Non-Muscle Invasive Bladder Cancer Market Set to Grow Substantially Through 2034, DelveInsight Projects | CG Oncology, Pfizer, UroGen Pharma, Janssen Research & Development, LLC, Protara Therapeutics

The Key Non-Muscle Invasive Bladder Cancer Companies in the market include - CG Oncology, Pfizer, UroGen Pharma, Janssen Research & Development, LLC, Protara Therapeutics, Binhui Biopharmaceutical, SURGE Therapeutics, Pfizer, AstraZeneca, ImmunityBio, Inc., Guarionex J. Decastro, Janssen Research & Development, Tollys, Aura Biosciences, Vaxiion Therapeutics, Incyte Corporation, Janssen Pharmaceuticals, Theralase Technologies, BristolMyers Squibb, Asieris Pharmaceuticals, and others.

DelveInsight's "Non-Muscle Invasive Bladder Cancer Market Insights, Epidemiology, and Market Forecast-2034 report offers an in-depth understanding of the Non-Muscle Invasive Bladder Cancer, historical and forecasted epidemiology as well as the Non-Muscle Invasive Bladder Cancer market trends in the United States, EU4 (Germany, Spain, Italy, France) the United Kingdom and Japan.

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Some of the key facts of the Non-Muscle Invasive Bladder Cancer Market Report:

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The Non-Muscle Invasive Bladder Cancer market size was valued ~USD 2,350 million in 2023 and is anticipated to grow with a significant CAGR during the study period (2020-2034)

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In January 2025, Pfizer Inc. (NYSE: PFE) has reported positive topline results from its Phase 3 CREST trial, which evaluated sasanlimab, an investigational anti-PD-1 monoclonal antibody, in combination with Bacillus Calmette-Guerin (BCG) for patients with BCG-naive, high-risk non-muscle invasive bladder cancer (NMIBC). The trial achieved its primary endpoint of event-free survival (EFS), as determined by investigators, demonstrating a statistically significant and clinically meaningful improvement when sasanlimab was combined with BCG (both induction and maintenance) compared to BCG alone.

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In January 2025, Tyra Biosciences, Inc. (Nasdaq: TYRA), a clinical-stage biotech company focused on next-generation precision therapies targeting FGFR (Fibroblast Growth Factor Receptor) biology, announced that the U.S. FDA has cleared its Investigational New Drug (IND) application for TYRA-300. This clearance enables the initiation of a Phase 2 clinical trial for patients with low-grade, intermediate-risk non-muscle invasive bladder cancer (IR NMIBC). The trial will be overseen by Dr. Erik Goluboff, recently appointed as SVP of Clinical Development, who brings over three decades of expertise in urologic oncology and drug development.

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In October 2024, Aura Biosciences, Inc. (NASDAQ: AURA) shared promising early data from its ongoing Phase 1 clinical trial of bel-sar (AU-011) in patients with non-muscle invasive bladder cancer (NMIBC). So far, 13 patients have been enrolled, with the study's primary focus on evaluating the safety and feasibility of locally administered bel-sar-both as a monotherapy (n=5) and in combination with light activation (n=8). Secondary objectives involve assessing biological activity and immune-related changes in the tumor microenvironment. Of the patients enrolled, 10 had low-grade and 3 had high-grade disease, consistent with the typical distribution in NMIBC. In the light-activated bel-sar group, 4 out of 5 low-grade patients achieved a clinical complete response (no tumor cells detected on histopathology), while 2 out of 3 high-grade patients demonstrated visible tumor reduction on cystoscopy.

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In October 2024, UroGen Pharma initiated dosing in its Phase III UTOPIA clinical trial, marking the administration of the first dose of its investigational therapy, UGN-103 (mitomycin). This intravesical solution is being developed to treat low-grade, intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC). The study aims to enroll 87 patients and will assess both the efficacy and safety of UGN-103 as a potential treatment option for this form of bladder cancer.

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Among all risk categories, high-risk NMIBC had the largest market size in the 7MM, reaching approximately USD 1,600 million in 2023.

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In the seven major markets (7MM), the United States recorded the highest number of cases in 2023, totaling approximately 600,000 prevalent cases. It is anticipated that these cases will continue to rise throughout the forecast period.

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As per the projections, in Japan, NMIBC was most commonly found in the age group of 70-89, constituting roughly 60% of the total cases observed in 2023.

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According to DelveInsight's projections, approximately 600,000 prevalent cases of NMIBC were reported in the US in 2023.

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As indicated by the American Urological Association and European Association of Urology, Non-Muscle Invasive Bladder Cancer (NMIBC) constitutes around 75% of all bladder cancer cases.

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As per Valenza et al. (2022), approximately 20-40% of patients experience disease recurrences or persistence after undergoing BCG treatment, leading to their classification as BCG unresponsive.

