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Opportunity Analyzer: Small Cell Lung Cancer (SCLC) - Opportunity Analysis and Forecasts to 2024

Summary

Initially considered a curable disease due to substantial sensitivity to first-line chemotherapies, small cell lung cancer (SCLC) remains a fatal disease with poor outcomes due to high relapse rates, with the majority of patients surviving one year or less after diagnosis. Unlike non-small cell lung cancer (NSCLC), in which major advances in treatment have been made following the approval of several targeted therapies, the field of SCLC has seen little advancement for several decades.

For the purposes of this report, GlobalData considers the Global SCLC market to include SCLC-specific drug sales in the 7MM (US, 5EU [France, Germany Italy, Spain, and the UK], and Japan). The current market across these countries is dominated by the sale of major generic chemotherapy regimens. GlobalData estimated that the Global SCLC market was valued at $198m in 2014. Following the expected approval of new agents over the forecast period, relapsed/refractory patients will have significantly improved therapeutic options leading to rapid uptake of these drugs. The increased use of branded therapies in treatment-naïve and advanced patients, such as Yervoy, Opdivo, roniciclib, and sacituzumab govitecan, will be the primary driver of the substantial growth in the SCLC market over the forecast period, which is expected to grow at a positive CAGR of almost 28% in the 7MM.

Highlights

Key Questions Answered

- Based on interviews with key opinion leaders (KOLs), GlobalData has identified the major unmet needs in the SCLC marketplace. Will the leading pipeline agents fulfil these unmet needs during the forecast period (2014-2024)?
- What research and development (R&D) strategies will companies leverage to compete in the future SCLC marketplace?
- Which pipeline products are poised to make a major clinical and commercial impact?
- What clinical and commercial factors are likely to influence SCLC drug uptake in the 7MM?

Key Findings

- The greatest driver of growth within the Global SCLC market will be the launch and increased use of premium-priced therapies, including anti-PD-1 immunotherapy and targeted agents such as roniciclib and sacituzumab govitecan. GlobalData expects Yervoy to reach blockbuster status by the end of the forecast period, with global sales of around $1bn.
- Continuous dosing regimens until disease progression and adoption of maintenance setting following induction therapy for first-line patients will contribute to the increased sales of branded drugs.
- Toxicity is likely to remain a major concern as new first-line treatment options are approved considering companies are developing them in combination with platinum-etoposide. Therefore, substantial opportunity remains to develop therapies that have improved safety profiles compared with agents in the current SCLC pipeline.
- An increasing emphasis on cost-consciousness is anticipated over the forecast period, which will limit premium pricing opportunities for developers of SCLC pipeline agents. GlobalData expects this era of austerity and healthcare reform to make it increasingly more difficult for pharmaceutical companies to gain reimbursement approval for their new SCLC therapies.

Scope

- Overview of SCLC, including epidemiology, etiology, pathophysiology, symptoms, diagnosis, and current treatment options.
- Topline SCLC drug market revenue from 2014-2024, annual cost of therapy (ACOT), and major product sales in six patient segments during the forecast period are included.
- Key topics covered include strategic competitor assessment, market characterization, unmet needs, opportunities, R&D strategies, and clinical trial mapping for the SCLC market.
- Pipeline analysis: comprehensive data split across different phases, emerging novel trends under development, synopses of innovative early-stage projects, and detailed analysis of late-stage pipeline products. An interactive clinical and commercial analyzer tool is available.
- Analysis of the current and future market competition in the global SCLC market. Insightful review of the key industry drivers, restraints, and challenges. Each trend is independently researched to provide qualitative analysis of its implications.

Reasons to buy

The report will enable you to -
- Develop and design your in-licensing and out-licensing strategies through a review of pipeline products and technologies, and by identifying the companies with the most robust pipeline.
- Develop business strategies by understanding the trends shaping and driving the global SCLC therapeutics market.
- Drive revenues by understanding the key trends, innovative products and technologies, market segments, and companies likely to impact the SCLC market in the future.
- Formulate effective sales and marketing strategies by understanding the competitive landscape and by analyzing the performance of various competitors.
- Identify emerging players with potentially strong product portfolios and create effective counter-strategies to gain a competitive advantage.
- Organize your sales and marketing efforts by identifying the market categories and segments that present maximum opportunities for consolidations, investments and strategic partnerships.

