Colorectal Cancer Therapeutics in Asia-Pacific Markets to 2023 – Launch of Premium Targeted Therapies and Increasing Prevalence to Drive the Market

Colorectal Cancer (CRC) is the most common cancer and the leading cause of cancer-related mortality globally. There were more than 1.4 million newly diagnosed CRC cases in 2012, accounting for 9.7% of the total number of cancer cases. This figure has been gradually rising in the Asia-Pacific region, with the growing elderly population and increasingly Westernized lifestyles.

CRC is a leading cause of death worldwide, accounting for 0.77 million deaths in 2015. Over half of the incident cases of CRC are diagnosed in patients over the age of 50, and as the aged population is projected to grow, the prevalence of CRC is anticipated to increase, acting as a driver for revenue growth.

The poor prognosis, particularly for patients with advanced disease, has created a pressing need for improved therapeutic options. The CRC market is therefore shifting from a focus on generic chemotherapy regimens to a complex treatment landscape based on the presence of various molecular aberrations.

The marketed products landscape comprises a wide range of treatment options, including EGFR-targeted therapies, angiogenesis inhibitors, multiple kinase inhibitors and new chemotherapies. In the current market, RAS-wild-type and RAS-mutant patients can be treated with angiogenesis inhibitors such as Avastin, Cyramza and Zaltrap, while patients with RAS- or KRAS-wild-type mutations can be prescribed EGFR-targeted therapies such as Erbitux and Vectibix. However, significant unmet need remains for products that can treat BRAF-mutant CRC patients. A therapy that targets mutant BRAF – encorafenib plus binimetinib – is being developed in the pipeline.

Scope

The CRC Asia-Pacific market will be valued at $7.9 billion in 2023, growing from $4.7 billion in 2016 at a CAGR of 7.9%.

– How will immune checkpoint inhibitors such as Keytruda and Tecentriq contribute to growth?

– What effect will patent expirations of currently branded therapies have on market value?

The CRC 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 BRAF-mutant CRC patients?

– What implications will the increased focus on targeted therapies have on the future of CRC 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 encorafenib plus binimetinib to treat BRAF-mutant 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, obesity and lifestyle influence the market?

Licensing deals are the most common form of strategic alliance in CRC, with total deal values ranging from under $10m to over $3 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 CRC 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 CRC 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 CRC 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 CRC 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 10

