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Non-Small Cell Lung Cancer Therapeutics in Major Developed Markets to 2021

Non-Small Cell Lung Cancer Therapeutics in Major Developed Markets to 2021

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Executive Summary

Non-Small Cell Lung Cancer Therapeutics in Major Developed Markets to 2021-Emergence of Immunotherapies Drives Market Growth and Creates A Competitive Second-Line

Non-Small Cell Lung Cancer (NSCLC) is the second most common cancer globally, and the most common cause of cancer-related mortality. Such a poor outlook, particularly for patients with advanced disease, has created a pressing need for improved therapeutic options. The NSCLC market is undergoing a gradual change from a focus on generic chemotherapy regimens to complex treatment landscape based on different NSCLC subtypes and the presence of various molecular aberrations. In the current market, patients with non-squamous histology can be treated with more efficacious therapies such as Alimta (pemetrexed), while patients harboring activating mutations in EGFR or ALK can be prescribed targeted therapy. While the NSCLC developmental pipeline must aim to improve the outlook for all patients, there is currently a lack of options for patients with squamous cell histology or other detectable molecular characteristics besides EFGR and ALK mutations.


The NSCLC market will be valued at USD 10.9 billion in 2021, growing from USD 6.1 billion in 2014 at a CAGR of 8.5%

-How will immunotherapies such as Keytruda affect growth?

-What effect will patent expirations of Tarceva and Alimta have on market value?

The NSCLC pipeline is large and diverse, with an increased presence of mAbs and specific targeted therapies in contrast to the market

-What are the common targets and mechanisms of action of pipeline therapies?

-Will the pipeline address unmet needs such as a lack of treatments for squamous cell patients?

-What implications will the increased focus on targeted therapies have on the future of NSCLC treatment?

Numerous late-stage pipeline therapies with a strong clinical record have the potential to enter the market over the forecast period

-How have promising late-stage therapies performed in clinical trials?

-How would the approval of Rociletinib affect the competitive landscape?

-What is the individual commercial forecast for each therapy?

The market forecasts indicate that the US contributes the most to global market value due to a large treatment population and the high price of premium therapies.

-How will ACoT and market size vary between the eight major markets?

-How could a change in risk factors such as population age or smoking habits influence the market?

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

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 NSCLC 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 NSCLC 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, highlighting clinical performance, potential commercial positioning, and how they will compete with other therapies.

Predict NSCLC market growth in eight major markets with epidemiological and ACoT forecasts across the US, Canada, UK, France, Germany, Italy, Spain and Japan, as well as individual drug contributions to market growth.

Identify commercial opportunities in the NSCLC deals landscape by analyzing trends in licensing and co-development deals.

