Breast Cancer Therapeutics in Southeast Asia Markets to 2022 – Increasing Prevalence and Usage of Premium Targeted Therapies to Drive the Market

Breast cancer is a malignant neoplasm that begins in the breast tissue. Most breast cancers are invasive cancers that have grown beyond the ducts or lobules and can metastasize to other parts of the body through the bloodstream and the lymphatic system. Broadly, patients can be segmented into two types: the human epidermal growth factor receptor (HER) 2-negative segment and the HER2-positive segment. HER2-positive breast cancer is aggressive and, historically, has had a worse overall survival than HER2-negative disease, which is considered less aggressive.

In HER2-negative breast cancer, a number of different factors can influence the choice of therapy that a patient receives, including the stage of the cancer, the hormonal receptor status of the cancer (ER-positive or -negative and PR-positive or -negative) and whether the patient is a BRCA-mutation carrier. Triple-negative breast cancer (TNBC) is a setting with incredibly high unmet needs, with no targeted therapy options being available. Chemotherapy is the mainstay of treatment in this setting. For HR-positive disease, endocrine therapies are the primary treatment.

Survival for HER2-positive breast cancer patients has increased, due to established disease management strategies using numerous combinations of chemotherapy along with targeted therapies such as Herceptin, Tykerb (lapatinib) and Perjeta (pertuzumab). These newer therapies are expected to significantly improve survival outcomes in all lines of the disease. The introduction of Herceptin, the first HER2-targeting agent for metastatic disease, greatly improved the outcome of patients with HER2-positive breast cancer, bringing survival rates close to those of HER2-negative, HR-positive breast cancer.

In most Southeast Asian countries, the highest unmet need lies in the lack of a defined treatment plan for the disease, poor affordability, and patients continuing to rely on the use of chemotherapies in the later lines of treatment. It is important for drug companies to consider the evolving reimbursement landscape when determining pricing strategies across the Southeast Asian markets, because this will significantly impact the uptake of premium drugs.

Scope

The current Southeast Asia breast cancer market contains well-established novel targeted products such as Perjeta and Kadcyla, tyrosine kinase inhibitors such as Tykerb, and CDK inhibitors such as Ibrance.

– Which drugs are used as the standard treatment in each setting of the disease?

– What are the competitive advantages of the existing novel drugs?

– Do branded therapies show continued growth, and how does their expected uptake influence the market growth over the forecast period?

There are about 1,150 active pipeline molecules. The pipeline contains a range of molecule types and molecular targets, including those that are well established in breast cancer, and novel, first-in-class therapies.

– Which molecular targets appear most frequently in the pipeline?

– There is currently no approved therapy in the TNBC setting. Are there any drugs in the pipeline to improve treatment for TNBC?

– Targets that are not currently represented by marketed products are virtually absent from the late-stage pipeline. Does the early stage pipeline have experimental molecules designed to target novel pathways?

Analysis of clinical trials since 2006 identified that the failure rates of breast cancer molecules were highest in Phase II, at 59%, with the overall attrition rate for breast cancer standing at 85%.

– How do failure rates vary by stage of development, molecule type, and molecular target?

– How do other factors, such as average trial duration and trial size, influence the costs and risks associated with product development?

The breast cancer Southeast Asian market will be valued at $2.7 billion in 2022, growing from $942.3m in 2015 at a CAGR of 16.2%.

– Despite an array of treatments being available for breast cancer, there is still an unmet need in the Southeast Asian markets related to low uptake of targeted therapies. Will this scenario change during the forecast period?

Market forecasts indicate that South Korea will continue to be the largest market in Southeast Asia, due to the emergence of novel therapies and the continued uptake of branded therapies.

– How will the annual cost of therapy and market size vary between the eight Southeast Asian markets?

– What are the factors that contribute to the increase in ACoT and market size for each of the assessed countries?

– How will branded therapies be affected by upcoming pipeline therapies in each of the assessed countries?

– How will the potential launch of biosimilars influence each country?

– Will the launch of biosimilars or emerging pipeline molecules threaten the commercial success of existing drugs?

Various drivers and barriers will influence the market over the forecast period.

– What barriers limit the uptake of premium-priced therapeutics in the assessed countries?

– What factors are most likely to drive the market in these countries?

Reasons to buy

This report will allow 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 dominant therapies, with their clinical and commercial standing. Unmet needs are also 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 eight Southeast Asian markets, with epidemiological and annual cost of therapy forecasts, as well as analysis of the 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.

