Merkel Cell Carcinoma Market

Therapies such as Pembrolizumab (MK-3475), ITI-3000, Retifanlimab, KRT-232, Nivolumab, Avelumab, Atezolizumab, and others are expected to drive growth in the Merkel Cell Carcinoma market in the coming years.

DelveInsight has published a detailed report titled “Merkel Cell Carcinoma – Market Insights, Epidemiology, and Market Forecast-2034,” providing an in-depth analysis of historical and projected epidemiology, as well as market trends for Merkel Cell Carcinoma across the United States, EU5 (Germany, Spain, Italy, France, and the United Kingdom), and Japan.

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Some of the key facts of the Merkel Cell Carcinoma Market Report:

• The Merkel Cell Carcinoma (MCC) market is projected to see steady growth, with a compound annual growth rate (CAGR) anticipated from 2024 to 2034. Expansion across the seven major markets (7MM) will be driven by the development of novel therapies, including IFx-2.0, NIDLEGY, and ITI-3000.

• In June 2025, the FDA lifted a manufacturing-related partial clinical hold on TuHURA Biosciences’ IFx-2.0 Phase III trial (NCT06947928) for advanced or metastatic MCC. This decision allows the activation of clinical sites and the enrollment of approximately 118 patients in the U.S., comparing IFx-2.0 plus pembrolizumab with pembrolizumab alone.

• According to DelveInsight, in 2023 there were approximately 9,000 new MCC cases across the 7MM. The United States accounted for about 37% of cases, the EU4 and UK for roughly 61%, and Japan for around 2%.

• The MCC treatment market in the 7MM was valued at approximately USD 411 million in 2023 and is expected to grow at a CAGR of 8.7% between 2024 and 2034. Key players in this space include Merck KGaA, Incyte Corporation/MacroGenics, and Merck & Co. Prominent approved therapies include BAVENCIO (US, EU4, UK, Japan), ZYNYZ (US, EU4, UK), and KEYTRUDA (US).

• In 2023, the United States reported the highest number of new MCC cases, around 3,000, with projections suggesting a 5% CAGR through 2034. Within the EU4 and UK, Germany had the highest incidence (~1,700 cases), followed by France (~1,300 cases), while Spain reported the fewest (~600 cases).

• Treating MCC in elderly patients presents challenges due to comorbidities, which can limit therapeutic effectiveness and negatively affect outcomes.

• Promising therapies in development include Pembrolizumab (MK-3475), ITI-3000, Retifanlimab, KRT-232, Nivolumab, Avelumab, Atezolizumab, and others, offering potential for improved outcomes in this rare and aggressive cancer.

Merkel Cell Carcinoma Overview

Merkel Cell Carcinoma (MCC) is a rare and highly aggressive neuroendocrine skin cancer originating from Merkel cells, which are specialized touch-sensitive cells located at the dermo-epidermal junction. Its rapid growth and early metastatic potential make MCC one of the most lethal forms of skin cancer, underscoring the dual role of Merkel cells in sensory function and tumor development.

MCC is classified according to the presence of Merkel Cell Polyomavirus (MCPyV). Virus-positive MCC occurs when MCPyV DNA integrates into the host genome, driving tumor formation through viral oncoproteins. These tumors usually have a lower mutation burden and respond better to immunotherapy. In contrast, virus-negative MCC is primarily caused by ultraviolet (UV) radiation, exhibits a higher mutation rate, is more aggressive, and generally has poorer clinical outcomes.

Sun exposure is a major risk factor, especially in older adults and immunocompromised individuals, including organ transplant recipients and patients with chronic lymphocytic leukemia (CLL) or HIV. MCC most commonly appears on sun-exposed areas, such as the head and neck.

The two main subtypes of MCC are:

• MCPyV-positive: driven by viral oncoproteins that interfere with tumor suppressors such as RB1 and p53.

• MCPyV-negative: associated with UV-induced DNA damage and a high mutational burden.

Merkel Cell Carcinoma Market Outlook

Merkel Cell Carcinoma (MCC) is a highly aggressive cancer characterized by rapid tumor growth, a strong tendency to metastasize, and poor prognosis, particularly in advanced stages. Treatment strategies depend on disease stage and patient-specific factors. For localized MCC, surgery combined with radiation remains the standard approach, whereas systemic therapies, especially immunotherapy, have substantially improved outcomes in advanced cases.

Localized MCC is typically treated with wide local excision, often alongside radiation therapy, and a sentinel lymph node biopsy is commonly performed to evaluate regional spread. In later stages, surgery is less effective due to widespread disease, highlighting the need for more effective treatments, especially given MCC’s rarity and high recurrence rate.

Immune checkpoint inhibitors have transformed the management of advanced MCC. FDA-approved therapies such as Avelumab (BAVENCIO), Pembrolizumab (KEYTRUDA), and Retifanlimab-dlwr (ZYNYZ) target PD-1 or PD-L1 pathways, enhancing the immune system’s ability to attack cancer cells.

By contrast, chemotherapy, which previously played a central role in metastatic MCC, now has a limited function. Drugs like etoposide and carboplatin can provide temporary tumor shrinkage but offer minimal long-term benefit. Their non-selective cytotoxic effects damage healthy tissues, contributing to high relapse rates and significant side effects, which restrict their sustained effectiveness in MCC treatment.

