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Bladder Cancer Drug Pipeline Analysis Report 2025

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    Drug Pipelines

  • 200 Pages
  • June 2025
  • Region: Global
  • Expert Market Research
  • ID: 6102847
According to the World Health Organization, bladder cancer is the 9th most common cancer globally. Statistics say that in 2022, approximately 600,0 00 people were diagnosed with bladder cancer and around 220,000 deaths were encountered with the condition. Several companies are conducting clinical trials for their drugs intended to combat bladder cancer. Such initiatives indicate a promising future for bladder cancer treatment in the coming years.

Report Coverage

Bladder Cancer Report by the publisher gives comprehensive insights on the bladder cancer drugs currently undergoing clinical trials and covers various aspects related to the details for each of these drugs under development. The report includes an analysis of over 100 pipeline drugs and 50+ companies . Moreover, the bladder cancer pipeline analysis based on efficacy and safety measures outcomes published for the trials will be covered including their adverse effects in bladder cancer.

The detailed analysis of each drug, drug class, clinical studies, phase type, drug type, route of administration and ongoing bladder cancer pipeline development activities are covered. Additionally, bladder cancer collaborations and commercial assessments are offered, helping stakeholders to make informed decisions.

Bladder Cancer Drug Pipeline Outlook

Bladder cancer occurs when there is an uncontrollable growth of cells in the bladder lining. Initially these cancerous cells affect the normal functions of bladder and later spread to surrounding areas. Bladder cancer is of two types - non-muscle-invasive bladder cancer and muscle-invasive bladder cancer. Non-muscle-invasive bladder cancer is considered early stage and represents about 70-75% of all diagnoses while muscle-invasive bladder cancer is considered as an advanced stage and represents 25-30% of diagnoses. Bladder cancer is the fourth most common cancer in men.

The symptoms of bladder cancer include blood in the urine (hematuria), which may lead to bright red urine, painful and frequent urge to urinate, as well as back pain among others. The bladder cancer treatment options for bladder cancer depend on factors such as the grade and stage of the cancer. It includes chemotherapy in the bladder, chemotherapy for the whole body, immunotherapy, targeted therapy, radiation therapy and surgery. The approaches for bladder cancer surgery include transurethral resection of bladder tumor (TURBT), cystectomy, neobladder reconstruction, and continent urinary reservoir among others.

The ongoing research on clinical trials aims to identify efficient therapeutic targets, development of novel therapies which are emerging as promising treatment alternatives for bladder cancer.

For instance, in 2023, the U.S. FDA approved a two-drug combination of pembrolizumab (EV/pemb ro) and enfortumab vedotin to treat metastatic urothelial bladder cancer. The results of clinical trial showed that EV/pembro was better than cisplatin-based combination chemotherapy as first-line treatment. The study results also highlighted a reduction of 55% in disease progression compared to cisplatin-based chemotherapy treatment.

Mayo Clinic is conducting another trial for a bladder cancer emerging drug and is under phase III. The study is being conducted to assess the efficacy of immunotherapy for treatment-resistant non-muscle-invasive bladder cancer.

The bladder cancer report assessment covers the pathophysiology and epidemiology of bladder cancer, developing treatment, and the progress and future aspects of ongoing clinical trials for the treatment of bladder cancer in detail.

Bladder Cancer - Drug Pipeline Therapeutic Assessment

This section of the bladder cancer report covers the analysis of bladder cancer drugs based on various segmentations such as:

By Phase

The pipeline assessment report covers 50+ drug analyses based on phase.
  • Late-Stage Products (Phase III and Phase IV)
  • Mid-Stage Products (Phase II)
  • Early-Stage Products (Phase I)
  • Preclinical and Discovery Stage Products

By Route of Administration

The bladder cancer therapeutic assessment report covers 50+ drug analyses based on the route of administration.
  • Oral
  • Parenteral
  • Others

Bladder Cancer - Pipeline Assessment Segmentation, By Phases

The bladder cancer report insights cover phase I, phase II, phase III, phase IV, and early phase drugs for bladder cancer. The coverage includes an in-depth analysis of each drug across these phases. According to analysis, phase II trials cover major share of the total bladder cancer clinical trials conducted.

