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Non-Small Cell Lung Cancer Market to 2020 - New Therapies to Enhance Treatment Segmentation and Drive Growth in an Increasingly Competitive Market

Summary

GBI Research, a leading business intelligence provider, has released its latest research report, “Non-Small Cell Lung Cancer Market to 2020 - New Therapies to Enhance Treatment Segmentation and Drive Growth in an Increasingly Competitive Market”. The value of the Non-Small Cell Lung Cancer (NSCLC) market is expected to increase significantly over the forecast period across the leading eight developed nations, from $5.1 billion in 2013 to $7.9 billion in 2020. This equates to a Compound Annual Growth Rate (CAGR) of 6.6%. Growth will be driven by novel therapies entering the squamous cell carcinoma market segment, which is currently lacking effective treatment, unlike the non-squamous market segment.

The report focuses on the increasing differentiation between the three main NSCLC subtypes: squamous cell, adenocarcinoma, and large cell carcinoma. Common genetic and molecular aberrations within these histologies are being extensively researched and targeted by novel therapeutics and so the treatment algorithm between histological subtypes is forecast to become more differentiated over the forecast period. Most notably, patients with squamous cell carcinoma are set to benefit from crucial first- and second-line therapies in the form of Yervoy (ipilimumab) and nivolumab, having relied on generic chemotherapy for the past decade. Non-squamous patients, on the other hand, have several successful histology-specific therapies, such as Alimta (pemetrexed), and mutation-specific therapies, such as Tarceva (erlotinib), that are already marketed. New second-line entrants will create a crowded and competitive environment. The generic erosion of market leaders Alimta and Tarceva late in the forecast period will make this a tough environment for new products that have shown only minor improvements in safety or efficacy.

Despite the potential of targeted therapies and the identification of several promising molecular targets, the development of these products remains in the early-stage pipeline. Epidermal Growth Factor Receptor (EGFR) and Anaplastic Lymphoma Kinase (ALK) mutations are likely to remain the only identified intracellular molecular aberrations targeted by marketed products, both of which are mainly found in adenocarcinoma tumors. Instead, the late-stage pipeline is primarily occupied by immunotherapies, which still offer a greater degree of specificity than chemotherapies; however, they initiate tumor destruction via the immune system. Necitumumab, Yervoy and nivolumab are all Phase III immunotherapies expected to reach the market in the forecast period, each with a different target.

Resistance to targeted therapies is a significant issue in the NSCLC market as the onset of acquired resistance to therapies such as Tarceva or Xalkori (crizotinib) has greatly reduced their potential. Despite the limited late-stage pipeline activity with new molecular targets, there are new drugs targeting EGFR and ALK that may combat resistance, thereby increasing the time frame in which patients are treatable with targeted therapy. Gilotrif (afatinib) is a recently launched EGFR inhibitor with a novel mechanism of action that may delay the onset of resistance, and Zykadia (LDK378) is an ALK inhibitor in the late-stage pipeline that is set to treat Xalkori-resistant patients.

Scope

The report assesses the current NSCLC market and predicts market trends to 2020, analyzing key drivers and barriers.The areas covered include -
- A disease introduction, which defines the disease and looks at symptoms, diagnosis and treatment
- Analysis of the NSCLC marketed landscape, including a comparison of the efficacy and safety of the most prominent brands, as well as the unmet needs of NSCLC treatment
- Detailed analysis of the NSCLC pipeline, covering among other parameters, drug distribution by Phase, molecule type and mechanism of action. The NSCLC clinical trial landscape is analyzed with particular emphasis on failure rates across different trial Phases, as well as the trends in clinical trial size, duration and primary endpoint. This section also includes profiles and single product forecasts for the most promising pipeline drugs.
- An epidemiological forecast of the major NSCLC markets, in which projected values include total and treated populations
- An in-depth forecasting model for the NSCLC market, which considers the current marketed therapies in addition to the potential entry of new products to the market. The model comprises a projected outcome with high and low variance results depending on the potential performance of pipeline therapies.
- Analysis of strategic consolidations within the NSCLC indication, including co-development and licensing agreements
- An overview of the drivers of and barriers to the NSCLC market

