Non-Muscle Invasive Bladder Cancer Market

• In 2023, the Non Muscle Invasive Bladder Cancer Therapeutics Market Size in the 7MM was approximately USD 2,350 million. This is expected to grow in the coming years due to the increasing Non Muscle Invasive Bladder Cancer Prevalence in the market, the launch of high-priced therapies, and the rising number of active companies in this field.
• Among all risks, High Risk NMIBC accounted for the highest Non Muscle Invasive Bladder Cancer Therapeutics Market Size of in the 7MM, i.e., nearly USD 1,600 million in 2023.
• The current treatment regimen for Non Muscle Invasive Bladder Cancer Therapeutics Market includes surgery, intravesical immunotherapy (BCG), and intravesical chemotherapy.
• There are only three drugs approved by the FDA for treating Non Muscle Invasive Bladder Cancer in the United States. KEYTRUDA (pembrolizumab) was approved in 2020, ADSTILADRIN MOA (nadofaragene firadenovec-vncg) in 2022, and the most recent, ANKTIVA (nogapendekin alfa inbakicept-pmln), was approved in 2024.
• Long before the COVID Pandemic fueled the supply chain crisis, there was a shortage of BCG. BCG has long been the go-to initial treatment for high-risk NMIBC. The continuing BCG shortage has forced doctors to rely on other treatments for their patients with high-risk NMIBC. Among the alternatives they have turned to is a combination of two chemotherapy drugs, gemcitabine and docetaxel.
• A recent collaboration between the Serum Institute of India and ImmunityBio, focusing on supplying traditional BCG and developing an enhanced recombinant BCG, strengthens efforts to address and alleviate the current BCG supply shortage for Non Muscle Invasive Bladder Cancer.
• The Non Muscle Invasive Bladder Cancer Pipeline is strong with promising therapies like CG0070 (CG Oncology), Sasanlimab (Pfizer), EG-70 (enGene), UGN-102 (Urogen), Ruvidar (Theralase), TAR-210 and TAR-200 (Johnson & Johnson) and others.
• Looking at the Non Muscle Invasive Bladder Cancer Pipeline, the companies are currently focusing on something other than the Low Risk Non Muscle Invasive Bladder Cancer segment. However, a large number of companies are preparing to enter the high and intermediate Risk Non Muscle Invasive Bladder Cancer.
• A substantial body of evidence supports UGN-102's attractive clinical profile. If authorized, it can be expected that UGN-102 would change the standard of therapy for low-grade, intermediate-risk Non Muscle Invasive Bladder Cancer from recurrent surgery to a minimally invasive, routine, non-surgical alternative. We hope that, owing to their first-mover advantage, Urogen's UG-102 will have the advantage over all other emerging therapies in the intermediate-Non Muscle Invasive Bladder Cancer segment. Urogen's treatments are likely to be already well-known by the time Cretostimogene and ADSTILADRIN MOA join the IR-Non Muscle Invasive Bladder Cancer segment.
• The growing array of novel therapeutic agents for individuals with Non Muscle Invasive Bladder Cancer presents challenges in determining the optimal treatment and sequence, given the diverse mechanisms of action and varying levels of efficacy. Customized treatment strategies are recommended, relying on a comprehensive understanding of disease characteristics, available treatments, and patient attributes and identifying and validating prognostic and predictive biomarkers.
• New medical devices and techniques are being employed to improve the delivery of intravesical agents. For example, TAR-200 and TAR-210 use hyperthermia or electromotive drug administration to enhance the uptake of gemcitabine and erdafitinib respectively.

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Key Factors Driving Non-Muscle Invasive Bladder Cancer (NMIBC) (Latest Version prepared in September) Market

Non Muscle Invasive Bladder Cancer Patient Pool and Rising Prevalence

In 2023, the total Non Muscle Invasive Bladder Cancer (NMIBC) therapeutics market in the 7MM was approximately USD 2,350 million, with high-risk NMIBC accounting for nearly USD 1,600 million. Prevalence is expected to grow due to increasing disease awareness, improved diagnostics, and the rising number of active companies developing therapies.

Non-Muscle Invasive Bladder Cancer Burden and Treatment Landscape

Current treatment strategies for NMIBC include surgery, intravesical immunotherapy (BCG), and intravesical chemotherapy. Persistent BCG shortages have driven the use of alternative chemotherapy combinations such as gemcitabine and docetaxel. Recent collaborations, like that between the Serum Institute of India and ImmunityBio, are strengthening efforts to improve BCG availability and develop enhanced recombinant formulations.

