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FEATURED COMPANIES
- AstraZeneca
- Boehringer Ingelheim
- Bristol-Myers Squibb Co.
- CEL-SCI
- Eli Lilly
- Incyte
- MORE
Head and Neck Squamous Cell Carcinoma - Opportunity Analysis and Forecast to 2026
Summary
The recent surge in investment in Head and Neck Squamous Cell Carcinoma (HNSCC) has resulted in an innovative pipeline. Because it is an area with high unmet need and little competition, pharmaceutical companies of varying sizes are attempting to capture their own share of this potentially lucrative market.
There are currently no known biomarkers for Head and Neck Squamous Cell Carcinoma (HNSCC) that can reliably predict patient response to drug treatment. This is expected to become an important issue as expensive immunotherapies are increasingly incorporated into the Head and Neck Squamous Cell Carcinoma (HNSCC) treatment algorithm. Predictive biomarkers will become especially important as the cost of treatment is increasingly becoming an issue for payers. With the controversially high cost of new cancer therapies, there is a greater need for better patient screening in order to identify patients who are most likely to respond to, and who would benefit the most from, targeted therapies.
While the pipeline agents under investigation are expected to address the main unmet needs in the Head and Neck Squamous Cell Carcinoma (HNSCC) space by decreasing the toxicity of current regimens for rmHNSCC and reducing the risk of recurrence in LA-HNSCC patients, KOLs reported a substantial unmet need for the identification of new druggable targets. Understanding the molecular or genetic basis for disease development would do much to improve patient care by helping developers to identify new druggable targets and helping physicians to identify patients who are more likely to benefit from specific treatments
Researchers expect that total Head and Neck Squamous Cell Carcinoma (HNSCC) market is expected to experience significant growth between 2016 and 2026; with drug sales in the seven major markets (7MM: US, France, Germany, Italy, Spain, UK, and Japan) will increase to $3.6B in 2026, at a Compound Annual Growth Rate (CAGR) of 20.1%.
The main growth drivers will be attributed to the incorporation of immune-checkpoint inhibitors into the first-line recurrent/metastatic and locally-advanced disease treatment paradigms. Due to the high cost of immunotherapy regimens, this is expected to cause large growth within the head and neck cancer market.
Scope
The report will enable you to:
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Summary
The recent surge in investment in Head and Neck Squamous Cell Carcinoma (HNSCC) has resulted in an innovative pipeline. Because it is an area with high unmet need and little competition, pharmaceutical companies of varying sizes are attempting to capture their own share of this potentially lucrative market.
There are currently no known biomarkers for Head and Neck Squamous Cell Carcinoma (HNSCC) that can reliably predict patient response to drug treatment. This is expected to become an important issue as expensive immunotherapies are increasingly incorporated into the Head and Neck Squamous Cell Carcinoma (HNSCC) treatment algorithm. Predictive biomarkers will become especially important as the cost of treatment is increasingly becoming an issue for payers. With the controversially high cost of new cancer therapies, there is a greater need for better patient screening in order to identify patients who are most likely to respond to, and who would benefit the most from, targeted therapies.
While the pipeline agents under investigation are expected to address the main unmet needs in the Head and Neck Squamous Cell Carcinoma (HNSCC) space by decreasing the toxicity of current regimens for rmHNSCC and reducing the risk of recurrence in LA-HNSCC patients, KOLs reported a substantial unmet need for the identification of new druggable targets. Understanding the molecular or genetic basis for disease development would do much to improve patient care by helping developers to identify new druggable targets and helping physicians to identify patients who are more likely to benefit from specific treatments
Researchers expect that total Head and Neck Squamous Cell Carcinoma (HNSCC) market is expected to experience significant growth between 2016 and 2026; with drug sales in the seven major markets (7MM: US, France, Germany, Italy, Spain, UK, and Japan) will increase to $3.6B in 2026, at a Compound Annual Growth Rate (CAGR) of 20.1%.
The main growth drivers will be attributed to the incorporation of immune-checkpoint inhibitors into the first-line recurrent/metastatic and locally-advanced disease treatment paradigms. Due to the high cost of immunotherapy regimens, this is expected to cause large growth within the head and neck cancer market.
Scope
- Overview of HNC, including epidemiology, etiology, pathophysiology, symptoms, diagnosis, and disease management.
- Annualized HNC therapeutics market revenue, cost of therapy per patient, and treatment usage patterns in seven patient segments, forecast from 2016 to 2026.
- Key topics covered include strategic competitor assessment, market characterization, unmet needs, clinical trial mapping and implications for the HNC therapeutics market.
- Overview of HNC, including epidemiology, etiology, pathophysiology, symptoms, diagnosis, and disease management.
- Annualized HNC therapeutics market revenue, cost of therapy per patient, and treatment usage patterns in seven patient segments, forecast from 2016 to 2026.
- Key topics covered include strategic competitor assessment, market characterization, unmet needs, clinical trial mapping and implications for the HNC therapeutics market.
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 HNC market.
- Drive revenues by understanding the key trends, innovative products and technologies, market segments, and companies likely to impact the global HNC 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.
Note: Product cover images may vary from those shown
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FEATURED COMPANIES
- AstraZeneca
- Boehringer Ingelheim
- Bristol-Myers Squibb Co.