Reasons to buy

The report will enable clients to develop a strong understanding of NSCLC as a disease and as a market. The current therapeutic needs and future market trends will highlight opportunities and the scope of competition between NSCLC therapeutics. Primarily, the report will allow clients to -
- Understand the NSCLC pipeline and the clinical needs that it is addressing, particularly the ways in which histology affects treatment options and where in the treatment algorithm new products will be positioned, as well as where unmet needs remain
- Develop their knowledge of key products that may enter the market before 2020. Detailed profiles of these products are provided, with a focus on their clinical trial performance, as well as how they can be incorporated into the NSCLC treatment plan and what competition they face.
- Assess the risk associated with NSCLC product development profiled by molecule type and mechanism of action and compared with both industry and therapy-area averages. In addition, data analyses offer a more detailed understanding of the trends in both trial size and duration for specific mechanisms of action or molecule types. The primary endpoint analysis infers trends in trial design within the therapy area, as well as the endpoints that are the best indicators of success.
- Identify patterns of growth in the NSCLC market over the forecast period and understand the underlying causes, as well as observing the contributions made by each major market and/or late-stage pipeline drug to this growth.

Table Of Contents

Non-Small Cell Lung Cancer Market to 2020 - New Therapies to Enhance Treatment Segmentation and Drive Growth in an Increasingly Competitive Market
1 Table of Contents
1 Table of Contents 4
1.1 List of Tables 7
1.2 List of Figures 8
2 Introduction 10
2.1 Disease Introduction 10
2.2 Epidemiology 11
2.3 Etiology and Pathophysiology 11
2.3.1 Adenocarcinoma 12
2.3.2 Squamous Cell Carcinoma 15
2.3.3 Large Cell Carcinoma 17
2.3.4 Immunotherapy 18
2.4 Symptoms 18
2.5 Diagnosis 18
2.6 Prognosis 21
2.7 Treatment 21
2.7.1 Treatment Algorithm 22
2.7.2 First-Line Treatment 26
2.7.3 Maintenance Therapy 33
2.7.4 Second-Line Therapy 35
2.7.5 Third-Line Therapy 39
2.7.6 Adjuvant Therapy 39
3 Marketed Products 41
3.1 Overview 41
3.2 Chemotherapies - Various 41
3.2.1 Cisplatin 41
3.2.2 Carboplatin 42
3.2.3 Vinorelbine 42
3.2.4 Paclitaxel 42
3.2.5 Docetaxel 43
3.2.6 Gemcitabine 43
3.3 Alimta - Eli Lilly 44
3.4 Abraxane - Celgene Corporation 45
3.5 Tarceva - Roche 46
3.6 Iressa - AstraZeneca 47
3.7 Gilotrif - Boehringer Ingelheim 48
3.8 Xalkori - Pfizer 49
3.9 Avastin (bevacizumab) - Roche 50
3.10 Marketed Products Heatmap 51
3.11 Conclusion 53
4 NSCLC Pipeline 54
4.1 Overview 54
4.2 Mechanisms of Action in the Pipeline 58
4.3 Clinical Trials 61
4.3.1 Failure Rate 61
4.3.2 Clinical Trial Duration 64
4.3.3 Clinical Trial Size 66
4.3.4 Clinical Trial Primary Endpoints 69
4.4 Late-Stage Pipeline Product Profiles 71
4.4.1 Custirsen - Teva Pharmaceutical Industries 71
4.4.2 Halaven - Eisai 72
