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PharmaPoint: HER2-Positive Breast Cancer - Global Drug Forecast and Market Analysis to 2025

Published By :

GlobalData

Published Date : Jun 2017

Category :

Pharmaceutical

No. of Pages : 416 Pages

PharmaPoint: HER2-Positive Breast Cancer - Global Drug Forecast and Market Analysis to 2025

Summary

HER2-positive breast cancer is the second most common cancer in the world and the most common cancer in women worldwide. Today, HER2-positive breast cancer patients are living longer with their disease, thanks to established disease management strategies using numerous combinations of chemotherapy with Herceptin, Perjeta, and the tyrosine kinase inhibitor (TKI) Tykerb (lapatinib). During the forecast period from 2015-2025, GlobalData expects that the HER2-positive market will grow due to the launch of HER2-targeted agents in the early disease setting and the aging populations in the US, 5EU (France, Germany, Italy, Spain, and the UK), Japan, and China.

Following the patent expiry of Herceptin and the subsequent highly anticipated introduction of trastuzumab biosimilars during the forecast period, the market is expected to face its biggest barrier to growth to date. Despite a lack of game-changing innovation in the HER2-positive market, the pipeline is diverse with several agents being investigated in the extended adjuvant and metastatic settings. A number of these agents are looking to address the greatest unmet need for HER2-positive breast cancer patients-brain metastases-which typically occur in the later lines of metastatic therapy and are caused by increasingly resistant disease.

Key Questions Answered

- How will biosimilar penetration impact the HER2-positive breast cancer market, especially following the launch of trastuzumab biosimilars in the 8MM?
- How will new pipeline agents such as Ibrance and neratinib impact the HER2-positive breast cancer market?
- The HER2-positive breast cancer market is characterized by a number of unmet needs in the current treatments. What are the main unmet needs in this market? Will the pipeline drugs under development fulfil these unmet needs?
- What impact will the approval of Roches Perjeta in the adjuvant setting following data from the Aphinity trial have on the HER2-positive breast cancer market? What will be the drugs peak sales, and why?

Scope

- Overview of HER2-positive breast cancer, including epidemiology, etiology, pathophysiology, symptoms, diagnosis, and disease management.
- Annualized HER2-positive breast cancer therapeutics market revenue, cost of therapy per patient, and treatment usage patterns in nine patient segments and two treatment strategies (episodic and prophylactic treatment), forecast from 2016 to 2026.
- Key topics covered include strategic competitor assessment, market characterization, unmet needs, clinical trial mapping and implications for the HER2-positive breast cancer therapeutics market.
- Pipeline analysis: comprehensive data assessing emerging trends and mechanisms of action under development for HER2-positive breast cancer. The most promising candidate in Phase III development is profiled.
- Analysis of the current and future market competition in the global HER2-positive breast cancer 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

