The non-muscle invasive bladder cancer market is witnessing significant growth due to the rising global incidence of bladder cancer, advancements in immunotherapy, targeted treatments, and launch of novel therapies such as CG0070 (cretostimogene grenadenorepvec) (CG Oncology), EG-70 (detalimogene voraplasmid) (enGene), TAR-210 (Janssen), Dabogratinib (Tyra Biosciences), UGN-103 (UroGen Pharma), TARA-002 (Protara Therapeutics), and others.
LAS VEGAS, June 23, 2026 /PRNewswire/ — Recently published Non-muscle Invasive Bladder Cancer Market Insights report includes a comprehensive understanding of current treatment practices, non-muscle invasive bladder cancer emerging drugs, market share of individual therapies, and current and forecasted market size from 2022 to 2036, segmented into leading markets [the United States, the EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan].
Non-muscle Invasive Bladder Cancer Market Summary
- The total market size of NMIBC in the 7MM in 2025 was approximately USD 3 billion.
- The United States accounted for the largest non-muscle invasive bladder cancer treatment market size in 2025, compared to other major markets, including the EU4 countries (Germany, France, Italy, and Spain), the United Kingdom, and Japan.
- The total prevalent cases of NMIBC in the 7MM were nearly 1.56 million. These cases are expected to increase by 2036.
- Leading non-muscle invasive bladder cancer companies, such as CG Oncology, enGene, Janssen, Tyra Biosciences, UroGen Pharma, Protara Therapeutics, Theralase Technologies, NanOlogy, Vaxiion Therapeutics, Aura Biosciences, Prokarium, Fidia Farmaceutici, HOIST Corporation, Astellas Pharma, Pfizer, AstraZeneca, Hoffmann-La Roche, and others, are developing new non-muscle invasive bladder cancer treatment drugs that can be available in the non-muscle invasive bladder cancer market in the coming years.
- The promising non-muscle invasive bladder cancer therapies in clinical trials include CG0070 (cretostimogene grenadenorepvec), EG-70 (detalimogene voraplasmid), TAR-210, Dabogratinib, UGN-103, TARA-002, TLD-1433, LSAM-DTX (docetaxel), VAX014, Belzupacap sarotalocan, ZH9, ONCOFID P-B, HM-001, PADCEV (enfortumab vedotin), IMFINZI (durvalumab), TECENTRIQ (atezolizumab), and others.
- In the 7MM, by 2036, among all the therapies, the highest revenue is expected to be generated by cretostimogene grenadenorepvec ± KEYTRUDA.
Discover who will dominate the NMIBC market by 2036 @ https://www.delveinsight.com/report-store/non-muscle-invasive-bladder-cancer-market
Key Factors Driving the Growth of the Non-muscle Invasive Bladder Cancer Market
- Rising Prevalence of Bladder Cancer: The increasing incidence of bladder cancer globally, particularly among the aging population, is significantly driving demand for effective non-muscle invasive bladder cancer (NMIBC) therapies and diagnostics.
- Growing Adoption of Immunotherapy: The success of immunotherapies such as KEYTRUDA and novel immune-modulating agents has expanded treatment options for BCG-unresponsive NMIBC patients, accelerating market growth.
- Advancements in Targeted Drug Delivery: Innovations in intravesical drug delivery systems and localized therapies are improving treatment efficacy while reducing systemic side effects, thereby increasing physician and patient preference.
- Strong Pipeline of Emerging Therapies: NMIBC pipeline possesses some drugs in various stage developments to be approved in the near future. The expected launch of therapies such as CCG0070 (cretostimogene grenadenorepvec) (CG Oncology), EG-70 (detalimogene voraplasmid) (enGene), TAR-210 (Janssen), Dabogratinib (Tyra Biosciences), UGN-103 (UroGen Pharma), TARA-002 (Protara Therapeutics), TLD-1433 (Theralase Technologies), LSAM-DTX (docetaxel) (NanOlogy), VAX014 (Vaxiion Therapeutics), Belzupacap sarotalocan (Aura Biosciences), ZH9 (Prokarium), ONCOFID P-B (Fidia Farmaceutici), HM-001 (HOIST Corporation), PADCEV (enfortumab vedotin) (Astellas Pharma/Pfizer), IMFINZI (durvalumab) (AstraZeneca), TECENTRIQ (atezolizumab) (Hoffmann-La Roche), and others shall further create a positive impact on the market.
