- 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 KEYTARGETS FOR
VACCINE DEVELOPMENT
- Summary
- Patients undergoing hospital stays face an elevated riskof infection
- Nosocomial infections are a key health concern across the7MM
- The risk of infection is highest in intensive care units
- Nosocomial pneumonia and bloodstream infections have thehighest
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 THEOPPORTUNITY FOR
NOSOCOMIAL VACCINES
- Summary
- A multitude of factors determine the market opportunityfor nosocomial
vaccines
- Costs associated with nosocomial infections vary betweentypes of
infections
- Multiple costs arise through nosocomial infections
- Most costs are directly associated with the increasinglength of
hospital stay
- Reimbursement regulations for costs related to nosocomialinfections
differ across the seven major markets
- US - Medicare changes on the horizon increase thefinancial pressure on
hospitals
- Despite common belief, US hospitals lose money onnosocomial
infections
- Medicare will cut reimbursement for certain nosocomialinfections
from October 2008
- Japan' s prospective payment system needs further amendmentto
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 ofnosocomial
infections
- Antibiotic resistance and worse clinical outcome provide astrong
rationale for prevention of nosocomial infections
- There are three key approaches for prevention ofnosocomial infection
aiming at different target populations
- Hygiene and infection-control-based strategies
- Advantages of hygiene and infection control strategiesinclude a
significant reduction in infection rates and hospital costs
- Disadvantages include lack of efficacy and problemsregarding
implementation
- Recommendations surrounding infection prevention varyacross the 7MM
- Immunoglobulins
- Fast protection and the chance to vaccinate patientsundergoing
unplanned hospitalization are the key advantages ofimmunoglobulin-based
strategies
- Unclear efficacy along with limited tolerance and highcosts are key
concerns linked to immunoglobulin-based preventionstrategies
- Infections caused by staphylococci and Pseudomonas are themain focus
of the nosocomial immunoglobulin pipeline
- Vaccines
- Long-lasting immunity is the key advantage of vaccinesover other
methods of prophylaxis
- Setbacks include efficacy and implementation ofvaccination in some
key target populations
- CHAPTER 3 STAPHYLOCOCCUS AUREUS
- Summary
- Disease background - S. aureus causes a wide variety ofinfections, often
initiated with commensal carriage of the pathogen
- Treatment options - S. aureus resistance patternsdetermine the choice of
drug
- Resistance development - MRSA has become a crucial concernin both
hospital and community
- Epidemiology - elderly and surgical patients are theprincipal risk
groups for S. aureus infection
- Key risk groups
- Epidemiology and spread of disease
- Rationale for vaccine development - high incidence andincreasing
resistance levels drive interest in vaccines
- Market potential - a large population would be eligiblefor vaccination
across the 7MM
- Target population and market opportunity
- Patients undergoing elective hospital operations
- Dialysis
- Elderly aged 65 years and over
- Others
- Pipeline - StaphVAX failure dampens hopes for rapid launchof 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 associatedwith medical
devices
- Treatment options - many antibacterial drugs are activeagainst S.
