Fortaz: key facts - page 228
Table 42: Flomox: key facts - page 229
Table 43: Cefzil: key facts - page 230
Table 44: Vantin/Orelox: key facts - page 231
Table 45: Maxipime: key facts - page 232
Table 46: Ceftin/Zinnat: key facts - page 233
Table 47: Spectracef: key facts - page 234
Table 48: Sulperazon: key facts - page 235
Table 49: Suprax: key facts - page 236
Table 50: Pansporin: key facts - page 237
Table 51: Ceclor: key facts - page 238
Table 52: Levaquin/Cravit/Tavanic: key facts - page 239
Table 53: Cipro: key facts - page 240
Table 54: Avelox: key facts - page 242
Table 55: Tequin: key facts - page 243
Table 56: Floxin: key facts - page 244
Table 57: Zithromax: key facts - page 245
Table 58: Biaxin/Klacid/Clarith: key facts - page 247
Table 59: Cleocin: key facts - page 248
Table 60: Ketek: key facts - page 249
Table 61: Erythromycin (molecule): key facts - page 250
Table 62: Augmentin: key facts - page 251
Table 63: Zosyn: key facts - page 252
Table 64: Unasyn: key facts - page 253
Table 65: Primaxin: key facts - page 254
Table 66: Merrem: key facts - page 255
Table 67: Invanz: key facts - page 256
Table 68: Farom: key facts - page 257
Table 69: Vancomycin (molecule): key facts - page 258
Table 70: Targocid: key facts - page 259
Table 71: Tobi: key facts - page 260
Table 72: Gentamicin (molecule): key facts - page 261
Table 73: Habekacin: key facts - page 262
Table 74: Doxycycline hyclate (molecule): key facts - page 263
Table 75: Minocin: key facts - page 264
Table 76: Zyvox: key facts - page 266
Table 77: Pyostacine: key facts - page 267
Table 78: Cubicin: key facts - page 268
Table 79: Synercid: key facts - page 269

