The prospects and challenges to 2016 for 21 oncology products valued at over US$1 billion This new (November 2010) report's glimpse into the future reveals a market environment where the new targeted therapies prevail as the future blockbusters, with biological, in particular, commanding substantial sales before the impact of any biosimilar competition in major markets.The pursuit of safe and effective cancer medicines dominates research funding and the sector has more blockbuster products than any other therapy area. There exists a huge variety of cancer treatments, from the widely-used chemotherapeutic agents to the recently-launched, first-in-class cancer vaccine, with many of these treatments achieving blockbuster sales in excess of US$1 billion. However, many existing brands face declining sales due to generic erosion as patents expire, and the rate at which new drugs reach the market is slowing, impacting company revenues.This report identifies the current oncology blockbuster products and assesses their future market potential, looking at both winners and losers in the competitive landscape to 2016. In addition, it highlights the promising products that, in Espicom's analysis, will successfully carve out a market share to become the oncology blockbusters of the future. Both current and future marketplaces are analysed from the companies' perspective, identifying the products on which their relative success or failure rests.All 21 products featured in this report are also detailed and analysed individually in terms of their current status, mode of action, clinical data, risks associated with their development, expertise of developing/marketing company and the competitive pressures they may face. This analysis is summarised in the form of a unique score that acts as a useful comparative tool and 7-year individual product forecasts are provided to 2016.Whether you are involved with competitive monitoring, product planning or business development, this new report will provide the facts and insight to fully understand the trends, companies and products which are shaping this critical area of the pharmaceutical industry. About the AuthorThis report has been researched by the Espicom product team led by senior Espicom pharmaceutical analyst Sue Viney. For over 10 years Sue has played a pivotal role in tracking trends in drug development and corporate performance. In addition to this report she has produced detailed product analysis in the Breast/Lung/Colorectal/Prostate Cancer, CNS, and Rheumatoid Arthritis sectors. More Information...Comprehensive analysis of trends and impacts on companies: assess the winners and losers! An assessment of key therapeutic approaches ' the rise of biologicalsDetailed analysis of 21 products that will dominate the cancer market in the near termDetailed 7-year sales forecasts to 2016, with sales by indication where appropriateAnswering key questions... Which companies will have increased their market share by 2016'Who will be the new members of the cancer blockbuster club in the future' What are the prospects for hormonal therapies' To what degree will Sprycel, Tasigna and generic competition affect Novartis' Gleevec' What product extensions did Roche get for Herceptin in 2010' Where to next for Pfizer after it suspended development of Sutent in a range of cancers in September 2009' How might cheaper generic doxetaxel affect sales of Dendreon's novel vaccine for CRPC patients'

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Cancer Drug Blockbusters
Published on November 2010
Report Summary
The prospects and challenges to 2016 for 21 oncology products valued at over US$1 billion
This new (November 2010) report's glimpse into the future reveals a market environment where the new targeted therapies prevail as
the future blockbusters, with biological, in particular, commanding substantial sales before the impact of any biosimilar competition in
major markets.
The pursuit of safe and effective cancer medicines dominates research funding and the sector has more blockbuster products than
any other therapy area.
There exists a huge variety of cancer treatments, from the widely-used chemotherapeutic agents to the recently-launched,
first-in-class cancer vaccine, with many of these treatments achieving blockbuster sales in excess of US$1 billion. However, many
existing brands face declining sales due to generic erosion as patents expire, and the rate at which new drugs reach the market is
slowing, impacting company revenues.
This report identifies the current oncology blockbuster products and assesses their future market potential, looking at both winners
and losers in the competitive landscape to 2016. In addition, it highlights the promising products that, in Espicom's analysis, will
successfully carve out a market share to become the oncology blockbusters of the future. Both current and future marketplaces are
analysed from the companies' perspective, identifying the products on which their relative success or failure rests.
All 21 products featured in this report are also detailed and analysed individually in terms of their current status, mode of action,
clinical data, risks associated with their development, expertise of developing/marketing company and the competitive pressures they
may face. This analysis is summarised in the form of a unique score that acts as a useful comparative tool and 7-year individual
product forecasts are provided to 2016.
Whether you are involved with competitive monitoring, product planning or business development, this new report will provide the
facts and insight to fully understand the trends, companies and products which are shaping this critical area of the pharmaceutical
industry.
