Summary

The leading business intelligence provider, has released its latest research, “Big Pharma's Key Lifecycle Management Strategies: Maximizing the Market Potential.” It provides key data, information and analysis on the key lifecycle management strategies implemented by pharmaceutical companies. This pharmaceutical and healthcare report provides information on the Lifestyle Management Strategies (LCM) market, the reasons why companies implement LCM strategies and the challenges faced by them. This report provides comprehensive analysis of five key LCM strategies (new indications, formulation variants, extended/controlled released versions, Rx-to-OTC switch and store brand generic) using case studies. The report also provides the sales growth patterns of key drugs for which LCM activities are being carried out. It also reviews the factors determining the success and failure of the strategies providing an understanding of how to ensure success for LCM.

This report is built using data and information sourced from proprietary databases, primary and secondary research and in house analysis by GBI Research’s team of industry experts.

Scope

The scope of this report includes:
- Analysis and data on LCM activities of top twenty pharmaceutical companies including Roche, Bayer, GSK, and Pfizer in terms of the LCM pipeline.
- Insight into the LCM activities in the top five therapeutic areas including cancer, central nervous system (CNS), cardiovascular system (CVS), metabolic diseases and infectious diseases.
- Detailed case studies for each of the key LCM strategies identified. Sales and growth trend data for selected examples for each of the key strategies.
- Sales growth analysis of top ten drugs under LCM and the timeline of LCM events
- Qualitative analysis of market drivers, restraints, future outlook and challenges faced by the LCM strategies of the companies
- Framework for measuring LCM performance and effective team structures for integrating the LCM team into the organization

Reasons to buy

The report will enhance your decision making capability. It will allow you to
- Align product portfolio to the markets with high growth potential
- Develop market-entry and market expansion strategies by identifying the leading therapeutic segments and geographic markets poised for strong growth
- Reinforce R&D pipelines by identifying new target mechanisms which can produce first in class molecules with more efficiency and better safety
- Develop key strategic initiatives by understanding key focus areas of leading companies
- Exploit in-licensing and out-licensing opportunities by identifying products that could fill portfolio gaps

