The oropharyngeal cancer market is anticipated to grow during the forecast period (2025-2034), driven by the launch of emerging therapies such as PDS Biotechnology's Versamune HPV, Inovio Pharmaceuticals and MedImmune's INO-3112/MEDI0457, Cue Biopharma's CUE-101, BioNTech's BNT113, and others, as well as global healthcare spending.
LAS VEGAS, Nov. 10, 2025 /PRNewswire/ -- DelveInsight's Oropharyngeal Cancer Market Insights report includes a comprehensive understanding of current treatment practices, 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).
Oropharyngeal Cancer Market Summary
- The market size for oropharyngeal cancer in the leading markets is expected to grow significantly by 2034.
- The United States accounted for the highest oropharyngeal cancer treatment market size in 7MM in 2024, in comparison to the other major markets, i.e., EU4 countries, the United Kingdom, and Japan.
- There were an estimated 170,000 incident cases of head and neck cancer across the 7MM in 2024, including nearly 150,000 cases of HNSCC. These figures are projected to fluctuate over the forecast period (2025-2034).
- Leading oropharyngeal cancer companies developing emerging therapies, such as PDS Biotechnology, Inovio Pharmaceuticals, MedImmune, Cue Biopharma, BioNTech, and others, are developing new therapy for oropharyngeal cancer that can be available in the oropharyngeal cancer market in the coming years.
- The promising oropharyngeal cancer therapies in clinical trials include Versamune HPV (PDS0101), INO-3112 (MEDI0457), CUE-101, BNT113, and others.
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Key Factors Driving the Growth of the Oropharyngeal Cancer Market
Rising Incidence of HPV+ Oropharyngeal Cancer
HPV-driven OPSCC has increased sharply in many regions, shifting the disease burden and creating demand for new diagnostics and specialized treatments.
Role of PD-1/PD-L1 Inhibitors
PD-1 inhibitors, including KEYTRUDA (pembrolizumab) and OPDIVO (nivolumab), have become pivotal in the treatment of recurrent/metastatic HNSCC by reactivating suppressed T-cell responses. In HNSCC, tumor cells often exploit the PD-1/PD-L1 pathway to evade immune surveillance. These agents block the interaction between PD-1 on T cells and its ligands (PD-L1/PD-L2), restoring T-cell activity and enabling immune-mediated tumor clearance.
Launch of Emering Oropharyngeal Cancer Drugs
The pipeline for oropharyngeal cancer is rising, with PDS Biotechnology (Versamune HPV/PDS0101), Inovio Pharmaceuticals and MedImmune (INO-3112/MEDI0457), Cue Biopharma (CUE-101), BioNTech (BNT113), and others in clinical development.
Oropharyngeal Cancer Market Analysis
The primary goal of oropharyngeal cancer treatment is to eradicate the disease while maintaining essential functions such as speech, swallowing, and facial appearance. Although current guidelines recommend similar therapeutic strategies for HPV-positive and HPV-negative head and neck squamous cell carcinoma (HNSCC), HPV status remains a key factor in staging and treatment planning due to its association with more favorable outcomes.
Management typically involves a combination of surgery, radiation therapy, chemotherapy, targeted therapy, and immunotherapy, with treatment choices guided by tumor biology and individual patient characteristics. Across the 7MM, therapeutic approaches differ by region, though chemotherapy remains a cornerstone. Research and development efforts are increasingly directed toward innovative combinations and emerging modalities, such as cell-based therapies, highlighting a transition toward more personalized, immune-focused treatments.
Among immunotherapies, KEYTRUDA and OPDIVO are the leading PD-1 inhibitors approved for recurrent or metastatic (R/M) HNSCC. Multiple HPV-targeted vaccines are also under clinical investigation, with the most promising outcomes observed when combined with checkpoint inhibitors as first-line treatments for recurrent or metastatic disease. While some trials are assessing these vaccines in treatment-refractory populations, response rates in such cases tend to be modest. Ongoing studies are also exploring the role of therapeutic vaccines as monotherapy or in non-immunotherapy settings.
The Versamune HPV platforms, both the doublet (Versamune HPV + KEYTRUDA) and the triplet (Versamune HPV + PDS01ADC + Bintrafusp alfa) regimens, have demonstrated sustained efficacy and are anticipated to influence the treatment landscape for HPV16-positive HNSCC significantly. Despite the transformative impact of PD-1 inhibitors, their effectiveness remains limited by resistance mechanisms, including immunosuppressive tumor microenvironments and immune evasion pathways, particularly in patients with low PD-L1 expression or prior chemotherapy.