- CEL-SCI
- Eli Lilly
- Incyte
- MORE
1 Table of Contents
2 Executive Summary
2.1 Dramatic Growth Is Projected for the 7MM HNSCC Market from 2016 to 2026
2.2 Immuno-oncology Drugs to Extend Their Reach to All HNSCC Market Segments
2.3 High Unmet Needs for Biomarker of Response in the HNSCC Market
2.4 Opportunities Remain for Developers Who Launch Novel Treatments for HNSCC Subpopulations and Identify New Druggable Targets
2.5 What Do the Physicians Think?
3 Introduction
3.1 Catalyst
3.2 Related Reports
3.3 Upcoming Related Reports
4 Disease Overview
4.1 Etiology and Pathophysiology
4.1.1 Etiology
4.1.2 Pathophysiology
4.1.3 Biomarkers
4.2 Clinical Staging
4.3 Symptoms
4.4 Prognosis
4.5 Quality of Life
5 Epidemiology
5.1 Disease Background
5.2 Risk Factors and Comorbidities
5.3 Global and Historical Trends
5.4 Forecast Methodology
5.4.1 Sources
5.4.2 Forecast Assumptions and Methods - Population
5.4.3 Forecast Assumptions and Methods - Diagnosed Incident Cases of HNCs
5.4.4 Forecast Assumptions and Methods - Five-Year Diagnosed Prevalent Cases of HNCs
5.4.5 Forecast Assumptions and Methods - Diagnosed Incident Cases of HNCs by Histology Distribution
5.4.6 Forecast Assumptions and Methods - Diagnosed Incident Cases of HNC by Clinical Stages at Diagnosis for Squamous Cell Carcinoma
5.4.7 Forecast Assumptions and Methods - Diagnosed Incident Cases of Oropharynx Cancer by Risk Factor (HPV+ and HPV-)
5.4.8 Forecast Assumptions and Methods - Diagnosed Incident Cases of Nasopharynx Cancer by Risk Factor (EBV+)
5.5 Epidemiological Forecast for HNCs (2016-2026)
5.5.1 Diagnosed Incident Cases of Lip, Oral Cavity, Pharynx, and Larynx Cancer
5.5.2 Age-Specific Diagnosed Incident Cases of Lip, Oral Cavity, Pharynx, and Larynx Cancer
5.5.3 Sex-Specific Diagnosed Incident Cases of Lip, Oral Cavity, Pharynx, and Larynx Cancer
5.5.4 Diagnosed Incident Cases of Lip, Oral Cavity, Pharynx, and Larynx Cancer by Histology Distribution
5.5.5 Diagnosed Incident Cases of Lip, Oral Cavity, Pharynx, and Larynx Cancer by Clinical Stage at Diagnosis for Squamous Cell Carcinoma
5.5.6 Five-Year Diagnosed Prevalent Cases of Lip, Oral Cavity, Pharynx, and Larynx Cancer
5.5.7 Diagnosed Incident Cases of Oropharynx Cancer by Histology Distribution and by Risk Factor (HPV)
5.5.8 Diagnosed Incident Cases of Nasopharynx Cancer by Histology Distribution and by Risk Factor (EBV)
5.5.9 Diagnosed Incident Cases of Salivary Gland and Nose, Sinuses, and Other Related Structures Cancer
5.5.10 Age-Specific Diagnosed Incident Cases of Salivary Gland and Nose, Sinuses, and Other Related Structures Cancer
5.5.11 Sex-Specific Diagnosed Incident Cases of Salivary Gland and Nose, Sinuses, and Other Related Structures Cancer
5.5.12 Diagnosed Incident Cases of Salivary Gland and Nose, Sinuses, and Other Related Structures Cancer by Histology Distribution
5.5.13 Diagnosed Incident Cases of Salivary Gland and Nose, Sinuses, and Other Related Structures Cancer by Clinical Stage at Diagnosis for Squamous Cell Carcinoma
5.5.14 Five-Year Diagnosed Prevalent Cases of Salivary Gland and Nose, Sinuses, and Other Related Structures Cancer
5.6 Discussion
5.6.1 Epidemiological Forecast Insight
5.6.2 Limitations of the Analysis
5.6.3 Strengths of the Analysis
6 Current Treatment Options
6.1 Overview
6.2 Diagnosis and Treatment
6.2.1 Diagnosis
6.2.2 Treatment Guidelines and Leading Prescribed Drugs
6.3 Clinical Practice
6.3.1 Overview
6.4 Product Profiles
6.4.1 Opdivo (Nivolumab)
6.4.2 Keytruda (Pembrolizumab)
6.4.3 Erbitux (Cetuximab)
6.4.4 TS-1 (Tegafur + Gimeracil + Oteracil)
6.5 Standard of Care Chemotherapy Review
6.5.1 Cisplatin
6.5.2 Docetaxel
6.5.3 Fluorouracil (5-FU)
6.5.4 Methotrexate
6.6 Other Therapeutic Classes
7 Unmet Needs Assessment and Opportunity Analysis
7.1 Overview
7.1.1 Less Aggressive 1L Treatments for rmHNSCC
7.1.2 Curative Intent Treatments for LA-HNSCC in the Adjuvant and Induction Settings
7.1.3 More Effective Treatments for HPV-Negative Disease
7.1.4 De-intensified Treatments for the HPV-Positive HNC Cohorts
7.1.5 Innovative Treatments for Rare Head and Neck Cancer Sites
7.1.6 Predictive Biomarkers to Guide and Improve the Current Treatments in Use
8 R&D Strategies
8.1 Overview
8.1.1 Identification of Predictive Biomarker of Response to Immunotherapies
8.1.2 Immunotherapy Combinations for rmHNSCC
8.1.3 Immunotherapies Move in the Untapped LA-HNSCC Setting
8.1.4 Evaluating More Potent, Highly Selective Kinase Inhibitors
8.1.5 Precision Medicine in Head and Neck Cancer
8.2 Clinical Trial Design
8.2.1 Overall Survival Remains Most Important Outcome for rmHNSCC
8.2.2 Multi-Arm Trials Becoming More Common in the Head and Neck Pipeline
8.2.3 Future Trial Design: Active Comparator Issue
9 Pipeline Assessment
9.1 Overview