The report will enable you to -
- 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-positive breast cancer market.
- Drive revenues by understanding the key trends, innovative products and technologies, market segments, and companies likely to impact the global HER2-positive breast cancer 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.
1 Table of Contents
1 Table of Contents 2
1.1 List of Tables 7
1.2 List of Figures 11
2 Executive Summary 13
2.1 HER2-Positive Breast Cancer Market to Increase by 50% by 2025 13
2.2 Perjeta Will Be the Strongest Driver of Market Growth 16
2.3 The Launch of Biosimilar Trastuzumab 17
2.4 Roche Will Continue to Monopolize the HER2-Positive Breast Cancer Market, Despite Herceptin Patent Loss 18
2.5 Improved Treatment for Brain Metastases Remains a Pressing Unmet Need 19
2.6 What Do Physicians Think? 21
3 Introduction 24
3.1 Catalyst 24
3.2 Related Reports 24
3.3 Upcoming Related Reports 25
4 Disease Overview 26
4.1 Etiology and Pathophysiology 26
4.1.1 Etiology 26
4.1.2 Pathophysiology 26
4.2 Basic Breast Anatomy 29
4.3 Breast Cancer Staging 30
4.4 Prognosis 31
4.5 Quality of Life 32
4.6 Symptoms 34
5 Epidemiology 35
5.1 Disease Background 35
5.2 Risk Factors and Comorbidities 36
5.3 Global Trends 38
5.3.1 US 39
5.3.2 5EU 39
5.3.3 Japan 40
5.3.4 China (Urban) 40
5.3.5 Prevalence and Survival 41
5.4 Forecast Methodology 44
5.4.1 Sources Used Tables 45
5.4.2 Forecast Assumptions and Methods 57
5.4.3 Sources Not Used 75
5.5 Epidemiological Forecast for Non-Invasive DCIS Breast Cancer (2015-2025) 76
5.5.1 Diagnosed Incident Cases of Non-Invasive DCIS Breast Cancer 76
5.5.2 Diagnosed Incident Cases of Non-Invasive DCIS Breast Cancer by HER2 Status 78
5.6 Epidemiological Forecast for Invasive Breast Cancer (2015-2025) 79
5.6.1 Diagnosed Incident Cases of Invasive Breast Cancer 79
5.6.2 Age-Specific Diagnosed Incident Cases of Invasive Breast Cancer 81
5.6.3 Age-Standardized Diagnosed Incidence of Invasive Breast Cancer 83
5.6.4 Five-Year Diagnosed Prevalent Cases of Invasive Breast Cancer 84
5.6.5 Diagnosed Incident Cases of Invasive Breast Cancer by Stage at Diagnosis 86
5.6.6 Diagnosed Incident Cases of Invasive Breast Cancer by HER2 Status 87
5.6.7 Diagnosed Incident Cases of HER2+ Invasive Breast Cancer by Stage at Diagnosis, Menopausal Status, and Site of Metastasis 89
5.6.8 Diagnosed Incident Cases of HER2-/HR+ Breast Cancer by Stage at Diagnosis, Menopausal Status, and Type of Biomarker Expression 92
5.6.9 Diagnosed Incident Cases of TN Breast Cancer by Stage at Diagnosis and BRCA Expression 95
5.7 Discussion 97
5.7.1 Epidemiological Forecast Insight 97
5.7.2 Limitations of the Analysis 99
5.7.3 Strengths of the Analysis 101
6 Disease Management 102
6.1 Treatment Overview 102
6.1.1 Treatment of Early-Stage Breast Cancer (Stage 0 to Stage IB) 102
6.1.2 Treatment of Locally Advanced and Regional Breast Cancer (Stage IB to IIIA) 103
6.1.3 Treatment of Metastatic HER2-Positive Breast Cancer (Stage IV) 106
6.2 US 109
6.2.1 Diagnosis 109
6.2.2 Clinical Practice 109
6.3 France 112
6.3.1 Diagnosis 112
6.3.2 Clinical Practice 113
6.4 Germany 114
6.4.1 Diagnosis 114
6.4.2 Clinical Practice 115
6.5 Italy 117
6.5.1 Diagnosis 117
6.5.2 Clinical Practice 117
6.6 Spain 119
6.6.1 Diagnosis 119
6.6.2 Clinical Practice 119
6.7 UK 121
6.7.1 Diagnosis 121
6.7.2 Clinical Practice 122
6.8 Japan 123
6.8.1 Diagnosis 123
6.8.2 Clinical Practice 124