About the Author
This report has been researched by the Espicom product team led by senior Espicom pharmaceutical analyst Sue Viney. For over 10
years Sue has played a pivotal role in tracking trends in drug development and corporate performance. In addition to this report she
has produced detailed product analysis in the Breast/Lung/Colorectal/Prostate Cancer, CNS, and Rheumatoid Arthritis sectors.
More Information...
Comprehensive analysis of trends and impacts on companies: assess the winners and losers!
An assessment of key therapeutic approaches ' the rise of biologicals
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Detailed analysis of 21 products that will dominate the cancer market in the near term
Detailed 7-year sales forecasts to 2016, with sales by indication where appropriate
Answering key questions...
Which companies will have increased their market share by 2016'
Who will be the new members of the cancer blockbuster club in the future'
What are the prospects for hormonal therapies'
To what degree will Sprycel, Tasigna and generic competition affect Novartis' Gleevec'
What product extensions did Roche get for Herceptin in 2010'
Where to next for Pfizer after it suspended development of Sutent in a range of cancers in September 2009'
How might cheaper generic doxetaxel affect sales of Dendreon's novel vaccine for CRPC patients'
Table of Content
Contents
Executive Summary .. 1
Espicom Market Analysis ... 2
Blockbuster Products 2
The Winners ..2
The Losers ..3
Patent Expiration ..5
Sales Forecasts to 2016 .6
Competitor Ratio Analysis 8
Current Blockbuster Market ..10
Blockbuster Market in 2016 ...14
Blockbuster products . 18
Alimta ... 18
Mode of Action ..18
Current Status ...18
Proof of Concept/Clinical Data ..19
Development Risks ...19
Company Expertise ...20
Competition within the Market-place .20
Data Exclusivity 21
Patent Expiry 21
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Generic Competition .21
Competitor Ratio Analysis 21
Forecast 21
Arimidex ...23
Mode of Action ..23
Current Status ...24
Proof of Concept/Clinical Data ..25
Development Risks ...25
Company Expertise ...26
Competition Within the Market-place .26
Data Exclusivity 27
Patent Expiry 27
Generic Competition .27
Competitor Ratio Analysis 28
Forecast 28
Avastin ..30
Mode of Action ..30
Current Status ...31
Proof of Concept/Clinical Data ..33
Development Risks ...36
Company Expertise ...37
Competition within the Market-place .38
Patent Expiry 40
Generic Competition .40
Competitor Ratio Analysis 40
Forecast 40
Eloxatin .45
Mode of Action ..45
Current Status ...45
Proof of Concept/Clinical Data ..46
Development Risks ...47
Company Expertise ...47
Competition within the Market-place .47
Patent Expiry 48
Generic Competition .48
Competitor Ratio Analysis 49
Forecast 49
Erbitux .. 51
Mode of Action ..51
Current Status ...52
Proof of Concept/Clinical Data ..53
Development Risks ...54
Company Expertise ...54
Competition within the Market-place .55
Generic Competition .56
Competitor Ratio Analysis 56
Forecast 56
Femara .59
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Mode of Action ..59
Current Status ...59
Proof of Concept/Clinical Data ..60
Development Risks ...60
Company Expertise ...60
Competition within the Market-place .60
Patent Expiry 61
Generic Competition .61
Competitor Ratio Analysis 61
Forecast 62
Gemzar .63
Mode of Action ..63
Current Status ...63
Proof of Concept/Clinical Data ..64
Development Risks ...65
Company Expertise ...65
Competition within the Market-place .66
Patent Expiry 66
Generic Competition .66
Competitor Ratio Analysis 68
Forecast 68
Glivec / Gleevec ...70
Mode of Action ..70
Current Status ...70
Proof of Concept/Clinical Data ..73
Development Risks ...73
Company Expertise ... 74
Competition within the Market-place . 74
Data Exclusivity 74
