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市場調查報告書

PharmaPoint:非小細胞肺癌 - 全球醫藥品的預測與市場分析

PharmaPoint: Non-Small Cell Lung Cancer (NSCLC) - Global Drug Forecast and Market Analysis to 2025

出版商 GlobalData 商品編碼 307125
出版日期 內容資訊 英文 608 Pages
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PharmaPoint:非小細胞肺癌 - 全球醫藥品的預測與市場分析 PharmaPoint: Non-Small Cell Lung Cancer (NSCLC) - Global Drug Forecast and Market Analysis to 2025
出版日期: 2016年11月03日 內容資訊: 英文 608 Pages
簡介

非小細胞肺癌(NSCLC)是最常見的肺癌,不論男女是第二大患者數的癌症。以前治療範例只有化療,不過自具特殊生物標記的患者取向標靶治療登場以來,市場與各患者對應,分類變得更細。今後這個趨勢也將持續,進行對應各種患者的未滿足需求新藥開發、上市,至今無法治療的患者也預期能夠對應。

本報告提供全球的非小細胞肺癌(NSCLC)市場現況與未來展望相關分析,疾病概要和今後的流行病學預測,主要國家的預防體性,主要企業簡介與代表性產品,市場未滿足需求與未來性的機會,現在臨床實驗中的開發中產品的資訊,今後的市場規模及影響要素等。

第1章 目錄

第2章 簡介

第3章 疾病概要

  • 病因、病理
    • 病因
    • 病理生理學、病歷
    • NSCLC的生物標記
    • 生活品質(QoL)
  • 症狀

第4章 流行病學

  • 風險要素和共生病症
    • 吸煙者比非吸煙者肺癌症風險高
    • 長期暴露於氡提高肺癌症風險
    • 各種癌症的家族病史提高肺癌症風險
    • 結核(TB)提高肺癌症風險、死亡率
    • 慢性阻塞性肺病(COPD):降低肺癌症存活率的共生病症
    • 肺癌篩檢計劃不太有效
    • 在各階段的診斷大幅度提高肺癌症的存活率
  • 全球各地的趨勢
    • 美國
    • 法國
    • 德國
    • 義大利
    • 西班牙
    • 英國
    • 日本
    • 中國
    • 印度
  • 預測手法
    • 利用之資訊來源
    • 未利用之資訊來源
    • 預測的前提條件與手法
  • 流行病學的預測(今後11年份)
    • NSCLC的發病數量、患病人數(總數)
    • NSCLC的發病數量(各年齡)
    • NSCLC的發病數量(男女)
    • NSCLC的已調整年齡的發病數量
    • NSCLC患者的分類
  • 議論
    • 全球各國的疫苗接種率預測
    • 分析的限制
    • 分析的優勢

第5章 疾病的管理

  • 治療概要
    • 診斷
    • 臨床階段
    • 檢驗、早期發現
    • 局部的治療、治療方法
    • 對全身的化療
    • 標靶治療
  • 美國
    • 診斷
    • 臨床診療
  • 法國
  • 德國
  • 義大利
  • 西班牙
  • 英國
  • 日本
  • 中國
  • 印度

第6章 競爭環境

  • 概要
  • 競爭企業的策略性評估
  • 產品簡介:領導品牌--化療
    • Alimta (pemetrexed disodium)
    • Abraxane (nab-Paclitaxel)
  • 產品簡介:領導品牌--標靶治療
    • Avastin(Bevacizumab)
    • Gilotrif(afachinibu)
    • Iressa (Gefitinib)
    • Tarceva (Erlotinib Hydrochloride)
    • Xalkori (Crizotinib)

第7章 市場機會及未滿足需求

  • 概要
  • 整體存活率的改善和毒性的減輕
  • 對有蛋白酪氨酸激酶抑制劑(TKI)後天抗性的患者的治療方法
  • 對扁平表皮細胞癌症患者的更佳治療選擇
  • 防止後退、復發
  • 更有效的第二選擇療法
  • 利用變異性分析可能性的改善
  • 更有成本效率的治療方法
  • 未滿足需求、差距分析

第8章 開發平台評估

  • 概要
  • 臨床實驗製圖(各國)
  • 各Phase、各臨床實驗階段臨床實驗進展
  • 臨床實驗中有前途的醫藥品
    • Onartuzumab (MetMab)
    • Necitumumab (IMC-11F8)
    • Ramucirumab (IMC-1121B)
    • Custirsen (OGX-011)
    • Ganetespib (STA-9090)
    • Nintedanib (BIBF1120)
    • Dacomitinib (PF-00299804)
    • LDK378 (ceritinib)
    • Yervoy (ipilimumab)
    • Nivolumab (BMS936558)
    • MPDL3280A (RG7446)
    • GSK1572932A (MAGE-A3癌症免疫疾病療法)
    • Halaven (Eribulin mesylate)

