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

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


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Executive Summary

HER2-Negative Breast Cancer - Japan 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).

There are several reasons for this decline, the most important of which is the fact that fewer drugs will be entering fewer settings in the Japanese market than in the US and 5EU, in particular, NeuVax in the highly lucrative adjuvant setting, and several premium-priced PARP inhibitors in the TNBC setting. Japan will also see the highest number of patent expiries (six) of any of the forecast countries, which will result in significant downsizing and curtailment of growth compared with the rest of the world. Japan also has a steadily declining population (AGR = -0.03%), meaning that the total potential patient pool that could be eligible for any given drug is reduced. Furthermore, the higher drug prices observed in the US and 5EU compared with the more modest prices observed in Japan, will contribute to the decline in the Japanese market.

*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 Japan including product HER2-Negative Breast Cancercription, safety and efficacy profiles as well as a SWOT analysis.

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

- Analysis of the impact of key events as well the drivers and restraints affecting the Japan 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 Japan.



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1 Table of Contents

1 Table of Contents 2

1.1 List of Tables 5

1.2 List of Figures 9

2 Introduction 11

2.1 Catalyst 11

2.2 Related Reports 11

2.3 Upcoming Related Reports 12

3 Disease Overview 13

3.1 Etiology and Pathophysiology 13

3.1.1 Etiology 13

3.1.2 Pathophysiology 14

3.1.3 Basic Breast Anatomy 15

3.2 Disease Classification/Staging Systems 16

3.3 Symptoms 18

3.4 Prognosis 18

3.5 Quality of Life 19

4 Disease Management 22

4.1 Diagnosis and Treatment Overview 22

4.1.1 Treatment of Early-Stage Breast Cancer (Stage 0 to Stage IB) 22

4.1.2 Treatment of Locally-Advanced and Regional Breast Cancer (Stage IB to IIIC) 24

4.1.3 Treatment Guidelines and Leading Prescribed Drugs 28

4.2 Japan 29

4.2.1 Diagnosis 29

4.2.2 Clinical Practice 30

5 Competitive Assessment 33

5.1 Overview 33

5.2 Product Profiles (Branded Therapies) 34

5.2.1 Abraxane (nab-paclitaxel) 34

5.2.2 Afinitor (everolimus) 39

5.2.3 Avastin (bevacizumab) 43

5.2.4 Doxil/Caelyx (pegylated liposomal doxorubicin) 48

5.2.5 Halaven (eribulin mesylate) 53

5.2.6 Ixempra (ixabepilone) 56

5.2.7 Xeloda (capecitabine) 59

5.3 Product Profiles (Hormonal Agents) 62

5.3.1 Tamoxifen 62

5.3.2 Faslodex (fulvestrant) 62

5.3.3 Aromatase Inhibitors 63

6 Unmet Need and Opportunity 67

6.1 Overview 67

6.1.1 Defined treatment plan for BRCA mutation-positive patients and prevention of prophylactic surgeries 69

6.1.2 Specific treatment options for TNBC patients 71

6.1.3 Prevention of brain metastasis 72

6.1.4 Neoadjuvant therapy that can downstage tumors 74

6.1.5 For HR+patients, reduced resistance to hormonal agents 75

6.1.6 Improved convenience of administration of hormonal agents 77

7 Pipeline Assessment 79

7.1 Overview 79

7.1.1 Abemaciclib (LY2835219) 80

7.1.2 Buparlisib (BKM- 120) 86

7.1.3 Javlor (vinflunine) 92

7.1.4 LEE011 96

7.1.5 NeuVax (nelipepimut-S/E75) 101

