膀胱癌：新型療法、未滿足的需求和TPP洞察報告，2026年

市場概覽

• 預計義大利膀胱癌市場將從2025年的4.2億美元成長到2035年的9.9億美元。
• 市場成長的驅動力是免疫腫瘤療法的普及和診斷率的提高。
• 未來的發展取決於標靶治療和聯合治療策略的進步。

膀胱癌的新治療方法及對TPP的深入研究

Thelansis 發布的《膀胱癌新興治療方法、未滿足的需求和目標產品概況（TPP）洞察報告 -2026》全面分析了該適應症的關鍵新興治療方法和主要藥物開發機會，包括新興的競爭格局、未滿足的需求、目標產品概況（TPP）、試驗設計和關鍵意見領袖（KOL）的見解。

膀胱癌概述

膀胱癌是泌尿系統最常見的惡性腫瘤，其中起源於膀胱黏膜移行上皮的尿路上皮癌是主要的組織學亞型。吸菸、職業性接觸芳香胺、慢性膀胱炎、接觸Cyclophosphamide是已知的危險因子。 FGFR3、TP53、RB1 和 PIK3CA 的體細胞突變可促進整個頻譜（包括非肌肉層浸潤性和肌層浸潤性）的致癌性轉化。患者通常表現為無痛性肉眼血尿（主要症狀），以及頻尿、尿急和排尿困難。膀胱鏡檢查和切片檢查仍然是診斷的黃金標準，上泌尿道影像檢查和 CT造影可作為輔助手段。非肌肉層浸潤性膀胱癌採用經尿道切除術進行內視鏡治療，對於高風險病例，膀胱內灌注卡介苗（BCG）免疫療法可降低復發和進展的風險。此外，Pembrolizumab已獲準用於治療對BCG無反應的原位癌。對於肌肉層浸潤性膀胱癌，通常先進行以Cisplatin為基礎的新輔助化療，隨後行根治根治性膀胱切除術或以保留膀胱為目標的三聯聯合治療。對於轉移性疾病，以含鉑類藥物為基礎的化療，在含鉑類藥物化療有效後，使用Avelumab進行維持免疫治療已被證實可顯著延長存活期。Erdafitinib針對FGFR3突變的轉移性疾病，而enfortumab vedotin（抗體藥物複合體偶聯物）與Pembrolizumab的聯合治療已成為轉移性疾病的一線治療方案，具有突破性意義。預後因疾病階段而異，但多學科管理、膀胱鏡後續觀察以及以患者為中心的生活品質最佳化對於長期照護非常重要。

主要亮點

• 在德國，根據存活率調整後，膀胱癌患者人數預計將從2025年的727,014 人增加到2035年的777,528 人。
• 人口老化和吸菸相關危險因子的不斷增加，持續推高了該疾病的盛行率。
• 免疫療法和標靶治療的日益普及改變我們治療疾病的方式。
• 進行性和復發性膀胱癌的治療仍有未滿足的需求。

基於對醫生和關鍵意見領袖（KOL）的調查得出的結論：

• 透過對關鍵意見領袖（KOL）的訪談，獲得了更多見解，進一步完善了調查結果。
• 調查問卷將根據客戶的要求進行客製化。

交付成果格式：

• PowerPoint簡報
• MS Excel

主要問題

• 詳細的競爭格局趨勢
• 管道分析
• 符合新興治療方法的患者
• 主要企業
• 主要作用機制
• 發布日期等的預測
• 臨床試驗趨勢分析
• 目標患者群
• 試驗終點
• 測試設計
• 受試者招募標準等。
• 未滿足的需求和機會
• 目前主要治療方法的有效性
• 未滿足需求的關鍵領域
• 估算主要未滿足需求的市場規模
• 目標產品概況
• 屬性和級別
• 醫生開立的處方
• 預期患者佔有率
• 關鍵意見領袖對領先新興治療方法的見解
• 意識
• 預期用途/處理線
• 對主要未滿足需求的滿意度
• KOL評論

