Colorectal Cancer Therapeutics in Asia-Pacific Markets to 2024 – 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. The five-year prevalence population for CRC in Asia-Pacific was 1.7 million in 2017. This figure has been gradually rising 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 2024, growing from $5.3 billion in 2017 at a CAGR of 6%.

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

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

– The CRC 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 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 $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 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 13

2.4.1 Etiology 13

2.4.2 Pathophysiology 14

2.4.3 Biomarkers/Targets of Interest 14

2.5 Diagnosis 16

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 18

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 24

3 Marketed Products 27

3.1 Overview 27

3.2 Chemotherapies 27

3.2.1 Lonsurf (Trifluridine plus Tipiracil) - Taiho Pharma 28

3.2.2 TS-1 (Tegafur plus Gimeracil plus Oteracil) - Taiho Pharma 29

3.2.3 UFT (tegafur plus uracil) - Merck KGaA 30

3.3 Epidermal Growth Factor Receptor Targeted Therapies 31

3.3.1 Erbitux (cetuximab) - Eli Lilly/Merck KGaA 31

3.3.2 Vectibix (panitumumab) - Amgen/Takeda 33

3.4 Anti-angiogenesis Therapies 35

3.4.1 Avastin (bevacizumab) - Roche 36

3.4.2 Cyramza (ramucirumab) - Eli Lilly 38

3.4.3 Zaltrap (Ziv-Aflibercept) - Sanofi/Regeneron 39

3.5 Kinase Inhibitors 40

3.5.1 Stivarga (regorafenib) - Bayer/Onyx 40

3.6 Comparative Efficacy and Safety of Marketed Products 41

4 Pipeline Analysis 44

4.1 Overview 44

4.2 Pipeline by Stage of Development, Molecule Type, Route of Administration and Program Type 44

4.3 Pipeline by Molecular Target 47

4.4 Promising Pipeline Candidates 49

4.4.1 Keytruda (pembrolizumab) - Merck & Co. 49

4.4.2 Opdivo (nivolumab) - Bristol-Myers Squib 51

4.4.3 Napabucasin (BBI-608) - Sumitomo Dainippon Pharma 53

4.4.4 Encorafenib plus binimetinib (LGX-818/MEK-162) - Array BioPharma 55

4.4.5 Fruquintinib (HMPL-013) - Hutchison MediPharma 57

4.4.6 Famitinib (SHR-1020) - Jiangsu Hengrui Medicine 58

4.4.7 Anlotinib (AL-3818) - Jiangsu Chia-Tai Tianqing 59

4.4.8 Donafenib (CM-4307) - Suzhou Zelgen Biopharmaceuticals 60

4.5 Comparative Efficacy and Safety of Pipeline Products 61

4.6 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 66

5.1.3 Failure Rate by Phase and Molecular Target 67

5.2 Clinical Trial Size 68

5.2.1 Patient Enrollment per Product by Molecule Type and Stage of Development 68

5.2.2 Patient Enrollment per Product by Molecular Target and Stage of Development 69

5.2.3 Patient Enrollment per Trial by Molecule Type and Stage of Development 69

5.2.4 Patient Enrollment per Trial by Molecular Target and Stage of Development 71

5.3 Clinical Trial Duration 71

5.3.1 Trial Duration by Molecule Type and Stage of Development 72

5.3.2 Trial Duration by Molecular Target and Stage of Development 73

5.4 Summary of Clinical Trial Metrics 74

6 Multi-scenario Forecast 75

6.1 Overview 75

6.2 Asia-Pacific Market 75

6.3 India 77

6.3.1 Treatment Usage Patterns 77

6.3.2 Annual Cost of Therapy 77

6.3.3 Market Size 79

6.4 China 80

6.4.1 Treatment Usage Patterns 80

6.4.2 Annual Cost of Therapy 81

6.4.3 Market Size 82

6.5 Australia 83

6.5.1 Treatment Usage Patterns 83

6.5.2 Annual Cost of Therapy 84

6.5.3 Market Size 84

6.6 South Korea 86

6.6.1 Treatment Usage Patterns 86

6.6.2 Annual Cost of Therapy 87

6.6.3 Market Size 88

6.7 Japan 89

6.7.1 Treatment Usage Patterns 89

6.7.2 Annual Cost of Therapy 89

6.7.3 Market Size 90

7 Drivers and Barriers 92

7.1 Drivers 92

7.1.1 Increasing Elderly Population and Incidence of CRC 92

7.1.2 Increasing Screening Programs and Approval of New Screening Tests for CRC to Drive Early Diagnosis Rate 92

7.1.3 Increase in Mutation Testing to Drive Market Growth 92

7.1.4 Availability of Novel First-, Second- and Third-Line Therapy Options in Pipeline 92

7.1.5 Diversified Healthcare Reform to Boost Market Growth 93

7.1.6 Diversified Health Insurance System to Help Nurture Growth 93

7.2 Barriers 94

7.2.1 Patent Expiration of Branded Therapies to Affect CRC Market Growth 94

