Oropharyngeal Cancer - Market Insight, Epidemiology, and Market Forecast - 2034

Key Highlights

• With declining rates of head and neck cancers related to alcohol and tobacco, HPV has become the principal etiologic factor in OPSCC, redefining prognostic outlooks and informing the development of tailored therapeutic approaches.
• Patients with HPV-positive oropharyngeal tumors exhibit significantly better prognosis and higher curability compared to HPV-negative counterparts receiving identical treatment.
• American and European guidelines for managing oropharyngeal squamous cell carcinoma (OPSCC) patients do not vary based on the HPV status of the tumor.
• OPSCC is frequently diagnosed at an advanced stage due to minimal early symptoms, underscoring the critical need for identifying and validating diagnostic biomarkers to enable earlier, more effective detection.
• Intensity-modulated radiation therapy (IMRT) remains the standard first-line treatment for early-stage OPSCC, though transoral robotic surgery (TORS) offers a viable alternative in select cases. HPV-positive patients demonstrate superior overall survival following primary IMRT but often experience longer-lasting functional impairments, underscoring the importance of weighing oncologic benefit against long-term quality-of-life outcomes.
• Immunotherapy may be more effective in HPV-positive patients, but its molecular mechanism is not yet fully understood. However, HPV status does not influence immunotherapy indications in recurrent or metastatic OPSCC.
• Advanced-stage oropharyngeal cancers are optimally managed with radiotherapy, often in combination with chemotherapy, while p16 positivity serves as a robust prognostic biomarker, correlating with significantly improved clinical outcomes.
• Open transpharyngeal and transmandibular approaches are best reserved for salvage settings. In carefully selected patients, transoral salvage surgery may offer superior functional and oncologic outcomes, supporting its strategic role in recurrence management.
• KEYTRUDA monotherapy is the preferred first-line treatment for recurrent or metastatic HNSCC with high PD-L1 expression. However, only about 20% of patients respond, and there is no significant difference based on HPV status. Currently, no treatments are specifically approved for HPV16+ cancers.
• Due to limited survival benefits, added costs, and potential functional impairments, definitive CRT should be the primary treatment for most HPV-positive locally advanced OPSCC patients, with surgery as a last resort.
• The pipeline for oropharyngeal cancer is rising, with 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 in clinical development.

DelveInsight’s “Oropharyngeal Cancer– Market Insights, Epidemiology, and Market Forecast – 2034” report delivers an in-depth understanding of oropharyngeal cancer, historical and forecasted epidemiology as well as oropharyngeal cancer market trends in the United States, EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan.

The oropharyngeal cancer market report provides current treatment practices, emerging drugs, market share of individual therapies, and current and forecasted 7MM oropharyngeal cancer market size from 2020 to 2034. The report also covers current oropharyngeal cancer treatment practices/algorithms and unmet medical needs to curate the best opportunities and assess the market’s potential.

Geography Covered

• The United States
• EU4 (Germany, France, Italy, and Spain) and the United Kingdom
• Japan

Oropharyngeal Cancer: Understanding and Treatment Algorithm

Oropharyngeal Cancer Overview

Oropharyngeal cancer is a subtype of head and neck cancer that arises in the oropharynx, the middle part of the pharynx, located behind the oral cavity. It commonly affects areas such as the back one-third of the tongue, soft palate, tonsils, and the side and back walls of the throat. The majority of oropharyngeal cancers are squamous cell carcinomas, which originate in the squamous cells, thin, flat cells that line the surface of many organs, including the oropharynx. Less commonly, lymphoma may develop in this region, particularly in the base of the tongue or tonsils, both of which contain lymphatic tissue. Major risk factors for oropharyngeal cancer include tobacco use, heavy alcohol consumption, and infection with HPV, particularly HPV type 16, which is strongly associated with HPV-positive oropharyngeal cancer

Oropharyngeal Cancer Diagnosis

Diagnosis of oropharyngeal cancer begins with a comprehensive clinical evaluation, including a review of symptoms, medical and family history, and a physical examination of the mouth, throat, and neck. If suspicious findings are noted, additional diagnostic tests are performed to confirm the presence of cancer and determine its stage. Initial assessments may involve a physical examination using a small mirror to inspect the oropharynx for abnormal areas, along with a neurological exam to evaluate brain and nerve function. Advanced imaging techniques such as PET-CT, MRI, and CT scans provide detailed visualization of the tumor and potential spread to surrounding structures or lymph nodes. PET scans highlight areas of increased glucose uptake, common in cancer cells, while CT and MRI offer high-resolution anatomical detail. Definitive diagnosis requires a biopsy, often obtained via fine-needle aspiration or during endoscopic procedures such as pharyngoscopy or laryngoscopy. These minimally invasive techniques allow direct visualization of the tumor and collection of tissue samples for pathological analysis. If cancer is confirmed, HPV testing is typically conducted on the tumor tissue. Identifying high-risk strains, particularly HPV type 16, is clinically important, as HPV-positive oropharyngeal cancers are associated with better outcomes and may be managed differently than HPV-negative tumors. Together, these diagnostic steps ensure accurate staging and inform personalized treatment planning.

