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PharmaPoint:非小細胞肺がん - 世界の医薬品の予測と市場分析

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

発行 GlobalData 商品コード 307125
出版日 ページ情報 英文 608 Pages
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PharmaPoint:非小細胞肺がん - 世界の医薬品の予測と市場分析 PharmaPoint: Non-Small Cell Lung Cancer (NSCLC) - Global Drug Forecast and Market Analysis to 2025
出版日: 2016年11月03日 ページ情報: 英文 608 Pages
概要

非小細胞肺がん(NSCLC)は最も一般的な肺がんで、男女を問わず二番目に患者数のおおい癌でもあります。かつて、治療パラダイムは化学療法のみでしたが、特殊なバイオマーカーを有する患者向けの標的療法が登場して以来、市場は各々の患者に対応して、より細かく分類されるようになりました。今後もこの傾向は続き、様々な患者のアンメットニーズに対応した新薬が開発・上市され、これまで治療不可能だった患者にも対応できるようになると期待されます。

当レポートでは、全世界の非小細胞肺がん(NSCLC)市場の現状と将来展望について分析し、疾患の概要や今後の疫学的予測、主要国での予防体性、主要企業のプロファイルと代表的製品、市場のアンメットニーズと将来的な機会、現在治験中のパイプライン製品の情報、今後の市場規模と影響要因などを調査しております。

第1章 目次

第2章 イントロダクション

第3章 疾患の概要

  • 病因・病態
    • 病因
    • 病態生理・病歴
    • NSCLCのバイオマーカー
    • 生活の質(QoL)
  • 症状

第4章 疫学

  • リスク要因と共存症
    • 喫煙者は非喫煙者よりも肺がんリスクが高い
    • ラドンへの長期的被爆は肺がんリスクを高める
    • 各種がんの家族歴は肺がんリスクを高める
    • 結核(TB)は肺がんリスク・死亡率を高める
    • 慢性閉塞性肺疾患(COPD):肺がんの生存率を下げる共存症
    • 肺がん検査プログラムはあまり有効的でない
    • 各ステージでの診断が肺がんの生存率を大幅に高める
  • 世界各地での傾向
    • 米国
    • フランス
    • ドイツ
    • イタリア
    • スペイン
    • 英国
    • 日本
    • 中国
    • インド
  • 予測手法
    • 利用した情報源
    • 利用しなかった情報源
    • 予測の前提条件と手法
  • 疫学的予測(今後11年間分)
    • NSCLCの発症件数・有病者数(総数)
    • NSCLCの発症件数(年齢別)
    • NSCLCの発症件数(男女別)
    • NSCLCの年齢調整済み発症件数
    • NSCLC患者の分類
  • 議論
    • 世界各国のワクチン摂取率の見通し
    • 分析の限界
    • 分析の強み

第5章 疾患の管理

  • 治療の概要
    • 診断
    • 臨床病期
    • 検査・早期発見
    • 局所的処置・治療法
    • 全身への化学療法
    • 標的療法
  • 米国
    • 診断
    • 臨床診療
  • フランス
  • ドイツ
  • イタリア
  • スペイン
  • 英国
  • 日本
  • 中国
  • インド

第6章 競争環境

  • 概要
  • 競合企業の戦略的評価
  • 製品プロファイル:主要ブランド−−化学療法
    • Alimta (ペメトレキセド・二ナトリウム)
    • Abraxane (nab-パクリタキセル)
  • 製品プロファイル:主要ブランド−−標的療法
    • アバスチン(ベバシズマブ)
    • Gilotrif(アファチニブ)
    • Iressa (ゲフィチニブ)
    • Tarceva (塩酸エルロチニブ)
    • Xalkori (クリゾチニブ)

第7章 市場機会とアンメットニーズ

  • 概要
  • 全体的な生存率の改善と毒性の軽減
  • チロシンキナーゼ阻害薬(TKI)の後天的耐性のある患者への治療法
  • 扁平上皮細胞がん患者へのより良い治療オプション
  • 退行・再発防止
  • より効果的な第二選択療法
  • 変異性解析の利用可能性の改善
  • よりコスト効率的な治療法
  • アンメットニーズ・ギャップの分析

第8章 パイプライン評価

  • 概要
  • 治験マッピング(国別)
  • 相別・治験段階別の治験進行状況
  • 治験中の有望な医薬品
    • 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がん免疫療法)
    • Halaven (メシル酸エリブリン)

第9章 現在・将来の市場参入企業

  • 概要
  • 企業戦略の概要
  • 企業プロファイル
    • Roche/Genentech
    • Pfizer
    • Bristol-Myers Squibb
    • Eli Lilly
    • Boehringer Ingelheim
    • Novartis

