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

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.

Report 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.
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Overview 1
Catalyst 1
Summary 1
Key Messages 2
Industry pressures to cut costs have companies turning to technology solutions 2
Regulatory requirements and standards pave the road for eClinical technologies 2
eClinical solutions enable adaptive trials 3
Having seen no significant efficiencies from early clinical systems, companies are skeptical 3
In a segmented eClinical market, partnerships are essential 3
Interoperability is the key to the future 4
TABLE OF CONTENTS 5
Table of figures 5
Market Opportunity 6
Industry pressures to cut costs have companies turning to technology solutions 6
What are eClinical solutions and why should pharma care? 6
EDC systems are required to increase efficiencies within paper-based clinical trials 8
Electronic data capture provides higher quality data 8
Reduction in database lockdown time is a true measurement of EDC success 9
EDC offers many advantages over the traditional data capture process 10
The growing complexity of clinical trials calls for a robust CTMS 11
The benefits of CTMS are endless 12
Globalization adds fuel to the fire 12
Regulatory requirements and standards pave the road for eClinical technologies 13
CDISC ODM defines standards for interchange of clinical trials data 13
New CDISC initiatives support clinical systems interoperability 13
Having seen no significant efficiencies from early clinical systems, companies are skeptical 14
EDC and CTMS adoption have been hindered by pharma's aversion to change 15
Misconceptions about eClinical technologies slows down implementation 16
Until recently, there has been a lack of need for full-featured, commercial CTMS solutions 16
Customer Impact: Clinical solutions increase efficiency and reduce cost 17
eClinical solutions enable adaptive trials 17
Adaptive trials result in lower development costs, reduced time-to-market and better patient safety 17
EDC provides real-time access to patient data 17
The continuous change involved with adaptive trials requires a robust CTMS 18
A paradigm shift must take place before eClinical adoption takes-off 18
Clinical trials solutions must provide an intuitive interface 19
Life science companies must be educated about the process change involved 19
Companies will require various hosting models to meet their needs 19
Current trends in clinical trials will lead to the increase in adoption of eClinical solutions 20
Cost reduction is a major factor in adopting eClinical solutions 20
The globalization of clinical trials leads to the need for enhanced management tools 20
Competitive Landscape 22
EDC solutions will no longer be a thing of the future 22
EDC solutions will soon be a commodity rather than a niche technology 22
As researchers become familiar with EDC, technology transfer models will become more commonplace 22
Standards and CRF libraries will ease the study building process 23
CTMS: a stand-alone solution or a value-added function of EDC systems? 23
CTMS solutions will be viewed as a combination of ERP and CRM technologies 24
Vendor Market 24
EDC 24
Akaza Research 29
Medidata 30
Nextrials 31
OmniComm 32
Phase Forward 33
CTMS 34
Atlantic Research Group 37
Perceptive Informatics / PAREXEL International 38
Winchester Business Systems 39
eClinical Suite - EDC and CTMS 40
ClinPhone 41
Oracle 42
The future of eClinical solutions is interoperability 44
Signal detection and safety systems will become an essential aspect of an eClinical solution 44
How will electronic health records integrate with eClinical solutions? 44
Go to market 46
Vendors must show how eClinical solutions will streamline the clinical process 46
Provide solutions to make Phase I EDC trials cost-effective 46
In a segmented eClinical market, partnerships are essential 47
Look to integrate essential technologies to reduce redundancy and increase efficiencies 47
Interoperability is the key to the future 47
EDC vendors must provide sufficient training for technology transfer 48
The evolution of clinical data standards will require companies to stay updated 48
Ensure that IT solutions meet government standards for electronic records 49
As clinical trials move to global locations, so should vendors 49
APPENDIX 50
Definitions and Abbreviations 50
Methodology 50
Further reading 51
Ask the analyst 51
Datamonitor consulting 51
Disclaimer 51
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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
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
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