OpportunityAnalyzer: Head and Neck Squamous Cell Carcinoma – Opportunity Analysis and Forecast to 2024

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Published: February 01, 2016 Report Code: GDHC054POA-ST

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The head and neck cancer (HNC) market is one currently dominated by generic chemotherapies, with little competition from branded therapies. The market landscape is set to undergo substantial growth between 2014 and 2024. The main drivers of growth will be an increase in the diagnosed HNC population and the launch of multiple premium-priced metastatic therapies, led by the class of immuno-oncology products. Historically, cytotoxic chemotherapies have comprised the bulk of the HNC market. Little competition between targeted therapies currently exists in the HNC market, leaving an area of considerable opportunity for interested new comers. Cisplatin is the standard treatment for HNC, due to its greater efficacy over other chemotherapy agents. However, as a cytotoxic agent, its use is limited by its high toxicity and poor safety profile. The recent investment in HNC has seen a significant increase in research activity. The launch of new agents into the market and continued innovation in the developmental pipeline promises to produce a dynamic market over the forecast period.

Scope

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

Annualized HNC therapeutics market revenue, annual cost of therapy and treatment usage pattern data from 2014 and forecast for ten years to 2024.

Key topics covered include strategic competitor assessment, market characterization, unmet needs, clinical trial mapping and implications for the HNC therapeutics market.

Pipeline analysis: comprehensive data split across different phases, emerging novel trends under development, and detailed analysis of late-stage pipeline drugs.

Analysis of the current and future market competition in the global HNC therapeutics 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 HNC market is marked by the presence of a number of unmet needs in current treatments. What are the main unmet needs in this market? Will the drugs under development fulfil the unmet needs of the HNC market?

The late-stage HNC pipeline is varied and innovative. Will the late-stage drugs make a significant impact on the HNC market? Which of these drugs will have the highest peak sales at the highest CAGR, and why?

The current HNC market is dominated by generic chemotherapy regimens with little branded competition. How will the advent of new targeted therapies change the treatment landscape for HNC? How will the drug treatment rate change over the next ten years? What are the key drivers and barriers to this change?

Advaxis, Inc.
Amgen
AstraZeneca
Azanta A/S
Boehringer Ingelheim
Bristol-Myers Squibb
CEL-SCI
Curis Pharmaceutical
Eli Lilly
F. Hoffman La-Roche
GlaxoSmithKline
Glycotope
Marsala Biotech
Merck & Co. (MSD)
Merck KGaA
Nordic Pharma
Oncolytics Biotech
Ono Pharmaceuticals
Pfizer
Pierre Fabre Medicament
Taiho Pharmaceutical

Table of Contents

1Table of Contents

1.1List of Tables

1.2List of Figures

2Introduction

2.1Catalyst

2.2Related Reports

2.3Upcoming Related Reports

3Disease Overview

3.1Etiology and Pathophysiology

3.1.1Etiology

3.1.2Biomarkers

3.1.3Pathophysiology

3.1.4Clinical Staging

3.2Diagnosis

3.3Symptoms

3.4Prognosis

3.4.1Quality of Life

4Epidemiology

4.1Risk Factors and Comorbidities

4.2Global and Historical Trends

4.2.1Incidence

4.2.2Relative Survival – 7MM

4.3Forecast Methodology

4.3.1Sources Used

4.3.2Sources Not Used

4.3.3Forecast Assumptions and Methods

4.4Epidemiological Forecast for HNC and Thyroid Cancer (2014–2024)

4.4.1Diagnosed Incident Cases of Lip, Oral Cavity, and Pharynx Cancer

4.4.2Diagnosed Incident Cases of Nose, Sinuses, and Related Cancers

4.4.3Diagnosed Incident Cases of Larynx Cancer

4.4.4Diagnosed Incident Cases of HNC

4.4.5Diagnosed Incident Cases of Thyroid Cancer

4.4.6Age-Specific Diagnosed Incident Cases of Lip, Oral Cavity, and Pharynx Cancer

4.4.7Age-Specific Diagnosed Incident Cases of Larynx Cancer

4.4.8Age-Specific Diagnosed Incident Cases of Thyroid Cancer

4.4.9Sex-Specific Diagnosed Incident Cases of Lip, Oral Cavity, and Pharynx Cancer

4.4.10Sex-Specific Diagnosed Incident Cases of Larynx Cancer

4.4.11Sex-Specific Diagnosed Incident Cases of Thyroid Cancer

4.4.12Age-Standardized Diagnosed Incidence of Lip, Oral Cavity, and Pharynx Cancer

