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

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 $5.9b in 2015. The NSCLC therapeutics market is expected to grow at a positive CAGR of 11.0%, reaching $16.9b 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.

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?

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.

Companies mentioned

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

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 Classification or Staging Systems

3.3 Symptoms

3.4 Prognosis

3.5 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 Histological Subtypes

4.3.3 Relative Survival

4.4 Forecast Methodology

4.4.1 Sources used

4.4.2 Forecast Assumptions and Methods – Base Forecast

4.4.3 Forecast Assumptions and Methods – Alternate Forecast

4.4.4 Sources Not Used

4.5 Epidemiological Forecast for NSCLC (2015–2025) – Base Forecast

4.5.1 Diagnosed Incident Cases of NSCLC

4.5.2 Age-Specific Diagnosed Incident Cases of NSCLC

4.5.3 Sex-Specific Diagnosed Incident Cases of NSCLC

4.5.4 Age-Standardized Diagnosed Incidence of NSCLC

4.5.5 Diagnosed Incident Cases of NSCLC by Clinical Stage at Diagnosis

4.5.6 Diagnosed Incident Cases of NSCLC by Histology Subtype

4.5.7 Mutations Among Diagnosed Incident Cases of Adenocarcinoma

4.5.8 Mutations Among Diagnosed Incident Cases of Squamous Cell Carcinoma

4.5.9 Mutations Among Diagnosed Incident Cases of NSCLC

4.5.10 Five-Year Diagnosed Prevalent Cases of NSCLC

4.6 Epidemiological Forecast for NSCLC (2015–2025) – Alternate Forecast

4.6.1 Alternate Forecast – Diagnosed Incident Cases of NSCLC by Histology

4.6.2 Alternate Forecast – Five-Year Diagnosed Prevalent Cases of NSCLC

4.7 Discussion

4.7.1 Epidemiological Forecast Insight

4.7.2 Limitations of the Analysis

4.7.3 Strengths of the Analysis

5 Disease Management

5.1 Diagnosis and Treatment Overview

5.1.1 Diagnosis

5.1.2 Treatment Guidelines and Leading Prescribed Drugs

5.1.3 Clinical Practice

5.2 US

5.3 France

5.4 Germany

5.5 Italy

5.6 Spain

5.7 UK

5.8 Japan

5.9 China

6 Competitive Assessment

6.1 Overview

6.2 Product Profiles – Major Brands, Epidermal Growth Factor Receptor-Targeting

6.2.1 Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitors

6.2.2 Tarceva (erlotinib hydrochloride)

6.2.3 Iressa (gefitinib)

6.2.4 Gilotrif (afatinib)

6.2.5 Tagrisso (osimertinib)

6.2.6 Portrazza (necitumumab)

6.2.7 Conmana (icotinib)

6.3 Product Profiles – Major Brands, Anaplastic Lymphoma Kinase-Targeting

6.3.1 Anaplastic Lymphoma Kinase Tyrosine Kinase Inhibitors

6.3.2 Xalkori (crizotinib)

6.3.3 Zykadia (ceritinib)

6.3.4 Alecensa (alectinib)

6.4 Product Profiles – Major Brands, Monoclonal Antibodies

6.4.1 Programmed Cell Death Protein 1/Programmed Death Ligand 1 Immune Checkpoint Inhibitors

6.4.2 Opdivo (nivolumab)

6.4.3 Keytruda (pembrolizumab)

6.4.4 Tecentriq (atezolizumab)

6.5 Product Profiles – Major Brands, Other

6.5.1 Avastin (bevacizumab)

6.5.2 Cyramza (ramucirumab)

6.5.3 Vargatef/Ofev (nintedanib)

6.6 Chemotherapies

7 Unmet Needs Assessment and Opportunity Analysis

7.1 Overview

7.2 First-Line Treatments That Extend Overall Survival in Advanced-Stage Nonsquamous NSCLC Without Actionable Mutations

7.2.1 Unmet Need

7.2.2 Gap Analysis

7.2.3 Opportunity

7.3 Therapies Targeting Novel Biomarkers

7.3.1 Unmet Need

7.3.2 Gap Analysis

7.3.3 Opportunity

