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Colorectal Cancer Therapeutics in Major Developed Markets to 2020-Increased Uptake of High Priced Drugs to Offset the Impact of Generics

Colorectal Cancer Therapeutics in Major Developed Markets to 2020-Increased Uptake of High Priced Drugs to Offset the Impact of Generics


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Executive Summary

Colorectal Cancer Therapeutics in Major Developed Markets to 2020-Increased Uptake of High Priced Drugs to Offset the Impact of Generics

GBI Research, the leading business intelligence provider, has released its latest research, "Colorectal Cancer Therapeutics in Major Developed Markets to 2020-Increased Uptake of High Priced Drugs to Offset the Impact of Generics", which provides in-depth analysis of the Colorectal Cancer (CRC) therapeutics market in the eight major geographies of the US, Canada, the UK, France, Germany, Spain, Italy and Japan. The report provides an estimation of the market size for 2013, along with market forecast until 2020. It also covers disease epidemiology, treatment algorithms, treatment patterns, in-depth pipeline analysis, and deal analysis.

The CRC therapeutics market in the eight major markets is expected to grow at a Compound Annual Growth Rate (CAGR) of 1.8% to USD 9.4 billion by 2020. The US had the largest market share in 2013, equivalent to a global share of 44.1%, followed by Japan and Germany with 14.7% and 11.9% respectively. Spain had the lowest market share of the leading eight at 4.1%. All markets covered in the report are expected to witness a slower growth rate than Japan, which will grow at a CAGR of 5%. However, this moderate growth will be stymied by the expected uptake of lower-priced biosimilar versions of bevacizumab and cetuximab due to the expiration of the patents of Avastin and Erbitux in the latter half of the forecast period. Also expected is the launch of generic versions of capecitabine, which will also affect the market. However, this will be offset by the launch of premium-priced emerging therapies. Stivarga is expected to be one of the biggest drivers of growth in the CRC market, primarily due to its expected line extension in the first-line metastatic setting as a maintenance treatment for patients with resected liver metastases. The launch of Lonsurf (TAS-102), approved in Japan in 2014, in the third- and fourth-line settings will further increase the pharmacological treatment rates in these lines, which will give patients a more tolerable alternative to Stivarga. The moderate uptake of other late-stage pipeline products, panitumumab and Xilonix, following their expected approval, is expected to drive additional growth within this market.

The CRC pipeline is highly robust, with potential drug candidates across various Phases of clinical development. With nearly 400 active pipeline molecules, the majority of the investigational drug candidates are being evaluated for the treatment of CRC in advanced stages, either as first-line or second-line therapies. The current investigational pipeline candidates include new combination therapies and targeted therapies, as well as promising immunotherapies and chemotherapy drug candidates. As well as these active progressing pipeline molecules, the pipeline also includes nearly 180 molecules that are either inactive or discontinued.

Scope

The report analyzes treatment usage patterns, market characterization, the pipeline, and key licensing and co-development deals in the eight major markets: the US, the UK, France, Germany, Spain, Italy, Japan and Canada. It includes

A brief introduction to CRC, including the disease's pathogenesis, etiology, diagnosis and treatment algorithms

In-depth analysis of currently marketed drugs for CRC, examining their safety, efficacy, treatment patterns and strengths/weaknesses and including a heat map that compares the drugs in terms of safety and efficacy

A comprehensive review of the pipeline for CRC, including individual analysis of a number of late-stage pipeline drugs that are likely to enter the market during the forecast period; the pipeline is analyzed on the basis of Phase distribution, molecule type, program type, mechanism of action and molecular target

Additional in-depth analysis of pipeline drug clinical trials by Phase, trial size, trial duration and program failure rate for each molecule type

Multi-scenario forecast data of the market to 2020, taking into account how the market may be affected by the introduction of new drugs, the expiry of key patents on current drugs and the changes in disease epidemiology across the key developed markets

Discussion of the drivers of and barriers to market growth

In-depth analysis of all licensing and co-development deals that have occurred in the CRC market since 2006

Reasons To Buy

The report will enhance your decision-making capability by allowing you to

Understand the CRC pipeline and the factors that indicate that it is becoming more innovative

Examine detailed profiles of promising pipeline products and gain an insight into how they are likely to compete in the market and who their main competitors will be

Follow the trends in CRC clinical trial size and duration in relation to industry averages and assess the potential risk of future developmental programs according to mechanism of action by considering the recorded clinical trial failure rates

Observe the potential growth patterns expected for the CRC market over the forecast period, identify which countries are expected to make the biggest contribution to this growth, and devise a more effective country strategy through an understanding of key drivers and barriers in the CRC market

