두경부 편평상피암 : 시장 점유율 분석, 업계 동향과 통계, 성장 예측(2026-2031년)

According to Mordor Intelligence, the head and neck squamous cell carcinoma market size is expected to increase from USD 4.90 billion in 2025 to USD 5.34 billion in 2026 and reach USD 8.18 billion by 2031, growing at a CAGR of 8.91% over 2026-2031.

Global Head and Neck Squamous Cell Carcinoma Market Trends and Insights

Rising HPV-Associated Oropharyngeal Cancer Burden

HPV-associated oropharyngeal disease is changing the patient mix treated in the head and neck squamous cell carcinoma market. Cases of oropharynx cancer increased 163.17% between 1990 and 2021 in the Global Burden of Disease Study 2021. HPV accounted for more than 70% of oropharyngeal cancers in Europe and the United States. Incidence among U.S. men aged 60 to 79 reached 32.4 cases per 100,000 person-years, and annual U.S. cases are projected to exceed 30,000 by 2029. UK rates among men increased 2.1-fold from 2010 to 2020, with further growth projected through 2039. This disease pattern supports demand for treatment programs that distinguish HPV-positive from HPV-negative tumors.

First-Line PD-1/PD-L1 Immunotherapy Adoption

Perioperative pembrolizumab has widened the clinical role of PD-1 blockade in the head and neck squamous cell carcinoma market. KEYNOTE-689 enrolled 714 patients with stage III to IVA resectable, locally advanced HNSCC. Among 682 patients with PD-L1 combined positive score of at least 1, median event-free survival was 59.7 months with perioperative pembrolizumab and 29.6 months with standard care. The reported hazard ratio was 0.70, with no increase in the inability to undergo surgery because of adverse reactions. PD-L1 CPS testing is therefore increasingly linked to treatment selection and to companion diagnostic demand. A U.S. economic model found perioperative pembrolizumab cost-effective in 83% of simulations at a USD 150,000 per quality-adjusted life-year threshold.

High Cost of Immunotherapy and Targeted Therapy

Treatment cost remains a major constraint on immunotherapy access in the head and neck squamous cell carcinoma market. A 2025 analysis found that 6 months of pembrolizumab represented 7,994% of monthly income in India and 591% in the United States. In South Asia, gefitinib costs represented 171% to 412% of monthly income in the same assessment. The cost of 1 pembrolizumab course could fund treatment for 18 to 22 patients using gefitinib. This cost gap favors oral treatment choices where affordability is the primary concern. It also sustains a split between premium treatments in higher-income systems and domestic alternatives in price-sensitive settings.

Other drivers and restraints analyzed in the detailed report include:

1. Guideline and Reimbursement Expansion
2. Growing Use of Biomarker-Guided Treatment
3. Rapid Acquired Resistance in Biomarker-Selected Disease

For complete list of drivers and restraints, kindly check the Table Of Contents.

Segment Analysis

Combination therapy represented 31.65% of head and neck squamous cell carcinoma market size in 2025. Its role reflects the use of surgery, radiotherapy, and systemic therapy within the same care plan. Immunotherapy is the fastest-growing treatment type, with a forecast CAGR of 10.54% through 2031. Pembrolizumab is being incorporated into perioperative care rather than simply replacing established local treatments. Surgery, chemotherapy, and radiation therapy remain central for patients who cannot receive immunotherapy. Targeted therapy remains relevant in EGFR-related treatment approaches, particularly cetuximab combinations. The head and neck squamous cell carcinoma industry continues to rely on multi-modality care because tumor stage, anatomy, and patient fitness differ substantially. This structure supports sustained use of established treatment types alongside newer systemic treatments.

The leading position of combination therapy also reflects differences in revenue per treatment episode. Immunotherapy-based protocols generally involve higher medical costs than surgery plus radiation protocols. HPV-positive oropharyngeal programs are evaluating whether immunotherapy can replace or modify radiation intensity in selected patients. PD-L1 CPS testing is required for the approved perioperative pembrolizumab population. This requirement links treatment access to diagnostic capacity. The Head and neck squamous cell carcinoma market therefore depends on coordination between surgical teams, radiation services, pathology, and systemic therapy providers. Hospitals with these capabilities can administer complex protocols more consistently. Treatment selection also remains constrained by affordability and by the management of treatment-related effects.

Oral cavity disease held 42.65% of the head and neck squamous cell carcinoma market share in 2025. It is supported by a high disease burden across multiple regions. India represented 21.8% of global oral cancer cases, while the United States represented 13.4%. Oral cavity cases increased 142.18% from 1990 to 2021 in the Global Burden of Disease analysis. South Asia had an age-standardized incidence rate of 9.79 per 100,000 for oral cavity cancer. Oropharynx is forecast to grow at a 9.99% CAGR through 2031. Its growth is linked to HPV-associated disease and to the expansion of perioperative immunotherapy.