Non-Muscle Invasive Bladder Cancer Emerging Therapies and Market Drivers

The NMIBC pipeline features promising therapies including CG0070 (CG Oncology), Sasanlimab (Pfizer), EG-70 (enGene), UGN-102 (UroGen), Ruvidar (Theralase), TAR-210, and TAR-200 (Johnson & Johnson). Innovations in drug delivery, such as hyperthermia or electromotive administration for TAR-200 and TAR-210, aim to enhance therapeutic efficacy. UGN-102, with its potential for minimally invasive treatment in low-grade, intermediate-risk NMIBC, may shift the standard of care from recurrent surgery to routine non-surgical alternatives.

Non Muscle Invasive Bladder Cancer Clinical Trials and Competitive Landscape

Recent regulatory developments include FDA approval of INLEXZO (gemcitabine intravesical system) by Johnson & Johnson for BCG-unresponsive NMIBC with CIS in September 2025. UroGen’s UGN-102 is under FDA review, with an ODAC meeting scheduled for May 2025, while ImmunityBio received a Refusal to File for ANKTIVA plus BCG. Leading companies in the NMIBC space include UroGen, ImmunityBio, Johnson & Johnson, Pfizer, CG Oncology, and Theralase, highlighting a competitive landscape focused on advancing patient outcomes and expanding therapeutic options.

DelveInsight’s "Non-muscle Invasive Bladder Cancer Market Insights, Epidemiology, and Market Forecast—2034" report delivers an in-depth understanding of Non-muscle invasive bladder cancer therapeutics market, its historical and forecasted epidemiology, and its market trends in the United States, EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan.

The Non Muscle Invasive Bladder Cancer Treatment Market Report provides current treatment practices, emerging drugs, non muscle invasive bladder cancer therapeutics market share of the individual therapies, and current and forecasted non-muscle invasive bladder cancer market size from 2020 to 2034, segmented by seven major markets. The report also covers current non-muscle invasive bladder cancer treatment market practices/algorithms and unmet medical needs to curate the best of the opportunities and assess the underlying potential of the market.

Non-muscle Invasive Bladder Cancer Treatment Market

Non muscle invasive bladder cancer represents a category of bladder cancer where the tumor is confined to the innermost layer of the bladder lining without invading the muscle. This early-stage form accounts for a significant proportion of bladder cancer cases. Non Muscle Invasive Bladder Cancer is often characterized by superficial tumor growth and typically presents with papillary tumors or carcinoma in situ. Due to its propensity for recurrence and progression, Non Muscle Invasive Bladder Cancer requires vigilant management involving transurethral resection of the tumor (TURBT) and subsequent intravesical therapies like BCG immunotherapy or chemotherapy. Surveillance through regular cystoscopies and adherence to guidelines are essential to monitor and manage this condition effectively.

Non muscle Invasive Bladder Cancer Diagnosis

The Non Muscle Invasive Bladder Cancer diagnosis relies upon cystoscopy and tissue sampling. Initial cystoscopic evaluation is often performed in the office setting with or without biopsies of visualized tumors. Flexible cystoscopy in conjunction with topical intraurethral anesthetic lubricant decreases patient discomfort during the procedure, particularly in men. Most cases of Non Muscle Invasive Bladder Cancer are initially treated with transurethral resection, but careful cystoscopic examination of the entire urethra and bladder should precede resection. However, surgeons may proceed directly to TURBT should CT or MRI reveal a bladder lesion during the evaluation of Hematuria Treatment. During resection, tumors of significant size should be resected and labeled. The anatomic location of tumors with respect to the bladder neck and ureteral orifices, tumor configuration (papillary or sessile), as well as both the size and number of tumors should be documented in some consistent manner (e.g., diagram, text description) to inform future follow-up and evaluate treatment response.

Further details related to diagnosis will be provided in the report…

Non muscle Invasive Bladder Cancer Treatment

High-Risk NMIBC is a prevalent form of bladder cancer; although less severe than its muscle-invasive counterpart, it can display significant aggressiveness. Treatment options encompass careful observation with regular cystoscopies, intravesical immunotherapy involving the administration of BCG into the bladder, and, in more extreme cases, surgical removal of the bladder (cystectomy). Despite favorable recovery prospects, managing this cancer often involves intensive treatment and prolonged observation over several years. The primary interventions for cases confined to the bladder's inner lining include surgery, intravesical immunotherapy with BCG, and intravesical chemotherapy. Surgery, either as a standalone procedure or in combination with other modalities, is commonly employed. TURBT, a surgical approach, is frequently performed to remove visible cancer cells, ensuring comprehensive management.

