Muscle Invasive Bladder Cancer Market Insights Highlight Expanding Outlook Till 2034, DelveInsight Evaluates

DelveInsight's "Muscle Invasive Bladder Cancer Market Insights, Epidemiology, and Market Forecast-2034′′ report offers an in-depth understanding of the Muscle Invasive Bladder Cancer, historical and forecasted epidemiology as well as the Muscle Invasive Bladder Cancer market trends in the United States, EU4 (Germany, Spain, Italy, France) the United Kingdom and Japan.

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Some of the key facts of the Muscle Invasive Bladder Cancer Market Report:
• In 2023, the Non-Muscle Invasive Bladder Cancer (NMIBC) therapeutics market size across the seven major markets (7MM) was about USD 2,350 million. The market is anticipated to expand over the coming years, driven by increasing disease prevalence, the introduction of premium-priced treatment options, and a growing number of pharmaceutical companies actively developing therapies in this area.
• In November 2025, Merck (NYSE: MRK), known as MSD outside the U.S. and Canada, announced that the U.S. FDA has granted approval for KEYTRUDA® (pembrolizumab) and KEYTRUDA QLEXTM (pembrolizumab and berahyaluronidase alfa-pmph) used in combination with Padcev® (enfortumab vedotin-ejfv) as neoadjuvant therapy followed by continued use as adjuvant therapy after cystectomy. This regimen is approved for adult patients with muscle-invasive bladder cancer (MIBC) who cannot receive cisplatin-based chemotherapy. The decision marks the first approved PD-1 inhibitor plus antibody-drug conjugate (ADC) combination for this patient segment.
• In September 2025, Johnson & Johnson (NYSE: JNJ) announced FDA approval of INLEXZOTM (gemcitabine intravesical system) for BCG-unresponsive, non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS), offering a new option for patients after failed BCG therapy or those ineligible for bladder removal surgery.
• In May 2025, the FDA's Oncologic Drugs Advisory Committee (ODAC) narrowly voted 5-4 against approving UGN-102 (mitomycin intravesical solution) for treating recurrent, low-grade, intermediate-risk non-muscle-invasive bladder cancer (NMIBC).
• In May 2025, UroGen (Nasdaq: URGN) announced that the FDA has scheduled an Oncologic Drugs Advisory Committee (ODAC) meeting for May 21, 2025, to review the new drug application (NDA) for UGN-102 (mitomycin) intravesical solution, an investigational treatment for recurrent LG-IR-NMIBC.
• Among the seven major markets (7MM), the United States recorded the largest prevalence of Non-Muscle Invasive Bladder Cancer, with approximately 616,000 cases in 2023, and this number is projected to grow over the forecast period.
• According to estimates, in Japan, Non-Muscle Invasive Bladder Cancer was most common among individuals aged 70-89, representing around 60% of all cases in 2023.
• In Japan, the Ta stage represented the largest share of stage-specific Non-Muscle Invasive Bladder Cancer cases, making up about 60% of cases in 2023.
• Only three FDA-approved therapies are currently available in the United States for treating Non-Muscle Invasive Bladder Cancer. KEYTRUDA (pembrolizumab) received approval in 2020, ADSTILADRIN (nadofaragene firadenovec-vncg) was approved in 2022, and the latest addition, ANKTIVA (nogapendekin alfa inbakicept-pmln), gained approval in 2024.
• Key Muscle Invasive Bladder Cancer Companies: CG Oncology, Pfizer, UroGen Pharma, Janssen Research & Development, LLC, Protara Therapeutics, Binhui Biopharmaceutical, SURGE Therapeutics, Pfizer, AstraZeneca, ImmunityBio, Inc., Guarionex J. Decastro, Janssen Research & Development, Tollys, Aura Biosciences, Vaxiion Therapeutics, Incyte Corporation, Janssen Pharmaceuticals, Theralase Technologies, BristolMyers Squibb, Asieris Pharmaceuticals, and others
• Key Muscle Invasive Bladder Cancer Therapies:CG0070, Sasanlimab (PF-06801591), UGN-102 (mitomycin), TAR-200, TARA-002, OH2 injection, STM-416, Durvalumab, BCG+N-803, Cabazitaxel, Cetrelimab, TL-532, AU-011, VAX 014, Pemigatinib, Erdafitinib, TLD 1433, Nivolumab, APL-1202, and others
• The Muscle Invasive Bladder Cancer market is expected to surge due to the disease's increasing prevalence and awareness during the forecast period. Furthermore, launching various multiple-stage Muscle Invasive Bladder Cancer pipeline products will significantly revolutionize the Muscle Invasive Bladder Cancer market dynamics.

Muscle Invasive Bladder Cancer Overview
Muscle Invasive Bladder Cancer (MIBC) is an advanced form of bladder cancer in which the tumor has grown into the muscular layer of the bladder wall. Unlike non-muscle invasive bladder cancer (NMIBC), MIBC has a higher risk of spreading (metastasizing) to other parts of the body.

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Muscle Invasive Bladder Cancer Epidemiology
The epidemiology section provides insights into the historical, current, and forecasted epidemiology trends in the seven major countries (7MM) from 2020 to 2034. It helps to recognize the causes of current and forecasted trends by exploring numerous studies and views of key opinion leaders. The epidemiology section also provides a detailed analysis of the diagnosed patient pool and future trends.