7.4 Treatment Options for Squamous Patients in the First-Line and Third-Line Setting

7.4.1 Unmet Need

7.4.2 Gap Analysis

7.4.3 Opportunity

7.5 Alternative Testing Options for Patients with Insufficient Biopsy Material

7.5.1 Unmet Need

7.5.2 Gap Analysis

7.5.3 Opportunity

7.6 Treatments for Patients with Acquired Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor Resistance

7.6.1 Unmet Need

7.6.2 Gap Analysis

7.6.3 Opportunity

8 Pipeline Assessment

8.1 Overview

8.2 Promising Drugs in Clinical Development

8.2.1 Immune Checkpoint Inhibitors

8.2.2 Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitors

8.2.3 Anaplastic Lymphoma Kinase Tyrosine Kinase Inhibitors

8.2.4 Therapeutic Cancer Vaccines

8.2.5 Anti-angiogenic Therapies

8.2.6 Avastin (bevacizumab) Biosimilars

8.2.7 KRAS Inhibitors

8.2.8 Tafinlar (dabrafenib) + Mekinist (trametinib)

8.2.9 Veliparib (ABT-888)

8.2.10 Seribantumab (MM-121)

8.2.11 IMMU-132 (sacituzumab govitecan)

8.2.12 Plinabulin (NPI-2358)

8.3 Promising Drugs in Early-Stage Development

8.3.1 Immune Checkpoint Inhibitors

8.3.2 Anaplastic Lymphoma Kinase Inhibitors

8.3.3 Neurotropic Tropomyosin-Related Kinase Inhibitors

8.3.4 MET inhibitors

8.3.5 Rearranged During Transfection Inhibitors

8.3.6 Human Epidermal Growth Factor 2 Inhibitors

8.3.7 PI3K Pathway Inhibitors

9 Current and Future Players

9.1 Overview

9.2 Trends in Corporate Strategy

9.3 Company Profiles

9.3.1 Roche/Genentech

9.3.2 Eli Lilly

9.3.3 Pfizer

9.3.4 AstraZeneca

9.3.5 Bristol-Myers Squibb

9.3.6 Merck & Co.

9.3.7 Novartis

9.3.8 Boehringer Ingelheim

10 Market Outlook

10.1 Global Markets

10.1.1 Forecast

10.1.2 Drivers and Barriers – Global Issues

10.2 US

10.2.1 Forecast

10.2.2 Key Events

10.2.3 Drivers and Barriers

10.3 5EU

10.3.1 Forecast

10.3.2 Key Events

10.3.3 Drivers and Barriers

10.4 Japan

10.4.1 Forecast

10.4.2 Key Events

10.4.3 Drivers and Barriers

10.5 China

10.5.1 Forecast

10.5.2 Key Events

10.5.3 Drivers and Barriers

11 Appendix

11.1 Bibliography

11.2 Abbreviations

11.3 Methodology

11.4 Forecasting Methodology

11.4.1 Diagnosed NSCLC Patients

11.4.2 Percent Drug-Treated Patients

11.4.3 Drugs Included in Each Therapeutic Class

11.4.4 Launch and Patent Expiry Dates

11.4.5 General Pricing Assumptions

11.4.6 Individual Drug Assumptions

11.4.7 Generic Erosion

11.4.8 Pricing of Pipeline Agents

11.5 Primary Research – KOLs

11.5.1 KOLs

11.6 About the Authors

11.6.1 Analyst

11.6.2 Therapy Area Director

11.6.3 Epidemiologist

11.6.4 Global Head of Healthcare

11.7 About GlobalData

11.8 Contact Us

11.9 Disclaimer

List of Tables

Table 1: Definitions Used in the AJCC Lung Cancer Staging System

Table 2: AJCC Staging of NSCLC

Table 3: Symptoms of NSCLC

Table 4: Prognostic Factors for NSCLC

Table 5: Prognosis for NSCLC Based on Initial Staging

Table 6: Risk Factors and Comorbidities for Lung Cancer

Table 7: Histological Subtype Distribution Among NSCLC

Table 8: 8MM, Relative Survival

Table 9: 8MM, Sources Used for Diagnosed Incidence of NSCLC

Table 10: 8MM, Sources Used for Cancer Stage at Diagnosis

Table 11: 8MM, Sources Used for NSCLC by Histological Subtypes

Table 12: US, Sources Used for Diagnosed Incident Cases of NSCLC Segmented by Mutation

Table 13: 5EU, Sources Used for Diagnosed Incident Cases of NSCLC Segmented by Mutation

Table 14: Japan, Sources Used for Diagnosed Incident Cases of NSCLC Segmented by Mutation