Non muscle Invasive Bladder Cancer Epidemiology

The Non-muscle invasive bladder cancer epidemiology chapter in the report provides historical as well as forecasted epidemiology segmented by the total number of prevalent cases of Non Muscle Invasive Bladder Cancer, stage-specific cases of Non Muscle Invasive Bladder Cancer, grade-specific cases of Non Muscle Invasive Bladder Cancer, risk-specific cases of Non Muscle Invasive Bladder Cancer, and age-specific cases of Non Muscle Invasive Bladder Cancer therapeutics market in the 7MM covering the United States, EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan from 2020 to 2034.

• Among the 7MM, the US accounted for the highest Non Muscle Invasive Bladder Cancer Prevalence, with around 616,000 in 2023; these cases are expected to increase during the forecast period.
• In 2023, the highest Non Muscle Invasive Bladder Cancer prevalence among EU4 and the UK was in Italy, while the lowest number of cases was in France.
• Among cases categorized by risk level, the highest number belonged to the intermediate-risk category, whereas the lowest number was associated with the high-risk NMIBC category.
• According to the estimates, in Japan, it is observed that Non Muscle Invasive Bladder Cancer was most prevalent in the 70-89 age group, accounting for approximately 60% of total cases in 2023.
• In Japan, the highest number of Non Muscle Invasive Bladder Cancer stage-specific cases was in the Ta stage, accounting for approximately 60% in 2023. 

Recent Developments in Non-Muscle Invasive Bladder Cancer Clinical Trials Landscape

• In September 2025, Johnson & Johnson (NYSE: JNJ) announced FDA approval of INLEXZO™ (gemcitabine intravesical system) for BCG-unresponsive, non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS), offering a new option for patients after failed BCG therapy or 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 treating recurrent, low-grade, intermediate-risk non–muscle-invasive bladder cancer (NMIBC).
• In May 2025, UroGen (Nasdaq: URGN) announced that the FDA has scheduled an Oncologic Drugs Advisory Committee (ODAC) meeting for May 21, 2025, to review the new drug application (NDA) for UGN-102 (mitomycin) intravesical solution, an investigational treatment for recurrent LG-IR-NMIBC.
• In May 2025, ImmunityBio, Inc. announced that it received a Refusal to File (RTF) letter from the FDA for its supplemental biologics license application (sBLA) for the use of ANKTIVA plus Bacillus Calmette-Guerin (BCG) in BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) with papillary disease. This decision came despite unanimous guidance and encouragement from the FDA leadership in January 2025, which had supported the sBLA submission based on data from the single-arm trial.
• On November 12, 2024, Protara Therapeutics provided updates on its Q3 2024 clinical programs. The company remains on track to release interim data from the ADVANCED-2 trial of TARA-002 in Non Muscle Invasive Bladder Cancer patients in Q4 2024, with 12-month data anticipated by mid-2025. In the Phase II STARBORN-1 trial, TARA-002 showed promising results in pediatric LMs patients. Additionally, the company received FDA Fast Track designation for IV Choline Chloride, with the first patient dosing in the THRIVE-3 trial expected in Q1 2025.
• On October 15, 2024, UroGen Pharma announced the FDA acceptance of its New Drug Application (NDA) for UGN-102, aimed at treating low-grade intermediate-risk non-muscle invasive bladder cancer (LG-IR-Non Muscle Invasive Bladder Cancer), with a PDUFA goal date of June 13, 2025.
• In October 2, 2024, UroGen Pharma Ltd. announced the dosing of the first patient in a Phase 3 clinical trial for UGN-103 (mitomycin). This investigational drug, formulated as an intravesical solution, is being developed to treat low-grade intermediate-risk non-muscle invasive bladder cancer (LG-IR-Non Muscle Invasive Bladder Cancer). UGN-103 represents a next-generation mitomycin-based formulation aimed at improving treatment outcomes for this specific cancer type.

Non-muscle Invasive Bladder Cancer Drugs Market Chapters

The drug chapter segment of the non-muscle invasive bladder cancer drugs market report encloses a detailed analysis of the late mid-stage (Phase III and Phase II) Non Muscle Invasive Bladder Cancer pipeline drugs analysis. The current key Non Muscle Invasive Bladder Cancer Companies such as Ferring Pharmaceuticals/FKD Therapies Oy (ADSTILADRIN MOA), Merck Sharp & Dohme (KEYTRUDA), ImmunityBio (ANKTIVA), and others. The drug chapter also helps understand the details of the Non-muscle invasive bladder cancer clinical trials details, expressive pharmacological action, agreements and collaborations, approval, and patent details, and the latest Non Muscle Invasive Bladder Cancer news and press releases.