Table of Contents

1 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 Epidemiology 12

2.3 Symptoms 14

2.4 Etiology 15

2.5 Pathophysiology 16

2.6 Diagnosis 16

2.7 Prognosis and Disease Staging 18

2.8 Treatment Options 20

2.8.1 Surgery and Radiation Therapy 20

2.8.2 Chemotherapy 21

2.8.3 Hormonal Therapies 21

2.8.4 Targeted Therapies 22

2.9 Treatment Guidelines 23

3 Marketed Products 26

3.1 Overview 26

3.1.1 Herceptin (trastuzumab) - Genentech 27

3.1.2 Perjeta (pertuzumab) - Genentech 28

3.1.3 Afinitor (everolimus) - Novartis 29

3.1.4 Tykerb/Tyverb (lapatinib ditosylate monohydrate) - Novartis 30

3.1.5 Ibrance (palbociclib) - Pfizer 30

3.1.6 Ixempra (ixabepilone) - R-Pharm 31

3.1.7 Halaven (eribulin mesylate) - Eisai 32

3.1.8 Avastin (bevacizumab) - Genentech 32

3.1.9 Kadcyla (ado-trastuzumab emtansine) - Genentech 33

3.2 Comparative Efficacy and Safety of Marketed Products 34

4 Pipeline Analysis 40

4.1 Overview 40

4.2 Pipeline by Stage of Development, Molecule Type, Route of Administration and Program Type 40

4.2.1 Pipeline by Molecular Target 42

4.3 Promising Pipeline Molecules 43

4.3.1 Olaparib - AstraZeneca 43

4.3.2 Veliparib - AbbVie 44

4.3.3 Neratinib - Puma Biotechnology 46

4.3.4 Pembrolizumab - Merck & Co. 47

4.3.5 Ribociclib (Kisqali) - Novartis 48

4.3.6 Alpelisib - Novartis 50

4.3.7 Taselisib - Genentech 51

4.3.8 Vinflunine - Pierre-Fabre 54

4.3.9 Abemaciclib - Eli Lily 55

4.3.10 Niraparib - Tesaro 56

4.3.11 Buparlisib - Novartis 56

4.3.12 NeuVax (nelipepimut-S) - Galena Biopharma 57

4.3.13 Talazoparib - BioMarin 58

4.3.14 Atezolizumab - Roche 58

4.3.15 Entinostat - Syndax 59

4.3.16 Margetuximab - MacroGenics 60

4.3.17 OBI-822/821 - OBI Pharma 61

4.4 Comparative Efficacy and Safety of Pipeline Products 61

4.5 Product Competitiveness Framework 63

5 Clinical Trial Analysis 64

5.1 Failure Rate 64

5.1.1 Overall Failure Rate 64

5.1.2 Failure Rate by Phase and Molecule Type 65

5.1.3 Failure Rate by Phase and Molecule Target 66

5.2 Clinical Trial Duration 67

5.2.1 Clinical Trial Duration by Molecule Type 67

5.2.2 Clinical Trial Duration by Molecular Target 68

5.3 Clinical Trial Size 69

5.3.1 Patient Enrollment per Product by Molecule Type, Molecular Target and Stage of Development 69

5.3.2 Patient Enrollment per Trial by Molecule Type, Molecular Target and Stage of Development 71

5.4 Competitive Clinical Trials Metrics Analysis 73

6 Multi-scenario Forecast 75

6.1 Geographical Markets 75

6.2 Southeast Asian Markets 75

6.3 South Korea 78

6.3.1 Treatment Usage Patterns 78

6.3.2 Annual Cost of Therapy 78

6.3.3 Market Size 80

6.4 Singapore 81

6.4.1 Treatment Usage Patterns 81

6.4.2 Annual Cost of Therapy 81

6.4.3 Market Size 82

6.5 Taiwan 83

6.5.1 Treatment Usage Patterns 83

6.5.2 Annual Cost of Therapy 84

6.5.3 Market Size 85

6.6 Malaysia 86

6.6.1 Treatment Usage Patterns 86

6.6.2 Annual Cost of Therapy 87

6.6.3 Market Size 88

6.7 Philippines 89

6.7.1 Treatment Usage Patterns 89

6.7.2 Annual Cost of Therapy 90

6.7.3 Market Size 91

6.8 Thailand 92

6.8.1 Treatment Usage Patterns 92

6.8.2 Annual Cost of Therapy 93

6.8.3 Market Size 94

6.9 Vietnam 95

6.9.1 Treatment Usage Patterns 95

6.9.2 Annual Cost of Therapy 96

6.9.3 Market Size 97

6.10 Indonesia 98

6.10.1 Treatment Usage Patterns 98

6.10.2 Annual Cost of Therapy 99

6.10.3 Market Size 100

7 Drivers and Barriers 102

7.1 Drivers 102

7.1.1 Aging Population and Change in Lifestyle Habits 102

