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										 메르켈 세포암(MCC) : 시장 인사이트, 역학, 시장 예측(2034년)Merkel Cell Carcinoma - Market Insight, Epidemiology, and Market Forecast - 2034 | ||||||
 DelveInsight
 
							DelveInsight
						
MCC는 빠른 증식, 높은 전이성, 낮은 생존율, 특히 진행 단계에서 특징이 있습니다. 치료 전략은 병기 및 개별 요인에 따라 달라집니다. 국소 MCC의 경우 수술과 방사선 치료가 여전히 필수적이지만, 전신 요법, 특히 면역 요법은 진행성 MCC에 대한 접근 방식을 바꾸어 놓았으며, 이러한 경우 환자의 예후를 개선하고 있습니다.
국소 MCC의 치료는 일반적으로 수술과 방사선 치료를 시행하지만, 진행성 MCC의 경우 면역관문억제제(예: 아벨루맙)와 같은 전신 요법이 필요한 경우가 많습니다. 화학요법의 장기적인 효과는 제한적입니다. 수술, 특히 광범위한 국소 절제술이 국소형 MCC의 주요 치료법이며, 전이 여부를 확인하기 위해 감시 림프절 생검을 시행합니다. 진행 단계에서는 전신 병변이 지배적이기 때문에 수술은 더 이상 효과적이지 않으며, 이 질환의 희귀성과 높은 재발률로 인해 더 효과적인 치료법의 필요성이 강조됩니다.
화학요법은 한때 진행성 MCC에 대한 중요한 치료법이었으나 장기적인 효과가 제한적이어서 그 역할이 축소되고 있으며, etoposide와 carboplatin과 같은 약물은 일시적으로 종양을 축소시키지만 재발률과 심각한 부작용으로 인해 선호도가 낮습니다. 선호되지 않습니다. 세포독성 화학요법은 DNA를 손상시키거나 세포분열을 억제하여 빠르게 분열하는 세포를 표적으로 삼는 것으로 전이성 MCC에 효과적이지만, 정상 세포에 영향을 미쳐 심각한 부작용을 유발하는 경우가 많습니다.
면역조절요법에 초점을 맞추고 있는 것을 반영하듯, 현재 MCC의 치료제로 승인되어 사용 가능한 약물이 있습니다. 주요 옵션으로는 Merck KGaA가 개발한 모노클로널 항체 BAVENCIO, Merck가 제공하는 PD-1 억제제 KEYTRUDA(pembrolizumab), Incyte Corporation과 MacroGenics가 공동개발한 PD-1 억제제 ZYNYZ(retifanlimab-dlwr) 등이 있습니다.
기존의 치료법으로는 이 질환을 효과적으로 제어할 수 없는 경우가 많기 때문에 MCC에 대한 치료 옵션의 개선이 시급한 상황입니다. 의약품 개발의 발전은 이 희귀한 침습성 암을 앓고 있는 환자들의 예후를 개선할 수 있는 보다 강력한 솔루션을 제공할 수 있는 잠재력을 가지고 있습니다. IFx-2.0, NIDLEGY(L19-IL2/L19-TNF), ITI-3000 등이 이러한 미충족 수요를 충족시킬 수 있을 것으로 기대되는 주목할 만한 후보물질들입니다.
이 보고서는 메르켈세포암(MCC)의 주요 7개 시장(미국, 독일, 스페인, 이탈리아, 프랑스, 영국, 일본)을 조사 분석하여 각 지역의 시장 규모, 현재 치료법, 미충족 수요, 신약 등에 대한 정보를 제공합니다.
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) 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.
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.
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.
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.
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.
Merkel Cell Carcinoma (MCC) report insights
Merkel Cell Carcinoma (MCC) report key strengths
Merkel Cell Carcinoma (MCC) report assessment
Market Insights
Epidemiology Insights
Current Treatment Scenario, Marketed Drugs, and Emerging Therapies