Aparna Thakur, an oncology expert at DelveInsight, said that Protara’s TARA-002 exhibits a strong mechanism of action and offers clear advantages in overcoming the challenges related to BCG manufacturing.
Non-muscle Invasive Bladder Cancer Market Analysis
- The current standard of care for NMIBC primarily involves surgical intervention, intravesical Bacillus Calmette–Guérin (BCG) immunotherapy, and intravesical chemotherapy.
- In the United States, several therapies have received approval from the FDA for NMIBC treatment in recent years, including KEYTRUDA in 2020, ADSTILADRIN in 2022, ANKTIVA in 2024, and, most recently ZUSDURI in 2025.
- Over the last decade, advances in investigational immunotherapy have significantly expanded treatment possibilities for patients with BCG-unresponsive NMIBC accompanied by carcinoma in situ (CIS). These developments have contributed to the FDA approvals of intravesical nadofaragene firadenovec, intravesical nogapendekin alfa-inbakicept, and systemic pembrolizumab.
- Innovative medical devices and drug-delivery technologies are also enhancing the effectiveness of intravesical therapies. For instance, TAR-200 and TAR-210 are designed to improve drug absorption through advanced delivery approaches such as hyperthermia and electromotive drug administration.
- Despite these advancements, the absence of a definitive curative therapy remains a major unmet need in NMIBC management. However, the market landscape is expected to evolve considerably in the coming years with the anticipated introduction of several emerging therapies.
- The NMIBC pipeline remains robust, with numerous companies advancing promising candidates across early- and late-stage clinical development. Key industry participants include Roche with TECENTRIQ, CG Oncology developing CG0070, enGene with EG-70, UroGen Pharma developing UGN-103, Theralase Technologies with RUVIDAR, and Emtora Biosciences advancing eRapa, among others.
Non-muscle Invasive Bladder Cancer Competitive Landscape
Some of the NMIBC drugs under development include CG0070 (cretostimogene grenadenorepvec) (CG Oncology), EG-70 (detalimogene voraplasmid) (enGene), TAR-210 (Janssen), Dabogratinib (Tyra Biosciences), UGN-103 (UroGen Pharma), TARA-002 (Protara Therapeutics), TLD-1433 (Theralase Technologies), LSAM-DTX (docetaxel) (NanOlogy), VAX014 (Vaxiion Therapeutics), Belzupacap sarotalocan (Aura Biosciences), ZH9 (Prokarium), ONCOFID P-B (Fidia Farmaceutici), HM-001 (HOIST Corporation), PADCEV (enfortumab vedotin) (Astellas Pharma/Pfizer), IMFINZI (durvalumab) (AstraZeneca), TECENTRIQ (atezolizumab) (Hoffmann-La Roche), and others.
CG Oncology’s CG0070 is a selectively replicating oncolytic immunotherapy engineered on a modified adenovirus type 5 platform. It incorporates a tumor-specific promoter along with a GM-CSF transgene, enabling it to selectively target and destroy bladder cancer cells through defects in the Rb pathway. Cretostimogene monotherapy is currently under investigation for high-risk BCG-unresponsive non-muscle invasive bladder cancer (NMIBC). Within the BOND-003 study, Cohort C focuses on patients with carcinoma in situ (CIS ± Ta/T1) and has progressed to Phase III clinical development, highlighting its advanced stage. Meanwhile, Cohort P is evaluating a distinct patient subgroup and remains in Phase II, representing an ongoing mid-stage clinical assessment.
enGene is advancing a non-viral gene therapy platform designed to deliver plasmid DNA directly to mucosal tissues, including the bladder urothelium. Its lead candidate, EG-70 (detalimogene voraplasmid), is a nanoparticle-based therapy containing a plasmid engineered to express three genes that stimulate both innate and adaptive immune responses in the bladder microenvironment. EG-70 is presently being evaluated in Phase II clinical trials. The therapy has also received Regenerative Medicine Advanced Therapy (RMAT) designation from the US FDA for the treatment of NMIBC.
