Commercial Perspectives: Vaccines - Nosocomial Pathogens

Table of Contents

CHAPTER 1 EXECUTIVE SUMMARY

Scope of the analysis

Datamonitor insight into the global vaccines market

The growth rate for the global vaccines market currently outpaces other infectious diseases sectors with predicted year-on-year growth of 10–12%. In 2010, this will equate to a market size of approximately $17 billion on a par with antivirals. Bearing in mind current dynamics, Datamonitor believes a large proportion of these sales will fall outside the existing four company oligopoly

Within the dominant high-volume pediatric segment, declining birth rates, uncertain market access and intense competition forces vaccine players to consider a range of new product strategies with varying levels of commercial risk. Examples include monoclonal antibodies, therapeutic vaccines, newer adjuvants and delivery systems

Along with smaller players, GSK and Wyeth have recognized growing unmet medical need within the treatment of nosocomial bacterial infections, especially those caused by drug-resistant Staphylococci and Enterococci. Significant global numbers of immunocompromised �eat-risk�f groups and limited antibacterial R&D increase the commercial attractiveness of this newer segment

With clear assumptions on pricing, coverage and target groups, Datamonitor commercial analyses reveals that peak global sales of a S. aureus prophylatic vaccine and therapeutic monoclonal antibody could reach $1.8 billion and $2.6 billion respectively. Market access is likely to be more feasible for the monoclonal product, as the current likelihood of mandated mass vaccination with a S. aureus vaccine is low

Summary

Key metrics

CHAPTER 2 VACCINES: WHICH DIRECTION?

Introduction

Drivers of growth

Increased competition and R&D diversity

Emerging middle classes in developing countries

Perceived effectiveness and economic benefit of vaccination

Blockbuster antigens

The rise of therapeutic antibodies

Resistors to growth

Safety concerns

Increasing barriers to entry

A strategic dilemna

Low product differentiation

High product differentiation

CHAPTER 3 KEY PLAYERS AND NEW CONTENDERS

GlaxoSmithKline

Market update

R&D update

Aventis Pasteur

Market update

R&D update

Merck & Co

Market update

Wyeth

Market update

R&D update

New contenders

Chiron

Berna Biotech

Baxter

Acambis

MedImmune

CHAPTER 4 FOCUS ON NOSOCOMIAL INFECTIONS

Introduction

Bacterial nosocomial infections overview

Fungal nosocomial infections overview

Target pathogen: Candida albicans

Strategies for nosocomial vaccination

Product type

Hospital target groups

Market acceptance of nosocomial vaccine products

Commercial evaluation of new vaccine products

S. aureus therapeutic monoclonal

CHAPTER 5 CANDIDATE NOSOCOMIAL PRODUCTS

Prophylatic vaccines

StaphVax

Enterovax

EpiVax

P. aeruginosa vaccine: Aerugen

C. difficile vaccine

Therapeutic monoclonal antibodies

BSYX-A110

AltaStaph

Aurograb

Mycograb

TMA-15

Anti-shiga toxin monoclonals (c-Stx1 and c-Stx2)

APPENDIX A

Bibliography

Epidemiology

Clinical trial data

Other

Website links

Report methodology

Disclaimer

List of Tables

Table 1: Predicted sales for S. aureus therapeutic monoclonals and prophylactic vaccine*

Table 2: Sales growth across infectious disease sectors ($m), 1999–2002

Table 3: Sales growth across infectious disease sectors ($m), 2002–10

Table 4: Key player vaccine sales ($m), 1999–2002

Table 5: Vaccine cost effectiveness

Table 6: MedImmune�fs marketed antibody portfolio

Table 7: Historical and forecast population, 0–4 years, across the seven major markets (000s), 1990–2015

