Market Report Source

Overview

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

• In-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

Table of Contents

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 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

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)