Gastric Cancer Therapeutics in Asia-Pacific Markets to 2022 - Growth Driven by Increasing Prevalence and Launch of Targeted Therapies

Gastric Cancer Therapeutics in Asia-Pacific Markets to 2022 - Growth Driven by Increasing Prevalence and Launch of Targeted Therapies


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Executive Summary

Gastric Cancer Therapeutics in Asia-Pacific Markets to 2022 - Growth Driven by Increasing Prevalence and Launch of Targeted Therapies

Summary

Gastric cancer is characterized by the formation of malignant cells in the inner lining of the stomach and is the fifth-most common cancer globally. There are many types of gastric cancer, but adenocarcinoma is the most common type and is diagnosed in 95% of cases. The life expectancy and survival rate for gastric cancer is heavily dependent on the stage of the disease when diagnosed. In Asia-Pacific, most of the incident cases of gastric cancer are diagnosed at the late stage and in patients over the age of 60. As the aged population continues to grow, the prevalence of gastric cancer will increase. This, coupled with increasing early diagnosis and an improved survival rate, will drive revenue growth. Due to its indolent nature, the disease remains one of the most common causes of cancer-related death worldwide. Such a poor outlook, particularly for patients with advanced disease, has created a pressing need for improved targeted therapeutic options. The current marketed products landscape comprises a wide range of treatment options, including HER2-targeted therapy, angiogenesis inhibitors and new chemotherapies. Nevertheless, significant unmet need remains for products that can treat HER2-negative gastric cancer patients. However, the gastric cancer market is undergoing a gradual change from a focus on generic chemotherapy regimens to a complex treatment landscape based on targeted therapies.

In the current market, patients with HER2-positive gastric cancer can be treated with targeted therapies, such as Herceptin, while HER2-negative patients still receive chemotherapy regimens as the first-line treatment. The market will be driven by recently launched products and upcoming targeted therapies during the forecast period. The main restraints will be the low penetration of new targeted therapies, owing to their high price, and constrained healthcare budgets.

Scope

The Asia-Pacific gastric cancer market is forecast to grow at a compound annual growth rate of 11.4% from USD1.3 billion in 2015 to USD2.7 billion in 2022.

- How will angiogenesis inhibitors contribute to growth?

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

The pipeline contains a range of molecule types and molecular targets, including those that are well-established in gastric cancer and novel targeted therapies.

- Which molecular targets appear most frequently in the pipeline?

- Will the pipeline address unmet needs such as a lack of diverse treatment options for gastric cancer patients?

- What are the most promising first-in-class targets for gastric cancer?

- Will the current first-in-class targets have broader therapeutic potential across the Asia-Pacific markets?

- Will the pipeline address unmet needs such as a lack of targeted treatments for HER2-negative gastric cancer patients?

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

- What are the barriers that limit the uptake of premium-priced targeted therapeutics in the assessed countries?

- Which factors are most likely to drive the market in these countries?

Licensing deals are the most common form of strategic alliance in gastric cancer, with total deal values ranging from under USD10m to over USD200m.

- 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 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 gastric cancer market in terms of dominant therapies for each patient subset along with their clinical and commercial standing. Unmet needs in the current market are highlighted to allow a competitive understanding of gaps in the current market.

- Analyze the gastric cancer pipeline and stratify pipeline therapies by stage of development, molecule type and molecular target. There are promising signs in the pipeline that the industry is seeking novel approaches to treating gastric cancer.

- 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 gastric cancer market growth in the five 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 gastric cancer deals landscape by analyzing trends in licensing and co-development deals.