Table 8: GSK�fs marketed vaccine portfolio, 2002

Table 9: GSK�fs vaccine R&D pipeline, 2003

Table 10: Aventis�fs marketed human vaccine portfolio

Table 11: Aventis�fs human vaccine R&D pipeline, 2003

Table 12: Merck & Co.�fs marketed vaccines portfolio

Table 13: Merck�fs vaccines R&D pipeline, 2003

Table 14: Wyeth�fs marketed vaccine portfolio

Table 15: Wyeth�fs vaccine R&D pipeline, 2003

Table 16: Chiron�fs vaccine business revenue by source ($m), 2001–02

Table 17: Chiron�fs vaccine sales by product group ($m), 2001–02

Table 18: Chiron�fs marketed vaccines, 2003

Table 19: Chiron�fs vaccine pipeline

Table 20: Berna�fs vaccine sales by product group ($m), 2001–02

Table 21: Berna�fs marketed vaccines, 2003

Table 22: Berna�fs pipeline vaccines

Table 23: Baxter�fs pipeline vaccines

Table 24: Acambis�fs pipeline vaccines

Table 25: MedImmune�fs marketed vaccines

Table 26: MedImmune�fs pipeline vaccines

Table 27: MedImmune predicted sales

Table 28: Percentage of nosocomial pathogens resistant to key hospital antibacterials

Table 29: Bacteria responsible for the onset of nosocomial pneumonia in general ward patients (% cases)

Table 30: Bacteria responsible for the onset of bloodstream infections (% cases)

Table 31: Causative fungi in hospitalized patients with an invasive fungal infection in the seven major markets, 2003

Table 32: Current incidence of invasive fungal infections in the seven major markets, 2003

Table 33: Advantages and disadvantages of monoclonal antibodies

Table 34: Human population demographics in various countries

Table 35: Proportion of surgery patients suffering from surgical site infection in the US (%), Jan 1992–June 2001

Table 36: Estimated total number of invasive fungal infections among surgical patients in the seven major markets, 2003

Table 37: Predicted sales for S. aureus therapeutic monoclonals and prophylactic vaccine*

Table 38: Summary of candidate nosocomial products

Table 39: Healthcare statistics across the seven major pharmaceutical markets, 2000

Table 40: Inhibitex�fs monoclonal antibody product pipeline

List of Figures

Figure 1: S. aureus vaccine* peak sales revenue by target group and country (%)

Figure 2: Key player vaccine sales ($m), 1999–2002

Figure 3: Global vaccine market by volume and revenue, 2000

Figure 4: Gross national product of India, 1985–99

Figure 5: Therapy area exposure of key antibody companies

Figure 6: High and low product differentiation in commercial vaccine strategy

Figure 7: Size of the over 65 populations in the seven major markets in 2000 and as predicted for 2020

Figure 8: Comparative analysis of leading influenza vaccines

Figure 9: Aventis is collaborating with five companies as part of its therapeutic vaccine development program

Figure 10: Global vaccines market share by company, 2002

Figure 11: Late-stage vaccine pipeline by company, 2003

Figure 12: Changes in incidence of nosocomial infection

Figure 13: Microorganisms causing SSIs in English hospitals, 1997–99

Figure 14: S. aureus bacteremia laboratory reports and methicillin susceptibility: England and Wales, 1992–2002

Figure 15: E. faecium bacteremia laboratory reports and vancomycin susceptibility: England and Wales, 1992–2001

Figure 16: Nosocomial BSIs due to Coagulase negative staphylococci, 2001*

Figure 17: Mean additional hospital costs associated with nosocomial infections in the UK, by site of infection

Figure 18: Mean additional hospital costs associated with nosocomial infections in the UK, by admission specialty

Figure 19: Predisposing factors associated to defects of the host�fs defenses against fungal infection

Figure 20: Pathway to nosocomial vaccine commercialization

Figure 21: Nosocomial infections target groups

Figure 22: Calculating S. aureus prophylactic peak sales vaccine revenue

Figure 23: Potential S. aureus prophylactic peak sales vaccine revenue

Figure 24: S. aureus vaccine peak sales revenue (%) by target group and country

Figure 25: Methodology to calculate S. aureus therapeutic monoclonal revenue

Figure 27: S.aureus therapeutic monoclonal revenue per target group and country

Figure 28: Phase III StaphVax clinical trial schematic diagram

Figure 29: Geometric mean levels of antibodies specific for S. aureus type 5 and 8 capsular polysaccharides.

Figure 30: Hospital-acquired enterococcus infections in the seven major markets

Figure 31: Percentage of patients that produced antibodies against toxin A or toxin B at different vaccine doses

Figure 32: BSYX-A110 Phase I studies

Figure 33: Survival rate of infected mice when treated with varying doses of TMA-15