9.2 Drugs in Late-Stage Clinical Development
9.3 Chemotherapies
9.3.1 Javlor (Vinflunine)
9.4 Kinase Inhibitors
9.4.1 Gilotrif (Afatinib)
9.5 Immunotherapies
9.5.1 Multikine (Leukocyte Interleukin)
9.5.2 TT-10 (Virus-Specific T-Cell Therapy)
9.6 Immune Checkpoint Modulators
9.6.1 Imfinzi (durvalumab)
9.6.2 Tecentriq (atezolizumab)
9.6.3 Bavencio (avelumab)
9.6.4 Yervoy (ipilimumab)
9.6.5 Tremelimumab
9.6.6 Epacadostat
9.7 Innovative Early-Stage Approaches
9.7.1 Immunotherapies - Combinations and New Targets
9.7.2 Kinase Inhibitors - Label Expansion and Continued Development
9.7.3 Adoptive T-Cell Therapies and Immune-Stimulants
9.7.4 Therapeutic Vaccines and Oncolytic Viruses
9.7.5 Other Therapies in Development
10 Pipeline Valuation Analysis
10.1 Clinical Benchmark of Key Pipeline Drugs
10.2 Commercial Benchmark of Key Pipeline Drugs
10.3 Competitive Assessment
10.4 Top-Line 10 Year Forecast
10.4.1 US
10.4.2 5EU
10.4.3 Japan
11 Appendix
11.1 Bibliography
11.2 Abbreviations
11.3 Methodology
11.4 Forecasting Methodology
11.4.1 Diagnosed Head and Neck Cancer 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
11.5 Primary Research
11.5.1 Physicians and Specialists Included in This Study
11.5.2 Online Survey of High-Prescribing Physicians
11.6 About the Authors
11.6.1 Analysts
11.6.2 Therapy Area Director
11.6.3 Epidemiologist
11.6.4 Reviewers
11.6.5 Global Director of Therapy Analysis and Epidemiology
11.7 About
11.8 Contact
11.9 Disclaimer
List of Tables
Table 1: Head and Neck Squamous Cell Carcinoma: Key Metrics in the Seven Major Pharmaceutical Markets, 2016-2026
Table 2: ICD-10 Codes Used to Classify HNCs
Table 3: HNC Locations and Their Clinically Defined Descriptions
Table 4: Comparison of Different Biomarkers with Potential in HNSCC
Table 5: TNM Classification of Lip, Oral Cavity, and Oropharyngeal Cancers
Table 6: TNM Classification of the Larynx
Table 7: TNM Classification of the Hypopharynx
Table 8: TNM Classification of Nasal Cavity and Paranasal Sinus Cancers
Table 9: TNM Classification of Salivary Gland Cancers
Table 10: TNM Classification of Nasopharyngeal Cancers
Table 11: Stage Grouping for HNC (Excluding Nasopharyngeal Cancer)
Table 12: Stage Grouping for Nasopharyngeal Cancer
Table 13: Symptoms of HNSCC
Table 14: Risk Factors and Comorbid Conditions Associated with HNCs
Table 15: 7MM, Diagnosed Incident Cases of Oropharynx Cancer by Histology Distribution and by Risk Factor (HPV), Both Sexes, Ages =18 Years, N, 2016
Table 16: 7MM, Diagnosed Incident Cases of Nasopharynx Cancer by Histology Distribution and by Risk Factor (EBV+), Both Sexes, Ages =18 Years, N, 2016
Table 17: Leading Treatments for HNCs
Table 18: Treatment Guidelines for HNSCC
Table 19: Most Prescribed Drugs for HNSCC by Class in the Global Markets, 2016
Table 20: Product Profile - Opdivo
Table 21: Ongoing Clinical Trials of Opdivo
Table 22: Efficacy of Opdivo versus Investigator’s Choice, CheckMate-141
Table 23: Safety of Opdivo in rmHNSCC
Table 24: Opdivo SWOT Analysis
Table 25: Product Profile - Keytruda
Table 26: Ongoing Clinical Trials of Keytruda
Table 27: Efficacy of Keytruda, Phase Ib KEYNOTE-012 Expansion Cohort
Table 28: Safety of Keytruda, KEYNOTE-012 Phase Ib trial
Table 29: Keytruda SWOT Analysis
Table 30: Product Profile - Erbitux
Table 31: Efficacy of Erbitux with Cisplatin and 5-FU in rmHNSCC Patients, in a Phase III, Randomized, Open-Label Trial
Table 32: Efficacy of Erbitux with Radiotherapy in LA-HNSCC in a Phase III, Randomized, Open-Label Trial
Table 33: Safety of Erbitux with Cisplatin and 5-FU Chemotherapy in rmHNSCC
Table 34: Erbitux SWOT Analysis
Table 35: Product Profile - TS-1
Table 36: Safety of TS-1 Monotherapy in Patients with rmHNSCC
Table 37: TS-1 SWOT Analysis
Table 38: Summary of Additional Chemotherapy Agents Used for HNSCC in 2016
Table 39: Phase III Trials for rmHNSCC
Table 40: Key Phase III Trials for LA-HNSCC
Table 41: Head and Neck Squamous Cell Carcinoma - Late Stage Pipeline, 2018
Table 42: Product Profile - Javlor
Table 43: Efficacy of Javlor with Methotrexate in rmHNSCC from the Single Arm, Phase I, Dose-Finding Trial
Table 44: Safety of Javlor with Methotrexate in rmHNSCC from a Single Arm, Phase I, Dose-Finding Trial
Table 45: Javlor SWOT Analysis
Table 46: Product Profile - Gilotrif
Table 47: Efficacy of Gilotrif with Methotrexate in rmHNSCC
Table 48: Safety of Gilotrif with Methotrexate in rmHNSCC (NCT01345682)
Table 49: Gilotrif SWOT Analysis
Table 50: Product Profile - Multikine (interleukin injection)
Table 51: Multikine SWOT Analysis
Table 52: Product Profile - TT-10
Table 53: Efficacy of TT-10 from Phase II Trials, Chemotherapy Plus EBV VSTs in NPC Patients
Table 54: TT-10 SWOT Analysis
Table 55: Product Profile - Imfinzi
