The HPV16+ HNSCC market is experiencing robust growth, driven by increasing awareness of HPV-related cancers and the rising incidence of oropharyngeal cancers. The development of immunotherapies and targeted treatments, such as immune checkpoint inhibitors, is fueling market expansion. Additionally, advancements in diagnostic techniques and personalized treatment options are improving patient outcomes, contributing to the market's upward trajectory.
LAS VEGAS, Feb. 24, 2025 -- DelveInsight's HPV16-Positive Head and Neck Squamous Cell Carcinoma Market Insights report includes a comprehensive understanding of current treatment practices, HPV16+ HNSCC emerging drugs, market share of individual therapies, and current and forecasted market size from 2020 to 2034, segmented into 7MM [the United States, the EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan].
Key Takeaways from the Human papillomavirus (HPV) 16-Positive Head and Neck Squamous Cell Carcinoma (HNSCC) Market Report
- According to DelveInsight's analysis, the market size for HPV16+ HNSCC was found to be approximately USD 750 million in the 7MM in 2023.
- Among the total site-specific cases of HNSCC in the US, the oropharynx was observed to have the highest cases of HNSCC in 2023.
- As per DelveInsight's estimates, the total incident cases of HPV16+ HNSCC in the 7MM were 45K in 2023.
- The epidemic of HPV-positive HNSCC will not peak until the 2030s due to the delayed adoption of preventative immunization in pediatric populations. Furthermore, because older age groups are not vaccinated, immunization will not reduce the prevalence of HPV16-positive OPSCC until beyond 2045. Until vaccination coverage does not reaches 100% penetration, the number of patients at risk of advancing on curative therapies is rapidly increasing, despite the fact that a larger proportion of patients have the opportunity of being cured. Therefore, there is an unmet need for improved therapies for these individuals.
- Leading HPV16+ HNSCC companies developing emerging therapies, such as Bristol Myers Squibb, Merck, Merus, Exelixis, ISA Pharmaceuticals, Regeneron Pharmaceuticals, PDS Biotechnology, BioNTech, Cue Biopharma, Immutep, Iovance Biotherapeutics, Inovio Pharmaceuticals, MedImmune, Nykode Therapeutics, RAPT Therapeutics, and others are developing novel drugs that can be available in the HPV16+ HNSCC market in the coming years.
- The promising HPV16+ HNSCC therapies in the pipeline include Petosemtamab (MCLA-158), Zanzalintinib, ISA101b, Versamune HPV (formerly PDS0101), BNT113, CUE-101, Eftilagimod alpha (Efti/IMP321), INO-3112 (MEDI0457), VB10.16 (VB-C-03), Tivumecirnon (FLX475), SCG142, and others.
- In February 2025, the US Food and Drug Administration (FDA) awarded Breakthrough Therapy designation (BTD) to Merus' petosemtamab in combination with pembrolizumab for the first-line treatment of adult patients with recurrent or metastatic, programmed death-ligand 1 (PD-L1) positive HNSCC with a combined positive score (CPS) ≥ 1. This is petosemtamab's second BTD designation. The first BTD and Fast Track designations were given to petosemtamab in May 2024 and August 2023, respectively, for the treatment of patients with recurrent and/or metastatic HNSCC whose disease has advanced after receiving platinum-based chemotherapy and an anti-PD-1 antibody.
- In February 2025, PDS Biotechnology confirmed that it would begin its VERSATILE-003 Phase III clinical trial with Versamune HPV plus KEYTRUDA in the first quarter of 2025 as a first-line treatment for recurrent and/or metastatic HPV16-positive HNSCC.
- In October 2024, Exelixis entered into a clinical development collaboration to evaluate the combination of zanzalintinib with KEYTRUDA in a Phase III pivotal trial for the treatment of patients with HNSCC.
- The established efficacy of immune checkpoint inhibitors in recurrent and metastatic HNSCC has sparked a growing interest in their neoadjuvant use. Neoadjuvant immunotherapy in HNSCC is promising, as it may reduce the risk of local recurrence and distant metastasis, potentially improving overall survival.
Discover which therapies are expected to grab the major HPV16+ HNSCC market share @ HPV16-Positive Head and Neck Squamous Cell Carcinoma Market Report
HPV16-Positive Head and Neck Squamous Cell Carcinoma Overview
HPV16-positive head and neck squamous cell carcinoma (HPV16+ HNSCC) is a type of cancer that arises in the mucosal surfaces of the oropharynx due to persistent infection with HPV16. Unlike traditional HNSCC, which is strongly linked to tobacco and alcohol use, HPV16+ HNSCC is primarily caused by high-risk HPV infection, often transmitted through oral sexual contact.
