CHAPTER 1 EXECUTIVE SUMMARY

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Scope of the analysis

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Datamonitor insight into the hospital antibacterial market

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Across the seven major markets the hospital antibacterial market is currently valued at $6.4 billion, representing approximately 30% of total antibacterial sales. Of these sales, $1.2 billion (25%) are attributable to the treatment of respiratory tract infections, a figure that will rise to $2.0 billion (28%) by 2008 (CAGR 2002-2008 6.2%);

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Increasing drug resistance in the hospital environment creates demand for novel more effective drug classes. However, restrictions on the use of such specialist products might equate to lower overall hospital sales. Datamonitor estimates that sales of Pfizer’s Zyvox and Monarch’s Synercid across the seven major markets reached only $133m and $51m, in 2002.

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The responsibility, care and treatment of hospital patients is increasingly being shared between varieties of health professionals. As a result, companies marketing antibacterials may need to re-evaluate promotional strategy to incorporate a selection of physicians, pharmacists and microbiologists, while also taking into account regional and sector variations.

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Historically, portfolio success within the hospital antibacterial sector has been achieved with one or two broad-spectrum products. Current drivers may increase the incentive to develop portfolios of multiple narrow spectrum products. In particular, smaller companies with expertise in target driven research and development may benefit from the reduced costs associated with smaller clinical trials.

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Summary

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Key metrics

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CHAPTER 2 HOSPITAL MARKET CONDITIONS

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Introduction

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Hospital-treated infections – patient composition

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Hospital-acquired infections

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Community-acquired infections treated in the hospital

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Hospital units

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Emergency room

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Specialist wards

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Drug resistance

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Resistance control measures

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The MRSA challenge

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Infection control

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Cost containment

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Generic competition

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CHAPTER 3 DRIVERS OF PRESCRIPTION CHOICE

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Decision makers

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Hospital physicians

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Interactions between decision makers

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Laboratory staff

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Pharmacists

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Interaction in the prescribing process

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Regulation and guidance

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Licensed indications

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Treatment guidelines

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Resistance issues

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Off-label use

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Regulatory control

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Product characteristics

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Targeted versus broad

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Cost of therapy

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Generic versus brand

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Promotional information

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CHAPTER 4 MARKET ANALYSIS

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Introduction

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Global market overview

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Product analyses

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Drivers of product switching

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Product profiles

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CHAPTER 5 STRATEGIC FOCUS

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Introduction

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Product costs and pricing

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Cost containment and pharmacoeconomics

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Cost of therapy

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Reimbursement & formulary inclusion

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Product characteristics

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Resistance issues

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Product attributes

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Product positioning

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Product promotion and marketing

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Portfolio composition

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Broad versus narrow spectrum

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Portfolio focus versus diversification

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Contributing experts

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List of tables

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List of figures

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Bibliography

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Physician research methodology

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Physician Sample breakdown

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US

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Japan

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France

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Germany

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Italy

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Spain

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UK

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Key Opinion Leader Interview - US 1

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Key Opinion Leader Interview – US 2

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Key Opinion Leader Interview – US 3

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Key Opinion Leader Interview – US 4

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Key Opinion Leader Interview – US 5

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Key Opinion Leader Interview – Germany 1

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Key Opinion Leader Interview – Germany 2

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Key Opinion Leader Interview – Germany 3

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Key Opinion Leader Interview – UK 1

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Key Opinion Leader Interview – UK 2

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Key Opinion Leader Interviews – Italy 1

242

Key Opinion Leader Interview – France 1

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Key Opinion Leader Interview – France 2

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Key Opinion Leader Interviews – France 3

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Key Opinion Leader Interview – Spain 1

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Key Opinion Leader Interviews – Pharmacist (UK) 1

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Key Opinion Leader Interviews – Pharmacist (US) 2

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SECTION 1:

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SECTION 2:

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Section 3:

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About Datamonitor

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About Datamonitor Healthcare

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Datamonitor Healthcare’s research and analysis methodologies

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Datamonitor Healthcare’s therapy area capabilities

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About the infectious disease analysis team

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Datamonitor Healthcare’s Consulting expertise

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Key therapy team members

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Disclaimer

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List of Tables

Table 1: Hospital antibacterial sales by site of infection, 2002 & 2008

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Table 2: Changing susceptibility of bacterial pathogens to key antibiotics, 1994–2000

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Table 3: Percentage of nosocomial pathogens resistant to key hospital antibacterials

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Table 4: Key patent expiries in antibacterials to 2007

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Table 5: Indications by site of infection

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Table 6: Indications by pathogens for the 10 products included in this study

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Table 7: Price per gram of selected hospital antibacterials in the UK

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Table 8: Cost of treatment with Cipro IV and oral Cipro in the UK

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Table 9: Ontario Drug Benefit (ODB) formulary: major listing changes effective March 2001

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Table 10: Leading companies and their marketed hospital antibacterial portfolios

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Table 11: Product use by site of infection in the US (%)

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Table 12: Product use by site of infection in Japan (%)

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Table 13: Product use by site of infection in Germany (%)

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Table 14: Product use by site of infection in France (%)

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Table 15: Product use by site of infection in Italy (%)

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Table 16: Product use by site of infection in Spain (%)

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Table 17: Product use by site of infection in the UK (%)

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Table 18: BTS treatment guidelines for community-acquired pneumonia in adults in the UK

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Table 19: ERS treatment guidelines for community-acquired pneumonia in adults in the EU

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Table 20: IDSA guidelines for the empiric treatment of CAP in adults

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Table 21: Overall cost of BTS recommended CAP treatment regimes in the UK

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Table 22: Overall cost of ERS recommended CAP treatment regimes in the EU

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Table 23: Cost per gram of selected antibacterial products

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Table 24: US physician sample breakdown, 2002

