皮膚鱗狀細胞癌（cSCC）：市場展望、流行病學、競爭格局、市場預測報告（2025-2035年）

市場概覽

• 德國 cSCC 市場預計將從 2025 年的 1.89 億美元成長到 2035 年的 3.57 億美元。
• 以下因素正在推動市場成長：
• 發病率和診斷率上升
• 以免疫查核點抑制劑治療進行晚期疾病
• 未來的成長取決於早期診斷和免疫腫瘤療法的推廣。

皮膚鱗狀細胞癌（cSCC）概述

皮膚鱗狀細胞癌（cSCC）是第二常見的皮膚癌，主要由表皮角質形成細胞因累積紫外線輻射引起的DNA損傷而發生惡性轉化所致。其他危險因子包括免疫抑制、慢性傷口、人類乳突病毒（HPV）感染、砷暴露以及遺傳性疾病，如色素性乾皮症。 TP53、CDKN2A、NOTCH1和HRAS基因的體細胞突變以及較高的腫瘤突變負荷是其基因組特徵。雖然大多數cSCC局限於局部，可透過手術切除治愈，但腫瘤大小超過2厘米、分化不良、神經周圍浸潤、深部組織浸潤和免疫抑制等高危險因子會增加復發和轉移的風險，因此需要多學科評估。診斷需透過切片檢查或切開切片檢查進行組織病理學評估來確診。對於高風險病例，前哨淋巴結活體組織切片和影像檢查用於局部和遠端分期。手術切除並確保適當的切緣是局部疾病治療的基礎，對於高風險臉部病變和解剖結構精細的病變，莫氏顯微外科手術可提供更優的切緣控制。輔助放射線治療用於病理特徵較差的高風險切除病變。抗PD-1查核點抑制劑Semiprimab是局部進行性、不可切除或轉移性皮膚鱗狀細胞癌（cSCC）的既定標準治療方案，可提供持續緩解並顯著延長存活期。Pembrolizumab珠單抗是合格的患者的已通過核准替代治療方案。雖然局部病變的預後通常良好，但免疫功能低下患者的復發和進展風險顯著升高，需要密切後續觀察，且多學科皮膚癌團隊的參與對於高風險疾病的管理至關重要。

主要亮點

• 德國預計，到 2035 年，新增 cSCC 病例數將從 2025 年的 38,675 例增加到 44,883 例，這反映了由於人口老化和累積紫外線照射導致的疾病負擔日益加重。
• cSCC 是第二常見的非黑色素瘤皮膚癌，在某些患者中，它會發展為局部晚期或轉移性疾病。
• 發病率上升與預期壽命延長、免疫抑制和檢測率提高有關。
• 免疫療法的廣泛應用正在改善進行性皮膚鱗狀細胞癌患者的預後。

格式化和更新訊息

• 詳細報告（PDF）
• 市場預測模型（基於微軟Excel）
• 流行病學數據（MS Excel，互動式工具）
• 高階主管洞察（PPT簡報）
• 其他功能：定期更新、自訂和顧問支援。
• 根據 Thelansis 的政策，我們確保所有最新更新在發布前都反映在報告內容和市場模型中。

主要問題

• 如何最佳化 G8 市場（美國、歐盟 5 國、日本、中國）的藥物開發與生命週期管理策略？
• 從發病率、盛行率、人群組成以及接受藥物治療的患者人數來看，患者數量分別是多少？
• 未來十年市場收入和病患佔有率的預測是多少？
• 哪些因素對市場趨勢影響最大？
• 受訪專家對目前和新興的治療方法有何看法？
• 哪款在研發線產品最有前景？其上市潛力及未來市場定位如何？
• 主要未被滿足的需求是什麼？ KOL 對目標受眾有何期望？
• 為確保藥物獲得批准並順利進入市場，必須滿足哪些關鍵的監管和支付方要求？

目標國家

• G8
  • 美國
  • EU5
    • 法國
    • 德國
    • 義大利
    • 西班牙
    • 英國
  • 日本
  • 中國

大公司

• Replimune, Inc.
• Incyte Corporation
• Regeneron Pharmaceuticals
• Merck Sharp &Dohme LLC
• Philogen SpA
• EvolveImmune United, Inc.
• Rakuten Medical, Inc.
• Hummingbird Bioscience
• Ankyra Therapeutics, Inc.
• Bicara Therapeutics
• KaliVir Immunotherapeutics
• Immunitas Therapeutics
• Memgen, Inc.
• Boundless Bio, Inc.
• Medicenna Therapeutics, Inc.

