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Breast Cancer Therapeutics in Asia-Pacific Markets to 2024 - Growth Driven by Increasing Uptake of Targeted Therapies and Rising Prevalence

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Date: 01-May-2018
No. of pages: 215

Breast cancer is the second most common cancer in the world overall, and the most common cancer in women. When diagnosed at a very early stage, the prognosis is positive, with a five-year survival rate of nearly 90%. However, in the later stages of the disease, the survival rate rapidly decreases. HER2-positive breast cancer is an aggressive disease, and historically has had a worse overall survival (OS) than HER2-negative disease, which is considered less aggressive.

The current marketed drug landscape in breast cancer includes a mix of targeted therapies, chemotherapies, and hormonal agents. Metastatic breast cancer is not considered a curable disease, and in the course of therapy patients can receive up to three lines of endocrine agents and four or more lines of chemotherapy, as well as targeted therapies for earlier lines of therapy often in no particular sequence.

Hormone therapy is the mainstay of treatment for patients with HR-positive disease, but triple-negative breast cancer (TNBC) patients who lack HR expression are normally treated with generic chemotherapies. This is because there are no approved targeted therapies currently available in the TNBC setting. The HER2-positive breast cancer market is dominated by the HER2-targeting mAb Herceptin, the most established drug in this disease area.

Herceptin is used in nearly all settings of HER2-positive breast cancer and in all markets accessed in this report, as it was demonstrated to significantly improve the OS of women with this disease type. The current breast cancer pipeline is demonstrative of strong innovation in cancer overall, and a significant number of new drug launches are expected during the forecast period.

This is likely to have a significant impact on the competitive landscape, particularly in the early lines of metastatic disease. The emergence of novel biomarkers will also impact treatment decisions for TNBC patients, and will provide new options for targeted therapy in this patient population, fulfilling a long-standing unmet need. One of the key drivers of the breast cancer therapeutics market in the APAC region is the increase in patient volume.

It is also expected to be driven by the anticipated approval of promising therapies within several distinct patient segments, as well as the growing market uptake of already approved therapies in the APAC markets.

Although several branded drugs are expected to go off patent during the forecast period, the impact of this on the market will be offset by the launch of upcoming therapies such as Verzenio, Lynparza, Nerlynx, talazoparib, alpelisib, taselisib, Keytruda, Tecentriq, margetuximab and ipatasertib, and the increasing uptake of already approved therapy such as Ibrance, Kadcyla, Perjeta and Kisqali.

Scope


  • The breast cancer Asia-Pacific market will be valued at $4.75 billion in 2024, growing from $2.16 billion in 2017 at a compound annual growth rate (CAGR) of 11.9%.

  • How will immune checkpoint inhibitors such as Keytruda and Tecentriq, PARP inhibitors such as Lynparza and talazoparib, and PI3K inhibitors such as taselisib and alpelisib contribute to growth?

  • What effect will the patent expirations of branded therapies have on market value?

  • The breast cancer pipeline is large and diverse, with a strong presence of mAbs and targeted therapies.

  • What are the common targets and mechanisms of action of pipeline therapies?

  • Will the pipeline address unmet needs such as the lack of targeted therapies available for TNBC patients?

  • What implications will the increased focus on targeted therapies have on the future of breast cancer treatment?

  • Numerous late-stage pipeline therapies with a strong clinical record have the potential to enter the market over the forecast period.

  • How have the late-stage therapies performed in clinical trials?

  • How would the approval of Keytruda, Tecentriq, Lynparza, talazoparib and ipatasertib to treat TNBC patients affect the competitive landscape, with no targeted therapy currently available to address this patient subset?

  • The market forecasts indicate that Japan will contribute the most to the Asia-Pacific market value due to the emergence of novel therapies.

  • How will the annual cost of therapy and market size vary between the five assessed Asia-Pacific markets?

  • How could changes in risk factors such as population age, early menstruation, late menopause, obesity, smoking, lack of breast-feeding and alcohol consumption influence the market?

