Market Report Source

Overview

Introduction

A total of 11 companies make up the top five across each of the four ID sectors, their core competencies ranging from a single disease area to generics prowess, producing a comprehensive portfolio to providing a specific offerings corresponding to highest unmet need. This report characterises the key players in each sector, and their approach to maximising their returns from a pressurised sector.

Scope

An inter and intra-sector overview of the four major components of the chemotherapeutic anti-infectives market in Japan, the US, and M5EU Disease backgrounds for each sector, drawing attention to the key clinical issues and unmet needs that shape commercial strategies for success Market size, structure, brand and company orientation by sector Portfolio analysis of the leading players by sector, highlighting winning tactics and strategies in portfolio management

Highlights

10 players in infectious disease account for two thirds of 7 major market chemotherapeutic anti-infective sales by value, but just one third by volume. However, as growth rates for the $38bn have fallen over the 2005-06 period, these companies have, collectively, been worst hit leading to a need for strategic re-evaluations for some players. This has placed an increased emphasis on high value niches of the market, and the need for effective tactics to ensure revenue loss minimisation (including, for example, OTC leveraging), line extension (reformulation and own generic production) and product succession in different measures. Other approaches have included minimising exposure to an anticipated continued shrinkage in the infectious disease market through scaling back infectious disease oriented operations altogether, focusing in on either areas considered to offer highest growth, or securing an exclusive grasp of a particular niche.

Reasons to Purchase

Understand the clinical and commercial characteristics and priorities for the major anti-infectives markets across Japan, the US and M5EU Identify the elements of strategies that have either kept players at the top of their field or failed to facilitate growth Understand how these businesses and strategies relate to your interest in the market, and how to position your products and services accordingly.

Table of Contents

ABOUT DATAMONITOR HEALTHCARE
About the Infectious & Respiratory Disease pharmaceutical analysis team

CHAPTER 1 EXECUTIVE SUMMARY
Scope of the analysis
Datamonitor insight into the Infectious Disease market
Related reports
Upcoming reports

CHAPTER 2 MARKET DEFINITIONS
Anatomical Therapeutic Classifications
Antibacterials
Antifungals
Antivirals excluding HIV
HIV
Geographic coverage
License status

CHAPTER 3 BACKGROUND AND OVERVIEW
Infectious Disease market performance
Volume sales are showing a nominal decline in both the medium and short term
Volume sales are relatively low by comparison to other ATCs
Sharp decline in value growth
Infectious Disease sector comparison
Sector key metrics
Market attractiveness
Leading molecules
Top 10 company involvement
Market leader performance and portfolio composition
Sector reliance
Geographic orientation

CHAPTER 4 ANTIBACTERIALS
Disease background
Pathogen and pathogen type
Antibiotic classes
Penicillins
Cephalosporins
Fluoroquinolones
Macrolides and ketolides
Other significant classes
Site of infection
Hospital versus community markets
Commercial analysis
Market size and structure
Geographic focus
Brand and company focus
Top five company analysis
Pfizer – success through accession, but will the formula work again?
Johnson & Johnson – cornering the market ahead of time
Abbott – will the last one out, turn off the lights?
Novartis – the best of both worlds: mixing high value brands with a generic assault
Sanofi-Aventis – what will you be remembered for: Tavanic and Claforan, or Synercid and Ketek?
Key portfolio management strategies – Antibiotics: Pfizer
Softening the blow of Zithromax
Zyvox and Zeven: creating a unified front

CHAPTER 5 ANTIFUNGALS
Disease background
Unmet need – driving product development of premium products
Changing patient populations
Transplant patients
Cancer
HIV
Children and neonates
The antifungal drug explosion
Class overviews
The shifting spectrum of causative pathogens
Linking patients to pathogens
From Candida to Aspergillus and beyond – changing fungal epidemiology
Diagnostic capabilities
Commercial analysis
Market size and structure
J2A0 and Azole market devaluation pulls market down
Echinocandins – a price war beckons
Polyenes – liposomal formulations sidelined
Others
Geographic focus
Brand and company focus
Top five company analysis
Novartis – one hit wonder?
Pfizer – the best of the rest
Merck & Co – the Cancidas honeymoon is over
Johnson & Johnson – let down by licensing opportunities?
Astellas Pharma – a simple value proposition in a costly market

CHAPTER 6 ANTIVIRALS
Disease background
Hepatitis
HCV management
HBV management
Respiratory viruses
Influenza
Respiratory syncytial virus (RSV)
HSV, CMV and similar viruses
Herpes simplex virus (HSV)
Varicella zoster virus (VZV)
Cytomegalovirus (CMV)
Commercial analysis
Market size and structure
Hepatitis
Respiratory viruses
HSV, CMV and similar viruses
Geographic focus
US
M5EU
Japan
Brand and company focus
Top five company analysis
GSK – opting for a biological future
Roche – the need for sector dominance
Schering-Plough – back-footed, but fighting on
Novartis – would generics be a better option?
Gilead – can leveraging portfolios yield sustainable growth?