Table 15: China (Urban), Sources Used for Diagnosed Incident Cases of NSCLC Segmented by Mutation

Table 16: 8MM, Sources Used for Relative Survival of NSCLC

Table 17: 8MM, Diagnosed Incident Cases of NSCLC, Both Sexes, Ages ≥18 Years, N, Select Years 2015–2025

Table 18: 8MM, Age-Specific Diagnosed Incident Cases of NSCLC, Both Sexes, N (Row %), 2015

Table 19: 8MM, Sex-Specific Diagnosed Incident Cases of NSCLC, Ages ≥18 Years, N (Row %), 2015

Table 20: 8MM, Diagnosed Incident Cases of NSCLC by Clinical Stage at Diagnosis, Ages ≥18 Years, N, 2015

Table 21: 8MM, Diagnosed Incident Cases of NSCLC by Histological Subtypes, Ages ≥18 Years, N, 2015

Table 22: 8MM, Mutations Among Diagnosed Incident Cases of ADC, Both Sexes, Ages ≥18 Years, N, 2015

Table 23: 8MM, Mutations Among Diagnosed Incident Cases of SCC, Both Sexes, Ages ≥18 Years, N, 2015

Table 24: 8MM, Mutations Among Diagnosed Incident Cases of NSCLC, Both Sexes, N, Ages ≥18 Years, 2015

Table 25: 8MM, Five-Year Diagnosed Prevalent Cases of NSCLC, Both Sexes, Ages ≥18 Years, N, Select Years 2015–2025

Table 26: 8MM, Alternate Forecast, Diagnosed Incident Cases of NSCLC by Histology Subtypes, Ages ≥18 Years, N, 2015 and 2025

Table 27: 8MM, Alternate Forecast, Five-Year Diagnosed Prevalent Cases of NSCLC, Both Sexes, Ages ≥18 Years, N, Select Years 2015–2025

Table 28: Prevalence of Brain and Bone Metastases in NSCLC

Table 29: Biomarker Testing Rates in Nonsquamous NSCLC

Table 30: Biomarker Testing Rates in Squamous NSCLC

Table 31: Treatment Guidelines for NSCLC

Table 32: Most Prescribed Drugs for NSCLC by Class in the 8MM, 2015–2025

Table 33: Country Profile – US

Table 34: Country Profile – France

Table 35: Country Profile – Germany

Table 36: Country Profile – Italy

Table 37: Country Profile – Spain

Table 38: Country Profile – UK

Table 39: Country Profile – Japan

Table 40: Country Profile – China

Table 41: Leading Treatments for NSCLC, 2016

Table 42: Marketed EGFR TKIs in NSCLC

Table 43: Product Profile – Tarceva

Table 44: Efficacy of Tarceva in First-Line Therapy, EGFR-mutant NSCLC

Table 45: Efficacy of Tarceva in Maintenance Therapy in NSCLC

Table 46: Efficacy of Tarceva in Second- and Third-Line Therapy in NSCLC

Table 47: Safety of Tarceva

Table 48: Tarceva SWOT Analysis, 2016

Table 49: Product Profile – Iressa

Table 50: Efficacy of Iressa in First-Line, EGFR-Mutant NSCLC (Study 1)

Table 51: Efficacy of Iressa in First-Line, EGFR-Mutant ADC NSCLC (Study 2)

Table 52: Safety of Iressa

Table 53: Iressa SWOT Analysis, 2016

Table 54: Product Profile – Gilotrif

Table 55: Efficacy of Gilotrif in First-Line, EGFR-Mutant ADC

Table 56: Efficacy of Gilotrif in First-Line, EGFR-Mutant ADC

Table 57: Efficacy of Gilotrif in Second-Line, EGFR-Wildtype, EGFR TKI-Naïve, Squamous NSCLC