6.9 China 126
6.9.1 Diagnosis 126
6.9.2 Clinical Practice 127
7 Competitive Assessment 129
7.1 Overview 129
7.2 Product Profiles - HER2-Targeted Therapies 130
7.2.1 Herceptin (Trastuzumab) 130
7.2.2 Tykerb (Lapatinib) 143
7.2.3 Perjeta (Pertuzumab) 151
7.2.4 Kadcyla (Ado-trastuzumab Emtansine, T-DM1) 159
7.3 Product Profiles - General Targeted Therapies 165
7.3.1 Halaven (Eribulin Mesylate) 165
7.3.2 Abraxane (Nab-Paclitaxel) 171
7.3.3 Ixempra (Ixabepilone) 176
7.4 Hormonal Agents 181
7.4.1 Tamoxifen 183
7.4.2 Faslodex (Fulvestrant) 183
7.4.3 Aromatase Inhibitors 184
8 Unmet Need and Opportunity 186
8.1 Overview 186
8.2 Treatment of Brain/CNS Metastases 187
8.2.1 Unmet Need 187
8.2.2 Gap Analysis 188
8.2.3 Opportunity 189
8.3 Resistance to HER2-Targeted Therapies 190
8.3.1 Unmet Need 190
8.3.2 Gap Analysis 191
8.3.3 Opportunity 192
8.4 Effective Alternatives to Chemotherapy 193
8.4.1 Unmet Need 193
8.4.2 Gap Analysis 194
8.4.3 Opportunity 194
9 Pipeline Assessment 195
9.1 Overview 195
9.2 HER2-Targeted Therapies 199
9.2.1 Neratinib 199
9.2.2 Margetuximab 212
9.2.3 Tucatinib (ONT-380) 218
9.2.4 Pyrotinib 225
9.3 Other Therapies 230
9.3.1 Utidelone (Depoxythilone; UTD-1) 230
9.3.2 Ibrance (Palbociclib) 236
9.3.3 Onzeald (Etirinotecan Pegol) 245
9.4 Drugs in Early-Stage Development 251
9.4.1 Abemaciclib 252
9.4.2 Adagloxad Simolenin (OBI-822/821) 254
9.4.3 Patritumab 257
9.4.4 NeuVax (nelipepimut-S) 259
9.4.5 Alpelisib 261
9.4.6 Buparlisib 262
9.4.7 Xtandi (Enzalutamide) 263
9.4.8 DS-8201a 264
9.5 Biosimilars 265
9.5.1 Overview 265
9.5.2 Nomenclature 266
9.5.3 EU 267
9.5.4 US 268
9.5.5 Japan 270
9.5.6 China 271
9.5.7 Ex-8MM Trastuzumab Biosimilars 272
9.5.8 Ongoing 8MM Development 273
10 Current and Future Players 277
10.1 Overview 277
10.2 Trends in Corporate Strategy 280
10.3 Company Profiles 282
10.3.1 Roche/Genentech 282
10.3.2 Novartis 285
10.3.3 Pfizer 288
10.3.4 Puma Biotechnology 290
10.3.5 The Biosimilar Players 292
11 Market Outlook 297
11.1 Global Markets 297
11.1.1 Forecast 297
11.1.2 Drivers and Barriers - Global Issues 302
11.2 US 305
11.2.1 Forecast 305
11.2.2 Key Events 309
11.2.3 Drivers and Barriers 309
11.3 5EU 312
11.3.1 Forecast 312
11.3.2 Key Events 315
11.3.3 Drivers and Barriers 316
11.4 Japan 319
11.4.1 Forecast 319
11.4.2 Key Events 322
11.4.3 Drivers and Barriers 322
11.5 China 325
11.5.1 Forecast 325
11.5.2 Key Events 328
11.5.3 Drivers and Barriers 328
12 Appendix 333
12.1 Bibliography 333
12.2 Abbreviations 378
12.3 Methodology 387
12.4 Forecasting Methodology 387
12.4.1 Diagnosed Patients with HER2-Positive Breast Cancer 387
12.4.2 Percent Drug-Treated Patients 388
12.4.3 Drugs Included in Each Therapeutic Class 388
12.4.4 Launch and Patent Expiration Dates 389
12.4.5 General Pricing Assumptions 390
12.4.6 Average Body Weight and Surface Area Across the 8MM 391
12.4.7 General Forecast Assumptions 391
12.4.8 Individual Drug Assumptions 391
12.4.9 Generic Erosion 402
12.4.10 Pricing of Pipeline Agents 403
12.5 Primary Research - KOLs Interviewed for this Report 409
12.6 Primary Research - Prescriber Survey 412
12.7 About the Authors 413
12.7.1 Analysts 413
12.7.2 Epidemiologist 413
12.7.3 Therapy Area Director 413
12.7.4 Epidemiology Director 414
12.7.5 Global Director of Therapy Analysis and Epidemiology 415
12.7.6 Global Head of Healthcare 415
12.8 About GlobalData 416
12.9 Contact Us 416
12.10 Disclaimer 416

