Re-evaluating Pharmaceutical Pipelines - Emerging Markets, Biologics and Orphan Drugs to Shape Future Decision Making
Publisher Name » GBI Research
Published Date » 2012-06-12
No. Of Pages » 120
GBI Research, a leading business intelligence provider, has released its latest research, Re-evaluating Pharmaceutical Pipelines Emerging Markets, Biologics and Orphan Drugs to Shape Future Decision Making, which examines the key issues influencing the re-evaluation of pharmaceutical pipelines due to changes in the economic environment, the emergence of new markets, M&A and partnering activity, and recent advances in science and technology. It discusses the strategies the industry has adopted to address both internal and external challenges through open innovation, strategic acquisitions, partnerships and licensing deals.
GBI Researchs analysis highlights the trends in pharma productivity, the impact of drug attrition rates on different drug therapies, and the routes taken by companies to improve R&D efficiencies and maximize their product lifecycle management to ensure future growth and shareholder value.
It has been estimated that more than half of the products currently in late stage clinical development in pharmaceutical companies were originally derived from external sources. However, as the pool of innovative biotech and start-up companies contracts due to lack of venture capitalist funding, where will Pharma turn next? Find out more about the ways in which pharma is re-evaluating its product pipelines to invest in the future.
Scope
- Data and analysis regarding novel approaches to de-risk product development and address the shift in the geographical and therapeutic demands due to pharmerging markets and the changes in healthcare reform.
- Market analysis of R&D trends, identifying key areas of drug attrition and the strategies to reduce drug attrition and optimize product lifecycle management, including the expansion into OTC medicines, generics and biosimilars.
- Key challenges and opportunities that have had a significant impact on the market regarding geographical and therapeutic diversification of leading pharmaceutical companies.
- Key M&A activities and partnerships refueling company pipelines, including strategic acquisitions, collaborations, licensing deals, PPPs, CRADA s, JVs and risk sharing models.
- The competitive landscape and pharma R&D growth strategies adopted by leading pharmaceutical companies, including Johnson & Johnson, Merck & Co., Pfizer, Roche Group and Novartis.
Reasons to buy
- Identify the key market opportunities and align R&D portfolios to maximize growth
- Develop business strategies to optimize strategic acquisitions, collaborations and partnerships and licensing deals
- Devise a more tailored R&D approach to address specific geographical and therapeutic demands
- Develop key strategic initiatives by understanding the key factors impacting pharma R&D and preventing late stage product failures
- Re-evaluate and reassess investment decisions and explore ways in which to diversify and de-risk product development.
Table of Content
1 Table of Contents 6
1.1 List of Tables 8
1.2 List of Figures 9
2 Introduction 11
2.1 Market Conditions 11
2.2 Emerging Markets 12
2.2.1 Brazil 12
2.2.2 Russia 12
2.2.3 India 12
2.2.4 China 13
2.3 Healthcare Reform 14
2.3.1 The US 14
2.3.2 European Austerity 15
2.4 M&A and Partnerships 16
2.4.1 M&A Activity 16
