09-04-2025
Merkel Cell Carcinoma Market to Grow Rapidly at a CAGR of 8.7% During the Study Period (2020-2034)
The Merkel cell carcinoma market is poised for steady growth, with a strong 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.
LAS VEGAS, April 9, 2025 /PRNewswire/ -- DelveInsight's Merkel Cell Carcinoma Market Insights report includes a comprehensive understanding of current treatment practices, Merkel cell carcinoma emerging drugs, market share of individual therapies, and current and forecasted market size from 2020 to 2034, segmented into 7MM [the United States, the EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan].
Key Takeaways from the Merkel Cell Carcinoma Market Report
According to DelveInsight's analysis, the market size for Merkel cell carcinoma was found to be USD 411 million in the 7MM in 2023.
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.
According to DelveInsight's estimates, in 2023, there were approximately 9K incident cases of MCC in the 7MM. Of these, the United States accounted for 37% of the cases.
Leading Merkel cell carcinoma companies developing emerging therapies, such as TuHURA Biosciences, Philogen, Immunomic Therapeutics, Phio Pharmaceuticals, AgonOx, Kymera Therapeutics, Merus N.V., and others are developing novel Merkel cell carcinoma drugs that can be available in the Merkel cell carcinoma market in the coming years.
The promising Merkel cell carcinoma therapies in the pipeline include IFx-2.0, NIDLEGY (L19-IL2/L19-TNF), ITI 3000, PH 762, KT 253, MCLA 145, and others.
Discover which therapies are expected to grab the major Merkel cell carcinoma market share @ Merkel Cell Carcinoma Market Report
Merkel Cell Carcinoma Overview
Merkel cell carcinoma (MCC) is a rare and aggressive skin cancer that originates from Merkel cells, which are neuroendocrine cells involved in touch sensation. While its exact causes are not completely understood, several risk factors have been identified, including prolonged exposure to ultraviolet (UV) radiation, advanced age, and a weakened immune system; additionally, infection with the Merkel Cell Polyomavirus (MCPyV) is associated with many cases of MCC.
Clinically, MCC often presents as a rapidly growing, firm, and painless nodule that may appear red, violet, or flesh-colored, typically on sun-exposed areas such as the head, neck, or extremities. Diagnosis usually begins with a detailed physical examination and imaging studies to assess the extent of the lesion, but a definitive diagnosis is made through a biopsy followed by histopathological and immunohistochemical analyses, which help distinguish MCC from other similar skin tumors.
Merkel Cell Carcinoma Epidemiology Segmentation
The Merkel cell carcinoma epidemiology section provides insights into the historical and current Merkel cell carcinoma patient pool and forecasted trends for the 7MM. It helps recognize the causes of current and forecasted patient trends by exploring numerous studies and views of key opinion leaders.
The Merkel cell carcinoma market report proffers epidemiological analysis for the study period 2020–2034 in the 7MM segmented into:
Total Incident Cases of MCC
Gender-specific Incident Cases of MCC
Stage-specific Incident Cases of MCC
Etiology-specific Incident Cases of MCC
Total Metastatic Cases of MCC
Merkel Cell Carcinoma Treatment Market
Treatment for localized Merkel cell carcinoma typically involves surgery and radiation, while advanced cases often require systemic therapies such as immune checkpoint inhibitors like avelumab. Chemotherapy provides limited long-term benefits. Wide local excision is the primary approach for localized MCC, often accompanied by a sentinel lymph node biopsy to assess disease spread. However, in advanced stages, surgery becomes less effective as systemic progression takes over, emphasizing the need for improved treatments due to MCC's rarity and high recurrence risk.
Chemotherapy, once a mainstay for advanced MCC, now plays a diminished role due to its limited long-term efficacy. Agents like etoposide and carboplatin may temporarily shrink tumors, but high relapse rates and significant side effects make them less favorable. Cytotoxic chemotherapy works by damaging DNA or disrupting cell division in rapidly proliferating cells, but while it has shown effectiveness in metastatic MCC, its impact on healthy cells leads to considerable adverse effects.
Currently, several approved therapies focus on immune modulation. Key treatments include BAVENCIO, a monoclonal antibody developed by Merck KGaA; KEYTRUDA (pembrolizumab), a PD-1 inhibitor from Merck; and ZYNYZ (retifanlimab-dlwr), a PD-1 inhibitor co-developed by Incyte Corporation and MacroGenics.
To know more about Merkel cell carcinoma treatment guidelines, visit @ Merkel Cell Carcinoma Management
Merkel Cell Carcinoma Pipeline Therapies and Key Companies
IFx-2.0: TuHURA Biosciences
NIDLEGY (L19-IL2/L19-TNF): Philogen
ITI 3000: Immunomic Therapeutics
PH 762: Phio Pharmaceuticals/AgonOx
KT 253: Kymera Therapeutics
MCLA 145: Merus N.V.