  • Licensing deals are the most common form of strategic alliance in breast cancer, with total deal values ranging from under $10m to over $1 billion.

  • How do deal frequency and value compare between target families and molecule types?

  • What were the terms and conditions of key licensing deals?


Reasons to buy

This report will enable you to -


  • Understand the current clinical and commercial landscape by considering disease pathogenesis, diagnosis, prognosis, and the treatment options available at each stage of diagnosis, including a clinical comparison of marketed therapies.

  • Visualize the composition of the breast cancer market in terms of the dominant therapies for each patient subset, along with their clinical and commercial standing. Unmet needs are highlighted to allow a competitive understanding of gaps in the market.

  • Analyze the breast cancer pipeline and stratify pipeline therapies by stage of development, molecule type and molecular target.

  • Understand the potential of late-stage therapies with extensive profiles of products that could enter the market over the forecast period, highlighting clinical performance, potential commercial positioning, and how they will compete with other therapies.

  • Predict breast cancer market growth in the five assessed Asia-Pacific markets, with epidemiological and annual cost of therapy forecasts across India, China, Australia, South Korea and Japan, as well as the individual contributions of promising late-stage molecules to market growth.

  • Identify commercial opportunities in the breast cancer deals landscape by analyzing trends in licensing and co-development deals.

Breast Cancer Therapeutics in Asia-Pacific Markets to 2024 - Growth Driven by Increasing Uptake of Targeted Therapies and Rising Prevalence

Table of Contents

1 Table of Contents 5
1.1 List of Tables 8
1.2 List of Figures 8

2 Introduction 11
2.1 Disease Introduction 11
2.2 Symptoms 12
2.3 Etiology 12
2.4 Pathophysiology 13
2.4.1 HER2 Testing 14
2.4.2 Other Biomarkers 15
2.5 Epidemiology 16
2.6 Diagnosis and Classification 18
2.7 Prognosis and Disease Staging 20
2.8 Treatment Options 21
2.8.1 Surgery and Radiation Therapy 22
2.8.2 Chemotherapy 23
2.8.3 Hormonal Therapies 23
2.8.4 Targeted Therapies 24
2.9 Treatment Guidelines 25

3 Marketed Products 29
3.1 Overview 29
3.1.1 Herceptin (trastuzumab) - Roche/Genentech 30
3.1.2 Perjeta (pertuzumab) - Roche/Genentech 34
3.1.3 Kadcyla (ado-trastuzumab emtansine) - Roche/Genentech 36
3.1.4 Tykerb/Tyverb (lapatinib ditosylate monohydrate) - Novartis 37
3.1.5 Ibrance (palbociclib) - Pfizer 39
3.1.6 Kisqali (ribociclib) - Novartis 42
3.1.7 Halaven (eribulin mesylate) - Eisai 44
3.1.8 Avastin (bevacizumab) - Roche/Genentech 45
3.1.9 Afinitor (everolimus) - Novartis 46
3.1.10 Abraxane (Nab-Paclitaxel) - Celgene 47
3.1.11 Ixempra (ixabepilone) - R-Pharm 49
3.1.12 Doxil/Caelyx (pegylated liposomal doxorubicin) - Johnson & Johnson 49
3.1.13 Faslodex (fulvestrant) - AstraZeneca 50
3.1.14 Tamoxifen 51
3.1.15 Aromatase Inhibitors (AIs) 52
3.2 Comparative Efficacy and Safety of Marketed Products 53