Merkel Cell Carcinoma Market Insights

The standard treatment for Merkel Cell Carcinoma usually starts with surgery, often followed by radiation or chemotherapy, particularly when the tumor does not respond adequately to surgery alone. For advanced or metastatic cases, immunotherapy, especially PD-1/PD-L1 inhibitors, is employed to boost the immune system’s ability to combat the cancer.

Several innovative therapies are currently in development for Merkel Cell Carcinoma. These include:

IFx-2.0, developed by TuHURA Biosciences, which activates the immune system to target cancer cells. A Phase III trial in combination with KEYTRUDA is planned for 2025 to treat advanced cases.

NIDLEGY, a combination of L19-IL2 and L19-TNF developed by Philogen, enhances immune activity while directly targeting tumor tissues, showing promise as a targeted immunotherapy for Merkel Cell Carcinoma.

MCLA-145, a next-generation T-cell agonist that targets both PD-L1 and CD137, is designed to strengthen immune responses against tumors and is currently being tested in Phase I trials alongside pembrolizumab.

Discover how the Merkel Cell Carcinoma market is rising in the coming years @ https://www.delveinsight.com/sample-request/merkel-cell-carcinoma-market?utm_source=abnewswire&utm_medium=market&utm_campaign=kpr

Marketed Merkel Cell Carcinoma Drugs

• BAVENCIO (avelumab): Merck KGaA

• ZYNYZ (retifanlimab-dlwr): Incyte Corporation/MacroGenics

• KEYTRUDA (pembrolizumab): Merck

Merkel Cell Carcinoma Emerging Drugs

• IFx-2.0: TuHURA Biosciences

• NIDLEGY (L19-IL2/L19-TNF): Philogen

• MCLA 145: Merus N.V.

Scope of the Merkel Cell Carcinoma Market Report

• Study Period: 2020-2034

• Coverage: 7MM [The United States, EU5 (Germany, France, Italy, Spain, and the United Kingdom), and Japan]

• Key Merkel Cell Carcinoma Companies: Amgen Inc., Pfizer Inc., BeiGene, OncoSec Medical Incorporated, Immune Design, Merck Sharp & Dohme LLC, Immunomic Therapeutics, Inc., Incyte Corporation, Kartos Therapeutics, Inc., Bristol-Myers Squibb, Memorial Sloan Kettering Cancer Center, Immune Oncology, and others

• Merkel Cell Carcinoma Therapies: Pembrolizumab (MK-3475), ITI-3000, Retifanlimab, KRT-232, Nivolumab, Avelumab, atezolizumab,, and others.

• Merkel Cell Carcinoma Therapeutic Assessment: Merkel Cell Carcinoma current marketed and Merkel Cell Carcinoma emerging therapies

• Merkel Cell Carcinoma Market Dynamics: Merkel Cell Carcinoma market drivers and Merkel Cell Carcinoma market barriers

• Competitive Intelligence Analysis: SWOT analysis, PESTLE analysis, Porter’s five forces, BCG Matrix, Market entry strategies

• Merkel Cell Carcinoma Unmet Needs, KOL’s views, Analyst’s views, Merkel Cell Carcinoma Market Access and Reimbursement

To know what’s more in our Merkel Cell Carcinoma report, visit https://www.delveinsight.com/report-store/merkel-cell-carcinoma-market?utm_source=abnewswire&utm_medium=market&utm_campaign=kpr

Key benefits of the Merkel Cell Carcinoma Market Report:

1. The Merkel Cell Carcinoma market report covers a descriptive overview and comprehensive insight of the Merkel Cell Carcinoma Epidemiology and Merkel Cell Carcinoma market in the 7MM (the United States, EU5 (Germany, Spain, France, Italy, UK) & Japan).

2. The Merkel Cell Carcinoma market report provides insights into the current and emerging therapies.

3. The Merkel Cell Carcinoma market report provides a global historical and forecasted market covering drug outreach in 7MM.

4. The Merkel Cell Carcinoma market report offers an edge that will help in developing business strategies by understanding trends shaping and driving the Merkel Cell Carcinoma market.

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Table of Contents

1. Report Introduction

2. Executive Summary

3. SWOT analysis

4. Merkel Cell Carcinoma Patient Share (%) Overview at a Glance

5. Merkel Cell Carcinoma Market Overview at a Glance

6. Merkel Cell Carcinoma Disease Background and Overview

7. Merkel Cell Carcinoma Epidemiology and Patient Population

8. Country-Specific Patient Population of Merkel Cell Carcinoma

9. Merkel Cell Carcinoma Current Treatment and Medical Practices

10. Unmet Needs

11. Merkel Cell Carcinoma Emerging Therapies

12. Merkel Cell Carcinoma Market Outlook

13. Country-Wise Merkel Cell Carcinoma Market Analysis (2020–2034)

14. Market Access and Reimbursement of Therapies

15. Market drivers

16. Market barriers

17. Appendix

18. Merkel Cell Carcinoma Report Methodology

19. DelveInsight Capabilities

20. Disclaimer

21. About DelveInsight

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Related Reports:

Merkel Cell Carcinoma Pipeline Insights, DelveInsight

“Merkel Cell Carcinoma Pipeline Insight, 2024” report by DelveInsight outlines comprehensive insights of present clinical development scenarios and growth prospects across the Merkel Cell Carcinoma market. A detailed picture of the Merkel Cell Carcinoma pipeline landscape is provided, which includes the disease overview and Merkel Cell Carcinoma treatment guidelines.

About DelveInsight

DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports Pharma companies by providing comprehensive end-to-end solutions to improve their performance.

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