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市場調査レポート
商品コード
1625353
メルケル細胞がん(MCC)- 市場考察、疫学、市場予測(2034年)Merkel Cell Carcinoma - Market Insight, Epidemiology, and Market Forecast - 2034 |
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メルケル細胞がん(MCC)- 市場考察、疫学、市場予測(2034年) |
出版日: 2024年12月01日
発行: DelveInsight
ページ情報: 英文 199 Pages
納期: 2~10営業日
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MCCは、特に進行期において、急速な増殖、高い転移性、生存率の低さを特徴とします。治療戦略は病期や個々の要因によって異なります。限局性MCCでは手術と放射線療法が不可欠であることに変わりはありませんが、全身療法、特に免疫療法は進行性MCCへのアプローチを一変させ、これらの症例における患者の転帰を改善しています。
限局性MCCの治療には通常、手術と放射線療法が行われますが、進行例では免疫チェックポイント阻害薬(avelumabなど)のような全身療法が必要となることが多いです。化学療法による長期的な効果は限られています。手術、特に広範な局所切除が限局型MCCの主な治療法であり、転移を検出するためにセンチネルリンパ節生検が行われます。進行期では、全身性の病変が支配的となるため手術は有効でなくなり、この疾患の稀少性と高い再発率から、より効果的な治療法の必要性が強調されます。
化学療法はかつて進行したMCCに対する重要な治療法でしたが、長期的な有効性が限られているため、現在ではその役割は縮小しています。etoposideやcarboplatinのような薬剤は一時的に腫瘍を縮小させますが、再発率や重篤な副作用のためにあまり好まれません。細胞毒性化学療法は、DNAに損傷を与えたり細胞分裂を阻害したりすることで、急速に分裂する細胞を標的とするもので、転移性MCCには有効ですが、正常細胞に影響を及ぼすことで重大な副作用を引き起こすことが多いです。
免疫調節療法に焦点が当てられていることを反映して、現在、MCCの治療薬として承認され、使用可能な薬剤もあります。主な選択肢としては、Merck KGaAが開発したモノクローナル抗体BAVENCIO、Merckが提供するPD-1阻害薬KEYTRUDA(pembrolizumab)、Incyte CorporationとMacroGenicsが共同開発したPD-1阻害薬ZYNYZ(retifanlimab-dlwr)などがあります。
既存の治療法ではこの疾患を効果的にコントロールできないことが多いため、MCCに対する治療オプションの改良が急務となっています。医薬品開発の進歩は、より強固なソリューションを提供し、この希少な侵攻性のがんと闘う患者の予後を改善する可能性を秘めています。開発中の注目すべき候補には、IFx-2.0、NIDLEGY(L19-IL2/L19-TNF)、ITI-3000などがあり、こうしたアンメットニーズへの対応が期待されています。
当レポートでは、メルケル細胞がん(MCC)の主要7市場(米国、ドイツ、スペイン、イタリア、フランス、英国、日本)について調査分析し、各地域の市場規模、現在の治療法、アンメットニーズ、新薬などの情報を提供しています。
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