Non-Muscle Invasive Bladder Cancer Pipeline Analysis | Insights into the Marketed and Emerging Therapies, Latest Regulatory Approvals, Clinical Trials, Treatment Outlook, Key Companies by DelveInsight

Non-Muscle Invasive Bladder Cancer Pipeline Analysis | Insights into the Marketed and Emerging Therapies, Latest Regulatory Approvals, Clinical Trials, Treatment Outlook, Key Companies by DelveInsight
Non-Muscle Invasive Bladder Cancer Pipeline

With over 30+ players proactively involved in developing novel therapies for Non-Muscle Invasive Bladder Cancer (NMIBC) and over 30+ therapies expected to get launched, Non-Muscle Invasive Bladder Cancer Pipeline presents quite a promising overall picture for the next decade. 

Non-Muscle Invasive Bladder Cancer (NMIBC) Pipeline Insight, 2022” by DelveInsight highlights the details around the NMIBC pipeline scenario, unmet needs, and Non-Muscle Invasive Bladder Cancer therapeutic assessment of the key pipeline therapies. 


Some of the key Non-Muscle Invasive Bladder Cancer Pipeline Highlights:

  • 30+ key companies including the APIM Therapeutics, UroGen Pharma, Pfizer, AstraZeneca, TARIS Biomedical, Bristol-Myers Squibb, Ono Pharmaceuticals, Janssen Pharmaceuticals, and several others. are involved in adding value to the Non-Muscle Invasive Bladder Cancer pipeline. 
  • 30+ emerging therapies are in the NMIBC pipeline at different stages of clinical development including ATX-10, Imfinzi, TAR-200, Sasanlimab, Balversa, UGN-102, Opdivo, and several others.
  • While ATX-101 and TAR-200 are in early stages of clinical development (ATX-101 in preclinical stages and TAR 200 in Phase I); UGN-102, and Balversa are in Phase II stage of trials with Opdivo and PF-06801591 in the end-stage (Phase III) of clinical development.
  • Anchiano Therapeutics is leveraging its expertise in small-molecule oncology development and is developing novel small-molecule inhibitors of RAS and PDE10/β-catenin in collaboration with ADT Pharmaceuticals
  • LIPAC is working to enhance the therapeutic index of proven cancer drugs, which results in more effective treatments for intracavitary cancers with the help of its proprietary proliposomal intracavitary paclitaxel drug delivery platform, LiPax. LIPAC announced the successful completion of a Phase 2A marker lesion clinical trial designed to predict long-term (two-year) recurrence-free survival rates in patients with low-grade highly recurrent NMIBC treated with LiPax.
  • In August 2020, GeneCentric Therapeutics entered into a research collaboration with Janssen around RNA-based drug response biomarkers for non-muscle invasive bladder cancer.

Non-Muscle Invasive Bladder Cancer is a common, heterogeneous cancer found in the tissue of the bladder’s inner surface, wherein the bladder muscle is not involved. 


NMIBC Pipeline Therapies

Opdivo: Bristol-Myers Squibb/Ono Pharmaceuticals

Opdivo (Nivolumab) is a programmed death-1 (PD-1) immune checkpoint inhibitor developed by Bristol-Myers Squibb. The drug harnesses the body’s immune system to help restore anti-tumor immune response by blocking the interaction between PD-1 and its ligands. 

Opdivo holds a vital place as the treatment option across multiple cancers. It has been approved for colorectal cancer; gastric cancer; Head and neck cancer; Hodgkin’s disease; Liver cancer; Malignant melanoma; Mesothelioma; Non-small cell lung cancer; Renal cell carcinoma; Urogenital cancer, and is currently in phase III clinical development for participants with High-risk Non-muscle Invasive Bladder Cancer that is persistent or recurrent after treatment with BCG in a phase III trial titled “a phase III, randomized, double-blind trial of Nivolumab in combination with Intravesical BCG Versus Standard of Care BCG alone’’ (NCT04149574)The trial is currently in the recruiting stage with an estimated enrollment of 700 participants and expected to be completed in August 2030. 

BMS is also evaluating Opdivo in a phase II trial titled “a phase II, randomized, open-label study of Nivolumab or Nivolumab/BMS-986205 alone or combined with intravesical BCG in participants with BCG-Unresponsive, high-risk, Non-Muscle Invasive Bladder Cancer” (NCT03519256). The trial is currently in the recruiting stage with an estimated enrollment of 358 participants and expected to be completed in September 2024. 

