Merkel Cell Carcinoma Market

Key Highlights

• According to Delveinsight, in 2024, Merkel Cell Carcinoma (MCC) accounted for approximately 4,500 cases in the 7MM.
• MCC is highly responsive to radiotherapy, making single-modality radiotherapy a viable option for patients who are considered inoperable. Radiotherapy targeting tumors and/or positive lymph nodes can control the disease in 75–85% of cases. The most promising treatment for mMCC involves immune checkpoint inhibitors (ICIs), which have demonstrated significant efficacy.
• If the cancer comes back on the skin where it first started, surgery (with wider margins) can often be done to try to remove it. This might be followed by radiation therapy to the area if it hasn’t been given before. If surgery can't be done, radiation therapy might be an option.
• Studies demonstrate that immunotherapy can benefit patients with advanced-stage disease and is superior to any form of therapy; however, a substantial portion of advanced-stage MCCs do not respond to PD1–PDL1 inhibitors.
• Approved drugs for MCC include BAVENCIO (avelumab, Merck KGaA), KEYTRUDA (pembrolizumab, Merck), ZYNYZ (retifanlimab-dlwr, Incyte), and others.
• In June 2025, the US FDA removed the manufacturing-related partial clinical hold on the TuHURA Biosciences’ Phase III accelerated approval trial for IFx-2.0, thereby allowing the trial to proceed as agreed to under the previously announced Special Protocol Assessment (SPA) Agreement with the FDA.
• According to a recent presentation by TuHURA Biosciences published in March 2025, the company anticipates reporting top-line data and potentially submitting a Biologics License Application (BLA) for IFx-Hu2 in the second half of 2026, with a planned product launch in the US in 2027 and in the EU in 2028.
• Pharmaceutical companies developing therapies for treating MCC include TuHURA Biosciences (IFx-Hu2/IFx-2.0), Transgene and BioInvent (BT-001), Memgen (MEM-288), Medicenna Therapeutics (MDNA11), Phio Pharmaceuticals (PH-762), and others with their candidates in different stages of clinical development.

Key Factors Driving Merkel Cell Carcinoma Market 

Merkel Cell Carcinoma Rising Incidence

Merkel Cell Carcinoma is a rare but aggressive skin cancer, with incidence increasing globally due to aging populations and greater UV exposure. Radiotherapy responsiveness makes it a key treatment option for patients who are inoperable. Disease control is achieved in 75–85% of cases with targeted radiotherapy to tumors or affected lymph nodes.

Merkel Cell Carcinoma Immune Checkpoint Therapy Adoption

Immune checkpoint inhibitors have transformed the treatment landscape for advanced MCC, offering significant efficacy and durable responses. Approved therapies such as BAVENCIO, KEYTRUDA, and ZYNYZ have expanded treatment options, with immunotherapy increasingly becoming the standard of care for metastatic or recurrent disease.

Merkel Cell Carcinoma Market Growth and Opportunities

The MCC market is growing as more patients gain access to immunotherapies, and new combination strategies are explored. Payers demonstrate high willingness to invest in therapies that improve survival and quality of life, driving rapid adoption of approved immune checkpoint inhibitors.

Merkel Cell Carcinoma Clinical Trials and Competitive Landscape

Emerging therapies like IFx-Hu2/IFx-2.0, BT-001, MEM-288, MDNA11, and PH-762 are in various stages of development, addressing unmet needs for patients resistant to PD-1/PD-L1 inhibitors. Clinical trials and innovative immuno-oncology candidates are shaping a competitive landscape, promising broader therapeutic options and improved outcomes for MCC patients.

DelveInsight's “Merkel Cell Carcinoma (MCC) – Market Insight, Epidemiology and Market Forecast – 2034” report delivers an in-depth analysis of MCC epidemiology, market, and clinical development in MCC. In addition to this, the report provides historical and forecasted epidemiology and market data as well as a detailed analysis of the MCC market trends in the United States, EU4 (Germany, France, Italy, and Spain ), the United Kingdom, and Japan.

MCC market report provides real-world prescription pattern analysis, emerging drugs assessment, market share, and uptake/adoption pattern of individual therapies, as well as historical and forecasted MCC market size from 2020 to 2034 in 7MM. The report also covers current MCC treatment practices/algorithms and unmet medical needs to curate the best opportunities and assess the market’s underlying potential.

