Breast Cancer Drug Discoveries: What the Future Holds
NEW YORK, Sept. 5, 2011 /PRNewswire/ -- Reportlinker.com announces that a new market research report is available in its catalogue:
Breast Cancer Drug Discoveries: what the future holds
http://www.reportlinker.com/p0610486/Breast-Cancer-Drug-Discoveries-what-the-future-holds.html#utm_source=prnewswire&utm_medium=pr&utm_campaign=Pathology
In 2010, almost 50% of breast cancer sales were due to three branded targeted therapies. With a large unmet clinical need, further agents are required to increase survival and delay disease progression.
Unique breast cancer market share, sales forecasts by launched and Phase III products to 2017
A comprehensive and critical examination and scoring of 72 major breast cancer treatments
Comprehensive market assessment of therapeutic approaches, company share, portfolios and prospects
Breast Cancer Therapy Sales Forecast 2010 - 2017
'What's the story behind this chart?'
The changing competitive landscape
By 2017, Espicom forecasts a modest increase in the number of players in the market-place compared to 2010, with Roche, and GlaxoSmithKline to a lesser extent, triumphing with targeted therapies directed against the specific subset of BC patients with HER2-positive disease. AstraZeneca, Novartis and Pfizer will face widespread generic competition for their hormonal therapies, leading to a loss of market share. Similarly, Sanofi and Eli Lilly will face declining sales for their chemotherapies.
The market in 2010...
In recent years, more effective treatments have decreased mortality and improved survival rates, resulting in a longer duration of therapy for an increased patient population. In the US, five-year relative survival rates have improved from 63% in the early 1960s to 90% in recent years, while in England, rates for women diagnosed with BC in 2001-2006 reached 82%, compared to 52% 1971-1975. This report estimates that sales of leading brands achieved sales of US$12.7 billion in 2010, with growth due to expanding sales for a number of existing treatments rather than the launch of new products. Sales were split between chemotherapies, hormonal therapies and novel molecular targeted therapies, with the majority of these agents used in combination.
And 2017: how things might change Hormonal therapies
The aromatase inhibitors will suffer from patent expiries in all major markets by 2012, and the report expects significant generic competition and sales for this group to decline by over 92% from US$3.4 billion in 2010, to just US$259 million in 2017. With widespread generic versions of the leading selective oestrogen receptor modulator, tamoxifen, the overall market share of branded hormonal therapies will decline as sales fall from US$4 billion to US$1.4 billion, a drop of 65%. These declines will be tempered by the relative success of AstraZeneca's Faslodex.
Chemotherapies
By 2017, most chemotherapies will be available as generics. In addition to patent expirations for Sanofi's Taxotere (docetaxel) and Eli Lilly's Gemzar (gemcitabine) in 2009/2010, the US patent on Roche's Xeloda (capecitabine) will expire in 2013. As a direct result, sales will decrease by almost 40% from over US$2.4 billion in 2010 to around US$1.5 billion in 2017, with market share continuing to decline, from 19 to 12%. This general trend is mitigated somewhat by the newer chemotherapies, which are demonstrating sales growth and carving out market share due to their improved safety and efficacy compared to older more established agents.
Targeted therapies – moving beyond HER2
By 2017, Espicom estimates that a total of ten products will command a 77% market share, with the current therapies, Roche's Herceptin and Avastin, along with GSK's Tykerb/Tyverb, accounting for over 80% of these sales. Herceptin will continue as the clear market leader. But what about patients who are HER2 negative? There is an urgent need for more therapies and just a handful are likely to be launched by 2017:
Bayer's Nexavar is a multi-targeted kinase inhibitor already marketed for the treatment of renal cell carcinoma and hepatocellular carcinoma.
Eli Lilly's anti-VEGFr2 monoclonal antibody, ramucirumab, an angiogenesisinhibitor, may be able to pick up market share from Avastin if the company can demonstrate an improved survival advantage.
There has been considerable optimism over a novel class of agents, the PARP inhibitors, including Sanofi's iniparib, which is under development for triplenegative breast cancer. Nevertheless, doubt has been cast over the effectiveness of this class following the termination of the development of AstraZeneca's olaparib.
About the Author: This report has been written by Sue Viney, a senior writer on Espicom's oncology analysis team. Sue has been evaluating companies, products and drugs in research for 12 years. She is editor of Cancer Drug Futures and, in addition, has also produced management reports on the lung, colorectal, prostate and renal cancer areas as well as studies on Rheumatoid Arthritis and CNS drug development.
