Bladder Cancer Pipeline Insight

DelveInsight’s, “Bladder cancer - Pipeline Insight, 2023,” report provides comprehensive insights about 100+ companies and 100+ pipeline drugs in 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

Bladder cancer Understanding

Bladder cancer: Overview

Bladder cancer is a disease that usually begins in the cells that line the inside of the bladder. It typically affects people older than 70 and occurs more often in men. Bladder cancer is the fifth most common form of cancer overall and the fourth most common among men. Bladder cancer usually responds well to treatment when diagnosed early. However, people who have been successfully treated for bladder cancer should be monitored afterward. Bladder cancer can return even years later. About 90 percent of bladder cancers begin in the cells on the surface of the bladder’s inner lining. This type of cancer is called urothelial carcinoma (also called transitional cell carcinoma). Most urothelial carcinoma is non-muscle invasive. That means the cancer stays within the bladder’s inner lining. Less common types of bladder cancer include squamous cell carcinoma, adenocarcinoma, and small cell carcinoma. These types can develop in the inner lining as a result of chronic irritation and inflammation. They usually grow into the muscle of the bladder over time. In most cases, the first sign of bladder cancer is blood in the urine. Other symptoms may include feeling pain or burning during urination or a change in urination habits. This can include frequent urination or a need to go but being unable to pass urine. More-advanced bladder cancer may involve lower back pain on one side, feeling tired or weak, or having no appetite and losing weight. Tobacco use is by far the biggest risk factor for developing bladder cancer. People who smoke cigarettes are up to four times more likely than nonsmokers to develop the disease. Studies have shown that smoking is responsible for approximately 50 percent of bladder cancers.


"Bladder cancer - Pipeline Insight, 2023" report by DelveInsight outlays comprehensive insights of present scenario and growth prospects across the indication. A detailed picture of the Bladder cancer pipeline landscape is provided which includes the disease overview and Bladder cancer treatment guidelines. The assessment part of the report embraces, in depth 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, Bladder cancer collaborations, licensing, mergers and acquisition, funding, designations and other product related details.

Report Highlights

  • A better understanding of disease pathogenesis contributing to the development of novel therapeutics for Bladder cancer.   
  • In the coming years, the Bladder cancer market is set to change due to the rising awareness of the disease, and incremental healthcare spending across the world; which would expand the size of the market to enable the drug manufacturers to penetrate more into the market.
  • The companies and academics that are working to assess challenges and seek opportunities that could influence Bladder cancer R&D. The therapies under development are focused on novel approaches to treat/improve the disease condition.
  • A detailed portfolio of major pharma players who are involved in fueling the Bladder cancer treatment market. Several potential therapies for Bladder cancer are under investigation. With the expected launch of these emerging therapies, it is expected that there will be a significant impact on the Bladder cancer market size in the coming years. 
  • Our in-depth analysis of the pipeline assets (in early-stage, mid-stage and late stage of development for the treatment of Bladder cancer) includes therapeutic assessment and comparative analysis. This will support the clients in the decision-making process regarding their therapeutic portfolio by identifying the overall scenario of the research and development activities.

Bladder cancer Emerging Drugs Chapters

This segment of the 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.


Bladder cancer Emerging Drugs


CG0070: CG Oncology

CG0070 is an investigational oncolytic immunotherapy based on a modified common cold adenovirus backbone that contains a cancer-specific promoter and a GM-CSF transgene. CG0070 was designed to work in two important and complementary ways. First, it replicates inside the tumor’s cells causing tumor cell lysis and immunogenic cell death. Then, the rupture of the cancer cells can release tumor-derived antigens, along with GM-CSF, that can stimulate a systemic anti-tumor immune response that involves the body’s own white blood cells. The scientific rationale and clinical profile of CG0070 make it an ideal agent to be developed for a variety of solid tumor types to be used alone or in combination with immune checkpoint modulators.


