Pipeline Insight: Nosocomial Vaccines - Minefield or Goldmine?

Published by: Datamonitor

Published: Apr. 17, 2008 - 205 Pages

Table of Contents

ABOUT DATAMONITOR HEALTHCARE

About the Infectious Diseases analysis team

CHAPTER 1 EXECUTIVE SUMMARY

Objective of the analysis

Datamonitor insight into the nosocomial vaccines market

Contributing experts

Related reports

Upcoming related reports

NOSOCOMIAL INFECTIONS - OVERVIEW OF EPIDEMIOLOGY AND KEY TARGETS FOR VACCINE DEVELOPMENT

Summary

Patients undergoing hospital stays face an elevated risk of infection

Nosocomial infections are a key health concern across the 7MM

The risk of infection is highest in intensive care units

Nosocomial pneumonia and bloodstream infections have the highest mortality rates

S. aureus, P. aeruginosa, S. epidermidis, enterococcus spp. and C. difficile are the most promising vaccine targets

CHAPTER 2 FACTORS TO CONSIDER FOR THE ASSESSMENT OF THE OPPORTUNITY FOR NOSOCOMIAL VACCINES

Summary

A multitude of factors determine the market opportunity for nosocomial vaccines

Costs associated with nosocomial infections vary between types of infections

Multiple costs arise through nosocomial infections

Most costs are directly associated with the increasing length of hospital stay

Reimbursement regulations for costs related to nosocomial infections differ across the seven major markets

US - Medicare changes on the horizon increase the financial pressure on hospitals

Despite common belief, US hospitals lose money on nosocomial infections

Medicare will cut reimbursement for certain nosocomial infections from October 2008

Japan's prospective payment system needs further amendment to incentivize hospitals effectively

Most major European markets operate DRG systems; however, levels of impact differ between countries

France

Germany

Italy

Spain

The UK

Various strategies exist for prevention and prophylaxis of nosocomial infections

Antibiotic resistance and worse clinical outcome provide a strong rationale for prevention of nosocomial infections

There are three key approaches for prevention of nosocomial infection aiming at different target populations

Hygiene and infection-control-based strategies

Advantages of hygiene and infection control strategies include a significant reduction in infection rates and hospital costs

Disadvantages include lack of efficacy and problems regarding implementation

Recommendations surrounding infection prevention vary across the 7MM

Immunoglobulins

Fast protection and the chance to vaccinate patients undergoing unplanned hospitalization are the key advantages of immunoglobulin-based strategies

Unclear efficacy along with limited tolerance and high costs are key concerns linked to immunoglobulin-based prevention strategies

Infections caused by staphylococci and Pseudomonas are the main focus of the nosocomial immunoglobulin pipeline

Vaccines

Long-lasting immunity is the key advantage of vaccines over other methods of prophylaxis

Setbacks include efficacy and implementation of vaccination in some key target populations

CHAPTER 3 STAPHYLOCOCCUS AUREUS

Summary

Disease background - S. aureus causes a wide variety of infections, often initiated with commensal carriage of the pathogen

Treatment options - S. aureus resistance patterns determine the choice of drug

Resistance development - MRSA has become a crucial concern in both hospital and community

Epidemiology - elderly and surgical patients are the principal risk groups for S. aureus infection

Key risk groups

Epidemiology and spread of disease

Rationale for vaccine development - high incidence and increasing resistance levels drive interest in vaccines

Market potential - a large population would be eligible for vaccination across the 7MM

Target population and market opportunity

Patients undergoing planned surgery

Dialysis

Elderly aged 65 years and over

Others

Pipeline - StaphVAX failure dampens hopes for rapid launch of a S. aureus vaccine

Summary

StaphVAX (Nabi Biopharmaceuticals)

Product profile

Clinical trial overview

Datamonitor assessment

V710 (Merck & Co/Intercell)

Product profile

Clinical trial data

Datamonitor assessment

SA75 (VRI plc)

Product profile

Clinical trial data

Datamonitor assessment

Assessment of the overall potential of S. aureus vaccines - good prospects, but significant challenges remain

CHAPTER 4 STAPHYLOCOCCUS EPIDERMIDIS

Summary

Disease background - S. epidermidis is mainly associated with medical devices

Treatment options - many antibacterial drugs are active against S. epidermidis

Resistance development - resistance levels are comparatively low, but have been increasing

Epidemiology - patients undergoing implant surgery are at greatest risk of infection

Key risk groups

Epidemiology and spread of disease

Rationale for vaccine development - protection against the next potential superbug

Market potential - orthopedic, ophthalmic and cardiac surgery patients would benefit most from vaccination

Target population and market opportunity

Implant and device surgery

Dialysis

Pipeline - no competition for Nabi

Summary

EpiVAX (Nabi Biopharmaceuticals)

Assessment of the overall potential of S. epidermidis vaccines - a combination vaccine with S. aureus is the way forward

CHAPTER 5 PSEUDOMONAS AERUGINOSA

Summary

Disease background - P. aeruginosa causes a wide range of different infections

Treatment options - resistances set a limit on therapy approaches

Resistance development - increasing non-response to a large variety of drugs makes prevention a key interest

