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PharmaPoint: HER2-Negative Breast Cancer - Global Drug Forecast and Market Analysis to 2023

Summary

Breast cancer is the second most common cancer in the world and the most common cancer in women worldwide. This report focuses on the current treatment landscape, unmet needs, current pipeline, and commercial opportunities in the HER2-negative breast cancer market, with coverage of multiple settings; neoadjuvant, adjuvant, first-, second-, third-, and fourth-line metastatic.

Overall five year survival in breast cancer is relatively high, at around 90%, but this is subjective to the subtype and stage of the disease. Importantly this report segments HER2 negative breast cancer into its two major subtypes; hormone receptor positive (HR+) and triple negative breast cancer (TNBC).

HR+ disease accounts for around 90% of all HER2 negative breast cancers. It responds well to hormonal agents such tamoxifen and the 3rd generation aromatase inhibitors. The advent of hormonal therapy has alleviated some of the unmet needs for these patients, however opportunities still remain. The pipeline for the HR+ market is very strong, with several exciting new agents such as the PI3K and CDK 4/6 inhibitors. GlobalData believes these will have a phenomenal effect on the treatment paradigm for patients with the disease and address many of the unmet needs which patients currently face.

TNBC accounts for around 10% of all HER2 negative breast cancers. TNBC does not respond to hormonal agents and few chemotherapies have been shown to work effectively at managing the disease. The level of unmet need for patients with this form of the disease is very high; furthermore around 30% of TNBC patients will carry a BRCA mutation- these patients have an even worse outcome, with an ultra-high degree of unmet needs. The pipeline for the TNBC market exclusive of the BRCA population is non-existent. However in regards to the BRCA mutation positive market, huge changes are to occur which could potentially redefine the way these patients are treated. This will be chiefly due to the entrance of several PARP inhibitors in the market.

Highlights

Key Questions Answered

- How is the disease management evolving? What is the impact for drug manufacturers?
- What are the R&D strategies being used by drug makers?
- What opportunities remain for future players?
- How large are the neoadjuvant, adjuvant, and metastatic markets for TNBC and HR+ breast cancer?
- What exciting, innovative approaches are being investigated in HER2-negative breast cancer?
- What to KOLs think about the latest therapies and drug development strategies?

Key Findings

- The HER2-negative breast cancer market will increase by 4-fold; from $1.45 billion in 2013 to $6.12 billion in 2023 at a CAGR of 15.5%. Growth will be driven by the rapid uptake of new premium priced agents in both the HR+ and TNBC settings. Presently the HR + and TNBC settings have around an equal share of the HER2 negative market, by 2023 this is expected to change drastically to around 80% and 20% respectively.
- In the HR+ setting, the launch of a number of innovative premium-priced products — namely, the PI3K and CDK 4/6 inhibitors, will act as the main drivers for growth. The collective sales from these agents alone will account for $3.6 billion and 79% of the global sales in the HR+ setting in 2023. GlobalData expects Pfizer’s Palbociclib to capture sales of $1.85 billion in 2023, making it the highest grossing drug in the HR+ setting and HER2 negative breast cancer as a whole.
- In the TNBC setting, the launch of several PARP inhibitors will act as the main drivers for growth. The collective sales from all of the PARP inhibitors will account for $1.02 billion and 94% of the global sales in the TNBC setting in 2023. Chief amongst them will be AstraZeneca’s Lynparza which will capture sales of $926.3m in 2023.
- By 2023, the adjuvant setting will prove to be the most lucrative setting in both HR+ and TNBC. Galena Biopharma’s NeuVax (nelipepimut-S/E75) will enter the adjuvant setting (HR+) in the US and 5EU; even with relatively low patient shares (<10%), it will score comparatively high global sales of $567m by 2023. AstraZeneca's Lynparza will also enter the adjuvant setting (TNBC), indeed the vast majority of its 2023 sales are expected to come from here 79%; $731m.