Table Of Contents

Opportunity Analyzer: Small Cell Lung Cancer (SCLC) - Opportunity Analysis and Forecasts to 2024
1 Table of Contents
1 Table of Contents 9
1.1 List of Tables 13
1.2 List of Figures 17
2 Introduction 19
2.1 Catalyst 19
2.2 Related Reports 19
2.3 Upcoming Related Reports 20
3 Disease Overview 21
3.1 Etiology and Pathophysiology 21
3.1.1 Etiology 21
3.1.2 Pathophysiology 22
3.2 Symptoms 23
3.3 Diagnosis 24
3.4 Clinical Staging 26
3.5 Prognostic Factors 29
3.6 Quality of Life 29
4 Epidemiology 31
4.1 Disease Background 31
4.2 Risk Factors and Comorbidities 32
4.3 Global Trends 34
4.3.1 Incidence 34
4.3.2 Stage at Diagnosis 34
4.3.3 Relative Survival 34
4.4 Forecast Methodology 35
4.4.1 Sources Used 36
4.4.2 Sources Not Used 42
4.4.3 Forecast Assumptions and Methods 43
4.5 Epidemiological Forecast for SCLC (2014-2024) 47
4.5.1 Diagnosed Incident Cases of SCLC 47
4.5.2 Age-Specific Incident Cases of SCLC 49
4.5.3 Sex-Specific Incident Cases of SCLC 51
4.5.4 Age-Standardized Incidence of SCLC 53
4.5.5 Stage-Specific Incident Cases of SCLC 54
4.5.6 Five-Year Diagnosed Prevalent Cases of SCLC 55
4.5.7 Five-Year Diagnosed Prevalent Cases of SCLC Segmented by Stage 57
4.6 Discussion 58
4.6.1 Epidemiological Forecast Insight 58
4.6.2 Limitations of the Analysis 60
4.6.3 Strengths of the Analysis 61
5 Current Treatment Options 62
5.1 First-Line Therapy 62
5.2 Second-Line Therapy 68
5.3 Subsequent Lines of Therapy 71
6 Unmet Needs Assessment and Opportunity Analysis 73
6.1 Overview 73
6.2 Unmet Needs Analysis 74
6.2.1 Early Diagnosis of Disease 74
6.2.2 Therapies That Improve Overall Survival 76
6.2.3 More Effective and Tolerable Therapies for Relapsed/Refractory Disease 78
6.2.4 Discovery of Predictive Biomarkers and Understanding of the Underlying Causes of Disease 79
6.2.5 Smoking Cessation Programs 80
6.3 Opportunity Analysis 81
6.3.1 Standardized Methods for Biomarker Testing 81
6.3.2 Developing Therapies with an Improved Safety Profile 82
6.3.3 Understanding the Mechanisms Underlying the Rapid Emergence of Drug and Radiation Resistance 83
6.3.4 Targeting Pathways Unique to Cancer Stem Cells 84
7 RandD Strategies 85
7.1 Overview 85
7.1.1 Deconstructing the SCLC Genome 85
7.1.2 New Diagnostic Approaches 89
7.1.3 Reformulation of Available Chemotherapeutic Agents 91
7.1.4 Combination Therapy 92
7.2 Clinical Trial Design 93
7.2.1 Evolution of Endpoints for Cancer Immunotherapy Trials 95
7.2.2 Health-Related Quality of Life Endpoints in Oncology Clinical Trials 96
7.2.3 Design of Current Phase II and III Trials in SCLC 97
8 Pipeline Assessment 99
8.1 Overview 99
8.2 Promising Drugs in Clinical Development 100
8.2.1 Alisertib (MLN8237) 101
8.2.2 MGN-1703 107
8.2.3 NGR-hTNF 112
8.2.4 Opdivo (nivolumab) 117
8.2.5 Roniciclib (BAY 1000394) 124
8.2.6 Sabarubicin (MEN10755) 130
8.2.7 Sacituzumab Govitecan (IMMU-132) 134
8.2.8 Sutent (sunitinib malate) 140
8.2.9 Tarextumab (OMP-59R5) 145
8.2.10 Yervoy (ipilimumab) 150
8.3 Innovative Early-Stage Approaches 158
8.3.1 Rovalpituzumab Tesirine (SC16LD6.5) 159
8.3.2 Keytruda (pembrolizumab) 160
8.3.3 PARP Inhibitors 161
8.3.4 Lurbinectedin (PM01183) 163
9 Pipeline Valuation Analysis 165
9.1 Clinical Benchmark of Key Pipeline Drugs 165
9.2 Commercial Benchmark of Key Pipeline Drugs 169
9.3 Competitive Assessment 173
9.4 Top-Line 10-Year Forecast 174
9.4.1 US 178
9.4.2 5EU 179
9.4.3 Japan 181
10 Appendix 183
10.1 Bibliography 183
10.2 Abbreviations 202
10.3 Methodology 207
10.4 Forecasting Methodology 207
10.4.1 Diagnosed SCLC Patients 207
10.4.2 Percent Drug-Treated Patients 208
10.4.3 Drugs Included in Each Therapeutic Class 209
10.4.4 Launch and Patent Expiry Dates 209
10.4.5 General Pricing Assumptions 210
10.4.6 Average Body Weight and Surface Area Across 7MM 211
10.4.7 Individual Drug Assumptions 212
10.4.8 Generic Erosion 224
10.5 Physicians and Specialists Included in this Study 225
10.6 About the Authors 226
10.6.1 Authors 226
10.6.2 Epidemiologist 227
10.6.3 Global Director of Therapy Analysis and Epidemiology 227
10.6.4 Global Head of Healthcare 228
10.7 About GlobalData 229
10.8 Disclaimer 229