Contents
Executive Summary...1
Current Treatments2
Surgery....2
Radiation Therapy...2
Hormonal Therapy..3
Current Products' Patent Exposure.5
Chemotherapy ..6
Current Products' Patent Exposure.7
Molecular Targeted Therapy....8
Current Products' Patent Exposure.8
Market Analysis...9
The Breast Cancer Market in 2010.9
Targeted Therapies.10
Hormonal Therapies.....10
Chemotherapies 12
The Players... 13
The Breast Cancer Market in 2017.....15
Hormonal Therapies.....16
Chemotherapies 17
Targeted Therapies.18
The Players...20
Drug Growth Drivers and Dampeners.22
Drug Growth Drivers...22
Drug Growth Dampeners.22
Sales Forecasts (2010 Actual - 2017 Estimates).....24
Competitive Analysis....27
Rese arch and Development ...29
Research and Development Strategies..29
Targeting ErbB ..29
Targeting VEGF..29
Targeting PAR P..30
Targeting IG F-1r.30
Therapeutic Vaccines....30
Research and Development Pipelines...31
Background Information34
What is Breast Cancer?34
Risk Factors for Breast Cancer34
Stages of Breast Cancer....35
Diagnosis and Screening..35
Factors Influencing Survival..36
Patients Statistics...37
Worldwide Variation in Breast Cancer Incidence and Mortality..39
Breast Cancer Products..43
Targeted Therapies .45
Approved Products.45
Avastin.45
Herceptin..61
Tykerb/Tyverb .....71
Phase III Products....79
Afinitor ..... 79
Iniparib..... 87
Neratinib...91
Nexavar.... 94
Omnitarg ..... 104
Ramucirumab... 109
Tovok .114
Trastuzumab emtansine....118
Votrient .. 123
Phase II Products...129
AE37.. 129
AMG 386..132
AZD8931..135
Bavituximab.137
BMS-690514.141
BMS-754807 143
Cabozantinib..... 145
CDX-011...151
Cixutumab... 153
Dalotuzumab.... 156
Dinaciclib..... 159
Dovitinib 162
Entinostat.... 165
Enzastaurin.. 168
Erbitux.....171
Ganetespib...179
AMG 479. 183
INCB7839 185
Linifanib. 187
Mesupron..... 190
MetMAb. 192
Motesanib.... 195
NeuVax... 199
OPT-822.. 203
PF-1367338..205
Ridaforolimus.... 207
SAR256212....211
Sprycel ....213
Tarceva ....218
TSU-68....225
Vandetanib.. 227
Vectibix... 231
Veliparib.238
Zolinza.... 241
YM155.....246
Hormonal Therapies . 249
Approved Products.... 249
Arimidex 249
Aromasin256
Evista 260
Fareston.264
Faslodex. 269
Femara....274
Nolvadex280
Zoladex...284
Phase III Products..291
Orazol..... 291
Decapeptyl..294
Zometa...298
Phase II Products...302
TAS-108... 302
Chemotherapies .... 304
Approved Products.... 304
Abraxane304
Gemzar....312
Halaven...319
Ixempra.. 323
Taxotere. 329
Xeloda .... 342
Phase II Products...351
Imetelstat..... 351
LEP-ETU.. 354
Tasisulam..... 356
Telcyta ... 358
Tesetaxel 363
Thermodox.. 367
Yondelis.. 370
Appendix.375
Phase Transition Probability..... 375
Glossary.... 376
Acronyms.378
Source Material...379
Websites.....379
General Bibliography..379
Product Bibliography. 380
List of Tables
Current Major Hormonal Therapies....3
Major Patent Exposure of Leading Brands5
Major Patent Exposure of Leading Brands7
Major Patent Exposure of Leading Brands8
Breast Cancer Therapy Sales Forecasts (2010-2017).25
Competitor Ratio Analysis Total Scores...27
Products under Phase III Development for Breast Cancer.....31
The Launch Landscape for Phase III Targeted Therapies.32
Products under Phase II Development for Breast Cancer32
Products under Phase I Development for Breast Cancer.33
TMN Classification of Breast Cancer..35
Five-year Relative Survival Rates by Stage at Diagnosis (US)36
Five-year Relative Survival Rates by Tumour Size (US)....36
Targeted Therapies for Breast Cancer43
Hormonal Therapies for Breast Cancer.. 44
Chemotherapies for Breast Cancer... 44
Avastin Sales by Company (2009-2017).57
Avastin Sales by Indication (2009-2017).58
Breast Cancer Drug Discoveries: What the future holds
Herceptin Sales by Company (2009-2017)...69
Herceptin Sales by Indication (2009-2017)..70
Tykerb/Tyverb Sales by Indication (2009-2017).77
Afinitor Sales by Indication (2009-2017).....86
Nexavar Sales by Indication (2009-2017)..102
Omnitarg Sales by Indication (2013-2017).108
Ramucirumab Sales by Indication (2015-2017)113
LUX-Lung Trials 114
Tovok Sales by Indication (2014-2017)..117
Trastuzumab Emtansine Sales (2014-2017).....122
Votrient Sales by Indication (2009-2017).. 128
Efficacy Results for Erlotinib+Gemcitabine in the Treatment of Pancreatic Cancer....220