Marketed Non Muscle Invasive Bladder Cancer Drugs

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

ADSTILADRIN is a gene therapy developed as a treatment for adult patients with BCG-unresponsive Non Muscle Invasive Bladder Cancer. It is a non-replicating adenovirus vector-based gene therapy containing the gene interferon alfa-2b, administered by catheter into the bladder once every three months. The drug is classified as an Advanced Therapy Medicinal Product (ATMP) by the European Medicines Agency.

• In December 2022, Ferring Pharmaceuticals announced that the US FDA approved ADSTILADRIN MOA for the treatment of adult patients with high-risk, BCG unresponsive Non Muscle Invasive Bladder Cancer with carcinoma in situ (CIS) with or without papillary tumors.
• In April 2024, Ferring Pharmaceuticals and SK Pharmteco announced an agreement to scale up commercial manufacturing capacity for the drug substance of Ferring’s intravesical gene therapy ADSTILADRIN MOA to ensure long-term future supply.

• ANKTIVA (nogapendekin alfa inbakicept-pmln): ImmunityBio

ANKTIVA is a novel IL-15 superagonist complex with an IL-15 mutant (IL-15N72D) bound to an IL-15 receptor a/IgG1 Fc fusion protein. In April 2024, the US FDA approved ANKTIVA plus BCG for the treatment of patients with BCG-unresponsive Non Muscle Invasive Bladder Cancer with CIS, with or without papillary tumors. The drug is currently being evaluated in adult patients in two clinical Non Muscle Invasive Bladder Cancer trials. QUILT-3.032 is studying N-803 in combination with BCG in patients with BCG-unresponsive Non Muscle Invasive Bladder Cancer CIS and Papillary Disease; QUILT-2.005 is investigating the use of N-803 in combination with BCG for patients with BCG-naïve Non Muscle Invasive Bladder Cancer. As per ImmunityBio corporate presentation 2024, the company has planned to explore ANKTIVA + iBCG (recombinant BCG) for BCG Replacement Non Muscle Invasive Bladder Cancer. This study will be in collaboration with the Serum Institute of India and ImmunityBio. The Ankitva cost is yet to be determined by the companies in the US.

Emerging Non-muscle Invasive Bladder Cancer Drugs

• CG0070 (cretostimogene grenadenorepvec): CG Oncology

CG0070, a selectively replicative oncolytic immunotherapy based on a modified adenovirus type 5 backbone that contains a cancer-selective promoter and a GM-CSF transgene, destroys bladder tumor cells through their defective Rb pathway. Monotherapy activity of cretostimogene grenadenorepvec in Non Muscle Invasive Bladder Cancer after BCG failure has been established in two past studies of cretostimogene grenadenorepvec, V0046 and BOND-002. Studies of cretostimogene grenadenorepvec alone (Phase III BOND-003, ongoing study) will further elucidate the potential role of cretostimogene grenadenorepvec-based therapy for BCG-unresponsive Non Muscle Invasive Bladder Cancer.

The company presented updated results from BOND-003 Cohort C at the American Urological Association (AUA) 2024 annual meeting.  CG0070 is also investigated in a clinical collaboration with Merck to evaluate the combination of CG0070 with the anti-PD-1 therapy, KEYTRUDA (pembrolizumab), in a Phase II CORE-001 clinical study for the treatment of high-grade Non Muscle Invasive Bladder Cancer in the BCG-unresponsive patient population. CG Oncology presented positive final results from this study at the ASCO 2024 annual meeting. The company believes that these results support further investigation of cretostimogene in combination with checkpoint inhibitors, and they plan to incorporate these findings into another planned CORE-008 trial in high-risk Non Muscle Invasive Bladder Cancer.

• Sasanlimab (PF-06801591): Pfizer

Sasanlimab is an anti-PD-1 treatment. It blocks the PD-1 protein on the surface of immune T-cells that can attack healthy cells. PD-1 is an immune checkpoint protein that prevents T-cells from attacking healthy cells. The drug is being evaluated in a Phase III study with BCG (BCG induction with or without BCG maintenance) versus BCG (induction and maintenance) in participants with high-risk, BCG-naïve Non Muscle Invasive Bladder Cancer.

