Commercial and Pipeline Insight: Vaccines for Adults and the Elderly - New blockbuster opportunities ahead

Commercial and Pipeline Insight: Vaccines for Adults and the Elderly - New blockbuster opportunities ahead

Introduction

Vaccines have re-emerged as successful revenue generators for Big Pharma, with adults and the elderly now increasingly coming into focus as the next big opportunity in this sector. An aging population, rising disease awareness and new technologies to overcome the scientific hurdles linked to the weakened immune response in the elderly are all contributing factors.

Scope

*Assessment of pneumococcal and zoster disease incidence, in-depth analysis of existing vaccines and key pipeline compounds

*Review of current and expected future immunization guidelines as well as existing and forecast immunization rates

*10-year sales forecast on a population basis for Zostavax, Prevnar 13 and Pneumovax-23

*Overview of current booster vaccine recommendations and commercial landscape with analysis of future market drivers

Highlights

Following the great success of Wyeth's heptavalent pneumococcal vaccine Prevnar in the infant sector, Datamonitor believes that Prevnar 13 could achieve blockbuster status in adults and elderly alone, if a superior efficacy compared to Pneumovax 23 is confirmed in ongoing clinical trials.

Merck & Co's Zostavax is the only available vaccine for the prevention of shingles and will continue to enjoy a monopoly in this promising market due to a lack of pipeline competitors. Datamonitor predicts peak sales between $1.5 and $2 billion.

Sanofi Pasteur and GSK are the leading players in the booster vaccines market. Overall, Datamonitor predicts significant growth potential in this sector, based on both geographic expansion of existing booster indications as well as the potential introduction of additional booster vaccinations for new indications.

Reasons to Purchase

*Size the available market opportunities and identify the unmet medical needs when immunizing an elderly patient population

*Gain insight into key opinion leaders' thinking on vaccines for the elderly

*Understand and identify the key challenges to achieving a better penetration of the next big opportunity in the vaccine area