National Cancer Institute (NCI) is conducting a phase II study of the drug - sorafenib to sylate to assess the efficacy for the treatment of advanced or metastatic cancer of the urinary tract.

Bladder Cancer -Pipeline Assessment Segmentation, By Route of Administration

The route of administration categories covered under bladder cancer pipeline landscape include oral, parenteral and others. The report covers a comparative analysis of the route of administration for each drug in various phases of clinical trials of bladder cancer. According to analysis, the parenteral route holds a significant market share-based route of administration.

Bladder Cancer Clinical Trials Analysis - Competitive Dynamics

The bladder cancer pipeline insight covers the profile of key companies involved in clinical trials and their drugs under development. Below is the list of a few players involved in bladder cancer clinical trials:
  • Endo Pharmaceuticals
  • Fidia Farmaceutici s.p.a.
  • TScan Therapeutics, Inc.
  • Bristol-Myers Squibb
  • AstraZeneca
  • BioNTech US Inc.
  • Eli Lilly and Company
  • F. Hoffmann-La Roche AG
  • Boehringer Ingelheim
  • Pfizer, Inc.
  • Others

Bladder Cancer - Emerging Drugs Profile

This section covers the detailed analysis of each drug under multiple phases including phase I, phase II, phase III, phase IV, and emerging drugs in the bladder cancer pipeline landscape. Moreover, the section covers product description, trial ID, study type, drug class, mode of administration, and recruitment status among others.

AU-011 - Aura Bios ciences

Aura Biosciences’ AU-011 is under phase I clinical trial, intended to assess the safety and feasibility against bladder cancer utilizing intratumoral injection.

BI 6727, IV infusion - Boehring er Ingelheim

Boehringer Ingelheim is conducting a clinical trial to evaluate the safety and efficacy of drug BI 6727 in patients with metastatic or recurrent urothelial cancer or locally advanced after failure of first-line chemotherapy. It is presently under phase II trial.

LOXO-435 - Eli Lilly and Com pany

LOXO-435 by Eli Lilly and Company is currently under phase I clinical trial. The study is conducted to know the safety, efficacy, and side effects of bladder cancer drug candidate LOXO-435. The drug may be used to treat cancer of the cells that line the urinary system.

Atezolizumab - Hoffmann-La Roche

The study is being conducted to evaluate the effects of atezolizumab treatment in participants with metastatic urothelial bladder or locally advanced.

Key Questions Answered in the Bladder Cancer - Pipeline Assessment Report

  • What is the current landscape of bladder cancer pipeline drugs?
  • Which companies/institutions are developing bladder cancer therapeutic drugs?
  • How many phase II drugs are currently present in bladder cancer pipeline drugs?
  • Which company is leading the bladder cancer pipeline development activities?
  • What is the current bladder cancer commercial assessment?
  • What are the opportunities and challenges present in the bladder cancer drug pipeline landscape?
  • What is the efficacy and safety profile of bladder cancer pipeline drugs?
  • Which companies/institutions are involved in bladder cancer collaborations aimed at providing enhanced therapeutic alternatives for patients?
  • What are the geographies covered for clinical trials in bladder cancer?