1.1 List of Tables
Table 1: HER2-Positive Breast Cancer: Key Metrics in the Eight Major Pharmaceutical Markets, 2015-2025 13
Table 2: Definitions of HER2 Status by IHC Staining 28
Table 3: AJCC Stage Definitions for Breast Cancer 31
Table 4: Prognosis for Breast Cancer in the US 32
Table 5: Risk Factors and Comorbidities for Breast Cancer 37
Table 6: 8MM, Most Recent Five-Year Relative Survival for Invasive Breast Cancer, Women (%) 41
Table 7: 8MM, Sources of Epidemiological Data Used to Forecast Diagnosed Incidence of Non-Invasive DCIS Breast Cancer 45
Table 8: 8MM, Sources of Epidemiological Data Used to Forecast Diagnosed Incident Cases of Non-Invasive DCIS Breast Cancer by HER2 Status 46
Table 9: 8MM, Sources of Epidemiological Data Used to Forecast Diagnosed Incidence of Invasive Breast Cancer 47
Table 10: 8MM, Sources of Epidemiological Data Used to Forecast Invasive Breast Cancer by HER2 Status 48
Table 11: 8MM, Sources of Epidemiological Data Used to Forecast the Relative Survival of Invasive Breast Cancer 49
Table 12: 8MM, Sources of Epidemiological Data Used to Forecast HER2+ Invasive Breast Cancer by Stage at Diagnosis 50
Table 13: 8MM, Sources of Epidemiological Data Used to Forecast HER2-, HR+ Invasive Breast Cancer by Stage at Diagnosis 51
Table 14: 8MM, Sources of Epidemiological Data Used to Forecast TN Invasive Breast Cancer by Stage at Diagnosis 52
Table 15: 8MM, Sources of Epidemiological Data Used to Forecast HER2-Specific Invasive Breast Cancer by Menopausal Status 53
Table 16: 8MM, Sources of Epidemiological Data Used to Forecast HER2+ Invasive Breast Cancer by Site of Metastasis 54
Table 17: 8MM, Sources of Epidemiological Data Used to Forecast HER2-Specific Invasive Breast Cancer by Type of Biomarker Expression 55
Table 18: 8MM, Sources Not Used in Epidemiological Analysis of Breast Cancer 75
Table 19: 8MM, Diagnosed Incident Cases of Non-Invasive DCIS Breast Cancer, Women, Ages 18 Years, N, Select Years, 2015-2025 77
Table 20: 8MM, Diagnosed Incident Cases of Non-Invasive DCIS Breast Cancer by HER2 Status, Women, Ages 18 Years, N, 2015 78
Table 21: 8MM, Diagnosed Incident Cases of Invasive Breast Cancer, Women, Ages 18 Years, N, Select Years, 2015-2025 80
Table 22: 8MM, Age-Specific Diagnosed Incident Cases of Invasive Breast Cancer, Women, Ages 18 Years, N (Row %), 2015 82
Table 23: 8MM, Five-Year Diagnosed Prevalent Cases of Invasive Breast Cancer, Women, Ages 18 Years, N, Select Years, 2015-2025 85
Table 24: 8MM, Diagnosed Incident Cases of Invasive Breast Cancer by Stage at Diagnosis, Women, Ages 18 Years, N, 2015 86
Table 25: 8MM, Diagnosed Incident Cases of Invasive Breast Cancer by HER2 Status, Women, Ages 18 Years, N, 2015 88
Table 26: Treatment Guidelines for HER2-Positive Breast Cancer 108
Table 27: Product Profile - Herceptin 131
Table 28: Clinical Studies for Herceptin in the Adjuvant Setting 137
Table 29: Efficacy of Herceptin + chemotherapy in untreated metastatic HER2-positive breast cancer 138
Table 30: Safety of Herceptin Monotherapy in Early-Stage HER2-Positive Breast Cancer 139
Table 31: Safety Profile of Herceptin + Chemotherapy in Untreated Metastatic HER2-Positive Breast Cancer 141
Table 32: Herceptin SWOT Analysis, 2017 142
Table 33: Product Profile - Tykerb 144
Table 34: Efficacy of Tykerb in Combination with Capecitabine for the Second-line Treatment of HER2-Positive Metastatic Breast Cancer 147
Table 35: Safety Profile of Tykerb in Combination with Capecitabine for the Treatment of Metastatic Breast Cancer 149
Table 36: Safety Profile of Tykerb in Combination with Letrozole for the Treatment of Metastatic Breast Cancer 150
Table 37: Tykerb SWOT Analysis, 2017 151
Table 38: Product Profile - Perjeta 152
Table 39: Efficacy of Perjeta in Combination with Herceptin and docetaxel for the Treatment of HER2-positive Metastatic Breast Cancer (CLEOPATRA, NCT00567190) 155
