Non-Muscle Invasive Bladder Cancer Market: Epidemiology, Therapies, Companies, DelveInsight | FKD Therapies Oy/Ferring Pharmaceuticals, Merck, Viventia Bio/Sesen Bio, CG Oncology, ImmunityBio/Altor Biosciences, Theralase

Non-Muscle Invasive Bladder Cancer therapies are expected to boost the Non-Muscle Invasive Bladder Cancer Market in the upcoming years.

DelveInsight has launched a new report on "Non-Muscle Invasive Bladder Cancer - Market Insights, Epidemiology, and Market Forecast-2034" that delivers 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, EU5 (Germany, Spain, Italy, France, and United Kingdom) and Japan.

Discover about the Non-Muscle Invasive Bladder Cancer market report @ https://www.delveinsight.com/report-store/non-muscle-invasive-bladder-cancer-market?utm_source=openpr&utm_medium=pressrelease&utm_campaign=kpr

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

In 2023, the Non-Muscle Invasive Bladder Cancer (NMIBC) therapeutics market in the 7 major markets (7MM) was valued at approximately USD 2,350 million, with projections indicating steady growth driven by rising disease prevalence, the entry of premium-priced therapies, and increased participation by pharmaceutical companies. High-risk NMIBC represented the largest market share, accounting for around USD 1,600 million in 2023. Standard treatment options currently include surgical intervention, intravesical immunotherapy (such as BCG), and intravesical chemotherapy.
Approved June 12, 2025 as the first nonsurgical, intravesical treatment for adults with recurrent low‐grade, intermediate‐risk NMIBC.
To date, the FDA has approved only three drugs specifically for NMIBC in the U.S.: KEYTRUDA (pembrolizumab) in 2020, ADSTILADRIN (nadofaragene firadenovec-vncg) in 2022, and ANKTIVA (nogapendekin alfa inbakicept-pmln) in 2024. However, a persistent shortage of BCG, which has long been the frontline treatment for high-risk NMIBC, continues to impact patient care. This scarcity, pre-dating the COVID-19 pandemic, has pushed clinicians toward alternatives such as gemcitabine and docetaxel combination therapy. A strategic alliance between the Serum Institute of India and ImmunityBio aims to alleviate this issue by ensuring the availability of traditional BCG and advancing recombinant BCG development.
The NMIBC therapeutic pipeline is robust, featuring promising candidates such as CG0070 (CG Oncology), Sasanlimab (Pfizer), EG-70 (enGene), UGN-102 (Urogen), Ruvidar (Theralase), TAR-210, and TAR-200 (Johnson & Johnson). While most companies are concentrating on high and intermediate-risk NMIBC, the low-risk segment has seen limited focus. Among the most anticipated therapies is UGN-102, which, if approved, could shift treatment standards for low-grade, intermediate-risk NMIBC from repetitive surgeries to a minimally invasive, non-surgical alternative. With its early clinical success, UGN-102 is positioned to gain a competitive edge over upcoming entrants like Cretostimogene and ADSTILADRIN in the intermediate-risk segment.
Among the seven major markets (7MM), the United States recorded the highest prevalence of non-muscle invasive bladder cancer in 2023, with approximately 616,000 cases. This number is projected to rise over the forecast period.
The expansion of innovative treatment options for NMIBC introduces complexity in choosing the most effective regimen and treatment sequence due to differing mechanisms of action and efficacy profiles. This underscores the importance of personalized treatment approaches, which consider disease characteristics, available therapies, patient-specific factors, and predictive biomarkers. Additionally, advancements in medical device technology are optimizing drug delivery; for instance, TAR-200 and TAR-210 utilize hyperthermia or electromotive administration to improve the intravesical absorption of gemcitabine and erdafitinib, respectively.
Key Non-Muscle Invasive Bladder Cancer companies such as FKD Therapies Oy/Ferring Pharmaceuticals, Merck, Viventia Bio/Sesen Bio, CG Oncology, ImmunityBio/Altor Biosciences, Theralase, and others are evaluating new drugs for Non-Muscle Invasive Bladder Cancer to improve the treatment landscape.

Non-Muscle Invasive Bladder Cancer Overview

Non-muscle invasive bladder cancer (NMIBC) refers to a form of bladder cancer in which the tumor remains limited to the bladder's innermost lining and has not penetrated the muscular wall. As an early-stage disease, NMIBC constitutes a large portion of all bladder cancer diagnoses and is typically marked by superficial growths such as papillary tumors or carcinoma in situ. Despite being non-invasive, NMIBC has a high risk of recurrence and potential for progression, making close and continuous management crucial. Standard treatment includes transurethral resection of the tumor (TURBT), followed by intravesical therapies like BCG immunotherapy or chemotherapy. Ongoing monitoring with regular cystoscopic evaluations and strict adherence to clinical guidelines are vital for effective disease control and long-term outcomes.
Non-Muscle Invasive Bladder Cancer Market Outlook

Non-muscle invasive bladder cancer (NMIBC) continues to pose significant treatment challenges due to its high rates of recurrence and progression despite available therapies. These limitations necessitate lifelong active surveillance, contributing to bladder cancer being the most costly malignancy to manage from diagnosis to end of life. This economic and clinical burden underscores the urgent need for more effective therapeutic options for NMIBC patients.