Discover more about Merkel cell carcinoma drugs in development @ Merkel Cell Carcinoma Clinical Trials
Merkel Cell Carcinoma Market Dynamics
The Merkel cell carcinoma market dynamics are expected to change in the coming years. With the increasing awareness and early detection of Merkel cell carcinoma, healthcare providers are now more proactive in diagnosing the disease, which in turn fuels demand for effective, targeted treatments. Recent regulatory approvals of novel therapies, such as checkpoint inhibitors, have not only improved patient outcomes but have also spurred further research and development investments from pharmaceutical companies. Additionally, the high unmet medical need in this niche area, coupled with supportive government policies and funding initiatives, continues to propel the growth and expansion of the Merkel cell carcinoma therapeutic market.
Furthermore, potential therapies are being investigated for the treatment of Merkel cell carcinoma, and it is safe to predict that the treatment space will significantly impact the Merkel cell carcinoma market during the forecast period. Moreover, the anticipated introduction of emerging therapies with improved efficacy and a further improvement in the diagnosis rate are expected to drive the growth of the Merkel cell carcinoma market in the 7MM.
However several factors may impede the growth of the Merkel cell carcinoma market. One major challenge is the rarity of the disease, which limits the availability of clinical trial participants and reduces incentives for pharmaceutical companies to invest in research. Additionally, the high costs of immunotherapies—the primary treatment option—pose affordability issues, leading to restricted patient access, especially in regions with limited healthcare coverage. Regulatory hurdles also slow the approval of novel therapies, as MCC lacks well-established treatment guidelines beyond immunotherapy. Furthermore, low disease awareness among healthcare providers and patients often results in delayed diagnosis, and worsening patient outcomes.
Moreover, Merkel cell carcinoma treatment poses a significant economic burden and disrupts patients' overall well-being and QOL. Furthermore, the Merkel cell carcinoma market growth may be offset by failures and discontinuation of emerging therapies, unaffordable pricing, market access and reimbursement issues, and a shortage of healthcare specialists. In addition, the undiagnosed, unreported cases and the unawareness about the disease may also impact the Merkel cell carcinoma market growth.
Merkel Cell Carcinoma Market Report Metrics
Details
Study Period
2020–2034
Coverage
7MM [the United States, the EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan].
Merkel Cell Carcinoma Market CAGR
8.7 %
Merkel Cell Carcinoma Market Size in 2023
USD 411 Billion
Key Merkel Cell Carcinoma Companies
TuHURA Biosciences, Philogen, Immunomic Therapeutics, Phio Pharmaceuticals, AgonOx, Kymera Therapeutics, Merus N.V., and others
Key Pipeline Merkel Cell Carcinoma Therapies
IFx-2.0, NIDLEGY (L19-IL2/L19-TNF), ITI 3000, PH 762, KT 253, MCLA 145, and others
Scope of the Merkel Cell Carcinoma Market Report
Therapeutic Assessment: Merkel Cell Carcinoma current marketed and emerging therapies
Merkel Cell Carcinoma Market Dynamics: Key Market Forecast Assumptions of Emerging Merkel Cell Carcinoma Drugs and Market Outlook
Competitive Intelligence Analysis: SWOT analysis and Market entry strategies
Unmet Needs, KOL's views, Analyst's views, Merkel Cell Carcinoma Market Access and Reimbursement
Download the report to understand which factors are driving Merkel cell carcinoma market trends @ Merkel Cell Carcinoma Market Trends
Table of Contents
1
Key Insights
2
Report Introduction
3
MCC Market Overview at a Glance
3.1
Market Share (%) Distribution of MCC by Therapies in the 7MM in 2020
3.2
Market Share (%) Distribution of MCC by Therapies in the 7MM in 2034
4
Executive Summary
5
Key Events
6
Disease Background and Overview
6.1
Introduction
6.2
Anatomy
6.3
Histology of MCC
6.4
Signs and Symptoms
6.5
Risk Factors
6.6
Types of MCC
6.7
Pathophysiology of MCC
6.8
Staging of MCC
6.9
Diagnosis
6.9.1
Differential Diagnosis of MCC
6.9.2
Diagnostic Algorithm
6.9.3
Diagnostic Guidelines and Recommendations for MCC
6.10
Treatment
6.10.1