N-803: ImmunityBio

The cytokine interleukin-15 (IL-15) plays a crucial role in the immune system by affecting the development, maintenance, and function of the natural killer (NK) and T cells. N-803 is a novel IL-15 superagonist complex consisting of an IL-15 mutant (IL-15N72D) bound to an IL-15 receptor α/IgG1 Fc fusion protein. Its mechanism of action is direct specific stimulation of CD8+ T cells and NK cells through beta gamma T-cell receptor binding (not alpha) while avoiding T-reg stimulation. N-803 has improved pharmacokinetic properties, longer persistence in lymphoid tissues and enhanced anti-tumor activity compared to native, non-complexed IL-15 in vivo. N-803 is currently being evaluated for adult patients in two clinical NMIBC trials. QUILT 2005 is investigating use of N-803 in combination with BCG for patients with BCG-naïve NMIBC; QUILT 3032 is studying N-803 in combination with BCG in patients with BCG-unresponsive NMIBC CIS and Papillary Disease. In May 2022, ImmunityBio, Inc. announced it had submitted a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for N-803, a first-in-class IL-15 superagonist, plus Bacillus Calmette-Guérin (BCG) for the treatment of BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) carcinoma in situ (CIS) with or without Ta or T1 disease.


UGN-102: UroGen

UroGen is developing UGN-102 (mitomycin) for intravesical solution as a primary nonsurgical alternative to repetitive TURBT. UGN-102 is an investigational formulation that utilizes our innovative technology, RTGel™ reverse-thermal hydrogel, for the treatment of low-grade NMIBC. Instilled via standard catheters, UGN-102 is designed to dwell for a period of several hours before being excreted via normal urine flow.


Trilaciclib: G1 Therapeutics

Trilaciclib, an IV-administered transient CDK4/6 inhibitor, is a first-in-class therapy designed to preserve bone marrow and immune system function during chemotherapy to improve patient outcomes. The company is currently enrolling patients in PRESERVE 3, Phase 2, randomized, open-label study of trilaciclib administered with first-line platinum-based chemotherapy and the immune checkpoint inhibitor avelumab maintenance therapy in patients with untreated, locally advanced or metastatic urothelial carcinoma (mUC). Myeloprotection and anti-tumor efficacy endpoints are being assessed in this study.

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

Bladder cancer: Therapeutic Assessment

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


Major Players in Bladder cancer

There are approx. 100+ key companies which are developing the therapies for Bladder cancer. The companies which have their Bladder cancer drug candidates in the most advanced stage, i.e. phase III include, CG Oncology.



DelveInsight’s report covers around 100+ 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

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

  • Inhalation
  • Inhalation/Intravenous/Oral
  • Intranasal
  • Intravenous
  • Intravenous/ Subcutaneous
  • NA
  • Oral
  • Oral/intranasal/subcutaneous
  • Parenteral
  • Subcutaneous


Molecule Type

Products have been categorized under various Molecule types such as

  • Antibody
  • Antisense oligonucleotides
  • Immunotherapy
  • Monoclonal antibody
  • Peptides
  • Protein
  • Recombinant protein
  • Small molecule
  • Stem Cell
  • Vaccine


Product Type

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

Bladder cancer: Pipeline Development Activities

The report provides insights into different therapeutic candidates in phase II, I, preclinical and discovery stage. It also analyses 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 Bladder cancer drugs.

Bladder cancer Report Insights

  • Bladder cancer Pipeline Analysis
  • Therapeutic Assessment
  • Unmet Needs
  • Impact of Drugs

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 Bladder cancer drugs?
  • How many 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 Bladder cancer?
  • What are the key collaborations (Industry–Industry, Industry–Academia), Mergers and acquisitions, licensing activities related to the 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 Bladder cancer and their status?
  • What are the key designations that have been granted to the emerging drugs?


Executive Summary

Bladder cancer: Overview

  • Causes
  • Mechanism of Action
  • Signs and Symptoms
  • Diagnosis
  • Disease Management

Pipeline Therapeutics

  • Comparative Analysis

Therapeutic Assessment

  • Assessment by Product Type
  • Assessment by Stage and Product Type
  • Assessment by Route of Administration
  • Assessment by Stage and Route of Administration
  • Assessment by Molecule Type
  • Assessment by Stage and Molecule Type

Bladder cancer – DelveInsight’s Analytical Perspective

Late Stage Products (Phase III)

  • Comparative Analysis

CG0070: CG Oncology

  • Product Description
  • Research and Development
  • Product Development Activities

Drug profiles in the detailed report…..