Scope

- Overview of HER2-negative breast cancer, including epidemiology, etiology, pathophysiology, symptoms, diagnosis, and disease management.
- Annualized HER2-negative breast cancer therapeutics market revenue, cost of therapy, and treatment usage patterns in 15 patient segments, forecast from 2013 to 2023.
- Key topics covered include strategic competitor assessment, market characterization, unmet needs, R&D strategies, and clinical trial design for the HER2-negative breast cancer therapeutics market
- Pipeline analysis: comprehensive data assessing emerging trends and mechanisms of action under development for different lines of therapy. The most promising candidates in Phase III development are profiled.
- Analysis of the current and future market competition in the global HER2-negative breast cancer therapeutics market. Insightful review of the key industry drivers, restraints and challenges. Each trend is independently researched to provide qualitative analysis of its implications.

Reasons to buy

- Develop and design your in-licensing and out-licensing strategies through a review of pipeline products and technologies, and by identifying the companies with the most robust pipeline.
- Develop business strategies by understanding the trends shaping and driving the global HER2-negative breast cancer therapeutics market.
- Drive revenues by understanding the key trends, innovative products and technologies, market segments, and companies likely to impact the global HER2-negative breast cancer therapeutics market in the future.
- Formulate effective sales and marketing strategies by understanding the competitive landscape and by analysing the performance of various competitors.
- Identify emerging players with potentially strong product portfolios and create effective counter-strategies to gain a competitive advantage.
- Organize your sales and marketing efforts by identifying the market categories and segments that present maximum opportunities for consolidations, investments and strategic partnerships.