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1 Table of Contents

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 12

2.4 Etiology 12

2.5 Pathophysiology 12

2.5.1 Helicobacter Pylori 13

2.5.2 Oncogenes 13

2.5.3 Tumor Suppressor Genes 13

2.5.4 Cell Adhesion Molecules and Metastasis-Related Genes 14

2.5.5 Cell Cycle Regulators 14

2.5.6 Microsatellite and Chromosomal Instability 14

2.5.7 Growth Factor and Cytokines 14

2.6 Diagnosis 15

2.6.1 Photofluorography or Barium Study 15

2.6.2 Endoscopy 15

2.6.3 Imaging Tests 15

2.6.4 Endoscopic Ultrasound 16

2.6.5 Laparoscopy 16

2.6.6 Laboratory Analysis 16

2.7 Classification and Disease Staging 16

2.7.1 Intestinal Subtype 16

2.7.2 Diffuse Subtype 16

2.8 Prognosis 18

2.9 Treatment Guidelines and Options 18

2.9.1 Surgery 18

2.9.2 First-Line Therapy 19

2.9.3 Second-Line Therapy 20

3 Marketed Products 21

3.1 Overview 21

3.2 HER2-Targeted Therapy 21

3.2.1 Herceptin (trastuzumab) - Roche/Genentech 21

3.3 Angiogenesis Inhibitors 23

3.3.1 Cyramza (ramucirumab) - Eli Lilly 23

3.3.2 Aitan (apatinib) - Jiangsu HengRui Medicine 24

3.4 Newer Chemotherapies 25

3.4.1 TS-1 (tegafur, gimeracil, oteracil) - Taiho 26

3.4.2 Abraxane (nab-paclitaxel) - Celgene/Taiho 26

3.5 Comparative Efficacy and Safety of Marketed Products 27

4 Pipeline Analysis 29

4.1 Overview 29

4.2 Pipeline by Stage of Development, Molecule Type, Route of Administration and Program Type 29

4.3 Pipeline by Molecular Target 31

4.4 Promising Pipeline Candidates 33

4.4.1 Opdivo (nivolumab) - Ono Pharmaceutical/Bristol-Myers Squibb 33

4.4.2 Keytruda (pembrolizumab) - Merck 35

4.4.3 Perjeta (pertuzumab) - Roche 37

4.4.4 Napabucasin - Boston Biomedical (subsidiary of Dainippon Sumitomo Pharma) 39

4.4.5 Lynparza (olaparib) - AstraZeneca 41

4.4.6 Nimotuzumab - Kuhnil Pharmaceutical/Daiichi Sankyo 43

4.4.7 Avelumab - Merck 44

4.4.8 GS-5745 - Gilead Bioscience 46

4.5 Comparative Efficacy and Safety of Pipeline Products 47

4.6 Product Competitive Framework 48

5 Clinical Trial Analysis 50

5.1 Failure Rate 50

5.1.1 Overall Failure Rate 50

5.1.2 Failure Rate by Phase and Molecule Type 51

5.1.3 Failure Rate by Phase and Molecular Target 53

5.2 Clinical Trial Size 55

5.2.1 Patient Enrollment per Product by Molecule Type, Molecular Target and Stage of Development 55

5.2.2 Patient Enrollment per Trial by Molecule Type, Molecular Target and Stage of Development 56

5.3 Clinical Trial Duration 58

5.3.1 Trial Duration by Stage of Development and Molecule Type 58

5.3.2 Trial Duration by Stage of Development and Molecular Target 59

5.4 Summary of Clinical Trial Metrics 60

6 Multi-Scenario Forecast 62

6.1 Geographical Markets 62

6.2 Asia-Pacific Market 62

6.3 India 64

6.3.1 Treatment Usage Patterns 64

6.3.2 Annual Cost of Therapy 64

6.3.3 Market Size 65

6.4 China 66

6.4.1 Treatment Usage Patterns 66

6.4.2 Annual Cost of Therapy 67

6.4.3 Market Size 68

6.5 Australia 69

6.5.1 Treatment Usage Patterns 69

6.5.2 Annual Cost of Therapy 70

6.5.3 Market Size 71

6.6 South Korea 72

6.6.1 Treatment Usage Patterns 72

6.6.2 Annual Cost of Therapy 73

6.6.3 Market Size 73

6.7 Japan 74

6.7.1 Treatment Usage Patterns 74

6.7.2 Annual Cost of Therapy 75

6.7.3 Market Size 76

7 Market Dynamics 77

7.1 Drivers 77

7.1.1 Increasing Prevalence and Treatment Rate Across All Lines of Therapy in the Metastatic Setting 77

7.1.2 Promising Drug Pipeline Focused on Targeted Therapies 77

7.1.3 Launch of Premium-Priced Drugs for the Metastatic Setting 77

7.1.4 Improved Treatment Options that Extend Duration of Therapy 77

7.1.5 Increasing Screening Programs and Government Reforms 78

7.2 Barriers 78

7.2.1 Lack of Development of Pipeline Agents as Pre-operative and Postoperative Treatments for Resectable Gastric Cancer 78

