OpportunityAnalyzer: Small Cell Lung Cancer (SCLC) – Opportunity Analysis and Forecasts to 2024

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.

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.

Key Highlights

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?

Companies mentioned

Abbvie

AstraZeneca

Bayer

BioMarin Pharmaceutical

Bristol Myers Squibb

Cerulean Pharma

GlaxoSmithKline

Immunomedics

Medivation

Menarini

Merck

MolMed

Mologen

OncoMed Pharmaceuticals

Pfizer

Pharma MaR

Stem CentRX

Takeda

Table of Contents

1Table of Contents

1.1List of Tables

1.2List of Figures

2Introduction

2.1Catalyst

2.2Related Reports

2.3Upcoming Related Reports

3Disease Overview

3.1Etiology and Pathophysiology

3.1.1Etiology

3.1.2Pathophysiology

3.2Symptoms

3.3Diagnosis

3.4Clinical Staging

3.5Prognostic Factors

3.6Quality of Life

4Epidemiology

4.1Disease Background

4.2Risk Factors and Comorbidities

4.3Global Trends

4.3.1Incidence

4.3.2Stage at Diagnosis

4.3.3Relative Survival

4.4Forecast Methodology

4.4.1Sources Used

4.4.2Sources Not Used

4.4.3Forecast Assumptions and Methods

4.5Epidemiological Forecast for SCLC (2014–2024)

4.5.1Diagnosed Incident Cases of SCLC

4.5.2Age-Specific Incident Cases of SCLC

4.5.3Sex-Specific Incident Cases of SCLC

4.5.4Age-Standardized Incidence of SCLC

4.5.5Stage-Specific Incident Cases of SCLC

4.5.6Five-Year Diagnosed Prevalent Cases of SCLC

4.5.7Five-Year Diagnosed Prevalent Cases of SCLC Segmented by Stage

4.6Discussion

4.6.1Epidemiological Forecast Insight

4.6.2Limitations of the Analysis

4.6.3Strengths of the Analysis

5Current Treatment Options

5.1First-Line Therapy

5.2Second-Line Therapy

5.3Subsequent Lines of Therapy

6Unmet Needs Assessment and Opportunity Analysis

6.1Overview

6.2Unmet Needs Analysis

6.2.1Early Diagnosis of Disease

6.2.2Therapies That Improve Overall Survival

6.2.3More Effective and Tolerable Therapies for Relapsed/Refractory Disease

6.2.4Discovery of Predictive Biomarkers and Understanding of the Underlying Causes of Disease

6.2.5Smoking Cessation Programs

6.3Opportunity Analysis

6.3.1Standardized Methods for Biomarker Testing

6.3.2Developing Therapies with an Improved Safety Profile

6.3.3Understanding the Mechanisms Underlying the Rapid Emergence of Drug and Radiation Resistance

6.3.4Targeting Pathways Unique to Cancer Stem Cells

7R&D Strategies

7.1Overview

7.1.1Deconstructing the SCLC Genome

7.1.2New Diagnostic Approaches

7.1.3Reformulation of Available Chemotherapeutic Agents

7.1.4Combination Therapy

7.2Clinical Trial Design

7.2.1Evolution of Endpoints for Cancer Immunotherapy Trials

7.2.2Health-Related Quality of Life Endpoints in Oncology Clinical Trials

7.2.3Design of Current Phase II and III Trials in SCLC

8Pipeline Assessment

8.1Overview

8.2Promising Drugs in Clinical Development

8.2.1Alisertib (MLN8237)

8.2.2MGN-1703

8.2.3NGR-hTNF

8.2.4Opdivo (nivolumab)

8.2.5Roniciclib (BAY 1000394)

8.2.6Sabarubicin (MEN10755)

8.2.7Sacituzumab Govitecan (IMMU-132)

8.2.8Sutent (sunitinib malate)

8.2.9Tarextumab (OMP-59R5)

8.2.10Yervoy (ipilimumab)

8.3Innovative Early-Stage Approaches

8.3.1Rovalpituzumab Tesirine (SC16LD6.5)

8.3.2Keytruda (pembrolizumab)

8.3.3PARP Inhibitors

8.3.4Lurbinectedin (PM01183)