List of Figures
Figure 1: Antibacterial sales across the seven major markets by sales and volume use, 2000-04 - page 17
Figure 2: Growth rates of individual antibacterial classes between 2000 and 2004 differed significantly, seven major markets - page 19
Figure 3: Market share of the leading antibacterial classes across the seven major markets, 2004 - page 21
Figure 4: Branded and generic ceftriaxone sales across the seven major markets, 2004 - page 23
Figure 5: Antibacterial sales across the seven major markets by class, 2000-04 - page 27
Figure 6: Antibacterial volume use across the seven major markets by class, 2000-04 - page 30
Figure 7: Parenteral penicillins are the penicillin sub-class least affected by generic incursion across the seven major markets, 2004 - page 31
Figure 8: Genericization across the seven major markets by sales and volume use, 2004 - page 32
Figure 9: Generic sales and volume use across the seven major markets by class, 2004 - page 34
Figure 10: Antibacterial sales across the seven major markets by geographical area, 2000-04 - page 36
Figure 11: Top seven antibacterial players across the seven major markets registering sales over $1 billion, 2004 - page 40
Figure 12: The population in the developed word is aging - page 43
Figure 13: US market shares of leading antibacterial brands by value, 2004 - page 60
Figure 14: Pacific Rim market shares of leading antibacterial brands by value, 2004 - page 69
Figure 15: Contribution of the three key sources to the Japanese healthcare system, 2001 - page 75
Figure 16: France market shares of leading antibacterial brands by value, 2004 - page 79
Figure 17: Germany market shares of leading antibacterial brands by value, 2004 - page 87
Figure 18: Parallel trade in the German antibacterial market, 2004 - page 91
Figure 19: Italy market shares of leading antibacterial brands by value, 2004 - page 94
Figure 20: Spain market shares of leading antibacterial brands by value, 2004 - page 102
Figure 21: UK market shares of leading antibacterial brands by value, 2004 - page 108
Figure 22: Number of MRSA bacteremias reported in England since the introduction off the DoH's mandatory MRSA surveillance system in acute Trusts in England, 2001-05 - page 109
Figure 23: Summary of global and country-specific opportunities and treats - page 115
Figure 24: Antibacterial sales forecasts, 2005-15, and key patent expiries - page 118
Figure 25: In the US, Omnicef is expected to continue growing until the loss of patent protection in 2007 - page 135
Figure 26: Total GSK antibacterial sales, seven major markets, 2000-04 - page 141
Figure 27: Augmentin follow-up products succeeded in reducing but not preventing sales erosion due to generic incursion - page 146
Figure 28: Contributions of the original and the follow-up products to overall Augmentin sales, US, 2002 and 2004 - page 147
Figure 29: Relative sales and volume use of branded and generic amoxicillin/clavulanic acid, 2004 - page 150
Figure 30: Cipro, Cipro XR and Cipro IV sales, 2000-04 - page 153
Figure 31: Cipro's sales in the US declined by 26.7% following the launch of Barr's generic ciprofloxacin - page 155
Figure 32: Sales of branded and generic ciprofloxacin, US, 2002 and 2004 - page 157
Figure 33: US sales for Biaxin and follow-up products, 2000-04 - page 161
Figure 34: Zithromax sales in the US, 2000-04 - page 165
Figure 35: Zithromax product types and approved indications - page 166
Figure 36: ZMax data presented at the 44th ICAAC, 2004 - page 169
Figure 37: Perceived strengths and weaknesses of ZMax - page 174
Figure 38: Zithromax revenue scenarios after patent expiry - page 175
Figure 39: Branded and generic ceftriaxone markets ($m) in 2004 - page 177
Figure 40: Rocephin use by site of infection across the seven major markets (%) - page 178
Figure 41: Regional focus on branded versus unbranded ceftriaxone, 2004 - page 180
Figure 42: Branded and generic ceftazidime markets in terms of sales value, 2004 - page 186
Figure 43: Regional focus on branded versus unbranded ceftazidime, 2004 - page 187
Figure 44: Antibacterial market share for the seven top companies with sales over $1 billion, seven major markets, 2000, 2002 and 2004 - page 188
Figure 45: Antibacterial market share for the seven top companies with sales over $1 billion, seven major markets, 2005, 2010 and 2015 - page 191
Figure 46: Pfizer's antibacterial portfolio, 2005 - page 192
Figure 47: Pfizer's antibacterial portfolio in 2015, leading brands only - page 193
Figure 48: Despite generic sales erosion, Augmentin is still GSK's leading antibacterial - page 195
Figure 49: GSK's antibacterial portfolio, leading drugs - page 196
Figure 50: GSK's antibacterial portfolio in 2015, leading brands only - page 197
Figure 51: The Levaquin (levofloxacin) brand accounted for 99.4% of J&J's antibacterial sales in 2004 in the seven major markets - page 197
Figure 52: J&J's antibacterial portfolio, leading drugs - page 198
Figure 53: Levaquin sales, US, 1999-2004 - page 200
Figure 54: J&J's antibacterial portfolio in 2015, leading brands only - page 201
Figure 55: In the US, Abbott derived 98% of its antibacterial sales from leading products Biaxin and Omnicef in 2004 - page 202
Figure 56: Abbott's antibacterial portfolio, leading drugs - page 203
Figure 57: Abbott's antibacterial portfolio in 2015 - page 204
Figure 58: Roche's antibacterial portfolio, leading drugs - page 205
Figure 59: Roche's lead antibacterial Rocephin is expected to lose two-thirds of its value to generics by 2015 - page 207
Figure 60: Blockbuster sales in each therapy area in 2004, seven major markets - page 208
Figure 61: Ketek sales, seven major markets, 2000-04 - page 209
Figure 62: Ketek forecast, 2005-2015, seven major markets - page 211
Figure 63: Zyvox versus Synercid, seven major markets, 2000-04 - page 218
Figure 64: 2004 sales of leading hospital antibacterials, seven major markets - page 221
Figure 65: Zyvox forecast, 2005-2015, seven major markets - page 221
Figure 66: Early Zyvox website product positioning - page 222

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Commercial Insight: Antibacterials

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