1 Table of Contents

1 Table of Contents 5

1.1 List of Tables 6

1.2 List of Figures 7

2 Introduction 8

2.1 Disease Introduction 8

2.2 Epidemiology 9

2.3 Etiology and Pathophysiology 9

2.3.1 Adenocarcinoma 11

2.3.2 Squamous Cell Carcinoma 13

2.3.3 Large Cell Carcinoma 15

2.3.4 Immunotherapy 16

2.4 Symptoms 17

2.5 Diagnosis 17

2.6 Prognosis 19

2.7 Treatment 20

2.7.1 Treatment Algorithm 21

2.7.2 First-Line Treatment 21

2.7.3 Maintenance Therapy 23

2.7.4 Second-Line Treatment 24

2.7.5 Third-Line Therapy 25

2.7.6 Adjuvant Therapy 25

2.8 Marketed Product Heatmaps 25

3 Marketed Products 29

3.1 Overview 29

3.2 Chemotherapies 29

3.3 Alimta-Eli Lilly 29

3.4 Abraxane-Celgene Corporation 30

3.5 Tarceva-Roche 31

3.6 Iressa-AstraZeneca 32

3.7 Gilotrif-Boehringer Ingelheim 33

3.8 Xalkori-Pfizer 34

3.9 Avastin-Roche 34

3.10 Cyramza-Eli Lilly 35

3.11 Opdivo-Bristol-Myers Squibb 36

3.12 Zykadia-Novartis 37

3.13 Alectinib-Roche 38

3.14 Conclusion 39

4 NSCLC Pipeline 40

4.1 Overview 40

4.2 Mechanisms of Action and Targets in the Pipeline 43

4.3 Clinical Trials 45

4.3.1 Failure rate 45

4.3.2 Clinical Trial Duration 48

4.3.3 Clinical Trial Size 50

4.3.4 Clinical Trial Summary 55

4.4 Late-Stage Pipeline Product Profiles 56

4.4.1 Ganetespib-Synta Pharmaceuticals 56

4.4.2 Yervoy-Bristol-Myers Squibb 57

4.4.3 Custirsen-Oncogenex Pharmaceuticals 59

4.4.4 Atezolizumab-Roche 60

4.4.5 Necitumumab-Eli Lilly 62

4.4.6 Patritumab-Daiichi Sankyo 63

4.4.7 Selumetinib-AstraZeneca 64

4.4.8 Rociletinib-Clovis Oncology 65

4.4.9 AZD-9291-AstraZeneca 67

4.4.10 Vaxira-Recombio 68

4.4.11 Keytruda-Merck 70

4.4.12 TG4010-Transgene 71

4.4.13 Veliparib-AbbVie 72

4.4.14 Abemaciclib-Eli Lilly 73

4.4.15 Bavituximab-Peregrine Pharmaceuticals 75

4.5 Pipeline Heatmaps and Product Competitiveness 76

4.5.1 Product Competitiveness Framework 79

4.6 Pipeline Conclusion 80

5 Market Forecast 81

5.1 Geographical Markets 81

5.1.1 Global Markets 82

5.1.2 North America 83

5.1.3 Top Five EU Countries 86

5.1.4 Japan 91

5.2 Drivers and Barriers 93

5.2.1 Drivers 93

5.2.2 Barriers 93

6 Strategic Consolidations 95

6.1 Major Licensing Deals 95

6.1.1 Boehringer Ingelheim Enters into Licensing Agreement with CureVac for CV9202 98

6.1.2 Novartis Enters into Licensing Agreement with Antisoma 98

6.1.3 Ariad Pharma Enters into a Collaboration Agreement with Merck 99

6.1.4 Astellas Pharma Enters into Licensing Agreement with AVEO Pharma for Tivozanib 99

6.2 Major Co-Development Deals 99

6.2.1 Pfizer Enters into Co-Development Agreement with Merck 102

6.2.2 Merck Enters into Co-Development Agreement with Endocyte 102

6.2.3 GlobeImmune Enters into Agreement with Celgene 103

6.2.4 Amgen Enters into Co-Development Agreement with Takeda Pharmaceutical 103

7 Appendix 104

7.1 References 104

7.2 Abbreviations 108

7.3 Research Methodology 109

7.3.1 Secondary Research 110

7.3.2 Marketed Product Profiles 110

7.3.3 Late-Stage Pipeline Candidates 110

7.3.4 Comparative Efficacy and Safety Heat Map for Marketed and Pipeline Products 111

7.3.5 Product Competitiveness Framework 111

7.3.6 Pipeline Analysis 111

7.3.7 Forecasting Model 112

7.3.8 Deals Data Analysis 113

7.4 Expert Panel Validation 113

7.5 Contact Us 113

7.6 Disclaimer 113

1.1 List of Tables

Table 1: NSCLC, Tumor Node Metastasis Classification, 2015 18

Table 2: NSCLC, Eastern Co-operative Oncology Group Criteria, 2015 19

Table 3: NSCLC, Treatment Options, 2015 21

1.2 List of Figures

Figure 1: NSCLC, Global, Molecular Characteristic Frequency (%) 10

Figure 2: NSCLC, Market Heatmap, First-Line Products 26

Figure 3: NSCLC, Market Heatmap, Maintenance Products 27

Figure 4: NSCLC, Market Heatmap, Second-Line Products 28

Figure 5: NSCLC, Pipeline Overview 42

Figure 6: NSCLC, Pipeline Molecular Targets 44

Figure 7: NSCLC, Pipeline by Molecular Target and Stage of Development 45

Figure 8: NSCLC, Clinical Trial Attrition Rates 46

Figure 9: NSCLC, Clinical Trial Attrition Rates by Molecule Type 47

Figure 10: NSCLC, Clinical Trial Attrition Rates by Molecular Target 48

Figure 11: NSCLC, Clinical Trial Duration by Molecule Type 49

Figure 12: NSCLC, Clinical Trial Duration by Molecular Target 50

Figure 13: NSCLC, Clinical Trial Size Per Product by Molecule Type 51

Figure 14: NSCLC, Clinical Trial Size Per Product Molecular Target 52

Figure 15: NSCLC, Clinical Trial Size Per Individual Trial by Molecule Type 53

Figure 16: NSCLC, Clinical Trial Size Per Individual Trial by Molecular Target 54

