Non Muscle Invasive Bladder Cancer Therapeutics Market Size (7MM) was ~USD 2,350 million in 2023, It is expected to grow by 2034, estimates DelveInsight

DelveInsight's "Non-Muscle Invasive Bladder Cancer Market Insights, Epidemiology, and Market Forecast-2034′′ report offers an in-depth understanding of the Non-Muscle Invasive Bladder Cancer, historical and forecasted epidemiology as well as the Non-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 Non-Muscle Invasive Bladder Cancer Market Report
• 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.
• In May 2025, ImmunityBio, Inc. announced that it received a Refusal to File (RTF) letter from the FDA for its supplemental biologics license application (sBLA) for the use of ANKTIVA plus Bacillus Calmette-Guerin (BCG) in BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) with papillary disease. This decision came despite unanimous guidance and encouragement from the FDA leadership in January 2025, which had supported the sBLA submission based on data from the single-arm trial.
• Among the 7MM, the US accounted for the highest Non Muscle Invasive Bladder Cancer Prevalence, with around 616,000 in 2023; these cases are expected to increase during the forecast period.
• In 2023, the highest Non Muscle Invasive Bladder Cancer prevalence among EU4 and the UK was in Italy, while the lowest number of cases was in France.
• Among cases categorized by risk level, the highest number belonged to the intermediate-risk category, whereas the lowest number was associated with the high-risk NMIBC category.
• According to the estimates, in Japan, it is observed that Non Muscle Invasive Bladder Cancer was most prevalent in the 70-89 age group, accounting for approximately 60% of total cases in 2023.
• In Japan, the highest number of Non Muscle Invasive Bladder Cancer stage-specific cases was in the Ta stage, accounting for approximately 60% in 2023.
• The leading Non-Muscle Invasive Bladder Cancer Companies such as 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
• Promising Non-Muscle Invasive Bladder Cancer Therapies such as 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

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Non-Muscle Invasive Bladder Cancer Overview
Non-Muscle Invasive Bladder Cancer (NMIBC) refers to a type of bladder cancer where the tumor is confined to the inner lining of the bladder and has not spread to the muscle layer. It is the most common form of bladder cancer, often detected through blood in the urine or urinary symptoms. Treatment typically involves transurethral resection, followed by surveillance for recurrence.

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

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Marketed Non Muscle Invasive Bladder Cancer Drugs
• ADSTILADRIN (nadofaragene firadenovec): Ferring Pharmaceuticals/FKD Therapies Oy
ADSTILADRIN is a gene therapy developed as a treatment for adult patients with BCG-unresponsive Non Muscle Invasive Bladder Cancer. It is a non-replicating adenovirus vector-based gene therapy containing the gene interferon alfa-2b, administered by catheter into the bladder once every three months. The drug is classified as an Advanced Therapy Medicinal Product (ATMP) by the European Medicines Agency.

• ANKTIVA (nogapendekin alfa inbakicept-pmln): ImmunityBio
ANKTIVA is a novel IL-15 superagonist complex with an IL-15 mutant (IL-15N72D) bound to an IL-15 receptor a/IgG1 Fc fusion protein. In April 2024, the US FDA approved ANKTIVA plus BCG for the treatment of patients with BCG-unresponsive Non Muscle Invasive Bladder Cancer with CIS, with or without papillary tumors. The drug is currently being evaluated in adult patients in two clinical Non Muscle Invasive Bladder Cancer trials. QUILT-3.032 is studying N-803 in combination with BCG in patients with BCG-unresponsive Non Muscle Invasive Bladder Cancer CIS and Papillary Disease; QUILT-2.005 is investigating the use of N-803 in combination with BCG for patients with BCG-naïve Non Muscle Invasive Bladder Cancer. As per ImmunityBio corporate presentation 2024, the company has planned to explore ANKTIVA + iBCG (recombinant BCG) for BCG Replacement Non Muscle Invasive Bladder Cancer. This study will be in collaboration with the Serum Institute of India and ImmunityBio. The Ankitva cost is yet to be determined by the companies in the US.

