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The blockbuster model now delivers just 5% return on investment and only one in six new drug prospects will deliver returns above their cost of capital, as a result competitive pressures and falling R&D productivity will instigate a new pharmaceutical model that replaces the unsustainable blockbuster model; personalized medicine and the "nichebuster". This report, Beyond the Blockbuster Drug: Strategies for nichebuster drugs, targeted therapies and personalized medicine, examines targeted therapies and targeted drug delivery strategies as alternative investment options for pharmaceutical companies, in the face of declining returns and slow growth in the blockbuster market. This report’s strategic insight is also supported by in-depth interviews with thought leaders from the pharmaceutical industry, providing you with their insight into how tomorrow’s pharmaceutical business model will develop. This report analyzes the niche pharmaceutical sectors with the greatest potential for profit and future growth. Harness the technological advances in personalized medicine and be part of the "nichebuster" revolution set to drive market growth and produce the market leading drugs of tomorrow.

Table of Contents
 
Beyond the blockbuster drug: Strategies for
 
nichebuster drugs, targeted therapies and personalized
 
medicine.
 
Acknowledgements 8
 
Executive summary 14
 
The blockbuster: An unsustainable model 14
 
Industry at a crossroads 15
 
Beyond the blockbuster: Personalized medicine 15
 
Targeted medicine: oncology 16
 
New drug technologies: discovery and delivery 17
 
Drug development: outsourcing and partnering 18
 
Case study: Roche 19
 
Case study: Novartis 20
 
Creating tomorrow’s winning company 21
 
Chapter 1 The blockbuster: An
 
unsustainable model 24
 
Summary 24
 
Introduction 25
 
The rise and fall of the blockbuster phenomenon 27
 
The blockbuster phenomenon 27
 
When blockbusters come off patent 29
 
Implications for the future of the industry 31
 
Chapter 2 The industry at a crossroads 34
 
Summary 34
 
The Failure of R&D 34
 
The R&D performance gap 38
 
The failure of the “mega-merger” 41
 
Conclusion 44
 
Chapter 3 Beyond the blockbuster:
 
Personalized medicine 48
 
Summary 48
 
Where next? 49
 
Personalized medicine 51
 
Gene-based therapies reach the market by 2010 51
 
The race for new therapies 53
 
Conclusion 55
 
Chapter 4 Targeted medicine: Oncology 58
 
Summary 58
 
Introduction 59
 
A promising therapeutic field 61
 
Gleevec 61
 
Therapeutic focus on cancer 62
 
Drug discovery deals 63
 
Molecularly targeted therapies 66
 
Herceptin 67
 
Promising treatments for breast cancer 69
 
Advances in treatment for colorectal cancer 70
 
Prostate cancer 70
 
Conclusion 71
 
Chapter 5 Targeted drug delivery 76
 
Summary 76
 
New drug technologies 78
 
Customized medicine 79
 
A future of unseen opportunity 80
 
Advances in science 81
 
Targeted drug delivery 82
 
Oral delivery of macromolecules 83
 
Enhanced bioavailability / Efflux inhibitors 83
 
SCF technologies 84
 
Inhibiting P-gp action 84
 
Injectable, biodegradable depot drug delivery 85
 
Parenteral drug delivery 85
 
PEGylation to deliver protein and cancer drugs 86
 
Conclusion 87
 
Chapter 6 Drug development: Outsourcing
 
and partnering 90
 
Summary 90
 
Introduction 91
 
Why outsource? 91
 
The changing CRO model 92
 
Biotechs are reshaping drug development 93
 
Moving from vendor to strategic partner 93
 
Realizing strategic value 94
 
The ideal CRO model for the new outsourcing paradigm 96
 
Models for outsourcing 97
 
Do-it-yourself 97
 
Architect 97
 
Integrated design and build 98
 
Risk-sharing 98
 
Conclusion 99
 
Chapter 7 Case study: Roche 102
 
Summary 102
 
Banking on “nichebusters” 102
 
A radically transformed Roche portfolio 103
 
Diagnostics: An essential precursor for targeted medicines 104
 
R&D partnerships for faster growth 106
 
Conclusion 107
 
Chapter 8 Case study: Novartis 110
 
Summary 110
 
Targeted medicine 110
 
Breadth vs depth? 111
 
Novartis portfolio 112
 
PTK787 (ZX 222584) 112
 
ICL670 113
 
Gimatecan 113
 
Femara 114
 
Conclusion 115
 
Beyond targeted medicine 115
 
Chapter 9 Creating tomorrow’s winning
 
company 120
 
Summary 120
 
Prisoners of ROI 121
 
Adding a dimension to the matrix 121
 
Pharmaceutical companies as service providers 122
 
Boom times knocking at the door.. 123
 
… But not without change 124
 
Alliances fuel innovation 125
 
Growing a product to its maximum sales 126
 
Medicines for “My” body 127
 
A broader view of the competition 128
 
Far-reaching psychological and structural transformation 129
 
Conclusion 131
 
Index 132
 

 
Figures
 
Figure 1.1: From therapy to health maintenance busters 26
 
Figure 2.2: Emergence of an elite group of R&D spenders 35
 
Figure 2.3: Ten year evolution of a drug’s development cost 36
 
Figure 2.4: Declining R&D success* 37
 
Figure 2.5: Drug candidates of major R&D-driven pharma companies 38
 
Figure 2.6: Performance gap in R&D 39
 
Figure 2.7: Breakdown of projects by clinical phase and source of drug 40
 
Figure 2.8: No economies of scale in pharmaceutical R&D 42
 
Figure 2.9: Shareholder returns of merged and non-merged companies 44
 
Figure 2.10: The need for alliances and partnering 45
 
Figure 3.11: Genomic research based products reach the market before 2010 52
 
Figure 3.12: Genetically manufactured substances in the pipeline 53
 
Figure 4.13: Therapeutic focus of clinical pipeline activity 62
 
Figure 4.14: Global oncology players, 2002 63
 
Figure 4.15: Deals by therapeutic focus (Sept ‘02 t0 Mar ‘04) 64
 
Figure 4.16: Therapeutic focus by company (Sept ‘02 to Mar ‘04) 65
 
Figure 4.17: Development of the global oncology market 2001-2008* 66
 
Figure 4.18: Breast cancer market opportunities 69
 
Figure 6.19: Today’s R&D environment 92
 
Figure 6.20: The future R&D environment 96
 
Figure 7.21: Leading products in the Roche portfolio, 2003 103
 
Figure 7.22: The Roche business model: Innovation and diagnostics 104
 
Table 8.23: Novartis, sales by type of business activity ($m), 2003 111
 
Figure 8.24: External sources contribute to Novartis´ product growth 115
 
Figure 9.25: Drug discovery holds immense possibilities 126
 
Figure 9.26: Reshaping the “traditional” healthcare model 128
 
Figure 9.27: The integrated virtual MegaPharma-Biotech company 130
 
List of Tables
 
Table 3.1: Drug candidates in early stage clinical development, 2002-2003 54
 
Table 4.2: Cancer pathologies (selected) in the US 60
 
Table 5.3: Novel drug technologies 78
 
Table 7.4: Roche: Early stage development alliances 107
 
Table 8.5: Estimated product launch timetable for Novartis´ drug pipeline 114