第9章 現在、未來市場參與企業

  • 概要
  • 企業策略概要
  • 企業簡介
    • Roche/Genentech
    • Pfizer
    • Bristol-Myers Squibb
    • Eli Lilly
    • Boehringer Ingelheim
    • Novartis

第10章 市場預測

  • 全球市場
    • 市場預測
    • 市場促進、阻礙因素:全球的課題
  • 美國
    • 市場預測
    • 近幾年主要的事件
    • 市場促進、阻礙因素
  • 法國
  • 德國
  • 義大利
  • 西班牙
  • 英國
  • 日本
  • 中國
  • 印度

第11章 附錄

圖表一覽

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目錄
Product Code: GDHC134PIDR

Lung cancer is currently the most common cancer in the world, and is the most common cause of death from cancer worldwide. Of the total lung cancer incident cases, approximately 85% are the non-small cell lung cancer (NSCLC) subtype. NSCLC patients are usually diagnosed in the later stages of the disease, resulting in a poor prognosis.

NSCLC market in the 8MM in 2015 was US$6.21B. Just over half of these sales, US$3.25B (52.4%), were generated in the US, with the 5EU representing the next largest region by sales, estimated at US$1.53B (24.5%). Japan and China contributed the smallest proportions of sales to the global NSCLC market, with 2015 sales of US$981M (15.8%) and US$445M (7.2%), respectively.

By the end of the forecast period in 2025, GlobalData projects NSCLC sales to rise to US$26.71B in the 8MM, at a moderate Compound Annual Growth Rate (CAGR) of 15.7%. In particular, GlobalData expects the China NSCLC market to grow most rapidly, increasing to US$4.3B (16.1% of global NSCLC shares) by 2025 at a robust CAGR of 25.4%.

As per Cai Xuan, Analyst, explains: “NSCLC space was largely dominated by generic chemotherapy and targeted therapies, which accounted for around 94% of the market, while immuno-oncology sales accounted for just 6%. In 2025, that trend will be reversed, with 65% of the total NSCLC market going to immuno-oncology therapies, and the remaining 35% being split between chemotherapy and targeted agents.”

The report “PharmaPoint: Non-Small Cell Lung Cancer (NSCLC) - Global Drug Forecast and Market Analysis to 2025” provides an overview of NSCLC, including epidemiology, etiology, pathophysiology, symptoms, diagnosis, and current treatment options. Additionally, this report provides comprehensive data split across different phases, emerging novel trends under development, synopses of innovative early-stage projects, and also detailed analysis of late-stage pipeline products and topline NSCLC drug market revenue from 2015-2025, annual cost of therapy (ACOT), and major product sales in 17 patient segments during the forecast period are included.

Companies mentioned in this report: Abbvie, Amgen, Ariad Pharmaceuticals, Astellas Pharma, AstraZeneca, Betta Pharmaceuticals, BeyondSpring Pharmaceuticals, Bioven Group, Boehringer Ingelheim, Bristol Myers Squibb, Eli Lilly, Hanmi Pharmacuticals, Hutchison MediPharma, Immunomedics, Merck & Co., Merck KGaA, Merrimack Pharmaceuticals, Novartis, Ono Pharmaceutical, OSE Immunotherapeutics, Pfizer, Roche/Genentech, Xcovery Holding Company.

Table of Contents

1 Table of Contents 10

  • 1.1 List of Tables 14
  • 1.2 List of Figures 26

2 Introduction 30

  • 2.1 Catalyst 30
  • 2.2 Related Reports 30
  • 2.3 Upcoming Related Reports 31

3 Disease Overview 32

  • 3.1 Etiology and Pathophysiology 32
  • 3.2 Classification or Staging Systems 36
  • 3.3 Symptoms 39
  • 3.4 Prognosis 40
  • 3.5 Quality of Life 42

4 Epidemiology 43

  • 4.1 Disease Background 43
  • 4.2 Risk Factors and Comorbidities 44
  • 4.3 Global Trends 46
  • 4.4 Forecast Methodology 49
  • 4.5 Epidemiological Forecast for NSCLC (2015-2025) - Base Forecast 72
  • 4.6 Epidemiological Forecast for NSCLC (2015-2025) - Alternate Forecast 86
  • 4.7 Discussion 89