UroGen Pharma developed UGN-103 to further strengthen and expand the clinical and commercial potential of ZUSDURI, the first and only FDA-approved therapy for adults with recurrent LG-IR-NMIBC. The candidate continues to utilize the company’s established RTGel technology, which allows prolonged exposure of mitomycin within the bladder, while introducing next-generation improvements such as a more efficient manufacturing process and easier reconstitution to enhance convenience in clinical settings. In January 2024, UroGen Pharma signed a licensing and supply agreement with medac to advance the development of UGN-103 for recurrent LG-IR-NMIBC.
Protara Therapeutics’ TARA-002 is an investigational cell-based therapy being developed for the treatment of non-muscle invasive bladder cancer (NMIBC) and lymphatic malformations (LMs). The therapy has received multiple regulatory designations from the FDA, including Rare Pediatric Disease, Orphan Drug, Breakthrough Therapy, and Fast Track status. As a first-in-class TLR2/NOD2 agonist and immunopotentiator derived from inactivated Streptococcus pyogenes, TARA-002 works by stimulating both innate and adaptive immune responses within the bladder wall.
Upon administration, it is believed to activate immune cells present in the tumor or cyst microenvironment, leading to a pro-inflammatory response characterized by the release of cytokines such as TNF-alpha, IFN-gamma, IL-6, IL-10, and IL-12. In addition to directly destroying tumor cells, TARA-002 promotes immunogenic cell death, further amplifying the body’s antitumor immune activity.
The anticipated launch of these emerging therapies are poised to transform the non-muscle invasive bladder cancer market landscape in the coming years. As these cutting-edge therapies continue to mature and gain regulatory approval, they are expected to reshape the non-muscle invasive bladder cancer market landscape, offering new standards of care and unlocking opportunities for medical innovation and economic growth.
Discover more about what therapies will replace or complement BCG @ Non-muscle Invasive Bladder Cancer Drugs
Recent Developments in the Non-muscle Invasive Bladder Cancer Market
- In May 2026, UroGen Pharma Ltd. reported that UGN-103 (mitomycin) for intravesical solution demonstrated a 94.5% durability of response (95% CI: 86.1–97.9) at six months, based on Kaplan-Meier estimates, in the ongoing Phase 3 UTOPIA study evaluating patients with recurrent low-grade intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC).
- In May 2026, Protara Therapeutics, Inc. announced encouraging updated 12-month results from Cohort A of the ongoing Phase II open-label ADVANCED-2 study evaluating TARA-002 in patients with carcinoma in situ (CIS) with or without Ta/T1 non-muscle invasive bladder cancer (NMIBC).
- In May 2026, ImmunityBio reported preliminary findings from a new health economics analysis showing that ANKTIVA® (nogapendekin alfa inbakicept-pmln; NAI), combined with Bacillus Calmette–Guérin (BCG), delivered a lower cost per sustained complete response than TAR-200 in patients with BCG-unresponsive non-muscle-invasive bladder cancer carcinoma in situ (NMIBC CIS) with or without papillary disease.
- In March 2026, Relmada Therapeutics, Inc. reported 12-month interim results from its ongoing Phase II study assessing NDV-01 in patients with high-risk non-muscle invasive bladder cancer (NMIBC).
- In February 2026, Pfizer withdrew its application for marketing authorization in the EU for high-risk NMIBC in early 2026, as regulatory advice suggested the current data were insufficient for approval.
What is Non-muscle Invasive Bladder Cancer?
Non-muscle invasive bladder cancer (NMIBC) is a type of bladder cancer in which the tumor remains confined to the inner lining of the bladder and has not spread into the muscular wall of the bladder. It is the most common form of bladder cancer at diagnosis and includes stages such as Ta, T1, and carcinoma in situ (CIS). NMIBC is generally associated with symptoms like blood in the urine, frequent urination, and painful urination. Although it is considered less aggressive than muscle-invasive bladder cancer, NMIBC has a high risk of recurrence and may progress over time if not properly managed. Standard treatment approaches include transurethral resection of bladder tumor (TURBT), intravesical therapies such as BCG immunotherapy or chemotherapy, and regular surveillance through cystoscopy to monitor recurrence.