Geography Covered

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

Merkel Cell Carcinoma (MCC) Understanding and Treatment Algorithm

MCC Overview

MCC is a rare type of skin cancer. It starts in the Merkel cells, which are usually in the top layer of the skin (the epidermis). These cells are near the nerve endings, and they help us respond to touch. MCC carcinogenesis is associated either with the presence of clonally integrated Merkel cell polyomavirus (MCPyV; also known as human polyomavirus (HPyV5)) or chronic ultraviolet light exposure.

MCC Diagnosis

The diagnosis and therapeutic management of MCC requires the coordinated efforts of a team of medical professionals who are focused on diagnosing and treating skin disorders (dermatologists); diagnosing and treating cancer (medical oncologists); cancer treatment through surgery (surgical oncologists); cancer treatment through radiation (radiation oncologists); oncology nurses; dietitians; psychiatrists; and/or other healthcare professionals. Psychosocial support for the entire family is also often indicated because of the rarity and relatively high risk of this cancer.

The main test to diagnose MCC is to take a biopsy. Further tests are done to see if the cancer has spread to other parts of the body or not. The patient might have: an ultrasound scan, a CT scan, or PET-CT scan, or an MRI scan.

Further details related to country-based variations in diagnosis are provided in the report...

MCC Treatment

Treatment consists of wide local excision with or without adjuvant radiotherapy for the local disease. New therapies for metastatic MCC have shown promise and include immune-based therapies. MCC is very responsive to radiotherapy; thus, single-­modality radiotherapy can be considered in patients who are deemed inoperable. Radiotherapy to tumors and/or positive lymph nodes can control the disease in 75–85% of cases. Furthermore, patients with a diagnosis of MCC should be followed every three to six months for three years and every six to 12 months thereafter, including complete skin and lymph node examinations. Imaging studies may be routinely performed in high-risk patients and otherwise as clinically indicated.

Several drugs are approved for the treatment of MCC, including BAVENCIO (avelumab), KEYTRUDA (pembrolizumab), and ZYNYZ (retifanlimab-dlwr).

Merkel Cell Carcinoma (MCC) Epidemiology

The MCC epidemiology chapter in the report provides historical as well as forecasted epidemiology segmented as total incident cases of MCC, gender-specific cases of MCC, age-specific cases of MCC, stage-specific cases of MCC, and total treatable cases of MCC in the first-line and second-line in the 7MM covering the United States, EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan from 2020 to 2034.

• According to DelveInsight's 2024 assessment, among the EU4 and the UK, Germany reported the highest incidence of MCC, accounting for approximately 25% of the total cases in the region. In contrast, Spain recorded the lowest incidence of MCC, representing about 15% of the total cases in the EU4 and the UK.
• Epidemiologic data suggest that there are approximately 2,500 new MCC cases per year within the European Union (EU), and approximately 1,000 of these patients will die from their disease.
• Approximately one-third of MCC patients eventually develop distant metastatic disease.
• Japan accounted for approximately 500 cases of MCC in 2024.

Merkel Cell Carcinoma (MCC) Recent Developments

• In September 2025, Merck (NYSE: MRK) announced U.S. FDA approval of KEYTRUDA QLEX™—a subcutaneous formulation of pembrolizumab combined with berahyaluronidase alfa—for use in adults across most solid tumor indications for KEYTRUDA®. Developed with Alteogen Inc.'s hyaluronidase technology, KEYTRUDA QLEX must be administered by a healthcare provider and is expected to be available in the U.S. by late September.

Merkel Cell Carcinoma (MCC) Drug Chapters

The drug chapter segment of the MCC report encloses a detailed analysis of MCC-marketed drugs and late-stage (Phase Ib/IIa, Phase I/II, and Phase I) pipeline drugs. It also deep dives into MCC’s pivotal clinical trial details, recent and expected market approvals, patent details, the latest news, and recent deals and collaborations.

Marketed Drugs

ZYNYZ (retifanlimab-dlwr): Incyte

ZYNYZ is an intravenous PD-1 inhibitor indicated in the US for the treatment of adult patients with metastatic or recurrent locally advanced MCC. In March 2023, the US FDA approved ZYNYZ for the treatment of adults with recurrent locally advanced or metastatic MCC.

The Biologics License Application (BLA) for ZYNYZ for this indication has been approved under accelerated approval by the US FDA based on tumor response rate and duration of response.

Incyte entered into an exclusive collaboration and license agreement with MacroGenics for global rights to ZYNYZ. ZYNYZ is a trademark of Incyte.

