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Report Title

HER2-Negative Breast Cancer - 5EU Drug Forecast and Market Analysis to 2023

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HER2-Negative Breast Cancer - 5EU Drug Forecast and Market Analysis to 2023


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HER2-Negative Breast Cancer - 5EU Drug Forecast and Market Analysis to 2023

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HER2-Negative Breast Cancer - 5EU Drug Forecast and Market Analysis to 2023



Executive Summary

HER2-Negative Breast Cancer - 5EU 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).

Indeed, the new drugs that will be entering the market will command a premium price in multiple settings, and there will be a steady increase in the incident cases of the disease (1.8% AGR) over the forecast period. However, it should be noted that, compared with other countries in the 5EU, the market in Germany will grow at a slower rate, with its share of the global market ultimately decreasing from 9% in 2013 to 8% in 2023.

*This is an on-demand report and will be delivered within 24 hrs. (excluding weekends) of the purchase.

Scope

- Overview of HER2-Negative Breast Cancer including epidemiology, etiology, symptoms, diagnosis, pathology and treatment guidelines as well as an overview on the competitive landscape.

- Detailed information on the key drugs in 5EU including product HER2-Negative Breast Cancercription, safety and efficacy profiles as well as a SWOT analysis.

- Sales forecast for the top drugs in 5EU from 2013-2023.

- Analysis of the impact of key events as well the drivers and restraints affecting the 5EU HER2-Negative Breast Cancer market.

Reasons to buy

- Understand and capitalize by identifying products that are most likely to ensure a robust return

- Stay ahead of the competition by understanding the changing competitive landscape for HER2-Negative Breast Cancer.

- Effectively plan your M&A and partnership strategies by identifying drugs with the most promising sales potential

- Make more informed business decisions from insightful and in-depth analysis of drug performance

- Obtain sales forecast for drugs from 2013-2023 in the 5EU.