In August 2022, the Sponsor announced the discontinuation of enrollment to Part B, which enrolled participants with BCG unresponsive Non Muscle Invasive Bladder Cancer. The decision to discontinue enrollment in Part B was not made for safety reasons. The company anticipated data readout from the Phase III trial of sasanlimab in Non Muscle Invasive Bladder Cancer in the first half of 2025.

Non Muscle Invasive Bladder Cancer Drugs Market Insights

Currently, BCG is the leading standard of care in the Non Muscle Invasive Bladder Cancer setting. In the emerging pipeline, checkpoint inhibitors (KEYTRUDA), gene therapy (ADSTILADRIN MOA), cell therapy (TARA-002), oncolytic Immunotherapy (Lerapolturev, CG0070, and others), virus-like drug conjugate (belzupacap sarotalocan), photodynamic compound (Ruvidar), and others are different classes that are showing positive results in Non Muscle Invasive Bladder Cancer Patients. Checkpoint inhibitors and gene therapy are already approved in the BCG unresponsive Non Muscle Invasive Bladder Cancer patient pool.

Immune checkpoint inhibitors (ICIs)

Immune checkpoint inhibitors (ICIs) are a powerful tool in cancer immunotherapy, designed to enhance the body's natural defenses against cancer cells. KEYTRUDA, approved in 2020 for BCG-unresponsive patients, has demonstrated significant efficacy in this population. The emerging pipeline includes several PD-(L)1 inhibitors in Phase III trials, such as TECENTRIQ, IMFINZI, and sasanlimab, all being evaluated in combination with BCG for BCG-naïve patients. However, results for these inhibitors in BCG-naïve patients are not yet available. It will be interesting to observe the efficacy and safety outcomes in this group and how their approval could alleviate the treatment burden for naïve patients, especially in the context of a BCG shortage. The lack of response in many cancer patients to immune checkpoint inhibitors highlights the significant clinical need to develop new therapies suitable for both immune checkpoint-naïve and -refractory patients.

• Interleukin-15 receptor superagonist

The most recent therapy approved by the FDA is ANKTIVA + BCG developed by ImmunityBio. Notably, in Non Muscle Invasive Bladder Cancer patients, the complete response rate (CRR) reached 62%, with a median duration of response not reached (0.0, 47.0+). Around 58% and 40% of patients reached a duration of response (DoR) of =12 and =24 months, respectively. In terms of safety, permanent discontinuation of ANKTIVA with BCG due to adverse reactions occurred in 7% of patients. The efficacy of ANKTIVA is better than other approved drugs, but in terms of safety it is not better than ADSTILADRIN MOA. ANKTIVA does not require any special freezers or equipment; it can be stored in standard refrigerators and freezers. Since ANKTIVA is administered as a mixture with BCG, it does not ’’necessitate any different equipment or processing from BCG administration. This means urology practices do not need to make any changes to order, store, or implement ANKTIVA. This ease of integration could lead to a rapid adoption of ANKTIVA in clinical settings.

• Oncolytic Immunotherapy

Currently, no oncolytic immunotherapy is approved for Non Muscle Invasive Bladder Cancer patients, but companies are exploring drugs for intermediate and high-risk Non Muscle Invasive Bladder Cancer patients. A key drug in this class is CG0070, which has a unique mechanism that may synergize with PD-1 inhibitors. Notably, 75.2% of patients evaluated for efficacy achieved a complete response at any time. The company is conducting another Phase II trial of CG0070 in combination with pembrolizumab. The CRR in the intent-to-treat (ITT) population at 24 months was 54%. Among patients who achieved a CRR at 12 months, 95% maintained this response for another 12 months, with the median DoR exceeding 21 months and still needs to be reached. This combination aims to enhance overall treatment efficacy by leveraging synergistic effects, potentially improving outcomes for BCG-unresponsive high-grade Non Muscle Invasive Bladder Cancer patients. After approval, CG0070 is expected to compete with ADSTILADRIN MOA and EG-70.

Non-muscle Invasive Bladder Cancer Market Outlook

Non Muscle Invasive Bladder Cancer remains a very challenging disease to treat, with high rates of recurrence and progression associated with current therapies. The high rates of progression and recurrence with current therapies for Non Muscle Invasive Bladder Cancer necessitate lifelong active surveillance, making bladder cancer the most expensive cancer to treat from diagnosis to death, as well as driving the need for the development of new therapies in patients with Non Muscle Invasive Bladder Cancer.