BAVENCIO (avelumab): Merck KGaA (EMD Serono)

Bavencio is a cancer medicine that interferes with the growth and spread of cancer cells in the body. Bavencio is used to treat a type of skin cancer called MCC in adults and children at least 12 years old when the cancer has spread to other parts of the body (metastatic). Bavencio is also used to treat a certain type of cancer of the bladder or urinary tract that has spread or cannot be removed with surgery. Bavencio is given for this condition after platinum cancer medicines did not work or have stopped working.

In March 2017, the US FDA granted accelerated approval to BAVENCIO (avelumab) for the treatment of patients 12 years and older with metastatic MCC. Approval was based on data from an open-label, single-arm, multi-center clinical trial (JAVELIN Merkel 200 trial) demonstrating a clinically meaningful and durable overall response rate (ORR). All patients had histologically confirmed metastatic MCC with disease progression on or after chemotherapy administered for metastatic disease.

Note: Detailed current therapies assessment will be provided in the full report of MCC….

Emerging Drugs

IFx-Hu2/IFx-2.0: TuHURA Biosciences

IFx-2.0 is a personalized innate immune agonist that involves injecting a small amount of pDNA into a patient's tumor, encoding an immunogenic bacterial protein expressed on the tumor's surface. This approach leverages the patient’s innate immune system to recognize the tumor as foreign, triggering an immune response against the tumor, even if it had previously evaded immune detection. By mimicking a bacterial infection, IFx-2.0 uses the tumor itself to prime the immune system for targeted attack.

• In June 2025, TuHURA Biosciences initiated its Phase III accelerated approval trial of IFx-2.0 in patients with advanced or metastatic MCC.
• In October 2024, TuHURA Biosciences announced the completion of its previously announced merger with Kintara Therapeutics, and the combined entity will operate under the TuHURA Biosciences name. The company is now preparing to initiate a single Phase III accelerated approval registration trial in the first half of 2025 for the treatment of first-line MCC under a SPA agreement with the US FDA.
• TuHURA Biosciences presented data from the Phase Ib (NCT04160065) trial of IFx-Hu2.0 at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting in May 2024. The results showed that IFx-Hu2.0 was safe and well-tolerated when administered at a once-weekly dosing schedule for three weeks.

BT-001: Transgene and BioInvent

BT-001 is an oncolytic vaccinia virus with enhanced replication selectivity in tumor cells and genetically engineered to express GM-CSF and a novel full-length anti-CTLA-4 hIgG1 mAb. Currently, the drug BT-001 is in the Phase I/II stage of clinical trials.

BT-001 is being co-developed as part of a 50/50 collaboration on oncolytic viruses between Transgene and BioInvent.

• According to Transgene's recent corporate presentation, the company anticipates Phase I data of BT-001 in H2 2025.
• In September 2024, Transgene and BioInvent presented preliminary data at ESMO 2024, showing that BT-001 alone or in combination with IV pembrolizumab was well tolerated and showed antitumoral activity, including in a PD-(L)1 resistant tumor.

Note: Detailed emerging therapies assessment will be provided in the final report.

Drug Class Insights

PD-1-directed therapies

The PD-1 pathway represents a critical focus in cancer treatment through immune checkpoint inhibitors (ICIs). Engagement of PD-1 by its ligands, PD-L1 or PD-L2, suppresses the activity of T effector cells by inhibiting signaling pathways essential for cell proliferation downstream of the T cell receptor. Merkel cell carcinoma (MCC) exhibits notable responsiveness to PD-1-targeted ICI therapies. Various drugs like ZYNYZ, KEYTRUDA, BAVENCIO, and others that target PD-1 in MCC are considered highly promising treatments for this condition.

Merkel Cell Carcinoma (MCC) Market Outlook

Recent advances in treatment and surveillance are now providing hope for patients with advanced disease. Similar to recent developments in the treatment of melanoma, immunotherapy has improved patient outcomes by providing effective and durable responses for some patients with MCC. Local radiation therapy has been shown to augment this response to immunotherapies, even at sites distant from the field of radiation, a phenomenon known as the abscopal effect. Also, monitoring of antibodies to the Merkel cell polyomavirus (MCPyV) is making it easier for physicians to anticipate and monitor for recurrence. Many ongoing clinical trials are focusing on combination or experimental treatments for MCC.

Key players, such as TuHURA Biosciences, Transgene and BioInvent, Phio Pharmaceuticals, Medicenna Therapeutics, Memgen, and others, are evaluating their lead candidates in different stages of clinical development. They aim to investigate their products for the treatment of MCC.