Table 40: Efficacy of Perjeta in Combination with Herceptin and docetaxel for the Treatment of Locally Advanced HER2-positive Breast Cancer (NeoSphere, NCT00545688) 156
Table 41: Safety Profile of Perjeta in Combination with Herceptin and Docetaxel for the Treatment of Metastatic Breast Cancer (CLEOPATRA, NCT00567190) 157
Table 42: Perjeta SWOT Analysis, 2017 158
Table 43: Product Profile - Kadcyla 160
Table 44: Efficacy of Kadcyla Monotherapy for the Second-Line Treatment of HER2-Positive Metastatic Breast Cancer (EMILIA, NCT00829166) 163
Table 45: Safety Profile of Kadcyla Monotherapy for the Second-Line Treatment of HER2-Positive Metastatic Breast Cancer (EMILIA, NCT00829166) 164
Table 46: Kadcyla SWOT Analysis, 2017 165
Table 47: Product Profile - Halaven 166
Table 48: Efficacy of Halaven in the Treatment of Metastatic Breast Cancer (EMBRACE, NCT00388726) 168
Table 49: Efficacy of Halaven in the Second-Line Treatment of Metastatic Breast Cancer (Study 301, NCT00337103) 168
Table 50: Safety Profile of Halaven in the Third-line Treatment of Metastatic Breast Cancer (EMBRACE, NCT00388726) 169
Table 51: Halaven SWOT Analysis, 2017 170
Table 52: Product Profile - Abraxane 172
Table 53: Efficacy of Abraxane Monotherapy in the Treatment of Metastatic Breast Cancer 174
Table 54: Safety of Abraxane Monotherapy in the Treatment of Metastatic Breast Cancer 175
Table 55: Abraxane SWOT Analysis, 2017 176
Table 56: Product Profile - Ixempra 177
Table 57: Efficacy of Ixempra in Combination with Xeloda for the Treatment of Metastatic Breast Cancer 179
Table 58: Safety of Ixempra in Combination with Capecitabine for the Treatment of Metastatic Breast Cancer 180
Table 59: Ixempra SWOT Analysis, 2017 181
Table 60: Summary of Minor Therapeutic Classes Used to Treat HER2-Positive Breast Cancer, 2017 183
Table 61: Unmet Need and Opportunity in HER2-Positive Breast Cancer 187
Table 62: Product Profile - Neratinib 201
Table 63: Efficacy of Neratinib from the Phase III ExteNET Trial (Two-Year Data Set) 206
Table 64: Efficacy of Neratinib from the Phase III ExteNET Trial (Five-Year Data Set) 206
Table 65: Safety of Neratinib Monotherapy Compared to Placebo from the ExteNET trial in HER2-Positive Breast Cancer Patients Who Received Adjuvant Herceptin Therapy 208
Table 66: Treatment-Emergent Diarrhea from the Phase III CONTROL Trial 209
Table 67: Neratinib SWOT Analysis, 2016 211
Table 68: Product Profile - Margetuximab 212
Table 69: Safety of Margetuximab Monotherapy in Metastatic HER2-Positve Breast Cancer Patients 215
Table 70: Margetuximab SWOT Analysis 217
Table 71: Product Profile - ARRY-380 219
Table 72: Efficacy of Tucatinib from the Phase I Trial in HER2-Positive Metastatic Breast Cancer 222
Table 73: Safety Profile of Tucatinib Administered at the MTD (600mg or 650 mg BID) from the Phase I Trial in HER2-Positive Metastatic Solid Cancers 223
Table 74: Tucatinib SWOT Analysis 225
Table 75: Product Profile - Pyrotinib 226
Table 76: Efficacy of Pyrotinib from the Phase I Clinical Trial (NCT01937689) 228
Table 77: Pyrotinib SWOT Analysis, 2017 229
Table 78: Product Profile - Utidelone 231
Table 79: Efficacy of Utidelone as a Monotherapy and in Combination with Capecitabine in the Treatment of Metastatic Breast Cancer 233
Table 80: Safety of Utidelone in Combination with Capecitabine and as a Monotherapy for the Treatment of Metastatic Breast Cancer from the Phase II Trial (CHiCTR-TRC-13004205) 234
Table 81: Utidelone SWOT Analysis, 2017 235
Table 82: Product Profile - Ibrance 237
Table 83: Efficacy of Ibrance from the Phase II Study, NA-PHER2 241
Table 84: Efficacy of Ibrance from the Phase II Study (NCT01037790) 241
Table 85: Ibrance SWOT Analysis, 2017 244
Table 86: Product Profile - Onzeald 245
