DelveInsight reports that over 20 key companies are actively engaged in developing more than 25 treatment therapies targeting Non-Muscle Invasive Bladder Cancer (NMIBC), reflecting a dynamic and evolving pipeline in this space.
Non-Muscle Invasive Bladder Cancer Overview:
Non-muscle invasive bladder cancer (NMIBC) represents a heterogeneous form of urothelial carcinoma, with varying risks of recurrence and progression to muscle-invasive stages. It originates in the bladder’s innermost lining and may either be asymptomatic or present with signs such as painless blood in the urine (hematuria), increased urinary frequency and urgency, painful urination, and lower abdominal or back pain.
Risk factors for bladder cancer include smoking—cigarette smokers are up to three times more likely to develop it—along with older age and male gender. The majority of diagnoses occur in people over 60, with men being three to four times more likely to be affected than women.
Diagnosis typically involves cystoscopy and histopathological examination of resected bladder tissue. About 4% of bladder cancer cases are found incidentally during imaging for unrelated health concerns. While conventional white light cystoscopy (WLC) detects only around 60% of tumors, advanced imaging technologies like hexyl aminolevulinate (HAL)-based photodynamic diagnosis (PDD) and narrow-band imaging (NBI) improve detection accuracy. Blue light cystoscopy (BLC), using HAL as a photosensitizer, highlights cancerous cells through red fluorescence under blue light, enabling more effective visualization and early identification of recurrences.
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“Non-Muscle Invasive Bladder Cancer Pipeline Insight 2025” report by DelveInsight provides a comprehensive analysis of the ongoing clinical development activities and growth prospects across the Non-Muscle Invasive Bladder Cancer Therapeutics Market.
Key Takeaways from the Non-Muscle Invasive Bladder Cancer Pipeline Report
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On April 22, 2024, the FDA approved Anktiva in combination with BCG for adults with BCG-unresponsive NMIBC with CIS, with or without papillary tumors. In a single-arm, multicenter trial of 77 patients, Anktiva demonstrated a CR rate of 62%, with 58% of responders maintaining CR for at least 12 months.
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On December 16, 2022, the U.S. Food and Drug Administration (FDA) approved Adstiladrin, an adenoviral vector-based gene therapy, for adult patients with high-risk Bacillus Calmette-Guérin (BCG)-unresponsive NMIBC with carcinoma in situ (CIS), with or without papillary tumors. In a multicenter, single-arm trial involving 157 patients, Adstiladrin achieved a complete response (CR) rate of 51%, with a median duration of response of 9.7 months.
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DelveInsight’s Non-Muscle Invasive Bladder Cancer pipeline report depicts a robust space with 20+ active players working to develop 25+ pipeline therapies for Non-Muscle Invasive Bladder Cancer treatment.
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Key Non-Muscle Invasive Bladder Cancer companies such as Prokarium Ltd., Vaxiion Therapeutics, Tyra Biosciences, Lipac Oncology, SURGE Therapeutics, Jiangsu Simcere Pharmaceutical, Shanghai Hengrui Pharmaceutical Co., enGene, and others are evaluating new drugs for Non-Muscle Invasive Bladder Cancer to improve the treatment landscape.
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Promising Non-Muscle Invasive Bladder Cancer pipeline therapies in various stages of development include TAR-200, VAX 014, SIM0237, and others.
Non-Muscle Invasive Bladder Cancer Pipeline Analysis
The report provides insights into:
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The report provides detailed insights into the key companies that are developing therapies in the Non-Muscle Invasive Bladder Cancer Market.
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The report also evaluates different therapeutic candidates segmented into early-stage, mid-stage, and late-stage of development for Non-Muscle Invasive Bladder Cancer treatment.
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It analyzes the key companies involved in targeted therapeutics development with respective active and inactive (dormant or discontinued) projects.
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It navigates the emerging drugs under development based on the stage of development, route of administration, target receptor, monotherapy or combination therapy, a different mechanism of action, and molecular type.
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Detailed analysis of collaborations (company-company collaborations and company-academia collaborations), licensing agreement, and financing details for future advancement of the Non-Muscle Invasive Bladder Cancer market.
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Non-Muscle Invasive Bladder Cancer Emerging Drugs
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TAR-200: TARIS Biomedical
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VAX 014: Vaxiion Therapeutics
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SIM0237: Simcere Pharmaceutical Group
Non-Muscle Invasive Bladder Cancer Companies
More than 20 prominent companies are actively engaged in developing treatments for Non-Muscle Invasive Bladder Cancer (NMIBC). Among these, TARIS Biomedical has the most advanced drug candidate, currently in Phase III of clinical development.
DelveInsight’s report covers around 25+ products under different phases of clinical development like
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Late stage products (Phase III)
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Mid-stage products (Phase II)
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Early-stage product (Phase I) along with the details of
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Pre-clinical and Discovery stage candidates
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Discontinued & Inactive candidates
Non-Muscle Invasive Bladder Cancer pipeline report provides the therapeutic assessment of the pipeline drugs by the Route of Administration. Products have been categorized under various ROAs such as
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Intravenous
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Subcutaneous
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Oral
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Intramuscular
Non-Muscle Invasive Bladder Cancer Products have been categorized under various Molecule types such as
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Monoclonal antibody
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Small molecule
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Peptide
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Non-Muscle Invasive Bladder Cancer Pipeline Therapeutic Assessment
• Non-Muscle Invasive Bladder Cancer Assessment by Product Type
• Non-Muscle Invasive Bladder Cancer By Stage
• Non-Muscle Invasive Bladder Cancer Assessment by Route of Administration
• Non-Muscle Invasive Bladder Cancer Assessment by Molecule Type
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Table of Content
1. Report Introduction
2. Executive Summary
3. Non-Muscle Invasive Bladder Cancer Current Treatment Patterns
4. Non-Muscle Invasive Bladder Cancer – DelveInsight’s Analytical Perspective
5. Therapeutic Assessment
6. Non-Muscle Invasive Bladder Cancer Late-Stage Products (Phase-III)
7. Non-Muscle Invasive Bladder Cancer Mid-Stage Products (Phase-II)
8. Early Stage Products (Phase-I)
9. Pre-clinical Products and Discovery Stage Products
10. Inactive Products
11. Dormant Products
12. Non-Muscle Invasive Bladder Cancer Discontinued Products
13. Non-Muscle Invasive Bladder Cancer Product Profiles
14. Non-Muscle Invasive Bladder Cancer Key Companies
15. Non-Muscle Invasive Bladder Cancer Key Products
16. Dormant and Discontinued Products
17. Non-Muscle Invasive Bladder Cancer Unmet Needs
18. Non-Muscle Invasive Bladder Cancer Future Perspectives
19. Non-Muscle Invasive Bladder Cancer Analyst Review
20. Appendix
21. Report Methodology
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