1
1 3
2 Introduction 7
2.1 GBI Research Report Guidance 7
3 Lifecycle Management – The Next Big Thing for the Pharmaceutical Industry 9
3.1 LCM Activities in Major 20 Pharmaceutical Companies 9
3.2 Increasing Urgency to Launch LCM Activities 10
3.3 Future Competitive Landscape: Tough Road Ahead 10
3.4 Conclusion 10
4 Reasons to Implement Lifecycle Management – Increasing Financial Pressures 12
4.1 Patent Expiration of Blockbuster Drugs 12
4.2 Penetration of Generics 14
4.3 Drought in the R&D Pipeline Products (Low R&D Productivity) 15
4.4 Stricter FDA Rules and Regulations for Drug Approval 17
4.5 Restriction on Pricing and Reimbursement of Originals 18
4.6 Changing Customer Landscape (Empowered Patients Influencing Physicians) 18
4.7 Conclusion 20
5 Process of Implementation of Lifecycle Management Strategies – Correct Selection and Efficient Execution is the Key 21
5.1 Objective of the Implementation of Lifecycle Management 21
5.1.1 To Maximize the Drug Value 21
5.1.2 To Capitalize on the Existing Brand 22
5.1.3 To Cater to an Unmet Patient Need 22
5.1.4 To Overcome Generic Competition 23
5.2 Major Strategies for the Implementation of Lifecycle Management 23
5.2.1 New Indications 23
5.2.2 Introducing Formulation Variants (Tablets, IVs, Syrups) 28
5.2.3 Extended/Controlled Release Versions 33
5.2.4 Planning Rx-to-OTC Switch 38
5.2.5 Store-Brand Generic 43
5.3 Strategies That Failed 44
5.3.1 Introduction 44
5.3.2 Case 1: Schering-Plough’s Clarinex 45
5.3.3 Case 2: Pfizer’s Xanax 46
5.4 Key Lessons 47
5.4.1 New Formulations, New Indications and Extended/Controlled Releases 47
5.4.2 Planned Rx-to-OTC Switch 48
5.4.3 Store-Brand Generic 48
5.4.4 Failed Strategies 48
6 The Pharmaceutical Pipeline and LCM Today – Cancer and CNS on the Top 49
6.1 The Pharmaceutical Pipeline and the Lifecycle Management Landscape 49
6.2 Analysis of the Top Five Lifecycle Management Therapeutic Areas of Research 55
6.2.1 Cancer 55
6.2.2 CNS 56
6.2.3 CVS 56
6.2.4 Infectious Diseases 57
6.2.5 Metabolic Diseases 58
6.3 Analysis of Top 10 Drugs under Lifecycle Management Research 59
6.3.1 Roche/Genentech’s Avastin (Cancer) 59
6.3.2 Bayer’s Xarelto (Hemocytic Disorder) 60
6.3.3 GSK’s Tykerb/Tyverb (Cancer) 61
6.3.4 Roche/Genentech’s Herceptin (Cancer) 61
6.3.5 Roche/Genentech’s Rituxan (Cancer) 62
6.3.6 Allergan’s Botox (CNS/Urology) 63
6.3.7 Bayer’s Nexavar (Cancer) 64
6.3.8 Pfizer’s Sutent (Cancer) 65
6.3.9 Takeda/J&J’s Velcade (Cancer) 66
6.3.10 Takeda’s Actos (Metabolic Diseases) 67
6.4 Conclusion 68
7 Ensuring Success of Lifecycle Management – Overcoming Challenges 69
7.1 LCM Strategy not Integrated with the Overall Strategy of the Company 69
7.1.1 Consistent Management Support for LCM Programs 70
7.1.2 A Dedicated Team for LCM 71
7.2 Consider All the Key Factors for Success at the Planning Stage 74
7.2.1 Unmet Patient Need 74
7.2.2 Impact on Profitability 74
7.2.3 Time of Launch 75
7.2.4 Competitive Landscape of the Market 76
7.3 Comprehensive System to Track or Assess Effectiveness of a Strategy 77
7.3.1 Framework for Measuring Effectiveness of Lifecycle Management Programs 77
7.4 Conclusion 79
8 Future Outlook – LCM to Drive the Profitability and Success Tomorrow 80
9 Appendix 81
9.1 Market Definitions 81
9.2 Abbreviations 81
9.3 Research Methodology 82
9.3.1 Coverage 83
9.3.2 Secondary Research 84
9.3.3 Primary Research 84
9.3.4 Expert Panel Validation 84
9.4 Contact Us 84
9.5 Disclaimer 85
9.6 Sources 85

1.1 List of tables
Table 1: Time-gap Between the Drug Launch and Related LCM Activity, 2010 10
Table 2: Value Of Drugs To Go Off-Patent By Therapeutic Area, $m, 2010–2014 13
Table 3: Adalat Worldwide Sales, €m, 1998–2008 25
Table 4: Fosamax Worldwide Sales, $m, 2002–2008 26
Table 5: Aciphex/Pariet Worldwide Sales, ¥bn, 2000–2008 28
Table 6: Aricept Worldwide Sales, ¥bn, FY 1999–FY 2008 30
Table 7: Concerta Worldwide Sales, $m, 2004–2008 31
Table 8: Takepron Worldwide Sales, ¥bn, FY2002–2008 33
Table 9: Risperdal/Risperdal Consta Worldwide Sales, $m, 2001–2008 35
Table 10: Zithromax/Zmax Worldwide Sales, $m, 1994–2008 36
Table 11: Coreg/Coreg CR Worldwide Sales, £m, 2001–2008 37
Table 12: Losec/Prilosec Worldwide Sales, $m, 1995–2008 39
Table 13: Advil Worldwide Sales, $m, 1999–2008 41
Table 14: Zantac Worldwide Sales, £m, 2000–2008 42
Table 15: Ventolin Worldwide Sales, £m, 1998–2003 44
Table 16: Claritin/OTC Claritin/Clarinex Worldwide Sales, $m, 1998–2008 46
Table 17: Xanax/Xanax XR Worldwide Sales, $m, 2003–2008 47
Table 18: Break-up of LCM Strategies Used for the Top Five Therapeutic Areas in the Pharmaceutical LCM Pipeline, 2010 52
Table 19: Break-up of LCM Strategies Used for the Top Ten Drugs in the Pharmaceutical LCM Pipeline, 2010 53
Table 20: Avastin Worldwide Sales, $m, 2004–2008 60
Table 21: Herceptin Worldwide Sales, $m, 1999–2008 62
Table 22: Rituxan Worldwide Sales, $m, 2004–2008 63
Table 23: Botox Worldwide Sales, $m, 1998–2008 64
Table 24: Nexavar Worldwide Sales, $m, 2006–2008 65
Table 25: Sutent Worldwide Sales, $m, 2006–2008 66
Table 26: Velcade Worldwide Sales, $m, 2004–2008 67
Table 27: Actos Worldwide Sales, ¥bn, 2000–2008 68
Table 28: Major LCM Players and Their Role in the Company Strategy, 2010 70
Table 29: LCM Pipeline Classification of Major Pharmaceutical Companies on the Basis of LCM Strategy Type, 2010 71