2.4.2 Partnership Activity 18
2.4.3 Trends in 2011 20
2.5 Adopting New Business Models 22
2.5.1 Open Innovation Business Models 23
2.6 Advances in Science and Technology 24
2.6.1 Preclinical 24
2.6.2 Clinical 25
2.1 Market Conditions 11
2.2 Emerging Markets 12
2.2.1 Brazil 12
2.2.2 Russia 12
2.2.3 India 12
2.2.4 China 13
2.3 Healthcare Reform 14
2.3.1 The US 14
2.3.2 European Austerity 15
2.4 M&A and Partnerships 16
2.4.1 M&A Activity 16
2.4.2 Partnership Activity 18
2.4.3 Trends in 2011 20
2.5 Adopting New Business Models 22
2.5.1 Open Innovation Business Models 23
2.6 Advances in Science and Technology 24
2.6.1 Preclinical 24
2.6.2 Clinical 25
3 R&D Trends 27
3.1 Introduction 27
3.1.1 Drug Attrition vs. Therapy 28
3.1.2 Drug Attrition vs. Business Strategy 31
3.1.3 Strategies to Reduce Failure Rates in Phase III 33
3.1.4 Other Strategies to Reduce Drug Attrition 35
3.2 Maximizing Product Portfolios 36
3.2.1 New Uses for Existing Therapeutic Classes 37
3.3 Conclusions 40
3.1 Introduction 27
3.1.1 Drug Attrition vs. Therapy 28
3.1.2 Drug Attrition vs. Business Strategy 31
3.1.3 Strategies to Reduce Failure Rates in Phase III 33
3.1.4 Other Strategies to Reduce Drug Attrition 35
3.2 Maximizing Product Portfolios 36
3.2.1 New Uses for Existing Therapeutic Classes 37
3.3 Conclusions 40
4 R&D Challenges and Opportunities 41
4.1 Introduction 41
4.2 Geographical Diversification 42
4.3 Therapeutic Diversification 45
4.3.1 Biologics 45
4.3.2 Vaccines 47
4.3.3 Orphan Drugs 51
4.4 Generics and Biosimilars 58
4.5 OTC Medicines 60
4.6 Business Diversification 62
4.6.1 Animal Health 62
4.6.2 Consumer Healthcare 62
4.6.3 Diagnostics 62
4.6.4 Ophthalmic 62
4.6.5 Medical Devices 62
4.7 Conclusions 63
4.1 Introduction 41
4.2 Geographical Diversification 42
4.3 Therapeutic Diversification 45
4.3.1 Biologics 45
4.3.2 Vaccines 47
4.3.3 Orphan Drugs 51
4.4 Generics and Biosimilars 58
4.5 OTC Medicines 60
4.6 Business Diversification 62
4.6.1 Animal Health 62
4.6.2 Consumer Healthcare 62
4.6.3 Diagnostics 62
4.6.4 Ophthalmic 62
4.6.5 Medical Devices 62
4.7 Conclusions 63
5 Mergers, Acquistions and Partnerships - Refuelling Pipelines 64
5.1 Mergers 64
5.2 Strategic Acquisitions 65
5.2.1 Acquisitions through Equity Stakes 65
5.2.2 Strategic Acquisitions in the New Market Segments 65
5.2.3 Strategic Acquisitions in the Therapeutic Areas 67
5.3 Collaborations and Partnerships 67
5.3.1 Collaborations 68
5.3.2 Licensing Deals 70
5.3.3 Public-Private Partnerships 71
5.3.4 Cooperative Research and Development Agreements 73
5.3.5 Joint Ventures 74
5.3.6 Risk Sharing Models 75
5.4 Conclusion 75
5.1 Mergers 64
5.2 Strategic Acquisitions 65
5.2.1 Acquisitions through Equity Stakes 65
5.2.2 Strategic Acquisitions in the New Market Segments 65
5.2.3 Strategic Acquisitions in the Therapeutic Areas 67
5.3 Collaborations and Partnerships 67
5.3.1 Collaborations 68
5.3.2 Licensing Deals 70
5.3.3 Public-Private Partnerships 71
5.3.4 Cooperative Research and Development Agreements 73
5.3.5 Joint Ventures 74
5.3.6 Risk Sharing Models 75
5.4 Conclusion 75
6 Company Anaylsis 76
6.1 Johnson & Johnson 77
6.1.1 Pharmaceuticals 78
6.1.2 Pharma R&D Growth Strategies 82
6.1.3 Divestments 83
6.1.4 Summary 83
6.2 Merck & Co. 84
6.2.1 Pharmaceuticals 85
6.2.2 Strategic Acquisitions and Partnerships 88
6.2.3 Pharma R&D Growth Strategies 89
6.2.4 Summary 91
6.3 Pfizer 92
6.3.1 Biopharmaceuticals 94