Patent Expiry 74
Generic Competition .75
Competitor Ratio Analysis 76
Forecast 76
Herceptin 77
Mode of Action ..77
Current Status ...78
Proof of Concept/Clinical Data ..79
Development Risks ...81
Company Expertise ...81
Competition within the Market-place .82
Patent Expiry 83
Generic Competition .83
Competitor Ratio Analysis 83
Forecast 84
MabThera / Rituxan 86
Mode of Action ..86
Current Status ...86
Proof of Concept/Clinical Data ..88
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Development Risks ...89
Company Expertise ...89
Competition within the Market-place .90
Generic Competition .90
Competitor Ratio Analysis 90
Forecast 90
Nexavar ... 92
Mode of Action ..92
Current Status ...93
Proof of Concept/Clinical Data ..94
Development Risks ...95
Company Expertise ...95
Competition within the Market-place .96
Data Exclusivity 96
Patent Expiry 97
Competitor Ratio Analysis 97
Forecast 97
Provenge 100
Mode of Action 100
Current Status .101
Proof of Concept/Clinical Data 102
Development Risks .103
Company Expertise .103
Competition Within the Market-place ...104
Competitor Ratio Analysis ..104
Forecast ..104
Sutent .106
Mode of Action 106
Current Status .107
Approvals/Filings 107
Proof of Concept/Clinical Data 107
Development Risks .109
Company Expertise .109
Competition within the Market-place ...109
Data Exclusivity ... 110
Patent Expiry ... 110
Generic Competition ... 110
Competitor Ratio Analysis .. 111
Forecast .. 111
Tarceva ... 114
Mode of Action 114
Current Status . 114
Proof of Concept/Clinical Data 115
Development Risks . 116
Company Expertise . 116
Competition within the Market-place ... 117
Data Exclusivity ... 117
Patent Expiry ... 117
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Generic Competition ... 118
Competitor Ratio Analysis .. 118
Forecast .. 118
Tasigna ...120
Mode of Action 120
Current Status .120
Proof of Concept/Clinical Data 121
Development Risks .121
Company Expertise .122
Competition within the Market-place ...122
Data Exclusivity ...122
Patent Expiry ...122
Competitor Ratio Analysis ..122
Forecast ..123
Taxotere . 124
Mode of Action 124
Current Status . 124
Proof of Concept/Clinical Data 126
Development Risks .130
Company Expertise .130
Competition within the Market-place ... 131
Data Exclusivity ...132
Patent Expiry ...132
Generic Competition ...132
Competitor Ratio Analysis ..133
Forecast ..133
Tykerb .136
Mode of Action 136
Current Status .137
Proof of Concept/Clinical Data 138
Development Risks .139
Company Expertise .139
Competition within the Market-place ...139
Data Exclusivity ...140
Patent Expiry ...140
Competitor Ratio Analysis ..140
Forecast ..140
Velcade ...144
Mode of Action 144
Current Status .145
Proof of Concept/Clinical Data 146
Development Risks .146
Company Expertise .147
Competition within the Market-place ..147
Data Exclusivity ...148
Patent Expiry ...148
Generic Competition ...148
Competitor Ratio Analysis ..148
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Forecast ..149
Xeloda 151
Mode of Action 151
Current Status .152
Proof of Concept/Clinical Data 153
Development Risks .155
Company Expertise .155
Competition within the Market-place ...156
Patent Expiry ...156
Competitor Ratio Analysis ..156
Forecast ..157
Zoladex ...160
Mode of Action 160
Current Status .160
Proof of Concept/Clinical Data 162
Development Risks .162
Company Expertise .163
Competition Within the Market-place ...163
Patent Expiry ...164
Generic Competition ...164
Competitor Ratio Analysis ..164
Forecast ..164
Zometa ...167
Mode of Action 167
Current Status .167
Proof of Concept/Clinical Data 168
Development Risks .168
Company Expertise .168
Competition within the Market-place ...169
Data Exclusivity ...169
Patent Expiry ...169
Generic Competition ...169
Competitor Ratio Analysis ..169
Forecast ..169
List of Tables
