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


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GlobalData

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HER2-positive 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-positive breast cancer market, with coverage of multiple settings of the disease including neoadjuvant, adjuvant, first-, second-, third-, and fourth-line metastatic.

 

Since its introduction in 1998, Roches gold standard therapy, Herceptin (trastuzumab), a monoclonal antibody, revolutionized the treatment of the disease. The realization that targeting the HER2 receptor could significantly improve disease-free survival (DFS) has created a large market for HER2-directed therapies. In 2013, Roche dominated the HER2-positive market, with a share of 95%. With Herceptins patent expiry looming in Europe Roche launched Perjeta and Kadcyla in 2012 and 2013 to maintain its leadership. GlobalData forecasts that the two monoclonal antibodies that also target the HER2 receptor will ensure Roche still occupies over 95% of the market in 2023.

 

The challenge for new entrants into the HER2-positive market is to find patient populations that are currently underserved, and can work cooperatively with Roches targeted therapies. The HER2-positive pipeline is weak, and there are still unmet needs that have yet to be suitably addressed. GlobalData expects that the HER2-positive market will grow due to the premium pricing of new agents, and an increasing aging population in the US, 5EU, Japan, and China.

 

Highlights

 

Key Questions Answered

 

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

 

Key Findings

 

  • The HER2-positive breast cancer market will increase by 2.5-fold, reaching $12.63bn by 2023, at a CAGR of 9.82%, driven by the rapid uptake of the latest premium-priced biologics. Approval of these agents in the early (non-metastatic) stages will have the greatest impact on the market, along with combinations of branded therapies.
  • By 2023, the largest market segment will be the adjuvant setting, with rapid growth at a CAGR of 12.3%, and representing 63% of the total HER2-positive market. Herceptin will no longer be the market leader, with new agents Perjeta and Kadcyla taking 37% and 39% market share respectively.
  • The patent expiry of Herceptin in the 5EU in 2014, and in the US in 2019, will significantly reduce Herceptin sales, however, its introduction of a more convenient subcutaneous reformulation of Herceptin will limit this impact.
  • Development of new HER2-targeting therapies is slow, with only one agent, Puma Biotechnologys neratinib, in Phase III, following the failure of BIs gilotrif. The recent failure of GSKs Tykerb in the adjuvant setting shows that TKIs are best suited to later stages of metastatic disease.
  • Entry into the Roche-dominated HER2-positive market is challenging, with new players needing to find alternative MOAs in underserved patient populations. KOLs identified areas of important unmet need that can still provide opportunities in the HER2-positive space.
  • Future drug development will begin to merge the HER2-positive and HER2-negative populations, as new targets and MOAs are developed, providing exciting opportunities.

 

Scope

 

  • Overview of HER2-positive breast cancer, including epidemiology, etiology, pathophysiology, symptoms, diagnosis, and disease management.
  • Annualized HER2-positive breast cancer therapeutics market revenue, annual cost of therapy, and treatment usage patterns in six patient segments (including neoadjuvant and adjuvant), 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-positive 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 candidate in Phase III development is profiled.
  • Analysis of the current and future market competition in the global HER2-positive 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-positive 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-positive 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.


1 Table of Contents 11
1.1 List of Tables 18
1.2 List of Figures 23

 

2 Introduction 25
2.1 Catalyst 25
2.2 Related Reports 26
2.3 Upcoming Related Reports 26
 

3 Disease Overview 27
3.1 Etiology and Pathophysiology 27
3.1.1 Etiology 27
3.1.2 Pathophysiology 27
3.2 Basic Breast Anatomy 29
3.3 Breast Cancer Staging 30
3.4 Prognosis 31
3.5 Quality of Life 32
3.6 Symptoms 34
 

