Head and Neck Squamous Cell Carcinoma – Global Drug Forecast and Market Analysis to 2030

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Head and Neck Squamous Cell Carcinomas Market Report Overview

Head and neck squamous cell carcinoma (HNSCC) was the sixth most common cancer type by worldwide incidence in 2020. However, until recently, there had been limited research and development in HNSCC, resulting in a market with little competition and a stagnant pipeline. Historically, cytotoxic chemotherapies have made up the majority of the HNSCC market. There is currently little competition between targeted therapies in the HNSCC market, leaving an area of considerable opportunity for interested newcomers. Despite the approvals of PD-1 inhibitors, which have changed the treatment for platinum (Pt)-refractory HNSCC patients, cisplatin-based chemotherapy still remains the standard treatment for locally advanced (LA) HNSCC and newly diagnosed recurrent/metastatic (R/M) HNSCC.

The approval of Eli Lilly’s Erbitux in 2006 introduced the only non-chemotherapy agent available to HNC patients until 2016. In 2016, immunotherapies entered the HNSCC space with the approval of Merck & Co.’s Keytruda and BMS’ Opdivo as treatments for R/M HNSCC, followed by Keytruda’s expansion into first-line setting for PD-L1 positive and all-comer patients. During 2020-2030, the competitive landscape will continue to evolve with the label extension of Keytruda as an adjuvant treatment for LA-HNC patients, and the launch of 11 pipeline agents. Among these, six belong to the ICI class, which, as a class, are expected to be the main driver of market growth. As a result of this active level of clinical development, specifically with immunotherapies, the HNSCC market is expected to grow dramatically across the 8MM.

This report covers opportunities for various marketed agents and pipeline agents in development across the 8MM, clinical and commercial assessments for agents in late-stage clinical development, R&D strategies, and innovative approaches in development for HNSCC breast cancer. This edition provides an update to the previous sales forecast for marketed and pipeline agents and highlights expected market dynamics by country and class of therapy across the forecast period, 2020-2030.

KEY QUESTIONS ANSWERED

– 11 late-stage pipeline agents are going to enter the HNSCC market from 2021 onwards. What impact will these agents have on the market? Which of these drugs will have the highest peak sales, and why?
– What are the current unmet needs in HNSCC, which pipeline agents are positioned to counter these unmet needs? What are the opportunities for R&D?
– What is the market outlook in the 8MM from 2020-2030? Considering major patent expiries, launch of new premium priced agents and expected label expansions.
– What are the main corporate trends? Who are the current and future players?

Scope

Overview of HNSCC including epidemiology, etiology, pathophysiology, symptoms, diagnosis, and treatment guidelines.

Topline HNSCC market revenue, annual cost of therapy, and major pipeline product sales in the forecast period.

Key topics covered include current treatment and pipeline therapies, unmet needs and opportunities, and the drivers and barriers affecting HNSCC therapeutics sales in the 8MM.

Pipeline analysis: Comprehensive data split across different phases, emerging novel trends under development, and detailed analysis of late-stage pipeline drugs (Phase III).

Analysis of the current and future market competition in the global HNSCC market. Insightful review of the key industry drivers, restraints and challenges. Each trend is independently researched to provide qualitative analysis of its implications.

Key Highlights

The main drivers of growth include the anticipated label expansion of currently marketed therapies and the approval and launch of 11 pipeline therapies and greater market access across the 8MM for premium priced agents.

The main barriers to growth in the 8MM are the patent expiries of the leading brands across the 8MM.

The most important unmet needs in the HNSCC market include: Efficacious treatments for patients via personalization of therapy and identification of druggable targets.

Reasons to Buy

The report will enable you to:

Develop and design your in-licensing and out-licensing strategies, using a detailed overview of current pipeline products and technologies to identify companies with the most robust pipelines.

Develop business strategies by understanding the trends shaping and driving the global HNSCC therapeutics market.

Drive revenues by understanding the key trends, innovative products and technologies, market segments, and companies likely to impact the global HNSCC 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.

Track drug sales in the global HNSCC therapeutics market from 2020-2030.