目錄

第1章：主要調查結果及分析師說明

• 主要趨勢：市場概況、SWOT分析、商業利益與風險等。

第2章：疾病背景

• 疾病定義、分類、病因和病理生理學、藥物標靶等。

第3章：流行病學

• 重點
• 發病率/盛行率
• 已確診並正在接受藥物治療的患者族群。
• 合併症
• 其他相關患者群

第4章 市場規模及預測

• 重點
• 市場促進因素與限制因素
• 按藥物類別分類的趨勢
• 各國具體趨勢

第5章 競爭情勢

• 目前的治療方法
• 重點
• 診斷和治療過程/演算法
• 目前主要療法－概述及關鍵意見領袖見解
• 新興療法
• 重點
• 值得關注的後期新興療法—概述、市場上市預期和關鍵意見領袖見解
• 值得關注的早期研發管線

第6章：未滿足的需求與目標產品分析

• 尚未滿足的主要需求及其透過新興療法實現的潛力。
• TPP分析與KOL展望

第7章 監理與報銷環境

第8章附錄

Cutaneous Squamous Cell Carcinoma (cSCC) Market Outlook

Thelansis's "Cutaneous Squamous Cell Carcinoma (cSCC) Market Outlook, Epidemiology, Competitive Landscape, and Market Forecast Report - 2025 To 2035" covers disease overview, epidemiology, drug utilization, prescription share analysis, competitive landscape, clinical practice, regulatory landscape, patient share, market uptake, market forecast, and key market insights under the potential Cutaneous Squamous Cell Carcinoma treatment modalities options for eight major markets (USA, Germany, France, Italy, Spain, UK, Japan, and China).

Cutaneous Squamous Cell Carcinoma (cSCC) Overview

Cutaneous squamous cell carcinoma (cSCC) is the second most common skin cancer, arising from malignant transformation of epidermal keratinocytes driven predominantly by cumulative ultraviolet radiation-induced DNA damage, with additional risk factors including immunosuppression, chronic wounds, human papillomavirus infection, arsenic exposure, and inherited conditions including xeroderma pigmentosum. Somatic mutations in TP53, CDKN2A, NOTCH1, and HRAS alongside high tumour mutational burden characterise the genomic landscape. The majority of cSCCs are localised and curable with surgical excision, however high-risk features including tumour diameter exceeding 2cm, poor differentiation, perineural invasion, deep tissue invasion, and immunosuppressed host status confer elevated recurrence and metastatic risk warranting multidisciplinary evaluation. Diagnosis is established by excisional or incisional biopsy with histopathological assessment; sentinel lymph node biopsy and cross-sectional imaging address regional and distant staging in high-risk disease. Surgical excision with appropriate margins remains the cornerstone of localised disease management, with Mohs micrographic surgery offering superior margin control for high-risk facial and anatomically sensitive lesions. Adjuvant radiotherapy addresses high-risk resected disease with adverse pathological features. Cemiplimab, an anti-PD-1 checkpoint inhibitor, is the established standard of care for locally advanced unresectable or metastatic cSCC, delivering durable responses and meaningful survival benefit. Pembrolizumab provides an approved alternative in eligible patients. Prognosis is excellent for localised disease; immunosuppressed patients warrant intensified surveillance given substantially elevated recurrence and progression risk, with multidisciplinary skin cancer team involvement integral to high-risk disease management.

Key Highlights

• In Germany, incident cSCC cases are projected to increase from 38,675 in 2025 to 44,883 by 2035, reflecting a growing disease burden driven by aging populations and cumulative UV exposure.
• cSCC is the second most common non-melanoma skin cancer, with a subset of patients progressing to locally advanced or metastatic disease.
• Rising incidence is associated with increased life expectancy, immunosuppression, and improved detection rates.
• Growing adoption of immunotherapy is improving outcomes in advanced cSCC patients.