4.4.3 Dacomitinib - Pfizer 74
4.4.4 Vargatef - Boehringer Ingelheim 75
4.4.5 Necitumumab - Eli Lilly 77
4.4.6 Ganetespib - Synta Pharmaceuticals 78
4.4.7 Zykadia- Novartis 79
4.4.8 Yervoy - Bristol Myers Squibb 80
4.4.9 Nivolumab - Ono Pharmaceuticals/Bristol-Myers Squibb 82
4.4.10 MK-3475 - Merck 83
4.4.11 RG7446 - Roche 84
4.4.12 Cyramza- Eli Lilly 84
4.4.13 Tavocept - BioNumerik Pharmaceuticals 86
4.4.14 Tecemotide - Merck Serono 87
4.4.15 Tertomotide - KAEL-GemVax 88
4.4.16 Lucanix - NovaRx Corporation 89
4.4.17 Bevacizumab Biosimilar - Various 91
4.5 Safety and Efficacy Heatmap 91
4.6 Conclusion 94
4.6.1 Product Competitiveness Framework 94
4.6.2 Future Treatment Algorithm 95
5 Market Forecast 98
5.1 Geographical Markets 98
5.1.1 Global Markets 99
5.1.2 North America 101
5.1.3 Top Five EU Countries 103
5.1.4 Japan 107
5.2 Drivers and Barriers 109
5.2.1 Drivers 109
5.2.2 Barriers 109
6 Strategic Consolidations 111
6.1 Major Co-Development deals 111
6.1.1 Merck Enters into Co-Development Agreement with Endocyte 112
6.1.2 Exelixis Enters into a Co-Development Agreement with Genentech 113
6.1.3 CancerVax Enters into an Agreement with CIMAB and YM Biosciences 113
6.1.4 SFJ Pharma Enters into Co-Development Agreement with Pfizer for Dacomitinib 113
6.1.5 OxOnc Development Enters into Co-Development Agreement with Pfizer for Crizotinib 113
6.2 Major Licensing Deals 114
6.2.1 Merck Serono Enters into Licensing Agreement with Ono Pharma 115
6.2.2 Astellas Pharma Enters into Licensing Agreement with Aveo Pharma 116
6.2.3 Clovis Oncology Enters into a Licensing Agreement with Avila Therapeutics 116
6.2.4 Novartis Enters into Licensing Agreement with Antisoma 116
6.2.5 Cell Therapeutics Enters into Licensing Agreement with Novartis 116
7 Appendix 118
7.1 References 132
7.2 Market Definition 137
7.3 Abbreviations 137
7.3.1 Research Methodology 138
7.3.2 Secondary Research 139
7.3.3 Marketed Product Profiles 139
7.3.4 Late-Stage Pipeline Candidates 140
7.3.5 Comparative Efficacy and Safety Heat Map for Marketed and Pipeline Products 140
7.3.6 Product Competitiveness Framework 140
7.3.7 Pipeline Analysis 140
7.3.8 Forecasting Model 141
7.3.9 Deals Data Analysis 142
7.4 Contact Us 142
7.5 Disclaimer 1431.1 List of Tables
Table 1: Non-Small Cell Lung Cancer Market, Global, Tumor Node Metastasis Classification, 2014 20
Table 2: Non-Small Cell Lung Cancer Market, Global, Eastern Co-operative Oncology Group Criteria, 2014 21
Table 3: Non-Small Cell Lung Cancer Market, Global, Treatment Options, 2014 23
Table 4: Non-Small Cell Lung Cancer Market, Global, Stage IIIB-IV Treatment Options, 2014 26
Table 5: Non-Small Cell Lung Cancer Market, Global, Chemotherapy Treatment, 2014 27
Table 6: Non-Small Cell Lung Cancer Market, Global, Chemotherapy Treatment by Regimen, 2014 28
Table 7: Non-Small Cell Lung Cancer Market, Global, Pipeline, Preclinical, 2014 118
Table 8: Non-Small Cell Lung Cancer Market, Global, Pipeline, Phase I, 2014 121
Table 9: Non-Small Cell Lung Cancer Market, Global, Pipeline, Phase II, 2014 123