ABOUT DATAMONITOR HEALTHCARE 2
About the Infectious Diseases analysis team 2
CHAPTER 1 EXECUTIVE SUMMARY 3
Objective of the analysis 3
Scope of the analysis 3
Datamonitor insight into the vaccines market for adults and elderly 4
Contributing experts 5
Related reports 6
Upcoming related reports 6
CHAPTER 2 VACCINES FOR ADULTS AND ELDERLY - MARKET OVERVIEW 8
Adult vaccines - the next blockbusters? 8
Currently recommended vaccines 9
Routine vaccinations 10
Booster vaccinations for adults and elderly 11
Vaccines for catch-up and high-risk populations 11
Market influencers 12
The increasing age of the population is a key driver for adult vaccination 13
Challenges are associated with the lack of homogeneity in the immune status of adults and elderly 14
New technologies better suited to vaccine design for the elderly are emerging 15
It will be challenging to achieve high turn-out rates for vaccination among adults and elderly 17
Increasing awareness of vaccine-preventable diseases will result in greater interest in vaccination 19
A private market could emerge for adult vaccines 20
Strategies for maximum market penetration 21
CHAPTER 3 PNEUMOCOCCAL VACCINATION IN ADULTS AND ELDERLY 23
Summary 23
Disease background 23
Epidemiology 25
Invasive pneumococcal disease is associated with high incidence and death rates 25
The elderly are at high risk of infection and show highest death rates associated with invasive pneumococcal disease 26
The introduction of childhood vaccination with Prevnar has also reduced the incidence of invasive pneumococcal disease caused by vaccine serotypes in the elderly 29
Recommendations 32
Coverage 34
Comparator therapy: Pneumovax 23 (Merck & Co/Sanofi Aventis) 37
Unmet needs 41
Pipeline vaccines 43
Prevnar 13 (Wyeth) 44
Vaccine profile 44
Clinical trial data 45
Marketing factors 53
Satisfaction of unmet needs 53
Potential role in boosting 55
Datamonitor vaccine assessment summary 58
GlaxoSmithKline's pneumococcal conjugate candidates 61
Intercell's pneumococcal vaccine 64
Market opportunity and forecast 65
Pneumococcal vaccination in elderly and adults has a significant commercial potential 65
Assumptions made for forecasting the pneumococcal vaccines market 66
Country forecasts 68
Six major markets 68
US 72
5EU 75
France 77
Germany 79
Italy 81
Spain 84
UK 86
CHAPTER 4 ZOSTER VACCINES 88
Summary 88
Disease background 88
Course of disease - shingles occurs upon reactivation of varicella zoster virus 88
Post-herpetic neuralgia is the most concerning complication of shingles 90
Epidemiology 91
In the western major markets, around 2 million people suffer from herpes zoster infections every year 91
So far, there is no clear evidence of an increase in shingles incidence following routine infant varicella vaccination; however, more data are needed 93
Vaccination recommendations 95
Cost-efficacy considerations 97
Comparator therapy: Zostavax (Merck & Co) 99
Vaccine profile 99
Efficacy 100
Safety 103
Strengths and weaknesses 103
Unmet needs 104
Pipeline vaccines 105
Market opportunity and forecast 106
Historical sales performance 106
Assumptions made for forecasting the zoster vaccines market 108
Country forecasts 109
Six major markets 109
US 111
5EU 113
France 114
Germany 115
Italy 116
Spain 119
UK 120
CHAPTER 5 BOOSTER VACCINES 122
Summary 122
Current situation 123
Recommended vaccines 123
Currently marketed vaccines 125
Future outlook 127
Existing booster indications may be rolled out to additional countries 128
New indications are likely to be added to the booster portfolio 130
BIBLIOGRAPHY 132
Literature 132
APPENDIX A 140
Forecasts 140
Forecast methodology 140
Datamonitor forecast methodology 140
Datamonitor's patient-based forecasting model 141
Limitations of the patient-based forecasting model 143
APPENDIX B - MARKET FORECAST DATA 144
Six major markets 144
US 145
5EU 146
France 147
Germany 148
Italy 149
Spain 150
UK 151
APPENDIX C 152
Contributing experts 152
Report methodology 152
About Datamonitor 152
About Datamonitor Healthcare 153
About the Infectious Diseases analysis team 154
Key therapy team members 155
Holger Rovini, Head of Respiratory and Infectious Diseases 155
Hedwig Kresse, Senior Analyst, Infectious Diseases 155
Disclaimer 156
List of Tables
Table 1: Routine and booster immunizations for adults and elderly in the seven major markets, 2008 9
Table 2: Vaccination recommended for adults and elderly as catch-up or for risk groups only in the seven major markets, 2008 10
Table 3: Diseases linked to S. pneumoniae 24
Table 4: Recommendations for pneumococcal revaccination in adults and elderly in the seven major markets, 2008 34
Table 5: Pneumovax 23: key facts 37
Table 6: Prevnar 13 - Vaccine overview 44
Table 7: Prevnar 13 - Late-stage safety and efficacy trials in adults and elderly naïve to pneumococcal vaccination 47
Table 8: Prevnar 13 - Late-stage re-vaccination trials 50
Table 9: Prevnar 13 - Late-stage trials for simultaneous vaccination with Prevnar 13 and trivalent influenza vaccine 52
Table 10: GlaxoSmithKline pneumococcal conjugate vaccine candidates - clinical trials in adults/elderly, 2008 62
Table 11: Forecast pneumococcal vaccines sales in adults and elderly summary - six major markets, 2007-2017 71
Table 12: Forecast pneumococcal vaccines in adults and elderly summary - US, 2007-2017 74
Table 13: Forecast pneumococcal vaccine sales in adults and elderly summary - 5EU, 2007-2017 76
Table 14: Forecast pneumococcal vaccines in adults and elderly summary - France, 2007-2017 78
Table 15: Forecast pneumococcal vaccines in adults and elderly summary - Germany, 2007-2017 81
Table 16: Forecast pneumococcal vaccines in adults and elderly summary - Italy, 2007-2017 83
Table 17: Forecast pneumococcal vaccines in adults and elderly - summary - Spain, 2007-2017 85
Table 18: Forecast pneumococcal vaccines in adults and elderly summary - UK, 2007-2017 87
Table 19: Herpes zoster incidence in the US and 5EU 92
Table 20: Vaccination recommendations regarding varicella and herpes zoster in the seven major markets, 2006 97