目標國家

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

主要企業

• Merck Sharp &Dohme LLC
• Ferring Pharmaceuticals
• ImmunityBio, Inc.
• Lipac Oncology LLC
• Daiichi Sankyo
• UroGen Pharma Ltd.
• CG Oncology, Inc.
• Astellas Pharma Global Development, Inc.
• Zhuhai Beihai Biotech Co., Ltd.
• ALX Oncology Inc.
• Hoffmann-La Roche
• Protara Therapeutics
• Monopar Therapeutics
• Eli Lilly and Company
• Incyte Corporation
• ViroMissile, Inc.
• Genentech, Inc.
• Palleon Pharmaceuticals, Inc.
• NGM Biopharmaceuticals, Inc.
• Toray Industries, Inc.
• BeiGene
• Arcus Biosciences, Inc.
• AstraZeneca
• Sensei Biotherapeutics, Inc.
• Beijing Biotech
• OncoC4, Inc.
• MacroGenics
• Pfizer
• OncoNano Medicine, Inc.
• Medicenna Therapeutics, Inc.
• EvolveImmune United, 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、商業性利益與風險等。

第2章 競爭情勢

• 目前的治療方法
• 重點
• 診斷和治療過程/演算法
• 主要治療方法概述及關鍵意見領袖見解
• 新興治療方法
• 重點
• 診斷和治療過程/演算法
• 領先的新興治療方法 - 概述和關鍵意見領袖見解

第3章 產品屬性分析

• 重點
• 科學屬性
• 商業性屬性
• 產品定位

第4章 初步調查

• 目前治療狀態
• 主要治療方法與目標患者族群的比較
• 主要特點和優勢
• 未來治療環境
• 當前挑戰
• 未滿足的需求
• 新興治療方法
• 主要治療方法與目標患者族群的比較
• 主要特點和優勢
• 未來治療前景
• 未滿足的需求和關鍵意見領袖的期望

第5章 未滿足的需求和TPP分析

• 新興治療方法的主要未滿足需求和未來成就
• TPP分析與KOL預期

第6章 監理與償付環境

第7章 附錄

Bladder Cancer Emerging Therapy and TPP Insights

Thelansis's "Bladder Cancer Emerging Therapy, with Unmet Needs and TPP Insights Report - 2026" provides a comprehensive analysis of the emerging competitive landscape, unmet needs, target product profiles (TPPs), trial designs, and KOL insights on key emerging therapies and key drug development opportunities in the indication.

Bladder Cancer Overview

Bladder cancer is the most common malignancy of the urinary tract, with urothelial carcinoma representing the predominant histological subtype, arising from the transitional epithelium lining the bladder mucosa. Tobacco smoking, occupational aromatic amine exposure, chronic bladder inflammation, and cyclophosphamide exposure are established risk factors, with somatic mutations in FGFR3, TP53, RB1, and PIK3CA driving oncogenic transformation across non-muscle-invasive and muscle-invasive disease spectrums. Patients present with painless macroscopic haematuria - the cardinal symptom - alongside urinary frequency, urgency, and dysuria; cystoscopy with biopsy remains the diagnostic gold standard, supplemented by upper tract imaging and CT urography. Non-muscle-invasive bladder cancer is managed endoscopically via transurethral resection, with intravesical BCG immunotherapy reducing recurrence and progression risk in high-risk disease; pembrolizumab is approved for BCG-unresponsive carcinoma in situ. Muscle-invasive disease warrants neoadjuvant cisplatin-based chemotherapy followed by radical cystectomy or bladder-preserving trimodality therapy. Metastatic disease is addressed with platinum-based chemotherapy, while maintenance avelumab immunotherapy following platinum response has demonstrated meaningful survival benefit. Erdafitinib targets FGFR3-altered metastatic disease, and enfortumab vedotin - a Nectin-4 directed antibody-drug conjugate - alongside pembrolizumab represents a transformative first-line metastatic standard. Prognosis varies with stage; multidisciplinary management, surveillance cystoscopy, and patient-centred quality-of-life optimisation are integral to long-term care.

