The HPV+ oropharyngeal cancer market is expanding rapidly, driven by a rising incidence of HPV-driven OPSCC and growing clinician awareness. The anticipated launch of emerging therapies such as Merck Sharp & Dohme (KEYTRUDA), Bristol Myers Squibb (OPDIVO), PDS Biotechnology (Versamune HPV/PDS0101), Inovio Pharmaceuticals and MedImmune (INO-3112/MEDI0457), Cue Biopharma (CUE-101), and others will further propel the market.
LAS VEGAS, Sept. 30, 2025 /PRNewswire/ -- DelveInsight's HPV+ Oropharyngeal Cancer Market Insights report includes a comprehensive understanding of current treatment practices, HPV+ oropharyngeal cancer emerging drugs, market share of individual therapies, and current and forecasted market size from 2020 to 2034, segmented into leading markets (the US, EU4, UK, and Japan).
HPV+ Oropharyngeal Cancer Market Summary
- The market size for HPV+ oropharyngeal cancer in the leading markets (the US, EU4, UK, and Japan) is expected to grow significantly by 2034.
- The United States accounted for the highest HPV+ oropharyngeal cancer treatment market size in 7MM in 2024, in comparison to the other major markets, i.e., EU4 countries (Germany, France, Italy, and Spain), the United Kingdom, and Japan.
- There were an estimated 170K incident cases of head and neck cancer across the 7MM in 2024, including nearly 150K cases of HNSCC.
- Leading HPV+ oropharyngeal cancer companies developing emerging therapies, such as PDS Biotechnology, Exelixis, Merus, BioNTech, ISA Pharmaceuticals, Regeneron Pharmaceuticals, Cue Biopharma, Immutep, Iovance Biotherapeutics, Inovio Pharmaceuticals, MedImmune, and others, are developing new therapy for HPV+ oropharyngeal cancer that can be available in the HPV+ oropharyngeal cancer market in the coming years.
- The promising HPV+ oropharyngeal cancer therapies in clinical trials include Versamune HPV (formerly PDS0101), Zanzalintinib, Petosemtamab (MCLA-158), BNT113, ISA101b, CUE-101, Eftilagimod alpha (Efti/IMP321), LN-145/LN-145-S1, INO-3112 (MEDI0457), and others.
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Key Factors Driving the Growth of the HPV+ Oropharyngeal Cancer Market
Rising incidence and shifting epidemiology
The proportion of oropharyngeal cancers caused by HPV has increased substantially over the past two decades in many countries, producing a growing patient pool specifically labeled as HPV+. This epidemiologic shift creates both demand for HPV-specific diagnostics and for tailored therapeutic approaches.
Broader adoption of molecular diagnostics and HPV testing
The routine use of p16 immunohistochemistry, HPV DNA/RNA testing, and improved pathology workflows has increased detection and more reliably stratified patients as HPV-positive. Better diagnostic capture expands the eligible market for HPV-specific treatment strategies and for companion diagnostics.
Active HPV+ oropharyngeal cancer clinical trial landscape
The oropharyngeal cancer pipeline is expanding, with key players such as Merck Sharp & Dohme (KEYTRUDA), Bristol Myers Squibb (OPDIVO), PDS Biotechnology (Versamune HPV/PDS0101), Inovio Pharmaceuticals and MedImmune (INO-3112/MEDI0457), Cue Biopharma (CUE-101), and others, advancing candidates in clinical development.
HPV+ Oropharyngeal Cancer Market Analysis
The treatment landscape for HPV-positive oropharyngeal cancer remains centered on surgery and radiation, with chemoradiotherapy (CRT) serving as the cornerstone for advanced-stage disease. In early-stage cases, transoral robotic surgery (TORS) and precision radiation methods such as IMRT are commonly employed, with adjuvant CRT reserved for patients presenting with high-risk features. While efforts toward treatment de-intensification are ongoing, current practice still emphasizes established CRT regimens and conventional surgical strategies to maintain long-term disease control. In recurrent and metastatic settings, immunotherapy leads the field; KEYTRUDA is the standard of care, administered alone in PD-L1-positive patients or in combination with chemotherapy. At the same time, OPDIVO is utilized after failure of platinum-based therapy.
