Non Muscle Invasive Bladder Cancer - Pipeline Insight, 2025

DelveInsight’s, “Non Muscle Invasive Bladder Cancer - Pipeline Insight, 2025” report provides comprehensive insights about 20+ companies and 25+ pipeline drugs in Non Muscle Invasive Bladder Cancer pipeline landscape. It covers the pipeline drug profiles, including clinical and nonclinical stage products. It also covers the therapeutics assessment by product type, stage, route of administration, and molecule type. It further highlights the inactive pipeline products in this space.

Geography Covered

• Global coverage

Non Muscle Invasive Bladder Cancer: Understanding

Non Muscle Invasive Bladder Cancer: Overview

Non muscle-invasive bladder cancer (NMIBC) is a heterogeneous sub classification of urothelial carcinoma with significant variation in individual risk of recurrence and progression to muscle-invasive disease. It is a cancer found in the tissue that lines the inner surface of the bladder. Some people may have symptoms that suggest they have bladder cancer. Others may feel nothing at all. Some symptoms should never be ignored. Some of the common symptoms are hematuria (blood in the urine) - the most common symptom, often without pain, frequent and urgent urination, pain when urine passes, pain in lower abdomen, and back pain. Research shows that people with certain risk factors are more likely to develop bladder cancer. These include smoking – cigarette smokers are up to three times more likely than nonsmokers to develop bladder cancer; older age – most people with bladder cancer are over 60, and the risk increases with age; being male – men are three to four times more likely than women to develop bladder cancer, and others.

The diagnosis of bladder cancer ultimately depends on cystoscopic examination of the bladder and histological evaluation of the resected tissue although about 4% of cases will be found incidentally, usually during imaging to investigate non-urological symptoms. However, the detection rate for white light cystoscopy (WLC) can be limited (as low as 60%). Strong evidence has shown that enhanced visualization methods using (hexyl aminolevulinate (HAL)-photodynamic diagnosis (PDD) or narrow band imaging (NBI)) may improve tumor detection and early recurrence. Blue light cystoscopy (BLC) or PDD requires preoperative intravesical instillation of hexaminolevulinate (HAL), a photosensitizer that preferentially accumulates in neoplastic cells. Under blue light, red fluorescence is emitted by neoplastic cells.

The main treatments for when the cancer cells are found only in the bladder's inner lining (non-muscle-invasive bladder cancer) are surgery, immunotherapy and intravesical chemotherapy. Surgery, on its own or combined with other treatments, is used in most cases. Most people with non-muscle-invasive bladder cancer have an operation called transurethral resection of bladder tumour (TURBT). This is done during a cystoscopy under a general anaesthetic. It takes 15–40 minutes, and does not involve any external cuts to the body. Immunotherapy uses substances that encourage the body's own natural defenses (immune system) to fight disease. Bacillus Calmette-Guérin (BCG) is a vaccine that was originally used to treat tuberculosis. It can also stimulate a person's immune system to stop or delay bladder cancer coming back or becoming invasive.

""Non Muscle Invasive Bladder Cancer- Pipeline Insight, 2025"" report by DelveInsight outlays comprehensive insights of present scenario and growth prospects across the indication. A detailed picture of the Non Muscle Invasive Bladder Cancer pipeline landscape is provided which includes the disease overview and Non Muscle Invasive Bladder Cancer treatment guidelines. The assessment part of the report embraces, in depth Non Muscle Invasive Bladder Cancer commercial assessment and clinical assessment of the pipeline products under development. In the report, detailed description of the drug is given which includes mechanism of action of the drug, clinical studies, NDA approvals (if any), and product development activities comprising the technology, Non Muscle Invasive Bladder Cancer collaborations, licensing, mergers and acquisition, funding, designations and other product related details.

Report Highlights

• The companies and academics are working to assess challenges and seek opportunities that could influence Non Muscle Invasive Bladder Cancer R&D. The therapies under development are focused on novel approaches to treat/improve Non Muscle Invasive Bladder Cancer.

Non Muscle Invasive Bladder Cancer Emerging Drugs Chapters

This segment of the Non Muscle Invasive Bladder Cancer report encloses its detailed analysis of various drugs in different stages of clinical development, including phase II, I, preclinical and Discovery. It also helps to understand clinical trial details, expressive pharmacological action, agreements and collaborations, and the latest news and press releases.

Non Muscle Invasive Bladder Cancer Emerging Drugs

• TAR-200: TARIS Biomedical

TAR-200 is an investigational targeted releasing system enabling controlled release of gemcitabine into the bladder, sustaining local drug exposure for weeks at a time. The safety and efficacy of TAR-200 are being evaluated in Phase 2 and Phase 3 studies in patients with muscle-invasive bladder cancer in SunRISe-2 and SunRISe-4 and NMIBC in SunRISe-1 and SunRISe-3. Currently, the drug is in Phase III stage of its clinical trial for the treatment of non muscle invasive bladder cancer.