7.1.2 Increasing Awareness and Diagnosis 102

7.1.3 Potential Launch of Biosimilars to Increase Treatment Pool 102

7.1.4 Launch and Uptake of Pipeline Products and Continued Uptake of Existing Premium-Priced Therapies 103

7.2 Barriers 103

7.2.1 Inadequate Screening Programs and Social Factors 103

7.2.2 Lack of Proper Established Treatment Guidelines 104

7.2.3 Lack of Insurance and Adequate Publically Subsidized Services 104

8 Deals and Strategic Consolidations 105

8.1 Licensing Deals 105

8.1.1 Deals by Region and Value 105

8.1.2 Number of Disclosed and Undisclosed Deals by Year, Aggregate Deal Value 106

8.1.3 Deal Value by Stage of Development, Molecule Type, and Molecular Target 106

8.1.4 Key Licensing Deals 109

8.2 Co-development Deals 113

8.2.1 Deals by Region and Value 113

8.2.2 Number of Disclosed and Undisclosed Deals by Year, Aggregate Deal Value 113

8.2.3 Key Co-development Deals 116

9 Appendix 118

9.1 All Pipeline Drugs by Stage of Development 118

9.1.1 Discovery 118

9.1.2 IND/CTA- filed 124

9.1.3 Preclinical 125

9.1.4 Phase I 146

9.1.5 Phase II 152

9.1.6 Phase III 158

9.1.7 Pre-registration 159

9.2 Summary of Multi-Scenario Market Forecasts to 2022 160

9.2.1 Southeast Asia 160

9.2.2 South Korea 160

9.2.3 Singapore 160

9.2.4 Taiwan 161

9.2.5 Malaysia 161

9.2.6 Philippines 161

9.2.7 Thailand 162

9.2.8 Vietnam 162

9.2.9 Indonesia 162

9.3 Bibliography 163

9.4 Abbreviations 169

9.5 Research Methodology 171

9.5.1 Secondary Research 172

9.5.2 Marketed Product Profiles 172

9.5.3 Late-Stage Pipeline Candidates 173

9.5.4 Comparative Efficacy and Safety Heat Map for Marketed and Pipeline Products 173

9.5.5 Product Competitiveness Framework 173

9.5.6 Pipeline Analysis 173

9.5.7 Forecasting Model 174

9.5.8 Deals Data Analysis 175

9.6 Contact Us 175

9.7 Disclaimer 176

List of Tables

1.1 List of Tables

Table 1: Breast Cancer Therapeutics, Global, Tumor, Nodes and Metastasis Staging, 2010-2013 18

Table 2: Breast Cancer Therapeutics, Southeast Asia, Five-year Survival Rate (%) 19

Table 3: Breast Cancer Therapeutics Market, Global, Licensing Deals in Southeast Asia and Deals with Disclosed Values, 2006-2016 110

Table 4: Breast Cancer Therapeutics Market, Global, Co-development Deals in Southeast Asia and Deals with Disclosed Values, 2006-2016 117

Table 5: Breast Cancer Therapeutics Market, Global, All Pipeline Products, Discovery, 2016 118

Table 6: Seasonal Influenza Therapeutics Market, Global, All Pipeline Products, IND/CTA- filed, 2016 124

Table 7: Breast Cancer Therapeutics Market, Global, All Pipeline Products, Preclinical, 2016 125

Table 8: Breast Cancer Therapeutics Market, Global, All Pipeline Products, Phase I, 2016 146

Table 9: Breast Cancer Therapeutics Market, Global, All Pipeline Products, Phase II, 2016 152

Table 10: Breast Cancer Therapeutics Market, Global, All Pipeline Products, Phase III, 2016 158

Table 11: Breast Cancer Therapeutics Market, Global, All Pipeline Products, Pre-registration Phase, 2016 159

Table 12: Breast Cancer Therapeutics Market, Southeast Asia, Market Forecast, 2015-2022 160

Table 13: Breast Cancer Therapeutics Market, South Korea, Market Forecast, 2015-2022 160

Table 14: Breast Cancer Therapeutics Market, Singapore, Market Forecast, 2015-2022 160

Table 15: Breast Cancer Therapeutics Market, Taiwan, Market Forecast, 2015-2022 161

Table 16: Breast Cancer Therapeutics Market, Malaysia, Market Forecast, 2015-2022 161