Figure 17: NSCLC, Comparison of Average Trial Metrics by Phase and Molecule Type 55

Figure 18: NSCLC, Comparison of Average Trial Metrics by Phase and Molecular Target 56

Figure 19: NSCLC, Ganetespib Revenue Forecast (USD m), 2017-2021 57

Figure 20: NSCLC, Yervoy Revenue Forecast (USD m), 2017-2021 59

Figure 21: NSCLC, Custirsen Revenue Forecast (USD m), 2018-2021 60

Figure 22: NSCLC, Atezolizumab Revenue Forecast (USD m), 2017-2021 61

Figure 23: NSCLC, Necitumumab Revenue Forecast (USD m), 2016-2021 63

Figure 24: NSCLC, Patritumab Revenue Forecast (USD m), 2020-2021 64

Figure 25: NSCLC, Selumetinib Revenue Forecast (USD m), 2019-2021 65

Figure 26: NSCLC, Rociletinib Revenue Forecast (USD m), 2017-2021 66

Figure 27: NSCLC, AZD-9291 Revenue Forecast (USD m), 2016-2021 68

Figure 28: NSCLC, Vaxira Revenue Forecast (USD m), 2018-2021 69

Figure 29: NSCLC, Keytruda Revenue Forecast (USD m), 2016-2021 71

Figure 30: NSCLC, TG4010 Revenue Forecast (USD m), 2020-2021 72

Figure 31: NSCLC, Veliparib Revenue Forecast (USD m), 2019-2021 73

Figure 32: NSCLC, Abemaciclib Revenue Forecast (USD m), 2018-2021 75

Figure 33: NSCLC, Bavituximab Revenue Forecast (USD m), 2019-2021 76

Figure 34: NSCLC, Pipeline Heatmap, First-Line Products 77

Figure 35: NSCLC, Pipeline Heatmap, Second-Line Products 78

Figure 36: NSCLC, Marketed and Pipeline Product Competitiveness Framework 79

Figure 37: NSCLC, Global Treatment Patterns, 2014-2021 82

Figure 38: NSCLC, Global Market Size (USD bn), 2014-2021 83

Figure 39: NSCLC, North America Treatment Usage Patterns, 2014-2021 84

Figure 40: NSCLC, North America, Annual Cost of Therapy, 2014-2021 85

Figure 41: NSCLC, North America, Market Size, 2014-2021 86

Figure 42: NSCLC, Top Five EU Countries, Treatment Usage Patterns, 2014-2021 87

Figure 43: NSCLC, Top Five EU Countries, Annual Cost of Therapy, 2014-2021 89

Figure 44: NSCLC, Top Five EU Countries, Market Size, 2014-2021 90

Figure 45: NSCLC, Japan, Treatment Usage Patterns, 2014-2021 91

Figure 46: NSCLC, Japan, Annual Cost of Therapy, 2014-2021 92

Figure 47: NSCLC, Japan, Market Size, 2014-2021 92

Figure 48: NSCLC, Licensing Deals by Territory, 2006-2015 95

Figure 49: NSCLC, Licensing Deals Overview, 2006-2015 96

Figure 50: NSCLC, Licensing Deals by Molecule Type, 2006-2015 97

Figure 51: NSCLC, Licensing Deals by Molecular Target, 2006-2015 98

Figure 52: NSCLC, Co-Development Deals by Territory, 2006-2015 100

Figure 53: NSCLC, Co-Development Deals Overview, 2006-2015 101

Figure 54: NSCLC Co-Development by Molecule Type, 2006-2015 101

Figure 55: NSCLC, Co-Development by Molecular Target, 2006-2015 102

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