Epidemiology - P. aeruginosa is a critical pathogen in the ICU

Key risk groups

Epidemiology and spread of disease

Rationale for vaccine development - resistance is the key driver, but vaccine design will be challenging

Market potential - patients with severe respiratory diseases and those at risk of an ICU stay are key target populations

Target population and market opportunity

Cystic fibrosis patients

Chronic obstructive pulmonary disease (COPD)

Patients undergoing planned surgery with subsequent pre-planned or highly likely ICU stay

Others

Pipeline - after many pipeline failures, IC43 looks promising

Summary

IC43 (Intercell)

Product profile

Clinical trial data

Assessment of the overall potential for P. aeruginosa vaccines

CHAPTER 6 CLOSTRIDIUM DIFFICILE

Summary

Disease background - C. difficile causes severe diarrhea and colitis

Treatment - antibiotic drugs are available, but many patients relapse

Resistance development - emergence of strain 027 is associated with worse clinical outcomes

Epidemiology - the elderly are at greatest risk of C. difficile infection

Key risk groups

Epidemiology and spread of disease

The UK

The US

Germany

Economic burden

Rationale for vaccine development - high clinical need is the key driver

Market potential - annual peak sales exceeding $1.5 billion are realistic in the elderly population

Target population

Commercial opportunity

Initial market: people in institutionalized care

Long-term opportunity: vaccination of all people turning 65

C. difficile vaccines pipeline - no competition for Acambis in sight

Summary

C. difficile vaccine (Acambis)

Product profile

Clinical trial data

Datamonitor assessment

Assessment of the overall potential for C. difficile vaccines - C. difficile is a highly promising target for nosocomial vaccination

CHAPTER 7 ENTEROCOCCUS SPP.

Summary

Disease background - E. faecalis and E. faecium are key causes of enterococcal infections

Treatment - resistances have limited the efficacy of available antibiotic options

Resistance development - VRE is emerging as severe concern

Epidemiology - incidence and mortality of enterococcal infections are increasing

Key risk groups

Epidemiology and spread of disease

Rationale for vaccine development

Market potential - it will be hard to construct a viable cost-efficacy case for enterococcal vaccination

Target population and commercial opportunity

Pipeline - no clinical candidates are developed for enterococcal infections yet

Summary

Assessment of the overall potential for enterococcal vaccines - alternative prevention strategies have better potential

APPENDIX A

Bibliography

APPENDIX B

Report methodology

About Datamonitor

About Datamonitor Healthcare

About the Infectious Diseases analysis team

Key therapy team members

Holger Rovini, Head of Respiratory and Infectious Diseases

Hedwig Kresse, Senior Analyst, Infectious Diseases

Disclaimer

List of Tables

Table 1: Costs associated with nosocomial infections

Table 2: Antibodies against nosocomial infections pipeline, March 2008

Table 3: S. aureus - Annual incidence estimates of overall planned surgery and key subtypes in the 7MM, 2008

Table 4: S. aureus - Annual incidence estimates of dialysis in the 7MM, 2008

Table 5: S. aureus - elderly recurrent and total population sizes in the 7MM, 2008 (million)

Table 6: S. aureus vaccine pipeline, January 2008

Table 7: StaphVAX - product profile, 2008

Table 8: StaphVAX - end-stage renal disease trials, January 2008

Table 9: StaphVAX - orthopedic surgery trials, January 2008

Table 10: StaphVAX - cardiovascular surgery trials, 2008

Table 11: StaphVAX - lot comparison trial, January 2008

Table 12: V710 - product profile, 2008

Table 13: V710 - clinical trial overview, January 2008

Table 14: SA75 - Product profile, 2008

Table 15: S. epidermidis - annual incidence estimates of key types of orthopedic/ophthalmic surgery in the 7MM, 2008

Table 16: S. epidermidis - annual incidence estimates of key types of cardiac surgery in the 7MM, 2008

Table 17: S. epidermidis - annual incidence estimates of dialysis in the 7MM, 2008

Table 18: S. epidermidis vaccine pipeline, January 2008

Table 19: EpiVAX - Product profile, 2008

Table 20: P. aeruginosa - Annual incidence estimates of cystic fibrosis in the 7MM, 2008

Table 21: P. aeruginosa - prevalence estimates of different stages of COPD in the 7MM, 2008

Table 22: Breakdown of patients at elevated risk of ICU stay (median hospital stay >7 days) by type of procedure and admission in England, 2006

Table 23: Pseudomonas aeruginosa- total vaccination target population sizes (7MM)

Table 24: P. aeruginosa vaccines - overview of key bacterial targets and candidates, 2008

Table 25: P. aeruginosa vaccines - clinical pipeline, January 2008

Table 26: Estimated incidence of C. difficile infections across the 7MM

Table 27: C. difficile - total recurrent vaccination target population sizes in the 7MM, 2008 (million)

Table 28: C. difficile - commercial opportunity and cost-efficacy estimate for vaccination in people undergoing institutionalized care in the 7MM, 2008