4 Epidemiology 35
4.1 Disease Background 35
4.2 Risk Factors and Comorbidities 36
4.2.1 A family history of breast cancer and BRCA1/2 gene mutations significantly increase the breast cancer risk 37
4.2.2 Reproductive hormonal factors influence the risk of breast cancer 38
4.2.3 Modifiable lifestyle-related factors increase the risk of mortality in breast cancer patients 40
4.2.4 Screening programs have been shown to reduce breast cancer mortality, although the benefits need to be carefully weighed against the risks 42
4.3 Global Trends 44
4.3.1 Incidence 44
4.3.2 Prevalence and Survival 50
4.4 Forecast Methodology 54
4.4.1 Sources Used 55
4.4.2 Sources Not Used 60
4.4.3 Forecast Assumptions and Methods 60
4.5 Epidemiological Forecast for Breast Cancer (2013-2023) - Diagnosed Incident Cases 64
4.5.1 Diagnosed Incident Cases of Breast Cancer 64
4.5.2 Diagnosed Incident Cases of Breast Cancer by Age 66
4.5.3 Diagnosed Incident Cases of Breast Cancer by Menopausal Status 68
4.5.4 Diagnosed Incident Cases of Breast Cancer Segmented by Stage at Diagnosis 70
4.5.5 Age-Standardized Diagnosed Incidence Rate of Breast Cancer 71
4.6 Epidemiological Forecast for Breast Cancer (2013-2023) Diagnosed Prevalent Cases 72
4.6.1 Five-Year Diagnosed Prevalent Cases of Breast Cancer 72
4.6.2 Five-Year Diagnosed Prevalent Cases by Menopausal Status 75
4.6.3 Five-Year Diagnosed Prevalent Cases by Hormone Receptor Subtypes 76
4.7 Discussion 78
4.7.1 Epidemiological Forecast Insight 78
4.7.2 Limitations of the Analysis 79
4.7.3 Strengths of the Analysis 80
 

5 Disease Management 82
5.1 Treatment Overview 82
5.1.1 Treatment of Early-Stage Breast Cancer (Stage 0 to Stage IB) 82
5.1.2 Treatment of Locally-Advanced and Regional Breast Cancer (Stage IB to IIIA) 83
5.1.3 Treatment of Metastatic HER2-Positive Breast Cancer (Stage IV) 86
5.2 US 89
5.2.1 Diagnosis 89
5.2.2 Clinical Practice 89
5.3 France 92
5.3.1 Diagnosis 92
5.3.2 Clinical Practice 93
5.4 Germany 95
5.4.1 Diagnosis 95
5.4.2 Clinical Practice 96
5.5 Italy 98
5.5.1 Diagnosis 98
5.5.2 Clinical Practice 98
5.6 Spain 101
5.6.1 Diagnosis 101
5.6.2 Clinical Practice 102
5.7 UK 103
5.7.1 Diagnosis 103
5.7.2 Clinical Practice 104
5.8 Japan 107
5.8.1 Diagnosis 107
5.8.2 Clinical Practice 107
5.9 China 108
5.9.1 Diagnosis 108
5.9.2 Clinical Practice 109
 

6 Competitive Assessment 111
6.1 Overview 111
6.2 Product Profiles - HER2-Targeted Therapies 112
6.2.1 Herceptin (trastuzumab) 112
6.2.2 Tykerb (lapatinib) 119
6.2.3 Perjeta (pertuzumab) 124
6.2.4 Kadcyla (ado-trastuzumab emtansine, T-DM1) 129
6.3 Product Profiles - General Targeted Therapies 133
6.3.1 Afinitor (everolimus) 133
6.3.2 Xeloda (capecitabine) 137
6.3.3 Avastin (bevacizumab) 140
6.3.4 Halaven (eribulin mesylate) 143
6.3.5 Abraxane (nab-paclitaxel) 147
6.3.6 Ixempra (ixabepilone) 150
6.4 Hormonal Agents 154
6.4.1 Tamoxifen 154
6.4.2 Faslodex (fulvestrant) 154
6.4.3 Aromatase Inhibitors 155
 

7 Unmet Need and Opportunity 157
7.1 Overview 157
7.2 Brain Metastases 158
7.2.1 Unmet Need 158
7.2.2 Gap Analysis 158
7.2.3 Opportunity 160
7.3 Resistance to HER2-Targeting Therapies 160
7.3.1 Unmet Need 160
7.3.2 Gap Analysis 161
7.3.3 Opportunity 162
 

8 Pipeline Assessment 164
8.1 Overview 164
8.2 Promising Drugs in Clinical Development 165
8.2.1 Gilotrif (afatinib) 165
8.2.2 Neratinib 170
8.3 Promising Drugs in Early-Stage Development 175
8.3.1 Palbociclib 176
8.3.2 NeuVax (nelipepimut-S) 180
8.3.3 Patritumab 184
8.3.4 Ganetespib 187
8.3.5 ARRY-380 (ONT-380) 190
8.3.6 NVP-BYL719 193
8.4 Biosimilars 195
 