4 Pipeline Analysis 61
4.1 Overview 61
4.2 Pipeline by Stage of Development, Molecule Type, Route of Administration and Program Type 62
4.2.1 Pipeline by Molecular Target 64
4.3 Promising Pipeline Molecules 66
4.3.1 Nerlynx (Neratinib) - Puma Biotechnology 66
4.3.2 Verzenio (abemaciclib) - Eli Lily 69
4.3.3 Lynparza (olaparib) - AstraZeneca 71
4.3.4 Talazoparib - Pfizer/BioMarin 73
4.3.5 Keytruda (pembrolizumab) - Merck & Co. 75
4.3.6 Tecentriq (atezolizumab) - Roche 77
4.3.7 Taselisib - Genentech 79
4.3.8 Alpelisib - Novartis 82
4.3.9 Margetuximab - MacroGenics 83
4.3.10 OBI-822/821 (adagloxad simolenin) - OBI Pharma 84
4.3.11 Utidelone (UTD-1) - Beijing Biostar Technologies 85
4.3.12 Pyrotinib (HTI1001/SHR1258) - Jiangsu Hengrui Medicine 86
4.3.13 Ipatasertib (RG-7440/GDC-0068) - Array Biopharma/Genentech 87
4.3.14 Epidaza (Tucidinostat/ HBI8000/ CS055) - Chipscreen Biosciences 87
4.3.15 BAT8001 - Bio-Thera Solutions 88
4.4 Comparative Efficacy and Safety of Pipeline Products 89
4.5 Product Competitiveness Framework 91

5 Clinical Trial Analysis 94
5.1 Failure Rate 94
5.1.1 Overall Failure Rate 94
5.1.2 Failure Rate by Phase and Molecule Type 96
5.1.3 Failure Rate by Phase and Molecule Target 97
5.2 Clinical Trial Duration 98
5.2.1 Clinical Trial Duration by Molecule Type 98
5.2.2 Clinical Trial Duration by Molecular Target 99
5.3 Clinical Trial Size 100
5.3.1 Patient Enrollment per Product by Molecule Type, Molecular Target and Stage of Development 100
5.3.2 Patient Enrollment per Trial by Molecule Type, Molecular Target and Stage of Development 102
5.4 Competitive Clinical Trials Metrics Analysis 104

6 Multi-scenario Forecast 106
6.1 Overview 106
6.2 Asia-Pacific Market 107
6.3 India 110
6.3.1 Treatment Usage Patterns 110
6.3.2 Annual Cost of Therapy 111
6.3.3 Market Size 112
6.4 China 113
6.4.1 Treatment Usage Patterns 113
6.4.2 Annual Cost of Therapy 115
6.4.3 Market Size 116
6.5 Australia 118
6.5.1 Treatment Usage Patterns 118
6.5.2 Annual Cost of Therapy 119
6.5.3 Market Size 120
6.6 South Korea 122
6.6.1 Treatment Usage Patterns 122
6.6.2 Annual Cost of Therapy 123
6.6.3 Market Size 124
6.7 Japan 125
6.7.1 Treatment Usage Patterns 125
6.7.2 Annual Cost of Therapy 126
6.7.3 Market Size 128

7 Drivers and Barriers 130
7.1 Drivers 130
7.1.1 Increased Uptake of Targeted and Combination Therapies for Breast Cancer 130
7.1.2 Increasing Aging Population and Incident Cases of Breast Cancer 130
7.1.3 Prolonged Treatment Duration 131
7.1.4 Expansion of Branded Therapies into the Early Disease Regimen 131
7.1.5 Diversified Healthcare Reform and Insurance System to Boost Market Growth 131
7.2 Barriers 132
7.2.1 Usage of Surgical Therapies at Early Stage Reduces Drug Treatment Rate 132
7.2.2 Multiple Drugs to Lose Patent Protection in the Forecast Period 132
7.2.3 Delayed Presentation of Symptoms, Lack of Access and Awareness to Hamper Proper Treatment 133
7.2.4 High Level of Competition 133
7.2.5 Drug Pricing Reforms 133
7.2.6 Problems with the Reimbursement of Premium-Priced Therapeutics will Limit their Uptake 134