Organize your sales and marketing efforts by identifying the market categories and segments that present maximum opportunities for consolidations, investments and strategic partnerships.

Replimune Ltd
SQZ Biotechnologies
Iovance Biotherapeutics Inc

Table of Contents

Table of Contents

| About GlobalData

1 Head and Neck Squamous Cell Carcinoma: Executive Summary

1.1 The Head and Neck Squamous Cell Carcinoma Market Will Grow to $5.2B in 2030

1.2 Merck & Co. Expected to Maintain Its Market-Leading Position

1.3 Extending Overall Survival Remains a Major Unmet Need

1.4 Immune Checkpoint Inhibitors Expected to Launch in Locally Advanced and Recurrent/Metastatic Settings

1.5 What Do Physicians Think?

2 Introduction

2.1 Catalyst

2.2 Related Reports

2.3 Upcoming Reports

3 Disease Overview

3.1 Etiology and Pathophysiology

3.1.1 Etiology

3.1.2 Pathophysiology

3.2 Classification or Staging Systems

4 Epidemiology

4.1 Disease Background

4.2 Risk Factors and Comorbidities

4.3 Global and Historical Trends

4.4 8MM Forecast Methodology

4.4.1 Sources

4.4.2 Forecast Assumptions and Methods

4.4.3 Forecast Assumptions and Methods: Diagnosed Incident Cases of HNC

4.4.4 Forecast Assumptions and Methods: Diagnosed Incident Cases of HNC by Histology Distribution

4.4.5 Forecast Assumptions and Methods: Diagnosed Incident Cases of HNC by Clinical Stage at Diagnosis for Squamous Cell Carcinoma

4.4.6 Forecast Assumptions and Methods: Diagnosed Incident Cases of Oropharynx Cancer by Risk Factor (HPV+ and HPV-)

4.4.7 Forecast Assumptions and Methods: Diagnosed Incident Cases of Nasopharynx Cancer by Risk Factor (EBV+)

4.4.8 Forecast Assumptions and Methods: Tobacco Smoking History

4.4.9 Forecast Assumptions and Methods: Five-Year Diagnosed Prevalent Cases of HNC

4.5 Epidemiological Forecast for HNC (2020-2030)

4.5.1 Diagnosed Incident Cases of Lip, Oral Cavity, Pharynx, and Larynx Cancer (ICD-10 = C00-C06, C09, C12-C14, C32, and C10 [HPV-])

4.5.2 Diagnosed Incident Cases of Lip, Oral Cavity, Pharynx, and Larynx Cancer (ICD-10 = C00-C06, C09, C12-C14, C32, and C10 [HPV-]) by Risk Factor, Histology Distribution, and Stage at Diagnosis

4.5.3 Five-Year Diagnosed Prevalent Cases of Lip, Oral Cavity, Pharynx, and Larynx Cancer (ICD-10 = C00-C06, C09, C12-C14, C32, and C10 [HPV-])

4.5.4 Diagnosed Incident Cases of Oropharynx Cancer (ICD-10 = C10)

4.5.5 Diagnosed Incident Cases of Oropharynx Cancer by Risk Factors, Histology Distribution, and Stage at Diagnosis

4.5.6 Diagnosed Incident Cases of Nasopharynx Cancer (ICD-10 = C11)

4.5.7 Age-Specific Diagnosed Incident Cases of Nasopharynx Cancer

4.5.8 Sex-Specific Diagnosed Incident Cases of Nasopharynx Cancer

4.5.9 Diagnosed Incident Cases of Nasopharynx Cancer by Risk Factors, Histology Distribution, and Stage at Diagnosis

4.5.10 Five-Year Diagnosed Prevalent Cases of Nasopharynx Cancer

4.5.11 Diagnosed Incident Cases of Salivary Gland and Nose, Sinuses, and Other Related Structures Cancer (ICD-10 = C07-C08 and C30-C31)