1.1 List of Tables
Table 1: Symptoms of Neurologic and Endocrine Paraneoplastic Syndromes in SCLC 24
Table 2: AJCC TNM Classification System for Small Cell Lung Cancer 27
Table 3: AJCC TNM Staging System for Small Cell Lung Cancer 28
Table 4: Risk Factors and Comorbidities Associated with SCLC 33
Table 5: 7MM, Sources Used for Diagnosed Incidence of SCLC, 2014 36
Table 6: 7MM, Sources Used for Diagnosed Incident Cases of SCLC Segmented by Stage at Diagnosis 37
Table 7: 7MM, Sources Used for the Five-Year Diagnosed Prevalent Cases of LS-SCLC 38
Table 8: 7MM, Sources Used for the Five-Year Relative Survival of ES-SCLC 39
Table 9: 7MM, Diagnosed Incident Cases of SCLC, Both Sexes, Ages ?18 Years, Select Years, 2014-2024 48
Table 10: 7MM, Age-Specific Diagnosed Prevalent Cases of SCLC, Ages ?18 Years, N (Row %), 2014 50
Table 11: 7MM, Sex-Specific Diagnosed Incident Cases of SCLC, Ages ?18 Years, N (Row %), 2014 52
Table 12: 7MM, Diagnosed Incident Cases of SCLC Segmented by Stage at Diagnosis, Ages ?18 Years, N, 2014 55
Table 13: 7MM, Five-Year Diagnosed Prevalent Cases of SCLC, Both Sexes, Ages ?18 Years, Select Years, 2014-2024 56
Table 14: 7MM, Five-Year Diagnosed Prevalent Cases of SCLC Segmented by Stage at Diagnosis, Ages ?18 Years, N, 2014 58
Table 15: The Efficacy of Chemotherapeutic Agents in the First-Line Treatment of SCLC 65
Table 16: The Efficacy of Various TRT Regimens in SCLC 67
Table 17: The Efficacy of PCI in SCLC 68
Table 18: The Efficacy of Chemotherapeutic Agents in the Second-Line Treatment of SCLC 71
Table 19: Overall Unmet Needs - Current Level of Attainment 73
Table 20: Genes of Interest in SCLC 86
Table 21: Clinical Development of Potential Biomarkers for SCLC 89
Table 22: Potential Surrogate Endpoints by Disease Stage 94
Table 23: Design of Current Clinical Trials in the First-Line Treatment of SCLC 97
Table 24: Design of Current Clinical Trials in the Second-Line Treatment of SCLC 98
Table 25: Product Profile - Alisertib (MLN8237) 102
Table 26: Efficacy of Alisertib in Relapsed/Refractory SCLC 105
Table 27: Safety of Alisertib in Relapsed/Refractory SCLC 106
Table 28: Alisertib (MLN8237) 106
Table 29: Global Sales Forecast ($m) for Alisertib, 2014-2024 107
Table 30: Product Profile - MGN-1703 109
Table 31: Efficacy of MGN-1703 in Heavily Pretreated Patients with Metastatic Solid Tumors 111
Table 32: MGN-1703 112
Table 33: Product Profile - NGR-hTNF 113
Table 34: Efficacy of NGR-hTNF in Combination with Doxorubicin in Relapsed/Refractory SCLC 115
Table 35: NGR-hTNF 116
Table 36: Global Sales Forecast ($m) for NGR-hTNF, 2014-2024 117
Table 37: Product Profile - Opdivo 119
Table 38: Efficacy of Nivolumab Monotherapy and Nivolumab + Ipilimumab in Relapsed/Refractory 122
