Non-Muscle invasive bladder cancer (NMIBC) is an early-stage bladder cancer where tumors remain confined to the bladder’s inner lining without invading the muscle wall. As per Diego Parrao et al., 2024, it accounts for approximately 75% of all bladder cancer cases, with a mortality rate under 1%. According to the non-muscle invasive bladder cancer pipeline analysis by Expert Market Research, the market is witnessing rising interest in intravesical therapies and immune-based treatments. A notable therapy in development is TAR-200 by Johnson & Johnson, a novel drug-delivery system designed for sustained release. The non-muscle invasive bladder cancer therapeutics pipeline is expected to grow significantly in the coming years.
Major companies involved in the non muscle invasive bladder cancer pipeline analysis includes Janssen Research & Development, LLC, Pfizer, and others.
Leading drugs currently in the pipeline include APL-1202, BH011, RAG-01, and others.
Rising clinical trials for intravesical immunotherapies, increased FDA fast-track designations, and investment in BCG-refractory therapies are driving strong pipeline expansion in non-muscle invasive bladder cancer drug pipeline.
The Non Muscle Invasive Bladder Cancer Pipeline Analysis Report by Expert Market Research gives comprehensive insights into non muscle invasive bladder cancer therapeutics currently undergoing clinical trials. It covers various aspects related to the details of each of these drugs under development for non muscle invasive bladder cancer. The non muscle invasive bladder cancer report assessment includes the analysis of over 100 pipeline drugs and 50+ companies. The non muscle invasive bladder cancer pipeline landscape will include an analysis based on efficacy and safety measure outcomes published for the trials, including their adverse effects on patients suffering from the condition, and alignment with non muscle invasive bladder cancer treatment guidelines to ensure optimal care practices.
The assessment part will include a detailed analysis of each drug, drug class, clinical studies, phase type, drug type, route of administration, and ongoing product development activities related to non muscle invasive bladder cancer.
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Non-Muscle invasive bladder cancer (NMIBC) is a type of bladder cancer confined to the inner lining of the bladder and has not spread into the muscle layer. It typically develops when abnormal cells grow uncontrollably in the bladder lining, often due to genetic mutations triggered by risk factors like smoking, chronic infections, or chemical exposure.
Non-muscle invasive bladder cancer is commonly treated through transurethral resection of bladder tumor (TURBT), followed by intravesical therapy such as Bacillus Calmette-Guérin (BCG) or chemotherapy to prevent recurrence and progression. In April 2024, the U.S. Food and Drug Administration approved nogapendekin alfa inbakicept-pmln (Anktiva) with BCG for adults with BCG-unresponsive NMIBC with carcinoma in situ. The drug showed a complete response rate of 62% in a multicenter trial.
According to Diego Parrao et al., 2024, non-muscle invasive bladder cancer (NMIBC) represents approximately 75% of all bladder cancer cases and has a mortality rate of around 1%, but a notably high recurrence rate. According to Yanting Zhang et al., 2023, bladder cancer is the tenth most diagnosed cancer and the thirteenth leading cause of cancer death globally. The incidence has risen in Europe with decreasing mortality, while in Asia, incidence has declined but male mortality has increased.
This section of the report covers the analysis of non muscle invasive bladder cancer drug candidates based on several segmentations, including:
By Phase
The pipeline assessment report covers 50+ drug analyses based on phase:
By Drug Class
The non muscle invasive bladder cancer pipeline analysis report covers 50+ drug analyses based on drug classes:
By Route of Administration
The pipeline assessment report covers 50+ drug analyses based on the route of administration.
The report covers phase I, phase II, phase III, phase IV, and early-phase drugs. The coverage includes an in-depth analysis of each drug across these phases. According to EMR analysis, phase II covers a major share of the total non muscle invasive bladder cancer clinical trials, accounting for 44% of all trials. It is followed by phase I (29%), and phase III (25%). The concentration of candidates in Phase II highlights a strong momentum in clinical development, signaling significant potential for innovation and advancement in treatment options within the non-muscle invasive bladder cancer treatment.
The drug molecule categories covered under the non muscle invasive bladder cancer pipeline analysis include small molecules, monoclonal antibodies, peptides, gene therapies, and polymer. The non muscle invasive bladder cancer report provides a comparative analysis of the drug classes for each drug in various phases of clinical trials for non muscle invasive bladder cancer. Immune checkpoint inhibitors are gaining prominence in the non-muscle invasive bladder cancer drug pipeline. Sasanlimab, a humanized IgG4 monoclonal antibody, blocks PD-1 interaction with its ligands PD-L1 and PD-L2, restoring T-cell activity. It is administered subcutaneously every four weeks using a 2 mL prefilled syringe, offering a targeted and convenient therapeutic option.
The EMR report for the non muscle invasive bladder cancer pipeline covers the profile of key companies involved in clinical trials and their drugs under development. It provides a detailed non muscle invasive bladder cancer therapeutic assessment, analyzing the competitive dynamics of the clinical trial landscape. Below is the list of a few players involved in non muscle invasive bladder cancer clinical trials:
This section covers the detailed analysis of each drug under multiple phases, including phase I, phase II, phase III, phase IV, and emerging drugs for non muscle invasive bladder cancer. It includes product description, trial ID, study type, drug class, mode of administration, and recruitment status of non muscle invasive bladder cancer drug candidates.
APL-1202, sponsored by Jiangsu Yahong Meditech Co., Ltd (Asieris), is currently undergoing a Phase 3 clinical trial aimed at evaluating its safety and efficacy as a single-agent oral treatment for naïve intermediate-risk non-muscle invasive bladder cancer (NMIBC). This study is comparing APL-1202 to intravesical Epirubicin. APL-1202 is an orally available MetAP2 inhibitor with anti-angiogenic and anti-tumor properties, showing promising synergy in bladder cancer models.
BH011, sponsored by Zhuhai Beihai Biotech Co., Ltd, is a novel intravesical docetaxel formulation currently being evaluated in Phase I/II trials for high-risk non-muscle-invasive bladder cancer (NMIBC) after BCG failure. The study is assessing the safety, tolerability, and preliminary efficacy of BH011, which enhances tissue permeability and drug concentration compared to TAXOTERE, offering a potential bladder-sparing alternative to cystectomy.
RAG-01, sponsored by Ractigen Therapeutics, is currently undergoing a Phase 1 study in patients with BCG-unresponsive non–muscle-invasive bladder cancer (NMIBC). It is an investigational small activating RNA therapeutic and in a study that aims to evaluate the safety, tolerability, pharmacokinetics, and early efficacy. RAG-01 works by upregulating the p21 tumor suppressor gene, showing dose-dependent urinary concentration with minimal systemic exposure. The study is following a “3+3” dose escalation model across multiple centers.
*Please note that this is only a partial list; the complete list of drugs will be available in the full report.*
The Non Muscle Invasive Bladder Cancer Pipeline Analysis Report provides a strategic overview of the latest and future landscape of treatments for non muscle invasive bladder cancer. It provides necessary information for making informed investment decisions along with research, development, and strategic planning efforts. The stakeholders will benefit from the essential insights into non muscle invasive bladder cancer collaborations, regulatory environments, and potential growth opportunities.
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*While we strive to always give you current and accurate information, the numbers depicted on the website are indicative and may differ from the actual numbers in the main report. At Expert Market Research, we aim to bring you the latest insights and trends in the market. Using our analyses and forecasts, stakeholders can understand the market dynamics, navigate challenges, and capitalize on opportunities to make data-driven strategic decisions.*
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