4.5.12 Age-Specific Diagnosed Incident Cases of Salivary Gland and Nose, Sinuses, and Other Related Structures Cancer

4.5.13 Sex-Specific Diagnosed Incident Cases of Salivary Gland and Nose, Sinuses, and Other Related Structures Cancer

4.5.14 Diagnosed Incident Cases of Salivary Gland and Nose, Sinuses, and Other Related Structures Cancer by Risk Factors, Histology Distribution, and Stage at Diagnosis

4.5.15 Five-Year Diagnosed Prevalent Cases of Salivary Gland and Nose, Sinuses, and Other Related Structures Cancer

4.6 Discussion

4.6.1 Epidemiological Forecast Insight

4.6.2 COVID-19 Impact

4.6.3 Limitations of the Analysis

4.6.4 Strengths of the Analysis

5 Disease Management

5.1 Diagnosis and Treatment Overview

5.2 Key Opinion Leader Insights on Disease Management

6 Current Treatment Options

6.1 Overview

7 Unmet Needs and Opportunity Assessment

7.1 Overview

7.2 Superior Efficacy/Overall Survival

7.3 Reducing Risk of Recurrence

7.4 Personalized Therapy in LA-HNSCC

7.5 Identification of New Druggable Targets

7.6 Therapeutic De-Intensification in HPV-Positive Oropharyngeal HNSCC Patients

8 R&D Strategies

8.1 Overview

8.1.1 Immunotherapy in Locally Advanced HNSCC

8.1.2 Precision Medicine in Head and Neck Cancer

8.1.3 Regulatory Submissions Through Overseas Clinical Trials

8.2 Clinical Trials Design

8.2.1 Preferred Trial Endpoints

8.2.2 Study Inclusion/Exclusion Criteria

8.2.3 Need for Head-to-Head Comparisons

9 Pipeline Assessment

9.1 Overview

9.2 Promising Drugs in Clinical Development

10 Pipeline Valuation Analysis

10.1 Overview

10.2 Competitive Assessment

11 Current and Future Players

11.1 Overview

11.2 Deal-Making Trends

12 Market Outlook

12.1 Global Markets

12.1.1 Forecast

12.1.2 Drivers and Barriers – Global Issues

12.2 US

12.2.1 Forecast

12.2.2 Key Events

12.2.3 Drivers and Barriers

12.3 5EU

12.3.1 Forecast

12.3.2 Key Events

12.3.3 Drivers and Barriers

12.4 Japan

12.4.1 Forecast

12.4.2 Key Events

12.4.3 Drivers and Barriers

12.5 Urban China

12.5.1 Forecast

12.5.2 Key Events

12.5.3 Drivers and Barriers

13 Appendix

13.1 Bibliography

13.2 Abbreviations

13.3 Methodology

13.3.1 Forecasting Methodology

13.4 Primary Research – Key Opinion Leaders Interviewed for This Report

13.5 Primary Research – Prescriber Survey

13.6 About the Authors

13.6.1 Analyst

13.6.2 Therapy Area Director

13.6.3 Epidemiologist

13.6.4 Reviewers

13.6.5 Global Director of Therapy Analysis and Epidemiology

13.6.6 Global Head and EVP of Healthcare Operations and Strategy

| Contact Us

Table

Table 1: Head and Neck Squamous Cell Carcinoma: Key Metrics in the 8MM

Table 2: ICD-10 Codes Used to Classify HNC

Table 3: TNM Classification of Cancers of the Oral Cavity (Including Mucosa of the Lip)

Table 4: TNM Classification of Cancers of the Oropharynx (p16-) and Hypopharynx

Table 5: TNM Classification of Cancers of the Oropharynx – HPV Mediated (p16+)

Table 6: TNM Classification of Cancers of the Larynx

Table 7: TNM Classification of Cancers of the Nasal Cavity and Paranasal Sinuses

Table 8: TNM Classification of Cancers of the Nasopharynx

Table 9: Stage Grouping for Cancers of the Oral Cavity (Including Mucosa of the Lip)

Table 10: Stage Grouping for Cancers of the Larynx

Table 11: Stage Grouping for Cancers of the Oropharynx (p16+)

