Commercial & Pipeline Insight: Hospital Antibacterials A market beyond MRSA

Publication Date	August 2007
Publisher	Datamonitor
Product Type	Report
Pages	368
ISBN Number	not applicable
Product Code	DAT07187

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Summary

Introduction

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

Content

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 ?-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 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
- Table 21: Indexed Total Market Branded And Generic Others, Volume And Value Sales And Pricing, 2003-06
- Table 22: 7mm Leading Brands By Value Sales 2006 ($M) And Cagr Growth (2003-2006)
- Table 23: 7mm Top Ten Brands By Volume Sales 2006 ($M) And Cagr Growth (2003-2006)
- Table 24: Global Opportunities And Threats
- Figure 29: Healthcare Spending As A Proportion Of Gdp In The 7mm, 2004
- Table 25: Relative Net Present Value (Npv) By Therapy Area
- Table 26: Us Top Ten Brands By 2006 Sales Value ($M) And Cagr (2003-2006)
- Table 27: Us Top Ten Brands By 2006 Sales Volume (Sum) And Cagr (2003-2006)
- Table 28: Us Total Market Indexed Sales By Brand 2003-2006, Sales By Value 2006 ($M)
- Table 29: Core Us Market Branded, Generic, Oral And Iv Volume And Value Share 2003-2006 (%)
- Table 30: United States Summary Of Opportunities And Threats
- Table 31: Japanese Top Ten Brands By 2006 Sales Value ($M) And Cagr (2003-2006)
- Table 32: Japanese Top Ten Brands By 2006 Sales Volume (Sum) And Cagr (2003-2006
- Table 33: Japan Total Market Indexed Sales By Brand 2003-2006, Sales By Value 2006 ($M)
- Table 34: Japan Summary Of Opportunities And Threats
- Table 35: M5eu Top Ten Brands By 2006 Sales Value ($M) And Cagr (2003-2006)
- Table 36: M5eu Top Ten Brands By 2006 Sales Volume (Sum) And Cagr (2003-2006)
- Table 37: M5eu Total Market Indexed Sales By Brand 2003-2006, Sales By Value 2006 ($M)
- Table 38: Indexed Total Market Growth In The M5eu, 2003-2006, Value And Volume Shares, 2006 Sales ($M) And Cagr 2003-2006
- Table 39: Indexed Core Market M5eu Branded, Generic, Oral And Iv Value Share 2003-2006
- Table 40: 5eu Opportunities And Threats
- Table 41: France Total Market Indexed Sales By Brand 2003-2006, Sales By Value 2006 ($M)
- Table 42: France Opportunities And Threats
- Table 43: Germany Total Market Indexed Sales By Brand 2003-2006, Sales By Value 2006 ($M)
- Table 44: Germany Opportunities And Threats
- Table 45: Italy Total Market Indexed Sales By Brand 2003-2006, Sales By Value 2006 ($M)
- Table 46: Italy - Opportunities And Threats
- Table 47: Spain Total Market Indexed Sales By Brand 2003-2006, Sales By Value 2006 ($M)
- Table 48: Spain - Opportunities And Threats
- Table 49: Uk Total Market Indexed Sales By Brand 2003-2006, Sales By Value 2006 ($M)
- Table 50: Uk Opportunities And Threats
- Figure 51: Clinical Trial Issues In Severe Bacterial Infections
- Table 51: Late-Stage Pipeline Hospital Antibacterial Agents. 2007
- Table 52: Dalbavancin: Summary Information
- Table 53: Telavancin: Summary Information
- Table 54: Oritavancin: Summary Information
- Table 55: Ceftaroline Fosamil: Summary Information
- Table 56: Ceftobiprole Medocaril: Summary Information
- Table 57: Iclaprim: Summary Information
- Table 58: Cubicin Launch
- Table 59: Tygacil Launch
- Table 60: Zeven Launch
- Table 61: Arbelic Launch
- Table 62: Finibax Launch
- Table 63: Ceftobiprole Launch
- Table 64: Iclaprim Launch
- Table 65: Ceftaroline Launch
- Table 66: Rocephin Patent Expiry: Knock On Effects
- Table 67: Zosyn Patent Expires 2007/7, Generics Launch After Petition Settlement2008/03
- Table 68: Maxipime
- Table 69: Merrem Patent Expiry
- Table 70: Synercid Patent Expiry
- Table 71: Tequin Patent Expiry
- Table 72: Levaquin Iv Patent Expiry
- Table 73: Invanz Patent Expiry
- Table 74: Tygacil Patent Expiry
- Table 75: Zyvox Oral/Iv Patent Expiry
- Table 76: Avelox Iv/Oral: Patent Expiry
- Table 77: Rise Of Gram-Negatives
- Table 78: Inhaled Aztreonam Approved For Cystic Fibrosis Rtis