Accelerate and strengthen your market position by identifying key companies for strategic partnerships

1 Table of Contents

1 Table of Contents 5

1.1 List of Tables 7

1.2 List of Figures 8

2 Introduction 9

2.1 Colorectal Cancer 9

2.2 Symptoms 9

2.3 Epidemiology 9

2.4 Pathophysiology 10

2.4.1 Histology 10

2.4.2 Genetic Basis 10

2.4.3 Etiology of Colorectal Cancer 10

2.5 Diagnosis 12

2.5.1 Digital Rectal Examination 12

2.5.2 Fecal Occult Blood Test 12

2.5.3 Flexible Sigmoidoscopy 12

2.5.4 Colonoscopy 13

2.5.5 Virtual Colonoscopy 13

2.5.6 Double Contrast Barium Enema 13

2.6 Prognosis and Disease Staging 14

2.7 Treatment Options 15

2.7.1 Surgery and Radiation Therapy 16

2.7.2 Chemotherapy 16

2.7.3 Targeted Therapies 16

2.7.4 Resistance to Pharmacological Therapies 17

2.7.5 Treatment Guidelines 18

3 Marketed Products 22

3.1 Key Marketed Products 22

3.1.1 Immunotherapies 22

3.1.2 Targeted Therapies 25

3.1.3 Hyperthermic Intraperitoneal Chemotherapy 30

3.2 Heat Map for Marketed Products 31

4 Pipeline Analysis 33

4.1 Overall Pipeline 33

4.2 Pipeline Analysis by Molecule Type 34

4.3 Pipeline Analysis by Mechanism of Action 35

4.4 Clinical Trials 37

4.5 Failure Rate 37

4.6 Clinical Trial Size 39

4.7 Duration 41

4.8 Promising Drug Candidates in Pipeline 43

4.8.1 Lonsurf (TAS-102 (tipiracil + trifluridine)-Taiho Pharmaceutical 43

4.8.2 Cyramza-ramucirumab-Eli Lilly and Company 43

4.8.3 TS-1/Teysuno (tegafur + gimeracil + oteracil)-Taiho Pharmaceutical 44

4.8.4 CPP-1X (eflornithine hydrochloride) + sulindac-Cancer Prevention Pharmaceuticals 45

4.8.5 MelCancerVac-DanDrit Biotech 46

4.8.6 Xilonix-XBiotech 47

4.8.7 Nintedanib-Boehringer Ingelheim 47

5 Market Forecast to 2020 49

5.1 Global Market 49

5.1.1 Treatment Use Patterns 49

5.1.2 Market Size 49

5.2 North America 50

5.2.1 Treatment Use Patterns 50

5.2.2 Annual Cost of Therapy 51

5.2.3 Market Size 52

5.3 Top Five European Markets 53

5.3.1 Treatment Use Patterns 53

5.3.2 Annual Cost of Therapy 55

5.3.3 Market Size 56

5.4 Japan 57

5.4.1 Treatment Use Patterns 57

5.4.2 Annual Cost of Therapy 58

5.4.3 Market Size 59

5.5 Drivers and Barriers for the Colorectal Cancer Therapeutics in Major Developed Markets to 2020 60

5.5.1 Drivers 60

5.5.2 Barriers 61

6 Deals and Strategic Consolidations 63

6.1 Licensing Agreements 63

6.1.1 Major Licensing Deals 64

6.2 Co-development Agreements 65

6.2.1 Major Co-development Agreements 67

7 Appendix 68

7.1 All Pipeline Drugs by Phase 68

7.1.1 Discovery 68

7.1.2 Preclinical 70

7.1.3 IND/CTA-Filed 75

7.1.4 Phase I 75

7.1.5 Phase II 80

7.1.6 Phase III 86

7.2 Market Forecasts to 2020 87

7.2.1 Global 87

7.2.2 US 87

7.2.3 Canada 88

7.2.4 UK 88

7.2.5 France 88

7.2.6 Germany 89

7.2.7 Italy 89

7.2.8 Spain 89

7.2.9 Japan 90

7.3 Market Definitions 90

7.4 Abbreviations 91

7.5 References 94

7.6 References for Heat Map 99

7.7 Research Methodology 100

7.7.1 Coverage 100

7.7.2 Secondary Research 100

7.7.3 Primary Research 101

7.7.4 Therapeutic Landscape 101

7.7.5 Geographical Landscape 104

7.7.6 Pipeline Analysis 104

7.8 Expert Panel Validation 104

7.9 Contact Us 104

7.10 Disclaimer 104

1.1 List of Tables

Table 1 Colorectal Cancer Therapeutics, Global, TNM Staging, 2013 15

Table 2 Surgical Options for Colorectal Cancer 16

Table 3 Colorectal Cancer Therapeutics, Global, All Pipeline Products (Discovery), 2014 68