Cetuximab remains an option for cisplatin-ineligible patients, often paired with radiotherapy. A notable development has been the approval of KEYTRUDA for perioperative use in resectable locally advanced head and neck cancers, broadening the role of immunotherapy into earlier disease stages and directly impacting HPV-driven cases. Thus, today's market is built on a strong foundation of CRT and surgery, now reinforced by the rapid adoption of KEYTRUDA, OPDIVO, and advanced radiotherapy delivery platforms.
Emerging immunotherapy combinations are also gaining traction. The Versamune HPV doublet (Versamune HPV + KEYTRUDA) and the triplet regimen (Versamune HPV + PDS01ADC + Bintrafusp alfa) have demonstrated promising efficacy. They are poised to transform the treatment paradigm for HPV16+ head and neck squamous cell carcinoma (HNSCC). Despite the progress made with PD-1 inhibitors, their effectiveness remains limited by resistance mechanisms, including immunosuppressive tumor microenvironments and immune escape pathways, particularly in patients with low PD-L1 expression or those who have received prior chemotherapy.
To know more about HPV+ oropharyngeal cancer treatment options, visit @ Approved HPV+ Oropharyngeal Cancer Drugs
HPV+ Oropharyngeal Cancer Competitive Landscape
The oropharyngeal cancer clinical trial landscape is expanding, with key players including MerckSharp&Dohme (KEYTRUDA), BristolMyersSquibb (OPDIVO), PDSBiotechnology (Versamune HPV/PDS0101), InovioPharmaceuticals, and MedImmune (INO-3112/MEDI0457), as well as Cue Biopharma (CUE-101), among others, in various stages of clinical development.
PDS Biotechnology's Versamune HPV (formerly PDS0101) is an investigational immunotherapy designed to target human papillomavirus (HPV) by activating a strong, HPV-specific T cell response against HPV-positive cancers. Administered via a simple subcutaneous injection, it is evaluated in combination with other immunotherapies and cancer treatments. Currently, it is in a Phase III clinical trial with pembrolizumab for the treatment of oropharyngeal squamous cell carcinoma (OPSCC).
Inovio Pharmaceuticals/MedImmune's INO-3112 is a DNA-based therapeutic candidate that targets HPV 16/18 and incorporates a DNA plasmid encoding IL-12 to enhance immune activation. INOVIO is assessing its ability to generate antigen-specific T cells and promote tumor infiltration in HPV-related cancers, particularly in combination therapy approaches.
Cue Biopharma's lead candidate, CUE-101, is being developed for the treatment of recurrent or metastatic HPV16-positive head and neck cancer. It is in a Phase I trial as a monotherapy for patients who have progressed after standard treatments. Additionally, CUE-101 is under investigation in a Phase I dose-escalation/expansion study with pembrolizumab as a first-line therapy, and in a Phase II investigator-sponsored neoadjuvant trial for newly diagnosed, locally advanced HPV16+ OPSCC in HLA-A*0201-positive patients. Cue Biopharma plans to advance development through partnerships and collaborations, and is aligned with the FDA on a potential registration pathway. In July 2025, the company reported results from the Phase I trial.
The anticipated launch of these emerging therapies are poised to transform the HPV+ oropharyngeal cancer market landscape in the coming years. As these cutting-edge therapies continue to mature and gain regulatory approval, they are expected to reshape the HPV+ oropharyngeal cancer market landscape, offering new standards of care and unlocking opportunities for medical innovation and economic growth.
Discover more about therapy for HPV+ oropharyngeal cancer @ HPV+ Oropharyngeal Cancer Clinical Trials
Recent Developments in the HPV+ Oropharyngeal Cancer Market
- In August 2025, PDS Biotech announced final top-line survival data from its VERSATILE-002 Phase II clinical trial. VERSATILE-002 evaluated PDS0101 + KEYTRUDA in patients with HPV16-positive 1L R/M HNSCC.
- In the August 2025 corporate presentation, Regeneron Pharmaceuticals announced plans to initiate 1L HNSCC (PD-L1+; HPV+ and HPV-) in Q1 2026 and perioperative HNSCC trials in 2026.
- In June 2025, PDS Biotechnology announced the publication of three Versamune HPV abstracts, including clinical studies named VERSATILE-002 and VERSATILE-003, which were presented at the 2025 American Society of Clinical Oncology (ASCO) annual meeting.