Table Of Contents

PharmaPoint: HER2-Negative Breast Cancer - Global Drug Forecast and Market Analysis to 2023
1 Table of Contents
2 Introduction 26
2.1 Catalyst 26
2.2 Related Reports 27
2.3 Upcoming Related Reports 27
3 Disease Overview 28
3.1 Etiology and Pathophysiology 28
3.1.1 Etiology 28
3.1.2 Pathophysiology 29
3.1.3 Basic Breast Anatomy 30
3.2 Disease Classification/Staging Systems 31
3.3 Symptoms 33
3.4 Prognosis 33
3.5 Quality of Life 34
4 Epidemiology 37
4.1 Disease Background 37
4.2 Risk Factors and Comorbidities 37
4.2.1 A family history of breast cancer and BRCA1/2 gene mutations significantly increase the breast cancer risk 39
4.2.2 Reproductive hormonal factors influence the risk of breast cancer 39
4.2.3 Modifiable lifestyle-related factors increase the risk of mortality in breast cancer patients 41
4.2.4 Screening programs have been shown to reduce breast cancer mortality, although the benefits need to be carefully weighed against the risks 43
4.3 Global Trends 46
4.3.1 Incidence 46
4.3.2 Prevalence and Survival 52
4.4 Forecast Methodology 56
4.4.1 Sources Used 58
4.4.2 Sources Not Used 62
4.4.3 Forecast Assumptions and Methods 63
4.5 Epidemiological Forecast for Breast Cancer (2013-2023) - Diagnosed Incident Cases 66
4.5.1 Diagnosed Incident Cases of Breast Cancer 66
4.5.2 Diagnosed Incident Cases of Breast Cancer by Age 68
4.5.3 Diagnosed Incident Cases of Breast Cancer by Menopausal Status 70
4.5.4 Diagnosed Incident Cases of Breast Cancer Segmented by Stage at Diagnosis 72
4.5.5 Age-Standardized Diagnosed Incidence Rate of Breast Cancer 73
4.6 Epidemiological Forecast for Breast Cancer (2013-2023) — Diagnosed Prevalent Cases 74
4.6.1 Five-Year Diagnosed Prevalent Cases of Breast Cancer 74
4.6.2 Five-Year Diagnosed Prevalent Cases by Menopausal Status 76
4.6.3 Five-Year Diagnosed Prevalent Cases by Hormone Receptor Subtypes 77
4.7 Discussion 79
4.7.1 Epidemiological Forecast Insight 79
4.7.2 Limitations of the Analysis 81
4.7.3 Strengths of the Analysis 82
5 Disease Management 84
5.1 Diagnosis and Treatment Overview 84
5.1.1 Treatment of Early-Stage Breast Cancer (Stage 0 to Stage IB) 84
5.1.2 Treatment of Locally-Advanced and Regional Breast Cancer (Stage IB to IIIC) 86
5.1.3 Treatment Guidelines and Leading Prescribed Drugs 90
5.2 US 91
5.2.1 Diagnosis 91
5.2.2 Clinical Practice 92
5.3 France 95
5.3.1 Diagnosis 95
5.3.2 Clinical Practice 96
5.4 Germany 99
5.4.1 Diagnosis 99
5.4.2 Clinical Practice 100
5.5 Italy 103
5.5.1 Diagnosis 103
5.5.2 Clinical Practice 104
5.6 Spain 106
5.6.1 Diagnosis 106
5.6.2 Clinical Practice 107
5.7 UK 110
5.7.1 Diagnosis 110
5.7.2 Clinical Practice 111
5.8 Japan 114
5.8.1 Diagnosis 114
5.8.2 Clinical Practice 115
5.9 China 117
5.9.1 Diagnosis 117
5.9.2 Clinical Practice 119
6 Competitive Assessment 122
6.1 Overview 122
6.2 Product Profiles (Branded Therapies) 123
6.2.1 Abraxane (nab-paclitaxel) 123
6.2.2 Afinitor (everolimus) 128
6.2.3 Avastin (bevacizumab) 133
6.2.4 Doxil/Caelyx (pegylated liposomal doxorubicin) 137