5 Disease Management 92

  • 5.1 Diagnosis and Treatment Overview 92
  • 5.2 US 102
  • 5.3 France 103
  • 5.4 Germany 104
  • 5.5 Italy 105
  • 5.6 Spain 106
  • 5.7 UK 107
  • 5.8 Japan 108
  • 5.9 China 109

6 Competitive Assessment 110

  • 6.1 Overview 110
  • 6.2 Product Profiles - Major Brands, Epidermal Growth Factor Receptor-Targeting 112
  • 6.3 Product Profiles - Major Brands, Anaplastic Lymphoma Kinase-Targeting 160
  • 6.4 Product Profiles - Major Brands, Monoclonal Antibodies 181
  • 6.5 Product Profiles - Major Brands, Other 216
  • 6.6 Chemotherapies 231

7 Unmet Needs Assessment and Opportunity Analysis 233

  • 7.1 Overview 233
  • 7.2 First-Line Treatments That Extend Overall Survival in Advanced-Stage Nonsquamous NSCLC Without Actionable Mutations 235
  • 7.3 Therapies Targeting Novel Biomarkers 238
  • 7.4 Treatment Options for Squamous Patients in the First-Line and Third-Line Setting 242
  • 7.5 Alternative Testing Options for Patients with Insufficient Biopsy Material 247
  • 7.6 Treatments for Patients with Acquired Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor Resistance 251

8 Pipeline Assessment 256

  • 8.1 Overview 256
  • 8.2 Promising Drugs in Clinical Development 258
  • 8.3 Promising Drugs in Early-Stage Development 423

9 Current and Future Players 447

  • 9.1 Overview 447
  • 9.2 Trends in Corporate Strategy 452
  • 9.3 Company Profiles 455

10 Market Outlook 478

  • 10.1 Global Markets 478
  • 10.2 US 485
  • 10.3 5EU 492
  • 10.4 Japan 499
  • 10.5 China 505

11 Appendix 512

  • 11.1 Bibliography 512
  • 11.2 Abbreviations 558
  • 11.3 Methodology 569
  • 11.4 Forecasting Methodology 569
  • 11.5 Primary Research - KOLs 596
  • 11.6 About the Authors 600
  • 11.7 About GlobalData 603
  • 11.8 Disclaimer 603

