DelveInsight’s “Non-Muscle Invasive Bladder Cancer Market Insights, Epidemiology, and Market Forecast – 2036” report delivers an in-depth understanding of Non-Muscle Invasive Bladder Cancer, historical and forecasted epidemiology, as well as the NMIBC market trends in the United States, EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan.

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Key Takeaways from the Non-Muscle Invasive Bladder Cancer Market Report

• The leading Non-Muscle Invasive Bladder Cancer companies include Merck, Ferring Pharmaceuticals, ImmunityBio, CG Oncology, Pfizer, enGene, UroGen, Theralase, Johnson & Johnson, Roche, AstraZeneca, Protara Therapeutics, Fidia Farmaceutici, and others.

• The total market size of NMIBC in the 7MM was approximately USD 3 billion in 2025 and is expected to grow in the coming years due to the increasing prevalence of NMIBC, the launch of high-priced therapies, and the rising number of active companies in the field.

• Among the 7MM, the United States accounted for the largest NMIBC market share in 2025, representing approximately 65% of the total 7MM market, driven by a high diagnosed prevalent base of nearly 640,000 cases.

• Breakthroughs in oncolytic immunotherapy, gene therapy, interleukin-15 receptor superagonism, checkpoint inhibition, and novel intravesical drug delivery devices are expanding the therapeutic landscape and improving clinical outcomes for BCG-unresponsive and BCG-naïve patient populations.

• In 2025, the total prevalent cases of NMIBC across the 7MM were nearly 1.56 million, with intermediate-risk cases accounting for the highest proportion; these figures are expected to increase by 2036.

• Key targets and mechanisms currently under development include anti-PD-1 and anti-PD-L1 checkpoint inhibition, GM-CSF agonism, IL-15 receptor superagonism, FGFR inhibition, DNA synthesis inhibition, and photodynamic compounds, among others.

• By 2036, among all therapies across the 7MM, the highest revenue is expected to be generated by cretostimogene grenadenorepvec (CG0070) ± KEYTRUDA.

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Non-Muscle Invasive Bladder Cancer Epidemiology Segmentation in the 7MM

• Total NMIBC Prevalence Cases

• NMIBC Stage-specific Cases

• NMIBC Grade-specific Cases

• NMIBC Risk-specific Cases

• NMIBC Age-specific Cases

Non-Muscle Invasive Bladder Cancer Treatment MarketNon-Muscle Invasive Bladder Cancer Pipeline Analysis

ADSTILADRIN (nadofaragene firadenovec-vncg): Ferring Pharmaceuticals/FKD Therapies Oy

ADSTILADRIN is a non-replicating adenovirus vector-based gene therapy containing the gene encoding interferon alfa-2b, administered intravesically via catheter once every three months for adult patients with high-risk, BCG-unresponsive NMIBC with carcinoma in situ (CIS), with or without papillary tumors. Approved by the US FDA in December 2022, it is also classified as an Advanced Therapy Medicinal Product (ATMP) by the European Medicines Agency. In April 2024, Ferring Pharmaceuticals and SK Pharmteco announced an agreement to scale up commercial manufacturing capacity for the drug substance to ensure long-term future supply.

ANKTIVA (nogapendekin alfa inbakicept-pmln): ImmunityBio

ANKTIVA is a novel IL-15 superagonist complex comprising an IL-15 mutant (IL-15N72D) bound to an IL-15 receptor α/IgG1 Fc fusion protein, administered intravesically in combination with BCG. Approved by the US FDA in April 2024 for BCG-unresponsive NMIBC with CIS, ANKTIVA demonstrated a complete response rate of 62% in clinical trials, with 58% and 40% of patients achieving a duration of response of 12 and 24 months, respectively. A key advantage is that ANKTIVA requires no specialized freezers or equipment, enabling easy integration into existing urology practice workflows without changes to ordering, storage, or administration processes.

CG0070 (cretostimogene grenadenorepvec): CG Oncology

CG0070 is a selectively replicative oncolytic immunotherapy based on a modified adenovirus type 5 backbone containing a cancer-selective promoter and a GM-CSF transgene, designed to destroy bladder tumor cells through their defective Rb pathway. It is currently in Phase III development (BOND-003 Cohort C) for high-risk BCG-unresponsive NMIBC with CIS, and in Phase II (BOND-003 Cohort P) for a separate patient population. In clinical evaluation, 75.2% of patients achieved a complete response at any time; when used in combination with pembrolizumab, the CRR in the intent-to-treat population at 24 months was 54%, with 95% of patients who achieved CRR at 12 months maintaining that response for a further 12 months. CG0070 is anticipated to launch by 2026 and could capture a billion-dollar market by 2036.

EG-70 (detalimogene voraplasmid): enGene

EG-70 is a non-viral, nanoparticle-formulated plasmid-based gene therapy that simultaneously activates both innate and adaptive immune responses within the bladder through expression of three key immune-stimulatory genes, including dual IL-12/RIG-I activation. Currently in Phase I/II development, EG-70 has received Regenerative Medicine Advanced Therapy (RMAT) designation from the US FDA for NMIBC. enGene expects to file a Biologics License Application (BLA) for EG-70 in mid-2026 based on results from the LEGEND study, with a projected commercial launch by 2027.