6.2.5 Halaven (eribulin mesylate) 142
6.2.6 Ixempra (ixabepilone) 145
6.2.7 Xeloda (capecitabine) 148
6.3 Product Profiles (Hormonal Agents) 151
6.3.1 Tamoxifen 151
6.3.2 Faslodex (fulvestrant) 151
6.3.3 Aromatase Inhibitors 152
7 Unmet Need and Opportunity 156
7.1 Overview 156
7.1.1 Defined treatment plan for BRCA mutation-positive patients and prevention of prophylactic surgeries 158
7.1.2 Specific treatment options for TNBC patients 160
7.1.3 Prevention of brain metastasis 161
7.1.4 Neoadjuvant therapy that can downstage tumors 163
7.1.5 For HR+patients, reduced resistance to hormonal agents 164
7.1.6 Improved convenience of administration of hormonal agents 166
8 Pipeline Assessment 168
8.1 Overview 168
8.1.1 Abemaciclib (LY2835219) 169
8.1.2 Buparlisib (BKM- 120) 175
8.1.3 Javlor (vinflunine) 181
8.1.4 LEE011 185
8.1.5 NeuVax (nelipepimut-S/E75) 190
8.1.6 Niraparib (MK4827) 195
8.1.7 NKTR- 102 (etirinotecan pegol) 200
8.1.8 Lynparza (olaparib) 204
8.1.9 Palbociclib (PD-0332991) 209
8.1.10 Talazoparib (BMN 673) 215
8.1.11 Veliparib (ABT-888) 219
8.2 Promising Drugs in Clinical Development 224
8.2.1 PD-/PD-L 1 Immunotherapies 225
9 Current and Future Players 227
9.1 Overview 227
9.2 Trends in Corporate Strategy 229
9.3 Company Profiles 232
9.3.1 AstraZeneca 232
9.3.2 Bristol-Myers Squibb 233
9.3.3 Eli Lilly 235
9.3.4 Pfizer 236
9.3.5 Novartis/GlaxoSmithKline 239
10 Market Outlook 241
10.1 Global Markets 241
10.1.1 Forecast 241
10.1.2 Drivers and Barriers - Global Issues 247
10.2 US 249
10.2.1 Forecast 249
10.2.2 Key Events 252
10.2.3 Drivers and Barriers 253
10.3 France 255
10.3.1 Forecast 255
10.3.2 Key Events 258
10.3.3 Drivers and Barriers 259
10.4 Germany 260
10.4.1 Forecast 260
10.4.2 Key Events 264
10.4.3 Drivers and Barriers 265
10.5 Italy 266
10.5.1 Forecast 266
10.5.2 Key Events 270
10.5.3 Drivers and Barriers 271
10.6 Spain 272
10.6.1 Forecast 272
10.6.2 Key Events 275
10.6.3 Drivers and Barriers 276
10.7 UK 277
10.7.1 Forecast 277
10.7.2 Key Events 281
10.7.3 Drivers and Barriers 282
10.8 Japan 284
10.8.1 Forecast 284
10.8.2 Key Events 287
10.8.3 Drivers and Barriers 288
10.9 China 289
10.9.1 Forecast 289
10.9.2 Key Events 292
10.9.3 Drivers and Barriers 292
11 Appendix 294
11.1 Bibliography 294
11.2 Abbreviations 321
11.3 Methodology 329
11.4 Forecasting Methodology 329
11.4.1 Diagnosed HER2-Negative Breast Cancer Patients 329
11.4.2 Percentage of Drug-Treated Patients 330
11.4.3 Drugs Included in Each Therapeutic Class 330
11.4.4 Launch and Patent Expiry Dates 331
11.4.5 General Pricing Assumptions 332
11.4.6 Individual Drug Assumptions 334
11.4.7 Generic Erosion 342
11.4.8 Pricing of Pipeline Agents 342
11.5 Primary Research - KOLs Interviewed for This Report 353
11.6 Primary Research - High-Prescriber Survey 355
11.7 About the Authors 356
11.7.1 Analyst 356
11.7.2 Director of Oncology 356
11.7.3 Epidemiologist 357
11.7.4 Director of Epidemiology 357
11.7.5 Global Head of Healthcare 358
11.8 About GlobalData 359
11.9 Disclaimer 359