Emerging Non-muscle Invasive Bladder Cancer Drugs

• CG0070 (cretostimogene grenadenorepvec): CG Oncology
CG0070, a selectively replicative oncolytic immunotherapy based on a modified adenovirus type 5 backbone that contains a cancer-selective promoter and a GM-CSF transgene, destroys bladder tumor cells through their defective Rb pathway. Monotherapy activity of cretostimogene grenadenorepvec in Non Muscle Invasive Bladder Cancer after BCG failure has been established in two past studies of cretostimogene grenadenorepvec, V0046 and BOND-002. Studies of cretostimogene grenadenorepvec alone (Phase III BOND-003, ongoing study) will further elucidate the potential role of cretostimogene grenadenorepvec-based therapy for BCG-unresponsive Non Muscle Invasive Bladder Cancer. The company presented updated results from BOND-003 Cohort C at the American Urological Association (AUA) 2024 annual meeting. CG0070 is also investigated in a clinical collaboration with Merck to evaluate the combination of CG0070 with the anti-PD-1 therapy, KEYTRUDA (pembrolizumab), in a Phase II CORE-001 clinical study for the treatment of high-grade Non Muscle Invasive Bladder Cancer in the BCG-unresponsive patient population. CG Oncology presented positive final results from this study at the ASCO 2024 annual meeting. The company believes that these results support further investigation of cretostimogene in combination with checkpoint inhibitors, and they plan to incorporate these findings into another planned CORE-008 trial in high-risk Non Muscle Invasive Bladder Cancer.

• Sasanlimab (PF-06801591): Pfizer
Sasanlimab is an anti-PD-1 treatment. It blocks the PD-1 protein on the surface of immune T-cells that can attack healthy cells. PD-1 is an immune checkpoint protein that prevents T-cells from attacking healthy cells. The drug is being evaluated in a Phase III study with BCG (BCG induction with or without BCG maintenance) versus BCG (induction and maintenance) in participants with high-risk, BCG-naïve Non Muscle Invasive Bladder Cancer.

Non-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 Non-Muscle Invasive Bladder Cancer market or expected to get launched during the study period. The analysis covers Non-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 Non-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.

Non-Muscle Invasive Bladder Cancer Therapies and Key Companies
• 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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Non-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.

Non-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 Non-Muscle Invasive Bladder Cancer Market Report
• Study Period: 2020-2034
• Coverage: 7MM
• Non-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
• Non-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
• Non-Muscle Invasive Bladder Cancer Therapeutic Assessment: Non-Muscle Invasive Bladder Cancer current marketed and Non-Muscle Invasive Bladder Cancer emerging therapies
• Non-Muscle Invasive Bladder Cancer Market Dynamics: Non-Muscle Invasive Bladder Cancer market drivers and Non-Muscle Invasive Bladder Cancer market barriers
• Competitive Intelligence Analysis: SWOT analysis, PESTLE analysis, Porter's five forces, BCG Matrix, Market entry strategies
• Non-Muscle Invasive Bladder Cancer Unmet Needs, KOL's views, Analyst's views, Non-Muscle Invasive Bladder Cancer Market Access and Reimbursement

Examine the evolving landscape of the Non-Muscle Invasive Bladder Cancer Market: Analyze epidemiology, therapeutic penetration, and future opportunities. Stay proactive with our latest market projections. Click here to lead in advancements @ Non-Muscle Invasive Bladder Cancer Clinical Trials Assessment- https://www.delveinsight.com/sample-request/non-muscle-invasive-bladder-cancer-market?utm_source=openpr&utm_medium=pressrelease&utm_campaign=ypr

Table of Contents
1. Non-Muscle Invasive Bladder Cancer Market Report Introduction
2. Executive Summary for Non-Muscle Invasive Bladder Cancer
3. SWOT analysis of Non-Muscle Invasive Bladder Cancer
4. Non-Muscle Invasive Bladder Cancer Patient Share (%) Overview at a Glance
5. Non-Muscle Invasive Bladder Cancer Market Overview at a Glance
6. Non-Muscle Invasive Bladder Cancer Disease Background and Overview
7. Non-Muscle Invasive Bladder Cancer Epidemiology and Patient Population
8. Country-Specific Patient Population of Non-Muscle Invasive Bladder Cancer
9. Non-Muscle Invasive Bladder Cancer Current Treatment and Medical Practices
10. Non-Muscle Invasive Bladder Cancer Unmet Needs
11. Non-Muscle Invasive Bladder Cancer Emerging Therapies
12. Non-Muscle Invasive Bladder Cancer Market Outlook
13. Country-Wise Non-Muscle Invasive Bladder Cancer Market Analysis
14. Non-Muscle Invasive Bladder Cancer Market Access and Reimbursement of Therapies
15. Non-Muscle Invasive Bladder Cancer Market Drivers
16. Non-Muscle Invasive Bladder Cancer Market Barriers
17. Non-Muscle Invasive Bladder Cancer Appendix
18. Non-Muscle Invasive Bladder Cancer Report Methodology
19. DelveInsight Capabilities
20. Disclaimer
21. About DelveInsight

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