Table 58: Efficacy of Gilotrif in Fourth-Line, EGFR-Mutant NSCLC

Table 59: Safety of Gilotrif

Table 60: Gilotrif SWOT Analysis, 2016

Table 61: Product Profile – Tagrisso

Table 62: Efficacy of Tagrisso in Second-Line, EGFR-Mutant NSCLC

Table 63: Safety of Tagrisso

Table 64: Tagrisso SWOT Analysis, 2016

Table 65: Product Profile – Portrazza

Table 66: Efficacy of Portrazza in First-Line, Squamous NSCLC

Table 67: Safety of Portrazza

Table 68: Portrazza SWOT Analysis, 2016

Table 69: Efficacy of Conmana in 2L Advanced NSCLC

Table 70: Efficacy of Conmana in 1L EGFR-mutant NSCLC

Table 71: Safety of Conmana

Table 72: Conmana SWOT Analysis, 2016

Table 73: Marketed ALK TKIs in NSCLC

Table 74: Product Profile – Xalkori

Table 75: Efficacy of Xalkori in Treatment-Naïve ALK+ Metastatic NSCLC

Table 76: Efficacy of Xalkori in Previously Treated ALK+ Metastatic NSCLC

Table 77: Safety of Xalkori in Treatment-Naïve, ALK+ Metastatic NSCLC

Table 78: Safety of Xalkori in Previously Treated, Metastatic NSCLC

Table 79: Xalkori SWOT Analysis, 2016

Table 80: Product Profile – Zykadia

Table 81: Efficacy of Zykadia

Table 82: Safety of Zykadia

Table 83: Zykadia SWOT Analysis, 2016

Table 84: Product Profile – Alecensa

Table 85: Efficacy of Alecensa

Table 86: Efficacy of Alecensa in NSCLC patients with CNS lesions

Table 87: Safety of Alecensa

Table 88: Alecensa SWOT Analysis, 2016

Table 89: Marketed PD-1/PD-L1 ICIs in NSCLC

Table 90: Product Profile – Opdivo

Table 91: Efficacy of Opdivo in Metastatic Squamous NSCLC

Table 92: Efficacy of Opdivo in Metastatic Nonsquamous NSCLC

Table 93: Safety of Opdivo

Table 94: Opdivo SWOT Analysis, 2016

Table 95: Product Profile – Keytruda

Table 96: Efficacy of Keytruda

Table 97: Safety of Keytruda

Table 98: Keytruda SWOT Analysis, 2016

Table 99: Product Profile – Tecentriq (atezolizumab)

Table 100: Patient Demographics in the Phase II POPLAR Trial (NCT01903993)

Table 101: Efficacy of Tecentriq in the Phase II POPLAR Trial (NCT01903993)

Table 102: Efficacy of Tecentriq in the Phase III OAK Trial (NCT02008227)

Table 103: Patient Demographics in the Phase II FIR Trial (NCT01846416)

Table 104: Efficacy of Tecentriq in the Phase II FIR Trial (NCT01846416)

Table 105: Efficacy of Tecentriq in the Phase II BIRCH Trial (NCT02031458)

Table 106: Safety of Tecentriq in the Phase II POPLAR Trial (NCT01903993)

Table 107: Safety of Tecentriq in the Phase II FIR Trial (NCT01846416)

Table 108: Tecentriq SWOT Analysis, 2016

Table 109: Product Profile – Avastin

Table 110: Efficacy of Avastin in Nonsquamous NSCLC

Table 111: Safety of Avastin

Table 112: Avastin SWOT Analysis, 2016

Table 113: Product Profile – Cyramza

Table 114: Efficacy of Cyramza

Table 115: Safety of Cyramza

Table 116: Cyramza SWOT Analysis, 2016

Table 117: Product Profile – Vargatef

Table 118: Efficacy of Vargatef in ADC NSCLC

Table 119: Safety of Vargatef in ADC NSCLC

Table 120: Vargatef SWOT Analysis, 2016

Table 121: Summary of Chemotherapies, 2015

Table 122: Unmet Need and Opportunity in NSCLC

Table 123: Product Profile – Yervoy (ipilimumab)

Table 124: Demographics in the Phase II NCT00527735 Trial

Table 125: Efficacy of Yervoy + Carboplatin + Paclitaxel in Advanced NSCLC (NCT00527735)

Table 126: Demographics in the Phase I CheckMate 012 Trial (NCT01454102)

Table 127: Efficacy of the Opdivo + Yervoy Combination in the CheckMate 012 Trial (NCT01454102)

Table 128: Safety of Yervoy (ipilimumab) + Carboplatin + Paclitaxel in Advanced NSCLC (NCT00527735)

Table 129: Safety of the Opdivo + Yervoy Combination in the CheckMate 012 Trial (NCT01454102)

Table 130: Yervoy SWOT Analysis, 2016

Table 131: Product Profile – Avelumab (MSB-0010718C)

Table 132: Patient Demographics in the Phase Ib Dose-Expansion Study (NCT01772004)

Table 133: Efficacy of Avelumab in the Phase Ib Dose-Expansion Study (NCT01772004)