7.2.2 High Prices of Therapeutics to Slow Down Market Growth 94

7.2.3 Limited Incorporation of Immunotherapies in the CRC Treatment Algorithm 94

7.2.4 Lack of Development of Neoadjuvant and Adjuvant Pipeline Products 94

7.2.5 Lack of Reimbursement and Penetration of Generic Drugs to Hinder Market Growth in China and India 95

7.2.6 Drug Pricing Reforms 95

8 Deals and Strategic Consolidations 96

8.1 Licensing Deals 96

8.1.1 Deals by Region and Value 96

8.1.2 Number of Disclosed and Undisclosed Deals by Year, Aggregate Deal Value 97

8.1.3 Deal Value by Stage of Development, Molecule Type, and Molecular Target 98

8.1.4 Key Licensing Deals 100

8.2 Co-development Deals 103

8.2.1 Deals by Region and Value 103

8.2.2 Number of Disclosed and Undisclosed Deals by Year, Aggregate Deal Value 104

8.2.3 Deal Value by Stage of Development, Molecule Type, and Molecular Target 105

8.2.4 Key Co-development Deals 107

9 Appendix 110

9.1 All Pipeline Drugs by Stage of Development 110

9.1.1 Discovery 110

9.1.2 Preclinical 111

9.1.3 Investigational New Drug/Clinical Trial Authorization-Filed 119

9.1.4 Phase I 120

9.1.5 Phase II 125

9.1.6 Phase III 130

9.1.7 Pre-registration 131

9.2 Summary of Multi-scenario Market Forecasts to 2024 131

9.2.1 Asia-Pacific 131

9.2.2 India 131

9.2.3 China 132

9.2.4 Australia 132

9.2.5 South Korea 133

9.2.6 Japan 133

9.3 Bibliography 134

9.4 Abbreviations 145

9.5 Research Methodology 148

9.5.1 Secondary Research 149

9.5.2 Marketed Product Profiles 149

9.5.3 Late-Stage Pipeline Candidates 149

9.5.4 Comparative Efficacy and Safety Heat Map for Marketed and Pipeline Products 149

9.5.5 Product Competitiveness Framework 149

9.5.6 Pipeline Analysis 150

9.5.7 Forecasting Model 150

9.5.8 Deals Data Analysis 151

9.6 Contact Us 152

9.7 Disclaimer 152

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, 2007-2018 102

Table 6: CRC Therapeutics Market, Global, Co-development Deals Value, 2007-2018 109

Table 7: CRC Therapeutics Market, Global, All Pipeline Products, Discovery, 2018 110

Table 8: CRC Therapeutics Market, Global, All Pipeline Products, Preclinical, 2018 111

Table 9: CRC Therapeutics Market, Global, All Pipeline Products, IND/CTA-Filed, 2018 119

Table 10: CRC Therapeutics Market, Global, All Pipeline Products, Phase I, 2018 120

Table 11: CRC Therapeutics Market, Global, All Pipeline Products, Phase II, 2018 125

Table 12: CRC Therapeutics Market, Global, All Pipeline Products, Phase III, 2018 130

Table 13: CRC Therapeutics Market, Global, All Pipeline Products, Pre-registration, 2018 131

Table 14: CRC Therapeutics Market, APAC, Market Forecast, 2017-2024 131

Table 15: CRC Therapeutics Market, India, Market Forecast, 2017-2024 131

Table 16: CRC Therapeutics Market, China, Market Forecast, 2017-2024 132

Table 17: CRC Therapeutics Market, Australia, Market Forecast, 2017-2024 132

Table 18: CRC Therapeutics Market, South Korea, Market Forecast, 2017-2024 133

Table 19: CRC Therapeutics Market, Japan, Market Forecast, 2017-2024 133

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 25

Figure 3: CRC Therapeutics Market, Comparative Efficacy and Safety Heatmap for Marketed Products, 2018 41

Figure 4: CRC Therapeutics Market, Comparative Efficacy and Safety Heatmap for First-line Marketed Products, 2018 42

Figure 5: CRC Therapeutics Market, Comparative Efficacy and Safety Heatmap for Second-line Marketed Products, 2018 43

Figure 6: CRC Therapeutics Market, Comparative Efficacy and Safety Heatmap for Third or Fourth-line Marketed Products, 2018 43

Figure 7: CRC Therapeutics Market, Global, Pipeline, 2018 46

Figure 8: CRC Therapeutics Market, Global, Pipeline by Molecular Target, 2018 48

Figure 9: CRC Therapeutics Market, Pipeline by Molecular Target and Stage of Development, 2018 49

Figure 10: CRC Therapeutics Market, APAC, Keytruda Forecast ($m), 2020-2024 51

Figure 11: CRC Therapeutics Market, APAC, Opdivo Forecast ($m), 2023-2024 53

Figure 12: CRC Therapeutics Market, APAC, Napabucasin Forecast ($m), 2022-2024 55

Figure 13: CRC Therapeutics Market, APAC, Encorafenib plus Binimetinib Forecast ($m), 2021-2024 57

Figure 14: CRC Therapeutics Market, APAC, Fruquintinib Forecast ($m), 2018-2024 58