Table 87: Efficacy of Onzeald from the Phase III Study, BEACON 248
Table 88: Safety of Onzeald from the Phase III Study, BEACON 249
Table 89: Onzeald SWOT Analysis, 2017 250
Table 90: Comparison of Therapeutic Classes in Development for HER2-Positive/HER2-Negative Breast Cancer, 2017 251
Table 91: HER2-Positive Breast Cancer - Early-Phase Pipeline, 2017 252
Table 92: Safety of Adagloxad Simolenin in Combination with Cyclophosphamide for the Treatment of Metastatic Breast Cancer 256
Table 93: Trastuzumab Biosimilars, 2017 266
Table 94: Trastuzumab Biosimilars, 2016 274
Table 95: Key Companies in the HER2-Positive Breast Cancer Market in the 8MM, 2015-2025 278
Table 96: Roches HER2-Positive Breast Cancer Portfolio Assessment, 2017 284
Table 97: Roche SWOT Analysis, 2017 285
Table 98: Novartis HER2-Positive Breast Cancer Portfolio Assessment, 2017 287
Table 99: Novartis SWOT Analysis, 2017 287
Table 100: Pfizers HER2-Positive Breast Cancer Portfolio Assessment, 2017 289
Table 101: Pfizer SWOT Analysis, 2017 289
Table 102: Puma Biotechnologys HER2-Positive Breast Cancer Portfolio Assessment, 2017 291
Table 103: Puma Biotechnology SWOT Analysis, 2017 292
Table 104: Mylans HER2-Positive Breast Cancer Portfolio Assessment, 2017 293
Table 105: Mylan/Biocon SWOT Analysis, 2017 294
Table 106: Tevas HER2-Positive Breast Cancer Portfolio Assessment, 2017 295
Table 107: Teva/Celltrion SWOT Analysis, 2017 295
Table 108: Merck & Co.s HER2-Positive Breast Cancer Portfolio Assessment, 2017 296
Table 109: Merck & Co./Samsung Bioepsis SWOT Analysis, 2017 296
Table 110: Global HER2-Positive Breast Cancer Market - Drivers and Barriers, 2015-2025 302
Table 111: Key Events Impacting Sales for HER2-Positive Breast Cancer in the US, 2015-2025 309
Table 112: US HER2-Positive Breast Cancer Market - Drivers and Barriers, 2015-2025 309
Table 113: Key Events Impacting Sales for HER2-Positive Breast Cancer in the 5EU, 2015-2025 315
Table 114: 5EU HER2-Positive Breast Cancer Market - Drivers and Barriers, 2015-2025 316
Table 115: Key Events Impacting Sales for HER2-Positive Breast Cancer in Japan, 2015-2025 322
Table 116: Japanese HER2-Positive Breast Cancer Market - Drivers and Barriers, 2015-2025 322
Table 117: Key Events Impacting Sales for HER2-Positive Breast Cancer in China, 2015-2025 328
Table 118: Chinese HER2-Positive Breast Cancer Market - Drivers and Barriers, 2015-2025 328
Table 119: Key Launch Dates in HER2-Positive Breast Cancer 389
Table 120: Key Patent/Exclusivity Expiries 389
Table 121: Average Body Weight and Surface Area Across the 8MM 391
Table 122: Average Cost of Therapy of Generic Chemotherapy in the 8MM 392
Table 123: Average Cost of Therapy of Liposomal Doxorubicin in the 8MM 393
Table 124: Cost of Therapy of Generic Capecitabine in the US 393
Table 125: Average Cost of Therapy of Herceptin in the 8MM 395
Table 126: Average Cost of Therapy of Perjeta in the 8MM 396
Table 127: Average Cost of Therapy of Tykerb/Tyverb in the 8MM 397
Table 128: Average Cost of Therapy of Kadcyla in the 8MM 398
Table 129: Average Cost of Endocrine Therapy in the 8MM 399
Table 130: Average Cost of Therapy of Faslodex in the 8MM 400
Table 131: Average Cost of Therapy of Halaven in the 8MM 401
Table 132: Average Cost of Therapy of Abraxane in the 8MM 402
Table 133: Average Cost of Therapy of Ixempra in the 8MM 402
Table 134: Average Cost of Therapy of Neratinib in the 8MM 403
Table 135: Average Cost of Therapy of Ibrance in the 8MM 404
Table 136: Average Cost of Therapy of Onzeald in the 8MM 405
Table 137: Average Cost of Therapy of Tucatinib in the 8MM 406
Table 138: Average Cost of Therapy of Margetuximab in the 8MM 406
Table 139: Average Cost of Therapy of Pyrotinib in the 8MM 407
Table 140: Average Cost of Therapy of UTD-1 in the 8MM 408
Table 141: High-Prescribing Physicians (non-KOLs) Surveyed, by Country 412