1.1 List of Tables

Table 1: AJCC Stage Definitions for Breast Cancer 32
Table 2: Prognosis for Breast Cancer 33
Table 3: Selected Major Risk Factors and Comorbidities for Breast Cancer 38
Table 4: Breast Cancer Mortality Attributable to Lifestyle-Related Risk Factors 42
Table 5: 8MM, Current Status and Plans of Large-Scale Breast Cancer Screening Programs 45
Table 6: 8MM, Relative Survival Rate for Breast Cancer, All Ages*, Women, %, 1991-2004** 53
Table 7: Conversion of Common Staging Systems for Breast Cancer Used in the Forecast 57
Table 8: 8MM, Sources of the Breast Cancer Diagnosed Incidence Data Used in the Epidemiological Forecast 57
Table 9: 8MM, Diagnosed Incident Cases of Breast Cancer, Ages ?20 Years, Women, N, 2013-2023 67
Table 10: 8MM, Diagnosed Incident Cases of Breast Cancer by Age, Women, N (Row %), 2013 69
Table 11: 8MM, Diagnosed Incident Cases of Breast Cancer by Menopausal Status, Ages ?20 Years, Women, N (Row %), 2013 71
Table 12: 8MM, Diagnosed Incident Cases of Breast Cancer by Stage at Diagnosis, Ages ?20 Years, Women, N, 2013 72
Table 13: 8MM, Five-Year Diagnosed Prevalent Cases of Breast Cancer, Ages ?20 Years, Women, N, 2013-2023 75
Table 14: 8MM, Five-Year Diagnosed Prevalent Cases of Breast Cancer by Hormone Receptor Subtypes, Ages ?20 Years, Women, N, 2013 78
Table 15: Treatment Guidelines for HER2-Negative Breast Cancer 90
Table 16: Most Prescribed Regimens for HER2-Negative Breast Cancer by Drug Class in the Global Markets, 2013 91
Table 17: HER2-Negative Breast Cancer Diagnosis and Treatment, Country Profile - US 92
Table 18: HER2-Negative Breast Cancer Diagnosis and Treatment, Country Profile - France 96
Table 19: HER2-Negative Breast Cancer Diagnosis and Treatment, Country Profile - Germany 100
Table 20: HER2-Negative Breast Cancer Diagnosis and Treatment, Country Profile - Italy 104
Table 21: HER2-Negative Breast Cancer Diagnosis and Treatment, Country Profile - Spain 107
Table 22: HER2-Negative Breast Cancer Diagnosis and Treatment, Country Profile - UK 111
Table 23: HER2-Negative Breast Cancer Diagnosis and Treatment Country Profile - Japan 115
Table 24: HER2-Negative Breast Cancer Diagnosis and Treatment, Country Profile - China 119
Table 25: Product Profile - Abraxane 125
Table 26: Abraxane SWOT Analysis, 2013 127
Table 27: Global Sales Forecast ($m) for Abraxane, 2013-2023 128
Table 28: Product Profile - Afinitor (everolimus) 130
Table 29: Afinitor SWOT Analysis, 2013 131
Table 30: Global Sales Forecast ($m) for Afinitor, 2013-2023 132
Table 31: Product Profile - Avastin 134
Table 32: Avastin SWOT Analysis, 2013 136
Table 33 Global Sales Forecast ($m) for Avastin, 2013-2023 137
Table 34: Product Profile - Doxil 139
Table 35: Doxil SWOT Analysis, 2013 141
Table 36: Global Sales Forecast ($m) for Doxil/Caelyx, 2013-2023 141
Table 37: Product Profile - Halavan 143
Table 38: Halaven SWOT Analysis, 2013 144
Table 39: Global Sales Forecast ($m) for Halaven, 2013-2023 145
Table 40: Product Profile - Ixempra 146
Table 41: Ixempra SWOT Analysis, 2013 147
Table 42: Global Sales Forecast ($m) for Ixempra, 2013-2023 148
Table 43: Product Profile - Xeloda 149
Table 44: Xeloda SWOT Analysis, 2013 150
Table 45: AI Approvals in the US and 5EU 154
Table 46: Unmet Need and Opportunity in HER2-Negative Breast Cancer 158
Table 47: Product Profile - Abemaciclib (LY2835219) 172