Symptoms may include a persistent sore throat, difficulty swallowing, hoarseness, ear pain, enlarged lymph nodes, and unexplained weight loss. This cancer tends to present with small primary tumors but significant lymph node involvement. Diagnosis involves a combination of physical examination, imaging (CT, MRI, or PET scans), and tissue biopsy. HPV status is confirmed using polymerase chain reaction (PCR) or in situ hybridization (ISH) to detect viral DNA, and p16 immunohistochemistry (IHC) serves as a surrogate marker for HPV-driven malignancy. HPV16+ HNSCC has a better prognosis and response to treatment compared to HPV-negative HNSCC, making accurate diagnosis crucial for therapeutic decisions.
HPV16+ HNSCC Epidemiology Segmentation
The HPV16+ HNSCC epidemiology section provides insights into the historical and current HPV16+ HNSCC patient pool and forecasted trends for the 7MM. It helps recognize the causes of current and forecasted patient trends by exploring numerous studies and views of key opinion leaders.
The HPV16+ HNSCC market report proffers epidemiological analysis for the study period 2020–2034 in the 7MM segmented into:
- Total Incident Cases of Head and Neck Cancer
- Total Incident Cases of HNSCC
- Site-specific Cases of HNSCC
- Total Incident Cases of HPV+ HNSCC
- Total Incident Cases of HPV16+ HNSCC
- Stage-specific cases of HPV16+ OPSCC
- Stage-specific cases of HPV16+ Non-OPSCC
HPV16-Positive Head and Neck Squamous Cell Carcinoma Treatment Market
The typical treatment for locoregionally advanced HPV16+ HNSCC involves chemoradiation (CRT) or surgery followed by adjuvant therapy. Despite this, recurrence and metastasis rates remain high, especially in later stages. KEYTRUDA and OPDIVO are the main PD-1 inhibitors approved for treating recurrent or metastatic HNSCC.
In November 2016, the US FDA approved OPDIVO for treating patients with recurrent or metastatic SCCHN who experienced disease progression after platinum-based therapy. In April 2017, the European Commission granted approval for OPDIVO as a monotherapy for adult patients with SCCHN progressing on or after platinum-based treatment.
In 2021, the UK's NICE recommended OPDIVO for patients with recurrent or metastatic HNSCC who had progression during or after platinum-based chemotherapy. OPDIVO was also approved in Japan in March 2017 for the treatment of relapse or distant metastasis of HNC. In April 2016, BMS announced that the US FDA had given OPDIVO Breakthrough Therapy Designation (BTD) for the potential indication of recurrent or metastatic SCCHN following platinum-based therapy.
In June 2019, the US FDA approved KEYTRUDA for use as a first-line treatment for patients with metastatic or unresectable recurrent HNSCC, including those with HPV. In August 2016, KEYTRUDA received accelerated approval from the US FDA for the treatment of patients with recurrent or metastatic HNSCC who showed disease progression following platinum-based chemotherapy, also including those with HPV.
In November 2019, Merck announced that the European Commission had approved KEYTRUDA as a first-line treatment for metastatic or unresectable recurrent HNSCC in patients whose tumors express PD-L1 (CPS ≥1). In December 2019, Merck also reported that the Japan Pharmaceuticals and Medical Devices Agency (PMDA) had approved KEYTRUDA, both in combination with chemotherapy and as a monotherapy, for the first-line treatment of patients with recurrent or metastatic head and neck cancer (HNC).
KEYTRUDA monotherapy is the recommended first-line treatment for recurrent or metastatic HNSCC with high PD-L1 expression, though only around 20% of patients respond, and HPV status does not significantly affect the response. Currently, there are no treatments specifically approved for HPV16+ cancers.