Figure 15: CRC Therapeutics Market, APAC, Famitinib Forecast ($m), 2021-2024 59

Figure 16: CRC Therapeutics Market, APAC, Anlotinib Forecast ($m), 2020-2024 60

Figure 17: CRC Therapeutics Market, APAC, Donafenib Forecast ($m), 2021-2024 61

Figure 18: CRC Therapeutics Market, Comparative Efficacy and Safety Heatmap for Pipeline Products, 2018 61

Figure 19: CRC Therapeutics Market, Competitor Matrix for CRC Marketed and Pipeline Products, 2018 63

Figure 20: CRC Therapeutics, Global, Average Clinical Trial Failure Rate (%), 2007-2017 65

Figure 21: CRC Therapeutics, Global, Clinical Trial Failure Rates by Molecule Type (%), 2007-2017 66

Figure 22: CRC Therapeutics, Global, Clinical Trial Failure Rates by Molecular Target (%), 2007-2017 67

Figure 23: CRC Therapeutics, Global, Clinical Trial Size per Product by Molecule Type (participants), 2007-2017 68

Figure 24: CRC Therapeutics, Global, Clinical Trial Size per Product by Molecular Target (participants), 2007-2017 69

Figure 25: CRC Therapeutics, Global, Clinical Trial Size per Trial by Molecule Type (participants), 2007-2017 70

Figure 26: CRC Therapeutics, Global, Clinical Trial Size per Trial by Molecular Target (participants), 2007-2017 71

Figure 27: CRC Therapeutics, Global, Clinical Trial Duration by Molecule Type (months), 2007-2017 72

Figure 28: CRC Therapeutics, Global, Clinical Trial Duration by Molecular Target (months), 2007-2017 73

Figure 29: CRC Therapeutics Market, Global, Comparison of Average Trial Metrics by Phase and Molecule Type 74

Figure 30: CRC Therapeutics Market, Global, Comparison of Average Trial Metrics by Phase and Molecular Target 74

Figure 31: CRC Therapeutics Market, APAC, Treatment Patterns (‘000), 2017-2024 76

Figure 32: CRC Therapeutics Market, APAC, Market Size ($bn), 2017-2024 76

Figure 33: CRC Therapeutics Market, India, Treatment Patterns (‘000), 2017-2024 77

Figure 34: CRC Therapeutics Market, India, Annual Cost of Therapy ($), 2017-2024 78

Figure 35: CRC Therapeutics Market, India, Market Size ($m), 2017-2024 79

Figure 36: CRC Therapeutics Market, China, Treatment Patterns (‘000), 2017-2024 80

Figure 37: CRC Therapeutics Market, China, Annual Cost of Therapy ($), 2017-2024 81

Figure 38: CRC Therapeutics Market, China, Market Size ($bn), 2017-2024 82

Figure 39: CRC Therapeutics Market, Australia, Treatment Patterns (‘000), 2017-2024 83

Figure 40: CRC Therapeutics Market, Australia, Annual Cost of Therapy ($), 2017-2024 84

Figure 41: CRC Therapeutics Market, Australia, Market Size ($m), 2017-2024 85

Figure 42: CRC Therapeutics Market, South Korea, Treatment Patterns (‘000), 2017-2024 86

Figure 43: CRC Therapeutics Market, South Korea, Annual Cost of Therapy ($), 2017-2024 87

Figure 44: CRC Therapeutics Market, South Korea, Market Size ($m), 2017-2024 88

Figure 45: CRC Therapeutics Market, Japan, Treatment Patterns (‘000), 2017-2024 89

Figure 46: CRC Therapeutics Market, Japan, Annual Cost of Therapy ($), 2017-2024 90

Figure 47: CRC Therapeutics Market, Japan, Market Size ($bn), 2017-2024 90

Figure 48: CRC Therapeutics Market, Global, Licensing Deals by Region and Value, 2007-2018 96

Figure 49: CRC Therapeutics Market, Global, Number of Disclosed and Undisclosed Licensing Deals by Year, Aggregate Deal Value and Aggregate Upfront Payment Value, 2007-2018 97

Figure 50: CRC Therapeutics Market, Global, Licensing Deals by Stage of Development, Deal Value and Upfront Payment Value, 2007-2018 98

Figure 51: CRC Therapeutics Market, Global, Licensing Deals by Molecule Type and Stage of Development, 2007-2018 99

Figure 52: CRC Therapeutics, Global, Licensing Deals by Molecular Targets and Aggregate Deal Value ($), 2007-2018 100

Figure 53: CRC Therapeutics Market, Global, Co-development Deals by Region and Deal Value, 2007-2018 103

Figure 54: CRC Therapeutics Market, Global, Number of Disclosed and Undisclosed Co-development Deals by Year, Aggregate Deal Value and Aggregate Upfront Payment Value, 2007-2018 104

Figure 55: CRC Therapeutics Market, Global, Co-development Deals by Stage of Development, Deal Value and Upfront Payment Value, 2007-2018 105

Figure 56: CRC Therapeutics Market, Global, Co-development Deals by Molecule type and Stage of Development, 2007-2018 106

Figure 57: CRC Therapeutics Market, Global, Co-development Deals by Molecular Target, 2007-2018 107

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