Table 48: Abemaciclib SWOT Analysis, 2013 174
Table 49: Global Sales Forecast ($m) for Abemaciclib, 2013-2023 175
Table 50: Product Profile - Buparlisib (BKM- 120) 177
Table 51: Buparlisib SWOT Analysis, 2013 179
Table 52: Global Sales Forecast ($m) for Buparlisib, 2013-2023 180
Table 53: Product Profile - Javlor 182
Table 54: Javlor SWOT Analysis, 2013 184
Table 55: Global Sales Forecast ($m) for Buparlisib, 2013-2023 185
Table 56: Product Profile - LEE011 187
Table 57: LEE011 SWOT Analysis, 2013 189
Table 58: Global Sales Forecast ($m) for LEE011, 2013-2023 190
Table 59: Product Profile - NeuVax 192
Table 60: NeuVax SWOT Analysis, 2013 194
Table 61: Global Sales Forecast ($m) for NeuVax, 2013-2023 195
Table 62: Product Profile - Niraparib 197
Table 63: Niraparib SWOT Analysis, 2013 199
Table 64: Global Sales Forecast ($m) for Niraparib, 2013-2023 200
Table 65: Product Profile - NKTR- 102 201
Table 66: NKTR-102 SWOT Analysis, 2013 203
Table 67: Global Sales Forecast ($m) for NKTR 102, 2013-2023 204
Table 68: Product Profile - Lynparza 206
Table 69: Lynparza SWOT Analysis, 2013 208
Table 70: Global Sales Forecast ($m) for Lynparza, 2013-2023 209
Table 71: Product Profile - Palbociclib 211
Table 72: Palbociclib SWOT Analysis, 2013 213
Table 73: Global Sales Forecast ($m) for Palbociclib, 2013-2023 215
Table 74: Product Profile - Talazoparib 217
Table 75: Talazoparib SWOT Analysis, 2013 218
Table 76 Global Sales Forecast ($m) for Talazoparib, 2013-2023 219
Table 77: Product Profile - Veliparib 221
Table 78: Veliparib SWOT Analysis, 2013 223
Table 79: Global Sales Forecast ($m) for Veliparib, 2013-2023 224
Table 80: Early-Stage Immunotherapies in Development for HER2-Negative Breast Cancer, 2014 225
Table 81: AstraZeneca's, Breast Cancer Portfolio Assessment, 2014 233
Table 82: AstraZeneca SWOT Analysis, 2014 233
Table 83: BMS' Breast Cancer Portfolio Assessment, 2014 235
Table 84: BMS SWOT Analysis, 2014 235
Table 85: Eli Lilly SWOT Analysis, 2014 236
Table 86: Pfizer's Breast Cancer Portfolio Assessment, 2014 238
Table 87: Pfizer SWOT Analysis, 2014 238
Table 88: Novartis' Breast Cancer Portfolio Assessment, 2014 240
Table 89: Novartis SWOT Analysis, 2014 240
Table 90: Global Sales Forecasts ($m) for HER2-Negative Breast Cancer, 2013-2023 244
Table 91: Global HER2-Negative Breast Cancer Market - Drivers and Barriers, 2013-2023 247
Table 92: Sales Forecasts ($m) for HER2-Negative Breast Cancer in the US, 2013-2023 250
Table 93: Key Events Impacting Sales for HER2-Negative Breast Cancer in the US, 2013-2023 252
Table 94: US HER2-Negative Breast Cancer Market - Drivers and Barriers, 2013-2023 253
Table 95: Sales Forecasts ($m) for HER2-Negative Breast Cancer in France, 2013-2023 256
Table 96: Key Events Impacting Sales for HER2-Negative Breast Cancer in France, 2013-2023 258
Table 97: French HER2-Negative Breast Cancer Market - Drivers and Barriers, 2013-2023 259
Table 98: Sales Forecasts ($m) for HER2-Negative Breast Cancer in Germany, 2013-2023 262
Table 99: Key Events Impacting Sales for HER2-Negative Breast Cancer in Germany, 2013-2023 264
Table 100: German HER2-Negative Breast Cancer Market - Drivers and Barriers, 2013-2023 265
Table 101: Sales Forecasts ($m) for HER2-Negative Breast Cancer in Italy, 2013-2023 268
Table 102: Key Events Impacting Sales for HER2-Negative Breast Cancer in Italy, 2013-2023 270
