Home / Therapeutic Area / Head and Neck Cancer Therapeutics in Asia-Pacific Markets to 2023 – Launch of Premium Immunotherapies and Increasing Prevalence to Drive the Market

Head and Neck Cancer Therapeutics in Asia-Pacific Markets to 2023 – Launch of Premium Immunotherapies and Increasing Prevalence to Drive the Market

Published: Feb 2018 | Published By: GBI Research

Head and neck cancer (HNC) is the sixth most common cancer, and its incidence is growing. The annual incidence of HNCs worldwide is more than 550,000 cases, with around 300,000 related deaths occurring each year. In terms of the initial site of development, 44% of HNCs involve the oral cavity, 31% the larynx and 25% the pharynx. The incidence of tobacco-related HNC is decreasing, but the incidence of cancer due to the human papillomavirus continues to increase at a rate of 2–4% per year. HNC is most common in the middle aged, with a peak incidence rate between the ages of 55 and 64, and a median age of diagnosis of 62. The HNC market is characterized by a small selection of marketed drug options, consisting of chemotherapies, targeted therapies (anti-EGFR), and immunotherapies (PD1/PD-L1 inhibitor). Historically, cytotoxic chemotherapies have made up the bulk of the HNC market. Little competition currently exists in the HNC market, leaving an area of considerable opportunity for interested newcomers. Currently, four targeted therapies are available in the APAC HNC market, which are Erbitux, BIOMAb EGFR, Opdivo and Keytruda. The remainder of this market is composed of generics. Recent additions to the market have highlighted that the treatment landscape is diversifying and becoming less reliant on chemotherapy options. With the approval of Keytruda in Australia, and Opdivo in Australia, South Korea and Japan, there has been an increase in targeted therapy options. Additionally avelumab (a PD-L1 inhibitor) is likely to be approved in APAC countries at the end of the forecast period, as it is currently undergoing Phase III trials in all the assessed countries. A number of mAbs are in development in HNC for the inhibition of various different pathways and signaling systems. Many companies are following a strategy of developing products with similar mechanisms of action to those of existing products already approved in either HNC or other oncology indications. EGFR and PD-1/PD-L1 are the most commonly addressed targets in the current pipeline. However, there are also many innovative products in the HNC pipeline, which reflects a deepening scientific understanding of the underlying pathophysiology of HNC and the growing list of molecules that have been implicated in the initiation and progression of the disease.

Scope

  • The HNC Asia-Pacific market will be valued at $424.5m in 2023, growing from $265.9m in 2016 at a CAGR of 6.9%.
  • How will immune checkpoint inhibitors such as Opdivo, Keytruda and Imfinzi contribute to growth?
  • What effect will patent expirations of branded therapies have on market value?
  • The HNC pipeline is large and diverse, with an 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 locally advanced HNC patients?
  • What implications will the increased focus on targeted therapies have on the future of HNC 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, Opdivo and Bavencio to treat locally advanced HNC patients affect the competitive landscape, with no immunotherapy 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, tobacco use (both smoked and smokeless) and alcohol consumption influence the market?
  • Licensing deals are the most common form of strategic alliance in HNC, 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

  • 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 HNC 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 HNC 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 HNC 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 HNC deals landscape by analyzing trends in licensing and co-development deals.

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

2 Introduction 10
2.1 Disease Introduction 10
2.2 Epidemiology 10
2.3 Symptoms 13
2.4 Etiology and Pathophysiology 13
2.4.1 Etiology 13
2.4.2 Pathophysiology 16
2.4.3 Biomarkers/Targets of Interest 20
2.5 Diagnosis 21
2.6 Disease Stages 22
2.7 Prognosis 29
2.8 Treatment Guidelines and Options 31
2.8.1 Surgery and Radiation Therapy 33
2.8.2 Chemotherapy 34
2.8.3 Targeted Therapies 35

3 Marketed Products 37
3.1 Overview 37
3.2 Chemotherapies 38
3.2.1 TS-1 (tegafur plus gimeracil plus oteracil) – Taiho Pharma 38
3.2.2 Cisplatin 40
3.2.3 Docetaxel 41
3.2.4 Fluorouracil (5-FU) 42
3.2.5 Methotrexate 42
3.3 Epidermal Growth Factor Receptor Targeted Therapies 43
3.3.1 Erbitux (cetuximab) – Eli Lilly/Merck KGaA 43
3.3.2 BIOMAb EGFR (nimotuzumab) – Biocon/Biotech Pharmaceutical Co. 45
3.4 Programmed Cell Death Protein 1/Programmed Death Ligand 1 Immune Checkpoint Inhibitors 47
3.4.1 Opdivo (nivolumab) – Bristol-Myers Squibb 47
3.4.2 Keytruda (pembrolizumab) – Merck & Co. 50
3.5 Comparative Efficacy and Safety of Marketed Products 53