1.2 List of figures
Figure 1: LCM Activity in the Pipeline for Major 20 Pharmaceutical Companies, 2010 9
Figure 2: Total Value of the Drugs by Therapeutic Segment to Lose Patent Protection by 2014, $bn 12
Figure 3: Value Of Drugs To Go Off-Patent By Therapeutic Area, $m, 2010–2014 13
Figure 4: Proportion of LCM Projects in the Late-stage Development Pipeline by Therapeutic Area, 2010 15
Figure 5: Comparison of CAGR of R&D Expenditure v Turnover Over the Last Five Years for the Top Five Companies, 2003–2008 16
Figure 6: Decline in NME Approvals by the FDA, 1996–2008 17
Figure 7: DTC Advertising Expenditure by Pharmaceutical Companies in the US, $bn,
1996–2008 19
Figure 8: Objectives for Implementing Lifecycle Management Strategies, 2010 21
Figure 9: Adalat Worldwide Sales, €m, 1998–2008 25
Figure 10: Fosamax Worldwide Sales, $m, 2002–2008 26
Figure 11: Aciphex/Pariet Worldwide Sales, ¥bn, 2000–2008 28
Figure 12: Aricept Worldwide Sales, ¥bn, FYE 1999–FYE 2008 30
Figure 13: Concerta Worldwide Sales, $m, 2004–2008 31
Figure 14: Takepron Worldwide Sales, ¥bn, FY2002–2008 32
Figure 15: Risperdal/Risperdal Consta Worldwide Sales, $m, 2001–2008 34
Figure 16: Zithromax/Zmax Worldwide Sales, $m, 1994–2008 36
Figure 17: Coreg/Coreg CR Worldwide Sales, £m, 2001–2008 37
Figure 18: Losec/Prilosec Worldwide Sales, $m, 1995–2008 39
Figure 19: Advil Worldwide Sales, $m, 1999–2008 41
Figure 20: Zantac Worldwide Sales, £m, 2000–2008 42
Figure 21: Ventolin Worldwide Sales, £m, 1998–2003 44
Figure 22: Claritin/OTC Claritin/Clarinex Worldwide Sales, $m, 1998–2008 45
Figure 23: Xanax/Xanax XR Worldwide Sales, $m, 2003–2008 47
Figure 24: Top Five Therapeutic Areas of Research in the Pharmaceutical Pipeline, 2010 49
Figure 25: Top 10 Companies Performing Research in the Pharmaceutical Pipeline, 2010 50
Figure 26: Division of Pipeline Into Late-Stage and Early-stage Development for the Top Five Therapeutic Areas, 2010 51
Figure 27: Distribution of LCM Pipeline by Therapeutic Area, 2010 52
Figure 28: Top 10 Companies in LCM Research, 2010 53
Figure 29: Distribution of LCM Pipeline By Early-Stage and Late-stage Development, 2010 54
Figure 30: Distribution of Cance