epidermidis
- Resistance development - resistance levels arecomparatively low, but
have been increasing
- Epidemiology - patients undergoing implant surgery are atgreatest risk
of infection
- Key risk groups
- Epidemiology and spread of disease
- Rationale for vaccine development - protection against thenext potential
"superbug"
- Market potential - orthopedic, ophthalmic and cardiacsurgery 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. epidermidisvaccines - a
combination vaccine with S. aureus is the way forward
- CHAPTER 5 PSEUDOMONAS AERUGINOSA
- Summary
- Disease background - P. aeruginosa causes a wide range ofdifferent
infections
- Treatment options - resistances set a limit on therapyapproaches
- Resistance development - increasing non-response to alarge variety of
drugs makes prevention a key interest
- Epidemiology - P. aeruginosa is a critical pathogen in theICU
- Key risk groups
- Epidemiology and spread of disease
- Rationale for vaccine development - resistance is the keydriver, but
vaccine design will be challenging
- Market potential - patients with severe respiratorydiseases 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 subsequentpre-planned or
highly likely ICU stay
- Others
- Pipeline - after many pipeline failures, IC43 lookspromising
- Summary
- IC43 (Intercell)
- Product profile
- Clinical trial data
- Assessment of the overall potential for P. aeruginosavaccines
- CHAPTER 6 CLOSTRIDIUM DIFFICILE
- Summary
- Disease background - C. difficile causes severe diarrheaand colitis
- Treatment - antibiotic drugs are available, but manypatients relapse
- Resistance development - emergence of strain 027 isassociated with worse
clinical outcomes
- Epidemiology - the elderly are at greatest risk of C.difficile infection
- Key risk groups
- Epidemiology and spread of disease
- Economic burden
- Rationale for vaccine development - high clinical need isthe key driver
- Market potential - annual peak sales exceeding $1.5billion are realistic
in the elderly population
- Target population
- Commercial opportunity
- Initial market: people in institutionalized care
- Long-term opportunity: vaccination of all people turning65
- C. difficile vaccines pipeline - no competition forAcambis in sight
- Summary
- C. difficile vaccine (Acambis)
- Product profile
- Clinical trial data
- Datamonitor assessment
- Assessment of the overall potential for C. difficilevaccines - C.
difficile is a highly promising target for nosocomialvaccination
- CHAPTER 7 ENTEROCOCCUS SPP.
- Summary
- Disease background - E. faecalis and E. faecium are keycauses of
enterococcal infections
- Treatment - resistances have limited the efficacy ofavailable antibiotic
options
- Resistance development - VRE is emerging as severe concern
- Epidemiology - incidence and mortality of enterococcalinfections are
increasing
- Key risk groups
- Epidemiology and spread of disease
- Rationale for vaccine development
- Market potential - it will be hard to construct a viablecost-efficacy
case for enterococcal vaccination
- Target population and commercial opportunity
- Pipeline - no clinical candidates are developed forenterococcal
infections yet
- Assessment of the overall potential for enterococcalvaccines -
alternative prevention strategies have better potential
- APPENDIX A
- 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 infectionspipeline, March 2008
- Table 3: S. aureus - Annual incidence estimates ofoverall elective
hospital operations and key subtypes in the 7MM, 2008
- Table 4: S. aureus - Annual incidence estimates ofdialysis in the 7MM,
2008
- Table 5: S. aureus - elderly recurrent and totalpopulation 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, January2008
- 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 ofkey types of
orthopedic/ophthalmic surgery in the 7MM, 2008
- Table 16: S. epidermidis - annual incidence estimates ofkey types of
cardiac surgery in the 7MM, 2008
- Table 17: S. epidermidis - annual incidence estimates ofdialysis 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 ofcystic fibrosis
in the 7MM, 2008
- Table 21: P. aeruginosa - prevalence estimates ofdifferent stages of
COPD in the 7MM, 2008
- Table 22: Breakdown of patients at elevated risk of ICUstay (median
hospital stay >7 days) by type of procedure and admissionin England, 2006
- Table 23: Pseudomonas aeruginosa- total vaccinationtarget population
sizes (7MM)
- Table 24: P. aeruginosa vaccines - overview of keybacterial targets and
candidates, 2008
- Table 25: P. aeruginosa vaccines - clinical pipeline,January 2008
- Table 26: Estimated incidence of C. difficile infectionsacross the 7MM
- Table 27: C. difficile - total recurrent vaccinationtarget population
sizes in the 7MM, 2008 (million)
- Table 28: C. difficile - commercial opportunity andcost-efficacy