4 Pipeline Analysis 56
4.1 Overview 56
4.2 Pipeline by Stage of Development, Molecule Type, Route of Administration and Program Type 57
4.3 Pipeline by Molecular Target 60
4.4 Promising Pipeline Candidates 62
4.4.1 Imfinzi (durvalumab) – MedImmune 62
4.4.2 Gilotrif/Giotrif/Xovoltib (afatinib) – Boehringer Ingelheim 66
4.4.3 Bavencio (avelumab) – Merck KgaA/Pfizer 68
4.5 Comparative Efficacy and Safety of Pipeline Products 70
4.6 Product Competitiveness Framework 71

5 Clinical Trial Analysis 73
5.1 Failure Rate 73
5.1.1 Overall Failure Rate 73
5.1.2 Failure Rate by Phase and Molecule Type 75
5.1.3 Failure Rate by Phase and Molecular Target 76
5.2 Clinical Trial Size 77
5.2.1 Patient Enrollment per Product by Molecule Type and Stage of Development 77
5.2.2 Patient Enrollment per Product by Molecular Target and Stage of Development 78
5.2.3 Patient Enrollment per Trial by Molecule Type and Stage of Development 79
5.2.4 Patient Enrollment per Trial by Molecular Target and Stage of Development 80
5.3 Clinical Trial Duration 81
5.3.1 Trial Duration by Molecule Type and Stage of Development 81
5.3.2 Trial Duration by Molecular Target and Stage of Development 82
5.4 Summary of Clinical Trial Metrics 83

6 Multi-scenario Forecast 84
6.1 Overview 84
6.2 Asia-Pacific Market 85
6.3 India 87
6.3.1 Treatment Usage Patterns 87
6.3.2 Annual Cost of Therapy 88
6.3.3 Market Size 89
6.4 China 90
6.4.1 Treatment Usage Patterns 90
6.4.2 Annual Cost of Therapy 91
6.4.3 Market Size 92
6.5 Australia 94
6.5.1 Treatment Usage Patterns 94
6.5.2 Annual Cost of Therapy 95
6.5.3 Market Size 95
6.6 South Korea 97
6.6.1 Treatment Usage Patterns 97
6.6.2 Annual Cost of Therapy 98
6.6.3 Market Size 99
6.7 Japan 100
6.7.1 Treatment Usage Patterns 100
6.7.2 Annual Cost of Therapy 101
6.7.3 Market Size 102

7 Drivers and Barriers 104
7.1 Drivers 104
7.1.1 Increasing Incidence of HNC 104
7.1.2 Adoption of Immuno-oncology Therapies in the HNC Treatment Algorithm 104
7.1.3 Launch of Premium Priced Pipeline Products 104
7.1.4 Increasing Usage of High Premium Priced Combination Therapies 105
7.1.5 Diversified Healthcare Reform and Insurance System to Boost Market Growth 105
7.2 Barriers 106
7.2.1 Usage of Surgical Therapies at Early Stage Reduces Drug Treatment Rate 106
7.2.2 Patent Expiration of Branded Therapies to Affect HNC Market Growth 106
7.2.3 Lack of Development of Pipeline Products for Locally Advanced HNC 106
7.2.4 High Prices of Therapeutics, Lack of Reimbursement and Penetration of Generics to Slow Down Market Growth in China and India 106
7.2.5 Drug Pricing Reforms 107

8 Deals and Strategic Consolidations 108
8.1 Licensing Deals 108
8.1.1 Deals by Region and Value 108
8.1.2 Number of Disclosed and Undisclosed Deals by Year, Aggregate Deal Value 110
8.1.3 Deal Value by Stage of Development, Molecule Type, and Molecular Target 111
8.1.4 Key Licensing Deals 113
8.2 Co-development Deals 115
8.2.1 Deals by Region and Value 115
8.2.2 Number of Disclosed and Undisclosed Deals by Year, Aggregate Deal Value 116
8.2.3 Deal Value by Stage of Development, Molecule Type, and Molecular Target 117
8.2.4 Key Co-development Deals 119