4.4.13Age-Standardized Diagnosed Incidence of Larynx Cancer

4.4.14Age-Standardized Diagnosed Incidence of Thyroid Cancer

4.4.15Diagnosed Incident Cases of Lip, Oral Cavity, and Pharynx Cancer by Clinical Stage at Diagnosis

4.4.16Diagnosed Incident Cases of Larynx Cancer by Clinical Stage at Diagnosis

4.4.17Diagnosed Incident Cases of Thyroid Cancer by Clinical Stage at Diagnosis

4.4.18Diagnosed Incident Cases of Lip, Oral Cavity, and Pharynx Cancer by Histology Distribution

4.4.19Diagnosed Incident Cases of Nose, Sinuses, and Related Cancers by Histology Distribution

4.4.20Diagnosed Incident Cases of Larynx Cancer by Histology Distribution

4.4.21Diagnosed Incident Cases of Thyroid Cancer by Histology Distribution

4.4.22Five-Year Diagnosed Prevalent Cases of Lip, Oral Cavity, and Pharynx Cancer

4.4.23Five-Year Diagnosed Prevalent Cases of Larynx Cancer

4.4.24Five-Year Diagnosed Prevalent Cases of Thyroid Cancer

4.5Discussion

4.5.1Epidemiological Forecast Insight

4.5.2Limitations of the Analysis

4.5.3Strengths of the Analysis

5Current Treatment Options

5.1Overview

5.2Product Profiles

5.2.1Erbitux (cetuximab)

5.2.2TS-1 (tegafur + gimeracil + oteracil)

5.3Standard of Care Chemotherapy Review

5.3.1Cisplatin

5.3.2Docetaxel

5.3.3Fluorouracil (5-FU)

5.3.4Methotrexate

6Unmet Needs Assessment and Opportunity Analysis

6.1Overview

6.2Unmet Needs Analysis

6.2.1Treatments for Recurrent and Metastatic Disease

6.2.2Treatments for Locally Advanced Head and Neck Cancers

6.2.3Treatments for HPV-negative Disease

6.2.4Management of Co-morbidities and Adverse Events Arising from Traditional Therapy

6.2.5Predictive Biomarkers to Guide and Improve the Current Treatments in Use

6.2.6Investment in Non-squamous Cell Carcinomas of the Head and Neck

7R&D Strategies

7.1Overview

7.1.1Emergence of Immuno-Oncology Agents in the Late-Phase Pipeline

7.1.2Kinase Inhibitors in the Early Stage Pipeline

7.1.3Therapeutic HPV Vaccines for HPV-Positive Patients

7.2Clinical Trial Design

7.2.1Overall Patient Survival Most Important Outcome for Treatment

7.2.2Majority of New Drugs Targeting rmHNSCC

7.2.3Lack of Consistency in Comparator in the HNSCC Trials

8Pipeline Assessment

8.1Overview

8.2Drugs in Late-Stage Clinical Development

8.2.1Javlor (vinflunine)

8.2.2Gilotrif (afatinib)

8.2.3Multikine (leukocyte interleukin)

8.2.4Nimoral (nimorazole)

8.2.5Vectibix (panitumumab)

8.2.6Reolysin (pelareorep)

8.3Immune Checkpoint Inhibitors

8.3.1Overview

8.3.2Opdivo (nivolumab)

8.3.3Keytruda (pembrolizumab)

8.3.4Durvalumab (MEDI4736)