To know more about HPV16+ HNSCC treatment guidelines, visit @ HPV16-Positive Head and Neck Squamous Cell Carcinoma Management
HPV16+ HNSCC Pipeline Therapies and Key Companies
- Zanzalintinib (XL092): Exelixis
- Eftilagimod alpha (Efti/IMP321): Immutep/Merck Sharp & Dohme
- ISA101b: ISA Pharmaceuticals and Regeneron Pharmaceuticals
- Versamune HPV (PDS0101): PDS Biotechnology and Merck
- BNT113: BioNTech
- INO-3112 (MEDI0457): Inovio Pharmaceuticals and MedImmune
- CUE-101: Cue Biopharma
- VB10.16 (VB-C-03): Nykode Therapeutics
- Tivumecirnon (FLX475): RAPT Therapeutics
Discover more about HPV16+ HNSCC drugs in development @ HPV16+ HNSCC Clinical Trials
HPV16+ HNSCC Market Dynamics
The HPV16+ HNSCC market dynamics are expected to change in the coming years. The increasing incidence of HPV-related cancers, particularly HPV16+ HNSCC, is fueling demand for targeted therapies and preventive vaccines. As awareness grows about the link between HPV16 and HNSCC, there is a rising focus on early diagnosis and preventive measures, including vaccination programs. The development of novel immunotherapies and targeted treatments aimed specifically at HPV16+ cancers is another significant driver, offering improved efficacy over conventional chemotherapy and radiation.
Additionally, the growing prevalence of HPV infections, especially in younger populations, is prompting healthcare providers and researchers to invest in better screening methods and treatment options. Government support, regulatory approvals, and increased healthcare expenditure in oncology further contribute to the market's growth, creating opportunities for new treatments to emerge in this rapidly evolving space.
Apart from this, the landscape is highly competitive, with key players like PDS Biotechnology, ISA Pharmaceuticals, Immutep, BioNTech, Cue Pharma, and others driving innovative strategies to improve efficacy and broaden treatment options for HPV16+ HNSCC, offering new hope for patients with limited current alternatives.
Furthermore, potential therapies are being investigated for the treatment of HPV16+ HNSCC, and it is safe to predict that the treatment space will significantly impact the HPV16+ HNSCC market during the forecast period. Moreover, the anticipated introduction of emerging therapies with improved efficacy and a further improvement in the diagnosis rate are expected to drive the growth of the HPV16+ HNSCC market in the 7MM.
Currently, a number of HPV-targeted vaccines in HNSCC are being studied; the most encouraging findings have been seen when used in combination with checkpoint inhibitors as a first-line treatment for recurrent or metastatic disease. Although there are some studies looking at these vaccines in treatment-refractory patients, the response rate in that population tends to be lower. Additionally, ongoing trials are investigating the use of therapeutic vaccines without immunotherapy.
However, several factors may impede the growth of the HPV16+ HNSCC market. One of the primary challenges is the complex and heterogeneous nature of HNSCC, which can make it difficult to develop targeted therapies that work universally across patient populations. Additionally, while HPV16+ HNSCC is linked to a distinct patient subgroup, there is a lack of widespread screening, resulting in late-stage diagnoses that reduce the efficacy of available treatments. Regulatory hurdles also present obstacles, as the approval process for new therapies often involves lengthy clinical trials and extensive safety assessments.
Moreover, HPV16+ HNSCC treatment poses a significant economic burden and disrupts patients' overall well-being and QOL. Furthermore, the HPV16+ HNSCC market growth may be offset by failures and discontinuation of emerging therapies, unaffordable pricing, market access and reimbursement issues, and a shortage of healthcare specialists. In addition, the undiagnosed, unreported cases and the unawareness about the disease may also impact the HPV16+ HNSCC market growth.