Further details related to diagnosis are provided in the report…

Oropharyngeal Cancer Treatment

Treatment for oropharyngeal cancer depends on the stage of the disease, as well as the patient’s overall health and age. Surgery is often the preferred initial treatment, particularly for individuals with HPV-related oropharyngeal cancer. This group tends to be younger and healthier, and current treatment strategies aim to minimize long-term side effects by reducing or avoiding the use of chemotherapy when possible. In addition to surgery, other treatment options include radiation therapy, chemotherapy, targeted therapy, and immunotherapy. Radiation therapy is commonly used at all stages of oropharyngeal cancer and works by using high-energy beams to destroy cancer cells and prevent their growth. Chemotherapy involves the use of anticancer drugs, administered orally or intravenously, and may be used alone, alongside radiation therapy, before surgery to shrink tumors, or after surgery to destroy any remaining cancer cells. Targeted therapy focuses on specific molecules involved in cancer cell growth, aiming to kill cancer cells while sparing healthy tissue. Immunotherapy enhances the body’s immune system to recognize and attack cancer cells, and may be considered in cases where the cancer is advanced or has not responded to other treatments.

Further details related to diagnosis are provided in the report…

Oropharyngeal Cancer Epidemiology

The oropharyngeal cancer epidemiology chapter in the report provides historical as well as forecasted epidemiology segmented by 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 in the 7MM covering the United States, EU4 (Germany, France, Italy, and Spain), United Kingdom, and Japan from 2020 to 2034.

• 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).
• 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%.
• In 2024, EU4 and the UK reported around 10,000 cases of OPSCC, with France contributing the highest number at approximately 4,000 cases, while Spain recorded the lowest, with fewer than 1,000 cases.

Oropharyngeal Cancer Drug Chapters

The drug chapter segment of the oropharyngeal cancer report encloses a detailed analysis of oropharyngeal cancer marketed drugs. It also deep dives into oropharyngeal cancer pivotal clinical trial details, recent and expected market approvals, patent details, the latest news, and recent deals and collaborations.

Marketed Drugs

KEYTRUDA (pembrolizumab): Merck Sharp & Dohme

KEYTRUDA is an anti-PD-1 therapy that works by increasing the ability of the body’s immune system to help detect and fight tumor cells. KEYTRUDA is a humanized monoclonal antibody (mAb) that blocks the interaction between PD-1 and its ligands, PD-L1 and PD-L2, thereby activating T lymphocytes, which may affect both tumor cells and healthy cells.

• 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.

OPDIVO (nivolumab): Bristol Myers Squibb

OPDIVO is a programmed death-1 (PD-1) immune checkpoint inhibitor that is designed to uniquely harness the body’s immune system to help restore anti-tumor immune response. By harnessing the body’s immune system to fight cancer, OPDIVO has become an important treatment option across multiple cancers.

• The NIVOSTOP Phase III results presented at ASCO 2025 highlighted that adjuvant nivolumab with chemoradiotherapy in resected high-risk HNSCC improved disease-free survival regardless of tumor PD-L1 status.

Emerging Drugs

Versamune HPV (PDS0101): PDS Biotechnology

Versamune HPV (formerly PDS0101) is a novel investigational human papilloma virus (HPV)-targeted immunotherapy that stimulates a potent targeted T cell attack against HPV-positive cancers. Versamune HPV is given by a simple SC injection in combination with other immunotherapies and cancer treatments.

• 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 publication of three Versamune HPV abstracts with clinical studies named: VERSATILE-002 and VERSATILE-003, presented at 2025 American Society of Clinical Oncology (ASCO) annual meeting.

INO-3112 (MEDI0457): Inovio Pharmaceuticals and MedImmune

INO-3112 is a DNA medicine candidate targeting HPV 16/18 combined with a DNA plasmid for IL-12 as an immune activator. INOVIO is investigating the potential benefit of the antigen-specific T cell generation and tumor infiltration abilities of INO-3112 in HPV-related cancers, especially when used in novel combinations.

• In May 2025, INOVIO announced it has gained alignment with 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.
• In January 2024, INOVIO announced a clinical collaboration and supply agreement with Coherus BioSciences to evaluate the combination of INO-3112 and LOQTORZI as a potential treatment for patients with locoregionally advanced, high-risk, HPV16/18 positive OPSCC. Combination therapy to be evaluated in a Phase III trial in patients with locoregionally advanced, high-risk, HPV16/18-positive head and neck cancer.

