Executive Summary 10
The importance of new product launches 10
Global launch strategies 11
Optimal launch timing 12
Winning launch partnerships 13
Effective promotion and positioning 14
Key products, therapy areas and companies 15
Chapter 1 The importance of new product launches 18
Summary 18
Introduction 19
Declining R&D productivity 19
Stagnant returns on investment 21
Central importance of new product launches 23
Key product launch success factors 25
Chapter 2 Global launch strategies 30
Summary 30
Introduction 31
Global launch sequence 32
Case study: Zetia (ezetimibe) 34
Global brand strategies 35
Global marketing strategies 37
Reflections and recommendations 39
Chapter 3 Optimal launch timing 42
Summary 42
Introduction 43
Maximizing patent exclusivity period 44
Managing therapeutic franchises 46
Early product launch strategies 47
Case study: Alimta (pemetrexed) 50
Reflections and recommendations 52
Chapter 4 Winning launch partnerships 56
Summary 56
Introduction 57
Global licensing strategies 57
Product launch partnerships 59
Case study: Cymbalta (duloxetine) 60
Reflections and recommendations 62
Chapter 5 Effective promotion and positioning 66
Summary 66
Introduction 67
Size matters 67
DTC driving new market access 71
New product positioning strategies 73
Case study: Reyataz (atazanavir) 75
Reflections and recommendations 76
Chapter 6 Key products, therapy areas and companies 80
Summary 80
Key products 81
Case study: Neulasta (pegfilgrastim) 84
Case study: Avastin (bevacizumab) 86
Case study: Cialis (tadalafil) 87
Key therapy areas 89
Key companies 92
Chapter 7 Appendix 94
Product approval database 94
Index 100
List of Figures
Figure 1.1: New drug approvals per US$ billion of R&D in the US and EU, 2001-2005 20
Figure 1.2: Pharmaceutical sales per dollar of R&D in the US and EU, 2001-2005 21
Figure 1.3: Distribution of returns and costs for new drugs, arranged by sales deciles 22
Figure 1.4: New approvals as a proportion of pharma sales driving growth 24
Figure 1.5: Key success factors for new drug launches 26
Figure 2.6: Key new drug success factors: global launch 31
Figure 2.7: New global drug launches by first approval, 2001-2005 32
Figure 2.8: New global drug launches by launch sequence, 2001-2005 33
Figure 2.9: Zetia (ezetimibe) sales, 2003-2006 35
Figure 2.10: New global drug launches by brand strategy, 2001-2005 36
Figure 2.11: Global product development versus global marketing, new drugs 2001-2005 37
Figure 2.12: New global drug launches by marketing strategy, 2001-2005 38
Figure 3.13: Key new drug success factors: launch timing 43
Figure 3.14: Average post-launch US patent exclusivity period, 2001-2005 44
Figure 3.15: Distribution of post-launch US patent exclusivity periods, 2001-2005 45
Figure 3.16: Follow-on franchise product examples 46
Figure 3.17: US new drug approvals by review process, 2001-2005 48
Figure 3.18: US new drug approvals by orphan drug status, 2001-2005 49
Figure 3.19: US new drug approvals by market exclusivity period, 2001-2005 50
Figure 3.20: Alimta (pemetrexed) sales, 2004-2006 52
Figure 4.21: Key new drug success factors: partnering strategy 57
Figure 4.22: Global new drug approvals by licensing status, 2001-2005 58
Figure 4.23: US new drug approvals by US licensing status, 2001-2005 60
Figure 4.24: Cymbalta (duloxetine) sales, 2004-2006 62
Figure 5.25: Key new drug success factors: promotion and positioning 67
Figure 5.26: New approvals appear to be dominated by companies generating the greatest pharma
sales and sales growth 68
Figure 5.27: US new drug approvals by designated marketing company, 2001-2005 69
Figure 5.28: EU new drug approvals by designated marketing company, 2001-2005 70
Figure 5.29: Impact of DTC during new product launch: Crestor and Cialis 72
Figure 5.30: Reyataz (atazanavir) sales, 2003-2006 76
Figure 6.31: US new drug approvals by technology, 2001-2005 81
Figure 6.32: EU new drug approvals by technology, 2001-2005 82
Figure 6.33: Neulasta (pegfilgrastim) sales, 2002-2006 85
Figure 6.34: Avastin (bevacizumab) sales, 2004-2006 87
Figure 6.35: Cialis (tadalafil) sales, 2004-2006 89
Figure 6.36: US and EU new drug approvals by therapy area, 2001-2005 90
Figure 6.37: US and EU new drug approvals by ATC3 code, 2001-2005 91
Figure 6.38: US and EU new drug approvals by company, 2001-2005 92
List of Tables
Table 2.1: Zetia (ezetimibe) profile 34
Table 3.2: Alimta (pemetrexed) profile 51
Table 4.3: Cymbalta (duloxetine) profile 61
Table 5.4: Leading US new drug launches by DTC spend, 2001-2005 71
Table 5.5: Leading new drug launches by launch positioning, 2001-2005 74
Table 5.6: Reyataz (atazanavir) profile 75
Table 6.7: Selected leading new drug launches, 2001-2005 83
Table 6.8: Neulasta (pegfilgrastim) profile 84
Table 6.9: Avastin (bevacizumab) profile 86
Table 6.10: Cialis (tadalafil) profile 88
Table 7.11: US and EU product approvals, 2001 to 2005 94
Table: 7.12 US and EU product approvals, 2001 to 2005 (continued) 95
Table: 7.13 US and EU product approvals, 2001 to 2005 (continued) 96
Table: 7.14 US and EU product approvals, 2001 to 2005 (continued) 97
Table: 7.15 US and EU product approvals, 2001 to 2005 (continued) 98
Table: 7.16 US and EU product approvals, 2001 to 2005 (continued) 99