Table 39: Safety of Nivolumab Monotherapy and Nivolumab + Ipilimumab in Relapsed/Refractory SCLC 123
Table 40: Opdivo (nivolumab) SWOT Analysis 123
Table 41: Global Sales Forecast ($m) for Opdivo, 2014-2024 124
Table 42: Product Profile - Roniciclib (BAY 1000394) 126
Table 43: Efficacy of Roniciclib (BAY 1000394) in ES-SCLC 128
Table 44: Safety of Roniciclib (BAY 1000394) in ES-SCLC 129
Table 45: Roniciclib (BAY 1000394) SWOT Analysis 129
Table 46: Global Sales Forecast ($m) for Roniciclib, 2014-2024 130
Table 47: Product Profile - Sabarubicin (MEN10755) 131
Table 48: Efficacy of Sabarubicin + Cisplatin in ES-SCLC 132
Table 49: Safety of Sabarubicin + Cisplatin in ES-SCLC 133
Table 50: Sabarubicin (MEN10755) SWOT Analysis 134
Table 51: Product Profile - Sacituzumab Govitecan (IMMU-132) 135
Table 52: Efficacy of IMMU-132 in Relapsed/Refractory SCLC 137
Table 53: Safety of Sacituzumab Govitecan (IMMU-132) in Relapsed/Refractory SCLC 138
Table 54: Sacituzumab Govitecan (IMMU-132) SWOT Analysis 139
Table 55: Global Sales Forecast ($m) for Sacituzumab Govitecan, 2014-2024 140
Table 56: Product Profile - Sutent (Sunitinib Malate) 141
Table 57: Efficacy of Sutent Maintenance Therapy Following Chemotherapy in ES-SCLC 143
Table 58: Sutent (Sunitinib Malate) 144
Table 59: Global Sales Forecast ($m) for Sutent, 2014-2024 144
Table 60: Product Profile - Tarextumab (OMP-59R5) 146
Table 61: Safety of Tarextumab in ES-SCLC 148
Table 62: Tarextumab (OMP-59R5) 149
Table 63: Global Sales Forecast ($m) for Tarextumab, 2014-2024 150
Table 64: Product Profile - Yervoy 151
Table 65: Efficacy of Concurrent- and Phased-Ipilimumab in ES-SCLC 155
Table 66: Safety of the Concurrent- and Phased-Ipilimumab in Combination with Paclitaxel + Carboplatin in ES-SCLC 156
Table 67: Yervoy (ipilimumab) SWOT Analysis 157
Table 68: Global Sales Forecast ($m) for Yervoy, 2014-2024 158
Table 69: Early-Stage Pipeline Products in SCLC 159
Table 70: Clinical Benchmarking of Key Marketed and Pipeline Drugs-Small Cell Lung Cancer, First-Line Therapies 167
Table 71: Clinical Benchmarking of Key Marketed and Pipeline Drugs-Small Cell Lung Cancer, Relapsed/Refractory (R/R) Therapies 169
Table 72: Commercial Benchmarking of Key Marketed and Pipeline Drugs-Small Cell Lung Cancer 172
Table 73: Top-Line Sales Forecasts ($m) for SCLC, 2014-2024 175
Table 74: Key Events Impacting Sales for SCLC, 2014-2024 177
Table 75: Small Cell Lung Cancer Market in the US - Drivers and Barriers, 2014-2024 179
Table 76: Small Cell Lung Cancer Market in the 5EU - Drivers and Barriers, 2014 181
Table 77: Small Cell Lung Cancer Market in Japan - Drivers and Barriers, 2014 182
Table 78: Key Launch Dates 209
Table 79: Key Patent/Exclusivity Expiries 210
Table 80: Average Body Weight and Surface Area Across the 7MM 211