Table 56: Ongoing Early-Stage Clinical Trials of Imfinzi
Table 57: Efficacy of Imfinzi in rmHNSCC PD-L1-Positive Patients (Phase II HAWK Study)
Table 58: Efficacy of Imfinzi and Tremelimumab in rmHNSCC PD-L1-Negative or Low Patients (Phase II CONDOR Study)
Table 59: Imfinzi SWOT Analysis
Table 60: Product Profile - Tecentriq
Table 61: Tecentriq SWOT Analysis
Table 62: Product Profile - Bavencio
Table 63: Safety Profile of Bavencio Based On the JAVELIN Solid Tumor Trial for Patients with Locally Advanced or Metastatic UC
Table 64: Bavencio SWOT Analysis
Table 65: Product Profile - Yervoy
Table 66: Yervoy SWOT Analysis
Table 67: Product Profile - Tremelimumab
Table 68: Tremelimumab SWOT Analysis
Table 69: Product Profile - Epacadostat
Table 70: Ongoing Clinical Trials of Epacadostat
Table 71: Efficacy of Epacadostat in Combination with Opdivo from the HNC Cohort, ECHO-204 Trial
Table 72: Efficacy of Epacadostat in Combination with Keytruda from the HNC cohort, ECHO-202 Trial
Table 73: Safety of Epacadostat, ECHO-204
Table 74: Epacadostat SWOT Analysis
Table 75: Innovative Early-Stage Pipeline Therapies Head & Neck Cancer, 2018
Table 76: Other Early-Stage Drugs in Development for HNC, 2018
Table 77: Clinical Benchmark of Pipeline Drugs - IO Therapies
Table 78: Clinical Benchmark of Pipeline Drugs - Non-IO
Table 79: Commercial Benchmark of Pipeline Drugs - IO Agents
Table 80: Commercial Benchmark of Pipeline Drugs - Non-IO
Table 81: Key Events Impacting Sales for HNSCC
Table 82: HNSCC Market - Drivers and Barriers, 2016-2026
Table 83: Key Historical and Projected Launch Dates, 2016-2026
Table 84: High-Prescribing Physicians Surveyed, by Country
List of Figures
Figure 1: Sales for HNSCC Therapeutics by Region, 7MM, 2016-2026
Figure 2: Competitive Assessment of Marketed and Pipeline HNSCC Agents, 2016-2026
Figure 3: Anatomical Sites of HNCs
Figure 4: 7MM, Age-Standardized Diagnosed Incidence of Lip, Oral Cavity, Pharynx, and Larynx Cancer (Cases per 100,000 Population), Men, Ages =18 Years, 2016-2026
Figure 5: 7MM, Age-Standardized Diagnosed Incidence of Lip, Oral Cavity, Pharynx, and Larynx Cancer (Cases per 100,000 Population), Women, Ages =18 Years, 2016-2026
Figure 6: 7MM, Age-Standardized Diagnosed Incidence of Salivary Gland and Nose, Sinuses, and Other Related Structures Cancer (Cases per 100,000 Population), Men, Ages =18 Years, 2016-2026
Figure 7: 7MM, Age-Standardized Diagnosed Incidence of Salivary Gland and Nose, Sinuses, and Other Related Structures Cancer (Cases per 100,000 Population), Women, Ages =18 Years, 2016-2026
Figure 8: 7MM, Sources Used, Diagnosed Incident Cases of Lip, Oral Cavity, Pharynx, and Larynx Cancer; Oropharynx Cancer; Nasopharynx Cancer; Salivary Gland and Nose, Sinuses, and Other Related Structures Cancer
Figure 9: 7MM, Sources Used, Diagnosed Incident Cases of Lip, Oral Cavity, Pharynx, and Larynx Cancer; Oropharynx Cancer; Nasopharynx Cancer by Histology Distribution
Figure 10: 7MM, Sources Used, Diagnosed Incident Cases of Salivary Gland and Nose, Sinuses, and Other Related Structures Cancer by Histology Distribution
Figure 11: 7MM, Sources Used, Diagnosed Incident Cases of Lip, Oral Cavity, Pharynx, and Larynx Cancer by Clinical Stage at Diagnosis for Squamous Cell Carcinoma
Figure 12: 7MM, Sources Used, Diagnosed Incident Cases of Oropharynx Cancer; Nasopharynx Cancer; Salivary Gland and Nose, Sinuses, and Other Related Structures Cancer by Clinical Stage at Diagnosis for Squamous Cell Carcinoma
Figure 13: 7MM, Sources Used, Five-Year Diagnosed Prevalent Cases of Lip, Oral Cavity, Pharynx, and Larynx Cancer
Figure 14: 7MM, Sources Used, Five-Year Diagnosed Prevalent Cases of Nasopharynx Cancer; Salivary Gland and Nose, Sinuses, and Other Related Structures Cancer
Figure 15: 7MM, Sources Used, Diagnosed Incident Cases of Oropharynx Cancer by Risk Factor (HPV+ and HPV-)
Figure 16: 7MM, Sources Used, Diagnosed Incident Cases of Nasopharynx Cancer by Risk Factor (EBV+)
Figure 17: 7MM, Diagnosed Incident Cases of Lip, Oral Cavity, Pharynx, and Larynx Cancer, Both Sexes, Ages =18 Years, N, 2016
Figure 18: 7MM, Age-Specific Diagnosed Incident Cases of Lip, Oral Cavity, Pharynx, and Larynx Cancer, Both Sexes, N, 2016
Figure 19: 7MM, Sex-Specific Diagnosed Incident Cases of Lip, Oral Cavity, Pharynx, and Larynx Cancer, Ages =18 Years, N, 2016
Figure 20: 7MM, Diagnosed Incident Cases of Lip, Oral Cavity, Pharynx, and Larynx Cancer by Histology Distribution, Both Sexes, Ages =18 Years, N, 2016
Figure 21: 7MM, Diagnosed Incident Cases of Lip, Oral Cavity, Pharynx, and Larynx Cancer by Clinical Stage at Diagnosis for Squamous Cell Carcinoma, Both Sexes, Ages =18 Years, N, 2016
Figure 22: 7MM, Five-Year Diagnosed Prevalent Cases of Lip, Oral Cavity, Pharynx, and Larynx Cancer, Both Sexes, Ages =18 Years, N, 2016