1.2 List of Figures
Figure 1: Global Sales for HER2-Positive Breast Cancer by Region, 2015-2025 16
Figure 2:Company Portfolio Gap Analysis in HER2-Positive Breast Cancer, 2015-2025 19
Figure 3: Competitive Assessment of Most Promising Agents for HER2-Positive Breast Cancer, 2015-2025 20
Figure 4: Basic Breast Anatomy, Including Key Lymph Nodes 29
Figure 5: 8MM, Crude Diagnosed Incidence Rates of Invasive Breast Cancer, Ages 18 Years, Women, Cases per 100,000 Population, 20052014 38
Figure 6: Case Flow Map 44
Figure 7: 8MM, Diagnosed Incident Cases of Non-Invasive DCIS Breast Cancer, Women, Ages 18 Years, Selected Years, 2015-2025 77
Figure 8: 8MM, Diagnosed Incident Cases of Non-Invasive DCIS Breast Cancer by HER2 Status, Women, Ages 18 Years, 2015 79
Figure 9: 8MM, Diagnosed Incident Cases of Invasive Breast Cancer, Women, Ages 18 Years, Selected Years, 2015-2025 80
Figure 10: 8MM, Age-Specific Diagnosed Incident Cases of Invasive Breast Cancer, Women, Ages 18 Years, N, 2015 83
Figure 11: 8MM, Age-Standardized Diagnosed Incident Cases of Invasive Breast Cancer, Women, Ages 18 Years, N, 2015 84
Figure 12: 8MM, Five-Year Diagnosed Prevalent Cases of Invasive Breast Cancer, Women, Ages 18 Years, Select Years, 2015-2025 85
Figure 13: 8MM, Diagnosed Incident Cases of Invasive Breast Cancer by Stage at Diagnosis, Women, Ages 18 Years, 2015 87
Figure 14: 8MM, Diagnosed Incident Cases of Breast Cancer by HER2 Status, Women, Ages 18 Years, 2015 88
Figure 15: 8MM, Diagnosed Incident Cases of HER2+ Invasive Breast Cancer by Stage at Diagnosis, Women, Ages 18 Years, 2015 89
Figure 16: 8MM, Proportion of HER2+/HR+ Diagnosed Incident Cases of Invasive Breast Cancer by Menopausal Status, Women, Ages 18 Years, 2015 90
Figure 17: 8MM, Proportion of HER2+/HR- Diagnosed Incident Cases of Invasive Breast Cancer by Menopausal Status, Women, Ages 18 Years, 2015 91
Figure 18: 8MM, Diagnosed Incident Cases of HER2+ Invasive Breast Cancer by Site of Metastasis, Women, Ages 18 Years, 2015 92
Figure 19: 8MM, Diagnosed Incident Cases of HER2-/HR+ Invasive Breast Cancer by Stage at Diagnosis, Women, Ages 18 Years, 2015 93
Figure 20: 8MM, Proportion of HER2-/HR+ Diagnosed Incident Cases of Invasive Breast Cancer by Menopausal Status, Women, Ages 18 Years, 2015 94
Figure 21: 8MM, Diagnosed Incident Cases of HER2-/HR+ Invasive Breast Cancer by Type of Biomarker Expression, Women, Ages 18 Years, 2015 95