List of Tables

  • Table 1: Definitions Used in the AJCC Lung Cancer Staging System 41
  • Table 2: AJCC Staging of NSCLC 42
  • Table 3: Symptoms of NSCLC 44
  • Table 4: Prognostic Factors for NSCLC 45
  • Table 5: Prognosis for NSCLC Based on Initial Staging 45
  • Table 6: Risk Factors and Comorbidities for Lung Cancer 49
  • Table 7: Histological Subtype Distribution Among NSCLC 52
  • Table 8: 8MM, Relative Survival 53
  • Table 9: 8MM, Sources Used for Diagnosed Incidence of NSCLC 54
  • Table 10: 8MM, Sources Used for Cancer Stage at Diagnosis 55
  • Table 11: 8MM, Sources Used for NSCLC by Histological Subtypes 57
  • Table 12: US, Sources Used for Diagnosed Incident Cases of NSCLC Segmented by Mutation 58
  • Table 13: 5EU, Sources Used for Diagnosed Incident Cases of NSCLC Segmented by Mutation 59
  • Table 14: Japan, Sources Used for Diagnosed Incident Cases of NSCLC Segmented by Mutation 61
  • Table 15: China (Urban), Sources Used for Diagnosed Incident Cases of NSCLC Segmented by Mutation 62
  • Table 16: 8MM, Sources Used for Relative Survival of NSCLC 63
  • Table 17: 8MM, Diagnosed Incident Cases of NSCLC, Both Sexes, Ages ≥18 Years, N, Select Years 2015-2025 77
  • Table 18: 8MM, Age-Specific Diagnosed Incident Cases of NSCLC, Both Sexes, N (Row %), 2015 79
  • Table 19: 8MM, Sex-Specific Diagnosed Incident Cases of NSCLC, Ages ≥18 Years, N (Row %), 2015 81
  • Table 20: 8MM, Diagnosed Incident Cases of NSCLC by Clinical Stage at Diagnosis, Ages ≥18 Years, N, 2015 84
  • Table 21: 8MM, Diagnosed Incident Cases of NSCLC by Histological Subtypes, Ages ≥18 Years, N, 2015 85
  • Table 22: 8MM, Mutations Among Diagnosed Incident Cases of ADC, Both Sexes, Ages ≥18 Years, N, 2015 86
  • Table 23: 8MM, Mutations Among Diagnosed Incident Cases of SCC, Both Sexes, Ages ≥18 Years, N, 2015 87
  • Table 24: 8MM, Mutations Among Diagnosed Incident Cases of NSCLC, Both Sexes, N, Ages ≥18 Years, 2015 88
  • Table 25: 8MM, Five-Year Diagnosed Prevalent Cases of NSCLC, Both Sexes, Ages ≥18 Years, N, Select Years 2015-2025 89
  • Table 26: 8MM, Alternate Forecast, Diagnosed Incident Cases of NSCLC by Histology Subtypes, Ages ≥18 Years, N, 2015 and 2025 91
  • Table 27: 8MM, Alternate Forecast, Five-Year Diagnosed Prevalent Cases of NSCLC, Both Sexes, Ages ≥18 Years, N, Select Years 2015-2025 93
  • Table 28: Prevalence of Brain and Bone Metastases in NSCLC 97
  • Table 29: Biomarker Testing Rates in Nonsquamous NSCLC 98
  • Table 30: Biomarker Testing Rates in Squamous NSCLC 99
  • Table 31: Treatment Guidelines for NSCLC 100
  • Table 32: Most Prescribed Drugs for NSCLC by Class in the 8MM, 2015-2025 100
  • Table 33: Country Profile - US 106
  • Table 34: Country Profile - France 107
  • Table 35: Country Profile - Germany 108
  • Table 36: Country Profile - Italy 109
  • Table 37: Country Profile - Spain 110
  • Table 38: Country Profile - UK 111
  • Table 39: Country Profile - Japan 112
  • Table 40: Country Profile - China 113
  • Table 41: Leading Treatments for NSCLC, 2016 115
  • Table 42: Marketed EGFR TKIs in NSCLC 118
  • Table 43: Product Profile - Tarceva 123
  • Table 44: Efficacy of Tarceva in First-Line Therapy, EGFR-mutant NSCLC 127
  • Table 45: Efficacy of Tarceva in Maintenance Therapy in NSCLC 128
  • Table 46: Efficacy of Tarceva in Second- and Third-Line Therapy in NSCLC 129
  • Table 47: Safety of Tarceva 130
  • Table 48: Tarceva SWOT Analysis, 2016 131
  • Table 49: Product Profile - Iressa 132