Figure 23: 7MM, Diagnosed Incident Cases of Salivary Gland and Nose, Sinuses, and Other Related Structures Cancer, Both Sexes, Ages =18 Years, N, 2016
Figure 24: 7MM, Age-Specific Diagnosed Incident Cases of Salivary Gland and Nose, Sinuses, and Other Related StructuresCancer, Both Sexes, Ages =18 Years, N, 2016
Figure 25: 7MM, Sex-Specific Diagnosed Incident Cases of Salivary Gland and Nose, Sinuses, and Other Related Structures Cancer, Ages =18 Years, N, 2016
Figure 26: 7MM, Diagnosed Incident Cases of Salivary Gland and Nose, Sinuses, and Other Related Structures Cancer by Histology Distribution, Both Sexes, Ages =18 Years, N, 2016
Figure 27: 7MM, Diagnosed Incident Cases of Salivary Gland and Nose, Sinuses, and Other Related StructuresCancer by Clinical Stage at Diagnosis for Squamous Cell Carcinoma, Both Sexes, Ages =18 Years, N, 2016
Figure 28: 7MM, Five-Year Diagnosed Prevalent Cases of Salivary Gland and Nose, Sinuses, and Other Related Structures Cancer, Both Sexes, Ages =18 Years, N, 2016
Figure 29: Treatment Overview in HNSCC Patients
Figure 30: Treatment Overview in Nasopharyngeal Carcinoma Patients
Figure 31: Opdivo’s Development in HNSCC
Figure 32: Keytruda’s Development in HNSCC
Figure 33: Unmet Needs and Opportunities in HNC
Figure 34: Overview of the Development Pipeline in HNSCC
Figure 35: HNSCC Phase III Pipeline in Development for the 7MM, 2016-2026
Figure 36: Javlor’s Development in HNSCC
Figure 37: Gilotrif’s Development in HNSCC
Figure 38: Multikine’s Development in HNSCC
Figure 39: TT-10’s Development in HNSCC
Figure 40: Imfinzi’s Development in HNSCC
Figure 41: Tecentriq’s Development in HNSCC
Figure 42: Bavencio’s Development in HNSCC
Figure 43: Yervoy’s Development in HNSCC
Figure 44: Tremelimumab’s Development in HNSCC
Figure 45: Epacadostat’s Development in HNSCC
Figure 46: Competitive Assessment of Marketed and Pipeline HNSCC Agents, 2016-2026
Figure 47: Sales for HNC Products by Region, 2016-2026
Figure 48: Sales for HNC Products by Drug Class, 2016-2026
Figure 49: Sales for HNC Products by Drug Class in the US, 2016-2026
Figure 50: Sales for HNC Products by Drug Class in the 5EU, 2016-2026
Figure 51: Sales for HNC Products by Drug Class in Japan, 2016-2026
2 Executive Summary
2.1 Dramatic Growth Is Projected for the 7MM HNSCC Market from 2016 to 2026
2.2 Immuno-oncology Drugs to Extend Their Reach to All HNSCC Market Segments
2.3 High Unmet Needs for Biomarker of Response in the HNSCC Market
2.4 Opportunities Remain for Developers Who Launch Novel Treatments for HNSCC Subpopulations and Identify New Druggable Targets
2.5 What Do the Physicians Think?
3 Introduction
3.1 Catalyst
3.2 Related Reports
3.3 Upcoming Related Reports
4 Disease Overview
4.1 Etiology and Pathophysiology
4.1.1 Etiology
4.1.2 Pathophysiology
4.1.3 Biomarkers
4.2 Clinical Staging
4.3 Symptoms
4.4 Prognosis
4.5 Quality of Life
5 Epidemiology
5.1 Disease Background
5.2 Risk Factors and Comorbidities
5.3 Global and Historical Trends
5.4 Forecast Methodology
5.4.1 Sources
5.4.2 Forecast Assumptions and Methods - Population
5.4.3 Forecast Assumptions and Methods - Diagnosed Incident Cases of HNCs
5.4.4 Forecast Assumptions and Methods - Five-Year Diagnosed Prevalent Cases of HNCs
5.4.5 Forecast Assumptions and Methods - Diagnosed Incident Cases of HNCs by Histology Distribution
5.4.6 Forecast Assumptions and Methods - Diagnosed Incident Cases of HNC by Clinical Stages at Diagnosis for Squamous Cell Carcinoma
5.4.7 Forecast Assumptions and Methods - Diagnosed Incident Cases of Oropharynx Cancer by Risk Factor (HPV+ and HPV-)
5.4.8 Forecast Assumptions and Methods - Diagnosed Incident Cases of Nasopharynx Cancer by Risk Factor (EBV+)
5.5 Epidemiological Forecast for HNCs (2016-2026)
5.5.1 Diagnosed Incident Cases of Lip, Oral Cavity, Pharynx, and Larynx Cancer
5.5.2 Age-Specific Diagnosed Incident Cases of Lip, Oral Cavity, Pharynx, and Larynx Cancer
5.5.3 Sex-Specific Diagnosed Incident Cases of Lip, Oral Cavity, Pharynx, and Larynx Cancer
5.5.4 Diagnosed Incident Cases of Lip, Oral Cavity, Pharynx, and Larynx Cancer by Histology Distribution
5.5.5 Diagnosed Incident Cases of Lip, Oral Cavity, Pharynx, and Larynx Cancer by Clinical Stage at Diagnosis for Squamous Cell Carcinoma
5.5.6 Five-Year Diagnosed Prevalent Cases of Lip, Oral Cavity, Pharynx, and Larynx Cancer
5.5.7 Diagnosed Incident Cases of Oropharynx Cancer by Histology Distribution and by Risk Factor (HPV)
5.5.8 Diagnosed Incident Cases of Nasopharynx Cancer by Histology Distribution and by Risk Factor (EBV)
5.5.9 Diagnosed Incident Cases of Salivary Gland and Nose, Sinuses, and Other Related Structures Cancer
