Report: Commercial Insight: Antibacterials - Regulations, Resistance & Generics TOC

TABLE OF CONTENTS ==================

ABOUT DATAMONITOR HEALTHCARE

About the Infectious Diseases pharmaceutical analysis team

CHAPTER 1 EXECUTIVE SUMMARY

Objective of the analysis
Datamonitor insight into the antibacterials market

CHAPTER 2 MARKET DEFINITION AND OVERVIEW

Market definition for this report
Current market situation

Limited growth driven by price increases
The US is the key market
Hospital growth is more rapid than community
Four classes dominate antibacterials sector
Generic products limit market growth
Highly segmented market with niche opportunities

Strategic scoping and focus

CHAPTER 3 COUNTRY MARKET ASSESSMENTS

Current and future opportunities and threats in the antibacterials market

Global opportunities and threats

Opportunities
Threats

US: opportunities and threats

Antibacterial market overview
Opportunities
Threats

Japan: opportunities and threats

Antibacterial market overview
Opportunities
Threats

France: opportunities and threats

Antibacterial market overview
Threats

Germany: opportunities and threats

Antibacterial market overview
Opportunities
Threats

Italy: opportunities and threats

Antibacterial market overview
Opportunities
Threats

Spain: opportunities and threats

Opportunities
Threats

UK: opportunities and threats

Antibacterial market overview
Opportunities
Threats

Summary of environmental issues affecting antibacterial market size

CHAPTER 4 FORECAST ANALYSIS

Assumptions and events

Market events

Changing age structure of key markets
Patent expiries
Watchful waiting paradigm

Macrolide events

Ketek in Japan
US launch of Ketek (2004)
Trial results boost uptake of Ketek
Zithromax approved for once daily 3 day ABS therapy
Discontinuation of Zithromax 500mg tablets (x3) in the UK

Cephalosporin events

Continued impact of Japanese launch of Rocephin 1g bag
Basilea lose Roche as partner for BAL5788
Omnicef recommended for acute bacterial sinusitis
Flomox sales do not meet expectation in Japan
Increased generic competition limits Ceftin sales

Penicillin events

Novartis and GSK settle over Augmentin dispute
Strawberry flavor Augmentin recaptures market share
Generics firms expand formulations of Augmentin copies
Augmentin ES better than Zithromax in AOM

Carbapenem events

Uptake of Merrem in meningococcal and purulent meningitis
Merrem warning and application for cSSTIs

Fluoroquinolone events

Impact of Cipro patent expiry (2004+)
Continued uptake of Cipro XR
Reddys launch 100mg ciprofloxacin in the US
Cystitis study boosts uptake of ciprofloxacin
Levaquin gains mild CAP indication
Generic levofloxacin gains tentative approval
Avelox gains indication for multi-drug resistant S. pneumoniae
Avelox patent secure to 2014
Avelox shows efficacy in AECB
Avelox beats levofloxacin resistant strains
Gatifloxacin competes for acute otitis media indication

Other class events

Trials demonstrate Zyvox benefits
Synercid may support vancomycin therapy
Tobramycin for injection re-launched
TOBI foundation

Pipeline product launches

Limitations of data

Standard units
Japanese market data
Regional launch dates for new products

Forecasts

CHAPTER 5 COMMERCIAL IMPACT AND LIFECYCLE MANAGEMENT: CASE STUDIES

Introduction
Case studies

Follow-up products - worth the investment?

Augmentin, Augmentin XR and Augmentin ES
Cipro and Cipro XR
Biaxin and Biaxin XL
Insight and recommendations

Line extensions - driving sales growth

New indications, new patient targets
New formulations allow access to new patient groups

Complete product management - improving Zosyns performance

Driving sales growth - Wyeths strategies

APPENDIX A - MARKET DATA AND MAJOR BRAND KEY FACTS

Global antibacterial market data
Aminoglycosides market data
Carbapenems market data
Cephalosporins market data
Fluoroquinolones market data
Glycopeptides market data
Macrolides market data
Others market data
Penicillins market data
Tetracylines market data