• VAX 014: Vaxiion Therapeutics

VAX014 is a novel rBMC-based oncolytic immunotherapy designed to have distinct advantages over traditional and emerging oncolytic virotherapies. VAX014's ability to specifically target both alpha3beta1(α3β1) and alpha5beta1 (α5β1) integrins facilitates broad spectrum activity against various solid tumor types because these two integrin family members are clinically validated as being selectively expressed or overexpressed in a wide variety of solid tumor indications (and most mouse models). Currently, the drug is in the Phase I stage of its development for the treatment of Non muscle-invasive bladder cancer.

• SIM0237: Simcere Pharmaceutical Group

SIM0237 is an anti-PD-L1 monoclonal antibody fused with potency-reduced IL-15/IL-15Rα sushi domain developed in-house by utilizing Simcere Zaiming’s protein engineering platform. As a bifunctional protein, the compound can block the PD-1/PD-L1 immunosuppressive pathway via binding to PD-L1 and activate the immune system through its IL-15 part, thus playing a synergistic role of relieving immunosuppression and boosting the immune activation to exhibit antitumor effect. The attenuated IL-15 part of SIM0237 increases MTD and avoids overstimulation and accompanied anergy of NK and CD8+ T cells. In the meantime, fusion of attenuated IL-15 to full anti-PD-L1 mAb further enhances the half-life of attenuated IL-15 and delivers IL-15 directly to the tumor microenvironment avoiding notorious CRS toxicity induced by systemic IL-15 exposure. Currently, the drug is in Phase I stage of its clinical trial for the treatment of non muscle invasive bladder cancer.

Further product details are provided in the report……..

Non Muscle Invasive Bladder Cancer: Therapeutic Assessment

This segment of the report provides insights about the different Non Muscle Invasive Bladder Cancer drugs segregated based on following parameters that define the scope of the report, such as:

• Major Players in Non Muscle Invasive Bladder Cancer
• There are approx. 20+ key companies which are developing the therapies for Non Muscle Invasive Bladder Cancer. The companies which have their Non Muscle Invasive Bladder Cancer drug candidates in the most advanced stage, i.e. Phase III include, TARIS Biomedical.
• Phases

DelveInsight’s report covers around 25+ products under different phases of clinical development like

• Late stage products (Phase III)
• Mid-stage products (Phase II)
• Early-stage product (Phase I) along with the details of
• Pre-clinical and Discovery stage candidates
• Discontinued & Inactive candidates
• Route of Administration

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

• Oral
• Intravenous
• Subcutaneous
• Parenteral
• Topical
• Molecule Type

Products have been categorized under various Molecule types such as

• Recombinant fusion proteins
• Small molecule
• Monoclonal antibody
• Peptide
• Polymer
• Gene therapy
• Product Type

Drugs have been categorized under various product types like Mono, Combination and Mono/Combination.

Non Muscle Invasive Bladder Cancer: Pipeline Development Activities

The report provides insights into different therapeutic candidates in phase II, I, preclinical and discovery stage. It also analyses Non Muscle Invasive Bladder Cancer therapeutic drugs key players involved in developing key drugs.

Pipeline Development Activities

The report covers the detailed information of collaborations, acquisition and merger, licensing along with a thorough therapeutic assessment of emerging Non Muscle Invasive Bladder Cancer drugs.

Non Muscle Invasive Bladder Cancer Report Insights

• Non Muscle Invasive Bladder Cancer Pipeline Analysis
• Therapeutic Assessment
• Unmet Needs
• Impact of Drugs

Non Muscle Invasive Bladder Cancer Report Assessment

• Pipeline Product Profiles
• Therapeutic Assessment
• Pipeline Assessment
• Inactive drugs assessment
• Unmet Needs

Key Questions

Current Treatment Scenario and Emerging Therapies:

• How many companies are developing Non Muscle Invasive Bladder Cancer drugs?
• How many Non Muscle Invasive Bladder Cancer drugs are developed by each company?
• How many emerging drugs are in mid-stage, and late-stage of development for the treatment of Non Muscle Invasive Bladder Cancer?
• What are the key collaborations (Industry–Industry, Industry–Academia), Mergers and acquisitions, licensing activities related to the Non Muscle Invasive Bladder Cancer therapeutics?
• What are the recent trends, drug types and novel technologies developed to overcome the limitation of existing therapies?
• What are the clinical studies going on for Non Muscle Invasive Bladder Cancer and their status?
• What are the key designations that have been granted to the emerging drugs?

Key Players

• Prokarium Ltd
• Vaxiion Therapeutics
• Tyra Biosciences
• Lipac Oncology
• SURGE Therapeutics
• Jiangsu Simcere Pharmaceutical
• Shanghai Hengrui Pharmaceutical Co.
• enGene

Key Products

• ZH9
• VAX014
• TYRA-300
• TSD-001
• STM-416
• SIM0237
• SHR-1501
• EG-70

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