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Oropharyngeal Cancer Competitive Landscape
The pipeline for oropharyngeal cancer is rising, with PDS Biotechnology (Versamune HPV/PDS0101), Inovio Pharmaceuticals and MedImmune (INO-3112/MEDI0457), Cue Biopharma (CUE-101), BioNTech (BNT113), and others in clinical development.
PDS Biotechnology's Versamune HPV (formerly PDS0101) is an innovative investigational immunotherapy targeting human papillomavirus (HPV). It activates a strong, HPV-specific T cell response to attack HPV-positive cancers. It is administered via a simple subcutaneous injection, typically in combination with other immunotherapies or cancer treatments.
Inovio Pharmaceuticals and MedImmune's INO-3112 is a DNA-based therapeutic candidate targeting HPV types 16 and 18, paired with a plasmid encoding IL-12 to enhance immune activation. INOVIO is studying INO-3112's ability to generate antigen-specific T cells and promote their infiltration into tumors, particularly in HPV-associated cancers and in combination with other treatments.
BioNTech's BNT113, an mRNA-based cancer immunotherapy, targets the HPV16-derived oncoproteins E6 and E7-key drivers in HPV16-positive solid tumors. In September 2024, BioNTech presented interim data from its oncology pipeline at the European Society for Molecular Oncology (ESMO) Congress, including preliminary findings from an ongoing Phase II/III study evaluating BNT113 in combination with PD-1 blockade and results from an investigator-initiated Phase I/II trial testing BNT113 as monotherapy in HPV16-driven cancers.
Currently, BNT113 is being assessed in a Phase II/III clinical trial comparing the combination of BNT113 and pembrolizumab with pembrolizumab alone as a first-line therapy for patients with unresectable, recurrent, or metastatic HPV16-positive head and neck squamous cell carcinoma (HNSCC) expressing PD-L1.
The anticipated launch of these emerging therapies are poised to transform the 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 oropharyngeal cancer market landscape, offering new standards of care and unlocking opportunities for medical innovation and economic growth.
Discover more about therapy for oropharyngeal cancer @ Oropharyngeal Cancer Clinical Trials
Recent Developments in the Oropharyngeal Cancer Market
- In June 2025, PDS Biotechnology announced hosting of a virtual key opinion leader (KOL) event, to discuss the unmet need and current treatment landscape for recurrent/metastatic HPV16-positive HNSCC. The event reviews the changing landscape of HNSCC in context with Merck's KEYNOTE-689 (KN-689) study and the rapidly increasing incidences of HPV16-positive HNSCC in the US and Europe, also including, review of Versamune HPV, which is currently being evaluated in a Phase III clinical trial in combination with pembrolizumab as a first-line treatment for R/M HPV16+ HNSCC, as well as in Phase II clinical trials for the treatment of various types of HPV16-positive cancers.
- In June 2025, PDS Biotechnology announced the publication of three Versamune HPV abstracts, including VERSATILE-002 and VERSATILE-003, which were presented at the 2025 American Society of Clinical Oncology (ASCO) annual meeting.
- In June 2025, Merck announced that the US Food and Drug Administration (FDA) approved KEYTRUDA (pembrolizumab), Merck's anti-PD-1 therapy, for the treatment of adult patients with resectable locally advanced HNSCC whose tumors express PD-L1 as a single agent as neoadjuvant treatment, continued as adjuvant treatment in combination with radiotherapy (RT) with or without cisplatin and then as a single agent.
- In June 2025, three abstracts on Versamune HPV, highlighting positive results from the VERSATILE-002 Phase II trial, were published on the ASCO 2025.
- In May 2025, INOVIO announced it had gained alignment with the FDA on the design of the planned Phase III trial in the US and received initial feedback from European regulatory authorities on the proposed design of the trial in Europe.
What is Oropharyngeal Cancer?
Oropharyngeal cancer is a form of head and neck cancer that develops in the oropharynx, the middle section of the throat located behind the mouth. It most often affects the back third of the tongue, the soft palate, the tonsils, and the side or rear walls of the throat. The majority of these cancers are squamous cell carcinomas, originating from the thin, flat squamous cells that line the surface of the oropharynx and many other organs. Occasionally, lymphomas may also arise in this area, especially in the tonsils or base of the tongue, which contain lymphatic tissue. Key risk factors for oropharyngeal cancer include tobacco use, excessive alcohol intake, and infection with human papillomavirus (HPV), particularly HPV type 16, which is strongly linked to HPV-positive oropharyngeal cancer.