Key Findings

• In April 2025, a Safety Monitoring Committee (SMC) recommended dose-escalation for a Phase Ib trial (NCT06014086) evaluating PH-762 in cutaneous squamous cell carcinoma, melanoma, and MCC.
• In January 2025, Phio Pharmaceuticals announced promising results from the second cohort of its ongoing clinical study of PH-762, reporting pathologic responses that include two patients achieving a complete response with 100% tumor clearance.
• In June 2024, TuHURA Biosciences and Kintara Therapeutics announced positive results from the primary analysis of TuHURA's completed Phase Ib trial evaluating IFx-2.0 among patients with advanced or metastatic MCC or cSCC who exhibited primary resistance to immune checkpoint inhibitor (ICIs) therapy.
• In April 2024, Kintara Therapeutics and TuHURA Biosciences entered into a Definitive Merger Agreement.

Merkel Cell Carcinoma (MCC) drug uptake

This section focuses on the uptake rate of potential drugs expected to be launched in the market during 2020–2034, which depends on the competitive landscape, safety, and efficacy data, along with the order of entry. It is important to understand that the key players evaluating their novel therapies in the pivotal and confirmatory trials should remain vigilant when selecting appropriate comparators to stand the greatest chance of a positive opinion from regulatory bodies, leading to approval, smooth launch, and rapid uptake.

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

Merkel Cell Carcinoma (MCC) Pipeline Development Activities

The report provides insights into different therapeutic candidates in the Phase II and Phase I stages. 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 MCC therapies.

KOL Views

To keep up with the real-world scenario in current and emerging market trends, we take opinions from Key Industry leaders working in the domain through primary research to fill the data gaps and validate our secondary research. Industry Experts were contacted for insights on the evolving treatment landscape, patient reliance on conventional therapies, patient therapy switching acceptability, and drug uptake, along with challenges related to accessibility, including Medical/Scientific Writers, Professors, and Others.

DelveInsight’s analysts connected with 20+ KOLs to gather insights; however, interviews were conducted with 10+ KOLs in the 7MM. Centers such as Fred Hutchinson Cancer Center, UNC Lineberger Comprehensive Cancer Center, UT Southwestern Medical Center in Dallas, Cancer Research UK Barts Centre in London, LUNGevity Foundation, etc., were contacted. Their opinion helps understand and validate current and emerging therapy treatment patterns or MCC market trends.

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 important 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 it sets a clear understanding of the side effects posed by the drug 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 a 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.

Scope of the Report

• The report covers a segment of key events, an executive summary, a descriptive overview of MCC, explaining its causes, signs and symptoms, pathogenesis, and currently available therapies.
• Comprehensive insight has been provided into the epidemiology segments and forecasts, the future growth potential of the diagnosis rate, and disease progression along treatment guidelines.
• Additionally, an all-inclusive account of both the current and emerging therapies, along with the elaborative profiles of late-stage and prominent therapies, will have an impact on the current treatment landscape.
• A detailed review of the MCC 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 in shaping and driving the 7MM MCC market.

Merkel Cell Carcinoma (MCC) Report Insights

• Patient Population
• Therapeutic Approaches
• MCC Pipeline Analysis
• MCC Market Size and Trends
• Existing and future Market Opportunity

Merkel Cell Carcinoma (MCC) Report Key Strengths

• Ten-Years Forecast
• 7MM Coverage
• MCC Epidemiology Segmentation
• Key Cross Competition
• Conjoint analysis
• Drugs Uptake and Key Market Forecast Assumptions

Merkel Cell Carcinoma (MCC) Report Assessment

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

FAQs

• What is the historical and forecasted MCC patient pool/patient burden in the United States, EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan?
• Which combination of treatment approaches will have a significant impact on the MCC drug treatment market size?
• How would the market drivers, barriers, and future opportunities affect the market dynamics and subsequent analysis of the associated trends?
• What are the current and emerging options for the treatment of MCC?
• What are the recent novel therapies, targets, mechanisms of action, and technologies developed to overcome the limitations of existing therapies?
• Patient acceptability in terms of preferred treatment options as per real-world scenarios?
• What are the country-specific accessibility issues of expensive, recently approved therapies?
• How many key players are developing therapies for MCC?
• Which drug is the major contributor MCC market by 2034?

Reasons to buy

• The report will help in developing business strategies by understanding the latest trends and changing treatment dynamics driving the MCC market.
• Insights on patient burden/disease Incidence, 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 conjoint analysis section to provide visibility around leading classes.
• Highlights of access and reimbursement policies of approved 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.