- In January 2025, Inovio Pharmaceuticals and MedImmune announced that they plan to align with European Union regulators on the planned Phase III trial design.
What is HPV+ Oropharyngeal Cancer?
Oropharyngeal cancer is a form of head and neck cancer that develops in the oropharynx, the middle section of the throat situated behind the mouth. It often involves the tonsils, soft palate, back third of the tongue, and the side or rear walls of the throat. Most cases are squamous cell carcinomas, originating in the thin, flat squamous cells that line the oropharynx and many other organs. In rarer instances, lymphoma can occur in this region, particularly in the tonsils or base of the tongue, which are rich in lymphatic tissue. Key risk factors include tobacco use, excessive alcohol intake, and infection with human papillomavirus (HPV), especially HPV type 16, which is strongly linked to HPV-positive oropharyngeal cancer.
HPV+ Oropharyngeal Cancer Epidemiology Segmentation
The HPV+ oropharyngeal cancer epidemiology section provides insights into the historical and current HPV+ oropharyngeal cancer patient pool and forecasted trends for the leading markets. Among HNSCC, approximately 20K cases of OPSCC were reported in the US in 2024. Among stage-specific cases of HPV16+ OPSCC, regional stages (III-IVB) account for over 70%.
The HPV+ oropharyngeal cancer market report proffers epidemiological analysis for the study period 2020-2034 in the leading markets, segmented into:
- Total Incident Cases of Head and Neck Cancer
- Total Incident Cases of HNSCC
- Total Incident Cases of OPSCC
- OPSCC Cases by HPV Status
- Stage-specific Cases of OPSCC
- Line-wise Treated Cases of OPSCC
HPV+ Oropharyngeal Cancer Market Report Metrics | Details |
Study Period | 2020-2034 |
HPV+ Oropharyngeal Cancer Market Report Coverage | 7MM [The United States, the EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan]. |
HPV+ Oropharyngeal Cancer Epidemiology Segmentation | Total Incident Cases of Head and Neck Cancer, Total Incident Cases of HNSCC, Total Incident Cases of OPSCC, OPSCC Cases by HPV Status, Stage-specific Cases of OPSCC, and Line-wise Treated Cases of OPSCC |
Key HPV+ Oropharyngeal Cancer Companies | PDS Biotechnology, Exelixis, Merus, BioNTech, ISA Pharmaceuticals, Regeneron Pharmaceuticals, Cue Biopharma, Immutep, Iovance Biotherapeutics, Inovio Pharmaceuticals, MedImmune, Merck Sharp & Dohme, Bristol Myers Squibb, and others |
Key HPV+ Oropharyngeal Cancer Therapies | Versamune HPV (formerly PDS0101), Zanzalintinib, Petosemtamab (MCLA-158), BNT113, ISA101b, CUE-101, Eftilagimod alpha (Efti/IMP321), LN-145/LN-145-S1, INO-3112 (MEDI0457), KEYTRUDA, OPDIVO, and others |
Scope of the HPV+ Oropharyngeal Cancer Market Report
- Therapeutic Assessment: HPV+ Oropharyngeal Cancer current marketed and emerging therapies
- HPV+ Oropharyngeal Cancer Market Dynamics: Key Market Forecast Assumptions of Emerging HPV+ Oropharyngeal Cancer Drugs and Market Outlook
- Competitive Intelligence Analysis: SWOT analysis and Market entry strategies
- Unmet Needs, KOL's views, Analyst's views, HPV+ Oropharyngeal Cancer Market Access and Reimbursement
Download the report to understand which factors are driving HPV+ oropharyngeal cancer therapeutics market trends @ HPV+ Oropharyngeal Cancer Market Trends
Table of Contents
1 | HPV+ Oropharyngeal Cancer Market Key Insights |
2 | HPV+ Oropharyngeal Cancer Market Report Introduction |
