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DRUG DELIVERY

Innovations in Injectables
Current and emerging technologies to improve drug
delivery

By Lucy Doorbar
Lucy Doorbar

Lucy Doorbar is an independent consultant with 10 years experience in the healthcare


market. Lucy worked for a range of companies prior to becoming freelance, including
HBS Consulting, the Planning Shop International and Ipsos Mori. Lucy has worked for
many of the major market participants, and across numerous therapeutic areas within
the healthcare industry and holds a degree in psychology and sociology from the
University of Surrey.

Copyright © 2010 Business Insights Ltd


This Management Report is published by Business Insights Ltd. All rights reserved.
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Report nor for any actions taken in reliance thereon.

While information, advice or comment is believed to be correct at the time of


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completeness or accuracy.

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Table of Contents
Innovations in injectables

Executive Summary 10
Introduction 10
Key therapeutic areas for injectables 11
Market drivers and barriers 13
Competitive landscape 14
Company profiles of key players 15
Conclusions 16

Chapter 1 Introduction 20
Summary 20
Introduction 21
Types of injectable drug delivery 23
Controlled release 23
Mechanisms of controlled release 24
Drivers and restraints for controlled release formulations 25
Needle free delivery 26
Mechanisms of needle free delivery 27
Drivers and restraints for needle free technologies 29
Nanotechnology and microspheres 30
Mechanisms of nanotechnology drug delivery 31
Drivers and restraints – nanotechnology 35
Gene based drug systems 35
Electrical techniques 37
Vector assisted delivery 37
Drivers and restraints – gene based drug systems 38

Chapter 2 Key areas for injectable drug


delivery 42
Summary 42

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Introduction 44
Acromegaly 44
Background to therapeutic area 44
Current treatments 45
Looking forward 46
Diabetes 46
Background to therapeutic area 46
Type 1 diabetes 47
Type 2 diabetes 47
Current treatments 48
Looking forward 49
Hepatitis C 50
Background to therapeutic area 50
Current treatments 51
Looking forward 51
HIV 52
Background to therapeutic area 52
Current treatments 53
Looking forward 53
Oncology 54
Background to therapeutic area 54
Current treatments 55
Looking forward 56
Pain 57
Schizophrenia and substance abuse 58
Background to therapeutic areas 58
Current treatments 59
Schizophrenia 59
Substance abuse 59
Looking forward 60

Chapter 3 Market drivers and resistors 62


Summary 62
Key drivers 63
Improving patient compliance 63
Reducing toxicity 65
Advances in nanotechnology 66
Advances in genomics 69
Resistors 71
The threat from alternative delivery methods 71
Oral delivery of proteins and peptides 71
Pulmonary delivery of proteins and peptides 72
Transdermal delivery of proteins and peptides 73
Conclusion 75

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Regulatory issues 75
Nanotechnology regulation 75
Gene therapy regulation 76
Regulations impacting needle free injections 77

Chapter 4 Competitive landscape 80


Summary 80
Overall injectables market 81
Sustained release 81
Marketed products and market share 81
Emerging technologies 84
Nanotechnology 88
Marketed products and market share 88
Emerging technologies 91
Other novel injectable formulations 96
Marketed products and market share 96
Emerging technologies 96

Chapter 5 Company profiles of key players 104


Summary 104
Introduction 105
Alkermes 106
Technology platforms 106
Product pipeline 107
SWOT analysis 109
Bioject 109
Technology platforms 110
Product pipeline 110
SWOT analysis 112
Debiopharm group 113
Technology platforms 113
Product pipeline 114
SWOT analysis 117
Elan 117
Technology platforms 118
Product pipeline 119
SWOT analysis 121
Enzon pharmaceuticals 121
Technology platforms 122
Pipeline 123
SWOT analysis 125

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Ferring 125
Technology platforms 126
SWOT analysis 127
Nektar therapeutics 127
Technology platforms 128
Pipeline 129
SWOT analysis of Nektar 134
QLT 134
Technology platforms 135
Pipeline 135
SWOT analysis for QLT 136

Chapter 6 Conclusions 138


Summary 138
Conclusions 138
Index 141

List of Figures
Figure 1.1: Liquid jet injection technology vs. needled injection 28
Figure 1.2: Glide SDI solid dosing needle free delivery 28
Figure 1.3: Liposomal drug delivery 33
Figure 2.4: Distribution of Global Cancer Burden by WHO Region (2008) 55
Figure 4.5: Sustained release injectable market share analysis of leading products worldwide 2008
82
Figure 4.6: Sustained release injectable market share analysis of leading drug delivery companies
2008 84
Figure 4.7: Nanotechnology injectable market share analysis of leading products worldwide 2008
89
Figure 4.8: Nanotechnology injectable market share analysis of leading drug delivery companies
2008 90
Figure 5.9: Medisorb microsphere technology 107
Figure 5.10: Alkermes product pipeline, Dec, 2009 108
Figure 5.11: SWOT analysis of Alkermes 109
Figure 5.12: Bioject pipeline 111
Figure 5.13: SWOT analysis of Bioject 112
Figure 5.14: Debiopharma pipeline 116
Figure 5.15: SWOT analysis of Debiopharm 117
Figure 5.16: Elan’s product pipeline 120
Figure 5.17: SWOT analysis of Elan 121
Figure 5.18: Enzon’s product pipeline 123
Figure 5.19: SWOT analysis of Enzon 125
Figure 5.20: SWOT analysis of Ferring 127
Figure 5.21: Nektar’s product profile 133

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Figure 5.22: SWOT analysis of Nektar 134
Figure 5.23: SWOT analysis of QLT 136

List of Tables
Table 1.1: Drivers and barriers for the use of injections in delivering drugs 22
Table 1.2: The role of innovative drug delivery technologies 23
Table 1.3: Types of microspheres 34
Table 1.4: DNA delivery methods 37
Table 2.5: Acromegaly – key injectable therapies 46
Table 2.6: Estimated numbers of people with diabetes by region for 2000 and 2030 and summary
of population changes 48
Table 2.7: Key injectable therapies for Diabetes 50
Table 2.8: Estimated incidence of hepatitis C by WHO region 51
Table 2.9: Hepatitis C key injectable therapies 51
Table 2.10: Regional HIV Statistics 2001 and 2007 52
Table 3.11: Notable drug delivery companies / platforms - nanotechnology 68
Table 3.12: Notable drug delivery companies / platforms - genomics 70
Table 4.13: Worldwide injectables market 81
Table 4.14: Sustained release injectable market share & CAGR analysis of leading products
worldwide 2008 82
Table 4.15: Sustained release injectable drug delivery companies market share analysis worldwide
2008 83
Table 4.16: Patent expiry leading sustained release compounds (still in patent) 84
Table 4.17: Selected emerging technologies in sustained release 86
Table 4.18: Nanotechnology injectable market share & CAGR analysis of leading products
worldwide 2008 89
Table 4.19: Nanotechnology injectable drug delivery companies market share analysis worldwide
2008 90
Table 4.20: Patent expiries of leading nanotechnology compounds (still in patent) 90
Table 4.21: Selected emerging technologies in nanotechnology 91
Table 4.22: Selected emerging technologies in nanotechnology 97
Table 5.23: Alkermes in brief 106
Table 5.24: Bioject in brief 109
Table 5.25: Debiopharm group in brief 113
Table 5.26: Elan in brief 117
Table 5.27: Enzon in brief 121
Table 5.28: Ferring in brief 125
Table 5.29: Nektar in brief 127
Table 5.30: QLT in brief 134

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