Table 103: Italian HER2-Negative Breast Cancer Market - Drivers and Barriers, 2013-2023 271
Table 104: Sales Forecasts ($m) for HER2-Negative Breast Cancer in Spain, 2013-2023 273
Table 105: Key Events Impacting Sales for HER2-Negative Breast Cancer in Spain, 2013-2023 275
Table 106: Spanish HER2-Negative Breast Cancer Market - Drivers and Barriers, 2013-2023 276
Table 107: Sales Forecasts ($m) for HER2-Negative Breast Cancer in the UK, 2013-2023 279
Table 108: Key Events Impacting Sales for HER2-Negative Breast Cancer in the UK, 2013-2023 281
Table 109: UK HER2-Negative Breast Cancer Market - Drivers and Barriers, 2013-2023 282
Table 110: Sales Forecasts ($m) for HER2-Negative Breast Cancer Japan, 2013-2023 285
Table 111: Key Events Impacting Sales for HER2-Negative Breast Cancer in Japan, 2013-2023 287
Table 112: Japanese HER2-Negative Breast Cancer Market - Drivers and Barriers, 2013-2023 288
Table 113: Sales Forecasts ($m) for HER2-Negative Breast Cancer in China, 2013-2023 290
Table 114: Key Events Impacting Sales for HER2-Negative Breast Cancer in China, 2013-2023 292
Table 115: Chinese HER2-Negative Breast Cancer Market - Drivers and Barriers, 2013-2023 292
Table 116: HER2-Negative Breast Cancer Incidence, 2013-2023 330
Table 117: Key Launch Dates of Marketed and Pipeline Drugs for HER2-Negative Breast Cancer 331
Table 118: Key Expiry Dates of Marketed and Pipeline Drugs Used in HER2-Negative Breast Cancer 332
Table 119: Average Body Weight and Surface Area Across the 8MM 333
Table 120: Cost per Treatment Cycle ($) - Abraxane, Metastatic Setting (HR+) 336
Table 121 Cost per Treatment Cycle ($) - Avastin, Metastatic Setting (HR+/TNBC) 337
Table 122: Cost per Treatment Cycle ($) - Afinitor, Third-Line Hormonal/ Targeted Therapy 338
Table 123: Cost per Treatment Cycle ($) - Doxil, Metastatic Setting (HR+/TNBC) 339
Table 124: Cost per Treatment Cycle ($) - Halaven, Metastatic Setting (HR+/TNBC) 340
Table 125: Cost per Treatment Cycle ($) - Ixempra, Metastatic Setting (HR+/TNBC) 341
Table 126 Cost per Treatment Cycle ($) - Xeloda, Metastatic Setting (HR+/TNBC) 342
Table 127: Cost per Treatment Cycle ($) - Abemaciclib, First-/Second-Line Hormonal/Targeted Metastatic Setting (HR+) 343
Table 128: Cost per Treatment Cycle ($) - Buparlisib, Postmenopausal Hormonal Neoadjuvant, Second- and Third-Line Hormonal/Targeted Metastatic Settings (HR+) 344
Table 129: Cost per Treatment Cycle ($) - Javlor, Third-Line Chemotherapy Metastatic Setting (HR+) 345
Table 130: Cost per Treatment Cycle ($) - LEE011, Postmenopausal Hormonal Neoadjuvan, and First-Line Hormonal/Targeted Metastatic Settings (HR+) 346
Table 131: Cost per Treatment Cycle ($) - NeuVax, Adjuvant Setting (HR+) 347
Table 132: Cost per Treatment Cycle ($) - Niraparib, Metastatic TNBC Setting 347
Table 133: Cost per Treatment Cycle ($) - NKTR-102, Third Line Chemotherapy Metastatic Setting (HR+) 348
Table 134: Cost per Treatment Cycle ($) - Lynparza, Adjuvant and First-Line Metastatic TNBC Settings 349
Table 135: Cost per Treatment Cycle ($) - Palbociclib, First- and Second-Line Hormonal/Targeted Metasatatic Setting (HR+) 350
Table 136: Cost per Treatment Cycle ($) - Talazoparib, Third-Line Metastatic TNBC Setting 351
Table 137: Cost per Treatment Cycle ($) - Veliparib, Neoadjuvant and Second-Line Metastatic TNBC Settings 352
Table 138: Physicians Surveyed by Country 355