Drug Class Insights

The drug classes include PD-1/PD-L1 inhibitor, T cell activator, Immune activators, Fc fusion protein, and others.

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. Pembrolizumab is approved as first-line therapy in PD-L1–positive tumors, while nivolumab is used post–platinum failure. Despite modest response rates, their durable benefit and tolerability mark a shift toward immunotherapy-driven treatment, highlighting the need for improved biomarkers and combination strategies.

Note: Detailed insights will be provided in the final report.

Oropharyngeal Cancer Market Outlook

Head and neck cancer includes a range of site-specific tumors, such as laryngeal, nasopharyngeal, oral, oropharyngeal, and salivary gland cancers, many of which are curable if detected early. Treatment aims to eliminate cancer while preserving vital functions like speech, swallowing, and appearance. Although guidelines recommend similar strategies for HPV-positive and -negative HNSCC, HPV status remains critical for staging and tailoring therapy, given the better prognosis in HPV-positive disease. Management typically involves surgery, radiation, chemotherapy, targeted therapy, and immunotherapy, with treatment selection based on tumor characteristics and patient factors. Across the 7MM, treatment patterns vary due to regional practices, but chemotherapy remains central. Ongoing R&D is focused on novel combinations and emerging approaches like cell transfer therapies, reflecting a shift toward personalized, immune-driven care

• KEYTRUDA and OPDIVO are the primary PD-1 inhibitors approved for treating recurrent or metastatic (R/M) HNSCC.
• 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 in the without immunotherapy.
• Versamune HPV doublet (Versamune HPV + KEYTRUDA) and triplet regimen (Versamune HPV + PDS01ADC + Bintrafusp alfa) continues to show efficacy. Both doublet and triplet are expected to change the landscape of HPV16+ HNSCC.
• Although PD-1 inhibitors have reshaped the therapeutic landscape, their efficacy remains constrained by resistance mechanisms, including immunosuppressive tumor microenvironments and immune escape pathways. These limitations are particularly evident in patients with low PD-L1 expression or prior chemotherapy exposure.

Oropharyngeal Cancer Drugs Uptake

This section focuses on the uptake rate of potential drugs expected to be launched in the market during 2020–2034. The landscape of oropharyngeal cancer treatment has experienced a profound transformation with the uptake of novel drugs. These innovative therapies are redefining standards of care. Furthermore, the increased uptake of these transformative drugs is a testament to the unwavering dedication of physicians, oncology professionals, and the entire healthcare community in their tireless pursuit of advancing cancer care. This momentous shift in treatment paradigms is a testament to the power of research, collaboration, and human resilience.

Further detailed analysis of emerging therapies drug uptake in the report…

Oropharyngeal Cancer Pipeline Development Activities

The report provides insights into therapeutic candidates in Phase III, Phase II, and Phase I/II. It also analyzes key players involved in developing targeted therapeutics.

Pipeline Development Activities

The report covers information on collaborations, acquisitions and mergers, licensing, and patent details for oropharyngeal cancer emerging therapy.

KOL Views

To keep up with current market trends, we take KOLs and SMEs’ opinions working in the domain through primary research to fill the data gaps and validate our secondary research. Industry Experts contacted for insights on oropharyngeal cancer evolving treatment landscape, patient reliance on conventional therapies, patient therapy switching acceptability, and drug uptake, along with challenges related to accessibility, including oncologists, radiation oncologists, surgical oncologists, and others.

Delveinsight’s analysts connected with 15+ KOLs to gather insights; however, interviews were conducted with 7+ KOLs in the 7MM. Centers such as MD Anderson Cancer Center, Jena University Hospital, University College London, Cambridge University, Yale University, International Agency for Research on Cancer, Carnegie Mellon University, University of Arizona, etc., were contacted. Their opinion helps understand and validate current and emerging therapy treatment patterns or oropharyngeal cancer market trends. This will support the clients in potential upcoming novel treatments by identifying the overall scenario of the market and the unmet needs.

Qualitative Analysis

We perform Qualitative and market Intelligence analysis using various approaches, such as SWOT analysis and Conjoint Analysis. In the SWOT analysis, strengths, weaknesses, opportunities, and threats in terms of gaps in disease diagnosis, patient awareness, physician acceptability, competitive landscape, cost-effectiveness, and geographical accessibility of therapies are provided.

Conjoint Analysis analyzes multiple approved and emerging therapies based on relevant attributes such as safety, efficacy, frequency of administration, route of administration, and order of entry. Scoring is given based on these parameters to analyze the effectiveness of therapy.

In efficacy, the trial’s primary and secondary outcome measures are evaluated; for instance, in event- free survival, one of the most crucial primary outcome measures is event-free survival and overall survival.