Mid Stage Products (Phase II)

  • Comparative Analysis

Trilaciclib: G1 Therapeutics

  • Product Description
  • Research and Development
  • Product Development Activities

Drug profiles in the detailed report…..

Early Stage Products (Phase I)

  • Comparative Analysis

MV-NIS: Vyriad

  • Product Description
  • Research and Development
  • Product Development Activities

Drug profiles in the detailed report…..

Preclinical and Discovery Stage Products

  • Comparative Analysis

FEP 633: PRISM BioLab

  • Product Description
  • Research and Development
  • Product Development Activities

Drug profiles in the detailed report…..

Inactive Products

  • Comparative Analysis

Bladder cancer Key Companies

Bladder cancer Key Products

Bladder cancer- Unmet Needs

Bladder cancer- Market Drivers and Barriers

Bladder cancer- Future Perspectives and Conclusion

Bladder cancer Analyst Views

Bladder cancer Key Companies


List of Table

Table 1: Total Products for Bladder cancer

Table 2: Late Stage Products

Table 3: Mid Stage Products

Table 4: Early Stage Products

Table 5: Pre-clinical & Discovery Stage Products

Table 6: Assessment by Product Type

Table 7: Assessment by Stage and Product Type

Table 8: Assessment by Route of Administration

Table 9: Assessment by Stage and Route of Administration

Table 10: Assessment by Molecule Type

Table 11: Assessment by Stage and Molecule Type                                              

Table 12: Inactive Products

List of Figures

Figure 1: Total Products for Bladder cancer

Figure 2: Late Stage Products                             

Figure 3: Mid Stage Products

Figure 4: Early Stage Products

Figure 5: Preclinical and Discovery Stage Products

Figure 6: Assessment by Product Type                                                                       

Figure 7: Assessment by Stage and Product Type

Figure 8: Assessment by Route of Administration

Figure 9: Assessment by Stage and Route of Administration

Figure 10: Assessment by Molecule Type

Figure 11: Assessment by Stage and Molecule Type

Figure 12: Inactive Products

• CG Oncology
• ImmunityBio
• UroGen
• G1 Therapeutics
• FKD Therapies
• Bristol-Myers Squibb
• LintonPharm Co.,Ltd.
• Nektar Therapeutics
• Hamlet Pharma AB
• Asieris Pharmaceuticals
• Wuhan Binhui Biotechnology
• Pfizer
• Taizhou Hanzhong biomedical co. LTD
• Hoffmann-La Roche
• Protara Therapeutics
• AstraZeneca
• CicloMed LLC
• enGene, Inc.
• Emtora Biosciences
• Qilu Pharmaceutical Co., Ltd.
• Theralase Inc.
• Vaxiion Therapeutics
• Janssen Research & Development, LLC
• Seagen Inc.
• RemeGen Co., Ltd.
• Taiho Oncology, Inc.
• Xennials Therapeutics
• Flame Biosciences
• Lindis Biotech
• Incyte Corporation
• Eli Lilly and Company
• Daiichi Sankyo
• Nektar Therapeutics
• Pieris Pharmaceuticals, Inc.
• Istari Oncology, Inc.
• BeiGene
• Vyriad, Inc.
• Adlai Nortye Biopharma Co., Ltd.
• Kyowa Kirin, Inc.
• Infinity Pharmaceuticals, Inc.
• Shanghai Hengrui Pharmaceutical Co., Ltd.
• HiberCell, Inc.
• Ikena Oncology
• Fusion Pharmaceuticals Inc.
• GI Innovation, Inc.
• SOTIO a.s.
• Celon Pharma SA
• Shanghai PerHum Therapeutics Co., Ltd.
• 4D Pharma PLC


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