Market Overview

• The Germany cSCC market is projected to grow from $189M in 2025 to $357M by 2035.
• Market growth is driven by:
• Increasing incidence and diagnosis rates
• Adoption of immune checkpoint inhibitors for advanced disease
• Future growth will depend on earlier diagnosis and expansion of immuno-oncology therapies.

Insights driven by robust research, including:

• In-depth interviews with leading KOLs and payers
• Physician surveys
• RWE analysis for claims and EHR datasets
• Secondary research (e.g., peer-reviewed journal articles, third-party research databases)

Deliverables format and updates*:

• Detailed Report (PDF)
• Market Forecast Model (MS Excel-based automated dashboard)
• Epidemiology (MS Excel; interactive tool)
• Executive Insights (PowerPoint presentation)
• Others: regular updates, customizations, consultant support
• As per Thelansis's policy, we ensure that we include all the recent updates before releasing the report content and market model.

Salient features of Market Forecast model:

• 10-year market forecast (2025-2035)
• Bottom-up patient-based market forecasts validated through the top-down sales methodology
• Covers clinically and commercially-relevant patient populations/ line of therapies
• Annualized drug-level sales and patient share projections
• Utilizes our proprietary Epilansis and Analog tool (e.g., drug uptake and erosion) datasets and conjoint analysis approach
• Detailed methodology/sources & assumptions
• Graphical and tabular outputs
• Users can customize the model based on requirements

Key business questions answered:

• How can drug development and lifecycle management strategies be optimized across G8 markets (US, EU5, Japan, and China)?
• How large is the patient population in terms of incidence, prevalence, segments, and those receiving drug treatments?
• What is the 10-year market outlook for sales and patient share?
• Which events will have the greatest impact on the market's trajectory?
• What insights do interviewed experts provide on current and emerging treatments?
• Which pipeline products show the most promise, and what is their potential for launch and future positioning?
• What are the key unmet needs and KOL expectations for target profiles?
• What key regulatory and payer requirements must be met to secure drug approval and favorable market access?

Countries Covered

• G8
  • United States
  • EU5
    • France
    • Germany
    • Italy
    • Spain
    • U.K.
  • Japan
  • China

Apart from the G8 Market, adding any additional country data to the dashboard will cost USD 1,750 per country

Companies Mentioned

• Replimune, Inc.
• Incyte Corporation
• Regeneron Pharmaceuticals
• Merck Sharp & Dohme LLC
• Philogen S.p.A.
• EvolveImmune United, Inc.
• Rakuten Medical, Inc.
• Hummingbird Bioscience
• Ankyra Therapeutics, Inc.
• Bicara Therapeutics
• KaliVir Immunotherapeutics
• Immunitas Therapeutics
• Memgen, Inc.
• Boundless Bio, Inc.
• Medicenna Therapeutics, Inc.

Table of Contents

1. Key Findings and Analyst Commentary

• Key trends: market snapshots, SWOT analysis, commercial benefits and risks, etc.

2. Disease Context

• Disease definition, classification, etiology and pathophysiology, drug targets, etc.

3. Epidemiology

• Key takeaways
• Incidence / Prevalence
• Diagnosed and Drug-Treated populations
• Comorbidities
• Other relevant patient segments

4. Market Size and Forecast

• Key takeaways
• Market drivers and constraints
• Drug-class specific trends
• Country-specific trends

5. Competitive Landscape

• Current therapies
• Key takeaways
• Dx and Tx journey/algorithm
• Key current therapies - profiles and KOL insights
• Emerging therapies
• Key takeaways
• Notable late-phase emerging therapies - profiles, launch expectations, KOL insights
• Notable early-phase pipeline

6. Unmet Need and TPP Analysis

• Top unmet needs and future attainment by emerging therapies
• TPP analysis and KOL expectations

7. Regulatory and Reimbursement Environments (by country and payer insights)

8. Appendix (e.g., bibliography, methodology)