Major Patent Expiries ... 5
Sales Forecasts (US$ millions) ... 6
Competitor Ratio Analysis Scores .. 8
Oncology Blockbusters by Sales Value, 2009 .. 10
Oncology Blockbusters by Sales Value, 2016 ... 14
Alimta Sales by Indication (2008-2016) .. 22
FDA ANDA Approvals for Anastrozole . 27
Arimidex Total Sales (2008-2016) ... 29
Avastin Sales by Company (2008-2016) . 41
Avastin Sales by Indication (2008-2016) 42
Eloxatin Sales (2008-2016) . 50
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Erbitux Sales by Company (2008-2016) .. 58
Femara Sales by Company (2008-2016) 62
FDA ANDA Approvals for Gemcitabine 67
Tentative ANDA Approvals for Gemcitabine ...68
Gemzar Sales By Indication (2008-2016) ... 69
Glivec/Gleevec Total Sales (2008-2016) .. 76
Herceptin Sales by Company (2008-2016) .. 85
Herceptin Sales by Indication (2008-2016) . 85
MabThera/Rituxan Sales by Indication (2008-2016) .. 91
Nexavar Sales by Indication ...98
Provenge Sales (2010-2016) . 105
Sutent Sales by Indication (2008-2016) .112
Efficacy Results for Erlotinib+Gemcitabine in the Treatment of Pancreatic Cancer ..115
Tarceva Sales by Company (2008-2016) 119
Tasigna Sales by Indication (2008-2016) ...123
Efficacy of Docetaxel in the Treatment of NSCLC Patients Previously Treated with a Platinum-Based CT Regimen (Intent-to-Treat
Analysis)
Taxotere Sales by Indication (2008-2016) ..134
Tykerb/Tyverb Sales by Indication (2008-2016) .141
Velcade Sales by Company (2008-2016) ... 149
Velcade Sales by Indication (2008-2016) .. 150
Xeloda Sales by Company (2008-2016) .157
Xeloda Sales by Indication (2008-2016) ... 158
Zoladex Sales by Indication (2008-2016) . 165
Zometa Sales (2008-2016) .170
List of Charts
Oncology Products, 2009 .. 7
Oncology Products, 2016 ... 7
Competitor Ratio Analysis Scores .. 9
Oncology Blockbuster Product Sales, 2009 ..11
Company Share of Oncology Blockbusters, 2009 .12
Therapy Split for Oncology Blockbusters, 2009 13
Oncology Blockbuster Product Sales, 2016 . 14
Company Share of Oncology Blockbusters, 2016 16
Therapy Split for Oncology Blockbusters, 2016 17
Alimta Sales (2008-2016) ... 22
Arimidex Total Sales (2008-2016) ... 28
Avastin Mode of Action ...30
Avastin Sales by Company (2008-2016) . 41
Avastin Sales by Indication, 2009 ... 43
Avastin Sales by Indication, 2016 44
Eloxatin Sales (2008-2016) . 49
Erbitux Sales (2008-2016) ... 57
Femara Sales by Company (2008-2016) . 62
Gemzar Sales (2008-2016) .. 69
Glivec/Gleevec Sales (2008-2016) ... 76
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HER2 Signalling Pathway ... 77
Herceptin Sales (2008-2016) ...84
MabThera/Rituxan Sales (2008-2016) 91
Nexavar's Dual Mode of Action ... 92
Nexavar Total Sales (2008-2016) 98
Nexavar Sales by Indication, 2009 ..99
Nexavar Sales by Indication, 2016 ..99
Schematic of Sipuleucel-T's Mechanism of Action 101
Provenge Sales (2010-2016) . 105
Sutent Mode of Action ...106
Sutent Sales (2008-2016) ...111
Sutent Sales by Indication, 2009 112
Sutent Sales by Indication, 2016 113
Tarceva Sales by Company (2008-2016) 119
Tasigna Sales (2008-2016) .123
TAX 317 Survival K_M Curves - Docetaxel 75mg/m2 vs Best Supportive Care . 128
TAX 320 Survival K_M Curves - Docetaxel 75mg/m2 vs Vinorelbine or Ifosfamide Control . 129
Taxotere Sales (2008-2016) 134
Taxotere Sales by Indication (2008) ...135
Taxotere Sales by Indication (2016) 135
Tykerb/Tyverb Total Sales (2008-2016) ..141
Tykerb Sales by Indication, 2009 142
Tykerb Sales by Indication, 2016 143
Velcade Sales by Company (2008-2016) ... 149
Xeloda Sales (2008-2016) ..157
Xeloda Sales by Indication (2009) . 158
Xeloda Sales by Indication (2016) ..159
Zoladex Sales (2008-2016) 165
Zoladex Sales By Indication, 2008 . 166
Zoladex Sales By Indication, 2016 . 166
Zometa Sales (2008-2016) .170
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