9 Current and Future Players 197
9.1 Overview 197
9.2 Trends in Corporate Strategy 200
9.3 Company Profiles 202
9.3.1 Roche/Genentech 202
9.3.2 GlaxoSmithKline 204
9.3.3 Boehringer Ingelheim 206
9.3.4 Novartis 207
9.3.5 Pfizer 210
 

10 Market Outlook 213
10.1 Global Markets 213
10.1.1 Forecast 213
10.1.2 Drivers and Barriers - Global Issues 218
10.2 United States 221
10.2.1 Forecast 221
10.2.2 Key Events 224
10.2.3 Drivers and Barriers 224
10.3 France 227
10.3.1 Forecast 227
10.3.2 Key Events 230
10.3.3 Drivers and Barriers 230
10.4 Germany 232
10.4.1 Forecast 232
10.4.2 Key Events 235
10.4.3 Drivers and Barriers 235
10.5 Italy 237
10.5.1 Forecast 237
10.5.2 Key Events 240
10.5.3 Drivers and Barriers 240
10.6 Spain 242
10.6.1 Forecast 242
10.6.2 Key Events 245
10.6.3 Drivers and Barriers 245
10.7 United Kingdom 247
10.7.1 Forecast 247
10.7.2 Key Events 250
10.7.3 Drivers and Barriers 250
10.8 Japan 253
10.8.1 Forecast 253
10.8.2 Key Events 256
10.8.3 Drivers and Barriers 256
10.9 China 258
10.9.1 Forecast 258
10.9.2 Key Events 261
10.9.3 Drivers and Barriers 261
 

11 Appendix 264
11.1 Bibliography 264
11.2 Abbreviations 294
11.3 Methodology 302
11.4 Forecasting Methodology 302
11.4.1 Diagnosed HER2-Positive Breast Cancer Patients 302
11.4.2 Percent Drug-Treated Patients 303
11.4.3 Drugs Included in Each Therapeutic Class 303
11.4.4 Launch and Patent Expiry Dates 304
11.4.5 General Pricing Assumptions 305
11.4.6 Individual Drug Assumptions 306
11.4.7 Generic Erosion 315
11.4.8 Pricing of Pipeline Agents 315
11.5 Primary Research - KOLs Interviewed for this Report 317
11.6 Primary Research - Prescriber Survey 318
11.7 About the Authors 319
11.7.1 Analyst 319
11.7.2 Therapy Area Director 319
11.7.3 Epidemiologist 320
11.7.4 Acting Director of Epidemiology 320
11.7.5 Global Head of Healthcare 321
11.8 About GlobalData 322
11.9 Disclaimer 322

 

Table 1: AJCC Stage Definitions for Breast Cancer 31

Table 2: Prognosis for Breast Cancer in the US 32

Table 3: Selected Major Risk Factors and Comorbidities for Breast Cancer 37

Table 4: Breast Cancer Mortality Attributable to Lifestyle-Related Risk Factors 41

Table 5: 8MM, Current Status and Plans of Large-Scale Breast Cancer Screening Programs 43

Table 6: 8MM, Relative Survival Rate for Breast Cancer, All Ages*, Women, %, 1991-2004** 50

Table 7: Conversion of Common Staging Systems for Breast Cancer Used in the Forecast 54

Table 8: 8MM, Sources of the Breast Cancer Diagnosed Incidence Data Used in the Epidemiological Forecast 55

Table 9: 8MM, Diagnosed Incident Cases of Breast Cancer, Ages ?20 Years, Women, N, 2013-2023 65

Table 10: 8MM, Diagnosed Incident Cases of Breast Cancer by Age, Women, N (Row %), 2013 67

Table 11: 8MM, Diagnosed Incident Cases of Breast Cancer by Menopausal Status, Ages ?20 Years, Women, N (Row %), 2013 69

Table 12: 8MM, Diagnosed Incident Cases of Breast Cancer by Stage at Diagnosis, Ages ?20 Years, Women, N, 2013 70

Table 13: 8MM, Five-Year Diagnosed Prevalent Cases of Breast Cancer, Ages ?20 Years, Women, N, 2013-2023 73