1 Table of Contents

1 Table of Contents 2

1.1 List of Tables 6

1.2 List of Figures 11

2 Introduction 13

2.1 Catalyst 13

2.2 Related Reports 13

2.3 Upcoming Related Reports 14

3 Disease Overview 15

3.1 Etiology and Pathophysiology 15

3.1.1 Etiology 15

3.1.2 Pathophysiology 16

3.1.3 Basic Breast Anatomy 17

3.2 Disease Classification/Staging Systems 18

3.3 Symptoms 20

3.4 Prognosis 20

3.5 Quality of Life 21

4 Disease Management 24

4.1 Diagnosis and Treatment Overview 24

4.1.1 Treatment of Early-Stage Breast Cancer (Stage 0 to Stage IB) 24

4.1.2 Treatment of Locally-Advanced and Regional Breast Cancer (Stage IB to IIIC) 26

4.1.3 Treatment Guidelines and Leading Prescribed Drugs 30

4.2 France 31

4.2.1 Diagnosis 31

4.2.2 Clinical Practice 32

4.3 Germany 35

4.3.1 Diagnosis 35

4.3.2 Clinical Practice 36

4.4 Italy 39

4.4.1 Diagnosis 39

4.4.2 Clinical Practice 40

4.5 Spain 42

4.5.1 Diagnosis 42

4.5.2 Clinical Practice 43

4.6 UK 45

4.6.1 Diagnosis 45

4.6.2 Clinical Practice 46

5 Competitive Assessment 50

5.1 Overview 50

5.2 Product Profiles (Branded Therapies) 51

5.2.1 Abraxane (nab-paclitaxel) 51

5.2.2 Afinitor (everolimus) 56

5.2.3 Avastin (bevacizumab) 60

5.2.4 Doxil/Caelyx (pegylated liposomal doxorubicin) 65

5.2.5 Halaven (eribulin mesylate) 70

5.2.6 Ixempra (ixabepilone) 73

5.2.7 Xeloda (capecitabine) 76

5.3 Product Profiles (Hormonal Agents) 79

5.3.1 Tamoxifen 79

5.3.2 Faslodex (fulvestrant) 79

5.3.3 Aromatase Inhibitors 80

6 Unmet Need and Opportunity 84

6.1 Overview 84

6.1.1 Defined treatment plan for BRCA mutation-positive patients and prevention of prophylactic surgeries 86

6.1.2 Specific treatment options for TNBC patients 88

6.1.3 Prevention of brain metastasis 89

6.1.4 Neoadjuvant therapy that can downstage tumors 91

6.1.5 For HR+patients, reduced resistance to hormonal agents 92

6.1.6 Improved convenience of administration of hormonal agents 94

7 Pipeline Assessment 96

7.1 Overview 96

7.1.1 Abemaciclib (LY2835219) 97

7.1.2 Buparlisib (BKM- 120) 103

7.1.3 Javlor (vinflunine) 109

7.1.4 LEE011 113

7.1.5 NeuVax (nelipepimut-S/E75) 118

7.1.6 Niraparib (MK4827) 123

7.1.7 NKTR- 102 (etirinotecan pegol) 128

7.1.8 Lynparza (olaparib) 132

7.1.9 Palbociclib (PD-0332991) 137

7.1.10 Talazoparib (BMN 673) 143

7.1.11 Veliparib (ABT-888) 147

7.2 Promising Drugs in Clinical Development 152

7.2.1 PD-/PD-L 1 Immunotherapies 153

8 Market Outlook 155

8.1 France 155

8.1.1 Forecast 155

8.1.2 Key Events 158

8.1.3 Drivers and Barriers 159

8.2 Germany 160

8.2.1 Forecast 160

8.2.2 Key Events 164

8.2.3 Drivers and Barriers 165

8.3 Italy 166

8.3.1 Forecast 166

8.3.2 Key Events 170

8.3.3 Drivers and Barriers 171

8.4 Spain 172

8.4.1 Forecast 172

8.4.2 Key Events 175

8.4.3 Drivers and Barriers 176

8.5 UK 177

8.5.1 Forecast 177

8.5.2 Key Events 181

8.5.3 Drivers and Barriers 182

9 Appendix 185

9.1 Bibliography 185

9.2 Abbreviations 212

9.3 Methodology 220

9.4 Forecasting Methodology 220

9.4.1 Diagnosed HER2-Negative Breast Cancer Patients 220

9.4.2 Percentage of Drug-Treated Patients 221

9.4.3 Drugs Included in Each Therapeutic Class 221

9.4.4 Launch and Patent Expiry Dates 222

9.4.5 General Pricing Assumptions 223

9.4.6 Individual Drug Assumptions 225

9.4.7 Generic Erosion 233

9.4.8 Pricing of Pipeline Agents 233

9.5 Primary Research - KOLs Interviewed for This Report 244

9.6 Primary Research - High-Prescriber Survey 246

9.7 About the Authors 247

9.7.1 Analyst 247

9.7.2 Director of Oncology 247

9.7.3 Epidemiologist 248

9.7.4 Director of Epidemiology 248

9.7.5 Global Head of Healthcare 249

9.8 About GlobalData 250

9.9 Disclaimer 250

To know more information on Purchase by Section, please send a mail to sales@kenresearch.com

1.2 List of Figures

Figure 1: Basic Breast Anatomy, Including Key Lymph Nodes 18

Figure 2: Key Late-Stage Clinical Trials of Abraxane 52

Figure 3: Key Late-Stage Clinical Trials of Afinitor 57

Figure 4: Key Late-Stage Clinical Trials of Avastin 62

Figure 5: Key Late-Stage Clinical Trials of Halaven 70

Figure 6: Late Stage Clinical Trials of Drugs in HR+ Breast Cancer 98

Figure 7: Late Stage Clinical Trials of Drugs in TNBC 99

Figure 8: Key Late-Stage Clinical Trials of Abemaciclib 99

Figure 9: Clinical and Commercial Positioning of Abemaciclib 101

Figure 10: Key Late-Stage Clinical Trials of Buparlisib 105

Figure 11: Clinical and Commercial Positioning of Buparlisib 107

Figure 12: Key Late-Stage Clinical Trials of Javlor 110

Figure 13: Clinical and Commercial Positioning of Javlor 111

Figure 14: Key Late-Stage Clinical Trials of LEE011 115

Figure 15: Clinical and Commercial Positioning of LEE011 116

Figure 16: Key Late-Stage Clinical Trials of NeuVax 120

Figure 17: Clinical and Commercial Positioning of NeuVax 122

Figure 18: Key Late-Stage Clinical Trials of Niraparib 124

Figure 19: Clinical and Commercial Positioning of Niraparib 126

Figure 20: Key Late-Stage Clinical Trials of NKTR-102 129

Figure 21: Clinical and Commercial Positioning of NKTR-102 130

Figure 22: Key Late-Stage Clinical Trials of Lynparza 133

Figure 23: Clinical and Commercial Positioning of Lynparza 135

Figure 24: Key Late-Stage Key Clinical Trials of Palbociclib 138

Figure 25: Clinical and Commercial Positioning of Palbociclib 141

Figure 26: Key Late-Stage Clinical Trials of Talazoparib 144

Figure 27: Clinical and Commercial Positioning of Talazoparib 146

Figure 28: Key Late-Stage Clinical Trials of Veliparib 148

Figure 29: Clinical and Commercial Positioning of Veliparib 150

Figure 30: Sales for HER2-Negative Breast Cancer in France by Drug, 2013-2023 157

Figure 31: Sales for HER2-Negative Breast Cancer in Germany by Drug, 2013-2023 163

