Head and Neck Squamous Cell Carcinoma – Opportunity Analysis and Forecast to 2026

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Published: March 30, 2018 Report Code: GDHC084POA-ST

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The head and neck (HNC) cancer market is expected to experience significant growth between 2016 and 2026 within the seven major markets (US, France, Germany, Italy, Spain, UK and Japan). 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.
Up until the approvals of Opdivo in the 7MM and Keytruda in the US during 2016 for the platinum-refractory recurrent/metastatic population, Erbitux was the only targeted agent ion the market, whilst the rest of the market was dominated by generic chemotherapy. Now that programmed cell death protein 1 (PD-1) inhibitors have penetrated into the second-line, label-expansions into earlier lines and in combinations with other immuno-oncology (IO) agents are expected during the forecast period. This will significantly expand the eligible population that can receive these premium-priced immunotherapies – The HNC competitive landscape is expected to experience a significant change, a new standard of care is predicted to be established in eight pipeline agents are expected to launch before 2026.
Key Questions Answered
How will the implementation of IO agents into earlier-lines of therapy affect the current treatment paradigm and which combinations are expected to have the greatest impact and highest chance of an approval?
The head and neck cancer market is characterized by a number of unmet needs. What are the main unmet needs in this market? Will the pipeline drugs under development fulfil these needs?
Eight late-stage pipeline agents are going to enter the head and neck cancer market from 2017 onwards. Will the late-stage drugs make a significant impact on the head and neck cancer market? Which of these drugs will have the highest peak sales, and why?

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.

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 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.

Merck & Co.
Bristol-Myers Squibb Co.
Eli Lilly
Taiho
AstraZeneca
Pfizer
Incyte
Tessa Therapeutics
Boehringer Ingelheim
CEL-SCI
Pierre Fabre

Table of Contents

1 Table of Contents

1.1 List of Tables

1.2 List of Figures

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 GlobalData

11.8 Contact Us

11.9 Disclaimer

Table

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

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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