3 | HPV+ Oropharyngeal Cancer Market Overview at a Glance |
3.1 | HPV+ Oropharyngeal Cancer Market Share (%) Distribution by Therapies in 2024 |
3.2 | HPV+ Oropharyngeal Cancer Market Share (%) Distribution by Therapies in 2034 |
4 | Methodology of Epidemiology and Market |
5 | Executive Summary |
6 | Key Events |
7 | HPV+ Oropharyngeal Cancer: Disease Background and Overview |
7.1 | HPV+ Oropharyngeal Cancer Introduction |
7.2 | HPV+ Oropharyngeal Cancer Signs and Symptoms |
7.3 | HPV+ Oropharyngeal Cancer Causes |
7.4 | HPV+ Oropharyngeal Cancer Related Conditions |
7.5 | HPV+ Oropharyngeal Cancer Etiology |
7.6 | HPV+ Oropharyngeal Cancer Risk Factors |
7.7 | HPV+ Oropharyngeal Cancer Pathophysiology |
7.8 | HPV+ Oropharyngeal Cancer Complications |
7.9 | HPV+ Oropharyngeal Cancer Diagnosis |
7.10 | HPV+ Oropharyngeal Cancer Management and Treatment |
8 | HPV+ Oropharyngeal Cancer Epidemiology and Patient Population |
8.1 | Key Findings |
8.2 | Assumptions and Rationale: The 7MM |
8.3 | Total Incident Cases of Head and Neck Cancer in the 7MM |
8.4 | The US |
8.4.1 | Total Incident Cases of Head and Neck Cancer in the US |
8.4.2 | Total Incident Cases of HNSCC in the US |
8.4.3 | Total Incident Cases of OPSCC in the US |
8.4.4 | OPSCC Cases by HPV Status in the US |
8.4.5 | Stage-specific Cases of OPSCC in the US |
8.4.6 | Line-wise Treated Cases of OPSCC in the US |
8.5 | EU4 and the UK |
8.6 | Japan |
9 | Patient Journey of HPV+ Oropharyngeal Cancer |
10 | Marketed Therapies of HPV+ Oropharyngeal Cancer |
10.1 | Key Cross Competition |
10.2 | KEYTRUDA (pembrolizumab): Merck |
10.2.1 | Product Description |
10.2.2 | Regulatory Milestones |
10.2.3 | Other Developmental Activities |
10.2.4 | Clinical Trials Information |
10.2.5 | Safety and Efficacy |
10.2.6 | Analyst Views |
10.3 | OPDIVO (nivolumab): Bristol-Myers Squibb |
List to be continued in the final report. | |
11 | Emerging Therapies of HPV+ Oropharyngeal Cancer |
11.1 | Key Cross Competition |
11.2 | Versamune HPV: PDS Biotechnology |
11.2.1 | Drug Description |
11.2.2 | Other Developmental Activities |
11.2.3 | Clinical Trials Information |
11.2.4 | Safety and Efficacy |
11.2.5 | Analyst Views |
11.3 | INO-3112 (MEDI0457): Inovio Pharmaceuticals and MedImmune |
11.4 | CUE-101: Cue Biopharma |
List of drugs to be continued in the report. | |
12 | HPV+ Oropharyngeal Cancer Market: 7MM Analysis |
12.1 | Key Findings |
12.2 | Key Market Forecast Assumptions |
12.3 | HPV+ Oropharyngeal Cancer Market Outlook |
12.4 | Attribute Analysis |
12.5 | Total Market Size of HPV+ Oropharyngeal Cancer in the 7MM |
12.6 | Total Market Size of HPV+ Oropharyngeal Cancer by Therapies in the 7MM |
12.7 | The US HPV+ Oropharyngeal Cancer Market Size |
12.7.1 | Total Market Size of HPV+ Oropharyngeal Cancer |
12.7.2 | The Market Size of HPV+ Oropharyngeal Cancer by Therapies |
12.8 | EU4 and the UK HPV+ Oropharyngeal Cancer Market Size |
12.9 | Japan HPV+ Oropharyngeal Cancer Market Size |
13 | KOL Opinion Leaders' Views of HPV+ Oropharyngeal Cancer |
14 | SWOT Analysis of HPV+ Oropharyngeal Cancer |
15 | Unmet Needs of HPV+ Oropharyngeal Cancer |
16 | Market Access and Reimbursement of HPV+ Oropharyngeal Cancer |
16.1 | The United States |
16.2 | In EU4 and the UK |
16.3 | Japan |
17 | Acronyms and Abbreviations |
18 | Bibliography |
19 | HPV+ Oropharyngeal Cancer Market Report Methodology |
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