Table 10: Non-Small Cell Lung Cancer Market, Global, Pipeline, Phase III, 2014 127
Table 11: Non-Small Cell Lung Cancer Market, Global, Pipeline, Pre-registration, 2014 128
Table 12: Non-Small Cell Lung Cancer Market, Global, Pipeline, Undisclosed, 2014 128
Table 13: Non-Small Cell Lung Cancer Market, Global, Market Forecast, 2013-2020 128
Table 14: Non-Small Cell Lung Cancer Market, US, Market Forecast, 2013-2020 129
Table 15: Non-Small Cell Lung Cancer Market, Canada, Market Forecast, 2013-2020 130
Table 16: Non-Small Cell Lung Cancer Market, UK, Market Forecast, 2013-2020 130
Table 17: Non-Small Cell Lung Cancer Market, France, Market Forecast, 2013-2020 130
Table 18: Non-Small Cell Lung Cancer Market, Germany, Market Forecast, 2013-2020 130
Table 19: Non-Small Cell Lung Cancer Market, Italy, Market Forecast, 2013-2020 131
Table 20: Non-Small Cell Lung Cancer Market, Spain, Market Forecast, 2013-2020 131
Table 21: Non-Small Cell Lung Cancer Market, Japan, Market Forecast, 2013-2020 1311.2 List of Figures
Figure 1: Non-Small Cell Lung Cancer Market, Global, Molecular Characteristic Frequency (%), 2014 12
Figure 2: Non-Small Cell Lung Cancer Market, Global, Non-Squamous Late-Stage Treatment Algorithm, 2014 24
Figure 3: Non-Small Cell Lung Cancer Market, Global, Squamous Late-Stage Treatment Algorithm, 2014 25
Figure 4: NSCLC, Global, Marketed Products Heatmap, 2013 52
Figure 5: Non-Small Cell Lung Cancer, Global, Pipeline Summary, 2014 57
Figure 6: Non-Small Cell Lung Cancer, Global, Pipeline Mechanisms of Action Overview, 2014 58
Figure 7: Non-Small Cell Lung Cancer, Global, Pipeline Mechanisms of Action Breakdown, 2014 60
Figure 8: Non-Small Cell Lung Cancer, Global, Clinical Trial Attrition Rates (%), 2006-2014 62
Figure 9: Non-Small Cell Lung Cancer, Global, Clinical Trial Mechanism of Action Failure Rates by Phase (%), 2006-2014 63
Figure 10: Non-Small Cell Lung Cancer, Global, Clinical Trial Duration (months), 2006-2013 64
Figure 11: Non-Small Cell Lung Cancer, Global, Clinical Trial Duration by Molecule Type (months), 2006-2013 65
Figure 12: Non-Small Cell Lung Cancer, Global, Clinical Trial Duration by Mechanism of Action (months), 2006-2013 66
Figure 13: Non-Small Cell Lung Cancer, Global, Clinical Trial Size per Product (participants), 2006-2013 67
Figure 14: Non-Small Cell Lung Cancer, Global, Clinical Trial Size per Product by Molecule Type (participants), 2006-2013 68
Figure 15: Non-Small Cell Lung Cancer, Global, Clinical Trial Size per Product by Mechanism of Action (months), 2006-2013 69
Figure 16: Non-Small Cell Lung Cancer, Global, Clinical Trial Primary Endpoints, 2006-2013 70
Figure 17: Non-Small Cell Lung Cancer, Global, Clinical Trial Primary Endpoint Combinations by Phase (%), 2006-2013 71
Figure 18: Non-Small Cell Lung Cancer Pipeline, Global, Custirsen Annual Sales ($m), 2018-2020 72
Figure 19: Non-Small Cell Lung Cancer Pipeline, Global, Halaven Annual Sales ($m), 2016-2020 73
Figure 20: Non-Small Cell Lung Cancer Pipeline, Global, Dacomitinib Annual Sales ($m), 2014-2020 75