Table 14: 8MM, Five-Year Diagnosed Prevalent Cases of Breast Cancer by Hormone Receptor Subtypes, Ages ?20 Years, Women, N, 2013 76

Table 15: Treatment Guidelines for HER2-Positive Breast Cancer 88

Table 16: Product Profile - Herceptin 114

Table 17: Clinical Studies for Herceptin in the Adjuvant Setting 116

Table 18: Herceptin SWOT Analysis, 2013 118

Table 19: Global Sales Forecast ($m) for Herceptin, 2013-2023 119

Table 20: Product Profile - Tykerb 121

Table 21: Tykerb SWOT Analysis, 2013 123

Table 22: Global Sales Forecast ($m) for Tykerb, 2013-2023 124

Table 23: Product Profile - Perjeta 126

Table 24: Perjeta SWOT Analysis, 2013 128

Table 25: Global Sales Forecast ($m) for Perjeta, 2013-2023 128

Table 26: Product Profile - Kadcyla 130

Table 27: Kadcyla SWOT Analysis, 2013 132

Table 28: Global Sales Forecast ($m) for Kadcyla, 2013-2023 133

Table 29: Product Profile - Afinitor 135

Table 30: Afinitor SWOT Analysis, 2013 136

Table 31: Product Profile - Xeloda 138

Table 32: Xeloda SWOT Analysis, 2013 140

Table 33: Product Profile - Avastin 141

Table 34: Summary of Avastin Phase III Clinical Trials in Metastatic Breast Cancer 142

Table 35: Avastin SWOT Analysis, 2013 143

Table 36: Product Profile - Halaven 144

Table 37: Halaven SWOT Analysis, 2013 146

Table 38: Global Sales Forecast ($m) for Halaven, 2013-2023 147

Table 39: Product Profile - Abraxane 148

Table 40: Abraxane SWOT Analysis, 2013 149

Table 41: Global Sales Forecast ($m) for Abraxane, 2013-2023 150

Table 42: Product Profile - Ixempra 151

Table 43: Ixempra SWOT Analysis, 2013 153

Table 44: Global Sales Forecast ($m) for Ixempra, 2013-2023 153

Table 45: Summary of Minor Therapeutic Classes Used to Treat HER-2 positive breast cancer, 2013 156

Table 46: Unmet Need and Opportunity in HER2-Positive Breast Cancer 157

Table 47: Product Profile - Gilotrif 167

Table 48: Gilotrif SWOT Analysis, 2014 169

Table 49: Product Profile - Neratinib 171

Table 50: Neratinib SWOT Analysis, 2013 174

Table 51: Global Sales Forecast ($m) for Neratinib, 2013-2023 174

Table 52: Comparison of Therapeutic Classes in Development for HER2-Positive/HER2-Negative Breast Cancer, 2014 175

Table 53: HER2-Positive Breast Cancer - Early-Phase Pipeline, 2014 176

Table 54: Product Profile - Palbociclib 178

Table 55: Palbociclib SWOT Analysis, 2014 180

Table 56: Product Profile - NeuVax 182

Table 57: NeuVax SWOT Analysis, 2014 184

Table 58: Product Profile - Patritumab 185

Table 59: Patritumab SWOT Analysis, 2014 187

Table 60: Product Profile - Ganetespib 188

Table 61: Ganetespib SWOT Analysis, 2014 190

Table 62: Product Profile - ARRY-380 191

Table 63: ARRY-380 SWOT Analysis, 2014 192

Table 64: Product Profile - NVP-BYL719 193

Table 65: NVP-BYL719 SWOT Analysis, 2014 194

Table 66: Trastuzumab Biosimilars, 2014 196

Table 67: Key Companies in the HER2-Positive Breast Cancer Market in the 8MM, 2013-2023 198

Table 68: Roche's HER2-Positive Breast Cancer Portfolio Assessment, 2014 203

Table 69: Roche SWOT Analysis, 2014 204

Table 70: GSK's HER2-Positive Breast Cancer Portfolio Assessment, 2014 205

Table 71: GSK SWOT Analysis, 2014 206

Table 72: BI's HER2-Positive Breast Cancer Portfolio Assessment, 2014 207

Table 73: BI SWOT Analysis, 2014 207

Table 74: Novartis' HER2-Positive Breast Cancer Portfolio Assessment, 2014 209

Table 75: Novartis SWOT Analysis, 2014 209

Table 76: Pfizer's HER2-Positive Breast Cancer Portfolio Assessment, 2014 211

Table 77: Pfizer SWOT Analysis, 2014 212

Table 78: Global Sales Forecast ($m) for HER2-Positive Breast Cancer, 2013-2023 215