Table 134: Efficacy of Avelumab in PD-L1-Positive and -Negative NSCLC

Table 135: Demographics in the Treatment-Naïve NSCLC Cohort in the Phase I Trial (NCT01772004)

Table 136: Efficacy of Avelumab in Treatment-Naïve NSCLC

Table 137: Unconfirmed ORR According to PD-L1 Expression in Treatment-Naïve NSCLC

Table 138: Safety of Avelumab in the Phase Ib Dose-Expansion Study (NCT01772004)

Table 139: Safety of Avelumab in Treatment-Naïve NSCLC (NCT01772004)

Table 140: Avelumab SWOT Analysis, 2016

Table 141: Product Profile – Durvalumab (MEDI4736)

Table 142: Patient Demographics and Disease Characteristics in the Phase I/II NCT01693562 Trial

Table 143: Efficacy of Durvalumab in the Phase I/II NCT01693562 Trial

Table 144: Baseline Characteristics of Patients With Treatment-Naïve NSCLC in the Phase I/II

Table 145: Efficacy of Durvalumab in Treatment-Naïve NSCLC

Table 146: Patient Demographics and Disease Characteristics in the Phase Ib NCT02000947 Trial

Table 147: Efficacy of Durvalumab + Tremelimumab in the Phase Ib NCT02000947 Trial

Table 148: Safety of Durvalumab in the Phase I/II Trial (NCT01693562)

Table 149: Safety of Durvalumab in Treatment-Naïve NSCLC

Table 150: Safety of Durvalumab + Tremelimumab in the Phase Ib NCT02000947 Trial

Table 151: Durvalumab SWOT Analysis, 2016

Table 152: Product Profile – Naquotinib Mesylate (ASP8273)

Table 153: Patient Demographics in the Phase I/II NCT02192697 and Phase I NCT02113813 Trials

Table 154: Efficacy of Naquotinib in EGFR-Mutant NSCLC in Japanese and US Patients

Table 155: Safety of Naquotinib in EGFR-Mutant NSCLC in Japanese and US Patients

Table 156: Naquotinib SWOT Analysis, 2016

Table 157: Product Profile – Olmutinib (BI 1482694; HM61713)

Table 158: Demographics in the Phase I/II NCT01588145 Trial

Table 159: Efficacy of Olmutinib in the Phase II Portion of the NCT01588145 Trial

Table 160: Safety Profile of Olmutinib in the Phase II Portion of the NCT01588145 Trial

Table 161: Olmutinib SWOT Analysis, 2016

Table 162: Product Profile – Dacomitinib

Table 163: Demographics in the Phase II NCT00818441 Trial

Table 164: Efficacy of Dacomitinib in the Phase II NCT00818441 Trial

Table 165: Safety of Dacomitinib in Phase II NCT00818441 Trial

Table 166: Dacomitinib SWOT Analysis, 2016

Table 167: Product Profile – Ensartinib

Table 168: Baseline Patient Characteristics in the Phase I/II eXalt2 Trial (NCT0162534)

Table 169: Efficacy of Ensartinib in the Phase I/II eXalt2 Trial (NCT0162534)

Table 170: Baseline Patient Characteristics in the Expansion Cohort of the Phase I/II eXalt2 Trial

Table 171: Efficacy of Ensartinib in the Expansion Phase of the eXalt2 Trial (NCT0162534)

Table 172: Safety of Ensartinib in the Phase I/II eXalt2 Trial (NCT0162534)

Table 173: Ensartinib SWOT Analysis, 2016

Table 174: Product Profile – Brigatinib

Table 175: Baseline Patient Characteristics in the Phase II ALTA Trial (NCT02094573)

Table 176: Efficacy of Brigatinib in the Phase II ALTA Trial (NCT02094573)

Table 177: Efficacy of Brigatinib in ALK+ NSCLC with Intracranial CNS Metastases

Table 178: Safety of Brigatinib in the Phase II ALTA Trial (NCT02094573)

Table 179: Brigatinib SWOT Analysis, 2016

Table 180: Product Profile – CimaVax-EGF

Table 181: Demographics in the Phase III trial of the CimaVax-EGF in Cuba

Table 182: Efficacy of the CimaVax-EGF in the Phase III trial in Cuba

Table 183: Safety of the CimaVax-EGF in the Phase III Trial in Cuba

Table 184: CimaVax-EGF SWOT Analysis, 2016

Table 185: Product Profile – Tedopi

Table 186: Demographics in the Phase II Trial of Tedopi in Advanced NSCLC

Table 187: Efficacy of Tedopi in Advanced NSCLC

Table 188: Tedopi SWOT Analysis, 2016

Table 189: Product Profile – Anlotinib

Table 190: Efficacy of Anlotinib in Pretreated NSCLC in the Phase II ALTER0302 Trial