5.5.10 Age-Specific Diagnosed Incident Cases of Salivary Gland and Nose, Sinuses, and Other Related Structures Cancer
5.5.11 Sex-Specific Diagnosed Incident Cases of Salivary Gland and Nose, Sinuses, and Other Related Structures Cancer
5.5.12 Diagnosed Incident Cases of Salivary Gland and Nose, Sinuses, and Other Related Structures Cancer by Histology Distribution
5.5.13 Diagnosed Incident Cases of Salivary Gland and Nose, Sinuses, and Other Related Structures Cancer by Clinical Stage at Diagnosis for Squamous Cell Carcinoma
5.5.14 Five-Year Diagnosed Prevalent Cases of Salivary Gland and Nose, Sinuses, and Other Related Structures Cancer
5.6 Discussion
5.6.1 Epidemiological Forecast Insight
5.6.2 Limitations of the Analysis
5.6.3 Strengths of the Analysis
6 Current Treatment Options
6.1 Overview
6.2 Diagnosis and Treatment
6.2.1 Diagnosis
6.2.2 Treatment Guidelines and Leading Prescribed Drugs
6.3 Clinical Practice
6.3.1 Overview
6.4 Product Profiles
6.4.1 Opdivo (Nivolumab)
6.4.2 Keytruda (Pembrolizumab)
6.4.3 Erbitux (Cetuximab)
6.4.4 TS-1 (Tegafur + Gimeracil + Oteracil)
6.5 Standard of Care Chemotherapy Review
6.5.1 Cisplatin
6.5.2 Docetaxel
6.5.3 Fluorouracil (5-FU)
6.5.4 Methotrexate
6.6 Other Therapeutic Classes
7 Unmet Needs Assessment and Opportunity Analysis
7.1 Overview
7.1.1 Less Aggressive 1L Treatments for rmHNSCC
7.1.2 Curative Intent Treatments for LA-HNSCC in the Adjuvant and Induction Settings
7.1.3 More Effective Treatments for HPV-Negative Disease
7.1.4 De-intensified Treatments for the HPV-Positive HNC Cohorts
7.1.5 Innovative Treatments for Rare Head and Neck Cancer Sites
7.1.6 Predictive Biomarkers to Guide and Improve the Current Treatments in Use
8 R&D Strategies
8.1 Overview
8.1.1 Identification of Predictive Biomarker of Response to Immunotherapies
8.1.2 Immunotherapy Combinations for rmHNSCC
8.1.3 Immunotherapies Move in the Untapped LA-HNSCC Setting
8.1.4 Evaluating More Potent, Highly Selective Kinase Inhibitors
8.1.5 Precision Medicine in Head and Neck Cancer
8.2 Clinical Trial Design
8.2.1 Overall Survival Remains Most Important Outcome for rmHNSCC
8.2.2 Multi-Arm Trials Becoming More Common in the Head and Neck Pipeline
8.2.3 Future Trial Design: Active Comparator Issue
9 Pipeline Assessment
9.1 Overview
9.2 Drugs in Late-Stage Clinical Development
9.3 Chemotherapies
9.3.1 Javlor (Vinflunine)
9.4 Kinase Inhibitors
9.4.1 Gilotrif (Afatinib)
9.5 Immunotherapies
9.5.1 Multikine (Leukocyte Interleukin)
9.5.2 TT-10 (Virus-Specific T-Cell Therapy)
9.6 Immune Checkpoint Modulators
9.6.1 Imfinzi (durvalumab)
9.6.2 Tecentriq (atezolizumab)
9.6.3 Bavencio (avelumab)
9.6.4 Yervoy (ipilimumab)
9.6.5 Tremelimumab
9.6.6 Epacadostat
9.7 Innovative Early-Stage Approaches
9.7.1 Immunotherapies - Combinations and New Targets
9.7.2 Kinase Inhibitors - Label Expansion and Continued Development
9.7.3 Adoptive T-Cell Therapies and Immune-Stimulants
9.7.4 Therapeutic Vaccines and Oncolytic Viruses
9.7.5 Other Therapies in Development
10 Pipeline Valuation Analysis
10.1 Clinical Benchmark of Key Pipeline Drugs
10.2 Commercial Benchmark of Key Pipeline Drugs
10.3 Competitive Assessment
10.4 Top-Line 10 Year Forecast
10.4.1 US
10.4.2 5EU
10.4.3 Japan
11 Appendix
11.1 Bibliography
11.2 Abbreviations
11.3 Methodology
11.4 Forecasting Methodology
11.4.1 Diagnosed Head and Neck Cancer 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
11.5 Primary Research
11.5.1 Physicians and Specialists Included in This Study
11.5.2 Online Survey of High-Prescribing Physicians
11.6 About the Authors
11.6.1 Analysts
11.6.2 Therapy Area Director
11.6.3 Epidemiologist
11.6.4 Reviewers
11.6.5 Global Director of Therapy Analysis and Epidemiology
11.7 About
11.8 Contact
11.9 Disclaimer
List of Tables
Table 1: Head and Neck Squamous Cell Carcinoma: Key Metrics in the Seven Major Pharmaceutical Markets, 2016-2026
Table 2: ICD-10 Codes Used to Classify HNCs
Table 3: HNC Locations and Their Clinically Defined Descriptions
Table 4: Comparison of Different Biomarkers with Potential in HNSCC
Table 5: TNM Classification of Lip, Oral Cavity, and Oropharyngeal Cancers
Table 6: TNM Classification of the Larynx
Table 7: TNM Classification of the Hypopharynx
Table 8: TNM Classification of Nasal Cavity and Paranasal Sinus Cancers
Table 9: TNM Classification of Salivary Gland Cancers
Table 10: TNM Classification of Nasopharyngeal Cancers
Table 11: Stage Grouping for HNC (Excluding Nasopharyngeal Cancer)
Table 12: Stage Grouping for Nasopharyngeal Cancer
Table 13: Symptoms of HNSCC
Table 14: Risk Factors and Comorbid Conditions Associated with HNCs
Table 15: 7MM, Diagnosed Incident Cases of Oropharynx Cancer by Histology Distribution and by Risk Factor (HPV), Both Sexes, Ages =18 Years, N, 2016