CHAPTER 7 HIV
Disease background
Patient population
Drug class overviews
Nucleoside reverse transcriptase inhibitors
Non-nucleotide reverse transcriptase inhibitors
Protease inhibitors
Entry inhibitors
Commercial analysis
Market size and structure
Geographic focus
Brand and company focus
Top five HIV company analysis
GSK – a behemoth with an ageing proposition
Gilead – young turk or smooth operator?
BMS – all about timing
Abbott – can in-licensing be relied on?
Roche – going for broke
Key portfolio management strategies – HIV FDC Case Study
GSK – plugging the pipeline let-down gap
Gilead – keeping options open – balancing FDCs with new product
BMS – what is there to lose?
FDCs from generics – Waiting in the wings

BIBLIOGRAPHY
Literature
Websites and similar
Other sources
Datamonitor sources

APPENDIX A

CHAPTER 8 APPENDIX B
About Datamonitor
About Datamonitor Healthcare
About the Infectious & Respiratory Disease analysis team
Key therapy team members
Holger Rovini, Head of Respiratory and Infectious Diseases
Disclaimer

List of Tables
Table 1: Key dynamics – Infectious Disease versus other key therapeutic sectors, 7MM, 2002-06
Table 2: Infectious disease sector dynamic comparisons – key volume and value metrics, 7MM, 2002-06
Table 3: Market attractiveness – product, company and generic dominance by sector, 7MM, 2006
Table 4: Top selling molecules across the antibiotic, antifungal, antiviral and HIV sectors, 7MM, 2006
Table 5: Top 10 companies by revenue across the antibiotic, antifungal, antiviral and HIV sectors, 7MM, 2006
Table 6: Top 10 company portfolio bias – percentage value sales across the antibiotic, antifungal, antiviral and HIV sectors, 7MM, 2006
Table 7: Regional revenues – top 10 companies, rest of market and total market sales across the antibiotic, antifungal, antiviral and HIV sectors, 7MM, 2006
Table 8: Examples of clinically significant pathogens by Gram stain
Table 9: Key pathogens targeted by marketed or developmental vaccines
Table 10: Cephalosporins’ spectrum of activity by generation
Table 11: Antibiotic class sales by volume and value, 7MM, 2006
Table 12: Late-stage pipeline antibiotic products by trial phase, indication and grouping, 2007
Table 13: Top five Antibacterial companies by 2006 revenues versus rest of market
Table 14: Top five antibacterial companies by 2006 revenues versus rest of market
Table 15: Pfizer SWOT analysis for the antibacterials market
Table 16: Pfizer antibiotics portfolio overview, 2002-06
Table 17: Johnson & Johnson SWOT analysis for the antibacterials market
Table 18: Johnson & Johnson antibiotics portfolio overview, 2002-06
Table 19: Abbott SWOT analysis for the antibacterials market
Table 20: Abbott antibiotics portfolio overview, 2002-06
Table 21: Novartis SWOT analysis for the antibacterials market
Table 22: Novartis antibiotics portfolio overview, 2002-06
Table 23: Sanofi-Aventis SWOT analysis for the antibacterials market
Table 24: Sanofi-Aventis antibiotics portfolio overview, 2002-06
Table 25: Systemic antifungals versus other antifungal sales, 2006
Table 26: Mortality due to invasive mycoses
Table 27: Nosocomial bloodstream infection organism distribution in the US, 2004
Table 28: Predominant and emerging opportunistic fungal pathogens of clinical significance, 2007
Table 29: Types of immunocompromise, causes and associated fungal pathogens
Table 30: Indexed 7MM antifungal sales by ATC – indexed volume and value sales, 2002-06, actual sales (SUm and $m) 2006, and CAGR (%) 2002-06
Table 31: Indexed 7MM J2A0 ATC antifungal sales by class – Indexed volume and value sales, 2002-06, actual sales (SUm and $m) 2006, and CAGR 2002-06%
Table 32: 7MM antifungal market key volume and value sales dynamics by region – US, M5EU, Japan, 2002-06
Table 33: Top five Antifungal companies by 2006 revenues versus rest of market
Table 34: Top five antifungal companies by 2006 revenues versus rest of market