Table 17: Breast Cancer Therapeutics Market, Philippines, Market Forecast, 2015-2022 161

Table 18: Breast Cancer Therapeutics Market, Thailand, Market Forecast, 2015-2022 162

Table 19: Breast Cancer Therapeutics Market, Vietnam, Market Forecast, 2015-2022 162

Table 20: Breast Cancer Therapeutics Market, Indonesia, Market Forecast, 2015-2022 162

List of Figures

1.2 List of Figures

Figure 1: Breast Cancer Therapeutics, Southeast Asia, Age-Standardized Incidence (per 100,000 population), 2012 12

Figure 2: Breast Cancer Therapeutics, South Korea, Age-Specific Incidence (%), 2012 13

Figure 3: Breast Cancer Therapeutics, Southeast Asia, Age-Standardized Mortality (per 100,000 population), 2012 14

Figure 4: Breast Cancer Therapeutics, Global, Treatment Algorithm for Cancer Diagnosed at Stages I-III 24

Figure 5: Breast Cancer Therapeutics, Global, Treatment Algorithm for Cancer Diagnosed at Stage IV 25

Figure 6: Breast Cancer Therapeutics Market, Global, Heatmap, 2017 34

Figure 7: Breast Cancer Therapeutics Market, Global, Overview of Pipeline Products 41

Figure 8: Breast Cancer Therapeutics Market, Global, Molecular Target in the Pipeline 43

Figure 9: Breast Cancer Therapeutics Market, Southeast Asia, Lynparza, Market Forecast ($m), 2020-2022 44

Figure 10: Breast Cancer Therapeutics Market, Southeast Asia, Veliparib, Market Forecast ($m), 2020-2022 46

Figure 11: Breast Cancer Therapeutics Market, Southeast Asia, Neratinib, Market Forecast ($m), 2020-2022 47

Figure 12: Breast Cancer Therapeutics Market, Southeast Asia, Pembrolizumab, Market Forecast ($m), 2019-2022 48

Figure 13: Breast Cancer Therapeutics Market, Southeast Asia, Ribociclib, Market Forecast ($m), 2020-2022 50

Figure 14: Breast Cancer Therapeutics Market, Southeast Asia, Alpelisib, Market Forecast ($m), 2020-2022 51

Figure 15: Breast Cancer Therapeutics Market, Southeast Asia, Taselisib, Market Forecast ($m), 2020-2022 53

Figure 16: Breast Cancer Therapeutics Market, Southeast Asia, Vinflunine, Market Forecast ($m), 2018-2022 55

Figure 17: Breast Cancer Therapeutics Market, Global, Pipeline Heatmap, 2017 62

Figure 18: Breast Cancer Therapeutics Market, Competitor Matrix for Breast Cancer Marketed and Pipeline Products, 2017 63

Figure 19: Breast Cancer Therapeutics Market, Global, Average Clinical Trial Failure Rate (%), 2006-2016 65

Figure 20: Breast Cancer Therapeutics Market, Global, Clinical Trial Failure Rates by Molecule Type (%), 2006-2016 66

Figure 21: Breast Cancer Therapeutics Market, Global, Clinical Trial Failure Rates by Molecular Target (%), 2006-2016 67

Figure 22: Breast Cancer Therapeutics Market, Global, Clinical Trial Duration by Stage of Development and Molecule Type (months), 2006-2016 68

Figure 23: Breast Cancer Therapeutics Market, Global, Clinical Trial Duration by Stage of Development and Molecular Target (months), 2006-2016 69

Figure 24: Breast Cancer Therapeutics Market, Global, Clinical Trial Size per Product by Molecule Type (participants), 2006-2016 70

Figure 25: Breast Cancer Therapeutics Market, Global, Clinical Trial Size per Product by Molecular target (participants), 2006-2016 71

Figure 26: Breast Cancer Therapeutics Market, Global, Clinical Trial Size per Individual Trial by Molecule Type (participants), 2006-2016 72

Figure 27: Breast Cancer Therapeutics Market, Global, Clinical Trial Size per Individual Trial by Molecular Target (participants), 2006-2016 73

Figure 28: Breast Cancer Therapeutics Market, Global, Comparison of Average Trial Metrics by Phase and Molecule Type 74

Figure 29: Breast Cancer Therapeutics Market, Global, Comparison of Average Trial Metrics by Phase and Molecular Target 74

Figure 30: Breast Cancer Therapeutics Market, Southeast Asia, Treatment Usage Pattern (‘000), 2015-2022 76