TAR-200 and TAR-210: Johnson & Johnson

TAR-200 is an intravesical drug-device system enabling sustained local delivery of gemcitabine via an indwelling device, currently in Phase III development for both BCG-naïve high-risk and BCG-unresponsive high-risk NMIBC. TAR-210 is a parallel intravesical drug-device system delivering erdafitinib using electromotive drug administration for NMIBC patients with FGFR mutations or fusions who have recurred following BCG therapy, also in Phase III. Both devices use hyperthermia or electromotive techniques to enhance intravesical drug uptake. In September 2025, Johnson & Johnson received FDA approval for INLEXZO (gemcitabine intravesical system) for BCG-unresponsive NMIBC with CIS.

Sasanlimab (PF-06801591): Pfizer

Sasanlimab is a subcutaneously administered anti-PD-1 monoclonal antibody currently in Phase III development for high-risk, BCG-naïve NMIBC. In February 2026, Pfizer withdrew its marketing authorization application in the EU for high-risk NMIBC, as regulatory advice indicated that current data were insufficient for approval.

Non-Muscle Invasive Bladder Cancer Market Insights

The current treatment regimen for NMIBC includes surgery (TURBT), intravesical immunotherapy with BCG, and intravesical chemotherapy. BCG has long been the gold standard initial treatment for high-risk NMIBC; however, persistent BCG shortages have forced physicians to rely on alternative regimens, most notably the gemcitabine and docetaxel combination.

Only three drugs are approved by the FDA for NMIBC in the United States: KEYTRUDA (pembrolizumab, 2020), ADSTILADRIN (nadofaragene firadenovec-vncg, 2022), and ANKTIVA (nogapendekin alfa inbakicept-pmln, 2024), all approved exclusively for BCG-unresponsive disease.

The competitive landscape is highly dynamic, with a large number of companies advancing assets across immune checkpoint inhibition, gene therapy, oncolytic immunotherapy, interleukin-based therapy, and novel intravesical drug-device platforms. A recent collaboration between the Serum Institute of India and ImmunityBio is focused on both traditional BCG supply and the development of an enhanced recombinant BCG to alleviate the ongoing shortage.

Companies are currently concentrating development efforts predominantly on the high- and intermediate-risk NMIBC segments, with low-risk disease remaining comparatively underserved.

The growing array of novel therapeutic agents presents challenges in determining optimal treatment sequencing, driving increasing focus on biomarker-driven, personalized treatment strategies and comprehensive understanding of disease characteristics and patient attributes.

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Non-Muscle Invasive Bladder Cancer Market Outlook

Non-Muscle Invasive Bladder Cancer is a form of bladder cancer where the tumor is confined to the innermost layer of the bladder lining without invading the muscle wall, typically presenting with papillary tumors or carcinoma in situ. Despite being an early-stage cancer, it is characterized by high rates of recurrence and progression, requiring lifelong active surveillance and making bladder cancer the most expensive cancer to treat from diagnosis to death. The BCG shortage, limited FDA-approved options, and the complexity of managing BCG-unresponsive patients continue to shape clinical practice and drive the urgent need for novel therapeutic approaches. The NMIBC pipeline is increasingly robust across Phase I, II, and III stages, spanning mechanistically diverse therapeutic classes, and the treatment space is expected to experience a significant positive market shift during the forecast period. Market growth may be offset by reimbursement challenges, BCG supply constraints, variability in biomarker-driven patient selection, and the complexity of sequencing a rapidly expanding therapeutic arsenal.

Scope of the Non-Muscle Invasive Bladder Cancer Market Report

• Coverage: 7MM

• Study Period: 2022–2036

• Forecast Period: 2026–2036

• Non-Muscle Invasive Bladder Cancer Companies: Merck, Ferring Pharmaceuticals, ImmunityBio, CG Oncology, Pfizer, enGene, UroGen, Theralase, Johnson & Johnson, Roche, AstraZeneca, Protara Therapeutics, Fidia Farmaceutici, and others

• Non-Muscle Invasive Bladder Cancer Therapies: KEYTRUDA, ADSTILADRIN, ANKTIVA, CG0070, EG-70, TAR-200, TAR-210, Sasanlimab, UGN-102, UGN-103, Ruvidar, TARA-002, ONCOFID P-B, and others

• Non-Muscle Invasive Bladder Cancer Market Access & Reimbursements, Unmet Needs and Perspectives

• Non-Muscle Invasive Bladder Cancer SWOT Analysis and KOL Views

Unlock Strategic Insights with DelveInsight’s Comprehensive Non-Muscle Invasive Bladder Cancer Market Report @ Non-Muscle Invasive Bladder Cancer Market Drivers and Barriers

Table of Contents

1. Key Insights

2. Report Introduction

3. Executive Summary of NMIBC

4. NMIBC Market Overview at a Glance

5. NMIBC Drug Development Overview by Phase and ROA

6. Key Events

7. Epidemiology and Market Forecast Methodology

8. Disease Background and Overview: NMIBC

9. Guidelines

10. Epidemiology and Patient Population

11. Patient Journey

12. Marketed Drugs

13. Emerging Drugs

14. NMIBC: The 7MM Analysis

15. NMIBC Unmet Needs

16. SWOT Analysis

17. KOL Views

18. Market Access and Reimbursement

19. Appendix

20. DelveInsight Capabilities

21. Disclaimer

22. About DelveInsight

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