  • Table 50: Efficacy of Iressa in First-Line, EGFR-Mutant NSCLC (Study 1) 135
  • Table 51: Efficacy of Iressa in First-Line, EGFR-Mutant ADC NSCLC (Study 2) 135
  • Table 52: Safety of Iressa 136
  • Table 53: Iressa SWOT Analysis, 2016 137
  • Table 54: Product Profile - Gilotrif 139
  • Table 55: Efficacy of Gilotrif in First-Line, EGFR-Mutant ADC 142
  • Table 56: Efficacy of Gilotrif in First-Line, EGFR-Mutant ADC 143
  • Table 57: Efficacy of Gilotrif in Second-Line, EGFR-Wildtype, EGFR TKI-Naive, Squamous NSCLC 143
  • Table 58: Efficacy of Gilotrif in Fourth-Line, EGFR-Mutant NSCLC 144
  • Table 59: Safety of Gilotrif 145
  • Table 60: Gilotrif SWOT Analysis, 2016 146
  • Table 61: Product Profile - Tagrisso 147
  • Table 62: Efficacy of Tagrisso in Second-Line, EGFR-Mutant NSCLC 150
  • Table 63: Safety of Tagrisso 151
  • Table 64: Tagrisso SWOT Analysis, 2016 152
  • Table 65: Product Profile - Portrazza 154
  • Table 66: Efficacy of Portrazza in First-Line, Squamous NSCLC 156
  • Table 67: Safety of Portrazza 157
  • Table 68: Portrazza SWOT Analysis, 2016 158
  • Table 69: Efficacy of Conmana in 2L Advanced NSCLC 161
  • Table 70: Efficacy of Conmana in 1L EGFR-mutant NSCLC 161
  • Table 71: Safety of Conmana 162
  • Table 72: Conmana SWOT Analysis, 2016 163
  • Table 73: Marketed ALK TKIs in NSCLC 164
  • Table 74: Product Profile - Xalkori 167
  • Table 75: Efficacy of Xalkori in Treatment-Naive ALK+ Metastatic NSCLC 169
  • Table 76: Efficacy of Xalkori in Previously Treated ALK+ Metastatic NSCLC 170
  • Table 77: Safety of Xalkori in Treatment-Naive, ALK+ Metastatic NSCLC 172
  • Table 78: Safety of Xalkori in Previously Treated, Metastatic NSCLC 173
  • Table 79: Xalkori SWOT Analysis, 2016 174
  • Table 80: Product Profile - Zykadia 175
  • Table 81: Efficacy of Zykadia 177
  • Table 82: Safety of Zykadia 178
  • Table 83: Zykadia SWOT Analysis, 2016 179
  • Table 84: Product Profile - Alecensa 180
  • Table 85: Efficacy of Alecensa 182
  • Table 86: Efficacy of Alecensa in NSCLC patients with CNS lesions 182
  • Table 87: Safety of Alecensa 184
  • Table 88: Alecensa SWOT Analysis, 2016 185
  • Table 89: Marketed PD-1/PD-L1 ICIs in NSCLC 186
  • Table 90: Product Profile - Opdivo 191
  • Table 91: Efficacy of Opdivo in Metastatic Squamous NSCLC 194
  • Table 92: Efficacy of Opdivo in Metastatic Nonsquamous NSCLC 195
  • Table 93: Safety of Opdivo 196
  • Table 94: Opdivo SWOT Analysis, 2016 197
  • Table 95: Product Profile - Keytruda 199
  • Table 96: Efficacy of Keytruda 202
  • Table 97: Safety of Keytruda 203
  • Table 98: Keytruda SWOT Analysis, 2016 204
  • Table 99: Product Profile - Tecentriq (atezolizumab) 206
  • Table 100: Patient Demographics in the Phase II POPLAR Trial (NCT01903993) 209
  • Table 101: Efficacy of Tecentriq in the Phase II POPLAR Trial (NCT01903993) 211
  • Table 102: Efficacy of Tecentriq in the Phase III OAK Trial (NCT02008227) 212
  • Table 103: Patient Demographics in the Phase II FIR Trial (NCT01846416) 213
  • Table 104: Efficacy of Tecentriq in the Phase II FIR Trial (NCT01846416) 214
  • Table 105: Efficacy of Tecentriq in the Phase II BIRCH Trial (NCT02031458) 216
  • Table 106: Safety of Tecentriq in the Phase II POPLAR Trial (NCT01903993) 217
  • Table 107: Safety of Tecentriq in the Phase II FIR Trial (NCT01846416) 218
  • Table 108: Tecentriq SWOT Analysis, 2016 219
  • Table 109: Product Profile - Avastin 221
  • Table 110: Efficacy of Avastin in Nonsquamous NSCLC 224
  • Table 111: Safety of Avastin 225