8.4Innovative Early-stage Approaches

8.4.1Therapeutic Cancer Vaccines

8.4.2Kinase Inhibitors for Prevention of Downstream Signaling

8.4.3Virus-based Therapies for the Treatment of Solid Tumors

9Pipeline Valuation Analysis

9.1Clinical Benchmark of Key Pipeline Drugs

9.2Commercial Benchmark of Key Pipeline Drugs

9.3Competitive Assessment

9.4Top-Line Ten Year Forecast

9.4.1US

9.4.25EU

9.4.3Japan

10Appendix

10.1Bibliography

10.2Abbreviations

10.3Methodology

10.4Forecasting Methodology

10.4.1Diagnosed Head and Neck Cancer patients

10.4.2Percent Drug-treated Patients

10.4.3Drugs Included in Each Therapeutic Class

10.4.4Launch and Patent Expiry Dates

10.4.5General Pricing Assumptions

10.4.6Individual Drug Assumptions

10.4.7Generic Erosion

10.4.8Pricing of Pipeline Agents

10.5Physicians and Specialists Included in this Study

10.6About the Authors

10.6.1Author

10.6.2Reviewer

10.6.3Therapy Area Director

10.6.4Epidemiologist

10.6.5Reviewers

10.6.6Global Director of Therapy Analysis and Epidemiology

10.6.7Global Head of Healthcare

10.7About GlobalData

10.8Contact Us

10.9Disclaimer

Table

Table 1: ICD-10 Codes used to classify Head and Neck Cancers

Table 2: Head and Neck Cancer Locations and Their Clinically Defined Locations

Table 3: TNM Classification of Lip, Oral Cavity, and Oropharyngeal Cancers

Table 4: TNM Classification of the Larynx

Table 5: TNM Classification of the Hypopharynx

Table 6: TNM Classification of Nasal Cavity and Paranasal Sinus Cancers

Table 7: TNM Classification of Salivary Gland Cancers

Table 8: TNM Classification of Nasopharyngeal Cancers

Table 9: TNM Classification of Thyroid Gland Cancers

Table 10: Stage Grouping for Head and Neck Cancer (Excluding Nasopharyngeal and Thyroid Cancer)

Table 11: Stage Grouping for Nasopharyngeal Cancer

Table 12: Stage Grouping of Thyroid Gland Cancers

Table 13: Symptoms of Head and Neck Squamous Cell Carcinoma

Table 14: Risk Factors for HNC

Table 15: Trends in the Age-Adjusted Incidence of Lip, Oral Cavity, and Pharynx Cancer in the 7MM, All Ages, 1998–2007

Table 16: Trends in the Age-Adjusted Incidence of Larynx Cancer in the 7MM, All Ages, 1998–2007

Table 17: Trends in the Age-Adjusted Incidence of Thyroid Cancer in the 7MM, All Ages, 1998–2007

Table 18: Trends in the Five-Year Relative Survival (%) of HNC and Thyroid Cancer in the 7MM, Both Sexes, 1993–2007

Table 19: 7MM, Sources of Epidemiological Data Used for the Forecast for the Diagnosed Incident Cases of Lip, Oral Cavity, and Pharynx Cancer

Table 20: 7MM, Sources of Epidemiological Data Used for the Forecast for the Diagnosed Incident Cases of Larynx Cancer

Table 21: 7MM, Sources of Epidemiological Data Used for the Forecast for the Diagnosed Incident Cases of Nose, Sinuses, and Related Cancer

Table 22: 7MM, Sources of Epidemiological Data Used for the Forecast for the Diagnosed Incident Cases of Thyroid Cancer

Table 23: 7MM, Sources of Epidemiological Data Used for the Forecast for the Five-Year Diagnosed Prevalent Cases of Lip, Oral Cavity, and Pharynx Cancer

Table 24: 7MM, Sources of Epidemiological Data Used for the Forecast for the Five-Year Diagnosed Prevalent Cases of Larynx Cancer

Table 25: 7MM, Sources of Epidemiological Data Used for the Forecast for the Five-Year Diagnosed Prevalent Cases of Thyroid Cancer

Table 26: 7MM, Sources of Epidemiological Data Used for the Segmentation of Diagnosed Incident Cases of HNC (Excluding Nose, Sinuses, and Related Cancers) and Thyroid Cancer by Clinical Stage at Diagnosis

Table 27: 7MM, Sources of Epidemiological Data Used for the Segmentation of the Diagnosed Incident Cases HNC and Thyroid Cancer by Histology Distribution

Table 28: 7MM, Diagnosed Incident Cases of Lip, Oral Cavity, and Pharynx Cancer, Both Sexes, All Ages, N, 2014–2024

Table 29: 7MM, Diagnosed Incident Cases of Nose, Sinuses, and Related Cancer, Both Sexes, All Ages, N, 2014–2024

Table 30: 7MM, Diagnosed Incident Cases of Larynx Cancer, Both Sexes, All Ages, N, 2014–2024

Table 31: 7MM, Diagnosed Incident Cases of HNC, Both Sexes, All Ages, N, 2014–2024

Table 32: 7MM, Diagnosed Incident Cases of Thyroid Cancer, Both Sexes, All Ages, N, 2014–2024

Table 33: 7MM, Age-Specific Diagnosed Incident Cases of Lip, Oral Cavity, and Pharynx Cancer, Both Sexes, N (Row %), 2014

Table 34: 7MM, Age-Specific Diagnosed Incident Cases of Larynx Cancer, Both Sexes, N (Row %), 2014

Table 35: 7MM, Age-Specific Diagnosed Incident Cases of Thyroid Cancer, Both Sexes, N (Row %), 2014