Table 16: 7MM, Diagnosed Incident Cases of Nasopharynx Cancer by Histology Distribution and by Risk Factor (EBV+), Both Sexes, Ages =18 Years, N, 2016
Table 17: Leading Treatments for HNCs
Table 18: Treatment Guidelines for HNSCC
Table 19: Most Prescribed Drugs for HNSCC by Class in the Global Markets, 2016
Table 20: Product Profile - Opdivo
Table 21: Ongoing Clinical Trials of Opdivo
Table 22: Efficacy of Opdivo versus Investigator’s Choice, CheckMate-141
Table 23: Safety of Opdivo in rmHNSCC
Table 24: Opdivo SWOT Analysis
Table 25: Product Profile - Keytruda
Table 26: Ongoing Clinical Trials of Keytruda
Table 27: Efficacy of Keytruda, Phase Ib KEYNOTE-012 Expansion Cohort
Table 28: Safety of Keytruda, KEYNOTE-012 Phase Ib trial
Table 29: Keytruda SWOT Analysis
Table 30: Product Profile - Erbitux
Table 31: Efficacy of Erbitux with Cisplatin and 5-FU in rmHNSCC Patients, in a Phase III, Randomized, Open-Label Trial
Table 32: Efficacy of Erbitux with Radiotherapy in LA-HNSCC in a Phase III, Randomized, Open-Label Trial
Table 33: Safety of Erbitux with Cisplatin and 5-FU Chemotherapy in rmHNSCC
Table 34: Erbitux SWOT Analysis
Table 35: Product Profile - TS-1
Table 36: Safety of TS-1 Monotherapy in Patients with rmHNSCC
Table 37: TS-1 SWOT Analysis
Table 38: Summary of Additional Chemotherapy Agents Used for HNSCC in 2016
Table 39: Phase III Trials for rmHNSCC
Table 40: Key Phase III Trials for LA-HNSCC
Table 41: Head and Neck Squamous Cell Carcinoma - Late Stage Pipeline, 2018
Table 42: Product Profile - Javlor
Table 43: Efficacy of Javlor with Methotrexate in rmHNSCC from the Single Arm, Phase I, Dose-Finding Trial
Table 44: Safety of Javlor with Methotrexate in rmHNSCC from a Single Arm, Phase I, Dose-Finding Trial
Table 45: Javlor SWOT Analysis
Table 46: Product Profile - Gilotrif
Table 47: Efficacy of Gilotrif with Methotrexate in rmHNSCC
Table 48: Safety of Gilotrif with Methotrexate in rmHNSCC (NCT01345682)
Table 49: Gilotrif SWOT Analysis
Table 50: Product Profile - Multikine (interleukin injection)
Table 51: Multikine SWOT Analysis
Table 52: Product Profile - TT-10
Table 53: Efficacy of TT-10 from Phase II Trials, Chemotherapy Plus EBV VSTs in NPC Patients
Table 54: TT-10 SWOT Analysis
Table 55: Product Profile - Imfinzi
Table 56: Ongoing Early-Stage Clinical Trials of Imfinzi
Table 57: Efficacy of Imfinzi in rmHNSCC PD-L1-Positive Patients (Phase II HAWK Study)
Table 58: Efficacy of Imfinzi and Tremelimumab in rmHNSCC PD-L1-Negative or Low Patients (Phase II CONDOR Study)
Table 59: Imfinzi SWOT Analysis
Table 60: Product Profile - Tecentriq
Table 61: Tecentriq SWOT Analysis
Table 62: Product Profile - Bavencio
Table 63: Safety Profile of Bavencio Based On the JAVELIN Solid Tumor Trial for Patients with Locally Advanced or Metastatic UC
Table 64: Bavencio SWOT Analysis
Table 65: Product Profile - Yervoy
Table 66: Yervoy SWOT Analysis
Table 67: Product Profile - Tremelimumab
Table 68: Tremelimumab SWOT Analysis
Table 69: Product Profile - Epacadostat
Table 70: Ongoing Clinical Trials of Epacadostat
Table 71: Efficacy of Epacadostat in Combination with Opdivo from the HNC Cohort, ECHO-204 Trial
Table 72: Efficacy of Epacadostat in Combination with Keytruda from the HNC cohort, ECHO-202 Trial
Table 73: Safety of Epacadostat, ECHO-204
Table 74: Epacadostat SWOT Analysis
Table 75: Innovative Early-Stage Pipeline Therapies Head & Neck Cancer, 2018
Table 76: Other Early-Stage Drugs in Development for HNC, 2018
Table 77: Clinical Benchmark of Pipeline Drugs - IO Therapies
Table 78: Clinical Benchmark of Pipeline Drugs - Non-IO
Table 79: Commercial Benchmark of Pipeline Drugs - IO Agents
Table 80: Commercial Benchmark of Pipeline Drugs - Non-IO
Table 81: Key Events Impacting Sales for HNSCC
Table 82: HNSCC Market - Drivers and Barriers, 2016-2026
Table 83: Key Historical and Projected Launch Dates, 2016-2026
Table 84: High-Prescribing Physicians Surveyed, by Country
List of Figures
Figure 1: Sales for HNSCC Therapeutics by Region, 7MM, 2016-2026
Figure 2: Competitive Assessment of Marketed and Pipeline HNSCC Agents, 2016-2026
Figure 3: Anatomical Sites of HNCs
Figure 4: 7MM, Age-Standardized Diagnosed Incidence of Lip, Oral Cavity, Pharynx, and Larynx Cancer (Cases per 100,000 Population), Men, Ages =18 Years, 2016-2026
Figure 5: 7MM, Age-Standardized Diagnosed Incidence of Lip, Oral Cavity, Pharynx, and Larynx Cancer (Cases per 100,000 Population), Women, Ages =18 Years, 2016-2026
Figure 6: 7MM, Age-Standardized Diagnosed Incidence of Salivary Gland and Nose, Sinuses, and Other Related Structures Cancer (Cases per 100,000 Population), Men, Ages =18 Years, 2016-2026
Figure 7: 7MM, Age-Standardized Diagnosed Incidence of Salivary Gland and Nose, Sinuses, and Other Related Structures Cancer (Cases per 100,000 Population), Women, Ages =18 Years, 2016-2026
