This publication has been discontinued on September 9, 2011.
Abstract
Big Pharma' s Key Lifecycle Management Strategies - Maximizing the Market
Potential
Summary
GBI Research, 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
Table of Contents
1 Table of contents
1 Table of contents 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 Cancer LCM
Pipeline by Companies, 2010 55
Figure 31: Distribution of CNS LCM Pipeline
by Companies, 2010 56
Figure 32: Distribution of CVS LCM Pipeline by
Companies, 2010 57
Figure 33: Distribution of Infectious Diseases LCM
Pipeline by Companies, 2010 58
Figure 34: Distribution of Metabolic
Diseases LCM Pipeline by Company, 2010 59
Figure 35: Avastin Worldwide
Sales, $m, 2004-2008 60
Figure 36: Herceptin Worldwide Sales, $m,
1999-2008 62
Figure 37: Rituxan Worldwide Sales, $m, 2004-2008
63
Figure 38: Botox Worldwide Sales, $m, 1998-2008 64
Figure 39:
Nexavar Worldwide Sales, $m, 2006-2008 65
Figure 40: Sutent
Worldwide Sales, $m, 2006-2008 66
Figure 41: Velcade Worldwide
Sales, $m, 2004-2008 67
Figure 42: Actos Worldwide Sales, ¥bn,
2000-2008 68
Figure 43: Reasons Why LCM Strategies Fail, 2010 69
Figure 44: LCM Pipeline Classification of Major Pharmaceutical Companies on
the Basis of LCM Strategy Type, 2010 71
Figure 45: STAR Structure, 2010
72
Figure 46: MESH Structure, 2010 73
Figure 47: HYBRID Structure,
2010 73
Figure 48: Framework Based on Competitive Landscape to Decide the
LCM Strategy, 2010 77
Figure 49: Framework for Measuring Effectiveness of
LCM Programs, 2010 78
Figure 50: GBI Research Methodology, 2010 83