Key Highlights

• In Germany, survival-adjusted prevalent Bladder Cancer cases are projected to increase from 727,014 in 2025 to 777,528 by 2035.
• Rising aging population and smoking-related risk burden continue to drive disease prevalence.
• Increasing adoption of immunotherapies and targeted agents is reshaping the treatment landscape.
• Persistent unmet need exists in advanced and recurrent bladder cancer management.

Market Overview

• The Italy Bladder Cancer market is projected to grow from USD 420 million in 2025 to USD 990 million by 2035.
• Market growth is driven by increasing uptake of immuno-oncology therapies and improved diagnosis rates.
• Future expansion will depend on advances in targeted therapies and combination treatment strategies.

Insights driven by surveys with physician / key opinion leaders:

• Survey findings are corroborated and enriched by insights from interviews with leading KOLs
• Survey is customized based on client requirements

Deliverables format:

• PowerPoint presentation
• MS Excel

Key business questions answered:

• Detailed emerging competitive landscape
• Pipeline analysis
• Target patients for emerging therapies
• Key companies
• Key mechanism of actions
• Launch date estimates, etc.
• Clinical trial landscape analysis
• Target patient segments
• Trial endpoints
• Trial design
• Recruitment criteria, etc.
• Unmet Needs and Opportunities
• Performance of key current therapies
• Top areas of unmet needs
• Opportunity sizing for key unmet needs
• Target Product Profiles
• Attributes and levels
• Physician likelihood of prescribing
• Expected patient shares
• KOL insights on key emerging therapies
• Level of awareness
• Expected use / line of therapy
• Extent to fulfil key unmet needs
• KOL quotes

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

• Merck Sharp & Dohme LLC
• Ferring Pharmaceuticals
• ImmunityBio, Inc.
• Lipac Oncology LLC
• Daiichi Sankyo
• UroGen Pharma Ltd.
• CG Oncology, Inc.
• Astellas Pharma Global Development, Inc.
• Zhuhai Beihai Biotech Co., Ltd.
• ALX Oncology Inc.
• Hoffmann-La Roche
• Protara Therapeutics
• Monopar Therapeutics
• Eli Lilly and Company
• Incyte Corporation
• ViroMissile, Inc.
• Genentech, Inc.
• Palleon Pharmaceuticals, Inc.
• NGM Biopharmaceuticals, Inc.
• Toray Industries, Inc.
• BeiGene
• Arcus Biosciences, Inc.
• AstraZeneca
• Sensei Biotherapeutics, Inc.
• Beijing Biotech
• OncoC4, Inc.
• MacroGenics
• Pfizer
• OncoNano Medicine, Inc.
• Medicenna Therapeutics, Inc.
• EvolveImmune United, Inc.

Table of Contents

1. Key Findings and Analyst Commentary

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

2. Competitive Landscape

• Current therapies
• Key takeaways
• Dx and Tx journey/algorithm
• Key current therapies - profiles and KOL insights
• Emerging therapies
• Key takeaways
• Dx and Tx journey/algorithm
• Key emerging therapies - profiles and KOL insights

3. Product Attribute Analysis

• Key takeaways
• Scientific attributes
• Commercial attributes
• Product positioning

4. Primary Market Research

• Current treatment landscape
• Key therapies vs. focused patient segment
• Key attributes and benefits
• Futures treatment landscape
• Current challenges
• Unmet needs
• Emerging therapies
• Key therapies vs. focused patient segment
• Key attributes and benefits
• Futures treatment landscape
• Unmet needs and KOL expectations

5. Unmet Need and TPP Analysis

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

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

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