FDA ANDA Approvals for Anastrozole..253
Arimidex Total Sales (2009-2017)..255
FDA ANDA Approvals for Exemestane..258
Aromasin Sales (2009-2017)....259
Fareston Sales (2009-2017).....268
Faslodex Sales (2009-2017).....273
FDA ANDA Approvals for Letrozole.277
Tentative ANDA Approvals for Letrozole.....277
Femara Sales by Company (2009-2017)....279
Nolvadex Sales (2009-2017)....283
Zoladex Sales by Indication (2009-2017)...289
Abraxane Sales by Company (2009-2017)..311
Abraxane Sales by Indication (2009-2017).311
FDA ANDA Approvals for Gemcitabine. 317
Tentative ANDA Approvals for Gemcitabine..... 317
Gemzar Sales By Indication (2009-2017)... 318
Halaven Sales by Indication (2010-2017)..322
Ixempra Sales by Indication (2009-2017)..328
Efficacy of Docetaxel in the Treatment of NSCLC Patients Previously Treated with a Platinum-Based CT Regimen (Intent-to-Treat Analysis) 332
FDA NDA Approvals.....338
Taxotere Sales by Indication (2009-2017)..339
Xeloda Sales by Company (2009-2017).....349
Xeloda Sales by Indication (2009-2017).....349
Probability of Launch... 375
List of Charts
Breast Cancer Sales by Therapy Class (2010)...9
Targeted Therapy Sales (2010)....10
Hormonal Therapy Sales by Class (2010)11
Hormonal Therapy Sales (2010)..11
Chemotherapy Sales (2010)..12
Market Share of Breast Cancer Players by Sales (2010)..13
Breast Cancer Sales by Therapy Class (2017).15
Hormonal Therapy Sales (2017)..16
Chemotherapy Sales (2017)..17
Targeted Therapy Sales (2017)....18
Targeted Therapy Market Share by Sales (2017).18
Major Breast Cancer Players (2017)..20
Market Share of Breast Cancer Players by Sales (2017)...21
Breast Cancer Therapy Sales Forecasts (2010-2017)24
Targeted Therapy Sales (2010-2017).24
Hormonal Therapy Sales Forecasts (2010-2017)26
Chemotherapy Sales Forecasts (2010-2017)26
Incidence of Major Cancers Worldwide (2008)..37
Mortality of Major Cancers Worldwide (2008) .37
Worldwide Female Breast Cancer Incidence Rates by Region (2008)....39
Worldwide Female Breast Cancer Mortality Rates by Region (2008)....40
Female Breast Cancer Incidence Rates by EU Country (2008)....41
Female Breast Cancer Mortality Rates by EU country (2008)....42
Avastin Mode of Action..45
Avastin Sales by Company (2009-2017)57
Avastin Sales by Indication (2010)...59
Avastin Sales by Indication (2017)...60
HER2 Signalling Pathway....61
Herceptin Sales (2009-2017).....69
Herceptin Sales by Indication (2017)70
Tykerb/Tyverb Total Sales (2009-2017)..77
Tykerb Sales by Indication (2017).....78
Afinitor Mode of Action..79
Afinitor Sales (2009-2017)...86
Nexavar's Dual Mode of Action..94
Nexavar Sales (2009-2017)101
Nexavar Sales by Indication (2010)102
Nexavar Sales by Indication (2017)103
Omnitarg Sales (2013-2017)....108
Ramucirumab Sales (2015-2017)....112
Ramucirumab Sales by Indication (2017)...113
Tovok Sales (2014-2017)117
HER2 Signalling Pathway.. 118
Trastuzumab Emtansine Sales (2014-2017)..... 121
Votrient Total Sales (2009-2017).... 127
Votrient Sales By Indication (2017) 128
Upregulation of MET as a Response to Treatment. 145
Dovitinib Mode of Action....162
Epigenetic Modification of a Histone...165
Ganetespib Mode of Action 179
MetMAb Mechanism of Action 192
NeuVax Mode of Action199
Schematic of EGFr Inhibition in Tumourigenesis....231
Vorinostat Mechanism of Action.... 241
Arimidex Total Sales (2009-2017)..254
Aromasin Sales (2009-2017)...259
Evista - Invasive BC Incidence - STAR Trial..261
Fareston Sales (2009-2017).....268
Faslodex Sales (2009-2017)....272
Femara Sales by Company (2009-2017)....278
Nolvadex Sales (2009-2017)...282
Zoladex Sales (2009-2017).289
Zoladex Sales By Indication (2010)290
Zoladex Sales By Indication (2017).290
Abraxane Sales by Company (2009-2017) 310
Gemzar Sales (2009-2017). 318
Halaven Sales (2010-2017)322
Ixempra Sales (2009-2017)327
TAX 317 Survival K_M Curves - Docetaxel 75mg/m2 vs Best Supportive Care 333
TAX 320 Survival K_M Curves - Docetaxel 75mg/m2 vs Vinorelbine or Ifosfamide Control.....334
Taxotere Sales (2009-2017)339
Taxotere Sales by Indication (2010).....340
Taxotere Sales by Indication (2017)340
Xeloda Sales (2009-2017)..349
Xeloda Sales by Indication (2010)..350
Xeloda Sales by Indication (2017)..350
Canfosfamide Mode of Action..359
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