Table 4 Colorectal Cancer Therapeutics, Global, All Pipeline Products (Preclinical), 2014 70

Table 5 Colorectal Cancer Therapeutics, Global, All Pipeline Products (IND/CTA-Filed), 2014 75

Table 6 Colorectal Cancer Therapeutics, Global, All Pipeline Products (Phase I), 2014 75

Table 7 Colorectal Cancer Therapeutics, Global, All Pipeline Products (Phase II), 2014 80

Table 8 Colorectal Cancer Therapeutics, Global, All Pipeline Products (Phase III), 2014 86

Table 9: Colorectal Cancer Therapeutics, Global, Forecast Data, 2013-2020 87

Table 10: Colorectal Cancer Therapeutics, US, Forecast Data, 2013-2020 87

Table 11: Colorectal Cancer Therapeutics, Canada, Forecast Data, 2013-2020 88

Table 12: Colorectal Cancer Therapeutics, UK, Forecast Data, 2013-2020 88

Table 13: Colorectal Cancer Therapeutics, France, Forecast Data, 2013-2020 88

Table 14: Colorectal Cancer Therapeutics, Germany, Forecast Data, 2013-2020 89

Table 15: Colorectal Cancer Therapeutics, Italy, Forecast Data, 2013-2020 89

Table 16: Colorectal Cancer Therapeutics, Spain, Forecast Data, 2013-2020 89

Table 17: Colorectal Cancer Therapeutics, Japan, Forecast Data, 2013-2020 90

Table 18: Colorectal Cancer Market, References for Heat Map 99

1.2 List of Figures

Figure 1: Colorectal Cancer Therapeutics, Global, European Society for Medical Oncology Treatment Guidelines (Colorectal Cancer at Stage I to III) 18

Figure 2: Colorectal Cancer Therapeutics, Global, European Society for Medical Oncology Treatment Guidelines (Colorectal Cancer at Stage IV) 19

Figure 3: Colorectal Cancer Therapeutics, Global, Heat Map (Marketed Products) 32

Figure 4: Colorectal Cancer Therapeutics, Global, Pipeline by Stage of Development and Program Type, 2014 33

Figure 5: Colorectal Cancer Therapeutics, Global, Pipeline by Molecule Type and Stage of Development, 2014 34

Figure 6: Colorectal Cancer Therapeutics, Global, Pipeline by Mechanism of Action and Stage of Development, 2014 36

Figure 7: Colorectal Cancer Therapeutics, Global, Clinical Trial Failure Rate (%), 2014 38

Figure 8: Colorectal Cancer Therapeutics, Global, Clinical Trial Size, 2014 40

Figure 9: Colorectal Cancer Therapeutics, Global, Clinical Trial Duration (months), 2014 42

Figure 10: Colorectal Cancer Therapeutics, Global, Treatment Use Patterns ('000) and Market Size (USD bn), 2013-2020 50

Figure 11: Colorectal Cancer Therapeutics, US and Canada, Treatment Use Patterns ('000), 2013-2020 51

Figure 12: Colorectal Cancer Therapeutics, US and Canada, Annual Cost of Therapy (USD ), 2013-2020 52

Figure 13: Colorectal Cancer Therapeutics, US and Canada, Market Size (USD m), 2013-2020 53

Figure 14: Colorectal Cancer Therapeutics, Top Five European Markets, Treatment Use Patterns ('000), 2013-2020 54

Figure 15: Colorectal Cancer Therapeutics, Top Five European Markets, Annual Cost of Therapy (USD ), 2013-2020 55

Figure 16: Colorectal Cancer Therapeutics, Top Five European Markets, Market Size (USD m), 2013-2020 57

Figure 17: Colorectal Cancer Therapeutics, Japan, Treatment Use Pattern, 2013-2020 58

Figure 18: Colorectal Cancer Therapeutics, Japan, Annual Cost of Therapy, 2013-2020 59

Figure 19: Colorectal Cancer Therapeutics, Japan, Market Size (USD m), 2013-2020 60

Figure 20: Colorectal Cancer Therapeutics, Global, Licensing Deals by Geography, 2006-2014 63

Figure 21: Colorectal Cancer Therapeutics, Global, Licensing Deals by Phase, Value, Mechanism of Action, 2006-2014 64

Figure 22: Colorectal Cancer Market, Global, Co-development Deals by Geography and by Value, 2006-2014 66

Figure 23: GBI Research Market Forecasting Model 103

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