estimate for vaccination in people undergoinginstitutionalized care in the
7MM, 2008
- Table 29: C. difficile - commercial opportunity forannual and cumulative
catch-up vaccination in all elderly aged 65 andolder in the 7MM, 2008
- Table 30: C. difficile vaccine pipeline, January 2008
- Table 31: C. difficile vaccine (Acambis) - productprofile, 2008
- Table 32: Enterococcal vaccine pipeline, January 2008
- List of Figures
- Figure 1: Number of deaths by leading cause of death inthe US, 2004
- Figure 2: Nosocomial infections -most common types ofinfection in the
US, 2007
- Figure 3: Estimated number of healthcare-associatedinfections by
subpopulation and major site of infection in the US, 2002
- Figure 4: Rates of healthcare-associated infections bysubpopulation 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-associatedinfections in the
US, 2002
- Figure 7: Key ICU infections by causative pathogen inGermany, Spain,
France, 2003/2005
- Figure 8: Factors influencing the assessment of themarket opportunity
for nosocomial vaccination in the 7MM, 2008
- Figure 9: Nosocomial infections - additional days spentin hospital by
type of infection
- Figure 10: Hospital costs, reimbursement and losses forcentral-line BSI
and pneumonia - Allegheny General Hospital in the US,2006
- Figure 11: Drawbacks of antibiotic therapy andvalue-added of preventive
strategies in nosocomial infections
- Figure 12: Patient groups likely to benefit fromdifferent infection
prevention strategies
- Figure 13: Advantages and disadvantages of hygiene andinfection
control-based strategies in the prevention and control ofnosocomial
infections
- Figure 14: Efficacy assessment of recommended preventivemeasures for the
four most frequent types of nosocomial infection
- Figure 15: Advantages and disadvantages ofimmunoglobulin-based
strategies in the prevention and control ofnosocomial infections
- Figure 16: Advantages and disadvantages of vaccinationstrategies in the
prevention and control of nosocomial infections
- Figure 17: MRSA - hospital discharges mentioning MRSA inthe US, 1993-2005
- Figure 18: MRSA - hospital discharges per 100,000population by age group
in the US, 2004
- Figure 19: MRSA - prevalence among all S. aureusinfections in the 5EU,
1999-2006
- Figure 20: MRSA -proportion of MRSA in ICUs versus otherhospital
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 targetpopulations
eligible for vaccination in the 7MM, 2008
- Figure 24: Target group expansion model for S. aureusvaccination
- Figure 25: S. aureus vaccine development - summary ofdrivers and
resistors, 2008
- Figure 26: S. epidermidis - sizing estimates of keytarget populations
eligible for vaccination in the 7MM, 2008
- Figure 27: S. epidermidis vaccine development - summaryof drivers and
resistors, 2008
- Figure 28: P. aeruginosa - antibiotic resistance levelsacross Europe,
2006
- Figure 29: P. aeruginosa - bacteremia laboratory reportsin 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 inGermany, 2000 and 2005
- Figure 32: P. aeruginosa - sizing estimates of keytarget populations
eligible for vaccination in the 7MM, 2008
- Figure 33: P. aeruginosa - potential annual cost savingsthrough
vaccination in cystic fibrosis patients in the 7MM, 2003
- Figure 34: P. aeruginosa vaccine development - summaryof drivers and
resistors, 2008
- Figure 35: C. difficile infection - course of disease
- Figure 36: Age and sex distribution of C. difficilereports in the UK,
January-December 2006 (voluntary surveillance)
- Figure 37: C. difficile reports for patients aged 65years and over in
the UK, 2000-06 (mandatory and voluntary reports)
- Figure 38: Deaths related to C. difficile infection inEngland &
Wales, 2001-06
- Figure 39: C. difficile infections per 100,000 hospitaldischarges in the
US, 1993-2003
- Figure 40: Annual Clostridium difficile-relatedmortality rates per
million population in the US, 1999-2004
- Figure 41: C. difficile infections per 100,000in-hospital patients in
Germany, 2000-04
- Figure 42: C. difficile - possible target groupexpansion strategy for
recurrent opportunity in the 7MM, 2008 (million)
- Figure 43: C. difficile - market opportunity forvaccination in the 7MM,
2008
- Figure 44: C. difficile vaccine development - summary ofdrivers and
resistors, 2008
- Figure 45: Vancomycin-resistant enterococci among ICUpatients in the US,
1995-2004
- Figure 46: E. faecalis /E. faecium susceptibility tovancomycin in
England and Wales, 1990-2005
- Figure 47: E. faecium - vancomycin resistance in Europe,2001-06
- Figure 48: Enterococcal infections by age group in theUK, 2005
- Figure 49: Enterococcal bacteremia reports by type inthe UK, 2002-06
- Figure 50: Enterococcal vaccine development - summary ofdrivers and
resistors, 2008
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