HPV+ Recurrent/Metastatic Head and Neck Cancer | Primary Research (KOL's Insight) | Market Intelligence | Epidemiology & Market Forecast-2035

Human papillomavirus (HPV) is the root cause of a growing number of head and neck cancers, and there is a pressing medical need to develop novel therapies to provide more effective and durable treatments against recurrent/metastatic HPV+ head and neck squamous cell cancer (HPV+ HNSCC). HNSCC is the sixth most common cancer worldwide with 890,000 new cases and 450,000 fatalities in 2018. The incidence of HNSCC is currently increasing, and by 2030, it is anticipated to increase by 1.08 million cases annually, or 30%. Understanding the patient's prior treatment experience, performance status, comorbidities, disease and symptom burden, and treatment objectives is necessary to determine the best first-line therapy for metastatic HNSCC. Additionally, microsatellite instability (although rare), HPV status, and PD-L1 expression on immune and tumor cells could all affect the choice of treatment.

Description

Human papillomavirus (HPV) is the root cause of a growing number of head and neck cancers, and there is a pressing medical need to develop novel therapies to provide more effective and durable treatments against recurrent/metastatic HPV+ head and neck squamous cell cancer (HPV+ HNSCC). Current checkpoint immunotherapy and platinum-based chemotherapy rarely cure recurrent/metastatic disease. In the past, locoregional recurrence was the main cause of treatment failure for patients with head and neck cancer. But over the past 20 years, the incidence of head and neck squamous cell carcinoma (HNSCC) has changed as a result of declining tobacco use and rising human papillomavirus (HPV) infection rates. The ninth most frequent malignant tumor worldwide, head and neck squamous cell carcinomas include those of the lip, oral cavity, nasal cavity, paranasal sinuses, oropharynx, larynx, and nasopharynx. They account for 6% of all cancer cases and up to 2% of all cancer-related deaths. Human papillomavirus-related (HPV positive) and human papillomavirus-unrelated (HPV-negative) HNSCC subtypes can be distinguished by their etiologies. The oropharynx is where HPV-positive disease is most prevalent.

HPV+ Recurrent/Metastatic Head and Neck Cancer (Epidemiology)

HNSCC is the sixth most common cancer worldwide with 890,000 new cases and 450,000 fatalities in 2018. The incidence of HNSCC is currently increasing, and by 2030, it is anticipated to increase by 1.08 million cases annually, or 30%. While rising oropharyngeal HPV infection rates in the USA and Western Europe have contributed to the high incidence of HNSCC in these regions, the high incidence of HNSCC in regions like Southeast Asia and Australia is associated with consumption of specific carcinogen-containing products. Men are typically 2-4 times more likely than women to develop HNSCC. In contrast to oropharyngeal cancer linked to HPV, which has a median age at diagnosis of 53 years, HNSCC that is not virally linked has a median age at diagnosis of 66 years. Despite the fact that alcohol and tobacco use are the risk factors for HNSCC that are most frequently associated with it, human papillomavirus (HPV) has been identified as a major cause of this illness, primarily as oropharyngeal HNSCC affecting the tonsils and base of the tongue. Despite a decline in the incidence of HNSCC brought on by alcohol and tobacco use, oropharyngeal HNSCC has been increasing since the 1980s, most likely due to an HPV infection epidemic. The HPV-16 genotype has been discovered to be the high-risk subtype most frequently associated, despite HPV-18, -31, and -33 also being implicated.

HPV+ Recurrent/Metastatic Head and Neck Cancer -Current Market Size & Forecast Trends

The market for HPV-positive recurrent or metastatic head and neck cancer is projected to grow significantly, with the global head and neck cancer therapeutics market valued at approximately USD 2.1 billion in 2025 and expected to expand by USD 4.02 billion, reflecting a compound annual growth rate (CAGR) of around 9.1% from 2025 to 2037. This growth is driven by an increasing number of diagnoses linked to HPV infections, which are associated with a substantial portion of head and neck cancers. The rising prevalence of HPV-related malignancies, particularly oropharyngeal cancers, has created a demand for innovative treatment options, including immunotherapies like pembrolizumab and nivolumab, which are showing promising outcomes in clinical settings.

The U.S. market is expected to dominate due to high incidence rates and a strong healthcare infrastructure, while the Asia-Pacific region is anticipated to witness rapid growth fueled by an aging population and increased adoption of immunotherapeutic agents. Additionally, advancements in research and development are leading to new therapeutic options that enhance treatment efficacy for patients with recurrent or metastatic disease. Overall, the HPV-positive recurrent metastatic head and neck cancer market is well-positioned for robust expansion through 2035, as ongoing innovations continue to improve patient outcomes and survival rates.

Understanding the patient's prior treatment experience, performance status, comorbidities, disease and symptom burden, and treatment objectives is necessary to determine the best first-line therapy for metastatic HNSCC. Additionally, microsatellite instability (although rare), HPV status, and PD-L1 expression on immune and tumor cells could all affect the choice of treatment. Pembrolizumab, an immune checkpoint inhibitor, is now the first-line systemic therapy of choice for the majority of patients, according to the phase III KN-048 trial. It can be used either alone or in combination with chemotherapy. In this study, the same chemotherapy with cetuximab was compared to pembrolizumab monotherapy or a novel combination of pembrolizumab with a platinating agent and 5-fluorouracil. In the entire population, the novel combination of chemotherapy and pembrolizumab increased overall survival (OS) in comparison to chemotherapy plus cetuximab (13 months vs. HR, 0 point77; p = .0034; 10.7 months). In all patients treated with pembrolizumab, adding chemotherapy increased the objective response rate, and among HPV+ cancers, the relative benefit of pembrolizumab plus chemotherapy was noticeably greater than the benefit of pembrolizumab monotherapy when compared with chemotherapy and cetuximab, which may be related to the inherent chemosensitivity of HPV+ HNSCC.

Report Highlights

HPV+ Recurrent/Metastatic Head and Neck Cancer - Current Market Trends

HPV+ Recurrent/Metastatic Head and Neck Cancer - Current & Forecasted Cases across the G8 Countries

HPV+ Recurrent/Metastatic Head and Neck Cancer - Market Opportunities and Sales Potential for Agents

HPV+ Recurrent/Metastatic Head and Neck Cancer - Patient-based Market Forecast to 2035

HPV+ Recurrent/Metastatic Head and Neck Cancer - Untapped Business Opportunities

HPV+ Recurrent/Metastatic Head and Neck Cancer - Product Positioning Vis-a-vis Competitors' Products

HPV+ Recurrent/Metastatic Head and Neck Cancer - KOLs Insight