  • Table 112: Avastin SWOT Analysis, 2016 225
  • Table 113: Product Profile - Cyramza 227
  • Table 114: Efficacy of Cyramza 229
  • Table 115: Safety of Cyramza 230
  • Table 116: Cyramza SWOT Analysis, 2016 231
  • Table 117: Product Profile - Vargatef 232
  • Table 118: Efficacy of Vargatef in ADC NSCLC 233
  • Table 119: Safety of Vargatef in ADC NSCLC 234
  • Table 120: Vargatef SWOT Analysis, 2016 235
  • Table 121: Summary of Chemotherapies, 2015 236
  • Table 122: Unmet Need and Opportunity in NSCLC 239
  • Table 123: Product Profile - Yervoy (ipilimumab) 267
  • Table 124: Demographics in the Phase II NCT00527735 Trial 269
  • Table 125: Efficacy of Yervoy + Carboplatin + Paclitaxel in Advanced NSCLC (NCT00527735) 271
  • Table 126: Demographics in the Phase I CheckMate 012 Trial (NCT01454102) 272
  • Table 127: Efficacy of the Opdivo + Yervoy Combination in the CheckMate 012 Trial (NCT01454102) 273
  • Table 128: Safety of Yervoy (ipilimumab) + Carboplatin + Paclitaxel in Advanced NSCLC (NCT00527735) 275
  • Table 129: Safety of the Opdivo + Yervoy Combination in the CheckMate 012 Trial (NCT01454102) 276
  • Table 130: Yervoy SWOT Analysis, 2016 278
  • Table 131: Product Profile - Avelumab (MSB-0010718C) 281
  • Table 132: Patient Demographics in the Phase Ib Dose-Expansion Study (NCT01772004) 283
  • Table 133: Efficacy of Avelumab in the Phase Ib Dose-Expansion Study (NCT01772004) 284
  • Table 134: Efficacy of Avelumab in PD-L1-Positive and -Negative NSCLC 285
  • Table 135: Demographics in the Treatment-Naive NSCLC Cohort in the Phase I Trial (NCT01772004) 286
  • Table 136: Efficacy of Avelumab in Treatment-Naive NSCLC 287
  • Table 137: Unconfirmed ORR According to PD-L1 Expression in Treatment-Naive NSCLC 288
  • Table 138: Safety of Avelumab in the Phase Ib Dose-Expansion Study (NCT01772004) 289
  • Table 139: Safety of Avelumab in Treatment-Naive NSCLC (NCT01772004) 290
  • Table 140: Avelumab SWOT Analysis, 2016 292
  • Table 141: Product Profile - Durvalumab (MEDI4736) 294
  • Table 142: Patient Demographics and Disease Characteristics in the Phase I/II NCT01693562 Trial 297
  • Table 143: Efficacy of Durvalumab in the Phase I/II NCT01693562 Trial 298
  • Table 144: Baseline Characteristics of Patients With Treatment-Naive NSCLC in the Phase I/II 299
  • Table 145: Efficacy of Durvalumab in Treatment-Naive NSCLC 300
  • Table 146: Patient Demographics and Disease Characteristics in the Phase Ib NCT02000947 Trial 301
  • Table 147: Efficacy of Durvalumab + Tremelimumab in the Phase Ib NCT02000947 Trial 303
  • Table 148: Safety of Durvalumab in the Phase I/II Trial (NCT01693562) 304
  • Table 149: Safety of Durvalumab in Treatment-Naive NSCLC 305
  • Table 150: Safety of Durvalumab + Tremelimumab in the Phase Ib NCT02000947 Trial 306
  • Table 151: Durvalumab SWOT Analysis, 2016 308
  • Table 152: Product Profile - Naquotinib Mesylate (ASP8273) 312
  • Table 153: Patient Demographics in the Phase I/II NCT02192697 and Phase I NCT02113813 Trials 313
  • Table 154: Efficacy of Naquotinib in EGFR-Mutant NSCLC in Japanese and US Patients 314
  • Table 155: Safety of Naquotinib in EGFR-Mutant NSCLC in Japanese and US Patients 315
  • Table 156: Naquotinib SWOT Analysis, 2016 316
  • Table 157: Product Profile - Olmutinib (BI 1482694; HM61713) 317
  • Table 158: Demographics in the Phase I/II NCT01588145 Trial 319
  • Table 159: Efficacy of Olmutinib in the Phase II Portion of the NCT01588145 Trial 320