7.2.2 Patent Expiration of Herceptin and Patient Share Erosion by Trastuzumab Biosimilars 78

7.2.3 Affordability and Reimbursement Issues in India and China 78

8 Deals and Strategic Consolidations 79

8.1 Licensing Deals 79

8.1.1 Deals by Region and Value 79

8.1.2 Number of Disclosed and Undisclosed Deals by Year, Aggregate Deal Value 79

8.1.3 Deal Value by Stage of Development, Molecule Type and Molecular Target 80

8.1.4 Key Licensing Deals 83

8.2 Co-development Deals 84

8.2.1 Deals by Region and Value 84

8.2.2 Number of Deals by Year 84

8.2.3 Deals by Stage of Development, Molecule Type and Molecular Target 85

8.2.4 Key Co-development Deals 87

9 Appendix 89

9.1 All Pipeline Drugs by Stage of Development 89

9.1.1 Discovery 89

9.1.2 Preclinical 90

9.1.3 Investigational New Drug/ Clinical Trial Authorization-filed 92

9.1.4 Phase I 93

9.1.5 Phase II 95

9.1.6 Phase III 97

9.2 Market Forecasts to 2021 97

9.2.1 Asia-Pacific 97

9.2.2 India 98

9.2.3 China 98

9.2.4 Australia 99

9.2.5 South Korea 99

9.2.6 Japan 100

9.3 Bibliography 100

9.4 Abbreviations 106

9.5 Research Methodology 108

9.5.1 Secondary Research 108

9.5.2 Marketed Product Profiles 109

9.5.3 Late-Stage Pipeline Candidates 109

9.5.4 Comparative Efficacy and Safety Heat Map for Marketed and Pipeline Products 109

9.5.5 Product Competitiveness Framework 109

9.5.6 Pipeline Analysis 109

9.5.7 Forecasting Model 110

9.5.8 Deals Data Analysis 111

9.6 Contact Us 112

9.7 Disclaimer 112

1.2 List of Figures

Figure 1: Gastric Cancer Therapeutics, Australia, Age-Specific Incidence Rate per 100,000 Population, 2004, 2008 and 2012 11

Figure 2: Gastric Cancer, Stage Grouping 17

Figure 3: Gastric Cancer, Market Heat Map 28

Figure 4: Pipeline for Gastric Cancer, Global, 2016 30

Figure 5: Pipeline for Gastric Cancer by Molecular Target, Global, 2016 32

Figure 6: Pipeline for Gastric Cancer by Molecular Target by Stage of Development, Global, 2016 33

Figure 7: Gastric Cancer Therapeutics Market, Asia-Pacific, Opdivo, Market Forecast (USDm), 2018-2022 35

Figure 8: Gastric Cancer Therapeutics Market, Asia-Pacific, Keytruda, Market Forecast (USDm), 2019-2022 37

Figure 9: Gastric Cancer Therapeutics Market, Asia-Pacific, Perjeta, Market Forecast (USDm), 2018-2022 39

Figure 10: Gastric Cancer Therapeutics Market, Asia-Pacific, Napabucasin, Market Forecast (USDm), 2018-2022 41

Figure 11: Gastric Cancer Therapeutics Market, Asia-Pacific, Lynparza, Market Forecast (USDm), 2019-2022 43

Figure 12: Gastric Cancer Therapeutics Market, Asia-Pacific, Nimotuzumab, Market Forecast (USDm), 2019-2022 44

Figure 13: Gastric Cancer Therapeutics Market, Asia-Pacific, Avelumab, Market Forecast (USDm), 2020-2022 46

Figure 14: Gastric Cancer, Pipeline Heat Map 47

Figure 15: Gastric Cancer, Marketed and Pipeline Product Competitiveness Framework 49

Figure 16: Gastric Cancer Therapeutics Market, Global, Overall Clinical Trial Attrition Rates by Stage of Development (%), 2006-2016 51

Figure 17: Gastric Cancer Therapeutics Market, Global, Clinical Trial Attrition Rates by Stage of Development and Molecule Type (%), 2006-2016 52

Figure 18: Gastric Cancer Therapeutics Market, Global, Clinical Trial Attrition Rates by Stage of Development and Molecular Target (%), 2006-2016 54

Figure 19: Gastric Cancer Therapeutics Market, Global, Clinical Trial Size per Product by Molecule Type and Stage of Development, 2006-2016 55

Figure 20: Gastric Cancer Therapeutics Market, Global, Clinical Trial Size per Product by Molecular Target and Stage of Development, 2006-2016 56

Figure 21: Gastric Cancer Therapeutics Market, Global, Clinical Trial Size per Trial by Stage of Development and Molecule Type, 2006-2016 57

Figure 22: Gastric Cancer Therapeutics Market, Global, Clinical Trial Size per Trial by Stage of Development and Molecular Target, 2006-2016 58

Figure 23: Gastric Cancer Therapeutics Market, Global, Clinical Trial Duration by Stage of Development and Molecule Type, 2006-2016 59

Figure 24: Gastric Cancer Therapeutics Market, Global, Clinical Trial Size by Molecular Target by Stage of Development (patients), 2006-2016 60

Figure 25: Gastric Cancer Therapeutics Market, Comparison of Average Trial Metrics by Phase and Molecule Type 60

Figure 26: Gastric Cancer Therapeutics Market, Comparison of Average Trial Metrics by Phase and Molecular Target 61

Figure 27: Gastric Cancer Therapeutics Market, Asia-Pacific, Treatment Patterns ('000), 2015-2022 63