Figure 32: Sales for HER2-Negative Breast Cancer in Italy by Drug, 2013-2023 169

Figure 33: Sales for HER2-Negative Breast Cancer in Spain by Drug, 2013-2022 174

Figure 34: Sales for HER2-Negative Breast Cancer in the UK by Drug, 2013-2023 180

1.1 List of Tables

Table 1: AJCC Stage Definitions for Breast Cancer 19

Table 2: Prognosis for Breast Cancer 20

Table 3: Treatment Guidelines for HER2-Negative Breast Cancer 30

Table 4: Most Prescribed Regimens for HER2-Negative Breast Cancer by Drug Class in the Global Markets, 2013 31

Table 5: HER2-Negative Breast Cancer Diagnosis and Treatment, Country Profile - France 32

Table 6: HER2-Negative Breast Cancer Diagnosis and Treatment, Country Profile - Germany 36

Table 7: HER2-Negative Breast Cancer Diagnosis and Treatment, Country Profile - Italy 40

Table 8: HER2-Negative Breast Cancer Diagnosis and Treatment, Country Profile - Spain 43

Table 9: HER2-Negative Breast Cancer Diagnosis and Treatment, Country Profile - UK 46

Table 10: Product Profile - Abraxane 53

Table 11: Abraxane SWOT Analysis, 2013 55

Table 12: Global Sales Forecast ($m) for Abraxane, 2013-2023 56

Table 13: Product Profile - Afinitor (everolimus) 58

Table 14: Afinitor SWOT Analysis, 2013 59

Table 15: Global Sales Forecast ($m) for Afinitor, 2013-2023 60

Table 16: Product Profile - Avastin 62

Table 17: Avastin SWOT Analysis, 2013 64

Table 18 Global Sales Forecast ($m) for Avastin, 2013-2023 65

Table 19: Product Profile - Doxil 67

Table 20: Doxil SWOT Analysis, 2013 69

Table 21: Global Sales Forecast ($m) for Doxil/Caelyx, 2013-2023 69

Table 22: Product Profile - Halavan 71

Table 23: Halaven SWOT Analysis, 2013 72

Table 24: Global Sales Forecast ($m) for Halaven, 2013-2023 73

Table 25: Product Profile - Ixempra 74

Table 26: Ixempra SWOT Analysis, 2013 75

Table 27: Global Sales Forecast ($m) for Ixempra, 2013-2023 76

Table 28: Product Profile - Xeloda 77

Table 29: Xeloda SWOT Analysis, 2013 78

Table 30: AI Approvals in the US and 5EU 82

Table 31: Unmet Need and Opportunity in HER2-Negative Breast Cancer 86

Table 32: Product Profile - Abemaciclib (LY2835219) 100

Table 33: Abemaciclib SWOT Analysis, 2013 102

Table 34: Global Sales Forecast ($m) for Abemaciclib, 2013-2023 103

Table 35: Product Profile - Buparlisib (BKM- 120) 105

Table 36: Buparlisib SWOT Analysis, 2013 107

Table 37: Global Sales Forecast ($m) for Buparlisib, 2013-2023 108

Table 38: Product Profile - Javlor 110

Table 39: Javlor SWOT Analysis, 2013 112

Table 40: Global Sales Forecast ($m) for Buparlisib, 2013-2023 113

Table 41: Product Profile - LEE011 115

Table 42: LEE011 SWOT Analysis, 2013 117

Table 43: Global Sales Forecast ($m) for LEE011, 2013-2023 118

Table 44: Product Profile - NeuVax 120

Table 45: NeuVax SWOT Analysis, 2013 122

Table 46: Global Sales Forecast ($m) for NeuVax, 2013-2023 123

Table 47: Product Profile - Niraparib 125

Table 48: Niraparib SWOT Analysis, 2013 127

Table 49: Global Sales Forecast ($m) for Niraparib, 2013-2023 128

Table 50: Product Profile - NKTR- 102 129

Table 51: NKTR-102 SWOT Analysis, 2013 131

Table 52: Global Sales Forecast ($m) for NKTR 102, 2013-2023 132

Table 53: Product Profile - Lynparza 134

Table 54: Lynparza SWOT Analysis, 2013 136

Table 55: Global Sales Forecast ($m) for Lynparza, 2013-2023 137

Table 56: Product Profile - Palbociclib 139

Table 57: Palbociclib SWOT Analysis, 2013 141

Table 58: Global Sales Forecast ($m) for Palbociclib, 2013-2023 143

Table 59: Product Profile - Talazoparib 145

Table 60: Talazoparib SWOT Analysis, 2013 146

Table 61 Global Sales Forecast ($m) for Talazoparib, 2013-2023 147

Table 62: Product Profile - Veliparib 149

Table 63: Veliparib SWOT Analysis, 2013 151

Table 64: Global Sales Forecast ($m) for Veliparib, 2013-2023 152

Table 65: Early-Stage Immunotherapies in Development for HER2-Negative Breast Cancer, 2014 153