Figure 22: 8MM, Diagnosed Incident Cases of TN Invasive Breast Cancer by Stage at Diagnosis, Women, Ages 18 Years, 2015 96
Figure 23: 8MM, Diagnosed Incident Cases of TN Invasive Breast Cancer with BRCA Expression, Women, Ages 18 Years, 2015 97
Figure 24: Active Late-Stage Clinical Trials for Herceptin 134
Figure 25: Active Late-Stage Clinical Trials for Tykerb 146
Figure 26: Active Late-Stage Clinical Trials for Perjeta 154
Figure 27: Active Phase III Clinical Trials for Kadcyla 161
Figure 28: Active Phase III Clinical Trials for Halaven 167
Figure 29: Active Phase III Clinical Trials for Abraxane 173
Figure 30: Overview of the Development Pipeline in HER2-Positive Breast Cancer 196
Figure 31: HER2-Positive Breast Cancer - Phase II-III Pipeline, 2015 198
Figure 32: Competitive Assessment of Late-Stage Pipeline Agents in HER2-Positive Breast Cancer, 2015-2025 199
Figure 33: Neratinibs Clinical Development 204
Figure 34: Clinical and Commercial Positioning of Neratinib 210
Figure 35: Margetuximabs Clinical Development 214
Figure 36: Clinical and Commercial Positioning of Margetuximab 216
Figure 37: Tucatinibs Clinical Development 221
Figure 38: Clinical and Commercial Positioning of tucatinib 224
Figure 39: Pyrotinibs Clinical Development 227
Figure 40: Clinical and Commercial Positioning of pyrotinib 229
Figure 41: Utidelones Clinical Development 232
Figure 42: Clinical and Commercial Positioning of utidelone 235
Figure 43: Ibrances Clinical Development 240
Figure 44: Clinical and Commercial Positioning of Ibrance 243
Figure 45: Onzealds Clinical Development 247
Figure 46: Clinical and Commercial Positioning of Onzeald 249
Figure 47: Global Sales ($m) of Branded Products for HER2-Positive Breast Cancer by Company, 2015-2025 279
Figure 48: Company Portfolio Gap Analysis in HER2-Positive Breast Cancer, 2013-2023 280
Figure 49: Global Sales for HER2-Positive Breast Cancer, by Region, 2015 and 2025 300
Figure 50: Global Sales for HER2-Positive Breast Cancer by Drug Class, 2015 and2025 301
Figure 51: Sales ($m) for HER2-Positive Breast Cancer in the US, by Drug Class, 2015-2025 308
Figure 52: Sales for HER2-Positive Breast Cancer in the 5EU, by Drug Class, 2015-2025 314
Figure 53: Sales for HER2-Positive Breast Cancer in Japan by Drug Class, 2015-2025 321
Figure 54: Sales for HER2-Positive Breast Cancer in China by Drug Class, 2015-2025 327

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