HPV16+ HNSCC Market Report | Details |
Study Period | 2020–2034 |
Coverage | 7MM [the United States, the EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan]. |
HPV16+ HNSCC Market CAGR (2020-2034) | 9.2 % |
HPV16+ HNSCC Market Size in 2023 | USD 750 million |
Key HPV16+ HNSCC Companies | Bristol Myers Squibb, Merck, Ono Pharmaceutical, Merus, Exelixis, ISA Pharmaceuticals, Regeneron Pharmaceuticals, PDS Biotechnology, BioNTech, Cue Biopharma, Immutep, Iovance Biotherapeutics, Inovio Pharmaceuticals, MedImmune, Nykode Therapeutics, RAPT Therapeutics, and others |
Key Pipeline HPV16+ HNSCC Therapies | KEYTRUDA, OPDIVO, Petosemtamab (MCLA-158), Zanzalintinib, ISA101b, Versamune HPV, BNT113, CUE-101, Eftilagimod alpha (Efti/IMP321), INO-3112 (MEDI0457), VB10.16 (VB-C-03), Tivumecirnon (FLX475), SCG142, Versamune HPV + PDS01ADC + Bintrafusp alfa and others |
Scope of the HPV16+ HNSCC Market Report
- Therapeutic Assessment: HPV16+ HNSCC current marketed and emerging therapies
- HPV16+ HNSCC Market Dynamics: Key Market Forecast Assumptions of Emerging HPV16+ HNSCC Drugs and Market Outlook
- Competitive Intelligence Analysis: SWOT analysis and Market entry strategies
- Unmet Needs, KOL's views, Analyst's views, HPV16+ HNSCC Market Access and Reimbursement
Download the report to understand which factors are driving HPV16+ HNSCC market trends @ HPV16+ HNSCC Market Trends
Table of Contents
1 | Key Insights |
2 | Report Introduction |
3 | Executive Summary of HPV 16-Positive HNSCC |
4 | Key Events |
5 | Epidemiology and Market Forecast Methodology |
6 | HPV16+ HNSCC Market Overview at a Glance |
6.1 | Market Share (%) Distribution of HPV16+ HNSCC by Line of therapy (LoT) in 2020 |
6.2 | Market Share (%) Distribution of HPV16+ HNSCC by Line of therapy (LoT) in 2034 |
7 | Disease Background and Overview |
7.1 | Introduction |
7.2 | Classification of HNSCC |
7.3 | Signs and Symptoms |
7.4 | Causes |
7.5 | HPV in HNSCC |
7.5.1 | HPV-positive HNSCC |
7.5.2 | Genomic Alterations and Key Pathways |
7.6 | Diagnosis |
7.6.1 | Diagnostic Tools and Applied Algorithm in HNSCC Classification |
7.6.2 | HPV Biomarkers in Body Fluids |
7.7 | Staging |
7.8 | Diagnosis Algorithm |
7.9 | Treatment and Management |
7.9.1 | Treatment Algorithm |
7.1 | Treatment Guidelines |
7.10.1 | American Society for Radiation Oncology (ASTRO) Clinical Practice Guideline |
7.10.2 | National Comprehensive Cancer Network (NCCN) Guidelines |
7.10.3 | EHNS–ESMO–ESTRO Clinical Practice Guidelines |
7.10.4 | Spanish Society of Medical Oncology (SEOM) Clinical Guidelines |
8 | Epidemiology and Patient Population |
8.1 | Key Findings |
8.2 | Assumptions and Rationale |
8.3 | Total Incident Cases of Head and Neck Cancer in the 7MM |
8.4 | HPV+ HNSCC Cases in the 7MM |
8.5 | Total Incident Cases of HPV16+ HNSCC in the 7MM |
8.6 | The United States |
8.6.1 | Total Incident Cases of HNSCC in the US |
8.6.2 | Site-specific Cases of HNSCC in the US |
8.6.3 | HPV+ HNSCC Cases in the US |
8.6.4 | Total Incident Cases of HPV16+ HNSCC in the US |
8.6.5 | Stage-specific Cases of HPV16+ OPSCC in the US |
8.6.6 | Stage-specific Cases of HPV16+ Non-OPSCC in the US |
8.7 | EU4 and the UK |
8.7.1 | Total Incident Cases of HNSCC in EU4 and the UK |
8.7.2 | Site-specific Cases of HNSCC in EU4 and the UK |
8.7.3 | HPV+ HNSCC Cases in EU4 and the UK |
8.7.4 | Total Incident Cases of HPV16+ HNSCC in EU4 and the UK |
8.7.5 | Stage-specific Cases of HPV16+ OPSCC in EU4 and the UK |
8.7.6 | Stage-specific Cases of HPV16+ Non-OPSCC in EU4 and the UK |
8.8 | Japan |
8.8.1 | Total Incident Cases of HNSCC in Japan |
8.8.2 | Site-specific Cases of HNSCC in Japan |
8.8.3 | HPV+ HNSCC Cases in Japan |
8.8.4 | Total Incident Cases of HPV16+ HNSCC in Japan |
8.8.5 | Stage-specific Cases of HPV16+ OPSCC in Japan |