Table 191: Anlotinib SWOT Analysis, 2016

Table 192: Product Profile – Aitan

Table 193: Efficacy of Aitan in Pretreated Nonsquamous NSCLC

Table 194: Aitan SWOT Analysis, 2016

Table 195: Product Profile – Fruquintinib

Table 196: Baseline Demographics in the Phase I Trial (HMP, NCT01645215) of Fruquintinib

Table 197: Efficacy of Fruquintinib in Advanced Solid Tumors

Table 198: Safety of Fruquintinib in Advanced Solid Tumors

Table 199: Fruquintinib SWOT Analysis, 2016

Table 200: Efficacy and Safety of ABP 215 in NSCLC in the Phase III Trial (NCT01966003)

Table 201: Product Profile – Abemaciclib

Table 202: Efficacy of Abemaciclib Monotherapy in Previously Treated NSCLC (NCT01394016)

Table 203: Efficacy of Abemaciclib in Combination with Other Therapies (NCT02079636)

Table 204: Safety of Abemaciclib in Combination with Multiple Single Agents

Table 205: Abemaciclib SWOT Analysis, 2016

Table 206: Product Profile – Tafinlar + Mekinist

Table 207: Demographics in Cohort B of the Pivotal Phase II BRF113928 Trial (GSK, NCT01336634)

Table 208: Efficacy of Tafinlar + Mekinist in Previously Treated BRAF V600E+ NSCLC

Table 209: Safety of Tafinlar + Mekinist in Previously Treated BRAF V600E+ NSCLC

Table 210: Tafinlar + Mekinist SWOT Analysis, 2016

Table 211: Product Profile – Veliparib

Table 212: Demographics in the Phase II NCT01560104 Trial

Table 213: Efficacy of VCP in Advanced NSCLC (NCT01560104)

Table 214: Efficacy of VCP by Smoking Status (NCT01560104)

Table 215: Safety of VCP in Advanced NSCLC (NCT01560104)

Table 216: Veliparib SWOT Analysis, 2016

Table 217: Product Profile – Seribantumab (MM-121)

Table 218: Demographics in Group A of the Phase I/II Trial (NCT00994123) of MM-121 + Tarceva in

Table 219: Efficacy of MM-121 + Tarceva in EGFR Wild-Type NSCLC

Table 220: Safety of MM-121 + Tarceva in EGFR Wild-Type NSCLC

Table 221: MM-121 SWOT Analysis, 2016

Table 222: Product Profile – Sacituzumab govitecan (IMMU-132)

Table 223: Demographics in the Phase II Portion of the Phase I/II Trial (NCT01631552)

Table 224: Efficacy of IMMU-132 in Pretreated NSCLC in the Phase I/II Trial (NCT01631552)

Table 225: Efficacy of IMMU-132 in Patients Who Progressed on Prior Checkpoint Inhibitor

Table 226: Safety of IMMU-132 in Pretreated NSCLC in the Phase I/II Trial (NCT01631552)

Table 227: IMMU-132 SWOT Analysis, 2016

Table 228: Product Profile – Plinabulin

Table 229: Efficacy of Plinabulin + Docetaxel in the Phase I/II Trial (NCT00630110)

Table 230: Safety of Plinabulin + Docetaxel in the Phase I/II Trial (NCT00630110)