6.3.2 Strategic Acquisitions and Partnerships 97
6.3.3 Pharma R&D Growth Strategies 98
6.3.4 Summary 100
6.4 Roche Group 100
6.4.1 Pharmaceuticals 102
6.4.2 Pharma R&D Growth Strategies 103
6.4.3 Personalized Healthcare 106
6.4.4 Summary 107
6.5 Novartis 108
6.5.1 Pharmaceuticals 109
6.5.2 Pharma R&D Strategy 112
6.5.3 Alcon Division 113
6.5.4 Summary 113
6.1 Johnson & Johnson 77
6.1.1 Pharmaceuticals 78
6.1.2 Pharma R&D Growth Strategies 82
6.1.3 Divestments 83
6.1.4 Summary 83
6.2 Merck & Co. 84
6.2.1 Pharmaceuticals 85
6.2.2 Strategic Acquisitions and Partnerships 88
6.2.3 Pharma R&D Growth Strategies 89
6.2.4 Summary 91
6.3 Pfizer 92
6.3.1 Biopharmaceuticals 94
6.3.2 Strategic Acquisitions and Partnerships 97
6.3.3 Pharma R&D Growth Strategies 98
6.3.4 Summary 100
6.4 Roche Group 100
6.4.1 Pharmaceuticals 102
6.4.2 Pharma R&D Growth Strategies 103
6.4.3 Personalized Healthcare 106
6.4.4 Summary 107
6.5 Novartis 108
6.5.1 Pharmaceuticals 109
6.5.2 Pharma R&D Strategy 112
6.5.3 Alcon Division 113
6.5.4 Summary 113
7 Market Outlook 114
7.1 Re-evaluation 114
7.1.1 Investing for the Future 114
7.1.2 Conflicts in the Business Model 115
7.1.3 Cost-Effectiveness of Drugs 115
7.1 Re-evaluation 114
7.1.1 Investing for the Future 114
7.1.2 Conflicts in the Business Model 115
7.1.3 Cost-Effectiveness of Drugs 115
8 Appendix 116
8.1 Market Definition 116
8.2 Abbreviations 116
8.3 Sources 117
8.4 Methodology 119
8.4.1 Primary Research 119
8.4.2 Secondary Research 120
8.5 Contacts Us 120
8.6 Disclaimer 120
8.1 Market Definition 116
8.2 Abbreviations 116
8.3 Sources 117
8.4 Methodology 119
8.4.1 Primary Research 119
8.4.2 Secondary Research 120
8.5 Contacts Us 120
8.6 Disclaimer 120
List of Tables
1.1 List of TablesTable 1: Re-evaluating Pharmaceutical Pipelines, Pharma Deals in India 13
Table 2: Re-evaluating Pharmaceutical Pipelines, Healthcare Spending, International Comparison (% of GDP) 14
Table 3: Re-evaluating Pharmaceutical Pipelines, Probability of Success Based on Therapy 29
Table 4: Re-evaluating Pharmaceutical Pipelines, Target-unbiased Molecular Property Differences 34
Table 5: Re-evaluating Pharmaceutical Pipelines, Repurposed Drugs 39
Table 6: Re-evaluating Pharmaceutical Pipelines, Recent Foreign Investment in BRIC 43
Table 7: Re-evaluating Pharmaceutical Pipelines, Leading Biologics, 2010 45
Table 8: Re-evaluating Pharmaceutical Pipelines, Pharma Acquisitions in Vaccines, 2006-2011 48
Table 9: Re-evaluating Pharmaceutical Pipelines, Pharma Alliances in Vaccines, 2006-2011 48
Table 10: Re-evaluating Pharmaceutical Pipelines, Strategic M&A and Licensing Activity in the Orphan Drug Arena 56
Table 11: Re-evaluating Pharmaceutical Pipelines, Drugs Losing Patent, 2011-2013 58
Table 12: Re-evaluating Pharmaceutical Pipelines, Mega Mergers, 2000-2011 64
Table 13: Re-evaluating Pharmaceutical Pipelines, Recent Strategic Acquisitions, 2008-2011 66
Table 14: Re-evaluating Pharmaceutical Pipelines, Recent Collaborations, 2008-2011 68
Table 15: Re-evaluating Pharmaceutical Pipelines, Recent Licensing Deals, 2008-2011 70
Table 16: Re-evaluating Pharmaceutical Pipelines, Recent Public-Private Partnerships 72
Table 17: Re-evaluating Pharmaceutical Pipelines, Recent CRADAs, 2011 73
Table 18: Re-evaluating Pharmaceutical Pipelines, Recent Joint Ventures, 2009-2011 74
Table 19: Re-evaluating Pharmaceutical Pipelines, J&J Top 10 Drugs, 2010 78
Table 20: Re-evaluating Pharmaceutical Pipelines, New Product Launches and NDA/sNDA and BLA Files 79