Table 36: 7MM, Sex-Specific Diagnosed Incident Cases of Lip, Oral Cavity, and Pharynx Cancer, All Ages, N (Row %), 2014

Table 37: 7MM, Sex-Specific Diagnosed Incident Cases of Larynx Cancer, All Ages, N (Row %), 2014

Table 38: 7MM, Sex-Specific Diagnosed Incident Cases of Thyroid Cancer, All Ages, N (Row %), 2014

Table 39: 7MM, Five-Year Diagnosed Prevalent Cases of Lip, Oral Cavity, and Pharynx Cancer, All Ages, Both Sexes, N, 2014–2024

Table 40: 7MM, Five-Year Diagnosed Prevalent Cases of Larynx Cancer, All Ages, Both Sexes, N, 2014–2024

Table 41: 7MM, Five-Year Diagnosed Prevalent Cases of Thyroid Cancer, All Ages, Both Sexes, N, 2014–2024

Table 42: Leading Treatments for Head and Neck Cancers

Table 43: Product Profile – Erbitux

Table 44: Efficacy of Erbitux with Cisplatin and 5-FU in rmHNSCC Patients, in a Phase III, Randomized Open-Label Trial.

Table 45: Efficacy of Erbitux with Radiotherapy in Locally Advanced HNSCC in Phase III, Randomized Open-Label Trial.

Table 46: Safety of Erbitux with Cisplatin and 5-FU Chemotherapy in rmHNSCC

Table 47: Erbitux SWOT Analysis

Table 48: Global Sales Forecast ($m) for Erbtiux, 2014-2024

Table 49: Product Profile – TS-1

Table 50: Safety of TS-1 Monotherapy in Patients with rmHNSCC

Table 51: TS-1 SWOT Analysis

Table 52: Global Sales Forecast ($m) for TS-1, 2014-2024

Table 53: Overall Unmet Needs – Current Level of Attainment

Table 54: Phase III Pipeline Clinical Trial Design

Table 55: Head and Neck Squamous Cell Carcinoma – Late Stage Pipeline, 2015

Table 56: Product Profile – Javlor

Table 57: Efficacy of Javlor with Methotrexate in rmHNSCC from Single Arm, Phase I Dose Finding Trial (ASCO 2015)

Table 58: Safety of Javlor with Methotrexate in rmHNSCC from a Single Arm, Phase I Dose Finding Trial (ASCO 2015)

Table 59: Javlor SWOT Analysis

Table 60: Global Sales Forecast ($m) for Javlor, 2014-2024

Table 61: Product Profile – Gilotrif

Table 62: Efficacy of Gilotrif with Methotrexate in rmHNSCC

Table 63: Safety of Gilotrif with Methotrxate in rmHNSCC (NCT01345682)

Table 64: Gilotrif SWOT Analysis

Table 65: Global Sales Forecast ($m) for Gilotrif, 2014–2024

Table 66: Product Profile – Multikine (interleukin injection)

Table 67: Disclosed Components of Multikine – Major Cytokines and Other Cellular Products

Table 68: Multikine SWOT Analysis

Table 69: Global Sales Forecast ($m) for Multikine, 2014–2024

Table 70: Product Profile – Opdivo

Table 71: Safety of dacarbazine v. Opdivo in advanced melanoma (checkmate-066)

Table 72: Opdivo SWOT Analysis

Table 73: Global Sales Forecast ($m) for Opdivo, 2014–2024

Table 74: Product Profile – Keytruda

Table 75: Safety of Investigator’s Chemotherapy versus Keytruda in Ipilimumab-Refractory Melanoma (KEYNOTE-002)

Table 76: Keytruda SWOT Analysis

Table 77: Global Sales Forecast ($m) for Keytruda, 2014–2024

Table 78: Product Profile – Durvalumab

Table 79: Safety of Durvalumab Single Agent in rmHNSCC from Single Arm, Phase I Dose Finding Trial (ASCO 2015)

Table 80: MEDI4736 SWOT Analysis

Table 81: Global Sales Forecast ($m) for durvalumab, 2014–2024

Table 82: Select early-stage pipeline products in HNSCC

Table 83: Clinical Benchmark of Key Pipeline Drugs – Locally advanced HNSCC

Table 84: Clinical Benchmark of Key Pipeline Drugs – rmHNSCC

Table 85: Commercial Benchmark of Key Pipeline Drugs

Table 86: Top Line Sales Forecasts ($million USD) for HNSCC, 2014-2024

Table 87: Key Events Impacting Sales for HNSCC

Table 88: HNSCC Market – Drivers and Barriers, 2014-2024

Table 89: Key Launch Dates, 2014–2024

Table 90: Key Patent Expiries, 2014–2024

Figures

Figure 1: Anatomical Sites of Head and Neck Cancers.