Nasopharynx, hypopharynx, and other sites retain distinct treatment needs and epidemiology. Malaysia recorded an age-standardized incidence rate of 6.09 per 100,000 for nasopharyngeal carcinoma. EBV-driven disease in East and Southeast Asia continues to rely on cisplatin-based chemoradiation as a cornerstone of care. HPV-positive and HPV-negative oropharyngeal tumors are biologically different and are being approached differently in clinical development. HPV-positive tumors have greater T-cell infiltration and generally better prognoses. HPV-negative disease is often tobacco-related and remains relevant to EGFR-MET and FGFR development. Johnson & Johnson reported a 56% response rate for amivantamab plus a PD-1 inhibitor in first-line HPV-unrelated oropharyngeal disease. These disease differences reinforce the need for site-specific treatment choices.

Complete Report Scope:

• By Treatment Type
  • Surgery
  • Radiation Therapy
  • Chemotherapy
  • Targeted Therapy
  • Immunotherapy
  • Combination Therapy
• By Cancer Site
  • Oral Cavity
  • Oropharynx
  • Nasopharynx
  • Hypopharynx
  • Other Cancer Sites
• By Drug Class
  • PD-1/PD-L1 Inhibitors
  • EGFR Inhibitors
  • VEGF and Angiogenesis Inhibitors
  • Multikinase and FGFR-Directed Inhibitors
  • Other Drug Classes
• By Route of Administration
  • Intravenous
  • Oral
  • Other Routes of Administrations
• By End User
  • Hospitals
  • Specialty Cancer Centers
  • Specialty Clinics
  • Other End Users
• Geography
  • North America
    • United States
    • Canada
    • Mexico
  • Europe
    • Germany
    • United Kingdom
    • France
    • Italy
    • Spain
    • Rest of Europe
  • Asia-Pacific
    • China
    • Japan
    • India
    • Australia
    • South Korea
    • Rest of Asia-Pacific
  • Middle East and Africa
    • GCC
    • South Africa
    • Rest of Middle East and Africa
  • South America
    • Brazil
    • Argentina
    • Rest of South America

Geography Analysis

North America held 43.54% of the Head and neck squamous cell carcinoma market share in 2025. The region combines high pharmaceutical pricing, established reimbursement, and dense specialty oncology capacity. The June 2025 FDA approval placed perioperative pembrolizumab into an existing U.S. treatment framework. Exelixis and Merck are studying zanzalintinib plus pembrolizumab in a Phase 3 program. Regeneron initiated a Phase 2 study of fianlimab plus cemiplimab in April 2026. Canada generally follows U.S. approvals closely. Mexico faces more limited immunotherapy reimbursement and a higher burden of tobacco-related oral cavity disease.

Europe is the second-largest regional area in the head and neck squamous cell carcinoma market. The European Commission approved perioperative pembrolizumab in October 2025 for the 27 EU member states, Iceland, Liechtenstein, and Norway. The United Kingdom is projected to incur GBP 14.3 billion in societal costs from HPV-associated oropharyngeal cancer between 2025 and 2039. Hungary reported an oropharyngeal cancer incidence rate of 6.19 per 100,000. Budget constraints remain important in countries with high disease burden. Spain's guideline recommendation may influence treatment decisions elsewhere in Southern Europe.

Asia-Pacific is forecast to grow at a 9.64% CAGR through 2031. China has expanded access to domestic PD-1 inhibitors through National Reimbursement Drug List negotiations. Domestic price reductions of 60% have supported broader use, while foreign drugs retain premium urban demand. Japan has a mature reimbursement setting for nivolumab supplied by Ono Pharmaceutical and Bristol Myers Squibb. India has the highest share of global oral cancer cases, but limited PD-L1 testing outside metropolitan centers. South America is led by Brazil and Argentina. The Middle East and Africa remain more dependent on chemotherapy, although GCC healthcare investment creates local differences. These access gaps define the regional opportunity for the head and neck squamous cell carcinoma market.

1. AstraZeneca
2. BeiGene, Ltd.
3. Bristol-Myers Squibb
4. CStone Pharmaceuticals
5. Eisai
6. Exelixis, Inc.
7. Eli Lilly and Company
8. Roche
9. GlaxoSmithKline
10. Iovance Biotherapeutics, Inc.
11. Innovent Biologics, Inc.
12. Jiangsu Hengrui Pharmaceuticals Co., Ltd.
13. Johnson & Johnson
14. Merck
15. Novartis
16. Ono Pharmaceutical
17. Pfizer
18. Regeneron Pharmaceuticals
19. Sanofi
20. Takeda Pharmaceuticals

Additional Benefits:

• The market estimate (ME) sheet in Excel format
• 3 months of analyst support

TABLE OF CONTENTS

1 Introduction

• 1.1 Study Assumptions & Market Definition
• 1.2 Scope Of The Study

2 Research Methodology

3 Executive Summary

4 Market Landscape

• 4.1 Market Overview
• 4.2 Market Drivers
  • 4.2.1 Rising HPV-Associated Oropharyngeal Cancer Burden
  • 4.2.2 First-Line PD-1/PD-L1 Immunotherapy Adoption
  • 4.2.3 Guideline and Reimbursement Expansion
  • 4.2.4 Growing Use of Biomarker-Guided Treatment
  • 4.2.5 AI-Enabled ENT Imaging and Earlier Lesion Detection
  • 4.2.6 HPV Therapeutic-Vaccine and T-Cell-Engager Pipeline Expansion
• 4.3 Market Restraints
  • 4.3.1 High Cost of Immunotherapy and Targeted Therapy
  • 4.3.2 Treatment-Related Toxicity and Functional Morbidity
  • 4.3.3 Uneven Biomarker-Testing and Radiation Infrastructure
  • 4.3.4 Rapid Acquired Resistance in Biomarker-Selected Disease
• 4.4 Supply-Chain Analysis
• 4.5 Regulatory Landscape
• 4.6 Technological Outlook
• 4.7 Porter's Five Forces Analysis
  • 4.7.1 Threat Of New Entrants
  • 4.7.2 Bargaining Power Of Buyers
  • 4.7.3 Bargaining Power Of Suppliers
  • 4.7.4 Threat Of Substitutes
  • 4.7.5 Competitive Rivalry

5 Market Size & Growth Forecasts (Value, USD)

• 5.1 By Treatment Type
  • 5.1.1 Surgery
  • 5.1.2 Radiation Therapy
  • 5.1.3 Chemotherapy
  • 5.1.4 Targeted Therapy
  • 5.1.5 Immunotherapy
  • 5.1.6 Combination Therapy
• 5.2 By Cancer Site
  • 5.2.1 Oral Cavity
  • 5.2.2 Oropharynx
  • 5.2.3 Nasopharynx
  • 5.2.4 Hypopharynx
  • 5.2.5 Other Cancer Sites
• 5.3 By Drug Class
  • 5.3.1 PD-1/PD-L1 Inhibitors
  • 5.3.2 EGFR Inhibitors
  • 5.3.3 VEGF and Angiogenesis Inhibitors
  • 5.3.4 Multikinase and FGFR-Directed Inhibitors
  • 5.3.5 Other Drug Classes
• 5.4 By Route of Administration
  • 5.4.1 Intravenous
  • 5.4.2 Oral
  • 5.4.3 Other Routes of Administrations
• 5.5 By End User
  • 5.5.1 Hospitals
  • 5.5.2 Specialty Cancer Centers
  • 5.5.3 Specialty Clinics
  • 5.5.4 Other End Users
• 5.6 Geography
  • 5.6.1 North America
    • 5.6.1.1 United States
    • 5.6.1.2 Canada
    • 5.6.1.3 Mexico
  • 5.6.2 Europe
    • 5.6.2.1 Germany
    • 5.6.2.2 United Kingdom
    • 5.6.2.3 France
    • 5.6.2.4 Italy
    • 5.6.2.5 Spain
    • 5.6.2.6 Rest of Europe
  • 5.6.3 Asia-Pacific
    • 5.6.3.1 China
    • 5.6.3.2 Japan
    • 5.6.3.3 India
    • 5.6.3.4 Australia
    • 5.6.3.5 South Korea
    • 5.6.3.6 Rest of Asia-Pacific
  • 5.6.4 Middle East and Africa
    • 5.6.4.1 GCC
    • 5.6.4.2 South Africa
    • 5.6.4.3 Rest of Middle East and Africa
  • 5.6.5 South America
    • 5.6.5.1 Brazil
    • 5.6.5.2 Argentina
    • 5.6.5.3 Rest of South America

6 Competitive Landscape

• 6.1 Market Concentration
• 6.2 Market Share Analysis
• 6.3 Company Profiles {(Includes Global Level Overview, Market Level Overview, Core Segments, Financials As Available, Strategic Information, Market Rank/Share For Key Companies, Products & Services, And Recent Developments)}
  • 6.3.1 AstraZeneca PLC
  • 6.3.2 BeiGene, Ltd.
  • 6.3.3 Bristol-Myers Squibb Company
  • 6.3.4 CStone Pharmaceuticals
  • 6.3.5 Eisai Co., Ltd.
  • 6.3.6 Exelixis, Inc.
  • 6.3.7 Eli Lilly and Company
  • 6.3.8 F. Hoffmann-La Roche Ltd
  • 6.3.9 GSK plc
  • 6.3.10 Iovance Biotherapeutics, Inc.
  • 6.3.11 Innovent Biologics, Inc.
  • 6.3.12 Jiangsu Hengrui Pharmaceuticals Co., Ltd.
  • 6.3.13 Johnson & Johnson
  • 6.3.14 Merck & Co., Inc.
  • 6.3.15 Novartis AG
  • 6.3.16 Ono Pharmaceutical Co., Ltd.
  • 6.3.17 Pfizer Inc.
  • 6.3.18 Regeneron Pharmaceuticals, Inc.
  • 6.3.19 Sanofi S.A.
  • 6.3.20 Takeda Pharmaceutical Company Limited

7 Market Opportunities & Future Outlook

• 7.1 White-Space & Unmet-Need Assessment