8 Deals and Strategic Consolidations 135
8.1 Licensing Deals 135
8.1.1 Deals by Region and Value 135
8.1.2 Number of Disclosed and Undisclosed Deals by Year, Aggregate Deal Value 136
8.1.3 Deal Value by Stage of Development, Molecule Type, and Molecular Target 137
8.1.4 Key Licensing Deals 139
8.2 Co-development Deals 142
8.2.1 Deals by Region and Value 142
8.2.2 Number of Disclosed and Undisclosed Deals by Year, Aggregate Deal Value 143
8.2.3 Deal Value by Stage of Development, Molecule Type, and Molecular Target 144
8.2.4 Key Co-development Deals 146

9 Appendix 148
9.1 All Pipeline Drugs by Stage of Development 148
9.1.1 Discovery 148
9.1.2 Preclinical 154
9.1.3 IND/CTA- filed 176
9.1.4 Phase I 177
9.1.5 Phase II 184
9.1.6 Phase III 190
9.1.7 Pre-registration 191
9.2 Summary of Multi-scenario Market Forecasts to 2022 192
9.2.1 Asia-Pacific 192
9.2.2 India 192
9.2.3 China 192
9.2.4 Australia 193
9.2.5 South Korea 193
9.2.6 Japan 193
9.3 Bibliography 194
9.4 Abbreviations 207
9.5 Research Methodology 211
9.5.1 Secondary Research 211
9.5.2 Marketed Product Profiles 212
9.5.3 Late-Stage Pipeline Candidates 212
9.5.4 Comparative Efficacy and Safety Heat Map for Marketed and Pipeline Products 212
9.5.5 Product Competitiveness Framework 212
9.5.6 Pipeline Analysis 212
9.5.7 Forecasting Model 213
9.5.8 Deals Data Analysis 214
9.6 Contact Us 215
9.7 Disclaimer 215

List of Tables

Table 1: Molecular Subtypes of Breast Cancer 14
Table 2: Definitions of HER2 Status by IHC Staining 15
Table 3: Breast Cancer Therapeutics, Global, Tumor, Nodes and Metastasis Staging, 2010-2013 20
Table 4: Breast Cancer Therapeutics Market, Global, Licensing Deals Valued $100m and Above, 2007-2017 141
Table 5: Breast Cancer Therapeutics Market, Global, Co-development Deals Value, 2007-2017 147
Table 6: Breast Cancer Therapeutics Market, Global, All Pipeline Products, Discovery, 2018 148
Table 7: Breast Cancer Therapeutics Market, Global, All Pipeline Products, Preclinical, 2018 154
Table 8: Breast Cancer Therapeutics Market, Global, All Pipeline Products, IND/CTA- filed, 2018 176
Table 9: Breast Cancer Therapeutics Market, Global, All Pipeline Products, Phase I, 2018 177
Table 10: Breast Cancer Therapeutics Market, Global, All Pipeline Products, Phase II, 2018 184
Table 11: Breast Cancer Therapeutics Market, Global, All Pipeline Products, Phase III, 2018 190
Table 12: Breast Cancer Therapeutics Market, Global, All Pipeline Products, Pre-registration, 2018 191
Table 13: Breast Cancer Therapeutics Market, APAC, Market Forecast, 2017-2024 192
Table 14: Breast Cancer Therapeutics Market, India, Market Forecast, 2017-2024 192
Table 15: Breast Cancer Therapeutics Market, China, Market Forecast, 2017-2024 192
Table 16: Breast Cancer Therapeutics Market, Australia, Market Forecast, 2017-2024 193
Table 17: Breast Cancer Therapeutics Market, South Korea, Market Forecast, 2017-2024 193
Table 18: Breast Cancer Therapeutics Market, Japan, Market Forecast, 2017-2024 193