1.2 List of Figures
Figure 1: 7MM, Diagnosed Incident Cases of SCLC, Both Sexes, Ages ?18 Years, 2014-2024 48
Figure 2: 7MM, Age-Specific Diagnosed Prevalent Cases of SCLC, Ages ?18 Years, Both Sexes, N, 2014 51
Figure 3: 7MM, Sex-Specific Diagnosed Prevalent Cases of SCLC, Ages ?18 Years, N, 2014 53
Figure 4: 7MM, Age-Standardized Diagnosed Incidence of SCLC, Ages ?18 Years, 2014 54
Figure 5: 7MM, Five-Year Diagnosed Prevalent Cases of SCLC, Both Sexes, Ages ?18 Years, 2014-2024 57
Figure 6: First-Line Treatment Options for SCLC Based on Staging 62
Figure 7: Small Cell Lung Cancer - Late-Stage Pipeline, 2015 100
Figure 8: Alisertib (MLN8237) in SCLC 103
Figure 9: Design of the Phase I/II Study Investigating the Activity of Alisertib in Relapsed/Refractory SCLC 104
Figure 10: MGN-1703 in SCLC 109
Figure 11: Design of the Phase I Study Investigating the Activity of MNG-1703 in Heavily Pretreated Patients with Metastatic Solid Tumors 110
Figure 12: NGR-hTNF in SCLC 114
Figure 13: Design of the Phase II Study Investigating the Activity of NGR-hTNF in Combination with Doxorubicin in Relapsed/Refractory SCLC 115
Figure 14: Opdivo (nivolumab) in SCLC 120
Figure 15: Design of the Phase I/II CheckMate 032 Study Investigating the Activity of Nivolumab Monotherapy or Nivolumab + Ipilimumab in Relapsed/Refractory SCLC 121
Figure 16: Roniciclib in SCLC 127
Figure 17: Design of the Phase Ib/II Study Investigating the Activity of Roniciclib (BAY 1000394) in ES-SCLC 128
Figure 18: Sacituzumab Govitecan in SCLC 136
Figure 19: Design of the Phase I/II Study Investigating the Activity of IMMU-132 in Relapsed/Refractory SCLC 137
Figure 20: Design of the Phase I/II Study Investigating the Activity of Sutent Maintenance Therapy in ES-SCLC 142
Figure 21: Tarextumab in SCLC 147
Figure 22: Design of the Phase Ib PINNACLE Study Investigating the Activity of Tarextumab in Combination with Platinum-Etoposide in ES-SCLC 147
Figure 23: Yervoy (ipilimumab) in SCLC 153
Figure 24: Design of CA184-041 Phase II Study Investigating the Potential of Concurrent- and Phased-Ipilimumab versus Placebo in Combination with Paclitaxel + Carboplatin in ES-SCLC 154
Figure 25: Competitive Assessment of Late-Stage Pipeline Agents in SCLC, 2014-2024 174
Figure 26: Global Sales for SCLC by Region, 2014-2024 176

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