9Pipeline Valuation Analysis

9.1Clinical Benchmark of Key Pipeline Drugs

9.2Commercial Benchmark of Key Pipeline Drugs

9.3Competitive Assessment

9.4Top-Line 10-Year Forecast

9.4.1US

9.4.25EU

9.4.3Japan

10Appendix

10.1Bibliography

10.2Abbreviations

10.3Methodology

10.4Forecasting Methodology

10.4.1Diagnosed SCLC Patients

10.4.2Percent Drug-Treated Patients

10.4.3Drugs Included in Each Therapeutic Class

10.4.4Launch and Patent Expiry Dates

10.4.5General Pricing Assumptions

10.4.6Average Body Weight and Surface Area Across 7MM

10.4.7Individual Drug Assumptions

10.4.8Generic Erosion

10.5Physicians and Specialists Included in this Study

10.6About the Authors

10.6.1Authors

10.6.2Epidemiologist

10.6.3Global Director of Therapy Analysis and Epidemiology

10.6.4Global Head of Healthcare

10.7About GlobalData

10.8Contact Us

10.9Disclaimer

List of Tables

Table 1: Symptoms of Neurologic and Endocrine Paraneoplastic Syndromes in SCLC

Table 2: AJCC TNM Classification System for Small Cell Lung Cancer

Table 3: AJCC TNM Staging System for Small Cell Lung Cancer

Table 4: Risk Factors and Comorbidities Associated with SCLC

Table 5: 7MM, Sources Used for Diagnosed Incidence of SCLC, 2014

Table 6: 7MM, Sources Used for Diagnosed Incident Cases of SCLC Segmented by Stage at Diagnosis

Table 7: 7MM, Sources Used for the Five-Year Diagnosed Prevalent Cases of LS-SCLC

Table 8: 7MM, Sources Used for the Five-Year Relative Survival of ES-SCLC

Table 9: 7MM, Diagnosed Incident Cases of SCLC, Both Sexes, Ages =18 Years, Select Years, 2014–2024

Table 10: 7MM, Age-Specific Diagnosed Prevalent Cases of SCLC, Ages =18 Years, N (Row %), 2014

Table 11: 7MM, Sex-Specific Diagnosed Incident Cases of SCLC, Ages =18 Years, N (Row %), 2014

Table 12: 7MM, Diagnosed Incident Cases of SCLC Segmented by Stage at Diagnosis, Ages =18 Years, N, 2014

Table 13: 7MM, Five-Year Diagnosed Prevalent Cases of SCLC, Both Sexes, Ages =18 Years, Select Years, 2014–2024

Table 14: 7MM, Five-Year Diagnosed Prevalent Cases of SCLC Segmented by Stage at Diagnosis, Ages =18 Years, N, 2014

Table 15: The Efficacy of Chemotherapeutic Agents in the First-Line Treatment of SCLC

Table 16: The Efficacy of Various TRT Regimens in SCLC

Table 17: The Efficacy of PCI in SCLC

Table 18: The Efficacy of Chemotherapeutic Agents in the Second-Line Treatment of SCLC

Table 19: Overall Unmet Needs – Current Level of Attainment

Table 20: Genes of Interest in SCLC

Table 21: Clinical Development of Potential Biomarkers for SCLC

Table 22: Potential Surrogate Endpoints by Disease Stage

Table 23: Design of Current Clinical Trials in the First-Line Treatment of SCLC

Table 24: Design of Current Clinical Trials in the Second-Line Treatment of SCLC

Table 25: Product Profile — Alisertib (MLN8237)

Table 26: Efficacy of Alisertib in Relapsed/Refractory SCLC

Table 27: Safety of Alisertib in Relapsed/Refractory SCLC

Table 28: Alisertib (MLN8237)

Table 29: Global Sales Forecast ($m) for Alisertib, 2014–2024

Table 30: Product Profile — MGN-1703

Table 31: Efficacy of MGN-1703 in Heavily Pretreated Patients with Metastatic Solid Tumors

Table 32: MGN-1703

Table 33: Product Profile — NGR-hTNF

Table 34: Efficacy of NGR-hTNF in Combination with Doxorubicin in Relapsed/Refractory SCLC

Table 35: NGR-hTNF

Table 36: Global Sales Forecast ($m) for NGR-hTNF, 2014–2024

Table 37: Product Profile — Opdivo

Table 38: Efficacy of Nivolumab Monotherapy and Nivolumab + Ipilimumab in Relapsed/Refractory

Table 39: Safety of Nivolumab Monotherapy and Nivolumab + Ipilimumab in Relapsed/Refractory SCLC

Table 40: Opdivo (nivolumab) SWOT Analysis

Table 41: Global Sales Forecast ($m) for Opdivo, 2014–2024

Table 42: Product Profile — Roniciclib (BAY 1000394)

Table 43: Efficacy of Roniciclib (BAY 1000394) in ES-SCLC

Table 44: Safety of Roniciclib (BAY 1000394) in ES-SCLC

Table 45: Roniciclib (BAY 1000394) SWOT Analysis

Table 46: Global Sales Forecast ($m) for Roniciclib, 2014–2024

Table 47: Product Profile — Sabarubicin (MEN10755)

Table 48: Efficacy of Sabarubicin + Cisplatin in ES-SCLC

Table 49: Safety of Sabarubicin + Cisplatin in ES-SCLC

Table 50: Sabarubicin (MEN10755) SWOT Analysis

Table 51: Product Profile — Sacituzumab Govitecan (IMMU-132)