Table 21: Zostavax: key facts 100
Table 22: Zoster vaccines - pipeline 105
Table 23: Zostavax market forecast - six major markets, 2007-2017 111
Table 24: Zostavax market forecast - US, 2007-2017 113
Table 25: Zostavax market forecast - 5EU, 2007-2017 114
Table 26: Zostavax market forecast - France, 2007-2017 115
Table 27: Zostavax market forecast - Germany, 2007-2017 116
Table 28: Zostavax market forecast - Italy, 2007-2017 119
Table 29: Zostavax market forecast - Spain, 2007-2017 120
Table 30: Zostavax market forecast - UK, 2007-2017 122
Table 31: Adolescent booster recommendations, seven major markets, 2008 124
Table 32: Adult booster recommendations, seven major markets, 2008 124
Table 33: Key marketed booster vaccines for adults and adolescents; 7MM, 2008 125
Table 34: Vaccine profiles for Adacel and Boostrix 127
Table 35: Six major markets pneumococcal and zoster vaccine sales ($m) forecasts, 2007-2017 144
Table 36: US pneumococcal and zoster vaccine sales ($m) forecasts, 2007-2017 145
Table 37: 5EU pneumococcal and zoster vaccine sales ($m) forecasts, 2007-2017 146
Table 38: France pneumococcal and zoster vaccine sales ($m) forecasts, 2007-2017 147
Table 39: Germany pneumococcal and zoster vaccine sales ($m) forecasts, 2007-2017 148
Table 40: Italy pneumococcal and zoster vaccine sales ($m) forecasts, 2007-2017 149
Table 41: Spain pneumococcal and zoster vaccine sales ($m) forecasts, 2007-2017 150
Table 42: UK pneumococcal and zoster vaccine sales ($m) forecasts, 2007-2017 151
List of Figures
Figure 1: Market growth cycle for vaccines 12
Figure 2: Population aged 65 years and older in the seven major markets, 1998-2018 13
Figure 3: Strategies for maximum market penetration of the adult vaccination market 22
Figure 4: Invasive pneumococcal disease (IPD) in the elderly in the seven major markets, 2007 25
Figure 5: Incidence of disease and case-fatality rate (CFR) of invasive pneumococcal disease by age groups in Scotland, 1999-2001 27
Figure 6: Pneumococcal disease - incidence and mortality of invasive pneumococcal disease in the US, 2004 28
Figure 7: Impact of Prevnar on incidence of invasive pneumococcal disease in children and elderly, in the US, 1998/99 versus 2003 29
Figure 8: Case and death rates linked to invasive pneumococcal disease caused by all serotypes of S. pneumoniae by age group, in the US, 1999-2006 31
Figure 9: Recommendations for adult pneumococcal vaccination in the seven major markets, 2008 33
Figure 10: Pneumococcal vaccination coverage by age group in the US, 1997-2006 35
Figure 11: Pneumovax 23 - strengths and weaknesses 38
Figure 12: Unmet needs in pneumococcal vaccination 41
Figure 13: Prevnar 13 - study design of re-vaccination trials 48
Figure 14: Pneumococcal booster strategies 56
Figure 15: Prevnar 13 - SWOT analysis 58
Figure 16: Forecast pneumococcal vaccines in adults and elderly by country - six major markets, 2007-2017 69
Figure 17: Forecast pneumococcal vaccines in adults and elderly by population group - six major markets, 2007-2017 70
Figure 18: Forecast pneumococcal vaccines in adults and elderly by brand - six major markets, 2007-2017 71
Figure 19: Forecast pneumococcal vaccines in adults and elderly by population group - US, 2007-2017 73
Figure 20: Forecast pneumococcal vaccines in adults and elderly by brand - US, 2007-2017 74
Figure 21: Forecast pneumococcal vaccines in adults and elderly by population group - 5EU, 2007-2017 75
Figure 22: Forecast pneumococcal vaccines in adults and elderly by brand - 5EU, 2007-2017 76
Figure 23: Forecast pneumococcal vaccines in adults and elderly by population group - France, 2007-2017 77
Figure 24: Forecast pneumococcal vaccines in adults and elderly by brand - France, 2007-2017 78
Figure 25: Forecast pneumococcal vaccines in adults and elderly by population group - Germany, 2007-2017 80
Figure 26: Forecast pneumococcal vaccines in adults and elderly by brand - Germany, 2007-2017 80
Figure 27: Forecast pneumococcal vaccines in adults and elderly by population group - Italy, 2007-2017 82
Figure 28: Forecast pneumococcal vaccines in adults and elderly by brand - Italy, 2007-2017 83
Figure 29: Forecast pneumococcal vaccines in adults and elderly by population group - Spain, 2007-2017 84
Figure 30: Forecast pneumococcal vaccines in adults and elderly by brand - Spain, 2007-2017 85
Figure 31: Forecast pneumococcal vaccines in adults and elderly by population group - UK, 2007-2017 86
Figure 32: Forecast pneumococcal vaccines in adults and elderly by brand - UK, 2007-2017 87
Figure 33: Varicella zoster virus infection - disease progression 89
Figure 34: Herpes zoster incidence by age group in Madrid, Spain, 1997-2004 93
Figure 35: Varicella and herpes zoster incidence in various age groups in the US, 1992-2002 94
Figure 36: Zostavax - efficacy in preventing herpes zoster infection by age group 101
Figure 37: Zostavax - efficacy in preventing post-herpetic neuralgia (PHN) in patients who developed herpes zoster infection by age group 102
Figure 38: Zostavax - duration of efficacy for preventing herpes zoster and post-herpetic neuralgia (PHN) following vaccination 103
Figure 39: Zostavax - sales 2006-Q1 2008 107
Figure 40: Zostavax market forecast by country - six major markets, 2007-2017 110
Figure 41: Zostavax market forecast - six major markets, 2007-2017 111
Figure 42: Zostavax market forecast - US, 2007-2017 112
Figure 43: Zostavax market forecast - 5EU, 2007-2017 114
Figure 44: Zostavax market forecast - France, 2007-2017 115
Figure 45: Zostavax market forecast - Germany, 2007-2017 116
Figure 46: Zostavax market forecast - Italy, 2007-2017 118
Figure 47: Zostavax market forecast - Spain, 2007-2017 120
Figure 48: Zostavax market forecast - UK, 2007-2017 122
Figure 49: Sanofi Pasteur - booster vaccine sales, 2002-07 126
Figure 50: Pertussis notifications in England and Wales for over 5 year-olds, 1999-2007 129
Figure 51: Datamonitor's patient-based vaccine forecasting model - influence factors 142