Merkel Cell Carcinoma - Market Insight, Epidemiology, and Market Forecast - 2034

Key Highlights:

• According to DelveInsight's estimates, in 2023, there were approximately 9 thousand incident cases of MCC in the 7MM. Of these, the United States accounted for 37% of the cases, while EU4 and the UK accounted for nearly 61% and Japan represented 2% of the cases, respectively.
• The MCC market is poised for steady growth, with a strong compound annual growth rate (CAGR) projected from 2024 to 2034. This expansion across the 7MM will be driven by the launch of innovative therapies, including IFx-2.0, NIDLEGY and ITI-3000.
• According to DelveInsight's analysis, the market size of MCC in the 7MM was valued at approximately USD 411 million in 2023. Over the forecast period from 2024 to 2034, this market is projected to grow at a CAGR of 8.7%.
• Merck KGaA, Incyte Corporation/MacroGenics, and Merck & Co. are leading players in the MCC market, offering approved treatments such as BAVENCIO (available in the US, EU4, the UK, and Japan), ZYNYZ (in the US, EU4, and the UK), and KEYTRUDA (in the US).
• The elderly population, often with comorbidities, faces challenges in MCC treatment, as these conditions reduce treatment effectiveness and outcome.

DelveInsight's "Merkel Cell Carcinoma (MCC) - Market Insights, Epidemiology, and Market Forecast - 2034" report delivers an in-depth understanding of MCC, historical and forecasted epidemiology, as well as the MCC market trends in the United States, EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan.

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

Merkel Cell Carcinoma (MCC) Understanding and Treatment Algorithm

Merkel Cell Carcinoma (MCC) Overview

MCC is a rare, aggressive neuroendocrine skin cancer arising from Merkel cells, specialized mechanoreceptors at the dermo-epidermal junction involved in touch sensation. Known for rapid growth and early metastasis, MCC's high malignancy makes it one of the deadliest skin cancers, emphasizing the dual role of Merkel cells in sensory function and cancer.

MCC is categorized by MCPyV involvement: virus-positive MCC arises from viral DNA integration, driving tumor growth with fewer mutations but better immune therapy response. Virus-negative MCC, caused by UV radiation, exhibits higher mutational burden and greater aggressiveness.

Sun exposure is a major risk factor for MCC, commonly affecting sun-exposed areas in older adults and immunocompromised individuals, including organ transplant recipients and those with CLL or HIV. While MCPyV is present in most cases, virus-negative MCC, often on the head or trunk, shows higher mutation rates and poorer outcomes.

MCC has two subtypes: MCPyV?, driven by viral oncoproteins disrupting RB1 and p53, and MCPyV?, linked to UV-induced mutations.

Merkel Cell Carcinoma (MCC) Diagnosis

Diagnosing MCC involves biopsy, histopathological analysis, imaging, and molecular testing. Detecting MCPyV is essential, as its presence can help confirm the diagnosis and guide treatment decisions. These steps ensure accurate identification and appropriate management of the condition.

Merkel Cell Carcinoma (MCC) Treatment

MCC treatment includes standard options like surgery, radiation, chemotherapy, and immunotherapy. Surgery often involves wide excision and lymph node dissection. Radiation targets cancer cells, while chemotherapy is used for advanced cases. Immunotherapy, including PD-1/PD-L1 and CTLA-4 inhibitors, enhances immune responses and is under investigation for advanced MCC.

Merkel Cell Carcinoma (MCC) Epidemiology

As the market is derived using a patient-based model, the MCC epidemiology chapter in the report provides historical as well as forecasted epidemiology segmented by Total Incident Cases of MCC, Gender-specific Incident Cases of MCC, Stage-specific Incident Cases of MCC, Etiology-specific Incident Cases of MCC, and Total Metastatic Cases of MCC in the 7MM covering the United States, EU4 countries (Germany, France, Italy, and Spain), the United Kingdom, and Japan from 2020 to 2034.

• In 2023, the US accounted for the highest incident cases of MCC with approximately 3 thousand cases, which are expected to increase by 2034 at a CAGR of 5%.
• In 2023, Germany reported the highest number of incident MCC cases among the EU4 and the UK, with approximately 1,700 cases. France followed with nearly 1,300 cases, while Spain recorded the lowest number of incident cases, at nearly 600.
• In 2023, Japan reported approximately 90 incident cases of MCC in males and 140 cases in females, with numbers projected to rise by 2034.
• In 2023, males accounted for 51% of MCC cases in the EU4 and the UK, while females represented 49%. These gender-specific patterns are expected to persist, with overall incidence projected to increase by 2034.
• In the EU4 and the UK, approximately 80% of MCC cases reported in 2023 were associated with MCPyV, while 20% were linked to UV damage, indicating that MCPyV is the primary causative factor.
• In 2023, Germany documented approximately 700 cases of Stage I MCC, nearly 200 cases of Stage II, 600 cases of Stage III, and 140 cases of Stage IV MCC. These numbers are expected to increase by 2034.