Table 35: Novartis SWOT analysis for the antifungals market
Table 36: Novartis antifungals portfolio overview, 2002-06
Table 37: Pfizer SWOT analysis for the antifungals market
Table 38: Pfizer antifungals portfolio overview , 2002-06
Table 39: Merck & Co SWOT analysis for the antifungals market
Table 40: Merck & Co antifungals portfolio overview, 2002-06
Table 41: Johnson & Johnson SWOT analysis for the antifungals market
Table 42: Johnson & Johnson antifungals portfolio overview, 2002-06
Table 43: Astellas SWOT analysis for the antifungals market
Table 44: Astellas Pharma antifungals portfolio overview, 2002-06
Table 45: HCV – treatment options, 2007
Table 46: HBV – treatment options, 2007
Table 47: Populations targeted for influenza vaccination, US, 2003
Table 48: Marketed influenza antivirals, 7MM, 2007
Table 49: Marketed RSV antiviral
Table 50: The human herpesviruses (HHV) fall into three sub-families
Table 51: Marketed HSV antivirals, 7MM, 2007
Table 52: Marketed VZV antivirals, 7MM, 2007
Table 53: Marketed CMV antivirals, 7MM, 2007
Table 54: 7MM antiviral sales by subsector – HSV, CMV and similar, hepatitis, respiratory and other molecule sales dynamics by volume and value (%), 2002-06
Table 55: Indexed 7MM antivirals market by sector – hepatitis, HSV CMV and similar, respiratory and other antivirals, 2002-06 and CAGR
Table 56: 7MM indexed respiratory virus drug sales 2002-06
Table 57: 7MM antiviral sales by geographic region, 2002-06
Table 58: Top five antiviral companies by 2006 revenues versus rest of market, 2002-06
Table 59: Top five antifungal companies by 2006 revenues versus rest of market
Table 60: GSK SWOT analysis for the antivirals sector
Table 61: GSK antivirals portfolio overview
Table 62: Roche SWOT analysis for the antivirals sector
Table 63: Roche antivirals portfolio overview, 2002-06
Table 64: Ribavirin, interferons and pegylated interferons – milestones in the Schering Plough/Roche HCV battle
Table 65: Schering-Plough SWOT analysis for the antivirals sector
Table 66: Schering Plough antivirals portfolio overview, 2002-06
Table 67: Novartis SWOT analysis for the antivirals sector
Table 68: Novartis antivirals portfolio overview, 2002-06
Table 69: Gilead SWOT analysis for the antivirals sector
Table 70: Gilead antivirals portfolio overview, 2002-06
Table 71: Changing drivers of demand in HIV, 2007
Table 72: 7MM HIV sales by class and product line composition, 2006
Table 73: Regional HIV sales dynamics, 7MM, 2006
Table 74: Top five HIV companies by combined revenues versus rest of market, 7MM, 2006
Table 75: Top five HIV companies by company revenues versus rest of market, 7MM, 2006
Table 76: GSK SWOT analysis for the HIV market
Table 77: GSK – HIV portfolio overview, 2007
Table 78: Agenerase and Lexiva background
Table 79: Gilead SWOT analysis for the HIV market
Table 80: Gilead – HIV portfolio overview, 2007
Table 81: BMS SWOT analysis for the HIV market
Table 82: BMS – HIV portfolio overview, 2007
Table 83: Abbott SWOT analysis for the HIV market
Table 84: Abbott -HIV portfolio overview, 2007
Table 85: Roche SWOT analysis for the HIV market
Table 86: Roche – HIV portfolio overview, 2007
Table 87: FDCs and original brands – overlaps in market exclusivity and potential revenue extension periods, 2007
Table 88: HIV FDCs currently available in India
Table 89: Antiviral market subdivisions by molecule
Table 90: US antiviral volume and value sales dynamics by therapeutic area
Table 91: M5EU antiviral volume and value sales dynamics by therapeutic area
Table 92: Japan antiviral volume and value sales dynamics by therapeutic area
Table 93: Hepatitis antiviral volume and value sales dynamics by geographic area
Table 94: HSV, CMV and similar antivirals volume and value sales dynamics by geographic area
Table 95: Respiratory antivirals volume and value sales dynamics by geographic area

