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

  • ID: 3699996
  • Drug Pipelines
  • 250 pages
  • GlobalData
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OpportunityAnalyzer: Head and Neck Squamous Cell Carcinoma - Opportunity Analysis and Forecast to 2024

Summary

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.

Highlights

Key Questions Answered

- 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?

Key Findings

- New drug launches will increase competition and drive expansion of the HNC market. Over the forecast period, six pipeline drugs are expected to file for approval in HNC and the launch of these premium priced agents will drive significant increase in total drug sales in the 7MM.
- Immuno-oncology agents will be a major driver of treatment innovation. Results from ongoing clinical trials are highly anticipated by the medical community and combination therapies hold promise of greater treatment efficacy.
- The lack of predictive biomarkers in HNC will continue to pose an issue in adopting personalized treatment, and the increasing costs of new therapies will make this a more pressing issue.
- KOLs interviewed for this report expressed a need for better treatments in earlier lines of disease in order for treatments to be effective. There needs to be an emphasis on the prevention of disease recurrence, not just treating the recurrences after they occur.

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.

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. Additionally a list of acquisition targets included in the pipeline product company list.
- Develop business strategies by understanding the trends shaping and driving the global HNC therapeutics market.
- Drive revenues by understanding the key trends, innovative products and technologies, market segments, and companies likely to impact the global HNC therapeutics market in future.
- Formulate effective sales and marketing strategies by understanding the competitive landscape and by analysing the performance of various competitors.
- Track drug sales in the global HNC therapeutics market from 2014-2024.
- Organize your sales and marketing efforts by identifying the market categories and segments that present maximum opportunities for consolidations, investments and strategic partnerships.
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FEATURED COMPANIES

  • Advaxis, Inc.
  • Azanta A/S
  • CEL-SCI
  • F. Hoffman La-Roche
  • Marsala Biotech
  • Nordic Pharma
  • MORE
1.1 List of Tables

1.2 List of Figures

2 Introduction

2.1 Catalyst

2.2 Related Reports

2.3 Upcoming Related Reports

3 Disease Overview

3.1 Etiology and Pathophysiology

3.1.1 Etiology

3.1.2 Biomarkers

3.1.3 Pathophysiology

3.1.4 Clinical Staging

3.2 Diagnosis

3.3 Symptoms

3.4 Prognosis

3.4.1 Quality of Life

4 Epidemiology

4.1 Risk Factors and Comorbidities

4.2 Global and Historical Trends

4.2.1 Incidence

4.2.2 Relative Survival - 7MM

4.3 Forecast Methodology

4.3.1 Sources Used

4.3.2 Sources Not Used

4.3.3 Forecast Assumptions and Methods

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

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

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

4.4.3 Diagnosed Incident Cases of Larynx Cancer

4.4.4 Diagnosed Incident Cases of HNC

4.4.5 Diagnosed Incident Cases of Thyroid Cancer

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

4.4.7 Age-Specific Diagnosed Incident Cases of Larynx Cancer

4.4.8 Age-Specific Diagnosed Incident Cases of Thyroid Cancer

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

4.4.10 Sex-Specific Diagnosed Incident Cases of Larynx Cancer

4.4.11 Sex-Specific Diagnosed Incident Cases of Thyroid Cancer

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

4.4.13 Age-Standardized Diagnosed Incidence of Larynx Cancer

4.4.14 Age-Standardized Diagnosed Incidence of Thyroid Cancer

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

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

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

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

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

4.4.20 Diagnosed Incident Cases of Larynx Cancer by Histology Distribution

4.4.21 Diagnosed Incident Cases of Thyroid Cancer by Histology Distribution

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

4.4.23 Five-Year Diagnosed Prevalent Cases of Larynx Cancer

4.4.24 Five-Year Diagnosed Prevalent Cases of Thyroid Cancer

4.5 Discussion

4.5.1 Epidemiological Forecast Insight

4.5.2 Limitations of the Analysis

4.5.3 Strengths of the Analysis

5 Current Treatment Options

5.1 Overview

5.2 Product Profiles

5.2.1 Erbitux (cetuximab)

5.2.2 TS-1 (tegafur + gimeracil + oteracil)

5.3 Standard of Care Chemotherapy Review

5.3.1 Cisplatin

5.3.2 Docetaxel

5.3.3 Fluorouracil (5-FU)

5.3.4 Methotrexate

6 Unmet Needs Assessment and Opportunity Analysis

6.1 Overview

6.2 Unmet Needs Analysis

6.2.1 Treatments for Recurrent and Metastatic Disease

6.2.2 Treatments for Locally Advanced Head and Neck Cancers

6.2.3 Treatments for HPV-negative Disease

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

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

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

7 R&D Strategies

7.1 Overview

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

7.1.2 Kinase Inhibitors in the Early Stage Pipeline

7.1.3 Therapeutic HPV Vaccines for HPV-Positive Patients

7.2 Clinical Trial Design

7.2.1 Overall Patient Survival Most Important Outcome for Treatment

7.2.2 Majority of New Drugs Targeting rmHNSCC

7.2.3 Lack of Consistency in Comparator in the HNSCC Trials

8 Pipeline Assessment

8.1 Overview

8.2 Drugs in Late-Stage Clinical Development

8.2.1 Javlor (vinflunine)

8.2.2 Gilotrif (afatinib)

8.2.3 Multikine (leukocyte interleukin)

8.2.4 Nimoral (nimorazole)

8.2.5 Vectibix (panitumumab)

8.2.6 Reolysin (pelareorep)

8.3 Immune Checkpoint Inhibitors

8.3.1 Overview

8.3.2 Opdivo (nivolumab)

8.3.3 Keytruda (pembrolizumab)

8.3.4 Durvalumab (MEDI4736)

8.4 Innovative Early-stage Approaches

8.4.1 Therapeutic Cancer Vaccines

8.4.2 Kinase Inhibitors for Prevention of Downstream Signaling

8.4.3 Virus-based Therapies for the Treatment of Solid Tumors

9 Pipeline Valuation Analysis

9.1 Clinical Benchmark of Key Pipeline Drugs

9.2 Commercial Benchmark of Key Pipeline Drugs

9.3 Competitive Assessment

9.4 Top-Line Ten Year Forecast

9.4.1 US

9.4.2 5EU

9.4.3 Japan

10 Appendix

10.1 Bibliography

10.2 Abbreviations

10.3 Methodology

10.4 Forecasting Methodology

10.4.1 Diagnosed Head and Neck Cancer patients

10.4.2 Percent Drug-treated Patients

10.4.3 Drugs Included in Each Therapeutic Class

10.4.4 Launch and Patent Expiry Dates

10.4.5 General Pricing Assumptions

10.4.6 Individual Drug Assumptions

10.4.7 Generic Erosion

10.4.8 Pricing of Pipeline Agents

10.5 Physicians and Specialists Included in this Study

10.6 About the Authors

10.6.1 Author

10.6.2 Reviewer

10.6.3 Therapy Area Director

10.6.4 Epidemiologist

10.6.5 Reviewers

10.6.6 Global Director of Therapy Analysis and Epidemiology

10.6.7 Global Head of Healthcare

10.7 About us

10.8 Disclaimer

1.1 List of Tables

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

1.2 List of 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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Advaxis, Inc.
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AstraZeneca
Azanta A/S
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Eli Lilly
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GlaxoSmithKline
Glycotope
Marsala Biotech
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