Merkel Cell Carcinoma (MCC) Drug Chapters

The drug chapter segment of the MCC report encloses a detailed analysis of MCC marketed drugs and mid to late-stage (Phase III and Phase II) pipeline drugs. It also helps understand the MCC clinical trial details, expressive pharmacological action, agreements and collaborations and approval, advantages and disadvantages of each included drug, and the latest news and press releases.

Marketed Drugs

BAVENCIO (avelumab): Merck KGaA

BAVENCIO is a human monoclonal antibody that targets PD-L1, administered intravenously. It works by binding to PD-L1, preventing tumor cells from using this protein to evade immune detection, thus enhancing the immune system's ability to attack and eliminate cancer cells. BAVENCIO also induces antibody-dependent cell-mediated cytotoxicity (ADCC) in lab studies. Its significant antitumor effects led to its approval as a first-line treatment for metastatic MCC. It is approved in the US, Europe, and Japan for this indication.

ZYNYZ (retifanlimab-dlwr): Incyte Corporation/MacroGenics

ZYNYZ (retifanlimab-dlwr) is a sterile, preservative-free solution for IV use, appearing as a clear to slightly opalescent, colorless to pale yellow liquid. It is a PD-1-blocking antibody approved under accelerated approval in the US for treating adult patients with metastatic or recurrent locally advanced MCC, based on tumor response rate and duration.

ZYNYZ is approved in both the US and Europe and has received Orphan Drug Designation (ODD) and Fast Track Designation (FTD).

KEYTRUDA (pembrolizumab): Merck

KEYTRUDA (pembrolizumab) is an anti-PD-1 therapy that boosts the immune system's ability to fight tumor cells. As a humanized monoclonal antibody, it blocks PD-1's interaction with PD-L1 and PD-L2, activating T lymphocytes. It is supplied as a sterile, preservative-free IV solution. KEYTRUDA was approved based on the CITN-09/KEYNOTE-017 and KEYNOTE-913 studies and is approved in the US, with ODD and Breakthrough Therapy Designation (BTD).

Emerging Drugs

IFx-2.0: TuHURA Biosciences

IFx-2.0, developed by TuHURA Biosciences, activates the innate immune system to target tumors by injecting plasmid DNA encoding a bacterial protein into the cancer, making it appear as a foreign pathogen. TuHURA plans a Phase III trial combining IFx-2.0 with KEYTRUDA for first-line treatment of advanced MCC, starting in 2025 under an SPA agreement with the FDA.

NIDLEGY (L19-IL2/L19-TNF): Philogen

NIDLEGY, developed by Philogen, combines L19-IL2 and L19-TNF to target the Fibronectin B domain, found in tumors but rarely in healthy tissue. L19-IL2 enhances immune activation, while L19-TNF aids in tumor destruction. This dual approach shows promise for treating MCC with fewer side effects and is currently in Phase II for patients with unresectable or metastatic MCC.

MCLA 145: Merus N.V.

MCLA-145 is a novel Biclonics T-cell agonist targeting both PD-L1 and CD137, showing potential for treating MCC. In preclinical models, it attracts T cells into tumors, activates immune cells, and blocks inhibitory signals, enhancing immune response. A Phase I study tested MCLA-145 alone and with pembrolizumab in advanced or metastatic cancers, including MCC, highlighting its potential in future trials.

Drug Class Insights

MCC treatment primarily involves surgery as the first-line therapy, often combined with radiation or chemotherapy for patients who do not respond adequately. Immunotherapy, such as PD-1/PD-L1 inhibitors, may also be used for advanced or metastatic cases to enhance the immune response against the tumor.

Emerging therapies include IFx-2.0, NIDLEGY (L19-IL2/L19-TNF), and MCLA 145.

IFx-2.0, developed by TuHURA Biosciences, activates the immune system to target tumors. A Phase III trial with KEYTRUDA for advanced MCC is set for 2025.

NIDLEGY, by Philogen, combines L19-IL2 and L19-TNF to target tumors, boosting immune activation and promoting tumor destruction, showing promise as a targeted therapy for MCC.

MCLA-145 is a novel T-cell agonist targeting PD-L1 and CD137, showing potential for MCC by boosting immune response. It is being tested in Phase I trials with pembrolizumab.

Market Outlook

MCC is characterized by rapid growth, high metastatic potential, and poor survival, especially in advanced stages. Treatment strategies depend on disease stage and individual factors. Surgery and radiation remain essential for localized MCC, while systemic therapies, particularly immunotherapy, have transformed the approach to advanced MCC, improving patient outcomes in these cases.