Figure 2: 7MM, Diagnosed Incident Cases of Lip, Oral Cavity, and Pharynx Cancer, Both Sexes, All Ages, N, 2014–2024

Figure 3: 7MM, Diagnosed Incident Cases of Nose, Sinuses, and Related Cancer, Both Sexes, All Ages, N, 2014–2024

Figure 4: 7MM, Diagnosed Incident Cases of Larynx Cancer, Both Sexes, All Ages, N, 2014–2024

Figure 5: 7MM, Diagnosed Incident Cases of HNC, Both Sexes, All Ages, N, 2014–2024

Figure 6: 7MM, Diagnosed Incident Cases of Thyroid Cancer, Both Sexes, All Ages, N, 2014–2024

Figure 7: 7MM, Age-Specific Diagnosed Incident Cases of Lip, Oral Cavity, and Pharynx Cancer, Both Sexes, N, 2014

Figure 8: 7MM, Age-Specific Diagnosed Incident Cases of Larynx Cancer, Both Sexes, N, 2014

Figure 9: 7MM, Age-Specific Diagnosed Incident Cases of Thyroid Cancer, Both Sexes, N, 2014

Figure 10: 7MM, Sex-Specific Diagnosed Incident Cases of Lip, Oral Cavity, and Pharynx Cancer, All Ages, N, 2014

Figure 11: 7MM, Sex-Specific Diagnosed Incident Cases of Larynx Cancer, All Ages, N, 2014

Figure 12: 7MM, Sex-Specific Diagnosed Incident Cases of Thyroid Cancer, All Ages, N, 2014

Figure 13: 7MM, Age-Standardized Diagnosed Incidence Cases of Lip, Oral Cavity, and Pharynx Cancer (Cases per 100,000 Population), All Ages, by Sex, 2014

Figure 14: 7MM, Age-Standardized Diagnosed Incidence Cases of Larynx Cancer (Cases per 100,000 Population), All Ages, by Sex, 2014

Figure 15: 7MM, Age-Standardized Diagnosed Incidence Cases of Thyroid Cancer (Cases per 100,000 Population), All Ages, by Sex, 2014

Figure 16: 7MM, Diagnosed Incident Cases of Lip, Oral Cavity, and Pharynx Cancer by Clinical Stage at Diagnosis, All Ages, Both Sexes, N, 2014

Figure 17: 7MM, Diagnosed Incident Cases of Larynx Cancer by Clinical Stage at Diagnosis, All Ages, Both Sexes, N, 2014

Figure 18: 7MM, Diagnosed Incident Cases of Thyroid Cancer by Clinical Stage at Diagnosis, All Ages, Both Sexes, N, 2014

Figure 19: 7MM, Diagnosed Incident Cases of Lip, Oral Cavity, and Pharynx Cancer by Histology Distribution, All Ages, Both Sexes, N, 2014

Figure 20: 7MM, Diagnosed Incident Cases of Nose, Sinuses, and Related Cancers by Histology Distribution, All Ages, Both Sexes, N, 2014

Figure 21: 7MM, Diagnosed Incident Cases of Larynx Cancer by Histology Distribution, All Ages, Both Sexes, N, 2014

Figure 22: 7MM, Diagnosed Incident Cases of Thyroid Cancer by Histology Distribution, All Ages, Both Sexes, N, 2014

Figure 23: 7MM, Five-Year Diagnosed Prevalent Cases of Lip, Oral Cavity, and Pharynx Cancer, All Ages, Both Sexes, N, 2014–2024

Figure 24: 7MM, Five-Year Diagnosed Prevalent Cases of Larynx Cancer, All Ages, Both Sexes, N, 2014–2024

Figure 25: 7MM, Five-Year Diagnosed Prevalent Cases of Thyroid Cancer, All Ages, Both Sexes, N, 2014–2024

Figure 26: Treatment Overview in HNSCC Patients

Figure 27: Treatment Overview in Nasopharyngeal Carcinoma Patients

Figure 28: Javlor’s Development in HNSCC

Figure 29: Gilotrif’s Development in HNSCC

Figure 30: Multikine’s Development in HNSCC

Figure 31: Opdivo’s Development in HNSCC

Figure 32: Keytruda’s Development in HNSCC

Figure 33: Durvalumab’s Development in HNSCC

Figure 34: Competitive Assessment of Marketed and Pipeline HNSCC Agents, 2014–2024

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