PharmaPoint: Non-Small Cell Lung Cancer - US Drug Forecast and Market Analysis to 2022



Summary



Non-Small Cell Lung Cancer (NSCLC) is the most common lung cancer, and the second-most common cancer in men and women. Historically, the treatment paradigm has centered around chemotherapy. However, the launch of targeted therapies for patients with specific biomarkers has begun to fragment the NSCLC treatment landscape into smaller niche patient populations. Over the forecast period, this trend will continue with the launch of multiple new drugs in several new drug classes to address the high unmet need among NSCLC patients, and provide new treatment options for previously underserved populations. Launch of premium-priced drug candidates combined with increasing incident cases of the disease will be major drivers of growth in the major markets.

The US is the largest NSCLC market due to high disease incidence and higher drug prices compared with the 5EU, Japan, and China. Increased sales of NSCLC therapies over the forecast period will be driven by increasing disease incident cases as the population ages, the launch of expensive new therapies that target patient segments with high unmet need, and increased rates of testing for EGFR and ALK mutations, identifying additional patients who are eligible for these targeted therapies.



Scope


- Overview of NSCLC including epidemiology, etiology, symptoms, diagnosis, pathology and treatment guidelines as well as an overview on the competitive landscape.
- Detailed information on the key drugs in the US including product description, safety and efficacy profiles as well as a SWOT analysis.
- Sales forecast for the top drugs in the US from 2012-2022.
- Analysis of the impact of key events as well the drivers and restraints affecting the US NSCLC market.



Reasons to buy


- Understand and capitalize by identifying products that are most likely to ensure a robust return
- Stay ahead of the competition by understanding the changing competitive landscape for NSCLC
- Effectively plan your M&A and partnership strategies by identifying drugs with the most promising sales potential
- Make more informed business decisions from insightful and in-depth analysis of drug performance
- Obtain sales forecast for drugs from 2012-2022 in the US.

Table Of Contents

1 Table of Contents
1 Table of Contents 5
1.1 List of Tables 8
1.2 List of Figures 10
2 Introduction 11
2.1 Catalyst 11
2.2 Related Reports 12
2.3 Upcoming Related Reports 14
3 Disease Overview 15
3.1 Etiology and Pathophysiology 15
3.1.1 Etiology 15
3.1.2 Pathophysiology and Histology 15
3.1.3 NSCLC Biomarkers 16
3.1.4 Quality of Life 17
3.2 Symptoms 18
4 Disease Management 20
4.1 Treatment Overview 20
4.1.1 Diagnosis 22
4.1.2 Clinical Staging 22
4.1.3 Screening and Early Detection 25
4.1.4 Localized Procedures and Therapies 26
4.1.5 Systemic Chemotherapy 27
4.1.6 Targeted Therapy 27
4.2 US 30
4.2.1 Diagnosis 30
4.2.2 Clinical Practice 30
5 Competitive Assessment 33
5.1 Overview 33
5.2 Strategic Competitor Assessment 34
5.3 Product Profiles - Major Brands, Chemotherapies 36
5.3.1 Alimta (pemetrexed disodium) 36
5.3.2 Abraxane (nab-paclitaxel) 40
5.4 Product Profiles - Major Brands, Targeted Therapies 44
5.4.1 Tarceva (erlotinib hydrochloride) 44
5.4.2 Xalkori (crizotinib) 49
5.4.3 Avastin (bevacizumab) 53
6 Opportunity and Unmet Need 57
6.1 Overview 57
6.2 Improved Overall Survival and Less Toxicity 58
6.3 Treatments for Patients with Acquired TKI Resistance 59
6.4 Better Treatment Options for Squamous Patients 59
6.5 Preventing Relapse or Recurrence 60
6.6 More Efficacious Second-Line Therapies 60
6.7 Increased Availability of Mutation Testing 61
6.8 More Cost-Effective Therapies 62
6.9 Unmet Needs Gap Analysis 62
7 Pipeline Assessment 66
7.1 Overview 66
7.2 Promising Drugs in Clinical Development 66
7.2.1 onartuzumab (MetMab) 70
7.2.2 necitumumab (IMC-11F8) 76
7.2.3 ramucirumab (IMC-1121B) 81
7.2.4 custirsen (OGX-011) 85
7.2.5 ganetespib (STA-9090) 90
7.2.6 nintedanib (BIBF1120) 96
7.2.7 Gilotrif (afatinib) 100
7.2.8 dacomitinib (PF-00299804) 106
7.2.9 LDK378 111
7.2.10 Yervoy (ipilimumab) 116
7.2.11 nivolumab (BMS936558) 120
7.2.12 GSK1572932A (MAGE-A3 Cancer Immunotherapeutic) 126
7.2.13 Halaven (eribulin mesylate) 130
8 Market Outlook 135
8.1 United States 135
8.1.1 Forecast 135
8.1.2 Key Events 138
8.1.3 Drivers and Barriers 139
9 Appendix 143
9.1 Bibliography 143
9.2 Abbreviations 161
9.3 Methodology 165
9.4 Forecasting Methodology 165
9.4.1 Number of NSCLC Patients Currently Seeking Treatment 165
9.4.2 Percent Drug-treated Patients 166
9.4.3 Drugs Included in Each Therapeutic Class 166
9.4.4 Launch and Patent Expiry Dates 167
9.4.5 General Pricing Assumptions 168
9.4.6 Individual Drug Assumptions 171
9.4.7 Generic Erosion 180
9.4.8 Pricing of Pipeline Agents 180
9.5 Physicians and Specialists Included in This Study 183
9.6 Survey of Prescribing Physicians 184
9.7 About the Authors 185
9.7.1 Authors 185
9.7.2 Epidemiologists 186
9.7.3 Global Head of Healthcare 187
9.8 About GlobalData 188
9.9 Disclaimer 188
1.1 List of Tables