Table 231: Plinabulin SWOT Analysis, 2016

Table 232: Early-Stage Clinical Development in NSCLC

Table 233: MET Status in the Phase II (NCT01610336) Trial

Table 234: Efficacy of Capmatinib + Iressa in MET+ NSCLC

Table 235: Demographics in the Phase II LURET Study

Table 236: Efficacy of Caprelsa in RET+ NSCLC

Table 237: Demographics in the Stage I of the Phase II NCT01639508 Trial

Table 238: Efficacy of Cometriq in RET+ NSCLC

Table 239: Key Companies in the NSCLC Market in the 8MM, 2015–2025

Table 240: Roche/Genentech’s NSCLC Portfolio Assessment, 2016

Table 241: Eli Lilly’s NSCLC Portfolio Assessment, 2016

Table 242: Pfizer’s NSCLC Portfolio Assessment, 2016

Table 243: AZ’s NSCLC Portfolio Assessment, 2016

Table 244: BMS’ NSCLC Portfolio Assessment, 2016

Table 245: Merck & Co.’s NSCLC Portfolio Assessment, 2016

Table 246: Novartis’ NSCLC Portfolio Assessment, 2016

Table 247: BI’s NSCLC Portfolio Assessment, 2016

Table 248: NSCLC – Global Drivers and Barriers, 2015‒2025

Table 249: Key Events Impacting Sales for NSCLC in the US, 2016

Table 250: NSCLC –Drivers and Barriers in the US, 2015‒2025

Table 251: Key Events Impacting Sales for NSCLC in the 5EU, 2016

Table 252: NSCLC –Drivers and Barriers in the 5EU, 2015‒2025

Table 253: Key Events Impacting Sales for NSCLC in Japan, 2016

Table 254: NSCLC –Drivers and Barriers in Japan, 2015‒2025

Table 255: Key Events Impacting Sales for NSCLC in China, 2016

Table 256: NSCLC –Drivers and Barriers in urban China, 2015-2025

Table 257: Key Launch Dates – Part I

Table 258: Key Launch Dates – Part II

Table 259: Key Patent Expiries

Table 260 Average Body Weight and Surface Area Across the 8MM

Table 261: Average Cost of Therapy of Alimta in the 8MM

Table 262: Average Cost of Therapy of Alecensa in the 8MM

Table 263: Average Cost of Therapy of Avastin

Table 264: Average Cost of Therapy of Cyramza

Table 265: Average Cost of Therapy of Gilotrif

Table 266: Average Cost of Therapy of Iressa

Table 267: Average Cost of Therapy of Portrazza

Table 268: Average Cost of Therapy of Tagrisso

Table 269: Average Cost of Therapy of Tarceva

Table 270: Average Cost of Therapy of Vargatef

Table 271: Average Cost of Therapy of Xalkori

Table 272: Average Cost of Therapy of Zykadia

Table 273: Average Cost of Therapy of Keytruda

Table 274: Average Cost of Therapy of Opdivo

Table 275: Average Cost of Therapy of Tecentriq

Table 276: Average Cost of Therapy of Conmana

Table 277: High-Prescribing Physicians Surveyed by Country

List of Figures

Figure 1: 8MM, Diagnosed Incident Cases of NSCLC, Both Sexes, Ages ≥18 Years, N, Select Years 2015–2025

Figure 2: 8MM, Age-Specific Diagnosed Incident Cases of NSCLC, Both Sexes, N, 2015

Figure 3: 8MM, Sex-Specific Diagnosed Incident Cases of NSCLC, Ages ≥18 Years, N, 2015

Figure 4: 8MM, Age-Standardized Diagnosed Incidence of NSCLC, Ages ≥18 Years, N, 2015

Figure 5: 8MM, Five-Year Diagnosed Prevalent Cases of NSCLC, Both Sexes, Ages ≥18 Years, N, Select Years 2015–2025

Figure 6: Disease Management Flowchart for nonsquamous NSCLC

Figure 7: Disease Management Flowchart for squamous NSCLC

Figure 8: Disease Management Flowchart for EGFR+ NSCLC

Figure 9: Disease Management Flowchart for ALK+ NSCLC

Figure 10: Tarceva’s Phase III Development in NSCLC

Figure 11: Iressa’s Phase II Development in NSCLC

Figure 12: Gilotrif’s Phase III Development in NSCLC

Figure 13: Tagrisso’s Phase III Development in NSCLC

Figure 14: Portrazza’s Phase II Development in NSCLC

Figure 15: Conmana’s Phase III Development in NSCLC

Figure 16: Xalkori’s Development in NSCLC

Figure 17: Zykadia’s Development in NSCLC

Figure 18: Alecensa’s Development in NSCLC

Figure 19: Opdivo’s Development in NSCLC

Figure 20: Keytruda’s Phase III Development in NSCLC

Figure 21: Tecentriq’s Clincal Development in NSCLC

Figure 22: Avastin’s Phase III Development in NSCLC

Figure 23: Cyramza’s Phase III Development in NSCLC

Figure 24: Vargatef’s Phase II Development in NSCLC

Figure 25: NSCLC – Phase II/III Pipeline, 2016, Part I

Figure 26: NSCLC – Phase II/III Pipeline, 2016, Part II

Figure 27: Competitive Assessment of Late-Stage Pipeline Agents in NSCLC, 2015–2025