APPENDIX B

Bibliography
Report methodology
About Datamonitor

About Datamonitor Healthcare
About the Infectious Diseases analysis team
Key therapy team members
John Savopoulos, Lead Analyst, Infectious Diseases
Contact details: tel. +44 20 7675 7615, email jsavopoulos@datamonitor.comDisclaimer
Disclaimer

List of Tables

Table 1: Antibacterial sales across the seven major markets by class, 1999-2003
Table 2: Key players in the antibacterial market
Table 3: Antibacterial sales in the US by class, 1999-2003
Table 4: Antibacterial sales in Japan by class, 2000-2003
Table 5: Breakdown of primary and secondary care facilities in Japan, 2001
Table 6: Antibacterial sales in France by class, 1999-2003
Table 7: Antibacterial sales in Germany by class, 1999-2003
Table 8: Antibacterial sales in Italy by class, 1999-2003
Table 9: Antibacterial sales in Spain by class, 1999-2003
Table 10: Antibacterial sales in the UK by class, 1999-2003
Table 11: Oral antibiotics and indications considered suitable for nurse prescribing, UK 2004
Table 12: Impact of changes in age breakdown on community antibacterial prescriptions in the US, 2003-2010
Table 13: Impact of changes in age breakdown on community antibacterial prescriptions in Spain, 2003-2010
Table 14: Impact of changes in age breakdown on community antibacterial prescriptions in Japan, 2003-2010
Table 15: Key patent expiries assessed in the country specific forecasts
Table 16: Patent expiry models used in the country-specific forecasts
Table 17: Comparator model used to assess impact of patent expiry
Table 18: R&D pipeline in antibacterials, December 2003
Table 19: Expert opinion regarding late-phase antibacterials
Table 20: Sales revenue ($) per standard unit of amoxicillin-clavulanic acid products in the US, 1999-2003
Table 21: Comparison of the cost of Augmentin and Augmentin ES in the management of otitis media in the US, 2003
Table 22: Comparison of the cost of Augmentin and Augmentin XR in the management of community-acquired pneumonia in the US, 2003
Table 23: Sales revenue ($) per standard unit for ciprofloxacin products in the US, 1999-2003
Table 24: Cost comparison of Cipro and Cipro XR in the management of uncomplicated and complicated urinary tract infections, US 2003
Table 25: Cost comparison of Biaxin and Biaxin XL in the treatment of AECB, AMS and CAP, US 2003
Table 26: Zosyn key event screen
Table 27: Historical sales data used for the forecasts, seven major markets 2000-2003 ($m)
Table 28: TOBI: key facts
Table 29: Zienam: key facts
Table 30: Merrem: key facts
Table 31: Invanz: key facts
Table 32: Farom: key facts
Table 33: Rocephin: key facts
Table 34: Cefzil: key facts
Table 35: Omnicef/Cefzon: key facts
Table 36: Flomox: key facts
Table 37: Fortum: key facts
Table 38: Maxipime: key facts
Table 39: Zinnat: key facts
Table 40: Levaquin/Cravit/Tavanic: key facts
Table 41: Ciproxin: key facts
Table42: Ciprofloxacin Barr: key facts
Table 43: Avelox: key facts
Table 44: Tequin: key facts
Table 45: Targocid: key facts
Table 46: Vancocin: key facts
Table 47: Zithromax: key facts
Table 48: Biaxin/Klacid/Clarith: key facts
Table 49: Dalacin C: key facts
Table 50: Erythrocin: key facts
Table 51: Ketek: key facts
Table 52: Zyvox: key facts
Table 53: Synercid: key facts
Table 54: Augmentin: key facts
Table 55: Novartis generic Augmentin: key facts
Table 56: Tevas generic Augmentin key facts
Table 57: Tazocin: key facts
Table 58: Unasyn: key facts
Table 59: Dynacin (generic Minocin): key facts
Table 60: Doryx: key facts