Muscle Invasive Bladder Cancer Epidemiology Segmentation:
The Muscle Invasive Bladder Cancer market report proffers epidemiological analysis for the study period 2020-2034 in the 7MM segmented into:
• Total Prevalence of Muscle Invasive Bladder Cancer
• Prevalent Cases of Muscle Invasive Bladder Cancer by severity
• Gender-specific Prevalence of Muscle Invasive Bladder Cancer
• Diagnosed Cases of Episodic and Chronic Muscle Invasive Bladder Cancer

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Muscle Invasive Bladder Cancer Drugs Uptake and Pipeline Development Activities
The drugs uptake section focuses on the rate of uptake of the potential drugs recently launched in the Muscle Invasive Bladder Cancer market or expected to get launched during the study period. The analysis covers Muscle Invasive Bladder Cancer market uptake by drugs, patient uptake by therapies, and sales of each drug.
Moreover, the therapeutics assessment section helps understand the drugs with the most rapid uptake and the reasons behind the maximal use of the drugs. Additionally, it compares the drugs based on market share.
The report also covers the Muscle Invasive Bladder Cancer Pipeline Development Activities. It provides valuable insights about different therapeutic candidates in various stages and the key companies involved in developing targeted therapeutics. It also analyzes recent developments such as collaborations, acquisitions, mergers, licensing patent details, and other information for emerging therapies.

Muscle Invasive Bladder Cancer Therapies and Key Companies
• ADSTILADRIN (nadofaragene firadenovec): Ferring Pharmaceuticals/FKD Therapies Oy
• ANKTIVA (nogapendekin alfa inbakicept-pmln): ImmunityBio
• CG0070: CG Oncology
• Sasanlimab (PF-06801591): Pfizer
• UGN-102 (mitomycin): UroGen Pharma
• TAR-200: Janssen Research & Development, LLC
• TARA-002: Protara Therapeutics
• OH2 injection: Binhui Biopharmaceutical
• STM-416: SURGE Therapeutics
• Durvalumab: AstraZeneca
• BCG+N-803: ImmunityBio, Inc.
• Cabazitaxel: Guarionex J. Decastro
• Cetrelimab: Janssen Research & Development
• TL-532: Tollys
• AU-011: Aura Biosciences
• VAX 014: Vaxiion Therapeutics
• Pemigatinib: Incyte Corporation
• Erdafitinib: Janssen Pharmaceuticals
• TLD 1433: Theralase Technologies
• Nivolumab: BristolMyers Squibb
• APL-1202: Asieris Pharmaceuticals

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Muscle Invasive Bladder Cancer Market Strengths
• Potent ICI-based gene therapies can alter the disease trajectory, halting its advancement to advanced stages-an impactful stride in managing NMIBC. Their potential to fulfill approval criteria further underscores their pivotal role in advancing NMIBC treatment.
• Sasanlimab's ease of subcutaneous administration and compelling clinical effectiveness position it as a standout candidate in the evolving field of cancer immunotherapy.

Muscle Invasive Bladder Cancer Market Opportunities
• The growing focus on research and development to introduce biomarkers for improved diagnosis and the exploration of combination therapy with BCG presents a promising opportunity in the NMIBC market.
• The emergence of innovative treatments like CG0070, N-803, non-viral plasmid based therapy, and others signifies a promising advancement in NMIBC treatment. These therapies offer targeted and innovative approaches to address cancer.

Scope of the Muscle Invasive Bladder Cancer Market Report
• Study Period: 2020-2034
• Coverage: 7MM [The United States, EU5 (Germany, France, Italy, Spain, and the United Kingdom), and Japan]
• Key Muscle Invasive Bladder Cancer Companies: CG Oncology, Pfizer, UroGen Pharma, Janssen Research & Development, LLC, Protara Therapeutics, Binhui Biopharmaceutical, SURGE Therapeutics, Pfizer, AstraZeneca, ImmunityBio, Inc., Guarionex J. Decastro, Janssen Research & Development, Tollys, Aura Biosciences, Vaxiion Therapeutics, Incyte Corporation, Janssen Pharmaceuticals, Theralase Technologies, BristolMyers Squibb, Asieris Pharmaceuticals, and others
• Key Muscle Invasive Bladder Cancer Therapies: CG0070, Sasanlimab (PF-06801591), UGN-102 (mitomycin), TAR-200, TARA-002, OH2 injection, STM-416, Durvalumab, BCG+N-803, Cabazitaxel, Cetrelimab, TL-532, AU-011, VAX 014, Pemigatinib, Erdafitinib, TLD 1433, Nivolumab, APL-1202, and others
• Muscle Invasive Bladder Cancer Therapeutic Assessment: Muscle Invasive Bladder Cancer current marketed and Muscle Invasive Bladder Cancer emerging therapies
• Muscle Invasive Bladder Cancer Market Dynamics: Muscle Invasive Bladder Cancer market drivers and Muscle Invasive Bladder Cancer market barriers
• Competitive Intelligence Analysis: SWOT analysis, PESTLE analysis, Porter's five forces, BCG Matrix, Market entry strategies
• Muscle Invasive Bladder Cancer Unmet Needs, KOL's views, Analyst's views, Muscle Invasive Bladder Cancer Market Access and Reimbursement

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