Market Report Source

Overview

Developing, manufacturing and marketing innovative new pharmaceutical drugs is highly complex and involves significant investment. Establishing an acceptable return on investment requires generating sufficient sales revenues which in turn requires maximizing market access at the highest possible price.

Table of Contents

Executive Summary 8
Introduction 8
Categorizing and valuing innovation 9
Region and therapy area specific considerations 10
Pricing challenges for recently launched innovative therapies 11
Upcoming launches of new innovative therapies 12

Chapter 1 Introduction 14
Summary 14
Introduction 15
Supply-side factors 17
Complexity and costs 17
Market size 17
Competition 18
Demand-side factors 19
Budget 19
Unmet need 19
Competition 20
Valuing innovation 20

Chapter 2 Categorizing and valuing innovation 24
Summary 24
Introduction 25
Categories of innovations 25
New market innovations 27
Redefining the category innovations 27
Second generation innovations 28
Incremental therapeutic innovations 29
Incremental formulation innovations 29
Innovative market access strategies 30
Orphan drugs 30
Risk-sharing 33

Chapter 3 Region and therapy area specificconsiderations 40
Summary 40
Introduction 41
Approaches to market access in major markets 41
USA 43
Japan 47
France 49
Germany 51
Italy 53
Spain 58
UK 60
Therapy area markets for innovative therapies 62
Oncology 63
HIV 64
Autoimmune diseases 64
Diabetes 66
Others 66

Chapter 4 Pricing challenges of recentlylaunched innovative therapies 70
Summary 70
Introduction 71
New market innovations 71
Gardasil (human papilloma virus vaccine): changing the treatment algorithm 71
Lysosomal storage diseases: pricing versus patient weight 73
Redefining the category innovations 77
Chantix (varenicline): redefining a therapeutic category 77
Nexavar (sorafenib) versus Sutent (sunitinib): meeting an unmet need 80
Second generation innovations 82
Lyrica (pregabalin): a new, improved neuropathic pain drug 83
Macugen vs Lucentis vs Avastin : premium pricing against off-label use 86
Incremental therapeutic innovations 90
Byetta vs Januvia: changing the treatment paradigm for type 2 diabetes 90
Prezista vs Fuzeon: premium pricing in HIV/AIDS 93
Incremental formulation innovations 96
Abraxane (paclitaxel): pricing incremental convenience 96
Vivitrol: market access vs premium pricing 99

Chapter 5 Upcoming launches of new innovative therapies 104
Summary 104
Introduction 105
New market innovations 106
Lupuzor (IPP-201101) – ImmuPharma 106
Sinunase – Accentia 107
Redefining the category innovations 108
Bapineuzumab – Elan/Wyeth 108
Multikine – CelSci 109
Second generation innovations 111
Arzoxifene – Eli Lilly 111
Cordaptive (niacin ER/laropiprant) – Merck 112
Incremental therapeutic innovations 113
Naproxcinod – NicOx 113
RhuDex – MediGene 114
Incremental formulation innovations 115
Denosumab – Amgen 115
Xarelto (rivaroxaban) – Bayer/J&J 116
Chapter 6 Appendix 119
Research sources 119
Pricing data 120

List of Figures

Figure 1.1: Supply and demand factors impacting market access for innovative therapies 18
Figure 2.2: Innovative drug categories by level of innovation and ease of market access 26
Figure 3.3: Source of prescription drug expenditures in the US, 2005-2006 46
Figure 3.4: Italian categorization for innovative new therapies 55
Figure 4.5: Gardasil global sales, 2006-07 ($m) 72
Figure 4.6: Selected lysosomal storage disease drugs global sales, 2006-07 74
Figure 4.7: Selected lysosomal storage disease drugs pricing in the UK and US, 2008 75
Figure 4.8: Smoking cessation drugs global sales, 2006-07 78
Figure 4.9: Smoking cessation drugs pricing in the UK and US, 2008 79
Figure 4.10: Nexavar and Sutent global sales, 2006-07 80
Figure 4.11: Nexavar and Sutent pricing in the UK and US, 2008 81
Figure 4.12: Selected neuropathic pain drugs global sales, 2006-07 83
Figure 4.13: Selected neuropathic pain drugs pricing in the UK and US, 2008 84
Figure 4.14: Age-related macular degeneration drugs global sales, 2006-07 87
Figure 4.15: Age-related macular degeneration drugs pricing in the UK and US, 2008 88
Figure 4.16: Selected type 2 diabetes drugs global sales, 2006-07 91
Figure 4.17: Selected type 2 diabetes drugs pricing in the UK and US, 2008 92
Figure 4.18: Selected HIV/AIDS drugs global sales, 2006-07 93
Figure 4.19: Selected HIV/AIDS drugs pricing in the UK and US, 2008 95
Figure 4.20: Taxane drugs global sales, 2006-07 97
Figure 4.21: Taxane drugs pricing in the US, 2008 98
Figure 4.22: Alcohol dependency drugs global sales, 2006-07 99
Figure 4.23: Alcohol dependency drugs pricing in the US, 2008 100

List of Tables

Table 3.1: Classification for price premium (Japanese healthcare system) 48
Table 4.2: Gardasil pricing in the UK and US, 2008 72
Table 4.3: Selected lysosomal storage disease drugs pricing in the UK and US, 2008 75
Table 4.4: Smoking cessation drugs pricing in the UK and US, 2008 79
Table 4.5: Nexavar and Sutent pricing in the UK and US, 2008 81
Table 4.6: Selected neuropathic pain drugs pricing in the UK and US, 2008 85
Table 4.7: Age-related macular degeneration drugs pricing in the UK and US, 2008 88
Table 4.8: Selected type 2 diabetes drugs pricing in the UK and US, 2008 91
Table 4.9: Selected HIV/AIDS drugs pricing in the UK and US, 2008 94
Table 4.10: Taxane drugs pricing in the UK and US, 2008 97
Table 4.11: Alcohol dependency drugs pricing in the UK and US, 2008 100
Table 5.12: Selected innovative therapies currently in late stage development 105
Table 6.13: Key UK and US pricing data for leading case studies, 2008 120
Table 6.13: Key UK and US pricing data for leading case studies, 2008 (continued) 121