The current Non-muscle Invasive Bladder Cancer treatment regimen includes surgery, intravesical immunotherapy (BCG), and intravesical chemotherapy. Intermediate- or high-risk NMIBC is generally treated with TURBT, followed by adjuvant BCG immunotherapy, which is the gold standard treatment for reducing tumor recurrence rates and preventing subsequent stage progression. Stage 0 bladder cancer is most often treated with TURBT with fulguration followed by intravesical therapy within 24 h. Sometimes, no further treatment is needed. Cystoscopy is then done every 3–6 months to watch for signs that cancer has come back.

In addition, the FDA has approved only three drugs for the treatment of Non Muscle Invasive Bladder Cancer: KEYTRUDA and ADSTILADRIN, which were approved in 2020 and 2022, respectively, and the latest addition, ANKTIVA, which the FDA approved in April 2024. All three are approved in the US only.

The landscape of managing BCG-unresponsive Non Muscle Invasive Bladder Cancer patients in real-world clinical practice reveals significant trends. Approximately a quarter of physicians' Non Muscle Invasive Bladder Cancer caseload comprised BCG-unresponsive patients for whom BCG therapy was no longer a viable option. Furthermore, about a third of the Non Muscle Invasive Bladder Cancer patient caseload had not undergone BCG therapy, possibly due to pending treatment post-TURBT. The global scarcity of BCG has exacerbated these challenges, limiting adequate induction and maintenance therapies and resulting in higher recurrence and failure rates.

Non Muscle Invasive Bladder Cancer pipeline possesses potential Non-muscle Invasive Bladder Cancer Drugs in mid and late-stage developments for low and high-risk NMIBC to be launched in the near future. The major high-risk NMIBC Pipeline Drugs include CG0070 (CG Oncology), Sasanlimab (Pfizer), EG-70 (enGene), UGN-102, and UGN-103 (Urogen), Ruvidar (Theralase), TAR-210 and TAR-200 (Johnson & Johnson), and others. Also, these emerging therapies are expected to launch during the forecast period [2024–2034].

This evolving Non Muscle Invasive Bladder Cancer treatment market landscape showcases the challenges and shifting paradigms in managing BCG-unresponsive Non Muscle Invasive Bladder Cancer patients, emphasizing the need for further research, personalized treatment strategies, and broader adoption of biomarker-driven approaches for improved patient outcomes.

Detailed market assessment will be provided in the final report.

Key Findings

• The US for bladder cancer treatment market size was estimated to be USD ~1,450 million in 2023, which is expected to grow during the forecast period (2024–2034).
• By 2034, among all the Non-muscle Invasive Bladder Cancer therapies, the highest revenue is expected to be generated by Cretostimogene Grenadenorepvec ± KEYTRUDA.
• In terms of risk, low-risk Non Muscle Invasive Bladder Cancer, intermediate-risk Non Muscle Invasive Bladder Cancer, and high-risk NMIBC accounted for ~12%, ~21%, and ~67% of the total market size, respectively.
• At present, Chemotherapy, BCG, and TURBT dominate the low-risk NMIBC Market, as no drug is approved for this segment, and no companies are exploring it.
• Many Non Muscle Invasive Bladder Cancer Companies are focusing on the BCG-unresponsive Non Muscle Invasive Bladder Cancer patient population. They're exploring various treatments, such as oncolytic virus (CG0070), non-viral plasmid-based therapy (EG-70), Drug device combination (TAR-200), and more.
• A broader market potential lies with the BCG-naïve Non Muscle Invasive Bladder Cancer patient segment, owing to the BCG shortage and lack of approved Non Muscle Invasive Bladder Cancer therapies.
• The expiration of KEYTRUDA patents in the United States by 2028 will create opportunities for biosimilar entry into the market, potentially affecting the sales of these products in the bladder cancer treatment landscape.

Non muscle Invasive Bladder Cancer Drugs Uptake

This section focuses on the uptake rate of potential Non-muscle Invasive Bladder Cancer drugs expected to be launched in the market during 2024–2034. The landscape of Non Muscle Invasive Bladder Cancer treatment has experienced a profound transformation with the uptake of novel drugs. These innovative therapies are redefining standards of care. Furthermore, the increased uptake of these transformative drugs is a testament to the unwavering dedication of physicians, oncology professionals, and the entire healthcare community in their tireless pursuit of advancing cancer care. This momentous shift in treatment paradigms is a testament to the power of research, collaboration, and human resilience.

CG0070, developed by CG Oncology, has demonstrated significantly better efficacy compared to approved drugs for BCG-unresponsive Non Muscle Invasive Bladder Cancer, achieving around a 75% CRR in these patients. Additionally, the drug has shown impressive results when used in combination with immunotherapy, with 95% of patients who achieved CRR at 12 months maintaining it for another 12 months. The median DoR has yet to be reached but exceeds 21 months. We have anticipated a launch by 2026; this drug could capture a billion-dollar market by 2034 following its approval.