Current treatment strategies for NMIBC include surgical tumor removal via transurethral resection (TURBT), followed by intravesical therapies such as BCG immunotherapy or chemotherapy. For intermediate- or high-risk cases, TURBT is typically followed by BCG, which remains the gold standard for reducing recurrence and preventing disease progression. In cases of Stage 0 NMIBC, TURBT with fulguration may be followed by intravesical treatment within 24 hours, although some patients may not require additional therapy. Regular cystoscopic surveillance every 3-6 months is essential for early detection of recurrence.

To date, the U.S. FDA has approved only three drugs specifically for NMIBC treatment: KEYTRUDA (2020), ADSTILADRIN (2022), and the most recent, ANKTIVA (April 2024)-all of which are currently approved only in the U.S.

Managing BCG-unresponsive NMIBC remains particularly difficult in clinical practice. Around 25% of physicians' NMIBC patients are unresponsive to BCG, making them ineligible for continued BCG treatment. Additionally, nearly one-third of NMIBC patients had not yet received BCG, often due to pending treatment post-TURBT. The global shortage of BCG has further complicated treatment, reducing the ability to provide adequate induction and maintenance therapy, ultimately leading to increased recurrence and treatment failure rates.

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Marketed Non Muscle Invasive Bladder Cancer Drugs

ADSTILADRIN (nadofaragene firadenovec): Ferring Pharmaceuticals/FKD Therapies Oy
ANKTIVA (nogapendekin alfa inbakicept-pmln): ImmunityBio

Emerging Non-muscle Invasive Bladder Cancer Drugs

CG0070 (cretostimogene grenadenorepvec): CG Oncology
Sasanlimab (PF-06801591): Pfizer

Scope of the Non-Muscle Invasive Bladder Cancer Market Report
Study Period: 2020-2034
Coverage: 7MM [The United States, EU5 (Germany, France, Italy, Spain, and the United Kingdom), and Japan]
Key Non-Muscle Invasive Bladder Cancer Companies: FKD Therapies Oy/Ferring Pharmaceuticals, Merck, Viventia Bio/Sesen Bio, CG Oncology, ImmunityBio/Altor Biosciences, Theralase, and others
Non-Muscle Invasive Bladder Cancer Therapeutic Assessment: Non-Muscle Invasive Bladder Cancer current marketed and Non-Muscle Invasive Bladder Cancer emerging therapies
Non-Muscle Invasive Bladder Cancer Market Dynamics: Non-Muscle Invasive Bladder Cancer market drivers and Non-Muscle Invasive Bladder Cancer market barriers
Competitive Intelligence Analysis: SWOT analysis, PESTLE analysis, Porter's five forces, BCG Matrix, Market entry strategies
Non-Muscle Invasive Bladder Cancer Unmet Needs, KOL's views, Analyst's views, Non-Muscle Invasive Bladder Cancer Market Access and Reimbursement

To know what's more in our Non-Muscle Invasive Bladder Cancer report, visit https://www.delveinsight.com/report-store/non-muscle-invasive-bladder-cancer-market?utm_source=openpr&utm_medium=pressrelease&utm_campaign=kpr

Key benefits of the Non-Muscle Invasive Bladder Cancer Market Report:
The Non-Muscle Invasive Bladder Cancer market report covers a descriptive overview and comprehensive insight of the Non-Muscle Invasive Bladder Cancer Epidemiology and Non-Muscle Invasive Bladder Cancer market in the 7MM (the United States, EU5 (Germany, Spain, France, Italy, UK) & Japan).
The Non-Muscle Invasive Bladder Cancer market report provides insights into the current and emerging therapies.
The Non-Muscle Invasive Bladder Cancer market report provides a global historical and forecasted market covering drug outreach in 7MM.
The Non-Muscle Invasive Bladder Cancer market report offers an edge that will help in developing business strategies by understanding trends shaping and driving the Non-Muscle Invasive Bladder Cancer market.

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Table of Contents

1. Report Introduction
2. Executive Summary
3. SWOT analysis
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. 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. Market Access and Reimbursement of Therapies
15. Market drivers
16. Market barriers
17. Appendix
18. Non-Muscle Invasive Bladder Cancer Report Methodology
19. DelveInsight Capabilities
20. Disclaimer
21. About DelveInsight

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Related Reports:

Non-Muscle Invasive Bladder Cancer Pipeline Insights, DelveInsight

"Non-Muscle Invasive Bladder Cancer Pipeline Insight, 2024" report by DelveInsight outlines comprehensive insights of present clinical development scenarios and growth prospects across the Non-Muscle Invasive Bladder Cancer market. A detailed picture of the Non-Muscle Invasive Bladder Cancer pipeline landscape is provided, which includes the disease overview and Non-Muscle Invasive Bladder Cancer treatment guidelines.

Contact Info:

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About DelveInsight

DelveInsight is a leading 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.

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