Non-muscle Invasive Bladder Cancer Epidemiology Segmentation
The non-muscle invasive bladder cancer epidemiology section provides insights into the historical and current non-muscle invasive bladder cancer patient pool and forecasted trends for the leading markets.
The non-muscle invasive bladder cancer treatment market report proffers epidemiological analysis for the study period 2022–2036 in the leading markets, segmented into:
- Total Prevalent Cases of Bladder Cancer
- Total Prevalent Cases of NMIBC
- Stage-specific Prevalent Cases of NMIBC
- Age-specific Prevalent Cases of NMIBC
- Risk-specific Prevalent Cases of NMIBC
- Grade-specific Prevalent Cases of NMIBC
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Non-muscle Invasive Bladder Cancer Market Report Metrics |
Details |
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Study Period |
2022–2036 |
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Coverage |
7MM [The United States, the EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan]. |
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Non-muscle Invasive Bladder Cancer Epidemiology Segmentation |
Total Prevalent Cases of Bladder Cancer, Total Prevalent Cases of NMIBC, Stage-specific Prevalent Cases of NMIBC, Age-specific Prevalent Cases of NMIBC, Risk-specific Prevalent Cases of NMIBC, and Grade-specific Prevalent Cases of NMIBC |
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Non-muscle Invasive Bladder Cancer Market Size in 2025 |
USD 3 Billion |
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Key Non-muscle Invasive Bladder Cancer Companies |
CG Oncology, enGene, Janssen, Tyra Biosciences, UroGen Pharma, Protara Therapeutics, Theralase Technologies, NanOlogy, Vaxiion Therapeutics, Aura Biosciences, Prokarium, Fidia Farmaceutici, HOIST Corporation, Astellas Pharma, Pfizer, AstraZeneca, Hoffmann-La Roche, and others |
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Key Non-muscle Invasive Bladder Cancer Therapies |
CG0070 (cretostimogene grenadenorepvec), EG-70 (detalimogene voraplasmid), TAR-210, Dabogratinib, UGN-103, TARA-002, TLD-1433, LSAM-DTX (docetaxel), VAX014, Belzupacap sarotalocan, ZH9, ONCOFID P-B, HM-001, PADCEV (enfortumab vedotin), IMFINZI (durvalumab), TECENTRIQ (atezolizumab), and others |
Scope of the Non-muscle Invasive Bladder Cancer Market Report
- Non-muscle Invasive Bladder Cancer Patient Population Forecast
- Non-muscle Invasive Bladder Cancer Therapeutics Market Size
- Non-muscle Invasive Bladder Cancer Pipeline Analysis
- Non-muscle Invasive Bladder Cancer Market Size and Trends
- Non-muscle Invasive Bladder Cancer Market Opportunity
- Non-muscle Invasive Bladder Cancer Market Unmet Needs
- KOL’s Views on Non-muscle Invasive Bladder Cancer
- Non-muscle Invasive Bladder Cancer Market Access and Reimbursement
Download the report to understand what drugs are in development for NMIBC @ Non-muscle Invasive Bladder Cancer Market Analysis
Table of Contents
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1 |
Non-muscle Invasive Bladder Cancer Market Key Insights |
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2 |
Non-muscle Invasive Bladder Cancer Market Report Introduction |
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3 |
Executive Summary of NMIBC |
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4 |
NMIBC Market Overview at a Glance |
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4.1 |
Marketed and Emerging Landscape Analysis (By Phase, RoA, and Molecule Type) |
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4.2 |
Market Share (%) Distribution by Risk (Low, Intermediate and High) in 2025 in the 7MM |
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4.3 |
Market Share (%) Distribution by Risk (Low, Intermediate and High) in 2036 in the 7MM |
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5 |
Key Events |
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6 |
Epidemiology and Market Forecast Methodology |
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7 |
Disease Background and Overview: NMIBC |
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7.1 |
Introduction |
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7.2 |
Sign and Symptoms |
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7.3 |
Clinical Stages of NMIBC |
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7.4 |
Grading |
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7.5 |
The Risk Stratification of NMIBC |
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7.6 |
Diagnosis of NMIBC |
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7.7 |
Treatment |
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8 |
Guidelines |
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9 |
Epidemiology and Patient Population |
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9.1 |
Key Findings |
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9.2 |
Assumptions and Rationale |
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9.3 |
Total Prevalent Cases of Bladder Cancer in the 7MM |
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9.4 |
Total Prevalent Cases of NMIBC in the 7MM |
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9.5 |
The United States |
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9.5.1 |
Total Prevalent Cases of NMIBC in the United States |
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9.5.2 |
Stage-specific Prevalent Cases of NMIBC in the United States |
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9.5.3 |
Grade-specific Prevalent Cases of NMIBC in the United States |
