Cover Image
市場調查報告書

小細胞肺癌 (SCLC) - 機會分析與預測

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

出版商 GlobalData 商品編碼 355919
出版日期 內容資訊 英文 230 Pages
訂單完成後即時交付
價格
Back to Top
小細胞肺癌 (SCLC) - 機會分析與預測 OpportunityAnalyzer: Small Cell Lung Cancer (SCLC) - Opportunity Analysis and Forecasts to 2024
出版日期: 2016年01月01日 內容資訊: 英文 230 Pages
簡介

小細胞肺癌當初考慮為一次性化療可能治癒的疾病,不過,以診斷後不滿1年生存的患者,大半以高確率復發等,結果惡劣,被認為是致生命的疾病。複數的標靶治療受認可的治療大有發展的非小細胞肺癌不同,小細胞肺癌的領域數十年間,幾乎無法看到發展。

本報告提供全球小細胞肺癌 (SCLC市場相關調查,市場未滿足需求,企業的研究開發策略,開發平台趨勢,歐美及日本等的各地區趨勢,今後的預測,及打入市場的主要企業簡介等彙整資料。

第1章 目錄

第2章 簡介

第3章 疾病概要

  • 病因及病理學
  • 症狀
  • 診斷
  • 臨床性分期
  • 預後因素
  • 生活品質

第4章 流行病學

  • 疾病的背景
  • 風險因素和合併症
  • 全球的趨勢
    • 適應
    • 診斷的時候的分期
    • 存活率
  • 預測方法
  • 小細胞肺癌的流行病學的預測
  • 考察

第5章 目前治療方法

  • 一次治療
  • 二次治療
  • 此後的治療方法

第6章 與未滿足需求評估機會分析

  • 概要
  • 未滿足需求分析
    • 疾病的早期診斷
    • 提高全存活率的治療方法
    • 復發/難治性疾病的更有效的治療方法
    • 預測的生物標記的發現與疾病原因的理解
    • 戒煙計劃
  • 機會分析
    • 生物標記檢驗的標準化方法
    • 安全性改良了的開發治療
    • 藥物和放射線抗性的即時表現的機制的理解
    • 癌症幹細胞特有的途徑標靶化

第7章 研究開發策略

  • 概要
    • 小細胞肺癌基因的破壞
    • 新的診斷方法
    • 可利用的化療的再製作
    • 聯合治療
  • 臨床實驗設計
    • 癌症免疫療法臨床實驗的試驗指標的發展
    • 腫瘤臨床實驗的健康相關的生活品質試驗指標
    • 目前第二階段,第三期臨床試驗 的設計

第8章 開發平台評估

  • 概要
  • 臨床開發的潛力藥物
  • 創新的早期方法

第9章 開發平台(管線)價值分析

  • 主要開發平台藥物的臨床性基準
  • 主要開發平台藥物的商業性基準
  • 競爭評估
  • top line:10年預測

第10章 附錄

圖表

目錄
Product Code: GDHC055POA

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-naive 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

1. Table of Contents

  • 1.1. List of Tables
  • 1.2. List of Figures

2. Introduction

  • 2.1. Catalyst
  • 2.2. Related Reports
  • 2.3. Upcoming Related Reports

3. Disease Overview

  • 3.1. Etiology and Pathophysiology
    • 3.1.1. Etiology
    • 3.1.2. Pathophysiology
  • 3.2. Symptoms
  • 3.3. Diagnosis
  • 3.4. Clinical Staging
  • 3.5. Prognostic Factors
  • 3.6. Quality of Life

4. Epidemiology

  • 4.1. Disease Background
  • 4.2. Risk Factors and Comorbidities
  • 4.3. Global Trends
    • 4.3.1. Incidence
    • 4.3.2. Stage at Diagnosis
    • 4.3.3. Relative Survival
  • 4.4. Forecast Methodology
    • 4.4.1. Sources Used
    • 4.4.2. Sources Not Used
    • 4.4.3. Forecast Assumptions and Methods
  • 4.5. Epidemiological Forecast for SCLC (2014-2024)
    • 4.5.1. Diagnosed Incident Cases of SCLC
    • 4.5.2. Age-Specific Incident Cases of SCLC
    • 4.5.3. Sex-Specific Incident Cases of SCLC
    • 4.5.4. Age-Standardized Incidence of SCLC
    • 4.5.5. Stage-Specific Incident Cases of SCLC
    • 4.5.6. Five-Year Diagnosed Prevalent Cases of SCLC
    • 4.5.7. Five-Year Diagnosed Prevalent Cases of SCLC Segmented by Stage
  • 4.6. Discussion
    • 4.6.1. Epidemiological Forecast Insight
    • 4.6.2. Limitations of the Analysis
    • 4.6.3. Strengths of the Analysis

