The global market for non-muscle invasive bladder cancer (NMIBC) therapeutics, covering the seven major markets (7MM), was valued at approximately USD 2,350 million in 2023 and is projected to expand steadily through 2034, according to DelveInsight’s latest report, “Non-Muscle Invasive Bladder Cancer Market Insights, Epidemiology, and Market Forecast-2034.” The report provides a detailed analysis of NMIBC epidemiology, treatment trends, and market dynamics across the United States, EU4 (Germany, France, Italy, Spain), the United Kingdom, and Japan.
Key Market Developments
In September 2025, Johnson & Johnson (NYSE: JNJ) received FDA approval for INLEXZOTM (gemcitabine intravesical system) to treat BCG-unresponsive NMIBC with carcinoma in situ (CIS). The therapy offers a new option for patients after failed BCG therapy or for those ineligible for bladder removal surgery.
In May 2025, the FDA’s Oncologic Drugs Advisory Committee (ODAC) narrowly voted 5-4 against approving UGN-102 (mitomycin intravesical solution) for recurrent, low-grade, intermediate-risk NMIBC. UroGen (Nasdaq: URGN) had submitted the NDA for this therapy, with an ODAC review scheduled for May 21, 2025.
ImmunityBio, Inc. received a Refusal to File (RTF) letter from the FDA for its supplemental biologics license application (sBLA) for ANKTIVA plus BCG in BCG-unresponsive NMIBC with papillary disease, despite earlier guidance supporting the submission.
Epidemiology Highlights (7MM, 2023)
The United States accounted for the highest prevalence, with around 616,000 cases.
In the EU4 and the UK, Italy had the highest prevalence, while France reported the lowest.
Intermediate-risk NMIBC cases were the most common, whereas high-risk cases were the least prevalent.
In Japan, 60% of cases occurred in the 70–89 age group, and most stage-specific cases were at the Ta stage.
Leading Companies and Therapies
Key players in the NMIBC market include CG Oncology, Pfizer, UroGen Pharma, Janssen R&D, Protara Therapeutics, AstraZeneca, ImmunityBio, Bristol Myers Squibb, and others. Promising therapies under development include CG0070, Sasanlimab (PF-06801591), UGN-102, TAR-200, Durvalumab, ANKTIVA + BCG, Cabazitaxel, and several others.
Therapeutic Landscape
ADSTILADRIN (nadofaragene firadenovec) – A gene therapy by Ferring Pharmaceuticals for BCG-unresponsive NMIBC, classified as an Advanced Therapy Medicinal Product (ATMP) in Europe.
ANKTIVA (nogapendekin alfa inbakicept-pmln) – An IL-15 superagonist complex approved by the FDA in 2024 in combination with BCG for CIS NMIBC. Clinical trials are ongoing to evaluate its broader applications, including with recombinant BCG in collaboration with the Serum Institute of India.
CG0070 (cretostimogene grenadenorepvec) – An oncolytic immunotherapy from CG Oncology, currently in Phase III trials, showing promising results in BCG-unresponsive patients. Combination studies with pembrolizumab (KEYTRUDA) are also underway.
Sasanlimab (PF-06801591) – An anti-PD-1 therapy by Pfizer under Phase III evaluation in high-risk, BCG-naïve NMIBC patients.
Market Trends and Drug Uptake
The report highlights drug adoption rates, patient uptake by therapy, and sales of newly launched or upcoming NMIBC drugs. It also provides insights into pipeline development, collaborations, licensing deals, mergers, and acquisitions shaping the market.
Overview of NMIBC
Non-muscle invasive bladder cancer refers to tumors confined to the bladder’s inner lining, without muscle involvement. It is the most common form of bladder cancer, often detected through hematuria or urinary symptoms. Standard treatment involves transurethral resection followed by surveillance to prevent recurrence.
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