1.2 List of Figures

Figure 1: Basic Breast Anatomy, Including Key Lymph Nodes 31
Figure 2: 8MM, Age-Standardized Incidence Rate of Breast Cancer, Ages ?15 Years, Women, Cases per 100,000 Population, 2008 46
Figure 3: 8MM, Incidence Rate of Breast Cancer, Ages ?15 Years, Women, Rate per 100,000 Population, 2008 47
Figure 4: US, Incidence Rate of Breast Cancer, All Ages, Women, Cases per 100,000 Population, 1975-2009 48
Figure 5: 5EU, Incidence Rate of Breast Cancer, Ages ?15 Years, Women, Cases per 100,000 Population, 1975-2010 50
Figure 6: Japan, Incidence Rate of Breast Cancer, All Ages, Women, Cases per 100,000 Population, 2003-2008 51
Figure 7: 8MM, Relative Survival Rate for Breast Cancer, All Ages*, Women, %, 1991-2004** 53
Figure 8: 8MM, Diagnosed Incident Cases of Breast Cancer, Ages ?20 Years, Women, N, 2013-2023 68
Figure 9: 8MM, Diagnosed Incident Cases of Breast Cancer, by Age, Women, N, 2013 70
Figure 10: 8MM, Diagnosed Incident Cases of Breast Cancer by Menopausal Status, Ages ?20 Years, Women, N, 2013 71
Figure 11: 8MM, Diagnosed Incident Cases of Breast Cancer by Stage at Diagnosis, Ages ?20 Years, Women, N, 2013 73
Figure 12: 8MM, Age-Standardized Diagnosed Incidence Rate of Breast Cancer, Ages ?20 Years, Women, Cases per 100,000 Population, 2013 74
Figure 13: 8MM, Five-Year Diagnosed Prevalent Cases of Breast Cancer, Ages ?20 Years, Women, N, 2013-2023 76
Figure 14: 8MM, Five-Year Diagnosed Prevalent Cases of Breast Cancer by Menopausal Status, Ages ?20 Years, Women, N, 2013 77
Figure 15: 8MM, Five-Year Diagnosed Prevalent Cases of Breast Cancer by Hormone Receptor Subtypes, Ages ?20 Years, Women, N, 2013 79
Figure 16: Key Late-Stage Clinical Trials of Abraxane 124
Figure 17: Key Late-Stage Clinical Trials of Afinitor 129
Figure 18: Key Late-Stage Clinical Trials of Avastin 134
Figure 19: Key Late-Stage Clinical Trials of Halaven 142
Figure 20: Late Stage Clinical Trials of Drugs in HR+ Breast Cancer 170
Figure 21: Late Stage Clinical Trials of Drugs in TNBC 171
Figure 22: Key Late-Stage Clinical Trials of Abemaciclib 171
Figure 23: Clinical and Commercial Positioning of Abemaciclib 173
Figure 24: Key Late-Stage Clinical Trials of Buparlisib 177
Figure 25: Clinical and Commercial Positioning of Buparlisib 179
Figure 26: Key Late-Stage Clinical Trials of Javlor 182
Figure 27: Clinical and Commercial Positioning of Javlor 183
Figure 28: Key Late-Stage Clinical Trials of LEE011 187
Figure 29: Clinical and Commercial Positioning of LEE011 188
Figure 30: Key Late-Stage Clinical Trials of NeuVax 192
Figure 31: Clinical and Commercial Positioning of NeuVax 194
Figure 32: Key Late-Stage Clinical Trials of Niraparib 196
Figure 33: Clinical and Commercial Positioning of Niraparib 198
Figure 34: Key Late-Stage Clinical Trials of NKTR-102 201
Figure 35: Clinical and Commercial Positioning of NKTR-102 202
Figure 36: Key Late-Stage Clinical Trials of Lynparza 205
Figure 37: Clinical and Commercial Positioning of Lynparza 207
Figure 38: Key Late-Stage Key Clinical Trials of Palbociclib 210
Figure 39: Clinical and Commercial Positioning of Palbociclib 213
Figure 40: Key Late-Stage Clinical Trials of Talazoparib 216
Figure 41: Clinical and Commercial Positioning of Talazoparib 218
Figure 42: Key Late-Stage Clinical Trials of Veliparib 220
Figure 43: Clinical and Commercial Positioning of Veliparib 222
Figure 44: Global Sales ($m) of Branded Products for HER2-Negative Breast Cancer by Company*, 2013-2023 228
Figure 45: Company Portfolio Gap Analysis in HER2-Negative Breast Cancer 2013-2023 229
Figure 46: Global Sales ($m) for HER2-Negative Breast Cancer by Region, 2013-2023 245
Figure 47: Global Sales for HER2-Negative Breast Cancer by Drug, 2013-2022 246
Figure 48: Sales for HER2-Negative Breast Cancer in the US by Drug, 2013-2022 251
Figure 49: Sales for HER2-Negative Breast Cancer in France by Drug, 2013-2023 257
Figure 50: Sales for HER2-Negative Breast Cancer in Germany by Drug, 2013-2023 263
Figure 51: Sales for HER2-Negative Breast Cancer in Italy by Drug, 2013-2023 269
Figure 52: Sales for HER2-Negative Breast Cancer in Spain by Drug, 2013-2022 274
Figure 53: Sales for HER2-Negative Breast Cancer in the UK by Drug, 2013-2023 280
Figure 54: Sales for HER2-Negative Breast Cancer in Japan by Drug, 2013-2023 286
Figure 55: Sales for HER20Negative Breast Cancer in China by Drug, 2013-2023 291

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Breast Cancer Diagnostic Tests - Medical Devices Pipeline Assessment, 2016 Summary GlobalData's Medical Devices sector report, “Breast Cancer Diagnostic Tests - Medical Devices Pipeline Assessment, 2016" ...


ref:plp2015

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