Table 21: Re-evaluating Pharmaceutical Pipelines, Strategic Partnerships, Collaboration and Licensing Deals 81
Table 22: Re-evaluating Pharmaceutical Pipelines, Mercks Top 10 Drugs, 2010 86
Table 23: Re-evaluating Pharmaceutical Pipelines, New Product Launches and NDA Drug Files, 2011 87
Table 24: Re-evaluating Pharmaceutical Pipelines, Strategic Partnerships, Collaboration and Licensing Deals, 2011 88
Table 25: Re-evaluating Pharmaceutical Pipelines, Pfizers Top 10 Drugs, 2010 94
Table 26: Re-evaluating Pharmaceutical Pipelines, New Product Launches and NDA/sNDA and BLA Files 95
Table 27: Re-evaluating Pharmaceutical Pipelines, Strategic Partnerships, Collaboration and Licensing Deals 97
Table 28: Re-evaluating Pharmaceutical Pipelines, Roches Top 10 Drugs, 2010 102
Table 29: Re-evaluating Pharmaceutical Pipelines, Novartis Top 10 Drugs, 2010 110
List of Figures
1.2 List of FiguresFigure 1: Re-evaluating Pharmaceutical Pipelines, M&A Deals by Value, 2008-2011 16
Figure 2: Re-evaluating Pharmaceutical Pipelines, M&A Deals by Market Segment, 2008-2011 17
Figure 3: Re-evaluating Pharmaceutical Pipelines, Partnering Activity by Value, 2008-2011 18
Figure 4: Re-evaluating Pharmaceutical Pipelines, Partnering Activity by Market Segment, 2008-2011 19
Figure 5: Re-evaluating Pharmaceutical Pipelines, M&A versus Partnering Activity, 2011 20
Figure 6: Re-evaluating Pharmaceutical Pipelines, Partnering Activity by Stage, 2011 21
Figure 7: Re-evaluating Pharmaceutical Pipelines, Partnering Activity by Therapy, 2011 21
Figure 8: Re-evaluating Pharmaceutical Pipelines, Open Innovation Business Model for Drug Development 22
Figure 9: Re-evaluating Pharmaceutical Pipelines, Application of Biomarkers in Drug Development 24
Figure 10: Re-evaluating Pharmaceutical Pipelines, Types of Biomarkers 25
Figure 11: Re-evaluating Pharmaceutical Pipelines, Learn and Confirm R&D Model 26
Figure 12: Re-evaluating Pharmaceutical Pipelines, FDA Approval Rates and R&D Expenditure, 2004-2010 27
Figure 13: Re-evaluating Pharmaceutical Pipelines, Probability of Success Based on Developmental Stage, 2005-2009 28
Figure 14: Re-evaluating Pharmaceutical Pipelines, Probability of Success Based on Therapy, 1991-2000 28
Figure 15: Re-evaluating Pharmaceutical Pipelines, Switch in Pipeline Focus,(%), 1990-1999 and 2000-2007 30
Figure 16: Re-evaluating Pharmaceutical Pipelines, FDA Approvals, 2006-2007 31
Figure 17: Re-evaluating Pharmaceutical Pipelines, Phase III Drug Failures, 2006-2007 32
Figure 18: Re-evaluating Pharmaceutical Pipelines, Reasons for Drug Failure in Late-stage Development, 1991 and 2000 33
Figure 19: Re-evaluating Pharmaceutical Pipelines, Maximizing Product Portfolio 36
Figure 20: Re-evaluating Pharmaceutical Pipelines, Drug Categories for Repurposing 37
Figure 21: Re-evaluating Pharmaceutical Pipelines, Maximizing Product Portfolio 38
Figure 22: Re-evaluating Pharmaceutical Pipelines, R&D Challenges and Opportunities 41
Figure 23: Re-evaluating Pharmaceutical Pipelines, Geographical Diversification 42
Figure 24: Re-evaluating Pharmaceutical Pipelines, FDA Drug Approvals, 2000-2010 46
Figure 25: Re-evaluating Pharmaceutical Pipelines, Pharmaceutical and Biological Revenues, $bn, 2010-2015 47
Figure 26: Re-evaluating Pharmaceutical Pipelines, Top Five Selling Vaccines, $m, 2009 50