8.8.6 | Stage-specific Cases of HPV16+ Non-OPSCC in Japan |
9 | Patient Journey |
10 | Key Endpoints |
11 | Marketed Drugs |
11.1 | Key Competitors |
11.2 | OPDIVO (nivolumab): Bristol Myers Squibb |
11.2.1 | Product Description |
11.2.2 | Regulatory Milestones |
11.2.3 | Other Developmental Activities |
11.2.4 | Safety and Efficacy |
11.2.5 | Analyst's Views |
11.3 | KEYTRUDA (pembrolizumab): Merck Sharp & Dohme |
11.3.1 | Product Description |
11.3.2 | Regulatory Milestones |
11.3.3 | Other Developmental Activities |
11.3.4 | Safety and Efficacy |
11.3.5 | Analyst's Views |
12 | Emerging Therapies |
12.1 | Key Cross Competition |
12.2 | Zanzalintinib (XL092): Exelixis |
12.2.1 | Product Description |
12.2.2 | Other Development Activities |
12.2.3 | Clinical Developmental |
12.2.4 | Analyst Views |
12.3 | Eftilagimod alpha (Efti/IMP321): Immutep/Merck Sharp & Dohme |
12.3.1 | Product Description |
12.3.2 | Other Developmental Activities |
12.3.3 | Clinical Developmental |
12.3.4 | Safety and Efficacy |
12.3.5 | Analyst Views |
12.4 | ISA101b: ISA Pharmaceuticals and Regeneron Pharmaceuticals |
12.4.1 | Product Description |
12.4.2 | Other Development Activity |
12.4.3 | Clinical Development |
12.4.4 | Safety and Efficacy |
12.4.5 | Analyst Views |
12.5 | Versamune HPV (PDS0101): PDS Biotechnology and Merck |
12.5.1 | Product Description |
12.5.2 | Other Development Activity |
12.5.3 | Clinical Development |
12.5.4 | Safety and Efficacy |
12.5.5 | Analyst Views |
12.6 | BNT113: BioNTech |
12.6.1 | Product Description |
12.6.2 | Other Development Activity |
12.6.3 | Clinical Development |
12.6.4 | Safety and Efficacy |
12.6.5 | Analyst Views |
12.7 | INO-3112 (MEDI0457): Inovio Pharmaceuticals and MedImmune |
12.7.1 | Product Description |
12.7.2 | Other Development Activity |
12.7.3 | Clinical Development |
12.7.4 | Safety and Efficacy |
12.7.5 | Analyst Views |
12.8 | CUE-101: Cue Biopharma |
12.8.1 | Product Description |
12.8.2 | Other Developmental Activities |
12.8.3 | Clinical Development |
12.8.4 | Safety and Efficacy |
12.8.5 | Analyst Views |
12.9 | VB10.16 (VB-C-03): Nykode Therapeutics |
12.9.1 | Product Description |
12.9.2 | Other Development Activity |
12.9.3 | Clinical Development |
12.9.4 | Analyst Views |
12.1 | Tivumecirnon (FLX475): RAPT Therapeutics |
12.10.1 | Product Description |
12.10.2 | Other Development Activities |
12.10.3 | Clinical Development |
12.10.4 | Safety and Efficacy |
13 | HPV16+ HNSCC: Seven Major Market Analysis |
13.1 | Key Findings |
13.2 | Market Outlook |
13.3 | Conjoint Analysis |
13.4 | Key Market Forecast Assumptions |
13.4.1 | Cost Assumptions and Rebate |
13.4.2 | Pricing Trends |
13.4.3 | Analogue Assessment |
13.4.4 | Launch Year and Therapy Uptake |
13.5 | Total Market Size of HPV16+ HNSCC in the 7MM |
13.6 | The United States |
13.6.1 | Total Market Size of HPV16+ HNSCC in the US |
13.6.2 | Market Size of HPV16+ HNSCC by Therapies in the US |
13.7 | EU4 and the UK |
13.7.1 | Total Market Size of HPV16+ HNSCC in EU4 and the UK |
13.7.2 | Market Size of HPV16+ HNSCC by Therapies in EU4 and the UK |
13.8 | Japan |
13.8.1 | Total Market Size of HPV16+ HNSCC in Japan |
13.8.2 | The Market Size of HPV16+ HNSCC by Therapies in Japan |
14 | Unmet Needs |
15 | SWOT Analysis |
16 | KOL Views |
17 | Market Access and Reimbursement |
17.1 | United States |
17.1.1 | Centre for Medicare & Medicaid Services (CMS) |
17.2 | EU4 and the UK |
17.2.1 | Germany |
17.2.2 | France |
17.2.3 | Italy |
17.2.4 | Spain |
17.2.5 | United Kingdom |
17.3 | Japan |
17.3.1 | MHLW |
17.4 | HPV16+ HNSCC Market Access and Reimbursement |
18 | Appendix |
18.1 | Bibliography |
18.2 | Report Methodology |
19 | DelveInsight Capabilities |
20 | Disclaimer |
21 | About DelveInsight |
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