Table 1: Symptoms of Disease NSCLC 19
Table 2: Treatment Guidelines for NSCLC 21
Table 3: Stage Definitions for NSCLC 24
Table 4: Treatment Overview by Stage of Diagnosis for NSCLC 29
Table 5: Leading Treatments for NSCLC 36
Table 6: Product Profile - Alimta (pemetrexed disodium) 38
Table 7: Alimta SWOT Analysis, 2013 40
Table 8: Product Profile - Abraxane (nab-paclitaxel) 41
Table 9: Abraxane SWOT Analysis, 2013 43
Table 10: Product Profile - Tarceva (erlotinib hydrochloride) 45
Table 11: Tarceva SWOT Analysis, 2013 48
Table 12: Product Profile - Xalkori (crizotinib) 50
Table 13: Xalkori SWOT Analysis, 2013 53
Table 14: Product Profile - Avastin (bevacizumab) 54
Table 15: Avastin SWOT Analysis, 2013 56
Table 16: Overall Unmet Needs - Current Level of Attainment 58
Table 17: Clinical Unmet Needs - Gap Analysis, 2013 63
Table 18: Non-Small Cell Lung Cancer - Phase I-II Pipeline, 2013 67
Table 19: NSCLC - Phase III Pipeline, 2013 68
Table 20: NSCLC - Advantages and Disadvantages of Therapeutic Classes 69
Table 21: Product Profile - onartuzumab (MetMab) 71
Table 22: onartuzumab SWOT Analysis, 2013 76
Table 23: Product Profile - necitumumab (IMC-11F8) 77
Table 24: necitumumab SWOT Analysis, 2013 81
Table 25: Product Profile - ramucirumab (IMC-1121B) 82
Table 26: ramucirumab SWOT Analysis, 2013 85
Table 27: Product Profile - custirsen (OGX-011) 86
Table 28: custirsen SWOT Analysis, 2013 90
Table 29: Product Profile - ganetespib (STA-9090) 91
Table 30: ganetespib SWOT Analysis, 2013 96
Table 31: Product Profile - nintedanib (BIBF-1120) 97
Table 32: nintedanib SWOT Analysis, 2013 100
Table 33: Product Profile - Gilotrif (afatinib) 101
Table 34: Gilotrif SWOT Analysis, 2013 106
Table 35: Product Profile - dacomitinib (PF-00299804) 107
Table 36: dacomitinib SWOT Analysis, 2013 110
Table 37: Product Profile - LDK378 112
Table 38: LDK378 SWOT Analysis, 2013 116
Table 39: Product Profile - Yervoy (ipilimumab) 117
Table 40: Yervoy SWOT Analysis, 2013 120
Table 41: Product Profile - nivolumab (BMS936558) 121
Table 42: nivolumab SWOT Analysis, 2013 126
Table 43: Product Profile - GSK1572932A (MAGE-A3 immunotherapy) 127
Table 44: MAGE-A3 (GSK1572932A ) SWOT Analysis, 2013 130
Table 45: Product Profile - Halaven (eribulin mesylate) 131
Table 46: Halaven SWOT Analysis, 2013 134
Table 47: Sales Forecasts ($m) for NSCLC in the United States, 2012-2022 136
Table 48: Key Events Impacting Sales for NSCLC in the United States, 2012-2022 138
Table 49: NSCLC Market in the United States- Drivers and Barriers, 2012-2022 139
Table 50: Five Year Prevalence 166
Table 51: Key Launch Dates 167
Table 52: Key Patent Expiries 168
Table 53: Physicians Surveyed by Country 184
1.2 List of Figures

Figure 1: Competitive Assessment of Late-Stage Pipeline Agents in NSCLC, 2012-2022 69
Figure 2: Sales for NSCLC in the United States by Drug, 2012-2022 137

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