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Table 25: Japan physician sample breakdown, 2002

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Table 26: France physician sample breakdown, 2002

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Table 27: Germany physician sample breakdown, 2002

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Table 28: Italy physician sample breakdown, 2002

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Table 29: Spain physician sample breakdown, 2002

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Table 30: UK physician sample breakdown, 2002

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List of Figures

Figure 1: Clinical and commercial drivers of broad versus narrow spectrum antibacterial therapy

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Figure 2: Hospital antibacterial sales by region and key products, 2002

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Figure 3: Treatment dynamics for bacterial infections

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Figure 4: Changes in incidence of nosocomial infection

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Figure 5: Mean additional hospital costs associated with nosocomial infections in the UK, by site of infection

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Figure 6: Mean additional hospital costs associated with nosocomial infections in the UK, by admission specialty

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Figure 7: Hospital treatment of community-acquired infections

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Figure 8: Level of implementation of infection control measures across the seven major markets, 2003

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Figure 9: Perceived effectiveness of infection control measures across the seven major markets, 2003

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Figure 10: Total expenditure on healthcare per capita in the seven major markets (US$/PPP*), 1995–2001

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Figure 11: Pharmaceutical expenditure as a proportion of total healthcare costs across the seven major markets, 1995–2001

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Figure 12: Expenditure on in-patient care across the seven major markets (% of total healthcare spend), 1995–2001

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Figure 13: Number of acute care beds across the seven major markets (per 1,000 population), 1995–2001

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Figure 14: Impact of cost pressures on antibacterial prescription decisions across the seven major markets, 2003

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Figure 15: Impact of cost pressures on antibacterial prescription decisions across hospital wards, 2003

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Figure 16: Physician perception of availability of generic equivalents across the seven major markets

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Figure 17: Interaction between hospital staff in the antibacterial prescription process

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Figure 18: UK treatment guidelines hierarchy

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Figure 19: The percentage product use for non-approved indications in the seven major markets

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Figure 20: Factors driving prescription choice across the seven major markets, 2003

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Figure 21: Changing antibiotic treatment paradigms in the seriously ill

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Figure 22: Most physicians would select potent broad spectrum therapy where patients are high risk

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Figure 23: Physician awareness of the relative costs of different antibacterial classes across the seven major markets, 2003

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Figure 24: Average price per gram of leading product in each class across the seven major markets, 2003

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Figure 25: Personnel determining the generic/brand prescription decision

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Figure 26: Geographical variation in personnel determining generic/brand decisions.

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Figure 27: Variation in personnel determining generic/brand decisions, across hospital wards.

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Figure 28: Factors affecting the generic/brand prescription choice across the seven major markets

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Figure 29: Impact of promotional information on prescription choice across the seven major markets

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Figure 30: Impact of promotional information on prescription choice of 10 key hospital antibacterials

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Figure 31: Total hospital antibacterial sales for 10 key products by site of infection in the seven markets, 2002

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Figure 32: Total hospital antibacterial sales by site of infection and by country in the seven markets, 2002

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Figure 33: Importance of efficacy on prescription decisions across the seven major markets, 2003

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Figure 34: Factors driving physician switching across the seven major markets, 2003

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Figure 35: Rocephin use by site of infection across the seven major markets (%)

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Figure 36: Rocephin sales by site of infection in the seven markets, 2002

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Figure 37: Fortum use by site of infection across the seven major markets (%)

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Figure 38: Fortum sales by site of infection in the seven markets, 2002

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Figure 39: Cipro use by site of infection across the seven major markets (%)

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Figure 40: Cipro sales by site of infection in the seven markets, 2002

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Figure 41: Levaquin use by site of infection across the seven major markets (%)

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Figure 42: Levaquin sales by site of infection in the seven markets, 2002

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Figure 43: Ketek use by site of infection in Italy and Spain (%)

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Figure 44: Ketek sales by site of infection in the seven markets, 2002

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Figure 45: Augmentin use by site of infection across the seven major markets (%)

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Figure 46: Augmentin sales by site of infection in the seven markets, 2002

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Figure 47: Primaxin use by site of infection across the seven major markets (%)

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Figure 48: Primaxin sales by site of infection in the seven markets, 2002

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Figure 49: Vancocin use by site of infection across the seven major markets (%)

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Figure 50: Vancocin sales by site of infection in the seven markets, 2002

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Figure 51: Zyvox use by site of infection in the UK, the US and Italy (%)

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Figure 52: Zyvox sales by site of infection in the seven markets, 2002

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Figure 53: Synercid use by site of infection in France, Italy and Germany (%)

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Figure 54: Synercid sales by site of infection in the seven markets, 2002

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Figure 55: Cost per gram of selected antibacterial products used in the treatment of CAP

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Figure 56: Minimum and maximum costs incurred in the treatment of non-severe CAP in the hospital as recommended by national guidelines

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Figure 57: Minimum and maximum costs incurred in the treatment of severe CAP in the hospital as recommended by national guidelines

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Figure 58: CAP decision tree

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Figure 59: IV/oral step down treatment for CAP

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Figure 60: Factors in the antibacterial reimbursement process

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Figure 61: Typical antibacterial prescription process for restricted products

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Figure 62: Factors driving use of broad and narrow spectrum therapies

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Figure 63: The impact of resistance on physician prescription decisions

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Figure 64: Differences in patient and product requirements in hospital wards

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Figure 65: Physician perception of how to improve marketing campaigns across the seven major markets

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Figure 66: Physician perception of how to improve marketing campaigns across different hospital units

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Figure 67: Information networks associated with the treatment of bacterial infections

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Figure 68: Datamonitor’s Healthcare Consultancy

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Figure 69: Datamonitor Healthcare’s Therapeutic Consulting capabilities