List of Figures
Figure 1: Key dynamics – Infectious disease versus other key therapeutic sectors, 7MM, 2002-06
Figure 2: Infectious disease overview – key volume and value sales dynamics by sector, 7MM, 2002-06
Figure 3: Infectious disease overview – market attractiveness by sector, 7MM, 2006
Figure 4: Leading original and branded molecule sales versus rest of market, 7MM, 2006
Figure 5: Top 10 companies by revenue across the antibiotic, antifungal, antiviral and HIV sectors, 7MM, 2006
Figure 6: Top 10 players’ infectious disease portfolio characteristics, 7MM, 2006
Figure 7: Top 10 company portfolio sector bias across the antibiotic, antifungal, antiviral and HIV sectors, 7MM, 2006
Figure 8: Top 10 players – Portfolio bias, performance and market attractiveness, 7MM, 2006
Figure 9: Regional revenues – top 10 companies, rest of market and total market sales across the antibiotic, antifungal, antiviral and HIV sectors, 7MM, 2006
Figure 10: Antibiotic class sales by volume and value, 7MM, 2006
Figure 11: Defining the market – acquisition, onset and treatment settings for severe bacterial infections
Figure 12: Antibiotic indexed volume and value sales, 6MM, 2002-06 – branded versus non-branded sales, hospital and retail sectors
Figure 13: 6MM Antibiotic sales – branded versus non-branded sales, hospital and retail sectors
Figure 14: Regional variations in class volume and value antibiotic sales, 2006
Figure 15: Comparative concentration of players in the antibiotic, antifungal, antiviral and HIV markets – cumulative number of companies per decile of sector market share, 2006
Figure 16: Comparative concentration of product sales in the antibiotic, antifungal, antiviral and HIV markets – cumulative market share of top selling molecules, 2006
Figure 17: Leading molecules by original and license brand sales, and hospital/retail bias, 2006
Figure 18: Top five antibacterial companies by 2006 revenues versus rest of market
Figure 19: Pfizer key antibiotics brand summary, 2007
Figure 20: The antifungal drug explosion – drug development since the 1950s
Figure 21: Cellular targets of antifungal classes
Figure 22: Changing spectrum of invasive candidiasis species: episodes per 1,000 admissions, 1988-1992
Figure 23: Changing spectrum of invasive moulds: incidence per 1,000 patient days, 2000-03
Figure 24: Indexed 7MM antifungal volume and value sales by ATC4, 2002-06
Figure 25: 7MM J2A0 ATC antifungal volume and value sales by class, 2002-06
Figure 26: Indexed US echinocandin wholesale pricing tactics by quarter, Q2 2005-Q2 2007
Figure 27: 7MM regional sales trends – US, M5EU and Japan volume and value sales and growth rates, 2002-06
Figure 28: Distribution of 7MM antifungal companies by volume and value sales, 2002 and 2006
Figure 29: Top five antifungal companies by 2006 revenues versus rest of market
Figure 30: Market focus of top five antifungal companies, 2007
Figure 31: HBV – impact of vaccination on case numbers, US, 1978-2006
Figure 32: 7MM antiviral volume and value sales by subsector, 2002-06
Figure 33: 7MM hepatitis molecule sales by type – interferons, pegylated interferons and other antivirals, 2002-06
Figure 34: 7MM indexed volume sales – pegylated versus standard interferons, 2002-06
Figure 35: 7MM indexed respiratory virus drug sales, 2002-06
Figure 36: HSV, CMV and similar – molecule sales dynamics by main indication, 7MM, 2005-06
Figure 37: 7MM antiviral sales by geographic region, 2002-06
Figure 38: Top five antiviral companies by 2006 revenues versus rest of market
Figure 39: HIV timelines – key events, 1981-2007
Figure 40: HIV market firsts – drug development since1986
Figure 41: 7MM HIV sales by class, 2003-06
Figure 42: 7MM HIV sales by class and product line composition, 2006
Figure 43: Major patent expiries of HIV agents and barriers to generic appeal, 2004-2016
Figure 44: Top five HIV companies by company revenues versus rest of market, 7MM, 2006
Figure 45: Single products and FDCs – portfolio rejuvenation strategies