Figure 21: Non-Small Cell Lung Cancer Pipeline, Global, Vargatef Annual Sales ($m), 2015-2020 76
Figure 22: Non-Small Cell Lung Cancer Pipeline, Global, Necitumumab Annual Sales ($m), 2015-2020 78
Figure 23: Non-Small Cell Lung Cancer Pipeline, Global, Ganetespib Annual Sales ($m), 2016-2020 79
Figure 24: Non-Small Cell Lung Cancer Pipeline, Global, Zykadia Annual Sales ($m), 2014-2020 80
Figure 25: Non-Small Cell Lung Cancer Pipeline, Global, Yervoy Annual Sales ($m), 2015-2020 82
Figure 26: Non-Small Cell Lung Cancer Pipeline, Global, Nivolumab Annual Sales ($m), 2015-2020 83
Figure 27: Non-Small Cell Lung Cancer Pipeline, Global, Cyramza Annual Sales ($m), 2015-2020 86
Figure 28: Non-Small Cell Lung Cancer Pipeline, Global, Tavocept Annual Sales ($m), 2017-2020 87
Figure 29: Non-Small Cell Lung Cancer Pipeline, Global, Tertomotide Annual Sales ($m), 2017-2020 89
Figure 30: Non-Small Cell Lung Cancer Pipeline, Global, Lucanix Annual Sales ($m), 2016-2020 90
Figure 31: Non-Small Cell Lung Cancer , Global, Safety and Efficacy Heatmap, 2013 92
Figure 32: Non-Small Cell Lung Cancer , Global, Marketed Products Heatmap, 2013 93
Figure 33: Non-Small Cell Lung Cancer Market, Global, Product Competitiveness Framework, 2014 95
Figure 34: Non-Small Cell Lung Cancer Market, Global, Non-Squamous Future Treatment Algorithm 2020 96
Figure 35: Non-Small Cell Lung Cancer Market, Global, Squamous Future Treatment Algorithm 97
Figure 36: Non-Small Cell Lung Cancer Market, Global, Treatment Patterns (‘000), 2013-2020 99
Figure 37: Non-Small Cell Lung Cancer Market, Global, Market Size ($bn), 2013-2020 100
Figure 38: Non-Small Cell Lung Cancer Market, North America, Treatment Usage Patterns (‘000), 2013-2020 101
Figure 39: Non-Small Cell Lung Cancer Market, North America, Annual Cost of Treatment ($), 2013-2020 102
Figure 40: Non-Small Cell Lung Cancer Market, North America, Market Size, 2013-2020 103
Figure 41: Non-Small Cell Lung Cancer Market, Top Five EU Countries, Treatment Patterns (‘000), 2013-2020 104
Figure 42: Non-Small Cell Lung Cancer Market, Top Five EU Countries, Annual Cost of Treatment ($), 2013-2020 105
Figure 43: Non-Small Cell Lung Cancer Market, Top Five EU Countries, Market Size ($m), 2013-2020 106
Figure 44: Non-Small Cell Lung Cancer Market, Japan, Treatment Usage Patterns (‘000), 2013-2020 107
Figure 45: Non-Small Cell Lung Cancer Market, Japan, Annual Cost of Treatment ($), 2013-2020 108
Figure 46: Non-Small Cell Lung Cancer Market, Japan, Market Size ($bn), 2013-2020 108
Figure 47: Non-Small Cell Lung Cancer, Global, Co-Development Deals by Region, 2006-2014 111
Figure 48: Non-Small Cell Lung Cancer, Global, Number of Co-Development Deals, 2006-2014 112
Figure 49: Non-Small Cell Lung Cancer, Global, Co-Development Deals by Phase, 2006-2014 112
Figure 50: Non-Small Cell Lung Cancer, Global, Licensing Deals by Region, 2006-2014 114
Figure 51: Non-Small Cell Lung Cancer, Global, Number of Licensing Deals, 2006-2014 115
Figure 52: Non-Small Cell Lung Cancer, Global, Licensing Deals by Phase, 2006-2014 115

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