Non muscle Invasive Bladder Cancer Pipeline Development Activities

The bladder cancer treatment drug market report provides insights into different non-muscle invasive bladder cancer clincial trials within Phase III, Phase II, and Phase I. It also analyzes key players involved in developing targeted therapeutics. Non Muscle Invasive Bladder Cancer Companies like Roche, Pfizer, AstraZeneca, UroGen Pharma, CG Oncology, Theralase Technologies, enGene, Protara Therapeutics, and others actively engage in mid and late-stage research and development efforts for non-muscle invasive bladder cancer. The pipeline of non-muscle invasive bladder cancer possesses few potential drugs. However, there is a positive outlook for the therapeutics market, with expectations of growth during the forecast period (2024–2034).

Development Activities

The Non-muscle Invasive Bladder Cancer clinical trials market report covers information on collaborations, acquisitions and mergers, licensing, and patent details for non-muscle invasive bladder cancer emerging therapy.

KOL- Views

To keep up with current Non Muscle Invasive Bladder Cancer Clinical Trials Market Trends, we take KOLs and SMEs’ opinions working in the domain through primary research to fill the data gaps and validate our secondary research. Industry Experts contacted for insights on the non-muscle invasive bladder cancer evolving Non Muscle Invasive Bladder Cancer Treatment Market Landscape, patient reliance on conventional therapies, patient therapy switching acceptability, and drug uptake, along with challenges related to accessibility, including oncologists, radiation oncologists, surgical oncologists, and others.

DelveInsight’s analysts connected with 30+ KOLs to gather insights; however, interviews were conducted with 15+ KOLs in the 7MM. Centers such as the Institute for Personalized Cancer Therapy, Urologist Cancer Center, University, etc., were contacted. Their opinion helps understand and validate current and emerging therapy treatment patterns or Non-muscle invasive bladder cancer therapeutics market trends. This will support the clients in potential upcoming novel treatments by identifying the overall scenario of the market and the unmet needs.

Non muscle Invasive Bladder Cancer Clinical Trials Market: Qualitative Analysis

We perform Qualitative and market Intelligence analysis using various approaches, such as SWOT analysis and Conjoint Analysis. In the SWOT analysis, strengths, weaknesses, opportunities, and threats in terms of gaps in disease diagnosis, patient awareness, physician acceptability, competitive landscape, cost-effectiveness, and geographical accessibility of therapies are provided.

Conjoint Analysis analyzes multiple approved and emerging Non Muscle Invasive Bladder Cancer therapies based on relevant attributes such as safety, efficacy, frequency of administration, route of administration, and order of entry. Scoring is given based on these parameters to analyze the effectiveness of therapy. In efficacy, the trial’s primary and secondary outcome measures are evaluated; for instance, in event-free survival, one of the most crucial primary outcome measures is event-free survival and overall survival.

Further, the therapies’ safety is evaluated, wherein the acceptability, tolerability, and adverse events are majorly observed, and this clearly explains the drug's side effects in the trials. In addition, the scoring is also based on the probability of success and the addressable patient pool for each therapy. According to these parameters, the final weightage score and the ranking of the emerging therapies are decided.

Non Muscle Invasive Bladder Cancer Clinical Trials Market Access and Reimbursement

Non Muscle Invasive Bladder Cancer is a costly disease to manage, with higher healthcare costs associated with an increased risk of disease progression. There is a high unmet need for safe and effective treatments that reduce the risk of disease progression and provide symptomatic relief and HRQoL improvements for patients. The Merck Access Program is designed to provide patients with reimbursement and insurance coverage-related information throughout their treatment process. The program helps with benefit investigations, billing and coding, copay assistance for eligible patients, prior authorizations and appeals, and referral to the Merck Patient Assistance Program for eligibility determination.

The representative medical expenses based on the Japanese health insurance system are as follows: one cystoscopy costs 9500 Japanese yen (equivalent to USD 67 as of July 2023), a single dose of BCG Tokyo 172 strain costs approximately 14,000 yen (USD 98), and one hospitalization for TURBT costs 400,000 yen (USD 2,821).