Treatment for localized MCC typically involves surgery and radiation, while advanced cases often require systemic therapies like immune checkpoint inhibitors (e.g., avelumab). Chemotherapy offers limited long-term benefits. Surgery, particularly wide local excision, is the primary treatment for localized MCC, with sentinel lymph node biopsy to detect spread. In advanced stages, surgery becomes less effective, as systemic disease dominates, highlighting the need for more effective therapies due to the disease's rarity and high recurrence rate.

Chemotherapy, once a key treatment for advanced MCC, now plays a reduced role due to limited long-term effectiveness. Drugs like etoposide and carboplatin may shrink tumors temporarily, but relapse rates and severe side effects make them less preferred. Cytotoxic chemotherapy targets rapidly dividing cells by damaging DNA or disrupting cell division, and while it has been effective for metastatic MCC, it often leads to significant side effects by affecting normal cells.

Some drugs are currently approved and available for the treatment of MCC, reflecting the focus on immune modulation therapies. Key options include BAVENCIO, a monoclonal antibody developed by Merck KGaA, KEYTRUDA (pembrolizumab), a PD-1 inhibitors offered by Merck and ZYNYZ (retifanlimab-dlwr), PD-1 inhibitors co-developed by Incyte Corporation and MacroGenics.

There is a pressing demand for improved treatment options for MCC, as existing therapies frequently fall short in effectively controlling the disease. Advancements in drug development hold the potential to provide more robust solutions, enhancing outcomes for patients battling this rare and aggressive cancer. Notable candidates in development include IFx-2.0, NIDLEGY (L19-IL2/L19-TNF), and ITI-3000, among others, which show promise in addressing these unmet needs.

• In 2023, the MCC market size in the US was approximately USD 180 million, representing 44% of the total market. This figure is expected to grow significantly with the introduction of emerging therapies.
• The total market size of the EU4 and the UK was estimated at approximately USD 220 million in 2023, accounting for nearly 54% of the total market revenue for the 7MM.
• Among the EU4 and the UK, Germany held the largest market share with approximately USD 65 million in 2023, followed by France with approximately USD 50 million, while Spain captured the smallest market share with nearly USD 20 million in the same year.
• In 2023, the total MCC market size in Japan was approximately USD 9 million, and this figure is anticipated to increase during the forecast period (2024-2034).
• According to estimates, among the currently marketed drugs, BAVENCIO (avelumab) as first line therapy held the largest market share, generating approximately USD 290 million in revenue across the 7MM in 2023.

Merkel Cell Carcinoma (MCC) Drugs Uptake

This section focuses on the uptake rate of potential drugs expected to be launched in the market during 2020-2034.

Merkel Cell Carcinoma (MCC) Pipeline Development Activities

The report provides insights into different therapeutic candidates in Phase III, Phase II, and Phase I. 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 emerging therapies for MCC.

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 MCC 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, Medical Professionals, Professors, Directors, and Others.

DelveInsight's analysts connected with 50+ KOLs to gather insights; however, interviews were conducted with 15+ KOLs in the 7MM. Centers like the Johns Hopkins University, the US, Columbia University Irving Medical Center, the US, National Cancer Institute, the US, University of Duisburg-Essen, Germany, University of Montpellier, France, University of L'Aquila, Italy, Universidad de Malaga, Spain, the University of Manchester, the UK, Saga University, Japan, among others, were contacted. Their opinion helps understand and validate current and emerging therapy treatment patterns or MCC market trends. This will support the clients in potential upcoming novel treatments by identifying the overall scenario of the market and the unmet needs.

Physician's View

As per the KOLs from the US, MCC is challenging to diagnose due to its rarity, unclear origin, and similarity to other skin lesions. The introduction of electron microscopy and immunohistochemical techniques, including neuron-specific enolase and cytokeratin 20 markers, has significantly improved diagnosis, making it possible to identify MCC more accurately.

As per the KOLs from Germany, The risk factors for MCC include older age, immunosuppression, pre-existing blood cancers, chronic UV exposure, and a history of other skin tumors. MCC can develop through two main mechanisms: virus-associated etiology, where the MCPyV integrates into the cells, and virus-negative etiology, which is driven by UV-induced DNA mutations and damage. Both pathways highlight the importance of understanding the underlying causes to improve prevention and treatment strategies.

As per the KOLs from Japan, The discovery of MCPyV has significantly advanced our understanding of MCC pathogenesis. Following MCPyV infection and genome integration into MCC cells, these tumor cells undergo clonal expansion. This suggests that MCPyV acts as a pathogen, not just a passenger virus, playing a key role in MCC development.

Qualitative Analysis

We perform Qualitative and market Intelligence analysis using various approaches, such as SWOT and Conjoint Analysis. In the SWOT analysis, strengths, weaknesses, opportunities, and threats in terms of disease diagnosis, patient awareness, patient burden, competitive landscape, cost-effectiveness, and geographical accessibility of therapies are provided. These pointers are based on the Analyst's discretion and assessment of the patient burden, cost analysis, and existing and evolving treatment landscape.