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Key Non-Muscle Invasive Bladder Cancer Companies: CG Oncology, Pfizer, UroGen Pharma, Janssen Research & Development, LLC, Protara Therapeutics, Binhui Biopharmaceutical, SURGE Therapeutics, Pfizer, AstraZeneca, ImmunityBio, Inc., Guarionex J. Decastro, Janssen Research & Development, Tollys, Aura Biosciences, Vaxiion Therapeutics, Incyte Corporation, Janssen Pharmaceuticals, Theralase Technologies, BristolMyers Squibb, Asieris Pharmaceuticals, and others

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Key Non-Muscle Invasive Bladder Cancer Therapies: CG0070, Sasanlimab (PF-06801591), UGN-102 (mitomycin), TAR-200, TARA-002, OH2 injection, STM-416, Durvalumab, BCG+N-803, Cabazitaxel, Cetrelimab, TL-532, AU-011, VAX 014, Pemigatinib, Erdafitinib, TLD 1433, Nivolumab, APL-1202, and others

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The Non-Muscle Invasive Bladder Cancer market is expected to surge due to the disease's increasing prevalence and awareness during the forecast period. Furthermore, launching various multiple-stage Non-Muscle Invasive Bladder Cancer pipeline products will significantly revolutionize the Non-Muscle Invasive Bladder Cancer market dynamics.

Non-Muscle Invasive Bladder Cancer Overview

Non-Muscle Invasive Bladder Cancer (NMIBC) refers to a type of bladder cancer where the tumor is confined to the inner lining of the bladder and has not spread to the muscle layer. It is the most common form of bladder cancer, often detected through blood in the urine or urinary symptoms. Treatment typically involves transurethral resection, followed by surveillance for recurrence.

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Non-Muscle Invasive Bladder Cancer Epidemiology

The epidemiology section provides insights into the historical, current, and forecasted epidemiology trends in the seven major countries (7MM) from 2020 to 2034. It helps to recognize the causes of current and forecasted trends by exploring numerous studies and views of key opinion leaders. The epidemiology section also provides a detailed analysis of the diagnosed patient pool and future trends.

Non-Muscle Invasive Bladder Cancer Epidemiology Segmentation:

The Non-Muscle Invasive Bladder Cancer market report proffers epidemiological analysis for the study period 2020-2034 in the 7MM segmented into:

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Total Prevalence of Non-Muscle Invasive Bladder Cancer

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Prevalent Cases of Non-Muscle Invasive Bladder Cancer by severity

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Gender-specific Prevalence of Non-Muscle Invasive Bladder Cancer

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Diagnosed Cases of Episodic and Chronic Non-Muscle Invasive Bladder Cancer

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Non-Muscle Invasive Bladder Cancer Drugs Uptake and Pipeline Development Activities

The drugs uptake section focuses on the rate of uptake of the potential drugs recently launched in the Non-Muscle Invasive Bladder Cancer market or expected to get launched during the study period. The analysis covers Non-Muscle Invasive Bladder Cancer market uptake by drugs, patient uptake by therapies, and sales of each drug.

Moreover, the therapeutics assessment section helps understand the drugs with the most rapid uptake and the reasons behind the maximal use of the drugs. Additionally, it compares the drugs based on market share.

The report also covers the Non-Muscle Invasive Bladder Cancer Pipeline Development Activities. It provides valuable insights about different therapeutic candidates in various stages and the key companies involved in developing targeted therapeutics. It also analyzes recent developments such as collaborations, acquisitions, mergers, licensing patent details, and other information for emerging therapies.

Non-Muscle Invasive Bladder Cancer Therapies and Key Companies

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CG0070: CG Oncology

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Sasanlimab (PF-06801591): Pfizer

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UGN-102 (mitomycin): UroGen Pharma

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TAR-200: Janssen Research & Development, LLC

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TARA-002: Protara Therapeutics

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OH2 injection: Binhui Biopharmaceutical

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STM-416: SURGE Therapeutics

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Durvalumab: AstraZeneca

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BCG+N-803: ImmunityBio, Inc.

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Cabazitaxel: Guarionex J. Decastro

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Cetrelimab: Janssen Research & Development

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TL-532: Tollys

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AU-011: Aura Biosciences

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VAX 014: Vaxiion Therapeutics

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Pemigatinib: Incyte Corporation

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Erdafitinib: Janssen Pharmaceuticals

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TLD 1433: Theralase Technologies

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Nivolumab: BristolMyers Squibb

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APL-1202: Asieris Pharmaceuticals

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Non-Muscle Invasive Bladder Cancer Market Strengths

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Potent ICI-based gene therapies can alter the disease trajectory, halting its advancement to advanced stages-an impactful stride in managing NMIBC. Their potential to fulfill approval criteria further underscores their pivotal role in advancing NMIBC treatment.