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9.5.4 |
Risk-specific Prevalent Cases of NMIBC in the United States |
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9.5.5 |
Age-specific Prevalent Cases of NMIBC in the United States |
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9.6 |
EU4 and the UK |
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9.7 |
Japan |
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10 |
Patient Journey |
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11 |
Marketed NMIBC Drugs |
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11.1 |
Key Competitors |
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11.2 |
ANKTIVA (N-803/ALT-803): ImmunityBio |
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11.2.1 |
Product Description |
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11.2.2 |
Regulatory Milestones |
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11.2.3 |
Other Development Activities |
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11.2.4 |
Clinical Development |
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11.2.4.1 |
Clinical Trial Information |
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11.2.5 |
Summary of Pivotal Trials |
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11.2.6 |
Safety and Efficacy |
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11.2.7 |
Analyst Views |
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11.3 |
ADSTILADRIN (nadofaragene firadenovec): Ferring Pharmaceuticals/FKD Therapies Oy |
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11.4 |
KEYTRUDA (pembrolizumab): Merck |
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11.5 |
ZUSDRI: UroGen Pharma |
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List to be continued in the report… |
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12 |
Emerging NMIBC Drugs |
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12.1 |
Key Cross Competition |
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12.2 |
TECENTRIQ (atezolizumab): Hoffmann-La Roche |
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12.2.1 |
Product Description |
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12.2.2 |
Other Developmental Activities |
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12.2.3 |
Clinical Development |
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12.2.3.1 |
Clinical Trial Information |
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12.2.4 |
Safety and Efficacy |
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12.2.5 |
Analyst Views |
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12.3 |
EG-70 (detalimogene voraplasmid): enGene |
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13.4 |
IMFINZI (durvalumab): AstraZeneca |
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13.5 |
PADCEV (enfortumab vedotin): Astellas Pharma/Pfizer |
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13.6 |
UGN-103 (mitomycin): UroGen Pharma |
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13.7 |
HM-001: HOIST Corporation |
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13.8 |
CG0070 (cretostimogene grenadenorepvec): CG Oncology |
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13.9 |
TAR-210 (intravesical erdafitinib): Johnson & Johnson |
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13.10 |
ONCOFID P-B: Fidia Farmaceutici |
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13.11 |
RUVIDAR (TLD-1433): Theralase Technologies |
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13.12 |
TARA-002: Protara Therapeutics |
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List to be continued in the report… |
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14 |
NMIBC Market: 7MM Analysis |
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14.1 |
Key Findings |
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14.2 |
Non-muscle Invasive Bladder Cancer Market Outlook |
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14.3 |
Conjoint Analysis |
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14.4 |
Key Market Forecast Assumptions |
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14.5 |
Total Market Size of NMIBC in the 7MM |
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14.6 |
Total Market Size of NMIBC by Risk in the 7MM |
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14.7 |
Total Market Size of NMIBC by Therapies in the 7MM |
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15 |
Unmet Needs |
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16 |
SWOT Analysis |
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17 |
KOL Views |
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18 |
Market Access and Reimbursement |
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18.1 |
United States |
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18.2 |
EU4 and the UK |
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18.3 |
Japan |
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18.4 |
Summary and Comparison of Market Access and Pricing Policy Developments in 2025 |
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18.5 |
Market Access and Reimbursement of NMIBC Therapies |
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19 |
Abbreviations |
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20 |
Bibliography |
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21 |
NMIBC Market Report Methodology |
Related Reports
Non-muscle Invasive Bladder Cancer Clinical Trial Analysis
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