9 Appendix 121
9.1 All Pipeline Drugs by Stage of Development 121
9.1.1 Discovery 121
9.1.2 Preclinical 122
9.1.3 IND/CTA-filed 125
9.1.4 Phase I 126
9.1.5 Phase II 130
9.1.6 Phase III 133
9.2 Market Forecasts to 2023 134
9.2.1 Asia-Pacific 134
9.2.2 India 134
9.2.3 China 134
9.2.4 Australia 135
9.2.5 South Korea 135
9.2.6 Japan 136
9.3 Bibliography 136
9.4 Abbreviations 148
9.5 Research Methodology 150
9.5.1 Secondary Research 151
9.5.2 Marketed Product Profiles 151
9.5.3 Late-Stage Pipeline Candidates 152
9.5.4 Comparative Efficacy and Safety Heat Map for Marketed and Pipeline Products 152
9.5.5 Product Competitiveness Framework 152
9.5.6 Pipeline Analysis 152
9.5.7 Forecasting Model 153
9.5.8 Deals Data Analysis 154
9.6 Contact Us 154
9.7 Disclaimer 155

Table 1: Symptoms of HNC, 2017 13

Table 2: Symptoms of HNC Metastasis, 2017 13

Table 3: Common Mutations in HNC Metastasis, 2017 19

Table 4: TNM Classification of Lip, Oral Cavity, and Oropharyngeal Cancers, 2017 23

Table 5: TNM Classification of the Larynx, 2017 24

Table 6: TNM Classification of the Hypopharynx, 2017 26

Table 7: TNM Classification of Salivary Gland Cancers, 2017 27

Table 8: TNM Classification of Nasopharyngeal Cancers, 2017 28

Table 9: Stage Grouping for HNC (Excluding Nasopharyngeal and Thyroid Cancer), 2017 29

Table 10: Stage Grouping for Nasopharyngeal Cancer, 2017 29

Table 11: HNC Therapeutics Market, Global, Licensing Deals Valued Above $10m, 2006–2017 114

Table 12: HNC Therapeutics Market, Global, Co-development Deals Valued Above $10m, 2006–2017 120

Table 13: HNC Therapeutics Market, Global, All Pipeline Products, Discovery, 2017 121

Table 14: HNC Therapeutics Market, Global, All Pipeline Products, Preclinical, 2016 122

Table 15: HNC Therapeutics Market, Global, All Pipeline Products, IND/CTA-filed, 2017 125

Table 16: HNC Therapeutics Market, Global, All Pipeline Products, Phase I, 2017 126

Table 17: HNC Therapeutics Market, Global, All Pipeline Products, Phase II, 2017 130

Table 18: HNC Therapeutics Market, Global, All Pipeline Products, Phase III, 2017 133

Table 19: HNC Therapeutics Market, APAC, Market Forecast, 2016–2023 134

Table 20: HNC Therapeutics Market, India, Market Forecast, 2016–2023 134

Table 21: HNC Therapeutics Market, China, Market Forecast, 2016–2023 134

Table 22: HNC Therapeutics Market, Australia, Market Forecast, 2016–2023 135

Table 23: HNC Therapeutics Market, South Korea, Market Forecast, 2016–2023 135

Table 24: HNC Therapeutics Market, Japan, Market Forecast, 2016–2023 136

Figure 1: HNC Therapeutics Market, Australia, Estimated Age-Specific Incidence and Mortality Rates for HNC, by Sex, 2017 12

Figure 2: HNC Therapeutics Market, Australia, Five-Year Relative Survival from HNC by Sex, 1984–2013 12

Figure 3: HNC Therapeutics Market, Treatment Algorithm for HNC (Excluding Nasopharyngeal and Thyroid Cancer) 32

Figure 4: HNC Therapeutics Market, Treatment Algorithm for Nasopharyngeal Cancer and Thyroid Cancer 33

Figure 5: HNC Therapeutics Market, Comparative Efficacy and Safety Heatmap for Marketed Products 53

Figure 6: HNC Therapeutics Market, Global, Pipeline, 2017 59

Figure 7: HNC Therapeutics Market, Global, Pipeline by Molecular Target, 2017 61

Figure 8: HNC Therapeutics Market, Pipeline by Molecular Target and Stage of Development, 2017 62

Figure 9: HNC Therapeutics Market, APAC, Imfinzi Forecast ($m), 2019–2023 65

Figure 10: HNC Therapeutics Market, APAC, Durvalumab plus Tremelimumab Forecast ($m), 2019–2023 66

Figure 11: HNC Therapeutics Market, APAC, Gilotrif/Giotrif/Xovoltib Forecast ($m), 2020–2023 68

Figure 12: HNC Therapeutics Market, Comparative Efficacy and Safety Heatmap for Pipeline Products 71

Figure 13: HNC Therapeutics Market, Competitor Matrix for HNC Marketed and Pipeline Products, 2017 72

Figure 14: HNC Therapeutics, Global, Average Clinical Trial Failure Rate (%), 2006–2016 74