Further, the therapies’ safety is evaluated, wherein the acceptability, tolerability, and adverse events are majorly observed, and this clearly explains the drugs side effects in the trials. In addition, the scoring is also based on the probability of success and the addressable patient pool for each therapy. According to these parameters, the final weightage score and the ranking of the emerging therapies are decided.

Market Access and Reimbursement

Reimbursement may be referred to as the negotiation of a price between a manufacturer and payer that allows the manufacturer access to the market. It is provided to reduce the high costs and make the essential drugs affordable. Health technology assessment (HTA) plays an important role in reimbursement decision-making and recommending the use of a drug. These recommendations vary widely throughout the seven major markets, even for the same drug. In the US healthcare system, both Public and Private health insurance coverage are included. Also, Medicare and Medicaid are the largest government-funded programs in the US. The major healthcare programs including Medicare, Medicaid, Health Insurance Program (CHIP), and the state and federal health insurance marketplaces are overseen by the Centers for Medicare & Medicaid Services (CMS). Other than these, Pharmacy Benefit Managers (PBMs), and third-party organizations that provide services, and educational programs to aid patients are also present.

The report further provides detailed insights on the country-wise accessibility and reimbursement scenarios, cost-effectiveness scenario of currently used therapies, programs making accessibility easier and out-of-pocket costs more affordable, insights on patients insured under federal or state government prescription drug programs, etc.

Further detailed analysis of emerging therapies drug uptake in the report…

Scope of the Report

• The report covers a segment of key events, an executive summary, and a descriptive overview of oropharyngeal cancer, explaining its causes, signs, symptoms, pathogenesis, and currently used therapies.
• Comprehensive insight into the epidemiology segments and forecasts, disease progression, and treatment guidelines has been provided.
• Additionally, an all-inclusive account of the emerging therapies and the elaborative profiles of late-stage and prominent therapies will impact the current treatment landscape.
• A detailed review of the oropharyngeal cancer market, historical and forecasted market size, market share by therapies, detailed assumptions, and rationale behind our approach is included in the report, covering the 7MM drug outreach.
• The report provides an edge while developing business strategies, by understanding trends, through SWOT analysis and expert insights/KOL views, patient journey, and treatment preferences that help shape and drive the 7MM oropharyngeal cancer market.

Oropharyngeal Cancer Report Insights

• Patient Population
• Therapeutic Approaches
• Oropharyngeal Cancer Pipeline Analysis
• Oropharyngeal Cancer Market Size and Trends
• Existing and Future Market Opportunity

Oropharyngeal Cancer Report Key Strengths

• 10 Years Forecast
• The 7MM Coverage
• Oropharyngeal Cancer Epidemiology Segmentation
• Key Cross Competition
• Drugs Uptake and Key Market Forecast Assumptions

Oropharyngeal Cancer Report Assessment

• Current Treatment Practices
• Unmet Needs
• Pipeline Product Profiles
• Market Attractiveness
• Qualitative Analysis (SWOT Analysis and Conjoint Analysis)

FAQs

• What was the oropharyngeal cancer market size, the market size by therapies, market share (%) distribution in 2024, and what would it look like by 2034? What are the contributing factors for this growth?
• What are the pricing variations among different geographies for approved therapies?
• What can be the future treatment paradigm of oropharyngeal cancer?
• What are the disease risks, burdens, and unmet needs of oropharyngeal cancer? What will be the growth opportunities across the 7MM concerning the patient population with oropharyngeal cancer?
• What are the current options for the treatment of oropharyngeal cancer? What are the current guidelines for treating oropharyngeal cancer in the US, Europe, and Japan?
• What are the recent novel therapies, targets, mechanisms of action, and technologies being developed to overcome the limitations of existing therapies?

Reasons to Buy

• The report will help develop business strategies by understanding the latest trends and changing treatment dynamics driving the oropharyngeal cancer market.
• Insights on patient burden/disease prevalence, evolution in diagnosis, and factors contributing to the change in the epidemiology of the disease during the forecast years.
• Understand the existing market opportunities in varying geographies and the growth potential over the coming years.
• Distribution of historical and current patient share based on real-world prescription data along with reported sales of approved products in the US, EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan.
• Identifying strong upcoming players in the market will help devise strategies to help get ahead of competitors.
• Detailed analysis and ranking of class-wise potential current and emerging therapies under the Analyst view section to provide visibility around leading classes.
• Highlights of access and reimbursement policies of current therapies, barriers to accessibility of expensive off-label therapies, and patient assistance programs.
• To understand Key Opinion Leaders’ perspectives around the accessibility, acceptability, and compliance-related challenges of existing treatment to overcome barriers in the future.
• Detailed insights on the unmet needs of the existing market so that the upcoming players can strengthen their development and launch strategy.

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