Table 79: Global HER2-Positive Breast Cancer Market - Drivers and Barriers, 2013-2023 218

Table 80: Sales Forecast ($m) for HER2-Positive Breast Cancer in the US, 2013-2023 222

Table 81: Key Events Impacting Sales for HER2-Positive Breast Cancer in the US, 2013-2023 224

Table 82: US HER2-Positive Breast Cancer Market - Drivers and Barriers, 2013-2023 224

Table 83: Sales Forecast ($m) for HER2-Positive Breast Cancer in France, 2013-2023 228

Table 84: Key Events Impacting Sales for HER2-Positive Breast Cancer in France, 2013-2023 230

Table 85: French HER2-Positive Breast Cancer Market - Drivers and Barriers, 2013-2023 230

Table 86: Sales Forecast ($m) for HER2-Positive Breast Cancer in Germany, 2013-2023 233

Table 87: Key Events Impacting Sales for HER2-Positive Breast Cancer in Germany, 2013-2023 235

Table 88: German HER2-Positive Breast Cancer Market - Drivers and Barriers, 2013-2023 235

Table 89: Sales Forecast ($m) for HER2-Positive Breast Cancer in Italy, 2013-2023 238

Table 90: Key Events Impacting Sales for HER2-Positive Breast Cancer in Italy, 2013-2023 240

Table 91: Italian HER2-Positive Breast Cancer Market - Drivers and Barriers, 2013-2023 240

Table 92: Sales Forecast ($m) for HER2-Positive Breast Cancer in Spain, 2013-2023 243

Table 93: Key Events Impacting Sales for HER2-Positive Breast Cancer in Spain, 2013-2023 245

Table 94: Spanish HER2-Positive Breast Cancer Market - Drivers and Barriers, 2013-2023 245

Table 95: Sales Forecast ($m) for HER2-Positive Breast Cancer in the UK, 2013-2023 248

Table 96: Key Events Impacting Sales for HER2-Positive Breast Cancer in the UK, 2013-2023 250

Table 97: UK HER2-Positive Breast Cancer Market - Drivers and Barriers, 2013-2023 250

Table 98: Sales Forecast ($m) for HER2-Positive Breast Cancer in Japan, 2013-2023 254

Table 99: Key Events Impacting Sales for HER2-Positive Breast Cancer in Japan, 2013-2023 256

Table 100: Japanese HER2-Positive Breast Cancer Market - Drivers and Barriers, 2013-2023 256

Table 101: Sales Forecast ($m) for HER2-Positive Breast Cancer in China, 2013-2023 259

Table 102: Key Events Impacting Sales for HER2-Positive Breast Cancer in China, 2013-2023 261

Table 103: Chinese HER2-Positive Breast Cancer Market - Drivers and Barriers, 2013-2023 261

Table 104: HER2-Positive Breast Cancer Incidence, 2013-2023 303

Table 105: HER2-Positive Breast Cancer Drugs, Key Launch Dates 304

Table 106: HER2-Positive Breast Cancer Drugs, Key Patent Expiries 305

Table 107: Average Body Weight and Surface Area Across the 8MM 306

Table 108: Average Annual Cost of Therapy ($) - Herceptin, Adjuvant 308

Table 109: Average Annual Cost of Therapy ($) - Subcutaneous Herceptin, Adjuvant 309

Table 110: Average Annual Cost of Therapy ($) - Perjeta, First Line 310

Table 111: Average Annual Cost of Therapy ($) - Tykerb, First Line 311

Table 112: Average Annual Cost of Therapy ($) - Kadcyla, Second Line 312

Table 113: Average Annual Cost of Therapy ($)- Halaven, Fourth Line 312

Table 114: Average Annual Cost of Therapy ($) - Abraxane, Fourth Line 313

Table 115: Average Annual Cost of therapy ($) - Ixempra, Fourth Line 314

Table 116: Average Annual Cost of Therapy ($) - Neratinib, Third Line 316

Table 117: Physicians Surveyed by Country 318

 