  • Table 160: Safety Profile of Olmutinib in the Phase II Portion of the NCT01588145 Trial 321
  • Table 161: Olmutinib SWOT Analysis, 2016 322
  • Table 162: Product Profile - Dacomitinib 324
  • Table 163: Demographics in the Phase II NCT00818441 Trial 326
  • Table 164: Efficacy of Dacomitinib in the Phase II NCT00818441 Trial 327
  • Table 165: Safety of Dacomitinib in Phase II NCT00818441 Trial 329
  • Table 166: Dacomitinib SWOT Analysis, 2016 330
  • Table 167: Product Profile - Ensartinib 333
  • Table 168: Baseline Patient Characteristics in the Phase I/II eXalt2 Trial (NCT0162534) 334
  • Table 169: Efficacy of Ensartinib in the Phase I/II eXalt2 Trial (NCT0162534) 335
  • Table 170: Baseline Patient Characteristics in the Expansion Cohort of the Phase I/II eXalt2 Trial 336
  • Table 171: Efficacy of Ensartinib in the Expansion Phase of the eXalt2 Trial (NCT0162534) 337
  • Table 172: Safety of Ensartinib in the Phase I/II eXalt2 Trial (NCT0162534) 338
  • Table 173: Ensartinib SWOT Analysis, 2016 339
  • Table 174: Product Profile - Brigatinib 341
  • Table 175: Baseline Patient Characteristics in the Phase II ALTA Trial (NCT02094573) 343
  • Table 176: Efficacy of Brigatinib in the Phase II ALTA Trial (NCT02094573) 344
  • Table 177: Efficacy of Brigatinib in ALK+ NSCLC with Intracranial CNS Metastases 345
  • Table 178: Safety of Brigatinib in the Phase II ALTA Trial (NCT02094573) 346
  • Table 179: Brigatinib SWOT Analysis, 2016 347
  • Table 180: Product Profile - CimaVax-EGF 350
  • Table 181: Demographics in the Phase III trial of the CimaVax-EGF in Cuba 352
  • Table 182: Efficacy of the CimaVax-EGF in the Phase III trial in Cuba 353
  • Table 183: Safety of the CimaVax-EGF in the Phase III Trial in Cuba 354
  • Table 184: CimaVax-EGF SWOT Analysis, 2016 356
  • Table 185: Product Profile - Tedopi 358
  • Table 186: Demographics in the Phase II Trial of Tedopi in Advanced NSCLC 359
  • Table 187: Efficacy of Tedopi in Advanced NSCLC 360
  • Table 188: Tedopi SWOT Analysis, 2016 362
  • Table 189: Product Profile - Anlotinib 364
  • Table 190: Efficacy of Anlotinib in Pretreated NSCLC in the Phase II ALTER0302 Trial 365
  • Table 191: Anlotinib SWOT Analysis, 2016 366
  • Table 192: Product Profile - Aitan 368
  • Table 193: Efficacy of Aitan in Pretreated Nonsquamous NSCLC 369
  • Table 194: Aitan SWOT Analysis, 2016 370
  • Table 195: Product Profile - Fruquintinib 372
  • Table 196: Baseline Demographics in the Phase I Trial (HMP, NCT01645215) of Fruquintinib 373
  • Table 197: Efficacy of Fruquintinib in Advanced Solid Tumors 374
  • Table 198: Safety of Fruquintinib in Advanced Solid Tumors 375
  • Table 199: Fruquintinib SWOT Analysis, 2016 376
  • Table 200: Efficacy and Safety of ABP 215 in NSCLC in the Phase III Trial (NCT01966003) 379
  • Table 201: Product Profile - Abemaciclib 383
  • Table 202: Efficacy of Abemaciclib Monotherapy in Previously Treated NSCLC (NCT01394016) 385
  • Table 203: Efficacy of Abemaciclib in Combination with Other Therapies (NCT02079636) 386
  • Table 204: Safety of Abemaciclib in Combination with Multiple Single Agents 387
  • Table 205: Abemaciclib SWOT Analysis, 2016 389
  • Table 206: Product Profile - Tafinlar + Mekinist 391
  • Table 207: Demographics in Cohort B of the Pivotal Phase II BRF113928 Trial (GSK, NCT01336634) 393
  • Table 208: Efficacy of Tafinlar + Mekinist in Previously Treated BRAF V600E+ NSCLC 394
  • Table 209: Safety of Tafinlar + Mekinist in Previously Treated BRAF V600E+ NSCLC 395