Table 66: Sales Forecasts ($m) for HER2-Negative Breast Cancer in France, 2013-2023 156

Table 67: Key Events Impacting Sales for HER2-Negative Breast Cancer in France, 2013-2023 158

Table 68: French HER2-Negative Breast Cancer Market - Drivers and Barriers, 2013-2023 159

Table 69: Sales Forecasts ($m) for HER2-Negative Breast Cancer in Germany, 2013-2023 162

Table 70: Key Events Impacting Sales for HER2-Negative Breast Cancer in Germany, 2013-2023 164

Table 71: German HER2-Negative Breast Cancer Market - Drivers and Barriers, 2013-2023 165

Table 72: Sales Forecasts ($m) for HER2-Negative Breast Cancer in Italy, 2013-2023 168

Table 73: Key Events Impacting Sales for HER2-Negative Breast Cancer in Italy, 2013-2023 170

Table 74: Italian HER2-Negative Breast Cancer Market - Drivers and Barriers, 2013-2023 171

Table 75: Sales Forecasts ($m) for HER2-Negative Breast Cancer in Spain, 2013-2023 173

Table 76: Key Events Impacting Sales for HER2-Negative Breast Cancer in Spain, 2013-2023 175

Table 77: Spanish HER2-Negative Breast Cancer Market - Drivers and Barriers, 2013-2023 176

Table 78: Sales Forecasts ($m) for HER2-Negative Breast Cancer in the UK, 2013-2023 179

Table 79: Key Events Impacting Sales for HER2-Negative Breast Cancer in the UK, 2013-2023 181

Table 80: UK HER2-Negative Breast Cancer Market - Drivers and Barriers, 2013-2023 182

Table 81: HER2-Negative Breast Cancer Incidence, 2013-2023 221

Table 82: Key Launch Dates of Marketed and Pipeline Drugs for HER2-Negative Breast Cancer 222

Table 83: Key Expiry Dates of Marketed and Pipeline Drugs Used in HER2-Negative Breast Cancer 223

Table 84: Average Body Weight and Surface Area Across the 8MM 224

Table 85: Cost per Treatment Cycle ($) - Abraxane, Metastatic Setting (HR+) 227

Table 86 Cost per Treatment Cycle ($) - Avastin, Metastatic Setting (HR+/TNBC) 228

Table 87: Cost per Treatment Cycle ($) - Afinitor, Third-Line Hormonal/ Targeted Therapy 229

Table 88: Cost per Treatment Cycle ($) - Doxil, Metastatic Setting (HR+/TNBC) 230

Table 89: Cost per Treatment Cycle ($) - Halaven, Metastatic Setting (HR+/TNBC) 231

Table 90: Cost per Treatment Cycle ($) - Ixempra, Metastatic Setting (HR+/TNBC) 232

Table 91 Cost per Treatment Cycle ($) - Xeloda, Metastatic Setting (HR+/TNBC) 233

Table 92: Cost per Treatment Cycle ($) - Abemaciclib, First-/Second-Line Hormonal/Targeted Metastatic Setting (HR+) 234

Table 93: Cost per Treatment Cycle ($) - Buparlisib, Postmenopausal Hormonal Neoadjuvant, Second- and Third-Line Hormonal/Targeted Metastatic Settings (HR+) 235

Table 94: Cost per Treatment Cycle ($) - Javlor, Third-Line Chemotherapy Metastatic Setting (HR+) 236

Table 95: Cost per Treatment Cycle ($) - LEE011, Postmenopausal Hormonal Neoadjuvan, and First-Line Hormonal/Targeted Metastatic Settings (HR+) 237

Table 96: Cost per Treatment Cycle ($) - NeuVax, Adjuvant Setting (HR+) 238

Table 97: Cost per Treatment Cycle ($) - Niraparib, Metastatic TNBC Setting 238

Table 98: Cost per Treatment Cycle ($) - NKTR-102, Third Line Chemotherapy Metastatic Setting (HR+) 239

Table 99: Cost per Treatment Cycle ($) - Lynparza, Adjuvant and First-Line Metastatic TNBC Settings 240

Table 100: Cost per Treatment Cycle ($) - Palbociclib, First- and Second-Line Hormonal/Targeted Metasatatic Setting (HR+) 241

Table 101: Cost per Treatment Cycle ($) - Talazoparib, Third-Line Metastatic TNBC Setting 242

Table 102: Cost per Treatment Cycle ($) - Veliparib, Neoadjuvant and Second-Line Metastatic TNBC Settings 243

Table 103: Physicians Surveyed by Country 246

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