United States Urinary Tract Cancer Treatment Market is to reach USD 10.5 billion by early 2030s; Merck acquired Enforta Biopharma, Astellas Pharma acquired Daiichi Sankyo URO Research | DataM Intelligence

Leander, Texas-The Urinary Tract Cancer Treatment Market size in the U.S. is estimated at approximately USD 3.3 billion in 2025, growing at a CAGR of around 18% over the coming years. The market is expected to reach values USD 10.5 billion by early 2030s

The market is driven by increasing prevalence of urinary tract cancers, an aging population, and significant advancements in treatment options like immunotherapy, targeted therapies, and minimally invasive robotic surgery.
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United states industry development
✅ Merck launched Keytruda + Enfortumab Vedotin Combo Regimen in February 2025, approved for first-line treatment of advanced urothelial carcinoma, offering significantly improved survival outcomes.

✅ Pfizer introduced Sotorasib-URO in May 2025, a KRAS G12C-targeted therapy formulated for metastatic urinary tract cancers with advanced biomarker-driven precision.

✅ Bristol Myers Squibb released Opdivo Rapid-Infusion 2025 in September 2025, enabling faster delivery of nivolumab for bladder cancer patients to reduce chair time and enhance clinic efficiency.

Japan industry developmen
✅ Astellas Pharma launched Padcev JP-Formulation in March 2025, optimized for Japanese patients with advanced urothelial carcinoma, improving tolerability and dosing flexibility.

✅ Daiichi Sankyo introduced DS-8201 URO Variant in July 2025, a HER2-targeted antibody-drug conjugate for HER2-expressing urinary tract cancers.

✅ Chugai Pharmaceutical released Tecentriq Auto-Dose 2025 in October 2025, an automated-dosing version of atezolizumab with enhanced real-world usability in oncology wards.

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Recent M&A data:-

⇥ Pfizer acquired Seagen's Uro-Oncology Portfolio: Completed in March 2025 for approximately USD 1.1 billion, expanding Pfizer's targeted therapy offerings for bladder and urothelial cancers.

⇥ Merck acquired Enforta Biopharma: Closed in May 2025, Merck gained rights to Enfortumab Vedotin derivatives and combination therapies for advanced urinary tract cancers.

⇥ Roche acquired Tiragolumab URO Assets from Genentech JV: Completed in February 2025, enhancing Roche's dual-immunotherapy pipeline for PD-L1-positive metastatic urothelial carcinoma.

⇥ Astellas Pharma acquired Daiichi Sankyo URO Research Unit: Finalized in June 2025, strengthening Astellas' R&D capabilities in HER2-targeted and antibody-drug conjugate therapies for urinary tract cancers.

⇥ Bristol Myers Squibb acquired NextGen Oncology URO Programs: Closed in April 2025, adding precision oncology therapies, including KRAS-targeted and combination immunotherapies for urothelial carcinoma.

🔹 Market segmentation with Market share -

⇥ Cancer Type Segmentation:

Bladder Cancer dominates with approximately 65% market share in 2025, driven by high prevalence and healthcare focus.

Urethral Cancer and Ureteric & Renal Pelvic Cancer hold smaller shares due to lower incidence rates.

⇥ Treatment Type Segmentation:

Immunotherapy leads with around 47% market share, propelled by advances in immune checkpoint inhibitors and targeted therapies.

Chemotherapy holds a significant share as foundational treatment but faces competition from immunotherapies.

Targeted therapies and surgery constitute the rest, with increasing adoption of precision medicine approaches.

🔹 Regional insights-

⇥ North America holds the largest market share at approximately 39% in 2025, valued around USD 1.29 billion, driven by the high prevalence of urothelial carcinoma and bladder cancer, advanced healthcare infrastructure, extensive clinical trials, and increased healthcare expenditure.

⇥ Asia-Pacific is the fastest-growing region with about 25% market share, valued at USD 824 million in 2025, expanding at a CAGR of approximately 17.2%. Growth is fueled by increasing bladder cancer cases in China, India, and Japan, rising smoking rates, government initiatives, and growing geriatric populations.

⇥ Europe accounts for a significant portion with steady growth, led by countries like Germany, France, the UK, Italy, and Spain. Factors include aging populations and high incidence of urothelial carcinoma, with Europe expected to achieve the highest CAGR from 2026 to 2035.

🔹 Market Drivers:-

⇥ Rising prevalence of urinary tract cancers: Increasing incidence of bladder, kidney, and ureter cancers globally is driving demand for effective therapies.

⇥ Advancements in treatment options: Introduction of targeted therapies, immunotherapies, and minimally invasive procedures enhances patient outcomes.

⇥ Growing geriatric population: Higher cancer susceptibility among older adults fuels market growth.

⇥ Increased healthcare expenditure: Expanding healthcare infrastructure and government funding for oncology treatments support market expansion.

⇥ Awareness and early diagnosis: Improved screening programs and early detection initiatives boost treatment adoption.

🔹 Emerging players :-

⇥ CG Oncology
Their therapy cretostimogene grenadenorepvec reportedly delivered a ~34% complete response rate after two years, with a median response duration of about 27.9 months in patients with recurrent non‐muscle invasive bladder cancer.Tyra Biosciences.

⇥ Seagen Inc.
The broader urinary tract cancer treatment market is increasingly shifting toward targeted therapies, immunotherapy, and combination regimens.

⇥ Astellas Pharma Inc.
While Astellas is not a "small startup," recent moves including approvals and aggressive development in urothelial cancers are boosting its role in urinary tract cancer, beyond legacy players.

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