Table 52: Efficacy of IMMU-132 in Relapsed/Refractory SCLC

Table 53: Safety of Sacituzumab Govitecan (IMMU-132) in Relapsed/Refractory SCLC

Table 54: Sacituzumab Govitecan (IMMU-132) SWOT Analysis

Table 55: Global Sales Forecast ($m) for Sacituzumab Govitecan, 2014–2024

Table 56: Product Profile — Sutent (Sunitinib Malate)

Table 57: Efficacy of Sutent Maintenance Therapy Following Chemotherapy in ES-SCLC

Table 58: Sutent (Sunitinib Malate)

Table 59: Global Sales Forecast ($m) for Sutent, 2014–2024

Table 60: Product Profile — Tarextumab (OMP-59R5)

Table 61: Safety of Tarextumab in ES-SCLC

Table 62:Tarextumab (OMP-59R5)

Table 63: Global Sales Forecast ($m) for Tarextumab, 2014–2024

Table 64: Product Profile — Yervoy

Table 65: Efficacy of Concurrent- and Phased-Ipilimumab in ES-SCLC

Table 66: Safety of the Concurrent- and Phased-Ipilimumab in Combination with Paclitaxel + Carboplatin in ES-SCLC

Table 67: Yervoy (ipilimumab) SWOT Analysis

Table 68: Global Sales Forecast ($m) for Yervoy, 2014–2024

Table 69: Early-Stage Pipeline Products in SCLC

Table 70: Clinical Benchmarking of Key Marketed and Pipeline Drugs—Small Cell Lung Cancer, First-Line Therapies

Table 71: Clinical Benchmarking of Key Marketed and Pipeline Drugs—Small Cell Lung Cancer, Relapsed/Refractory (R/R) Therapies

Table 72: Commercial Benchmarking of Key Marketed and Pipeline Drugs—Small Cell Lung Cancer

Table 73: Top-Line Sales Forecasts ($m) for SCLC, 2014–2024

Table 74: Key Events Impacting Sales for SCLC, 2014–2024

Table 75: Small Cell Lung Cancer Market in the US – Drivers and Barriers, 2014–2024

Table 76: Small Cell Lung Cancer Market in the 5EU – Drivers and Barriers, 2014

Table 77: Small Cell Lung Cancer Market in Japan – Drivers and Barriers, 2014

Table 78: Key Launch Dates

Table 79: Key Patent/Exclusivity Expiries

Table 80: Average Body Weight and Surface Area Across the 7MM

List of Figures

Figure 1: 7MM, Diagnosed Incident Cases of SCLC, Both Sexes, Ages =18 Years, 2014–2024

Figure 2: 7MM, Age-Specific Diagnosed Prevalent Cases of SCLC, Ages =18 Years, Both Sexes, N, 2014

Figure 3: 7MM, Sex-Specific Diagnosed Prevalent Cases of SCLC, Ages =18 Years, N, 2014

Figure 4: 7MM, Age-Standardized Diagnosed Incidence of SCLC, Ages =18 Years, 2014

Figure 5: 7MM, Five-Year Diagnosed Prevalent Cases of SCLC, Both Sexes, Ages =18 Years, 2014–2024

Figure 6: First-Line Treatment Options for SCLC Based on Staging

Figure 7: Small Cell Lung Cancer – Late-Stage Pipeline, 2015

Figure 8: Alisertib (MLN8237) in SCLC

Figure 9: Design of the Phase I/II Study Investigating the Activity of Alisertib in Relapsed/Refractory SCLC

Figure 10: MGN-1703 in SCLC

Figure 11: Design of the Phase I Study Investigating the Activity of MNG-1703 in Heavily Pretreated Patients with Metastatic Solid Tumors

Figure 12: NGR-hTNF in SCLC

Figure 13: Design of the Phase II Study Investigating the Activity of NGR-hTNF in Combination with Doxorubicin in Relapsed/Refractory SCLC

Figure 14: Opdivo (nivolumab) in SCLC

Figure 15: Design of the Phase I/II CheckMate 032 Study Investigating the Activity of Nivolumab Monotherapy or Nivolumab + Ipilimumab in Relapsed/Refractory SCLC

Figure 16: Roniciclib in SCLC

Figure 17: Design of the Phase Ib/II Study Investigating the Activity of Roniciclib (BAY 1000394) in ES-SCLC

Figure 18: Sacituzumab Govitecan in SCLC

Figure 19: Design of the Phase I/II Study Investigating the Activity of IMMU-132 in Relapsed/Refractory SCLC

Figure 20: Design of the Phase I/II Study Investigating the Activity of Sutent Maintenance Therapy in ES-SCLC

Figure 21: Tarextumab in SCLC

Figure 22: Design of the Phase Ib PINNACLE Study Investigating the Activity of Tarextumab in Combination with Platinum-Etoposide in ES-SCLC

Figure 23: Yervoy (ipilimumab) in SCLC

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

Figure 25: Competitive Assessment of Late-Stage Pipeline Agents in SCLC, 2014–2024

Figure 26:Global Sales for SCLC by Region, 2014–2024

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