List of Figures

Figure 1: Antibacterial sales across the seven major markets, 1999-2003
Figure 2: Antibacterial volume use across the US and EU5, 1999-2003
Figure 3: Antibacterial sales across the seven major markets by region, 1999-2003
Figure 4: Antibacterial sales by sector across the US and EU5, 1999-2003
Figure 5: Antibacterial sales across the seven major markets by class, 1999-2003
Figure 6: Generic incursion in the antibacterial field, seven major markets 1999-2003
Figure 7: Antibacterial generic incursion by class across the US and EU, 2003
Figure 8: Proportion of population over the age of 65, 1991 and 2000
Figure 9: Proportion of antibacterial value attributable to the over 65s, US drugstores 2003
Figure 10: Antibacterial prescriptions per capita by key age-group, US Drugstores 2003
Figure 11: Streptococcus pneumoniae susceptibility to leading antibacterials, seven major markets, 2003
Figure 12: The development of resistance can lead to premature sales erosion
Figure 13: Leading antibacterial products in the US, 2003
Figure 14: Generic incursion in the US antibacterial sector, 1999-2003
Figure 15: Leading antibacterial brands in Japan, 2003
Figure 16: Leading antibacterial brands in France, 2003
Figure 17: Leading antibacterial brands in Germany, 2003
Figure 18: Leading antibacterial brands in Italy, 2003
Figure 19: Leading antibacterial brands in Spain, 2003
Figure 20: Leading antibacterial brands in the UK, 2003
Figure 21: Securing nurse formulary status will become more important as more surgeries implement triage style systems
Figure 22: Summary of regional opportunities and threats
Figure 23: Quarterly Omnicef sales in the US, 1999-2003
Figure 24: Quarterly US sales performance of Cipro, Cipro XR and generic ciprofloxacin tablets, 2002-2003
Figure 25: Clinical cure rates for uncomplicated cystitis, treated with ciprofloxacin and amoxicillin-clavulanate
Figure 26: Avelox sales in the US by sector, 1999-2003
Figure 27: Global Augmentin sales by quarter, Q1 2001 - Q1 2004
Figure 28: Sales and volume use of Augmentin, Augmentin ES and Augmentin XR in the US, 1999-2003
Figure 29: Amoxicillin-clavulanate sales in the US by product, 2001-2003
Figure 30: Estimated impact of Augmentin XR and Augmentin ES on maintaining brand share
Figure 31: Promotional spend for amoxicillin-clavulanate products in the US, 1999-2003
Figure 32: US sales of Cipro and Cipro XR, 2002-03
Figure 33: Estimated impact of Cipro XR on maintaining market share
Figure 34: Proportion of ciprofloxacin prescriptions for key indications, US drugstores 2003
Figure 35: US retail promotional spend for Cipro and Cipro XR, 1999-2003
Figure 36: US sales of Biaxin and Biaxin XL, 1999- 2003
Figure 37: Volume use of Biaxin and Biaxin XL in the US, 1999-2003
Figure 38: Infectious Diseases Society of America treatment guidelines for CAP, 2003
Figure 39: Continued indication expansion has helped to maintain Levaquins sales growth in the US
Figure 40: Prescriptions of Levaquin by indication, US Drugstores 2001-2003
Figure 41: New indications and new formulations help to boost Avelox sales in the US
Figure 42: Prescriptions of Avelox by indication, US Drugstores 2001-2003
Figure 43: Quarterly promotional spend and sales of Levaquin and Avelox in the US community, 1999-2003
Figure 44: Promotional effectiveness of Levaquin and Avelox in the US community, 1999-2003
Figure 45: IV formulation of Avelox boosts hospital sales of oral formulation in the US, 2001-2003
Figure 46: IV formulation drives hospital use of all Tequin formulations, US 1999-2003
Figure 47: US Drugstore sales and prescriptions of Omnicef by age group, 2003
Figure 48: Omnicef prescriptions in the 0-9 age-group by formulation, US drugstores 2003
Figure 49: Global Zosyn sales, 1995-2002
Figure 50: Zosyn sales growth, 1993-2002
Figure 51: Quarterly sales of Zosyn (Tazocin) in the EU & Pacific Rim, 1998-2001
Figure 52: Quarterly sales of Zosyn in the US, 1998-2001
Figure 53: Quarterly sales in selected new Zosyn (Tazocin) markets, 1998-2001