2.1 Disease Introduction 10

2.2 Epidemiology 10

2.3 Symptoms 12

2.4 Etiology and Pathophysiology 12

2.4.1 Etiology 12

2.4.2 Pathophysiology 13

2.4.3 Biomarkers/Targets of Interest 14

2.5 Diagnosis 15

2.5.1 Digital Rectal Examination 16

2.5.2 Fecal Occult Blood Test 16

2.5.3 Flexible Sigmoidoscopy 16

2.5.4 Colonoscopy 16

2.5.5 Virtual Colonoscopy 17

2.5.6 Double Contrast Barium Enema 17

2.6 Disease Stages 17

2.7 Prognosis 19

2.8 Treatment Guidelines and Options 20

2.8.1 Surgery and Radiation Therapy 20

2.8.2 Chemotherapy 21

2.8.3 Targeted Therapies 22

2.8.4 Resistance to Pharmacological Therapies 23

2.8.5 Treatment Algorithm 23

3 Marketed Products 26

3.1 Overview 26

3.2 Chemotherapies 26

3.2.1 Lonsurf (Trifluridine plus Tipiracil) - Taiho Pharma 27

3.2.2 TS-1 (Tegafur plus Gimeracil plus Oteracil) - Taiho Pharma 28

3.2.3 UFT (tegafur plus uracil) - Merck KGaA 29

3.3 Epidermal Growth Factor Receptor Targeted Therapies 29

3.3.1 Erbitux (cetuximab) - Eli Lilly/Merck KGaA 30

3.3.2 Vectibix (panitumumab) - Amgen/Takeda 31

3.4 Anti-angiogenesis Therapies 33

3.4.1 Avastin (bevacizumab) - Roche 33

3.4.2 Cyramza (ramucirumab) - Eli Lilly 35

3.4.3 Zaltrap (Ziv-Aflibercept) - Sanofi/Regeneron 36

3.5 Kinase Inhibitors 37

3.5.1 Stivarga (regorafenib) - Bayer/Onyx 37

3.6 Comparative Efficacy and Safety of Marketed Products 38

4 Pipeline Analysis 40

4.1 Overview 40

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

4.3 Pipeline by Molecular Target 43

4.4 Promising Pipeline Candidates 45

4.4.1 Keytruda (pembrolizumab) - Merck & Co. 45

4.4.2 Tecentriq plus Cotellic (Atezolizumab plus cobimetinib) - Roche 47

4.4.3 Napabucasin (BBI-608) - Sumitomo Dainippon Pharma 49

4.4.4 Encorafenib plus binimetinib (LGX-818/MEK-162) - Array BioPharma 50

4.4.5 Masitinib - AB Science 52

4.4.6 Fruquintinib (HMPL-013) - Hutchison MediPharma 54

4.4.7 Famitinib (SHR-1020) - Jiangsu Hengrui Medicine 55

4.4.8 Anlotinib (AL-3818) - Jiangsu Chia-Tai Tianqing 56

4.4.9 Donafenib (CM-4307) - Suzhou Zelgen Biopharmaceuticals 57

4.5 Comparative Efficacy and Safety of Pipeline Products 58

4.6 Product Competitiveness Framework 59

5 Clinical Trial Analysis 61

5.1 Failure Rate 61

5.1.1 Overall Failure Rate 61

5.1.2 Failure Rate by Phase and Molecule Type 62

5.1.3 Failure Rate by Phase and Molecular Target 63

5.2 Clinical Trial Size 64

5.2.1 Patient Enrollment per Product by Molecule Type and Stage of Development 64

5.2.2 Patient Enrollment per Product by Molecular Target and Stage of Development 65

5.2.3 Patient Enrollment per Trial by Molecule Type and Stage of Development 66

5.2.4 Patient Enrollment per Trial by Molecular Target and Stage of Development 67

5.3 Clinical Trial Duration 68

5.3.1 Trial Duration by Molecule Type and Stage of Development 68

5.3.2 Trial Duration by Molecular Target and Stage of Development 69

5.4 Summary of Clinical Trial Metrics 70

6 Multi-scenario Forecast 72

6.1 Overview 72

6.2 Asia-Pacific Market 72

6.3 India 74

6.3.1 Treatment Usage Patterns 74

6.3.2 Annual Cost of Therapy 75

6.3.3 Market Size 77

6.4 China 78

6.4.1 Treatment Usage Patterns 78

6.4.2 Annual Cost of Therapy 79

6.4.3 Market Size 80

6.5 Australia 81

6.5.1 Treatment Usage Patterns 81

6.5.2 Annual Cost of Therapy 81

6.5.3 Market Size 82

6.6 South Korea 83

6.6.1 Treatment Usage Patterns 83

6.6.2 Annual Cost of Therapy 84

6.6.3 Market Size 86

6.7 Japan 87

6.7.1 Treatment Usage Patterns 87

6.7.2 Annual Cost of Therapy 88

6.7.3 Market Size 89

7 Drivers and Barriers 90

7.1 Drivers 90

7.1.1 Increasing Elderly Population and Incidence of CRC 90

7.1.2 Increasing Screening Programs and Approval of New Screening Tests for CRC to Drive Early Diagnosis Rate 90

7.1.3 Increase in Mutation Testing to Drive Market Growth 90

7.1.4 Availability of Novel First-, Second- and third-Line Therapy Options in Pipeline 90

7.1.5 Diversified Healthcare Reform to Boost Market Growth 91

7.1.6 Diversified Health Insurance System to Help Nurture Growth 91

7.2 Barriers 92

7.2.1 Patent Expiration of Branded Therapies to Affect CRC Market Growth 92

7.2.2 High Prices of Therapeutics to Slow Down Market Growth 92

7.2.3 Limited Incorporation of Immunotherapies in the CRC Treatment Algorithm 92

7.2.4 Lack of Development of Neoadjuvant and Adjuvant Pipeline Products 92

7.2.5 Lack of Reimbursement and Penetration of Generic Drugs to Hinder Market Growth in China and India 93

7.2.6 Drug Pricing Reforms 93