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Table of Contents

1 Preface
1.1 Introduction
1.2 Objectives of the Study
1.3 Research Methodology and Assumptions
2 Executive Summary
3 Overview of Bladder Cancer
3.1 Signs and Symptoms
3.2 Causes
3.3 Risk Factors
3.4 Types of Bladder Cancer
3.5 Diagnosis
3.6 Treatment
4 Patient Profile
4.1 Patient Profile Overview
4.2 Patient Psychology and Emotional Impact Factors
4.3 Risk Assessment and Treatment Success Rate
5 Bladder Cancer: Epidemiology Snapshot
5.1 Bladder Cancer Incidence by Key Markets
5.2 Bladder Cancer- Patients Seeking Treatment in Key Markets
6 Bladder Cancer: Market Dynamics
6.1 Market Drivers and Constraints
6.2 SWOT Analysis
7 Bladder Cancer: Key Facts Covered
7.1 Top Countries Contributing to Clinical Trials in Asia-Pacific
7.2 Top Countries Contributing to Clinical Trials in Europe
7.3 Top Countries Contributing to Clinical Trials in North America
7.4 Top Countries Contributing to Clinical Trials in Other Regions
8 Bladder Cancer, Drug Pipeline Assessment
8.1 Assessment by Treatment Type
8.2 Assessment by Route of Administration
8.3 Assessment by Drug Class
9 Drug Pipeline Comparative Analysis
9.1 List of Bladder Cancer Pipeline Drugs
9.1.1 By Company
9.1.2 By Phase
9.1.3 By Indication
9.1.4 By Trial Status
9.1.5 By Funder Type
9.2 Attribute Scoring Analysis of Pipeline Drugs (Top Drugs)
10 Bladder Cancer Drug Pipeline - Late-Stage Products (Phase III and IV) (Top Drugs)
10.1 Comparative Analysis for Late-Stage Drugs
10.1.1 Study Type
10.1.2 Recruitment Status
10.1.3 Company
10.1.4 Funder Type
10.2 Product Level Analysis*
10.2.1 TAR-200
10.2.1.1 Product Description
10.2.1.2 Trial ID
10.2.1.3 Sponsor Name
10.2.1.4 Study Type
10.2.1.5 Drug Class
10.2.1.6 Eligibility Criteria
10.2.1.7 Study Record Dates
10.2.1.7.1 First Submitted
10.2.1.7.2 First Posted
10.2.1.7.3 Last Update Posted
10.2.1.7.4 Last Verified
10.2.1.8 Indication
10.2.1.9 Study Design
10.2.1.10 Recruitment Status
10.2.1.11 Enrollment (Estimated)
10.2.1.12 Location Countries
10.2.1.13 Recent Results
10.2.2 Gemcitabine
10.2.3 Pembrolizumab
10.2.4 Nivolumab
10.2.5 Other Drug
11 Bladder Cancer Drug Pipeline - Mid-Stage Products (Phase II) (Top Drugs)
11.1 Comparative Analysis for Mid-Stage Drugs
11.1.1 Study Type
11.1.2 Recruitment Status
11.1.3 Company
11.1.4 Funder Type
11.2 Product Level Analysis*
11.2.1 Cabazitaxel
11.2.1.1 Product Description
11.2.1.2 Trial ID
11.2.1.3 Sponsor Name
11.2.1.4 Study Type
11.2.1.5 Drug Class
11.2.1.6 Eligibility Criteria
11.2.1.7 Study Record Dates
11.2.1.7.1 First Submitted
11.2.1.7.2 First Posted
11.2.1.7.3 Last Update Posted
11.2.1.7.4 Last Verified
11.2.1.8 Indication
11.2.1.9 Study Design
11.2.1.10 Recruitment Status
11.2.1.11 Enrollment (Estimated)
11.2.1.12 Location Countries
11.2.1.13 Recent Results
11.2.2 Nivolumab
11.2.3 Oncofid-P-B
11.2.4 Durvalumab
11.2.5 Other Drugs
12 Bladder Cancer Drug Pipeline - Early-Stage Products (Phase I) (Top Drugs)