7.1.6 Niraparib (MK4827) 106

7.1.7 NKTR- 102 (etirinotecan pegol) 111

7.1.8 Lynparza (olaparib) 115

7.1.9 Palbociclib (PD-0332991) 120

7.1.10 Talazoparib (BMN 673) 126

7.1.11 Veliparib (ABT-888) 130

7.2 Promising Drugs in Clinical Development 135

7.2.1 PD-/PD-L 1 Immunotherapies 136

8 Market Outlook 138

8.1 Japan 138

8.1.1 Forecast 138

8.1.2 Key Events 141

8.1.3 Drivers and Barriers 142

9 Appendix 144

9.1 Bibliography 144

9.2 Abbreviations 171

9.3 Methodology 179

9.4 Forecasting Methodology 179

9.4.1 Diagnosed HER2-Negative Breast Cancer Patients 179

9.4.2 Percentage of Drug-Treated Patients 180

9.4.3 Drugs Included in Each Therapeutic Class 180

9.4.4 Launch and Patent Expiry Dates 181

9.4.5 General Pricing Assumptions 182

9.4.6 Individual Drug Assumptions 184

9.4.7 Generic Erosion 192

9.4.8 Pricing of Pipeline Agents 192

9.5 Primary Research - KOLs Interviewed for This Report 203

9.6 Primary Research - High-Prescriber Survey 205

9.7 About the Authors 206

9.7.1 Analyst 206

9.7.2 Director of Oncology 206

9.7.3 Epidemiologist 207

9.7.4 Director of Epidemiology 207

9.7.5 Global Head of Healthcare 208

9.8 About GlobalData 209

9.9 Disclaimer 209

1.2 List of Figures

Figure 1: Basic Breast Anatomy, Including Key Lymph Nodes 16

Figure 2: Key Late-Stage Clinical Trials of Abraxane 35

Figure 3: Key Late-Stage Clinical Trials of Afinitor 40

Figure 4: Key Late-Stage Clinical Trials of Avastin 45

Figure 5: Key Late-Stage Clinical Trials of Halaven 53

Figure 6: Late Stage Clinical Trials of Drugs in HR+ Breast Cancer 81

Figure 7: Late Stage Clinical Trials of Drugs in TNBC 82

Figure 8: Key Late-Stage Clinical Trials of Abemaciclib 82

Figure 9: Clinical and Commercial Positioning of Abemaciclib 84

Figure 10: Key Late-Stage Clinical Trials of Buparlisib 88

Figure 11: Clinical and Commercial Positioning of Buparlisib 90

Figure 12: Key Late-Stage Clinical Trials of Javlor 93

Figure 13: Clinical and Commercial Positioning of Javlor 94

Figure 14: Key Late-Stage Clinical Trials of LEE011 98

Figure 15: Clinical and Commercial Positioning of LEE011 99

Figure 16: Key Late-Stage Clinical Trials of NeuVax 103

Figure 17: Clinical and Commercial Positioning of NeuVax 105

Figure 18: Key Late-Stage Clinical Trials of Niraparib 107

Figure 19: Clinical and Commercial Positioning of Niraparib 109

Figure 20: Key Late-Stage Clinical Trials of NKTR-102 112

Figure 21: Clinical and Commercial Positioning of NKTR-102 113

Figure 22: Key Late-Stage Clinical Trials of Lynparza 116

Figure 23: Clinical and Commercial Positioning of Lynparza 118

Figure 24: Key Late-Stage Key Clinical Trials of Palbociclib 121

Figure 25: Clinical and Commercial Positioning of Palbociclib 124

Figure 26: Key Late-Stage Clinical Trials of Talazoparib 127

Figure 27: Clinical and Commercial Positioning of Talazoparib 129

Figure 28: Key Late-Stage Clinical Trials of Veliparib 131

Figure 29: Clinical and Commercial Positioning of Veliparib 133

Figure 30: Sales for HER2-Negative Breast Cancer in Japan by Drug, 2013-2023 140

1.1 List of Tables

Table 1: AJCC Stage Definitions for Breast Cancer 17

Table 2: Prognosis for Breast Cancer 18

Table 3: Treatment Guidelines for HER2-Negative Breast Cancer 28

Table 4: Most Prescribed Regimens for HER2-Negative Breast Cancer by Drug Class in the Global Markets, 2013 29

Table 5: HER2-Negative Breast Cancer Diagnosis and Treatment Country Profile - Japan 30