8 Deals and Strategic Consolidations 94

8.1 Licensing Deals 94

8.1.1 Deals by Region and Value 94

8.1.2 Number of Disclosed and Undisclosed Deals by Year, Aggregate Deal Value 95

8.1.3 Deal Value by Stage of Development, Molecule Type, and Molecular Target 96

8.1.4 Key Licensing Deals 99

8.2 Co-development Deals 101

8.2.1 Deals by Region and Value 101

8.2.2 Number of Disclosed and Undisclosed Deals by Year, Aggregate Deal Value 102

8.2.3 Deal Value by Stage of Development, Molecule Type, and Molecular Target 103

8.2.4 Key Co-development Deals 106

9 Appendix 108

9.1 All Pipeline Drugs by Stage of Development 108

9.1.1 Discovery 108

9.1.2 Preclinical 110

9.1.3 Investigational New Drug/Clinical Trial Authorization-Filed 115

9.1.4 Phase I 115

9.1.5 Phase II 119

9.1.6 Phase III 123

9.1.7 Pre-registration 123

9.2 Summary of Multi-scenario Market Forecasts to 2023 124

9.2.1 Asia-Pacific 124

9.2.2 India 124

9.2.3 China 124

9.2.4 Australia 125

9.2.5 South Korea 125

9.2.6 Japan 125

9.3 Bibliography 126

9.4 Abbreviations 136

9.5 Research Methodology 139

9.5.1 Secondary Research 140

9.5.2 Marketed Product Profiles 140

9.5.3 Late-Stage Pipeline Candidates 140

9.5.4 Comparative Efficacy and Safety Heat Map for Marketed and Pipeline Products 140

9.5.5 Product Competitiveness Framework 141

9.5.6 Pipeline Analysis 141

9.5.7 Forecasting Model 142

9.5.8 Deals Data Analysis 143

9.6 Contact Us 143

9.7 Disclaimer 143

List of Tables

1.1 List of Tables

Table 1: CRC Therapeutics Market, Symptoms of CRC 12

Table 2: CRC Therapeutics Market, Stage Definitions for CRC 18

Table 3: CRC Therapeutics Market, Prognosis for CRC 20

Table 4 CRC Therapeutics, Surgical Options for CRC 20

Table 5: CRC Therapeutics Market, Global, Licensing Deals Valued $10m and Above, 2006-2017 101

Table 6: CRC Therapeutics Market, Global, Co-development Deals Value, 2006-2016 107

Table 7: CRC Therapeutics Market, Global, All Pipeline Products, Discovery, 2017 108

Table 8: CRC Therapeutics Market, Global, All Pipeline Products, Preclinical, 2017 110

Table 9: CRC Therapeutics Market, Global, All Pipeline Products, IND/CTA-Filed, 2017 115

Table 10: CRC Therapeutics Market, Global, All Pipeline Products, Phase I, 2017 115

Table 11: CRC Therapeutics Market, Global, All Pipeline Products, Phase II, 2017 119

Table 12: CRC Therapeutics Market, Global, All Pipeline Products, Phase III, 2017 123

Table 13: CRC Therapeutics Market, Global, All Pipeline Products, Pre-registration, 2017 123

Table 14: CRC Therapeutics Market, APAC, Market Forecast, 2016-2023 124

Table 15: CRC Therapeutics Market, India, Market Forecast, 2016-2023 124

Table 16: CRC Therapeutics Market, China, Market Forecast, 2016-2023 124

Table 17: CRC Therapeutics Market, Australia, Market Forecast, 2016-2023 125

Table 18: CRC Therapeutics Market, South Korea, Market Forecast, 2016-2023 125

Table 19: CRC Therapeutics Market, Japan, Market Forecast, 2016-2023 125

List of Figures

1.2 List of Figures

Figure 1: CRC Therapeutics Market, Australia, Age-Specific Incidence and Mortality Rate (per 100,000) in 2013 11

Figure 2: CRC Therapeutics, Treatment Algorithm for mCRC 24

Figure 3: CRC Therapeutics Market, Comparative Efficacy and Safety Heatmap for Marketed Products 39

Figure 4: CRC Therapeutics Market, Global, Pipeline, 2017 42

Figure 5: CRC Therapeutics Market, Global, Pipeline by Molecular Target, 2017 44

Figure 6: CRC Therapeutics Market, Pipeline by Molecular Target and Stage of Development, 2017 45

Figure 7: CRC Therapeutics Market, APAC, Keytruda Forecast ($m), 2021-2023 47

Figure 8: CRC Therapeutics Market, APAC, Tecentriq plus Cotellic Forecast ($m), 2021-2023 48

Figure 9: CRC Therapeutics Market, APAC, Napabucasin Forecast ($m), 2021-2023 50

Figure 10: CRC Therapeutics Market, APAC, Encorafenib plus Binimetinib Forecast ($m), 2021-2023 52

Figure 11: CRC Therapeutics Market, APAC, Masitinib Forecast ($m), 2019-2023 53

Figure 12: CRC Therapeutics Market, APAC, Fruquintinib Forecast ($m), 2018-2023 55

Figure 13: CRC Therapeutics Market, APAC, Famitinib Forecast ($m), 2019-2023 56

Figure 14: CRC Therapeutics Market, APAC, Anlotinib Forecast ($m), 2020-2023 57

Figure 15: CRC Therapeutics Market, APAC, Donafenib Forecast ($m), 2021-2023 58

Figure 16: CRC Therapeutics Market, Comparative Efficacy and Safety Heatmap for Pipeline Products 58

Figure 17: CRC Therapeutics Market, Competitor Matrix for CRC Marketed and Pipeline First-Line Products, 2017 60