Table 12: Stage Grouping for Cancers of the Oropharynx (p16-) and Hypopharynx

Table 13: Stage Grouping for Cancers of the Nasopharynx

Table 14: Risk Factors and Comorbid Conditions Associated with HNCs

Figure 15: 8MM, Diagnosed Incidence of HNC, Men and Women (Cases per 100,000 Population), Ages ≥18 Years, 2020

Table 16: 8MM, Diagnosed Incident Cases of Lip, Oral Cavity, Pharynx, and Larynx Cancer by Risk Factor, Histology Distribution, and Stage at Diagnosis, Both Sexes, Ages ≥18 Years, N, 2020

Table 17: 8MM, Diagnosed Incident Cases of Oropharynx Cancer by Risk Factor, Histology Distribution, and Stage at Diagnosis, Both Sexes, Ages ≥18 Years, N, 2020

Table 18: 8MM, Diagnosed Incident Cases of Nasopharynx Cancer by Risk Factors, Histology Distribution, and Stage at Diagnosis, Both Sexes, Ages ≥18 Years, N, 2020

Table 19: 8MM, Diagnosed Incident Cases of Salivary Gland and Nose, Sinuses, and Other Related Structures Cancer by Risk Factor, Histology Distribution, and Stage at Diagnosis, Both Sexes, Ages ≥18 Years, N, 2020

Table 20: Treatment Guidelines for HNSCC Across the 8MM

Table 21: Top 10 Deals by Value, 2018-2020

Table 22: HNSCC Market – Global Drivers and Barriers, 2020-2030

Table 23: Key Events Impacting Sales for HNSCC in the US, 2020-2030

Table 24: HNSCC Market – Drivers and Barriers in the US, 2020-2030

Table 25: Key Events Impacting Sales for HNSCC in the 5EU, 2020-2030

Table 26: HNSCC Market – Drivers and Barriers in the 5EU, 2020-2030

Table 27: Key Events Impacting Sales for HNSCC in Japan, 2020-2030

Table 28: HNSCC Market – Drivers and Barriers in Japan, 2020-2030

Table 29: Key Events Impacting Sales for HNSCC in Urban China, 2020-2030

Table 30: HNSCC Market – Drivers and Barriers in Urban China, 2020-2030

Table 31: High-Prescribing Physicians (non-KOLs) Surveyed, By Country

Figures

Figure 1: Global Sales Forecast by Country for HNSCC in 2020 and 2030

Figure 2: Analysis of the Company Portfolio Gap in HNSCC During the Forecast Period

Figure 3: Competitive Assessment of the Late-Stage Pipeline Agents that GlobalData Expects to Be Licensed for the Treatment of HNSCC During the Forecast Period in the Locally Advanced Setting

Figure 4: Competitive Assessment of the Late-Stage Pipeline Agents that GlobalData Expects to Be Licensed for the Treatment of HNSCC During the Forecast Period in the Recurrent/Metastatic Setting

Figure 5: Common Anatomical Sites of HNSCC

Figure 6: 8MM, Sources Used, Diagnosed Incident Cases of Lip, Oral Cavity, Pharynx, and Larynx Cancer (ICD-10 = C00-C06, C09, C12-C14, C32, and C10 [HPV-])

Figure 7: 8MM, Sources Used, Diagnosed Incident Cases of Oropharynx Cancer (ICD-10 = C10); Nasopharynx Cancer (ICD-10 = C11); Salivary Gland and Nose, Sinuses, and Other Related Structures Cancer (ICD-10 = C07-C08 and C30-C31)

Figure 8: 8MM, Sources Used, Five-Year Prevalent Cases of Lip, Oral Cavity, Pharynx, and Larynx Cancer (ICD-10 = C00-C06, C09, C12-C14, C32, and C10 [HPV-]), Oropharynx Cancer (ICD-10 = C10), Nasopharynx Cancer (ICD-10 = C11), Salivary Gland and Nose, Sinuses, and Other Related Structures Cancer (ICD-10 = C07-C08 and C30-C31)

