Stakeholder Opinions: Vaccine antigen delivery technologies - Molecular systems to open new markets

ABOUT DATAMONITOR HEALTHCARE 2
About the Infectious diseases pharmaceutical analysis team 2
CHAPTER 1 EXECUTIVE SUMMARY 3
Strategic scoping and focus 3
Datamonitor insight into the vaccine delivery technologies market 3
Related reports 6
Upcoming related reports 6
CHAPTER 2 ANTIGEN TYPES FOR HUMAN VACCINES 8
Historic overview of antigen development for vaccines 8
Live-attenuated pathogens 9
Inactivated/killed pathogens 12
Protein-based subunit or toxoid vaccines 13
Polysaccharide subunit vaccines 14
DNA/RNA vaccines 15
CHAPTER 3 RATIONALE FOR THE DEVELOPMENT OF NOVEL ANTIGEN DELIVERY SYSTEMS 18
Novel delivery vehicles could improve the efficacy of subunit vaccines 19
Improved antigen stability is a key need, particularly for mucosal administration routes 20
Delivery vehicles with additional adjuvant qualities could enable the development of vaccines against challenging indications 21
CHAPTER 4 CHALLENGES FOR THE DEVELOPMENT OF NOVEL ANTIGEN DELIVERY VEHICLES 23
Cost containment could become a key hurdle for novel vaccine delivery vehicles 24
More research is needed to understand the molecular mechanisms of antigen delivery 26
The conservative attitude of regulators towards novel adjuvants and delivery vehicles is a key challenge 26
Various new technologies are in development as antigen delivery vehicles 27
CHAPTER 5 BACTERIAL/VIRAL VECTORS 29
Summary 29
General considerations 29
Bacterial/viral vector vaccines in development 31
Acambis/Sanofi Pasteur - ChimeriVax technology 34
Crucell - Advax technology 36
Bavarian Nordic - MVA-BN 37
Datamonitor assessment 38
CHAPTER 6 LIPOSOMES 42
Summary 42
General considerations 42
Liposomal vaccines in development 44
Merck Serono - Stimuvax/L-BLP25 45
NasVax - VaxiSome technology 47
Datamonitor assessment 47
CHAPTER 7 VIROSOMES 50
Summary 50
General considerations 50
Marketed and pipeline virosomal vaccines 52
Crucell - Immunopotentiating reconstituted influenza virosome (IRIV) technology 52
Pevion Biotech - PeviPro and PeviTer virosome technologies 54
Datamonitor assessment 56
CHAPTER 8 VIRUS-LIKE PARTICLES 57
Summary 57
General considerations 57
Marketed and pipeline VLP vaccines 59
Cytos Biotechnology - Immunodrug platform 62
Novavax - baculovirus-based VLPs 64
Others 66
Datamonitor assessment 66
CHAPTER 9 ISCOM/ISCOMATRIX 69
Summary 69
General considerations 69
ISCOM/ISCOMATRIX-based vaccines in development 70
CSL and licensees - ISCOMATRIX 71
Datamonitor assessment 72
CHAPTER 10 MICROPARTICLES/NANOPARTICLES 74
Summary 74
General considerations 74
Micro-/nanoparticle technologies in development for vaccines 75
PLGA - poly(-lactide co-glycolide) 76
Chitosan 79
Datamonitor assessment 80
BIBLIOGRAPHY 83
Literature 83
APPENDIX 94
Contributing experts 94
Academic key opinion leaders 94
Industry key opinion leaders 94
Conferences 94
Report methodology 95
About Datamonitor 96
About Datamonitor Healthcare 96
About the Infectious Diseases analysis team 97
Key therapy team members 98
Holger Rovini, Head of Respiratory and Infectious Diseases 98
Hedwig Kresse, Senior Analyst, Infectious Diseases 98
Disclaimer 99
List of Tables
Table 1: Key marketed live-attenuated vaccines, 7MM, May 2009 10
Table 2: Summary of key antigen delivery technologies in development 28
Table 3: Viral and bacterial vector-based vaccines for prophylactic vaccine applications, May 2009 33
Table 4: Viral and bacterial vector-based vaccines for therapeutic vaccine applications, May 2009 34
Table 5: SWOT analysis: bacterial/viral vector based vaccine delivery 40
Table 6: Key pipeline liposomal vaccines 45
Table 7: SWOT analysis - liposome-based vaccine delivery 49
Table 8: Key marketed and pipeline virosomal vaccines 52
Table 9: SWOT analysis - virosome-based vaccine delivery 56
Table 10: Key marketed and pipeline virus-like particle (VLP)-based vaccines 61
Table 11: SWOT analysis - virus-like particle (VLP)-based vaccine delivery 68
Table 12: Key pipeline vaccines based on ISCOMATRIX 71
Table 13: SWOT analysis - ISCOM/ISCOMATRIX-based vaccine delivery 73
Table 14: Key micro- and nanoparticle technologies in development 76
Table 15: SWOT analysis - microparticle-/nanoparticle-based vaccine delivery 82
List of Figures
Figure 1: History of vaccine antigen design and delivery 8
Figure 2: Unmet needs in antigen delivery 19
Figure 3: Drivers and resistors for the development of antigen delivery vehicles 24
Figure 4: Public sector immunization cost per child in the US ($), 1975-2008 25
Figure 5: Vector vaccines 30
Figure 6: Liposomal vaccine delivery 43
Figure 7: Virosome structure 51
Figure 8: Production of virus-like particles (VLPs) 58