Figure 28: Gastric Cancer Therapeutics Market, Asia-Pacific, Market Size (USDbn), 2015-2022 63

Figure 29: Gastric Cancer Therapeutics Market, India, Treatment Patterns ('000), 2015-2022 64

Figure 30: Gastric Cancer Therapeutics Market, India, Annual Cost of Therapy (USD), 2015-2022 65

Figure 31: Gastric Cancer Therapeutics Market, India, Market Size (USDm), 2015-2022 66

Figure 32: Gastric Cancer Therapeutics Market, China, Treatment Patterns ('000), 2015-2022 67

Figure 33: Gastric Cancer Therapeutics Market, China, Annual Cost of Therapy (USD), 2015-2022 68

Figure 34: Gastric Cancer Therapeutics Market, China, Market Size (USDbn), 2015-2022 69

Figure 35: Gastric Cancer Therapeutics Market, Australia, Treatment Patterns, 2015-2022 70

Figure 36: Gastric Cancer Therapeutics Market, Australia, Annual Cost of Therapy (USD), 2015-2022 71

Figure 37: Gastric Cancer Therapeutics Market, Australia, Market Size (USDm), 2015-2022 71

Figure 38: Gastric Cancer Therapeutics Market, South Korea, Treatment Patterns ('000), 2015-2022 72

Figure 39: Gastric Cancer Therapeutics Market, South Korea, Annual Cost of Therapy (USD), 2015-2022 73

Figure 40: Gastric Cancer Therapeutics Market, South Korea, Market Size (USDm), 2015-2022 74

Figure 41: Gastric Cancer Therapeutics Market, Japan, Treatment Patterns ('000), 2015-2022 75

Figure 42: Gastric Cancer Therapeutics Market, Japan, Annual Cost of Therapy (USD), 2015-2022 75

Figure 43: Gastric Cancer Therapeutics Market, Japan, Market Size (USDbn), 2015-2022 76

Figure 44: Gastric Cancer Therapeutics Market, Global, Licensing Deals by Region and Value, 2006-2016 79

Figure 45: Gastric Cancer Therapeutics Market, Global, Number of Disclosed and Undisclosed Licensing Deals by Year and Aggregate Deal Value (USDm), 2006-2016 80

Figure 46: Gastric Cancer Therapeutics Market, Global, Licensing Deals by Stage of Development and Deal Value (USDm) 2006-2016 81

Figure 47: Gastric Cancer Therapeutics Market, Global, Licensing Deals by Molecule Type and Stage of Development, 2006-2016 82

Figure 48: Gastric Cancer Therapeutics Market, Global, Licensing Deals by Molecular Target and Aggregate Deal Value (USDm), 2006-2016 82

Figure 49: Gastric Cancer Therapeutics Market, Global, Co-development Deals by Region, 2006-2016 84

Figure 50: Gastric Cancer Therapeutics Market, Global, Number of Co-development Deals by Year, 2006-February 2016 85

Figure 51: Gastric Cancer Therapeutics Market, Global, Co-development Deals by Stage of Development, 2006-2016 85

Figure 52: Gastric Cancer Therapeutics Market, Global, Co-development Deals by Molecule Type, Stage of Development, 2006-2016 86

Figure 53: Gastric Cancer Therapeutics Market, Global, Co-development Deals by Molecular Target, 2006-2016 87

1.1 List of Tables

Table 1: Gastric Cancer, Tumor, Node and Metastasis Staging 17

Table 2: Gastric Cancer Therapeutics Market, Global, All Pipeline Products, Discovery, 2016 89

Table 3: Gastric Cancer Therapeutics Market, Global, All Pipeline Products, Preclinical, 2016 90

Table 4: Gastric Cancer Therapeutics Market, Global, All Pipeline Products, IND/CTA-Filed, 2016 92

Table 5: Gastric Cancer Therapeutics Market, Global, All Pipeline Products, Phase I, 2016 93

Table 6: Gastric Cancer Therapeutics Market, Global, All Pipeline Products, Phase II, 2016 95

Table 7: Gastric Cancer Therapeutics Market, Global, All Pipeline Products, Phase III, 2016 97

Table 8: Gastric Cancer Therapeutics Market, Asia-Pacific, Market Forecast, 2015-2022 97

Table 9: Gastric Cancer Therapeutics Market, India, Market Forecast, 2015-2022 98

Table 10: Gastric Cancer Therapeutics Market, China, Market Forecast, 2015-2022 98

Table 11: Gastric Cancer Therapeutics Market, Australia, Market Forecast, 2015-2022 99

Table 12: Gastric Cancer Therapeutics Market, South Korea, Market Forecast, 2015-2022 99

Table 13: Gastric Cancer Therapeutics Market, Japan, Market Forecast, 2015-2022 100

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