Figure 9: 8MM, Sources Used to Forecast the Risk Factors and Histology Distribution Among Diagnosed Incident Cases of Lip, Oral Cavity, Pharynx, and Larynx Cancer (ICD-10 = C00-C06, C09, C12-C14, C32, and C10 [HPV-]), Oropharynx Cancer (ICD-10 = C10), Nasopharynx Cancer (ICD-10 = C11), Salivary Gland and Nose, Sinuses, and Other Related Structures Cancer (ICD-10 = C07-C08 and C30-C31)

Figure 10: 8MM, Sources Used to Forecast the Stage at Diagnosis Among Diagnosed Incident Cases of Lip, Oral Cavity, Pharynx, and Larynx Cancer, Oropharynx Cancer, Nasopharynx Cancer, and Salivary Gland and Nose, Sinuses, and Other Related Structures Cancer

Figure 11: 8MM, Diagnosed Incident Cases of Lip, Oral Cavity, Pharynx, and Larynx Cancer, N, Both Sexes, Ages ≥18 Years, 2020

Figure 12: 8MM, Five-Year Diagnosed Prevalent Cases of Lip, Oral Cavity, Pharynx, and Larynx Cancer, N, Both Sexes, Ages ≥18 Years, 2020

Figure 13: 8MM, Diagnosed Incident Cases of Oropharynx Cancer, N, Both Sexes, Ages ≥18 Years, 2020

Figure 14: 8MM, Diagnosed Incident Cases of Nasopharynx Cancer, N, Both Sexes, Ages ≥18 Years, 2020

Figure 15: 8MM, Diagnosed Incident Cases of Nasopharynx Cancer by Age, N, Both Sexes, 2020

Figure 16: 8MM, Diagnosed Incident Cases of Nasopharynx Cancer by Sex, N, Ages ≥18 Years, 2020

Figure 17: 8MM, Five-Year Diagnosed Prevalent Cases of Nasopharynx Cancer, N, Both Sexes, Ages ≥18 Years, 2020

Figure 18: 8MM, Diagnosed Incident Cases of Salivary Gland and Nose, Sinuses, and Other Related Structures Cancer, N, Both Sexes, Ages ≥18 Years, 2020

Figure 19: 8MM, Diagnosed Incident Cases of Salivary Gland and Nose, Sinuses, and Other Related Structures Cancer by Age, N, Both Sexes, 2020

Figure 20: 8MM, Diagnosed Incident Cases of Salivary Gland and Nose, Sinuses, and Other Related Structures Cancer by Sex, N, Ages ≥18 Years, 2020

Figure 21: 8MM, Five-Year Diagnosed Prevalent Cases of Salivary Gland and Nose, Sinuses, and Other Related Structures Cancer, N, Both Sexes, Ages ≥18 Years, 2020

Figure 22: Treatment Algorithm in HNSCC: Oral Cavity (Including Mucosa of the Lip), Pharynx, Larynx, Salivary Glands, and Paranasal Sinuses

Figure 23: Treatment Algorithm in HNSCC: Nasopharynx

Figure 24: Unmet Needs and Opportunities in HNSCC

Figure 25: Overview of the Development Pipeline in HNSCC

Figure 26: Key Late-Stage Trials for the Promising Pipeline Agents that GlobalData Expects to Be Licensed for HNSCC in the 8MM During the Forecast Period

Figure 27: Competitive Assessment of Key Pipeline Products – LA-HNSCC

Figure 28: Competitive Assessment of Key Pipeline Products – R/M-HNSCC

Figure 29: Analysis of the Company Portfolio Gap in HNSCC During the Forecast Period

Figure 30: Global (8MM) Sales Forecast by Country for HNSCC in 2020 and 2030

Figure 31: Sales Forecast by Class for HNSCC in the US in 2020 and 2030

Figure 32: Sales Forecast by Class for HNSCC in the 5EU in 2020 and 2030

Figure 33: Sales Forecast by Class for HNSCC in Japan in 2020 and 2030

Figure 34: Sales Forecast by Class for HNSCC in Urban China in 2020 and 2030

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