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Sasanlimab's ease of subcutaneous administration and compelling clinical effectiveness position it as a standout candidate in the evolving field of cancer immunotherapy.

Non-Muscle Invasive Bladder Cancer Market Opportunities

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The growing focus on research and development to introduce biomarkers for improved diagnosis and the exploration of combination therapy with BCG presents a promising opportunity in the NMIBC market.

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The emergence of innovative treatments like CG0070, N-803, non-viral plasmid based therapy, and others signifies a promising advancement in NMIBC treatment. These therapies offer targeted and innovative approaches to address cancer.

Scope of the Non-Muscle Invasive Bladder Cancer Market Report

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Study Period: 2020-2034

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Coverage: 7MM [The United States, EU5 (Germany, France, Italy, Spain, and the United Kingdom), and Japan]

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Key Non-Muscle Invasive Bladder Cancer Companies: CG Oncology, Pfizer, UroGen Pharma, Janssen Research & Development, LLC, Protara Therapeutics, Binhui Biopharmaceutical, SURGE Therapeutics, Pfizer, AstraZeneca, ImmunityBio, Inc., Guarionex J. Decastro, Janssen Research & Development, Tollys, Aura Biosciences, Vaxiion Therapeutics, Incyte Corporation, Janssen Pharmaceuticals, Theralase Technologies, BristolMyers Squibb, Asieris Pharmaceuticals, and others

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Key Non-Muscle Invasive Bladder Cancer Therapies: CG0070, Sasanlimab (PF-06801591), UGN-102 (mitomycin), TAR-200, TARA-002, OH2 injection, STM-416, Durvalumab, BCG+N-803, Cabazitaxel, Cetrelimab, TL-532, AU-011, VAX 014, Pemigatinib, Erdafitinib, TLD 1433, Nivolumab, APL-1202, and others

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Non-Muscle Invasive Bladder Cancer Therapeutic Assessment: Non-Muscle Invasive Bladder Cancer current marketed and Non-Muscle Invasive Bladder Cancer emerging therapies

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Non-Muscle Invasive Bladder Cancer Market Dynamics: Non-Muscle Invasive Bladder Cancer market drivers and Non-Muscle Invasive Bladder Cancer market barriers

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Competitive Intelligence Analysis: SWOT analysis, PESTLE analysis, Porter's five forces, BCG Matrix, Market entry strategies

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Non-Muscle Invasive Bladder Cancer Unmet Needs, KOL's views, Analyst's views, Non-Muscle Invasive Bladder Cancer Market Access and Reimbursement

To know more about Non-Muscle Invasive Bladder Cancer companies working in the treatment market, visit @ Non-Muscle Invasive Bladder Cancer Clinical Trials and Therapeutic Assessment [https://www.delveinsight.com/sample-request/non-muscle-invasive-bladder-cancer-market?utm_source=abnewswire&utm_medium=promotion&utm_campaign=gpr]

Table of Contents

1. Non-Muscle Invasive Bladder Cancer Market Report Introduction

2. Executive Summary for Non-Muscle Invasive Bladder Cancer

3. SWOT analysis of Non-Muscle Invasive Bladder Cancer

4. Non-Muscle Invasive Bladder Cancer Patient Share (%) Overview at a Glance

5. Non-Muscle Invasive Bladder Cancer Market Overview at a Glance

6. Non-Muscle Invasive Bladder Cancer Disease Background and Overview

7. Non-Muscle Invasive Bladder Cancer Epidemiology and Patient Population

8. Country-Specific Patient Population of Non-Muscle Invasive Bladder Cancer

9. Non-Muscle Invasive Bladder Cancer Current Treatment and Medical Practices

10. Non-Muscle Invasive Bladder Cancer Unmet Needs

11. Non-Muscle Invasive Bladder Cancer Emerging Therapies

12. Non-Muscle Invasive Bladder Cancer Market Outlook

13. Country-Wise Non-Muscle Invasive Bladder Cancer Market Analysis (2020-2034)

14. Non-Muscle Invasive Bladder Cancer Market Access and Reimbursement of Therapies

15. Non-Muscle Invasive Bladder Cancer Market Drivers

16. Non-Muscle Invasive Bladder Cancer Market Barriers

17. Non-Muscle Invasive Bladder Cancer Appendix

18. Non-Muscle Invasive Bladder Cancer Report Methodology

19. DelveInsight Capabilities

20. Disclaimer

21. About DelveInsight

About DelveInsight

DelveInsight is a leading Healthcare Business Consultant, and Market Research firm focused exclusively on life sciences. It supports Pharma companies by providing comprehensive end-to-end solutions to improve their performance.

It also offers Healthcare Consulting Services, which benefits in market analysis to accelerate the business growth and overcome challenges with a practical approach.

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