Table 6: Product Profile - Abraxane 36

Table 7: Abraxane SWOT Analysis, 2013 38

Table 8: Global Sales Forecast ($m) for Abraxane, 2013-2023 39

Table 9: Product Profile - Afinitor (everolimus) 41

Table 10: Afinitor SWOT Analysis, 2013 42

Table 11: Global Sales Forecast ($m) for Afinitor, 2013-2023 43

Table 12: Product Profile - Avastin 45

Table 13: Avastin SWOT Analysis, 2013 47

Table 14 Global Sales Forecast ($m) for Avastin, 2013-2023 48

Table 15: Product Profile - Doxil 50

Table 16: Doxil SWOT Analysis, 2013 52

Table 17: Global Sales Forecast ($m) for Doxil/Caelyx, 2013-2023 52

Table 18: Product Profile - Halavan 54

Table 19: Halaven SWOT Analysis, 2013 55

Table 20: Global Sales Forecast ($m) for Halaven, 2013-2023 56

Table 21: Product Profile - Ixempra 57

Table 22: Ixempra SWOT Analysis, 2013 58

Table 23: Global Sales Forecast ($m) for Ixempra, 2013-2023 59

Table 24: Product Profile - Xeloda 60

Table 25: Xeloda SWOT Analysis, 2013 61

Table 26: AI Approvals in the US and 5EU 65

Table 27: Unmet Need and Opportunity in HER2-Negative Breast Cancer 69

Table 28: Product Profile - Abemaciclib (LY2835219) 83

Table 29: Abemaciclib SWOT Analysis, 2013 85

Table 30: Global Sales Forecast ($m) for Abemaciclib, 2013-2023 86

Table 31: Product Profile - Buparlisib (BKM- 120) 88

Table 32: Buparlisib SWOT Analysis, 2013 90

Table 33: Global Sales Forecast ($m) for Buparlisib, 2013-2023 91

Table 34: Product Profile - Javlor 93

Table 35: Javlor SWOT Analysis, 2013 95

Table 36: Global Sales Forecast ($m) for Buparlisib, 2013-2023 96

Table 37: Product Profile - LEE011 98

Table 38: LEE011 SWOT Analysis, 2013 100

Table 39: Global Sales Forecast ($m) for LEE011, 2013-2023 101

Table 40: Product Profile - NeuVax 103

Table 41: NeuVax SWOT Analysis, 2013 105

Table 42: Global Sales Forecast ($m) for NeuVax, 2013-2023 106

Table 43: Product Profile - Niraparib 108

Table 44: Niraparib SWOT Analysis, 2013 110

Table 45: Global Sales Forecast ($m) for Niraparib, 2013-2023 111

Table 46: Product Profile - NKTR- 102 112

Table 47: NKTR-102 SWOT Analysis, 2013 114

Table 48: Global Sales Forecast ($m) for NKTR 102, 2013-2023 115

Table 49: Product Profile - Lynparza 117

Table 50: Lynparza SWOT Analysis, 2013 119

Table 51: Global Sales Forecast ($m) for Lynparza, 2013-2023 120

Table 52: Product Profile - Palbociclib 122

Table 53: Palbociclib SWOT Analysis, 2013 124

Table 54: Global Sales Forecast ($m) for Palbociclib, 2013-2023 126

Table 55: Product Profile - Talazoparib 128

Table 56: Talazoparib SWOT Analysis, 2013 129

Table 57 Global Sales Forecast ($m) for Talazoparib, 2013-2023 130

Table 58: Product Profile - Veliparib 132

Table 59: Veliparib SWOT Analysis, 2013 134

Table 60: Global Sales Forecast ($m) for Veliparib, 2013-2023 135

Table 61: Early-Stage Immunotherapies in Development for HER2-Negative Breast Cancer, 2014 136

Table 62: Sales Forecasts ($m) for HER2-Negative Breast Cancer Japan, 2013-2023 139

Table 63: Key Events Impacting Sales for HER2-Negative Breast Cancer in Japan, 2013-2023 141

Table 64: Japanese HER2-Negative Breast Cancer Market - Drivers and Barriers, 2013-2023 142

Table 65: HER2-Negative Breast Cancer Incidence, 2013-2023 180

Table 66: Key Launch Dates of Marketed and Pipeline Drugs for HER2-Negative Breast Cancer 181

Table 67: Key Expiry Dates of Marketed and Pipeline Drugs Used in HER2-Negative Breast Cancer 182

Table 68: Average Body Weight and Surface Area Across the 8MM 183

Table 69: Cost per Treatment Cycle ($) - Abraxane, Metastatic Setting (HR+) 186

Table 70 Cost per Treatment Cycle ($) - Avastin, Metastatic Setting (HR+/TNBC) 187

Table 71: Cost per Treatment Cycle ($) - Afinitor, Third-Line Hormonal/ Targeted Therapy 188

Table 72: Cost per Treatment Cycle ($) - Doxil, Metastatic Setting (HR+/TNBC) 189

Table 73: Cost per Treatment Cycle ($) - Halaven, Metastatic Setting (HR+/TNBC) 190

Table 74: Cost per Treatment Cycle ($) - Ixempra, Metastatic Setting (HR+/TNBC) 191

Table 75 Cost per Treatment Cycle ($) - Xeloda, Metastatic Setting (HR+/TNBC) 192

Table 76: Cost per Treatment Cycle ($) - Abemaciclib, First-/Second-Line Hormonal/Targeted Metastatic Setting (HR+) 193

Table 77: Cost per Treatment Cycle ($) - Buparlisib, Postmenopausal Hormonal Neoadjuvant, Second- and Third-Line Hormonal/Targeted Metastatic Settings (HR+) 194

Table 78: Cost per Treatment Cycle ($) - Javlor, Third-Line Chemotherapy Metastatic Setting (HR+) 195

Table 79: Cost per Treatment Cycle ($) - LEE011, Postmenopausal Hormonal Neoadjuvan, and First-Line Hormonal/Targeted Metastatic Settings (HR+) 196

Table 80: Cost per Treatment Cycle ($) - NeuVax, Adjuvant Setting (HR+) 197

Table 81: Cost per Treatment Cycle ($) - Niraparib, Metastatic TNBC Setting 197

Table 82: Cost per Treatment Cycle ($) - NKTR-102, Third Line Chemotherapy Metastatic Setting (HR+) 198

Table 83: Cost per Treatment Cycle ($) - Lynparza, Adjuvant and First-Line Metastatic TNBC Settings 199

Table 84: Cost per Treatment Cycle ($) - Palbociclib, First- and Second-Line Hormonal/Targeted Metasatatic Setting (HR+) 200

Table 85: Cost per Treatment Cycle ($) - Talazoparib, Third-Line Metastatic TNBC Setting 201

Table 86: Cost per Treatment Cycle ($) - Veliparib, Neoadjuvant and Second-Line Metastatic TNBC Settings 202

Table 87: Physicians Surveyed by Country 205

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