Figure 18: CRC Therapeutics, Global, Average Clinical Trial Failure Rate (%), 2006-2016 62

Figure 19: CRC Therapeutics, Global, Clinical Trial Failure Rates by Molecule Type (%), 2006-2016 63

Figure 20: CRC Therapeutics, Global, Clinical Trial Failure Rates by Molecular Target (%), 2006-2016 64

Figure 21: CRC Therapeutics, Global, Clinical Trial Size per Product by Molecule Type (participants), 2006-2016 65

Figure 22: CRC Therapeutics, Global, Clinical Trial Size per Product by Molecular Target (participants), 2006-2016 66

Figure 23: CRC Therapeutics, Global, Clinical Trial Size per Trial by Molecule Type (participants), 2006-2016 67

Figure 24: CRC Therapeutics, Global, Clinical Trial Size per Trial by Molecular Target (participants), 2006-2016 68

Figure 25: CRC Therapeutics, Global, Clinical Trial Duration by Molecule Type (months), 2006-2016 69

Figure 26: CRC Therapeutics, Global, Clinical Trial Duration by Molecular Target (months), 2006-2016 70

Figure 27: CRC Therapeutics Market, Global, Comparison of Average Trial Metrics by Phase and Molecule Type 71

Figure 28: CRC Therapeutics Market, Global, Comparison of Average Trial Metrics by Phase and Molecular Target 71

Figure 29: CRC Therapeutics Market, APAC, Treatment Patterns (‘000), 2016-2023 73

Figure 30: CRC Therapeutics Market, APAC, Market Size ($bn), 2016-2023 74

Figure 31: CRC Therapeutics Market, India, Treatment Patterns (‘000), 2016-2023 75

Figure 32: CRC Therapeutics Market, India, Annual Cost of Therapy ($), 2016-2023 76

Figure 33: CRC Therapeutics Market, India, Market Size ($m), 2016-2023 77

Figure 34: CRC Therapeutics Market, China, Treatment Patterns (‘000), 2016-2023 78

Figure 35: CRC Therapeutics Market, China, Annual Cost of Therapy ($), 2016-2023 79

Figure 36: CRC Therapeutics Market, China, Market Size ($bn), 2016-2023 80

Figure 37: CRC Therapeutics Market, Australia, Treatment Patterns (‘000), 2016-2023 81

Figure 38: CRC Therapeutics Market, Australia, Annual Cost of Therapy ($), 2016-2023 82

Figure 39: CRC Therapeutics Market, Australia, Market Size ($m), 2016-2023 83

Figure 40: CRC Therapeutics Market, South Korea, Treatment Patterns (‘000), 2016-2023 84

Figure 41: CRC Therapeutics Market, South Korea, Annual Cost of Therapy ($), 2016-2023 85

Figure 42: CRC Therapeutics Market, South Korea, Market Size ($m), 2016-2023 86

Figure 43: CRC Therapeutics Market, Japan, Treatment Patterns (‘000), 2016-2023 87

Figure 44: CRC Therapeutics Market, Japan, Annual Cost of Therapy ($), 2016-2023 88

Figure 45: CRC Therapeutics Market, Japan, Market Size ($bn), 2016-2023 89

Figure 46: CRC Therapeutics Market, Global, Licensing Deals by Region and Value, 2006-2017 95

Figure 47: CRC Therapeutics Market, Global, Number of Disclosed and Undisclosed Licensing Deals by Year, Aggregate Deal Value and Aggregate Upfront Payment Value, 2006-2017 96

Figure 48: CRC Therapeutics Market, Global, Licensing Deals by Stage of Development, Deal Value and Upfront Payment Value, 2006-2017 97

Figure 49: CRC Therapeutics Market, Global, Licensing Deals by Molecule Type and Stage of Development, 2006-2017 98

Figure 50: CRC Therapeutics, Global, Licensing Deals by Molecular Targets and Aggregate Deal Value ($), 2006-2017 99

Figure 51: CRC Therapeutics Market, Global, Co-development Deals by Region and Deal Value, 2006-2017 102

Figure 52: CRC Therapeutics Market, Global, Number of Disclosed and Undisclosed Co-development Deals by Year, Aggregate Deal Value and Aggregate Upfront Payment Value, 2006-2017 103

Figure 53: CRC Therapeutics Market, Global, Co-development Deals by Stage of Development, Deal Value and Upfront Payment Value, 2006-2017 104

Figure 54: CRC Therapeutics Market, Global, Co-development Deals by Molecule type and Stage of Development, 2006-2016 105

Figure 55: CRC Therapeutics Market, Global, Co-development Deals by Molecular Target, 2006-2016 106

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