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Published by: Datamonitor
Published: Aug. 24, 2007 - 368 Pages
Table of Contents
- ABOUT DATAMONITOR HEALTHCARE
- About the Respiratory and Infectious Diseases pharmaceutical analysis team
- CHAPTER 1 EXECUTIVE SUMMARY
- Objective of the analysis
- Datamonitor insight into the Hospital Antibacterials market
- Generic incursion bites hard
- MRSA saturation: But what about the Gram- negatives?
- IV generics: escaping the oral market rush
- CHAPTER 2 MARKET DEFINITION AND OVERVIEW
- Market definition for this report
- Setting of treatment decision
- Route of antibiotic administration
- Classification of antibiotic treatments
- Core Market branded product coverage
- Late-stage pipeline coverage
- Current market situation
- A declining market with increasing needs
- Total Market value
- Core Market situation
- Core Market dynamics versus Total hospital market contributors
- Key players in the hospital antibacterials market
- Marketed product coverage
- Core Market branded product coverage
- Carbapenems
- Core Market coverage
- Class overview
- Core Market brand overviews
- Core Market comparative forecasts
- Cephalosporins
- Core Market coverage
- Class overview
- Core market brand overviews
- Core Market comparative forecasts
- Fluoroquinolones
- Core Market coverage
- Class overview
- Core Market brand overviews
- Core Market comparative forecasts
- Glycopeptides
- Core Market coverage
- Class overview
- Core Market brand overviews
- Core Market comparative forecasts
- Penicillins
- Core Market coverage
- Class overview
- Core Market brand overviews
- Core Market comparative forecasts
- Others
- Core Market coverage
- Core Market brand overviews
- Core Market comparative forecasts
- CHAPTER 3 COUNTRY MARKET ASSESSMENTS
- 7MM
- Key Facts
- Opportunities and threats
- Pharmacoeconomic analysis: Influencing key decision makers
- The rise and rise of problematic pathogens
- United States
- Key facts
- Market Overview
- Top 10 Brands - US market leaders by volume and value sales
- Class shares - Cephalosporin and fluoroquinolone class erosion
- Heavy brand preference, even IV/Oral split
- Opportunities and threats
- Broader FDA initiatives decrease time to market, but antibiotic scrutiny increases
- DTC advertising - ideal for the acute sector, but not for Hospital Antibacterials
- Pricing and reimbursement
- Prescription Drug User Fee Act (PDUFA) could reduce Net Present Value (NPV) further
- Japan
- Key facts
- Market Overview
- Top 10 Brands - Japanese market leaders by volume and value sales
- Class shares - a heavy â-lactam bias
- Genericisation still slow, oral formulations prefered
- Opportunities and threats
- The threat of foreign competition: enough to force domestic change?
- Price cuts - still dominating pricing and reimbursement in Japan
- Increasing uptake of generics
- Lengthy approval process slows down access to the Japanese market
- 5EU
- Key facts
- Market Overview
- Top 10 Brands - M5EU market leaders by volume and value sales
- Class Share - evenly spread sales
- High generic penetration, with an IV bias
- Opportunities and Threats
- EMEA drug approval process harmonization
- Smaller companies helped by European regulators
- France
- Sales overview
- Opportunities and threats
- Germany
- Sales overview
- Opportunities and threats
- Italy
- Sales Overview
- Opportunities and threats
- Spain
- Sales Overview
- Opportunities and threats
- United Kingdom
- Sales overview
- Opportunities and Threats
- CHAPTER 4 R&D APPROACH
- Clinical trial design in serious bacterial infections
- Target patient groups
- Site of infection
- The spectrum dilemma
- Choosing clinical trial objectives: what not to measure?