Figure 28: Yervoy’s Clinical Development in NSCLC

Figure 29: Clinical and Commercial Positioning of Yervoy

Figure 30: Estimated Sales of Ipilimumab Biosimilars Versus Branded Yervoy in NSCLC, 2015–2025

Figure 31: Avelumab’s Development in NSCLC

Figure 32: Clinical and Commercial Positioning of Avelumab

Figure 33: Durvalumab’s Clinical Development in NSCLC

Figure 34: Clinical and Commercial Positioning of Durvalumab

Figure 35: Naquotinib’s Clincal Development in NSCLC

Figure 36: Clinical and Commercial Positioning of Naquotinib

Figure 37: Olmutinib’s Clincal Development in NSCLC

Figure 38: Clinical and Commercial Positioning of Olmutinib

Figure 39: Dacomitinib’s Clinical Development in NSCLC

Figure 40: Clinical and Commercial Positioning of Dacomitinib

Figure 41: Ensartinib’s Clinical Development in NSCLC

Figure 42: Clinical and Commercial Positioning of Ensartinib

Figure 43: Brigatinib’s Clinical Development in NSCLC

Figure 44: Clinical and Commercial Positioning of Brigatinib

Figure 45: CimaVax-EGF’s Clinical Development in NSCLC

Figure 46: Clinical and Commercial Positioning of CimaVax-EGF

Figure 47: Tedopi’s Clinical Development in NSCLC

Figure 48: Clinical and Commercial Positioning of Tedopi

Figure 49: Anlotinib’s Clinical Development in NSCLC

Figure 50: Clinical and Commercial Positioning of Anlotinib

Figure 51: Aitan’s Clinical Development in NSCLC

Figure 52: Clinical and Commercial Positioning of Aitan

Figure 53: Fruquintinib’s Clinical Development in NSCLC

Figure 54: Clinical and Commercial Positioning of Fruquintinib

Figure 55: Clinical Development of Avastin Biosimilars in NSCLC

Figure 56: Estimated Sales of Bevacizumab Biosimilars Versus Branded Avastin in NSCLC, 2015–2025

Figure 57: Abemaciclib’s Clinical Development in NSCLC

Figure 58: Clinical and Commercial Positioning of Abemaciclib

Figure 59: Tafinlar + Mekinist’s Clinical Development in NSCLC

Figure 60: Clinical and Commercial Positioning of Tafinlar + Mekinist

Figure 61: Veliparib’s Clinical Development in NSCLC

Figure 62: Clinical and Commercial Positioning of Veliparib

Figure 63: MM-121’s Clinical Development in NSCLC

Figure 64: Clinical and Commercial Positioning of MM-121

Figure 65: IMMU-132’s Clinical Development in NSCLC

Figure 66: Clinical and Commercial Positioning of IMMU-132

Figure 67: Plinabulin’s Clinical Development in NSCLC

Figure 68: Clinical and Commercial Positioning of Plinabulin

Figure 69: Global Sales of Branded Products for NSCLC by Company, 2015–2025

Figure 70: Company Portfolio Gap Analysis in NSCLC, 2015–2025

Figure 71: Roche/Genentech SWOT Analysis in NSCLC, 2016

Figure 72: Eli Lilly SWOT Analysis in NSCLC, 2016

Figure 73: Pfizer SWOT Analysis in NSCLC, 2016

Figure 74: AZ SWOT Analysis in NSCLC, 2016

Figure 75: BMS SWOT Analysis in NSCLC, 2016

Figure 76: Merck & Co. SWOT Analysis in NSCLC, 2016

Figure 77: Novartis SWOT Analysis in NSCLC, 2016

Figure 78: BI SWOT Analysis in NSCLC, 2016

Figure 79: Global Sales for NSCLC (8MM), 2015–2025

Figure 80: Global Sales for NSCLC (8MM), 2015–2025

Figure 81: Global Sales for NSCLC (8MM), 2015–2025

Figure 82: Sales for NSCLC in the US by Drug Class, 2015–2025

Figure 83: Sales for NSCLC in the 5EU by Drug Class, 2015–2025

Figure 84: Sales for NSCLC in Japan, 2015–2025

Figure 85: Sales for NSCLC in urban China by Drug Class, 2015–2025

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