List of Figures

  • Figure 1: 8MM, Diagnosed Incident Cases of NSCLC, Both Sexes, Ages ≥18 Years, N, Select Years 2015-2025 77
  • Figure 2: 8MM, Age-Specific Diagnosed Incident Cases of NSCLC, Both Sexes, N, 2015 80
  • Figure 3: 8MM, Sex-Specific Diagnosed Incident Cases of NSCLC, Ages ≥18 Years, N, 2015 82
  • Figure 4: 8MM, Age-Standardized Diagnosed Incidence of NSCLC, Ages ≥18 Years, N, 2015 83
  • Figure 5: 8MM, Five-Year Diagnosed Prevalent Cases of NSCLC, Both Sexes, Ages ≥18 Years, N, Select Years 2015-2025 90
  • Figure 6: Disease Management Flowchart for nonsquamous NSCLC 102
  • Figure 7: Disease Management Flowchart for squamous NSCLC 103
  • Figure 8: Disease Management Flowchart for EGFR+ NSCLC 104
  • Figure 9: Disease Management Flowchart for ALK+ NSCLC 105
  • Figure 10: Tarceva's Phase III Development in NSCLC 124
  • Figure 11: Iressa's Phase II Development in NSCLC 133
  • Figure 12: Gilotrif's Phase III Development in NSCLC 141
  • Figure 13: Tagrisso's Phase III Development in NSCLC 148
  • Figure 14: Portrazza's Phase II Development in NSCLC 155
  • Figure 15: Conmana's Phase III Development in NSCLC 160
  • Figure 16: Xalkori's Development in NSCLC 168
  • Figure 17: Zykadia's Development in NSCLC 176
  • Figure 18: Alecensa's Development in NSCLC 181
  • Figure 19: Opdivo's Development in NSCLC 193
  • Figure 20: Keytruda's Phase III Development in NSCLC 201
  • Figure 21: Tecentriq's Clincal Development in NSCLC 208
  • Figure 22: Avastin's Phase III Development in NSCLC 222
  • Figure 23: Cyramza's Phase III Development in NSCLC 228
  • Figure 24: Vargatef's Phase II Development in NSCLC 233
  • Figure 25: NSCLC - Phase II/III Pipeline, 2016, Part I 262
  • Figure 26: NSCLC - Phase II/III Pipeline, 2016, Part II 263
  • Figure 27: Competitive Assessment of Late-Stage Pipeline Agents in NSCLC, 2015-2025 264
  • Figure 28: Yervoy's Clinical Development in NSCLC 268
  • Figure 29: Clinical and Commercial Positioning of Yervoy 277
  • Figure 30: Estimated Sales of Ipilimumab Biosimilars Versus Branded Yervoy in NSCLC, 2015-2025 279
  • Figure 31: Avelumab's Development in NSCLC 282
  • Figure 32: Clinical and Commercial Positioning of Avelumab 291
  • Figure 33: Durvalumab's Clinical Development in NSCLC 295
  • Figure 34: Clinical and Commercial Positioning of Durvalumab 307
  • Figure 35: Naquotinib's Clincal Development in NSCLC 312
  • Figure 36: Clinical and Commercial Positioning of Naquotinib 315
  • Figure 37: Olmutinib's Clincal Development in NSCLC 318
  • Figure 38: Clinical and Commercial Positioning of Olmutinib 321
  • Figure 39: Dacomitinib's Clinical Development in NSCLC 324
  • Figure 40: Clinical and Commercial Positioning of Dacomitinib 330
  • Figure 41: Ensartinib's Clinical Development in NSCLC 333
  • Figure 42: Clinical and Commercial Positioning of Ensartinib 338
  • Figure 43: Brigatinib's Clinical Development in NSCLC 342
  • Figure 44: Clinical and Commercial Positioning of Brigatinib 347
  • Figure 45: CimaVax-EGF's Clinical Development in NSCLC 351
  • Figure 46: Clinical and Commercial Positioning of CimaVax-EGF 355
  • Figure 47: Tedopi's Clinical Development in NSCLC 358
  • Figure 48: Clinical and Commercial Positioning of Tedopi 361
  • Figure 49: Anlotinib's Clinical Development in NSCLC 364
  • Figure 50: Clinical and Commercial Positioning of Anlotinib 366
  • Figure 51: Aitan's Clinical Development in NSCLC 368
  • Figure 52: Clinical and Commercial Positioning of Aitan 370
  • Figure 53: Fruquintinib's Clinical Development in NSCLC 372
  • Figure 54: Clinical and Commercial Positioning of Fruquintinib 376
  • Figure 55: Clinical Development of Avastin Biosimilars in NSCLC 378
  • Figure 56: Estimated Sales of Bevacizumab Biosimilars Versus Branded Avastin in NSCLC, 2015-2025 380
  • Figure 57: Abemaciclib's Clinical Development in NSCLC 384
  • Figure 58: Clinical and Commercial Positioning of Abemaciclib 388
  • Figure 59: Tafinlar + Mekinist's Clinical Development in NSCLC 392
  • Figure 60: Clinical and Commercial Positioning of Tafinlar + Mekinist 396
  • Figure 61: Veliparib's Clinical Development in NSCLC 400
  • Figure 62: Clinical and Commercial Positioning of Veliparib 405
  • Figure 63: MM-121's Clinical Development in NSCLC 408
  • Figure 64: Clinical and Commercial Positioning of MM-121 412
  • Figure 65: IMMU-132's Clinical Development in NSCLC 415
  • Figure 66: Clinical and Commercial Positioning of IMMU-132 420
  • Figure 67: Plinabulin's Clinical Development in NSCLC 423
  • Figure 68: Clinical and Commercial Positioning of Plinabulin 425
  • Figure 69: Global Sales of Branded Products for NSCLC by Company, 2015-2025 455
  • Figure 70: Company Portfolio Gap Analysis in NSCLC, 2015-2025 456
  • Figure 71: Roche/Genentech SWOT Analysis in NSCLC, 2016 462
  • Figure 72: Eli Lilly SWOT Analysis in NSCLC, 2016 465
  • Figure 73: Pfizer SWOT Analysis in NSCLC, 2016 468
  • Figure 74: AZ SWOT Analysis in NSCLC, 2016 471
  • Figure 75: BMS SWOT Analysis in NSCLC, 2016 474
  • Figure 76: Merck & Co. SWOT Analysis in NSCLC, 2016 477
  • Figure 77: Novartis SWOT Analysis in NSCLC, 2016 479
  • Figure 78: BI SWOT Analysis in NSCLC, 2016 481
  • Figure 79: Global Sales for NSCLC (8MM), 2015-2025 483
  • Figure 80: Global Sales for NSCLC (8MM), 2015-2025 484
  • Figure 81: Global Sales for NSCLC (8MM), 2015-2025 485
  • Figure 82: Sales for NSCLC in the US by Drug Class, 2015-2025 491
  • Figure 83: Sales for NSCLC in the 5EU by Drug Class, 2015-2025 498
  • Figure 84: Sales for NSCLC in Japan, 2015-2025 504
  • Figure 85: Sales for NSCLC in urban China by Drug Class, 2015-2025 510
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