Figure 27: Re-evaluating Pharmaceutical Pipelines, Exponential Growth of Drugs with Orphan Drug Designations in the US, 1985-2010 52
Figure 28: Re-evaluating Pharmaceutical Pipelines, FDA Orphan Diseases with the most Orphan Drug Approvals, 2010 53
Figure 29: Re-evaluating Pharmaceutical Pipelines, FDA Orphan Diseases with the Most Orphan Drug Designations 54
Figure 30: Re-evaluating Pharmaceutical Pipelines, Marketing approval of orphan medicines and COMP opinion on orphan designation by therapeutic area,%, 2000-2010 55
Figure 31: Re-evaluating Pharmaceutical Pipelines, FDA Orphan Drug Designations and Approvals for Large Pharma Companies, 1983-2011 57
Figure 32: Re-evaluating Pharmaceutical Pipelines, Top 10 Global Players in the Generics Market, $bn, 2008 59
Figure 33: Re-evaluating Pharmaceutical Pipelines, Geographical Sales Split of the OTC Market,(%), 2010 60
Figure 34: Re-evaluating Pharmaceutical Pipelines, Rx-to-OTC Product Switches by Company, 2000-2011 61
Figure 35: Re-evaluating Pharmaceutical Pipelines, Schematic Summarizing Business Model of Leading Companies 76
Figure 36: Re-evaluating Pharmaceutical Pipelines, Johnson & Johnson Global Revenues, $bn & %, 2010 77
Figure 37: Re-evaluating Pharmaceutical Pipelines, Johnson & Johnson, Revenue by Geography, $bn & %, 2010 78
Figure 38: Re-evaluating Pharmaceutical Pipelines, Johnson & Johnson New Product Revenues, $bn, 2010 80
Figure 39: Re-evaluating Pharmaceutical Pipelines, J&Js Pharma Growth Strategies 82
Figure 40: Re-evaluating Pharmaceutical Pipelines, J&Js New Product Launches Driving Future Growth 83
Figure 41: Re-evaluating Pharmaceutical Pipelines, Mercks Global Revenues, $bn, 2010 84
Figure 42: Re-evaluating Pharmaceutical Pipelines, Mercks Pharmaceutical Revenues, $bn, 2010 85
Figure 43: Re-evaluating Pharmaceutical Pipelines, Mercks Pharma Growth Strategies 89
Figure 44: Re-evaluating Pharmaceutical Pipelines, Mercks Late-Stage Product Pipeline, 2011 91
Figure 45: Re-evaluating Pharmaceutical Pipelines, Pfizer Global Revenues, $bn, 2010 92
Figure 46: Re-evaluating Pharmaceutical Pipelines, Pfizer Revenue by Geography, $bn, 2010 93
Figure 47: Re-evaluating Pharmaceutical Pipelines, Pfizer Biopharmaceutical Revenues, $bn, 2010 94
Figure 48: Re-evaluating Pharmaceutical Pipelines, Pfizer Product Pipeline, 2011 99
Figure 49: Re-evaluating Pharmaceutical Pipelines, Roches Global Revenues, $bn, 2010 100
Figure 50: Re-evaluating Pharmaceutical Pipelines, Roche, Regional Revenues, $bn, 2010 101
Figure 51: Re-evaluating Pharmaceutical Pipelines, Roche Group, FDA Approvals for NMEs and Line Extensions 103
Figure 52: Re-evaluating Pharmaceutical Pipelines, Roches Late-stage Pharma Pipeline, 2011 104
Figure 53: Re-evaluating Pharmaceutical Pipelines, Roche Group, Pipeline Products, 2011 105
Figure 54: Re-evaluating Pharmaceutical Pipelines, Roches PHC Strategy 106
Figure 55: Re-evaluating Pharmaceutical Pipelines, Novartis Global Revenues, $bn, 2010 108
Figure 56: Re-evaluating Pharmaceutical Pipelines, Novartis Regional Revenues, $bn, 2010 108
Figure 57: Re-evaluating Pharmaceutical Pipelines, Novartis Pharmaceutical Revenues, $bn, 2010 109
Figure 58: Re-evaluating Pharmaceutical Pipelines, Novartis Planned Product Filings, 2001-2015 111
Figure 59: Re-evaluating Pharmaceutical Pipelines, Novartis 2011 Strategic Priorities 112
Figure 60: Re-evaluating Pharmaceutical Pipelines, Novartis New Alcon Division 113
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