Figure 31: Breast Cancer Therapeutics Market, Southeast Asia, Market Size ($bn), 2015-2022 77

Figure 32: Breast Cancer Therapeutics Market, South Korea, Treatment Usage Patterns (‘000), 2015-2022 78

Figure 33: Breast Cancer Therapeutics Market, South Korea, Annual Cost of Therapy ($), 2015-2022 79

Figure 34: Breast Cancer Therapeutics Market, South Korea, Market Size ($m), 2015-2022 80

Figure 35: Breast Cancer Therapeutics Market, Singapore, Treatment Usage Patterns (‘000), 2015-2022 81

Figure 36: Breast Cancer Therapeutics Market, Singapore, Annual Cost of Therapy ($), 2015-2022 82

Figure 37: Breast Cancer Therapeutics Market, Singapore, Market Size ($m), 2015-2022 83

Figure 38: Breast Cancer Therapeutics Market, Taiwan, Treatment Usage Patterns (‘000), 2015-2022 84

Figure 39: Breast Cancer Therapeutics Market, Taiwan, Annual Cost of Therapy ($), 2015-2022 85

Figure 40: Breast Cancer Therapeutics Market, Taiwan, Market Size ($m), 2015-2022 86

Figure 41: Breast Cancer Therapeutics Market, Malaysia, Treatment Usage Patterns (‘000), 2015-2022 87

Figure 42: Breast Cancer Therapeutics Market, Malaysia, Annual Cost of Therapy ($), 2015-2022 88

Figure 43: Breast Cancer Therapeutics Market, Malaysia, Market Size ($m), 2015-2022 89

Figure 44: Breast Cancer Therapeutics Market, Philippines, Treatment Usage Patterns (‘000), 2015-2022 90

Figure 45: Breast Cancer Therapeutics Market, Philippines, Annual Cost of Therapy ($), 2015-2022 91

Figure 46: Breast Cancer Therapeutics Market, Philippines, Market Size ($m), 2015-2022 92

Figure 47: Breast Cancer Therapeutics Market, Thailand, Treatment Usage Patterns (‘000), 2015-2022 93

Figure 48: Breast Cancer Therapeutics Market, Thailand, Annual Cost of Therapy ($), 2015-2022 94

Figure 49: Breast Cancer Therapeutics Market, Thailand, Market Size ($m), 2015-2022 95

Figure 50: Breast Cancer Therapeutics Market, Vietnam, Treatment Usage Patterns (‘000), 2015-2022 96

Figure 51: Breast Cancer Therapeutics Market, Vietnam, Annual Cost of Therapy ($), 2015-2022 97

Figure 52: Breast Cancer Therapeutics Market, Vietnam, Market Size ($m), 2015-2022 98

Figure 53: Breast Cancer Therapeutics Market, Indonesia, Treatment Usage Patterns (‘000), 2015-2022 99

Figure 54: Breast Cancer Therapeutics Market, Indonesia, Annual Cost of Therapy ($), 2015-2022 100

Figure 55: Breast Cancer Therapeutics Market, Indonesia, Market Size ($m), 2015-2022 101

Figure 56: Breast Cancer Therapeutics Market, Global, Licensing Deals by Region and Value, 2006-2016 105

Figure 57: Breast Cancer Therapeutics Market, Global, Number of Disclosed and Undisclosed Licensing Deals by Year, Aggregate Deal Value and Aggregate Upfront Payment Value, 2006-2016 106

Figure 58: Breast Cancer Therapeutics Market, Global, Licensing Deals by Stage of Development, Deal Value and Upfront Payment Value, 2006-2016 107

Figure 59: Breast Cancer Therapeutics Market, Global, Licensing Deals by Molecule Type and Stage of Development, 2006-2016 108

Figure 60: Breast Cancer Therapeutics, Global, Licensing Deals by Molecular Targets and Aggregate Deal Value ($), 2006-2016 109

Figure 61: Breast Cancer Therapeutics Market, Global, Co-development Deals by Region, 2006-2016 113

Figure 62: Breast Cancer Therapeutics Market, Global, Number of Disclosed and Undisclosed Co-development Deals by Year, Aggregate Deal Value and Aggregate Upfront Payment Value, 2006-2016 114

Figure 63: Breast Cancer Therapeutics Market, Global, Co-development Deals by Stage of Development, 2006-2016 114

Figure 64: Breast Cancer Therapeutics Market, Global, Co-development Deals by Molecule type and Stage of Development, 2006-2016 115

Figure 65: Breast Cancer Therapeutics Market, Global, Co-development Deals by Molecular Target, 2006-2016 116

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