Conjoint Analysis analyzes multiple 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.

To analyze the effectiveness of these therapies, have calculated their attributed analysis by giving them scores based on their ability to improve atrial and ventricular dimension/function and ability to regulate heart rate.

Further, the therapies' safety is evaluated wherein the adverse events are majorly observed, and it sets a clear understanding of the side effects posed by the drug in the trials, which directly affects the safety of the molecule in the upcoming trials. 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 route of administration, order of entry and designation, 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

The Merck Access Program KEYTRUDA

KEYTRUDA is approved for treating recurrent, locally advanced, or metastatic MCC in both adults and pediatric patients. The list price is USD 11,564 for a 200 mg dose every 3 weeks and USD 23,138 for a 400 mg dose every 6 weeks. Out-of-pocket costs vary based on insurance coverage, with 59% of patients paying no costs for a 200 mg dose. Additional costs, such as medication and infusion fees, are not included. Patients should consult their insurance provider for precise cost estimates.

The report provides detailed insights on the country-wise accessibility and reimbursement scenarios, cost-effectiveness scenarios, 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, and a descriptive overview of Merkel Cell Carcinoma (MCC), explaining its causes, signs and symptoms, pathogenesis, and currently available therapies.
• Comprehensive insight into the epidemiology segments and forecasts, the future growth potential of diagnosis rate, disease progression, and treatment guidelines have been provided.
• Additionally, an all-inclusive account of the current and emerging therapies and the elaborative profiles of late-stage and prominent therapies will impact the current treatment landscape.
• A detailed review of the Merkel Cell Carcinoma (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 shape and drive the 7MM Merkel Cell Carcinoma (MCC).

Merkel Cell Carcinoma (MCC) report insights

• Patient Population
• Therapeutic Approaches
• Merkel Cell Carcinoma (MCC) Pipeline Analysis
• Merkel Cell Carcinoma (MCC) Market Size and Trends
• Existing and Future Market Opportunity

Merkel Cell Carcinoma (MCC) report key strengths

• 11 years Forecast
• The 7MM Coverage
• Merkel Cell Carcinoma (MCC) Epidemiology Segmentation
• Key Cross Competition
• Attribute 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 Attribute Analysis)

Key Questions:

Market Insights

• What was the total market size of Merkel Cell Carcinoma (MCC), the market size of Merkel Cell Carcinoma (MCC) by therapies, and market share (%) distribution in 2020, and what would it look like by 2034? What are the contributing factors for this growth?
• How will IFx-2.0 affect the treatment paradigm of Merkel Cell Carcinoma (MCC)?
• How will BAVENCIO compete with other upcoming products and marketed therapies?
• Which drug is going to be the largest contributor by 2034?
• What are the pricing variations among different geographies for approved and marketed therapies?
• How would future opportunities affect the market dynamics and subsequent analysis of the associated trends?

Epidemiology Insights

• What are the disease risks, burdens, and unmet needs of Merkel Cell Carcinoma (MCC)? What will be the growth opportunities across the 7MM with respect to the patient population pertaining to Merkel Cell Carcinoma (MCC)?
• What is the historical and forecasted Merkel Cell Carcinoma (MCC) patient pool in the United States, EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan?
• Out of the countries mentioned above, which country would have the highest incident cases of Merkel Cell Carcinoma (MCC) population during the forecast period (2024-2034)?
• What factors are contributing to the growth of Merkel Cell Carcinoma (MCC) cases?

Current Treatment Scenario, Marketed Drugs, and Emerging Therapies

• What are the current options for the treatment of Merkel Cell Carcinoma (MCC)? What are the current clinical and treatment guidelines for treating Merkel Cell Carcinoma (MCC)?
• How many companies are developing therapies for the treatment of Merkel Cell Carcinoma (MCC)?
• How many emerging therapies are in the mid-stage and late stage of development for treating Merkel Cell Carcinoma (MCC)?
• What are the recent novel therapies, targets, mechanisms of action, and technologies developed to overcome the limitations of existing therapies?
• What is the cost burden of current treatment on the patient?
• Patient acceptability in terms of preferred treatment options as per real-world scenarios?
• What are the accessibility issues of approved therapy in the US?
• What is the 7MM historical and forecasted market of Merkel Cell Carcinoma (MCC)?

Reasons to Buy:

• The report will help develop business strategies by understanding the latest trends and changing treatment dynamics driving the Merkel Cell Carcinoma (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.
• The distribution of historical and current patient share is based on real-world prescription data in the US, EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan.
• Identifying upcoming solid 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 for Merkel Cell Carcinoma (MCC), barriers to accessibility of approved therapy, 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.