- Overview of pipeline products
- Class 1: Glycopeptides
- Zeven (dalbavancin)
- Arbelic (telavancin)
- Oritovancin
- Class 2: Cephalosporins
- Ceftaroline fosamil
- Ceftobiprole medocaril
- Class 3: Other antibacterials
- Iclaprim
- Aztreonam
- CHAPTER 5 FORECAST ANALYSIS
- General assumptions
- IV/Oral genericization
- Pricing of generics and level of generic incursion
- Key events
- Product Launches: Sequence of Events and Key Assumptions
- Cubicin
- Tygacil
- Zeven
- Arbelic
- Finibax
- Ceftobiprole
- Iclaprim
- Ceftaroline
- Patent expiries: sequence of events and key assumptions
- Rocephin knock on effects
- Zosyn
- Maxipime
- Merrem
- Synercid
- Tequin
- Levaquin
- Invanz
- Tygacil
- Zyvox Oral/IV
- Avelox
- Usage expansion
- Rise of Gram-negatives
- Inhaled Aztreonam
- Cubicin
- Invanz
- Tygacil
- Arbelic
- Iclaprim
- Other events
- Tequin
- Fluoroquinolones
- Data definitions, limitations and assumptions
- Standard units
- Japanese market data
- Derivation of sales forecasts and pricing trends
- Forecasts
- Forecast methodology
- CHAPTER 6 APPENDIX A - MARKET DATA AND MAJOR BRAND KEY FACTS
- Summary data for the hospital antibiotics market
- Carbapenem market data
- Primaxin
- Merrem
- Invanz
- Finibax
- Cephalosporin market data
- Claforan
- Maxipime
- Fluoroquinolone market data
- Levaquin
- Cipro
- Avelox
- Tequin
- Glycopeptide Market Data
- Vancocin
- Targocid
- Others
- Cubicin
- Zyvox (IV&Oral)
- Synercid
- Tygacil
- CHAPTER 7 APPENDIX B - MARKET FORECAST DATA
- Seven major markets
- US
- Japan
- 5EU
- France
- Germany
- Italy
- Spain
- UK
- CHAPTER 8 APPENDIX C
- Bibliography
- Books
- Epidemiology
- Clinical trial data
- Pharmacoeconomic studies
- Other
- Report methodology
- Abbreviations
- About Datamonitor
- About Datamonitor Healthcare
- About the Antibacterials analysis team
- Key therapy team members
- Holger Rovini, Head of Respiratory and Infectious Diseases
- Disclaimer
- List of Tables
- Table 1: Marketed antimicrobial products by ATC class and groupings used in this report, 2007
- Table 2: Late-stage pipeline antibiotic products by trial phase, indication and grouping, 2007
- Table 3: Indexed Total Market sales by brand 2003-06, Sales by value 2006 ($m), seven major markets
- Table 4: Indexed Total Market hospital sales by class, volume and value, 2003-06, seven major markets
- Table 5: Indexed brand, generic, IV and oral sales for Core Market products (volume and value), 2003-06, seven major markets
- Table 6: Top 10 seven major market hospital antibacterials leaders by sales of Core Market branded products ($m), 2006
- Table 7: Total Market carbapenem sales by volume and value sales and market growth by geographic region (US, Japan, 5EU), 2003-06
- Table 8: Indexed Total Market carbapenem value sales, 2003-06, seven major markets
- Table 9: Cephalosporins' spectrum of activity by generation
- Table 10: Total Market cephalosporin sales by volume and value sales and market growth by geographic region (US, Japan, 5EU), 2003-06
- Table 11: Indexed Total Market cephalosporin volume and value sales, 2003-06, seven major markets
- Table 12: Indexed brand, generic, IV and oral sales for Core Market cephalosporins (volume and value), 2003-06, seven major markets
- Table 13: Total Market fluoroquinolone sales by volume and value sales and market growth by geographic region (US, Japan, 5EU), 2003-06
- Table 14: Indexed Total Market fluoroquinolone value sales, 2003-06 seven major markets
- Table 15: Indexed Core Market brand, generic, IV and oral sales for cephalosporins (volume and value),( 2003-06, seven major markets
- Table 16: Total Market glycopeptide sales by volume and value sales and market growth by geographic region (US, Japan, 5EU), 2003-06
- Table 17: Indexed Total Market branded and generic glycopeptides sales by value, 2003-06, seven major markets
- Table 18: Total Market penicillin sales by volume and value sales and market growth by geographic region (US, Japan, 5EU), 2003-06
- Table 19: Indexed Total Market branded and generic Penicillins, volume and value sales and pricing, 2003-06
- Table 20: Total Market "Others" sales by volume and value sales and market growth by geographic region (US, Japan, 5EU), 2003-06
AbstractIntroduction
The Hospital antibacterials market accounted for $9.9bn of the total $41bn anti-infectives market. Increasingly resistant and problematic pathogens make this an attractive target for premium priced products outside of the largely genericized Community market. However, high concentrations of patent expiries and similarly targeted product launches imply a highly competitive commercial landscape.
Scope
n-depth analysis of the hospital market sector across Japan, US, France, Italy, Germany Spain and the UK Product by product analysis of the key marketed and pipeline brands that will determine the market's evolution An assessment of key unmet needs and the opportunities they offer for new product development Case study analysis of the commercial implications of antibiotic drug development and commercialization
Highlights
The total value of the hospital antibacterial market is $9.9bn, but generic incursion has caused this to slump over the 2003-2006 period. Within this market, a core group of products, accounting for $5.7 billion have managed to maintain a modest growth of 3%. As sequential market leaders face patent expiry, competition within the generic industry will increase on oral formulations, leading select generic manufacturers to target the IV market with premium generic products. High numbers of Gram-positive targeted products imply very distinct winners and losers. Astellas' Arbelic Cubicin and Zeven have strong commercial backing, but oritavancin, ceftaroline and subsequent entrants will find that generic incursion combined with the marketing might of strong entrants form a formidable barrier to the success.
Reasons to Purchase
Balance the clinical and commercial aspects of key marketed and pipeline products to understand the future shape of the hospital antibacterials sector Understand the key supplemental clinical analysis that can make a critical difference to drug uptake post-approval Review the changes in class sales that signal the shift in prescribing practices resulting from prescribers' fear of resistance
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