Table 29: C. difficile - commercial opportunity for annual and cumulative catch-up vaccination in all elderly aged 65 and older in the 7MM, 2008

Table 30: C. difficile vaccine pipeline, January 2008

Table 31: C. difficile vaccine (Acambis) - product profile, 2008

Table 32: Enterococcal vaccine pipeline, January 2008

List of Figures

Figure 1: Number of deaths by leading cause of death in the US, 2004

Figure 2: Nosocomial infections -most common types of infection in the US, 2007

Figure 3: Estimated number of healthcare-associated infections by subpopulation and major site of infection in the US, 2002

Figure 4: Rates of healthcare-associated infections by subpopulation and major site of infection in the US, 2002

Figure 5: Origin of infection in ICU patients in the 5EU , 1992

Figure 6: Deaths associated with healthcare-associated infections in the US, 2002

Figure 7: Key ICU infections by causative pathogen in Germany, Spain, France, 2003/2005

Figure 8: Factors influencing the assessment of the market opportunity for nosocomial vaccination in the 7MM, 2008

Figure 9: Nosocomial infections - additional days spent in hospital by type of infection

Figure 10: Hospital costs, reimbursement and losses for central-line BSI and pneumonia - Allegheny General Hospital in the US, 2006

Figure 11: Drawbacks of antibiotic therapy and value-added of preventive strategies in nosocomial infections

Figure 12: Patient groups likely to benefit from different infection prevention strategies

Figure 13: Advantages and disadvantages of hygiene and infection control-based strategies in the prevention and control of nosocomial infections

Figure 14: Efficacy assessment of recommended preventive measures for the four most frequent types of nosocomial infection

Figure 15: Advantages and disadvantages of immunoglobulin-based strategies in the prevention and control of nosocomial infections

Figure 16: Advantages and disadvantages of vaccination strategies in the prevention and control of nosocomial infections

Figure 17: MRSA - hospital discharges mentioning MRSA in the US, 1993-2005

Figure 18: MRSA - hospital discharges per 100,000 population by age group in the US, 2004

Figure 19: MRSA - prevalence among all S. aureus infections in the 5EU, 1999-2006

Figure 20: MRSA -proportion of MRSA in ICUs versus other hospital departments in the 5EU, 2006

Figure 21: MRSA - incidence in Japan, 1999-2005 (sentinel reporting system)

Figure 22: S. aureus - incidence in the 5EU, 2001-06 (sentinel reporting)

Figure 23: S. aureus - sizing estimates of key target populations eligible for vaccination in the 7MM, 2008

Figure 24: Target group expansion model for S. aureus vaccination

Figure 25: S. aureus vaccine development - summary of drivers and resistors, 2008

Figure 26: S. epidermidis - sizing estimates of key target populations eligible for vaccination in the 7MM, 2008

Figure 27: S. epidermidis vaccine development - summary of drivers and resistors, 2008

Figure 28: P. aeruginosa - antibiotic resistance levels across Europe, 2006

Figure 29: P. aeruginosa - bacteremia laboratory reports in the UK, 1990-2004 (voluntary reporting)

Figure 30: P. aeruginosa - infections in Japan, 1999-2005 (sentinel reports from ~470 hospitals)

Figure 31: P. aeruginosa - infections in ICUs in Germany, 2000 and 2005

Figure 32: P. aeruginosa - sizing estimates of key target populations eligible for vaccination in the 7MM, 2008

Figure 33: P. aeruginosa - potential cost savings through vaccination in cystic fibrosis patients in the 7MM, 2003

Figure 34: P. aeruginosa vaccine development - summary of drivers and resistors, 2008

Figure 35: C. difficile infection - course of disease

Figure 36: Age and sex distribution of C. difficile reports in the UK, January-December 2006 (voluntary surveillance)

Figure 37: C. difficile reports for patients aged 65 years and over in the UK, 2000-06 (mandatory and voluntary reports)

Figure 38: Deaths related to C. difficile infection in England & Wales, 2001-06

Figure 39: C. difficile infections per 100,000 hospital discharges in the US, 1993-2003

Figure 40: Annual Clostridium difficile-related mortality rates per million population in the US, 1999-2004

Figure 41: C. difficile infections per 100,000 in-hospital patients in Germany, 2000-04

Figure 42: C. difficile - possible target group expansion strategy for recurrent opportunity in the 7MM, 2008 (million)

Figure 43: C. difficile - market opportunity for vaccination in the 7MM, 2008

Figure 44: C. difficile vaccine development - summary of drivers and resistors, 2008

Figure 45: Vancomycin-resistant enterococci among ICU patients in the US, 1995-2004

Figure 46: E. faecalis /E. faecium susceptibility to vancomycin in England and Wales, 1990-2005

Figure 47: E. faecium - vancomycin resistance in Europe, 2001-06

Figure 48: Enterococcal infections by age group in the UK, 2005

Figure 49: Enterococcal bacteremia reports by type in the UK, 2002-06

Figure 50: Enterococcal vaccine development - summary of drivers and resistors, 2008

Abstract

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