- Table 79: Cubicin: Expansion To Endocarditis, Off-Label Eu Use In Bacteremia
- Table 80: Invanz: Additional Indication Of Prophylaxis Of Surgical Site Infections In Colorectal Surgery
- Table 81: Tygacil
- Table 82: Telavancin
- Table 83: Iclaprim
- Table 84: Tequin
- Table 85: Fluoroquinolones: Safety Concerns
- Table 86: 7mm Total Market Summary Data
- Table 87: Us Total Market Summary Data
- Table 88: Japan Total Market Summary Data
- Table 89: 5eu Total Market Summary Data
- Table 90: France Total Market Summary Data
- Table 91: Germany Total Market Summary Data
- Table 92: Italy Total Market Summary Data
- Table 93: Spain Total Market Summary Data
- Table 94: United Kingdom Total Market Summary Data
- Table 95: Primaxin: Key Facts
- Table 96: Merrem: Key Facts
- Table 97: Invanz: Key Facts
- Table 98: Finibax: Key Facts
- Table 99: Claforan: Key Facts
- Table 100: Maxipime: Key Facts
- Table 101: Levaquin: Key Facts
- Table 102: Cipro: Key Facts
- Table 103: Avelox: Key Facts
- Table 104: Tequin: Key Facts Key Facts
- Table 105: Vancocin: Key Facts
- Table 106: Targocid: Key Facts
- Table 107: Cubicin: Key Facts
- Table 108: Zyvox: Key Facts
- Table 109: Synercid: Key Facts
- Table 110: Tygacil: Key Facts
- Table 111: Datamonitor Forecasts For Core Market Hospital Antibiotics In The 7mm To 2016 ($M)
- Table 112: Datamonitor Forecasts For Core Market Hospital Antibiotics In The Us To 2016 ($M)
- Table 113: Datamonitor Forecasts For Core Market Hospital Antibiotics In The Japan To 2016 ($M)
- Table 114: Datamonitor Forecasts For Core Market Hospital Antibiotics In The 5eu To 2016 ($M)
- Table 115: Datamonitor Forecasts For Core Market Hospital Antibiotics In The France To 2016 ($M)
- Table 116: Datamonitor Forecasts For Core Market Hospital Antibiotics In The Germany To 2016 ($M)
- Table 117: Datamonitor Forecasts For Core Market Hospital Antibiotics In The Italy To 2016 ($M)
- Table 118: Datamonitor Forecasts For Core Market Hospital Antibiotics In The Spain To 2016 ($M)
- Table 119: Datamonitor Forecasts For Core Market Hospital Antibiotics In The Uk To 2016 ($M)
List Of Figures
- Figure 1: Defining The Market - Acquisition, Onset And Treatment Settings For Severe Bacterial Infections
- Figure 2: Pharmaceutical Sales Across The Seven Major Markets ($ Billion), 2006
- Figure 3: Indexed Total Market Sales By Class, Volume And Value, 2003-06, Seven Major Markets
- Figure 4: Indexed Brand, Generic, Iv And Oral Sales For Core Market Products (Volume And Value), 2003-06, Seven Major Markets
- Figure 5: Total Market Versus Core Market Coverage By Class, Volume And Value, 2006, Seven Major Markets
- Figure 6: Core Market Versus Rest Of Market Volume And Value Growth Rates (%), 2003-06, Seven Major Markets
- Figure 7: Core Market Versus Rest Of Market Coverage Versus Rest Of Market By Class, Volume And Value, 2006
- Figure 8: Top 10 Seven Major Market Hospital Antibacterials Leaders By Sales Of Core Market Branded Products (%), 2006
- Figure 9: Total Market Carbapenem Sales By Volume And Value Sales By Geographic Region (Us, Japan, 5eu), 2003-06
- Figure 10: Indexed Total Market Carbapenem Sales By Volume And Value, 2003-06, Seven Major Markets
- Figure 11: Core Market Carbapenem Volume And Value Forecasts, 2006*-2016
- Figure 12: Total Market Cephalosporin Sales By Volume And Value Sales By Geographic Region (Us, Japan, 5eu), 2003-06
- Figure 13: Indexed Total Market Cephalosporin Sales By Volume And Value, 2003-06, Seven Major Markets
- Figure 14: Indexed Brand, Generic, Iv And Oral Sales For Core Market Cephalosporins (Volume And Value), 2003-06, Seven Major Markets
- Figure 15: Core Market Cephalosporin Volume And Value Forecasts, 2006*-2016
- Figure 16: Total Market Fluoroquinolone Sales By Volume And Value Sales By Geographic Region (Us, Japan, 5eu), 2003-06
- Figure 17: Indexed Total Market Fluoroquinolone Sales By Volume And Value, 2003-2006, Seven Major Markets
- Figure 18: Indexed Core Market Brand, Generic, Iv And Oral Sales For Fluoroquinolones (Volume And Value),( 2003-06, Seven Major Markets