List of Figures

Figure 1: Breast Cancer Therapeutics, APAC, Age-Standardized Incidence (per 100,000 population), 2012 16
Figure 2: Breast Cancer Therapeutics, Australia, Age-Specific Incidence Rate per 100,000 Population, 2012, 2013 and 2014 17
Figure 3: Breast Cancer Therapeutics, Global, Treatment Algorithm for Cancer Diagnosed at Stages I-III 26
Figure 4: Breast Cancer Therapeutics, Global, Treatment Algorithm for Cancer Diagnosed at Stage IV 27
Figure 5: Breast Cancer Therapeutics Market, Global, Comparative Efficacy and Safety Heatmap for Marketed Products for the Treatment of HER2-Positive Breast Cancer Patients, 2018 54
Figure 6: Breast Cancer Therapeutics Market, Global, Comparative Efficacy and Safety Heatmap for Marketed Products for the Treatment of HER2-Negative Breast Cancer Patients, 2018 56
Figure 7: Breast Cancer Therapeutics Market, Global, Overview of Pipeline Products, 2018 63
Figure 8: Breast Cancer Therapeutics Market, Global, Molecular Target in the Pipeline 65
Figure 9: Breast Cancer Therapeutics Market, Global, Molecular Target in the Pipeline 66
Figure 10: Breast Cancer Therapeutics Market, APAC, Neratinib, Market Forecast ($m), 2020-2024 69
Figure 11: Breast Cancer Therapeutics Market, APAC, Abemaciclib, Market Forecast ($m), 2018-2024 71
Figure 12: Breast Cancer Therapeutics Market, APAC, Olaparib, Market Forecast ($m), 2018-2024 73
Figure 13: Breast Cancer Therapeutics Market, APAC, Talazoparib, Market Forecast ($m), 2020-2024 75
Figure 14: Breast Cancer Therapeutics Market, APAC, Pembrolizumab, Market Forecast ($m), 2020-2024 77
Figure 15: Breast Cancer Therapeutics Market, APAC, Atezolizumab Forecast ($m), 2021-2024 79
Figure 16: Breast Cancer Therapeutics Market, APAC, Taselisib, Market Forecast ($m), 2020-2024 81
Figure 17: Breast Cancer Therapeutics Market, APAC, Alpelisib, Market Forecast ($m), 2021-2024 83
Figure 18: Breast Cancer Therapeutics Market, Comparative Efficacy and Safety Heatmap for Pipeline Products for HER2-Positive Breast Cancer, 2018 89
Figure 19: Breast Cancer Therapeutics Market, Comparative Efficacy and Safety Heatmap for Pipeline Products for HER2-Negative Breast Cancer, 2018 90
Figure 20: Breast Cancer Therapeutics Market, Comparative Efficacy and Safety Heatmap for Pipeline Products for TNBC, 2018 91
Figure 21: Breast Cancer Therapeutics Market, Competitor Matrix for HER2-Positive Breast Cancer Marketed and Pipeline Products, 2018 92
Figure 22: Breast Cancer Therapeutics Market, Competitor Matrix for HER2-Negative Breast Cancer Marketed and Pipeline Products, 2018 93
Figure 23: Breast Cancer Therapeutics Market, Global, Average Clinical Trial Failure Rate (%), 2007-2017 95
Figure 24: Breast Cancer Therapeutics Market, Global, Clinical Trial Failure Rates by Molecule Type (%), 2007-2017 96
Figure 25: Breast Cancer Therapeutics Market, Global, Clinical Trial Failure Rates by Molecular Target (%), 2007-2017 97
Figure 26: Breast Cancer Therapeutics Market, Global, Clinical Trial Duration by Stage of Development and Molecule Type (months), 2007-2017 98
Figure 27: Breast Cancer Therapeutics Market, Global, Clinical Trial Duration by Stage of Development and Molecular Target (months), 2007-2017 99
Figure 28: Breast Cancer Therapeutics Market, Global, Clinical Trial Size per Product by Molecule Type (participants), 2007-2017 100
Figure 29: Breast Cancer Therapeutics Market, Global, Clinical Trial Size per Product by Molecular target (participants), 2007-2017 101
