Non-Muscle Invasive Bladder Cancer (NMIBC) market

DelveInsight has released a new report titled “Non-Muscle Invasive Bladder Cancer – Market Insights, Epidemiology, and Market Forecast 2034,” offering a comprehensive analysis of the NMIBC landscape. The report covers historical and projected epidemiological data, market dynamics, and emerging trends across the United States, the EU5 (Germany, Spain, Italy, France, and the United Kingdom), and Japan.

Key companies shaping the NMIBC market include FKD Therapies Oy/Ferring Pharmaceuticals, Merck, Viventia Bio/Sesen Bio, CG Oncology, ImmunityBio/Altor Biosciences, and Theralase.

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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 across the seven major markets (7MM) was estimated at around USD 2.35 billion. The market is expected to experience steady growth, fueled by increasing disease prevalence, the introduction of premium-priced therapies, and greater involvement from pharmaceutical companies. The high-risk NMIBC segment dominated the market, contributing approximately USD 1.6 billion that year. Current standard treatment approaches primarily consist of surgical resection, intravesical immunotherapy (notably BCG), and intravesical chemotherapy.

• On June 12, 2025, a landmark approval introduced the first nonsurgical, intravesical therapy for adults with recurrent low-grade, intermediate-risk NMIBC. To date, only three drugs have gained FDA approval specifically for NMIBC in the U.S.—KEYTRUDA (pembrolizumab, 2020), ADSTILADRIN (nadofaragene firadenovec-vncg, 2022), and ANKTIVA (nogapendekin alfa inbakicept-pmln, 2024). However, an ongoing global shortage of BCG, the mainstay treatment for high-risk NMIBC, continues to challenge patient management. This shortage, which began even before the COVID-19 pandemic, has prompted clinicians to turn to gemcitabine-docetaxel combination regimens as alternatives. In response, the Serum Institute of India and ImmunityBio have formed a partnership to address supply constraints by ensuring BCG availability and advancing recombinant BCG production.

• The NMIBC pipeline remains highly active, with promising candidates such as CG0070 (CG Oncology), Sasanlimab (Pfizer), EG-70 (enGene), UGN-102 (Urogen), Ruvidar (Theralase), TAR-210, and TAR-200 (Johnson & Johnson) under development. While most efforts target high- and intermediate-risk NMIBC, the low-risk segment continues to receive limited attention. Among the most closely watched therapies is UGN-102, which, if approved, could transform the treatment paradigm for low-grade, intermediate-risk NMIBC, shifting care from repetitive surgeries to a minimally invasive, nonsurgical approach. With encouraging early clinical outcomes, UGN-102 is well-positioned to compete with emerging candidates like Cretostimogene and ADSTILADRIN in the intermediate-risk category.

• Within the 7MM, the United States had the highest prevalence of NMIBC in 2023, with an estimated 616,000 cases, a figure projected to increase throughout the forecast period.

• As new therapies emerge, the NMIBC treatment landscape is becoming increasingly complex, with variations in mechanism of action, response rates, and clinical applicability necessitating personalized treatment strategies. These approaches must account for individual disease profiles, available drug options, patient-specific considerations, and predictive biomarkers. Additionally, medical device innovations are enhancing intravesical drug delivery; for example, TAR-200 and TAR-210 employ hyperthermia or electromotive administration to boost absorption of gemcitabine and erdafitinib, respectively.

• Leading players such as FKD Therapies Oy/Ferring Pharmaceuticals, Merck, Viventia Bio/Sesen Bio, CG Oncology, ImmunityBio/Altor Biosciences, and Theralase, among others, continue to advance novel therapeutic candidates aimed at reshaping the NMIBC treatment landscape.

Non-Muscle Invasive Bladder Cancer Overview

Non-muscle invasive bladder cancer (NMIBC) is a type of bladder cancer in which the tumor remains confined to the bladder’s inner lining without invading the muscular layer. Representing an early stage of the disease, NMIBC accounts for a significant proportion of bladder cancer cases and is commonly characterized by superficial lesions such as papillary tumors or carcinoma in situ. Although non-invasive, NMIBC carries a substantial risk of recurrence and disease progression, necessitating vigilant and ongoing management. The standard treatment approach involves transurethral resection of the bladder tumor (TURBT) followed by intravesical therapy, which may include BCG immunotherapy or chemotherapy. Continuous cystoscopic surveillance and adherence to established clinical protocols are essential to achieving optimal disease control and improving long-term patient outcomes.

Non-Muscle Invasive Bladder Cancer Market Outlook

Non-muscle invasive bladder cancer (NMIBC) remains a major therapeutic challenge, largely due to its high recurrence and progression rates, even with existing treatment options. These challenges necessitate lifelong surveillance, making bladder cancer the most expensive malignancy to manage over a patient’s lifetime—from diagnosis through long-term care. This significant clinical and economic burden highlights the urgent need for more effective and durable treatment approaches for NMIBC.

The standard treatment paradigm for NMIBC involves transurethral resection of the bladder tumor (TURBT), followed by intravesical therapy, such as BCG immunotherapy or chemotherapy. In intermediate- and high-risk cases, TURBT followed by BCG remains the gold standard for minimizing recurrence and delaying disease progression. For Stage 0 NMIBC, TURBT combined with fulguration may be followed by intravesical therapy within 24 hours; however, some patients may not require further treatment. Continuous cystoscopic monitoring every 3–6 months is critical for the timely detection of disease recurrence.

As of now, the U.S. FDA has approved only three therapies specifically for NMIBC: KEYTRUDA (pembrolizumab, 2020), ADSTILADRIN (nadofaragene firadenovec-vncg, 2022), and ANKTIVA (nogapendekin alfa inbakicept-pmln, April 2024)—all approved solely in the United States.

BCG-unresponsive NMIBC continues to present one of the greatest clinical hurdles. Approximately 25% of patients do not respond to BCG, rendering them ineligible for further BCG therapy. Moreover, nearly one-third of NMIBC patients have yet to receive BCG, often awaiting initiation following TURBT. The ongoing global BCG shortage has exacerbated these challenges, limiting the availability of both induction and maintenance treatments, which in turn has contributed to higher recurrence rates and greater treatment failures.

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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

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Key benefits of the Non-Muscle Invasive Bladder Cancer Market Report:

1. 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).

2. The Non-Muscle Invasive Bladder Cancer market report provides insights into the current and emerging therapies.

3. The Non-Muscle Invasive Bladder Cancer market report provides a global historical and forecasted market covering drug outreach in 7MM.

4. 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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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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