Pipeline Insight: Nosocomial Vaccines

Content

• 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