12.1 Comparative Analysis for Early-Stage Drugs
12.1.1 Study Type
12.1.2 Recruitment Status
12.1.3 Company
12.1.4 Funder Type
12.2 Product Level Analysis*
12.2.1 Atezolizumab
12.2.1.1 Product Description
12.2.1.2 Trial ID
12.2.1.3 Sponsor Name
12.2.1.4 Study Type
12.2.1.5 Drug Class
12.2.1.6 Eligibility Criteria
12.2.1.7 Study Record Dates
12.2.1.7.1 First Submitted
12.2.1.7.2 First Posted
12.2.1.7.3 Last Update Posted
12.2.1.7.4 Last Verified
12.2.1.8 Indication
12.2.1.9 Study Design
12.2.1.10 Recruitment Status
12.2.1.11 Enrollment (Estimated)
12.2.1.12 Location Countries
12.2.2 Cabazitaxel
12.2.3 VAX014
12.2.4 Other Drugs
13 Bladder Cancer Drug Pipeline - Preclinical and Discovery Stage Products (Top Drugs)
13.1 Comparative Analysis for Preclinical and Discovery Stage Drugs
13.1.1 Study Type
13.1.2 Recruitment Status
13.1.3 Company
13.1.4 Funder Type
13.2 Product Level Analysis*
13.2.1 FL-101
13.2.1.1 Product Description
13.2.1.2 Trial ID
13.2.1.3 Sponsor Name
13.2.1.4 Study Type
13.2.1.5 Drug Class
13.2.1.6 Eligibility Criteria
13.2.1.7 Study Record Dates
13.2.1.7.1 First Submitted
13.2.1.7.2 First Posted
13.2.1.7.3 Last Update Posted
13.2.1.7.4 Last Verified
13.2.1.8 Indication
13.2.1.9 Study Design
13.2.1.10 Recruitment Status
13.2.1.11 Enrollment (Estimated)
13.2.1.12 Location Countries
13.2.2 Abemaciclib
13.2.3 re-TURBT
13.2.4 18F-fluciclovine
13.2.5 Other Drugs
14 Bladder Cancer, Key Drug Pipeline Companies
14.1 Endo Pharmaceuticals
14.1.1 Company Snapshot
14.1.2 Pipeline Product Portfolio
14.1.3 Financial Analysis
14.1.4 Recent News and Developments
14.2 Fidia Farmaceutici s.p.a.
14.2.1 Company Snapshot
14.2.2 Pipeline Product Portfolio
14.2.3 Financial Analysis
14.2.4 Recent News and Developments
14.3 TScan Therapeutics, Inc.
14.3.1 Company Snapshot
14.3.2 Pipeline Product Portfolio
14.3.3 Financial Analysis
14.3.4 Recent News and Developments
14.4 Bristol-Myers Squibb
14.4.1 Company Snapshot
14.4.2 Pipeline Product Portfolio
14.4.3 Financial Analysis
14.4.4 Recent News and Developments
14.5 AstraZeneca
14.5.1 Company Snapshot
14.5.2 Pipeline Product Portfolio
14.5.3 Financial Analysis
14.5.4 Recent News and Developments
14.6 BioNTech US Inc.
14.6.1 Company Snapshot
14.6.2 Pipeline Product Portfolio
14.6.3 Financial Analysis
14.6.4 Recent News and Developments
14.7 Eli Lilly and Company
14.7.1 Company Snapshot
14.7.2 Pipeline Product Portfolio
14.7.3 Financial Analysis
14.7.4 Recent News and Development
14.8 Hoffmann-La Roche
14.8.1 Company Snapshot
14.8.2 Pipeline Product Portfolio
14.8.3 Financial Analysis
14.8.4 Recent News and Development
14.9 Boehringer Ingelheim
14.9.1 Company Snapshot
14.9.2 Pipeline Product Portfolio
14.9.3 Financial Analysis
14.9.4 Recent News and Development
14.10 Pfizer, Inc.
14.10.1 Company Snapshot
14.10.2 Pipeline Product Portfolio
14.10.3 Financial Analysis
14.10.4 Recent News and Developments
15 Regulatory Framework for Drug Approval, By Region16 Terminated or Suspended Pipeline Products