Figure 1: Basic Breast Anatomy, Including Key Lymph Nodes 29

Figure 2: 8MM, Age-Standardized Incidence Rate of Breast Cancer, Ages ?15 Years, Women, Cases per 100,000 Population, 2008 44

Figure 3: 8MM, Incidence Rate of Breast Cancer, Ages ?15 Years, Women, Rate per 100,000 Population, 2008 45

Figure 4: US, Incidence Rate of Breast Cancer, All Ages, Women, Cases per 100,000 Population, 1975-2009 46

Figure 5: 5EU, Incidence Rate of Breast Cancer, Ages ?15 Years, Women, Cases per 100,000 Population, 1975-2010 48

Figure 6: Japan, Incidence Rate of Breast Cancer, All Ages, Women, Cases per 100,000 Population, 2003-2008 49

Figure 7: 8MM, Relative Survival Rate for Breast Cancer, All Ages*, Women, %, 1991-2004** 51

Figure 8: 8MM, Diagnosed Incident Cases of Breast Cancer, Ages ?20 Years, Women, N, 2013-2023 65

Figure 9: 8MM, Diagnosed Incident Cases of Breast Cancer, by Age, Women, N, 2013 68

Figure 10: 8MM, Diagnosed Incident Cases of Breast Cancer by Menopausal Status, Ages ?20 Years, Women, N, 2013 69

Figure 11: 8MM, Diagnosed Incident Cases of Breast Cancer by Stage at Diagnosis, Ages ?20 Years, Women, N, 2013 71

Figure 12: 8MM, Age-Standardized Diagnosed Incidence Rate of Breast Cancer, Ages ?20 Years, Women, Cases per 100,000 Population, 2013 72

Figure 13: 8MM, Five-Year Diagnosed Prevalent Cases of Breast Cancer, Ages ?20 Years, Women, N, 2013-2023 74

Figure 14: 8MM, Five-Year Diagnosed Prevalent Cases of Breast Cancer by Menopausal Status, Ages ?20 Years, Women, N, 2013 75

Figure 15: 8MM, Five-Year Diagnosed Prevalent Cases of Breast Cancer by Hormone Receptor Subtypes, Ages ?20 Years, Women, N, 2013 77

Figure 16: Primary Completion Dates of Active Phase III Clinical Trials for Tykerb 120

Figure 17: Active Late-Stage Clinical Trials for Perjeta 125

Figure 18: Active Phase III Clinical Trials for Kadcyla 130

Figure 19: Active Phase III Clinical Trials for Afinitor 134

Figure 20: Clinical Trials for Halaven 144

Figure 21: HER2-Positive Breast Cancer - Phase II-III Pipeline, 2013 165

Figure 22: Gilotrif's Clinical Development in Breast Cancer 166

Figure 23: Clinical and Commercial Positioning of Gilotrif 169

Figure 24: Neratinib's Clinical Development 171

Figure 25: Clinical and Commercial Positioning of neratinib. 173

Figure 26: Global Sales ($m) of Branded Products for HER2-Positive Breast Cancer by Company, 2013-2023 199

Figure 27: Company Portfolio Gap Analysis in HER2-Positive Breast Cancer, 2013-2023 200

Figure 28: Global Sales for HER2-Positive Breast Cancer by Region, 2013-2023 216

Figure 29: Global Sales for HER2-Positive Breast Cancer by Drug Class, 2013-2023 217

Figure 30: Sales for HER2-Positive Breast Cancer in the US by Drug Class, 2013-2023 223

Figure 31: Sales for HER2-Positive Breast Cancer in France by Drug Class, 2013-2023 229

Figure 32: Sales for HER2-Positive Breast Cancer in Germany by Drug Class, 2013-2023 234

Figure 33: Sales for HER2-Positive Breast Cancer in Italy by Drug Class, 2013-2023 239

Figure 34: Sales for HER2-Positive Breast Cancer in Spain by Drug Class, 2013-2023 244

Figure 35: Sales for HER2-Positive Breast Cancer in the UK by Drug Class, 2013-2023 249

Figure 36: Sales for HER2-Positive Breast Cancer in Japan by Drug Class, 2013-2023 255

Figure 37: Sales for HER2-Positive Breast Cancer in China by Drug Class, 2013-2023 260