Figure 15: HNC Therapeutics, Global, Clinical Trial Failure Rates by Molecule Type (%), 2006–2016 75

Figure 16: HNC Therapeutics, Global, Clinical Trial Failure Rates by Molecular Target (%), 2006–2016 76

Figure 17: HNC Therapeutics, Global, Clinical Trial Size per Product by Molecule Type (participants), 2006–2016 77

Figure 18: HNC Therapeutics, Global, Clinical Trial Size per Product by Molecular Target (participants), 2006–2016 78

Figure 19: HNC Therapeutics, Global, Clinical Trial Size per Trial by Molecule Type (participants), 2006–2016 79

Figure 20: HNC Therapeutics, Global, Clinical Trial Size per Trial by Molecular Target (participants), 2006–2016 80

Figure 21: HNC Therapeutics, Global, Clinical Trial Duration by Molecule Type (months), 2006–2016 81

Figure 22: HNC Therapeutics, Global, Clinical Trial Duration by Molecular Target (months), 2006–2016 82

Figure 23: HNC Therapeutics Market, Global, Comparison of Average Trial Metrics by Phase and Molecule Type 83

Figure 24: HNC Therapeutics Market, Global, Comparison of Average Trial Metrics by Phase and Molecular Target 83

Figure 25: HNC Therapeutics Market, APAC, Treatment Patterns (‘000), 2016–2023 86

Figure 26: HNC Therapeutics Market, APAC, Market Size ($m), 2016–2023 87

Figure 27: HNC Therapeutics Market, India, Treatment Patterns (‘000), 2016–2023 88

Figure 28: HNC Therapeutics Market, India, Annual Cost of Therapy ($), 2016–2023 89

Figure 29: HNC Therapeutics Market, India, Market Size ($m), 2016–2023 90

Figure 30: HNC Therapeutics Market, China, Treatment Patterns (‘000), 2016–2023 91

Figure 31: HNC Therapeutics Market, China, Annual Cost of Therapy ($), 2016–2023 92

Figure 32: HNC Therapeutics Market, China, Market Size ($m), 2016–2023 93

Figure 33: HNC Therapeutics Market, Australia, Treatment Patterns (‘000), 2016–2023 94

Figure 34: HNC Therapeutics Market, Australia, Annual Cost of Therapy ($), 2016–2023 95

Figure 35: HNC Therapeutics Market, Australia, Market Size ($m), 2016–2023 96

Figure 36: HNC Therapeutics Market, South Korea, Treatment Patterns (‘000), 2016–2023 98

Figure 37: HNC Therapeutics Market, South Korea, Annual Cost of Therapy ($), 2016–2023 99

Figure 38: HNC Therapeutics Market, South Korea, Market Size ($m), 2016–2023 100

Figure 39: HNC Therapeutics Market, Japan, Treatment Patterns (‘000), 2016–2023 101

Figure 40: HNC Therapeutics Market, Japan, Annual Cost of Therapy ($), 2016–2023 102

Figure 41: HNC Therapeutics Market, Japan, Market Size ($m), 2016–2023 103

Figure 42: HNC Therapeutics Market, Global, Licensing Deals by Region and Value, 2006–2017 109

Figure 43: HNC Therapeutics Market, Global, Number of Disclosed and Undisclosed Licensing Deals by Year, Aggregate Deal Value ($m) and Aggregate Upfront Value ($m), 2006–2017 110

Figure 44: HNC Therapeutics Market, Global, Licensing Deals by Stage of Development, Deal Value ($m) and Upfront Payment Value ($m), 2006–2017 111

Figure 45: HNC Therapeutics Market, Global, Licensing Deals by Molecule Type, Stage of Development and Aggregate Deal Value ($m), 2006–2017 112

Figure 46: HNC Therapeutics Market, Global, Licensing Deals by Molecular Target and Aggregate Deal Value ($m), 2006–2017 113

Figure 47: HNC Therapeutics Market, Global, Co-development Deals by Region, 2006–2017 115

Figure 48: HNC Therapeutics Market, Global, Number of Disclosed and Undisclosed Co-development Deals by Year, Aggregate Deal Value ($m) and Aggregate Upfront Value ($m), 2006–2017 116

Figure 49: HNC Therapeutics Market, Global, Co-development Deals by Stage of Development, Deal Value ($m) and Upfront Payment Value ($m), 2006–2017 117

Figure 50: HNC Therapeutics Market, Global, Co-development Deals by Molecule Type, Stage of Development and Aggregate Deal Value ($m), 2006–2017 118

Figure 51: HNC Therapeutics Market, Global, Co-development Deals by by Molecular Target and Aggregate Deal Value ($m), 2006–2017 119

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