Oropharyngeal Cancer Epidemiology Segmentation
The oropharyngeal cancer epidemiology section provides insights into the historical and current oropharyngeal cancer patient pool and forecasted trends for the leading markets. Among HNSCC, approximately 20,000 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 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
Oropharyngeal Cancer Market Report Metrics | Details |
Study Period | 2020-2034 |
Oropharyngeal Cancer Market Report Coverage | 7MM [The United States, the EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan]. |
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 Oropharyngeal Cancer Companies | PDS Biotechnology, Inovio Pharmaceuticals, MedImmune, Cue Biopharma, BioNTech, Merck Sharp & Dohme, Bristol Myers Squibb, and others |
Key Oropharyngeal Cancer Therapies | Versamune HPV (PDS0101), INO-3112 (MEDI0457), CUE-101, BNT113, KEYTRUDA, OPDIVO, and others |
Scope of the Oropharyngeal Cancer Market Report
- Therapeutic Assessment: Oropharyngeal Cancer current marketed and emerging therapies
- Oropharyngeal Cancer Market Dynamics: Key Market Forecast Assumptions of Emerging Oropharyngeal Cancer Drugs and Market Outlook
- Competitive Intelligence Analysis: SWOT analysis and Market entry strategies
- Unmet Needs, KOL's views, Analyst's views, Oropharyngeal Cancer Market Access and Reimbursement
Download the report to understand which factors are driving oropharyngeal cancer therapeutics market trends @ Oropharyngeal Cancer Market Trends
Table of Contents
1 | Oropharyngeal Cancer Market Key Insights |
2 | Oropharyngeal Cancer Market Report Introduction |
3 | Oropharyngeal Cancer Market Overview at a Glance |
3.1 | Oropharyngeal Cancer Market Share (%) Distribution by Therapies in 2024 |
3.2 | Oropharyngeal Cancer Market Share (%) Distribution by Therapies in 2034 |
4 | Methodology of Epidemiology and Market |
5 | Executive Summary |
6 | Key Events |
7 | Disease Background and Overview |
7.1 | Introduction |
7.2 | Oropharyngeal Cancer Signs and Symptoms |
7.3 | Oropharyngeal Cancer Causes |
7.4 | Related Conditions |
7.5 | Oropharyngeal Cancer Etiology |
7.6 | Oropharyngeal Cancer Risk Factors |
7.7 | Oropharyngeal Cancer Pathophysiology |
7.8 | Oropharyngeal Cancer Complications |
7.9 | Oropharyngeal Cancer Diagnosis |
7.10 | Oropharyngeal Cancer Management and Treatment |
8 | Epidemiology and Patient Population |
8.1 | Key Findings |
8.2 | Assumptions and Rationale: The 7MM |
8.3 | Total Incident Cases of OPSCC 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 | Oropharyngeal Cancer Patient Journey |
10 | Marketed Oropharyngeal Cancer Therapies |
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 Oropharyngeal Cancer Therapies |
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 | BNT113: BioNTech |
11.4 | CUE-101: Cue Biopharma |
List of drugs to be continued in the report. | |
12 | Oropharyngeal Cancer Market: 7MM Analysis |
12.1 | Key Findings |
12.2 | Key Oropharyngeal Cancer Market Forecast Assumptions |
12.3 | Oropharyngeal Cancer Market Outlook |
12.4 | Attribute Analysis |
12.5 | Total Market Size of Oropharyngeal Cancer in the 7MM |
12.6 | Total Market Size of Oropharyngeal Cancer by Therapies in the 7MM |
12.7 | The US Oropharyngeal Cancer Market Size |
12.7.1 | Total Market Size of Oropharyngeal Cancer |
12.7.2 | The Market Size of Oropharyngeal Cancer by Therapies |
12.8 | EU4 and the UK Oropharyngeal Cancer Market Size |
12.9 | Japan Oropharyngeal Cancer Market Size |
13 | KOL Opinion Leaders' Views on Oropharyngeal Cancer |
14 | Oropharyngeal Cancer Market SWOT Analysis |
15 | Oropharyngeal Cancer Market Unmet Needs |
16 | Oropharyngeal Cancer Market Access and Reimbursement |
16.1 | The United States |
16.2 | In EU4 and the UK |
16.3 | Japan |
17 | Acronyms and Abbreviations |
18 | Bibliography |
19 | Oropharyngeal Cancer Market Report Methodology |
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