Figure 30: Breast Cancer Therapeutics Market, Global, Clinical Trial Size per Individual Trial by Molecule Type (participants), 2007-2017 102
Figure 31: Breast Cancer Therapeutics Market, Global, Clinical Trial Size per Individual Trial by Molecular Target (participants), 2007-2017 103
Figure 32: Breast Cancer Therapeutics Market, Global, Comparison of Average Trial Metrics by Phase and Molecule Type 104
Figure 33: Breast Cancer Therapeutics Market, Global, Comparison of Average Trial Metrics by Phase and Molecular Target 105
Figure 34: Breast Cancer Therapeutics Market, APAC, Treatment Patterns (‘000), 2017-2024 108
Figure 35: Breast Cancer Therapeutics Market, APAC, Market Size ($bn), 2017-2024 110
Figure 36: Breast Cancer Therapeutics Market, India, Treatment Patterns (‘000), 2017-2024 111
Figure 37: Breast Cancer Therapeutics Market, India, Annual Cost of Therapy ($), 2017-2024 112
Figure 38: Breast Cancer Therapeutics Market, India, Market Size ($m), 2017-2024 113
Figure 39: Breast Cancer Therapeutics Market, China, Treatment Patterns (‘000), 2017-2024 115
Figure 40: Breast Cancer Therapeutics Market, China, Annual Cost of Therapy ($), 2017-2024 116
Figure 41: Breast Cancer Therapeutics Market, China, Market Size ($m), 2017-2024 118
Figure 42: Breast Cancer Therapeutics Market, Australia, Treatment Patterns (‘000), 2017-2024 119
Figure 43: Breast Cancer Therapeutics Market, Australia, Annual Cost of Therapy ($), 2017-2024 120
Figure 44: Breast Cancer Therapeutics Market, Australia, Market Size ($m), 2017-2024 121
Figure 45: Breast Cancer Therapeutics Market, South Korea, Treatment Patterns (‘000), 2017-2024 122
Figure 46: Breast Cancer Therapeutics Market, South Korea, Annual Cost of Therapy ($), 2017-2024 123
Figure 47: Breast Cancer Therapeutics Market, South Korea, Market Size ($m), 2017-2024 125
Figure 48: Breast Cancer Therapeutics Market, Japan, Treatment Patterns (‘000), 2017-2024 126
Figure 49: Breast Cancer Therapeutics Market, Japan, Annual Cost of Therapy ($), 2017-2024 127
Figure 50: Breast Cancer Therapeutics Market, Japan, Market Size ($bn), 2017-2024 129
Figure 51: Breast Cancer Therapeutics Market, Global, Licensing Deals by Region and Value, 2007-2017 135
Figure 52: Breast Cancer Therapeutics Market, Global, Number of Disclosed and Undisclosed Licensing Deals by Year, Aggregate Deal Value and Aggregate Upfront Payment Value, 2007-2017 136
Figure 53: Breast Cancer Therapeutics Market, Global, Licensing Deals by Stage of Development, Deal Value and Upfront Payment Value, 2007-2017 137
Figure 54: Breast Cancer Therapeutics Market, Global, Licensing Deals by Molecule Type and Stage of Development, 2007-2017 138
Figure 55: Breast Cancer Therapeutics, Global, Licensing Deals by Molecular Targets and Aggregate Deal Value ($), 2007-2017 139
Figure 56: Breast Cancer Therapeutics Market, Global, Co-development Deals by Region, 2007-2017 142
Figure 57: Breast Cancer Therapeutics Market, Global, Number of Disclosed and Undisclosed Co-development Deals by Year, Aggregate Deal Value and Aggregate Upfront Payment Value, 2007-2017 143
Figure 58: Breast Cancer Therapeutics Market, Global, Co-development Deals by Stage of Development, 2007-2017 144
Figure 59: Breast Cancer Therapeutics Market, Global, Co-development Deals by Molecule type and Stage of Development, 2007-2017 145
Figure 60: Breast Cancer Therapeutics Market, Global, Co-development Deals by Molecular Target, 2007-2017 146

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