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Commercial Insight: Antibacterials - Regulations, Resistance & Generics


Description: Antibacterial players are currently facing significant hurdles in terms of increasing and maintaining product revenue. These include growing resistance across classes, greater restrictions relating to the use of antibacterials and an expected increase in generic competition following the expiry of a number of key patents in the next 2-3 years. Scope of report: In-depth analysis of country-specific environmental factors that affect the performance of antibacterial products Review of recent and expected product specific events and other aspects that will impact sales of leading products Country-specific sales forecasts to 2014 of leading brands and classes, for each for the seven major markets Detailed case-study analysis of life-cycle management strategies such as follow-up products and reformulations Highlights: Increased regulatory scrutiny, drug resistance and generic competition have placed greater pressure on antibacterial profit margins. This explains the lack of significant activity in the current antibacterial pipeline. We predict that, by 2014, pipeline compounds will only account for 10.9% of total antibacterial revenue. Regulatory scrutiny and pharmacovigilance responsibilities are becoming ever more intense. Key players should support initiatives aimed at easing product approval processes and should also tighten compliance practices throughout their businesses in order to reduce the risk of heavy fines and reductions to ROI. Novel formulations can allow access to additional market segments while even minor clinical advantages can drive uptake of follow-ups, provided they are accompanied by improvements in cost-efficiency. We believe that key players will need to increase their focus on such activities in order to maintain their market position. Reasons to Purchase: Quantify future size and scope of the antibacterial market and potential for new products Understand key drivers and predict the future performance of key compounds Evaluate a range of lifecycle-management strategies to combat the threat of generic incursion


Contents: CHAPTER 1 EXECUTIVE SUMMARY 3 Objective of the analysis 3 Insight into the antibacterials market 3 CHAPTER 2 MARKET DEFINITION AND OVERVIEW 11 Market definition for this report 11 Current market situation 12 Limited growth driven by price increases 12 The US is the key market 13 Hospital growth is more rapid than community 14 Four classes dominate antibacterials sector 16 Generic products limit market growth 18 Highly segmented market with niche opportunities 21 Strategic scoping and focus 22 CHAPTER 3 COUNTRY MARKET ASSESSMENTS 24 Current and future opportunities and threats in the antibacterials market 24 Global opportunities and threats 24 Opportunities 24 Threats 34 US: opportunities and threats 36 Antibacterial market overview 36 Opportunities 37 Threats 41 Japan: opportunities and threats 46 Antibacterial market overview 46 Opportunities 47 Threats 52 France: opportunities and threats 54 Antibacterial market overview 54 Threats 55 Germany: opportunities and threats 58 Antibacterial market overview 58 Opportunities 60 Threats 61 Italy: opportunities and threats 64 Antibacterial market overview 64 Opportunities 66 Threats 67 Spain: opportunities and threats 71 Opportunities 73 Threats 73 UK: opportunities and threats 74 Antibacterial market overview 74 Opportunities 76 Threats 81 Summary of environmental issues affecting antibacterial market size 85 CHAPTER 4 FORECAST ANALYSIS 86 Assumptions and events 86 Market events 86 Changing age structure of key markets 86 Patent expiries 88 ‘Watchful waiting’ paradigm 92 Macrolide events 94 Ketek in Japan 94 US launch of Ketek (2004) 94 Trial results boost uptake of Ketek 96 Zithromax approved for once daily 3 day ABS therapy 97 Discontinuation of Zithromax 500mg tablets (x3)in the UK 97 Cephalosporin events 98 Continued impact of Japanese launch of Rocephin 1g bag 98 Basilea lose Roche as partner for BAL5788 98 Omnicef recommended for acute bacterial sinusitis 99 Flomox sales do not meet expectation in Japan 100 Increased generic competition limits Ceftin sales 100 Penicillin events 100 Novartis and GSK settle over Augmentin dispute 100 Strawberry flavor Augmentin recaptures market share 100 Generics firms expand formulations of Augmentin copies 101 Augmentin ES better than Zithromax in AOM 101 Carbapenem events 101 Uptake of Merrem in meningococcal and purulent meningitis 101 Merrem warning and application for cSSTIs 102 Fluoroquinolone events 102 Impact of Cipro patent expiry (2004+) 102 Continued uptake of Cipro XR 103 Reddy’s launch 100mg ciprofloxacin in the US 105 Cystitis study boosts uptake of ciprofloxacin 106 Levaquin gains mild CAP indication 106 Generic levofloxacin gains tentative approval 108 Avelox gains indication for multi-drug resistant S. pneumoniae 108 Avelox patent secure to 2014 110 Avelox shows efficacy in AECB 110 Avelox beats levofloxacin resistant strains 112 Gatifloxacin competes for acute otitis media indication 112 Other class events 113 Trials demonstrate Zyvox benefits 113 Synercid may support vancomycin therapy 114 Tobramycin for injection re-launched 116 TOBI foundation 117 Pipeline product launches 117 Limitations of data 120 Standard units 120 Japanese market data 120 Regional launch dates for new products 121 Forecasts 121 CHAPTER 5 COMMERCIAL IMPACT AND LIFECYCLE MANAGEMENT: CASE STUDIES 122 Introduction 122 Case studies 122 Follow-up products - worth the investment? 122 Augmentin, Augmentin XR and Augmentin ES 123 Cipro and Cipro XR 131 Biaxin and Biaxin XL 136 Insight and recommendations 141 Line extensions - driving sales growth 141 New indications, new patient targets 142 New formulations allow access to new patient groups 150 Complete product management – improving Zosyn’s performance 154 Driving sales growth – Wyeth’s strategies 156 APPENDIX A – MARKET DATA AND MAJOR BRAND KEY FACTS 160 Global antibacterial market data 160 Aminoglycosides market data 161 Carbapenems market data 161 Cephalosporins market data 165 Fluoroquinolones market data 170 Glycopeptides market data 175 Macrolides market data 177 Others market data 182 Penicillins market data 184 Tetracylines market data 188 APPENDIX B 191 Bibliography 191 Epidemiology 191 Clinical trial data 191 Report methodology 191




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Please fax this form to:
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