UGN-102: UroGen Pharma

UGN-102 (mitomycin gel) is an investigational formulation that utilizes innovative technology, RTGel reverse-thermal hydrogel, for the treatment of low-grade NMIBC.

UroGen Pharma is investigating the therapy in phase 3, to assess the long-term efficacy and safety of UGN-102 (mitomycin) for an intravesical solution with or without (±) transurethral resection of bladder tumors. The trial is currently in the recruiting stage with an estimated enrolment of 632 participants and expected to be completed in December 2023.

Atezolizumab: Hoffmann-La Roche

Roche’s Atezolizumab (Tecentriq)a monoclonal antibody designed to bind with a protein called PD-L1 expressed on tumour cells and tumour-infiltrating immune cells, is already commercially available for Breast cancer; Liver cancer; Malignant melanoma; Non-small cell lung cancer; Small cell lung cancer; and Urogenital cancer. Roche is also evaluating the drug for Non-Muscle Invasive Bladder Cancer. It is currently in the recruiting stage with an estimated enrollment of 614 participants and expected to be completed in February 2028.




To learn more about NMIBC Drugs Development, request NMIBC Drugs Pipeline Sample Report 


Scope of NMIBC Pipeline Report

Coverage: Global 

Major Players: 30+ companies

Prominent Players:  Bristol-Myers Squibb, Ono Pharmaceuticals, Pfizer, Merck Sharp & Dohme Corp., Ferring Pharmaceuticals, UroGen Pharma, Roche, Viventia Bio, ImmunityBio

Key Drugs: 30+ pipeline drugs

Non-Muscle Invasive Bladder Cancer Therapies: Atezolizumab, ALT-803, UGN-102, Vicinium, Nivolumab, Pembrolizumab, PF-06801591, Durvalumab, APL-1202


  • Non-Muscle Invasive Bladder Cancer Therapies Late-stage (Phase III)  
  • NMIBC Therapies (Phase II)
  • NMIBC Therapies (Phase I) 
  • Non-Muscle Invasive Bladder Cancer Therapies Pre-clinical stage candidates 
  • Inactive candidates and Discovery candidates for Non-Muscle Invasive Bladder Cancer


  • Protease
  • Immune System 
  • Multiple Kinase 
  • And others

Mechanism of Action

  • Protease Inhibitor 
  • Immunomodulatory 
  • Multiple Kinase Inhibitor
  • And others

Molecule Types  

  • Antineoplastics
  • Vaccine
  • Gene therapies
  • Immunotherapy
  • Metal
  • Monoclonal antibodies
  • Nanoparticle
  • Oncolytic viruses
  • Peptide
  • Plasmid
  • Protein
  • Small molecule
  • Ligand
  • Bacteria and others.

Route of Administration

  • Infusion
  • Intradermal
  • Intravenous
  • Intravesical
  • Oral
  • And others

Product Types

  • Mono
  • Combination 
  • Mono/Combination


Visit to know more about the report offerings @ Non-Muscle Invasive Bladder Cancer Emerging Therapies


Key Questions Answered in Non-Muscle Invasive Bladder Cancer Pipeline Report

  • 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 emerging drugs?


Get in touch with our Business Executive @ NMIBC Pipeline Trends and Futuristic Outlook to learn more about the domain.


Table of Contents 




Executive Summary


Non-Muscle Invasive Bladder Cancer: Overview


NMIBC Pipeline Therapeutics


Therapeutic Assessment


Non-Muscle Invasive Bladder Cancer – DelveInsight’s Analytical Perspective


In-depth Commercial Assessment


Non-Muscle Invasive Bladder Cancer Collaboration Deals


NMIBC Late-Stage Products


NMIBC Mid-Stage Products


NMIBC Early-Stage Products


NMIBC Pre-clinical and Discovery Stage Products


NMIBC Inactive Products


Non-Muscle Invasive Bladder Cancer Key Companies


Non-Muscle Invasive Bladder Cancer Key Products


NMIBC Unmet Needs


NMIBC Future Perspectives and Conclusion


Analyst Views on NMIBC Future Trends




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