第10章 市場の見通し

  • 世界市場
    • 市場予測
    • 市場促進・阻害要因:世界的課題
  • 米国
    • 市場予測
    • 近年の主な出来事
    • 市場促進・阻害要因
  • フランス
  • ドイツ
  • イタリア
  • スペイン
  • 英国
  • 日本
  • 中国
  • インド

第11章 付録

図表一覧

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目次
Product Code: GDHC134PIDR

Lung cancer is currently is the most common cause of death from cancer worldwide. Of 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, with poor prognosis. Historically, treatment options for advanced-stage NSCLC patients have been dominated by chemotherapy. However, the launch of targeted therapies such as Iressa (gefitinib) in 2003, Tarceva (erlotinib) in 2004, and Xalkori (crizotinib) in 2011, has shifted the treatment landscape towards personalized medicine.

For the purposes of this report, GlobalData considers the Global NSCLC market to include NSCLC-specific drug sales in the 8MM (US, 5EU [France, Germany Italy, Spain, and the UK], Japan, and China). The current market across these countries is dominated by the sale of major chemotherapy regimens, anti-angiogenic agents and targeted therapies for patients with EGFR+ and ALK+ NSCLC. GlobalData estimated that the Global NSCLC market was valued at $6.2b in 2015. The NSCLC therapeutics market is expected to grow at a positive CAGR of 15.7%, reaching 26.71b in the 8MM by 2025.

The growth of the NSCLC market during the forecast period will be driven partly by increasing incident cases of NSCLC in the US, 5EU, Japan, and China, as the population ages. In addition, the launch of premium-priced immuno-oncology (I/O) and targeted pipeline agents will drive the uptake of new therapies and prolong the duration of treatment in the first-line and beyond. The increased used of branded I/O therapies, such as Keytruda, Opdivo, and Tecentriq will be the primary driver of growth during the forecast period. The projected increase in mutation testing rate during the forecast period coupled with the launch of new generation EGFR and ALK TKIs, and BRAF inhibitors will significantly promote the sales of the targeted therapies, Tagrisso, Alecensa, and Tafinlar + Mekinist.

Highlights

Key Questions Answered

  • Based on interviews with key opinion leaders (KOLs), GlobalData has identified the major unmet needs in the NSCLC marketplace. Will the leading pipeline agents fulfil these unmet needs during the forecast period (2015-2025)?
  • What research and development (R&D) strategies will companies leverage to compete in the future NSCLC marketplace?
  • Which pipeline products are poised to make a major clinical and commercial impact?
  • What clinical and commercial factors are likely to influence NSCLC drug uptake in the 8MM?

Key Findings

  • The increasing incorporation of premium-priced immune checkpoint inhibitor immunotherapies into the NSCLC treatment algorithm, particularly in the first-line setting, will be one major driver. Collectively, immunotherapies will reach $17.5B in sales by 2025, accounting for roughly 65% of total sales in the NSCLC market. Of the $17.5B total, Keytruda, Opdivo, and Tecentriq are projected to contribute $5.2B, $5.5B, and $2.8B, respectively.
  • The increasing incidence of NSCLC in the 8MM will also drive growth. China, in particular, will see its NSCLC incident cases increase dramatically over the forecast period, at an Annual Growth Rate (AGR) of 4.7%. Overall, across the 8MM, the incidence of NSCLC is expected to increase at an AGR of 3.1% from 2015-2025. This increase, coupled with an anticipated increase in branded therapy prescriptions in China, will drive the growth of both the Chinese and global NSCLC markets over the forecast period.
  • Patent expiration of several blockbuster drugs, including Tarceva and Alimta, and the uptake of generics will limit growth. GlobalData expects sales of the patented drug in the 8MM to decrease from $783M in 2015 to $18M by 2025. In addition, sales of Alimta will decrease from $2.1B in 2015 to $54M in 2025.
  • An increasing emphasis on cost-consciousness is anticipated over the forecast period, which will limit premium pricing opportunities for developers of NSCLC 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 NSCLC therapies.

Scope

  • Overview of NSCLC, including epidemiology, etiology, pathophysiology, symptoms, diagnosis, and current treatment options.
  • 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.
  • Key topics covered include strategic competitor assessment, market characterization, unmet needs, opportunities, R&D strategies, and clinical trial mapping for the NSCLC 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.
  • Analysis of the current and future market competition in the global NSCLC 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 NSCLC therapeutics market.
  • Drive revenues by understanding the key trends, innovative products and technologies, market segments, and companies likely to impact the NSCLC 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 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

1.1 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

1.2 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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