5. Current Treatment Options

  • 5.1. First-Line Therapy
  • 5.2. Second-Line Therapy
  • 5.3. Subsequent Lines of Therapy

6. Unmet Needs Assessment and Opportunity Analysis

  • 6.1. Overview
  • 6.2. Unmet Needs Analysis
    • 6.2.1. Early Diagnosis of Disease
    • 6.2.2. Therapies That Improve Overall Survival
    • 6.2.3. More Effective and Tolerable Therapies for Relapsed/Refractory Disease
    • 6.2.4. Discovery of Predictive Biomarkers and Understanding of the Underlying Causes of Disease
    • 6.2.5. Smoking Cessation Programs
  • 6.3. Opportunity Analysis
    • 6.3.1. Standardized Methods for Biomarker Testing
    • 6.3.2. Developing Therapies with an Improved Safety Profile
    • 6.3.3. Understanding the Mechanisms Underlying the Rapid Emergence of Drug and Radiation Resistance
    • 6.3.4. Targeting Pathways Unique to Cancer Stem Cells

7. R&D Strategies

  • 7.1. Overview
    • 7.1.1. Deconstructing the SCLC Genome
    • 7.1.2. New Diagnostic Approaches
    • 7.1.3. Reformulation of Available Chemotherapeutic Agents
    • 7.1.4. Combination Therapy
  • 7.2. Clinical Trial Design
    • 7.2.1. Evolution of Endpoints for Cancer Immunotherapy Trials
    • 7.2.2. Health-Related Quality of Life Endpoints in Oncology Clinical Trials
    • 7.2.3. Design of Current Phase II and III Trials in SCLC

8. Pipeline Assessment

  • 8.1. Overview
  • 8.2. Promising Drugs in Clinical Development
    • 8.2.1. Alisertib (MLN8237)
    • 8.2.2. MGN-1703
    • 8.2.3. NGR-hTNF
    • 8.2.4. Opdivo (nivolumab)
    • 8.2.5. Roniciclib (BAY 1000394)
    • 8.2.6. Sabarubicin (MEN10755)
    • 8.2.7. Sacituzumab Govitecan (IMMU-132)
    • 8.2.8. Sutent (sunitinib malate)
    • 8.2.9. Tarextumab (OMP-59R5)
    • 8.2.10. Yervoy (ipilimumab)
  • 8.3. Innovative Early-Stage Approaches
    • 8.3.1. Rovalpituzumab Tesirine (SC16LD6.5)
    • 8.3.2. Keytruda (pembrolizumab)
    • 8.3.3. PARP Inhibitors
    • 8.3.4. Lurbinectedin (PM01183)

9. Pipeline Valuation Analysis

  • 9.1. Clinical Benchmark of Key Pipeline Drugs
  • 9.2. Commercial Benchmark of Key Pipeline Drugs
  • 9.3. Competitive Assessment
  • 9.4. Top-Line 10-Year Forecast
    • 9.4.1. US
    • 9.4.2. 5EU
    • 9.4.3. Japan

10. Appendix

  • 10.1. Bibliography
  • 10.2. Abbreviations
  • 10.3. Methodology
  • 10.4. Forecasting Methodology
    • 10.4.1. Diagnosed SCLC Patients
    • 10.4.2. Percent Drug-Treated Patients
    • 10.4.3. Drugs Included in Each Therapeutic Class
    • 10.4.4. Launch and Patent Expiry Dates
    • 10.4.5. General Pricing Assumptions
    • 10.4.6. Average Body Weight and Surface Area Across 7MM
    • 10.4.7. Individual Drug Assumptions
    • 10.4.8. Generic Erosion
  • 10.5. Physicians and Specialists Included in this Study
  • 10.6. About the Authors
    • 10.6.1. Authors
    • 10.6.2. Epidemiologist
    • 10.6.3. Global Director of Therapy Analysis and Epidemiology
    • 10.6.4. Global Head of Healthcare
  • 10.7. About GlobalData
  • 10.8. Disclaimer

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
Back to Top