Figure 8: 7MM, Sources Used, Diagnosed Incident Cases of Lip, Oral Cavity, Pharynx, and Larynx Cancer; Oropharynx Cancer; Nasopharynx Cancer; Salivary Gland and Nose, Sinuses, and Other Related Structures Cancer
Figure 9: 7MM, Sources Used, Diagnosed Incident Cases of Lip, Oral Cavity, Pharynx, and Larynx Cancer; Oropharynx Cancer; Nasopharynx Cancer by Histology Distribution
Figure 10: 7MM, Sources Used, Diagnosed Incident Cases of Salivary Gland and Nose, Sinuses, and Other Related Structures Cancer by Histology Distribution
Figure 11: 7MM, Sources Used, Diagnosed Incident Cases of Lip, Oral Cavity, Pharynx, and Larynx Cancer by Clinical Stage at Diagnosis for Squamous Cell Carcinoma
Figure 12: 7MM, Sources Used, Diagnosed Incident Cases of Oropharynx Cancer; Nasopharynx Cancer; Salivary Gland and Nose, Sinuses, and Other Related Structures Cancer by Clinical Stage at Diagnosis for Squamous Cell Carcinoma
Figure 13: 7MM, Sources Used, Five-Year Diagnosed Prevalent Cases of Lip, Oral Cavity, Pharynx, and Larynx Cancer
Figure 14: 7MM, Sources Used, Five-Year Diagnosed Prevalent Cases of Nasopharynx Cancer; Salivary Gland and Nose, Sinuses, and Other Related Structures Cancer
Figure 15: 7MM, Sources Used, Diagnosed Incident Cases of Oropharynx Cancer by Risk Factor (HPV+ and HPV-)
Figure 16: 7MM, Sources Used, Diagnosed Incident Cases of Nasopharynx Cancer by Risk Factor (EBV+)
Figure 17: 7MM, Diagnosed Incident Cases of Lip, Oral Cavity, Pharynx, and Larynx Cancer, Both Sexes, Ages =18 Years, N, 2016
Figure 18: 7MM, Age-Specific Diagnosed Incident Cases of Lip, Oral Cavity, Pharynx, and Larynx Cancer, Both Sexes, N, 2016
Figure 19: 7MM, Sex-Specific Diagnosed Incident Cases of Lip, Oral Cavity, Pharynx, and Larynx Cancer, Ages =18 Years, N, 2016
Figure 20: 7MM, Diagnosed Incident Cases of Lip, Oral Cavity, Pharynx, and Larynx Cancer by Histology Distribution, Both Sexes, Ages =18 Years, N, 2016
Figure 21: 7MM, Diagnosed Incident Cases of Lip, Oral Cavity, Pharynx, and Larynx Cancer by Clinical Stage at Diagnosis for Squamous Cell Carcinoma, Both Sexes, Ages =18 Years, N, 2016
Figure 22: 7MM, Five-Year Diagnosed Prevalent Cases of Lip, Oral Cavity, Pharynx, and Larynx Cancer, Both Sexes, Ages =18 Years, N, 2016
Figure 23: 7MM, Diagnosed Incident Cases of Salivary Gland and Nose, Sinuses, and Other Related Structures Cancer, Both Sexes, Ages =18 Years, N, 2016
Figure 24: 7MM, Age-Specific Diagnosed Incident Cases of Salivary Gland and Nose, Sinuses, and Other Related StructuresCancer, Both Sexes, Ages =18 Years, N, 2016
Figure 25: 7MM, Sex-Specific Diagnosed Incident Cases of Salivary Gland and Nose, Sinuses, and Other Related Structures Cancer, Ages =18 Years, N, 2016
Figure 26: 7MM, Diagnosed Incident Cases of Salivary Gland and Nose, Sinuses, and Other Related Structures Cancer by Histology Distribution, Both Sexes, Ages =18 Years, N, 2016
Figure 27: 7MM, Diagnosed Incident Cases of Salivary Gland and Nose, Sinuses, and Other Related StructuresCancer by Clinical Stage at Diagnosis for Squamous Cell Carcinoma, Both Sexes, Ages =18 Years, N, 2016
Figure 28: 7MM, Five-Year Diagnosed Prevalent Cases of Salivary Gland and Nose, Sinuses, and Other Related Structures Cancer, Both Sexes, Ages =18 Years, N, 2016
Figure 29: Treatment Overview in HNSCC Patients
Figure 30: Treatment Overview in Nasopharyngeal Carcinoma Patients
Figure 31: Opdivo’s Development in HNSCC
Figure 32: Keytruda’s Development in HNSCC
Figure 33: Unmet Needs and Opportunities in HNC
Figure 34: Overview of the Development Pipeline in HNSCC
Figure 35: HNSCC Phase III Pipeline in Development for the 7MM, 2016-2026
Figure 36: Javlor’s Development in HNSCC
Figure 37: Gilotrif’s Development in HNSCC
Figure 38: Multikine’s Development in HNSCC
Figure 39: TT-10’s Development in HNSCC
Figure 40: Imfinzi’s Development in HNSCC
Figure 41: Tecentriq’s Development in HNSCC
Figure 42: Bavencio’s Development in HNSCC
Figure 43: Yervoy’s Development in HNSCC
Figure 44: Tremelimumab’s Development in HNSCC
Figure 45: Epacadostat’s Development in HNSCC
Figure 46: Competitive Assessment of Marketed and Pipeline HNSCC Agents, 2016-2026
Figure 47: Sales for HNC Products by Region, 2016-2026
Figure 48: Sales for HNC Products by Drug Class, 2016-2026
Figure 49: Sales for HNC Products by Drug Class in the US, 2016-2026
Figure 50: Sales for HNC Products by Drug Class in the 5EU, 2016-2026
Figure 51: Sales for HNC Products by Drug Class in Japan, 2016-2026
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- Merck & Co.
- Bristol-Myers Squibb Co.
- Eli Lilly
- Taiho
- AstraZeneca
- Pfizer
- Incyte
- Tessa Therapeutics
- Boehringer Ingelheim
- CEL-SCI
- Pierre Fabre
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