Follow-up and Recurrence
6.10.2
Treatment Algorithm
6.10.3
Treatment Guidelines and Recommendations for MCC
7
Epidemiology and Market Methodology
8
Epidemiology and Patient Population
8.1
Key Findings
8.2
Assumptions and Rationale: 7MM
8.2.1
Total Incident Cases of MCC
8.2.2
Gender-specific Incident Cases of MCC
8.2.3
Stage-specific Incident Cases of MCC
8.2.4
Etiology-specific Incident Cases of MCC
8.2.5
Progression Rate of MCC
8.3
Total Incident Cases of MCC in the 7MM
8.4
The United States
8.4.1
Total Incident Cases of MCC in the US
8.4.2
Gender-specific Incident Cases of MCC in the US
8.4.3
Stage-specific Incident Cases of MCC in the US
8.4.4
Etiology-specific Incident Cases of MCC in the US
8.4.5
Total Metastatic Cases of MCC in the US
8.5
EU4 and the UK
8.5.1
Total Incident Cases of MCC in EU4 and the UK
8.5.2
Gender-specific Incident Cases of MCC in EU4 and the UK
8.5.3
Stage-specific Incident Cases of MCC in EU4 and the UK
8.5.4
Etiology-specific Incident Cases of MCC in EU4 and the UK
8.5.5
Total Metastatic Cases of MCC in EU4 and the UK
8.6
Japan
8.6.1
Total Incident Cases of MCC in Japan
8.6.2
Gender-specific Incident Cases of MCC in Japan
8.6.3
Stage-specific Incident Cases of MCC in Japan
8.6.4
Etiology-specific Incident Cases of MCC in Japan
8.6.5
Total Metastatic Cases of MCC in Japan
9
Patient Journey
10
Marketed Therapies
10.1
Key Cross Competition
10.2
BAVENCIO (avelumab): Merck KGaA (EMD Serono)
10.2.1
Product Description
10.2.2
Regulatory Milestone
10.2.3
Other Developmental Activities
10.2.4
Clinical Trials Information
10.2.5
Safety and Efficacy
10.3
ZYNYZ (retifanlimab-dlwr): Incyte Corporation/MacroGenics
10.3.1
Product Description
10.3.2
Regulatory Milestone
10.3.3
Other Developmental Activities
10.3.4
Clinical Trials Information
10.3.5
Safety and Efficacy
10.4
KEYTRUDA (pembrolizumab): Merck
10.4.1
Product Description
10.4.2
Regulatory Milestone
10.4.3
Other Developmental Activities
10.4.4
Clinical Trials Information
10.4.5
Safety and Efficacy
To be continued in the report...
11
Emerging Drug Profiles
11.1
Key Cross Competition of Emerging Drugs
11.2
IFx-2.0: TuHURA Biosciences
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
Analysts' View
11.3
NIDLEGY (L19-IL2/L19-TNF): Philogen
11.3.1
Drug Description
11.3.2
Other Developmental Activities
11.3.3
Clinical Trials Information
11.3.4
Analysts' View
11.4
ITI 3000: Immunomic Therapeutics
11.4.1
Drug Description
11.4.2
Other Developmental Activities
11.4.3
Clinical Trials Information
11.4.4
Safety and Efficacy
11.4.5
Analysts' View
11.5
PH 762: Phio Pharmaceuticals/AgonOx
11.5.1
Drug Description
11.5.2
Other Developmental Activities
11.5.3
Clinical Trials Information
11.5.4
Safety and Efficacy
11.5.5
Analysts' View
11.6
KT 253: Kymera Therapeutics
11.6.1
Drug Description
11.6.2
Other Developmental Activities
11.6.3
Clinical Trials Information
11.6.4
Safety and Efficacy
11.6.5
Analysts' View
11.7
MCLA 145: Merus N.V.
11.7.1
Drug Description
11.7.2
Other Developmental Activities
11.7.3
Clinical Trials Information
11.7.4
Safety and Efficacy
11.7.5
Analysts' View
To be continued in the report...
12
MCC: Market Analysis
12.1
Key Findings
12.2
Key Market Forecast Assumptions
12.2.1
Cost Assumptions and Rebates
12.2.2
Pricing Trends
12.2.3
Analogue Assessment
12.2.4
Launch Year and Therapy Uptake
12.3
Market Outlook
12.4
Total Market Size of MCC in the 7MM
12.5
Market Size of MCC by Therapies in the 7MM
12.6
Market Size of MCC in the United States
12.6.1
Total Market of MCC
12.6.2
Market Size of MCC by Therapies in the United States
12.7
Market Size of MCC in EU4 and the UK
12.7.1
Total Market Size of MCC
12.7.2
Market Size of MCC by Therapies in EU4 and the UK
12.8
Market Size of MCC in Japan
12.8.1
Total Market Size of MCC
12.8.2
Market Size of MCC by Therapies in Japan
13
Key Opinion Leaders' Views
14
Unmet Needs
15
SWOT Analysis
16
Market Access and Reimbursement
16.1
The United States
16.1.1
Center for Medicare and Medicaid Services (CMS)
16.2
In EU4 and the UK
16.2.1
Germany
16.2.2
France
16.2.3
Italy
16.2.4
Spain
16.2.5
The United Kingdom
16.3
Japan
16.3.1
MHLW
17
Appendix
17.1
Acronyms and Abbreviations
17.2
Bibliography
17.3
Report Methodology
18
DelveInsight Capabilities
19
Disclaimer
20
About DelveInsight
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