- Figure 19: Core Market Fluoroquinolone Volume And Value Forecasts, 2006*-2016
- Figure 20: Total Market Glycopeptide Sales By Volume And Value Sales By Geographic Region (Us, Japan, 5eu), 2003-06
- Figure 21: Indexed Total Market Branded And Generic Glycopeptides, Volume And Value Sales And Pricing, 2003-06, Seven Major Markets
- Figure 22: Core Market Glycopeptide Volume And Value Forecasts, 2006*-2016
- Figure 23: Total Market Penicillin Sales By Volume And Value Sales By Geographic Region (Us, Japan, 5eu), 2003-06
- Figure 24: Total Market Penicillin Sales By Volume And Value Sales, 2003-06
- Figure 25: Core Market Penicillin Volume And Value Forecasts, 2006*-2016
- Figure 26: Total Market "Others" Sales By Volume And Value Sales By Geographic Region (Us, Japan, 5eu), 2003-06
- Figure 27: Indexed Core Market Branded And Generic Others Volume And Value Sales And Pricing, 2003-06
- Figure 28: Core Market Others Volume And Value Forecasts, 2006*-2016
- Figure 30: Key Pricing Controls Used Globally, 2006
- Figure 31: Total Cost Of Care - Beyond Antibiotic Costs
- Figure 32: Stakeholder Balance Of Power
- Figure 33: Data Relevance To Stakeholders
- Figure 34: Audience-Targeted Pharmacoeconomic Data
- Figure 35: Pharmacoeconomic Impact Of Antibiotic Policies In The Treatment Of Ventilator Associated Pneumonia
- Figure 36: Net Present Value - Why The Antibiotic Pipeline Suffers
- Figure 37: Relative Net Present Value By Therapy Area
- Figure 38: Incentivizing Antibiotic R&D - Optimizing Returns And Reducing Costs
- Figure 39: Indexed Total Market Growth In The Us In The Hospital Antibacterials Market, 2003-06, Value And Volume Share (%)
- Figure 40: Core Market Us Branded, Generic, Oral And Iv Hospital Antibacterials, Volume And Value Share (%), 2003-06
- Figure 41: Decrease Of Fda's Mean Total Approval Time
- Figure 42: Indexed Total Market Growth In The Hospital Antibacterials Market In Japan, Value And Volume Share (%), 2003-06
- Figure 43: Core Market Japanese Branded, Generic, Oral And Iv Hospital Antibacterials Volume And Value Share (%), 2003-06
- Figure 44: Indexed Total Market Growth In The Hospital Antibacterials Market In The 5eu, Value And Volume Share (%), 2003-06
- Figure 45: Core Market 5eu Branded, Generic, Oral And Iv Hospital Antibacterials Volume And Value Share (%), 2003-06
- Figure 46: Core France Market Branded, Generic, Oral And Iv Volume And Value Share 2003-2006 (%)
- Figure 47: Core German Market Branded, Generic, Oral And Iv Volume And Value Share 2003-2006 (%)
- Figure 48: Core Italian Market Branded, Generic, Oral And Iv Volume And Value Share 2003-2006 (%)
- Figure 49: Core Spanish Market Branded, Generic, Oral And Iv Volume And Value Share 2003-2006 (%)
- Figure 50: Core Uk Market Branded, Generic, Oral And Iv Volume And Value Share 2003-2006 (%)
- Figure 52: The Spectrum Dilemma - Pros And Cons Of Broad Versus Specialist Indication Trial Design
- Figure 53: Typical Phase Iii Trial Inclusion And Exclusion Criteria
- Figure 54: The Spectrum Dilemma: Broad Versus Narrow Applicability
- Figure 55: Dalbavancin Phase Ii Trial In Complicated Skin And Soft Tissue Infections
- Figure 56: Dalbavancin Phase Ii Trial In Catheter-Related Blood Stream Infections
- Figure 57: Dalbavancin Phase Iii Trial In Complicated Skin And Soft Tissue Infections Versus Linezolid
- Figure 58: Dalbavancin Phase Iii Trial In Skin Or Soft Tissue Infections, Versus Iv And Oral Cephalosporins
- Figure 59: Dalbavancin Phase Iii Trial In Skin Or Soft Tissue Infections Versus Vancomycin
- Figure 60: Telavancin Phase Iii Trial In Complicated Skin And Skin Structure Infections Versus Vancomycin
- Figure 61: Oritavancin Phase Iii Trials In Complicated Skin And Skin Structure Infections Versus Vancomycin And Oral Cephalexin
- Figure 62: Oritavancin Phase Iii Trials In Complicated Skin And Skin Structure Infections Versus Vancomycin And Oral Cephalexin
- Figure 63: Ceftobiprole Phase Iii Trial In Complicated Skin And Skin Structure Infections Versus Vancomycin