Non-Muscle Invasive Bladder Cancer Clinical Trials Market Report Scope

• The Non-muscle Invasive Bladder Cancer treatment drugs market report covers a segment of critical events, an executive summary, and a descriptive overview, explaining its causes, signs, symptoms, pathogenesis, and currently used therapies.
• Comprehensive insight into the epidemiology segments and forecasts, disease progression, and treatment guidelines has been provided.
• Additionally, an all-inclusive account of emerging therapies and elaborate profiles of late-stage and prominent therapies will impact the current treatment landscape.
• A detailed review of the Non-muscle invasive bladder cancer therapeutics market, historical and forecasted Non Muscle Invasive Bladder Cancer treatment market size, Non Muscle Invasive Bladder Cancer drugs market share by therapies, detailed assumptions, and rationale behind our approach is included in the report, covering the 7MM drug outreach.
• The Non Muscle Invasive Bladder Cancer treatment drugs market report provides an edge while developing business strategies by understanding trends through SWOT analysis and expert insights/KOL views, patient journey, and treatment preferences that help shape and drive non-muscle invasive bladder cancer.

Non muscle Invasive Bladder Cancer Clinical Trials Market Report Insights

• Patient-based Non Muscle Invasive Bladder Cancer Market Forecasting
• Non-muscle Invasive Bladder Cancer Therapeutic Approaches
• Non-muscle Invasive Bladder Cancer Pipeline Drugs Analysis
• Non-muscle Invasive Bladder Cancer Market Size
• Non Muscle Invasive Bladder Cancer Therapeutics Market Trends
• Existing and Future Non Muscle Invasive Bladder Cancer Diagnostics Market Opportunity

Non muscle Invasive Bladder Cancer Clinical Trials Market Report Key Strengths

• 11 Years Non Muscle Invasive Bladder Cancer Market Forecast
• The 7MM Coverage for Non Muscle Invasive Bladder Cancer Treatment Drugs Market
• Non-muscle Invasive Bladder Cancer Epidemiology Segmentation
• Key Cross Competition
• Non-muscle Invasive Bladder Cancer Drugs Uptake
• Key Non-muscle Invasive Bladder Cancer Market Forecast Assumptions

Non-muscle Invasive Bladder Cancer Clinical Trials Market Report Assessment

• Current Non-muscle Invasive Bladder Cancer Treatment Practices
• Non Muscle Invasive Bladder Cancer Unmet Needs
• Non-muscle Invasive Bladder Cancer Pipeline Drugs Profiles
• Non-muscle Invasive Bladder Cancer Treatment Drugs Market Attractiveness
• Qualitative Analysis (SWOT and Analyst Views)
• Non-muscle Invasive Bladder Cancer Market Drivers
• Non-muscle Invasive Bladder Cancer Market Barriers

FAQs

• What was the size of the Non-muscle invasive bladder cancer diagnostics market, the Non Muscle Invasive Bladder Cancer treatment market size by therapies, and the Non Muscle Invasive Bladder Cancer drugs market share (%) distribution in 2020, and what would it look like by 2034? What are the contributing factors for this growth?
• What can be the future treatment paradigm for non-muscle invasive bladder cancer?
• What are the disease risks, burdens, and Non Muscle Invasive Bladder Cancer Unmet Needs? What will be the growth opportunities across the 7MM concerning the patient population with non-muscle invasive bladder cancer?
• How much market share will PD-(L)1 capture by 2034?
• Which therapy is anticipated to take a significant share of the Non Muscle Invasive Bladder Cancer Diagnostics Market by 2024?
• What are the current options for the Non Muscle Invasive Bladder Cancer Treatment? What are the current guidelines for treating non-muscle invasive bladder cancer in the 7MM?
• What are the recent novel therapies, targets, Non Muscle Invasive Bladder Cancer mechanisms of action, and technologies being developed to overcome the limitations of existing therapies?
• What is the Non Muscle Invasive Bladder Cancer Therapeutics Market Size by low, intermediate and high risk?
• Which segment is most explored under high-risk NMIBC (Naïve, unresponsive, and recurrent)?

Reasons to Buy

• The muscle invasive bladder cancer diagnostics market report will help develop business strategies by understanding the latest trends and changing treatment dynamics driving non-muscle invasive bladder cancer.
• Insights on patient burden/disease Non Muscle Invasive Bladder Cancer Prevalence, evolution in diagnosis, and factors contributing to the change in the epidemiology of the disease during the forecast years.
• Understand the existing Non Muscle Invasive Bladder Cancer Diagnostics Market opportunities in varying geographies and the growth potential over the coming years.
• Identifying upcoming solid Non-muscle Invasive Bladder Cancer companies in the Non Muscle Invasive Bladder Cancer Diagnostics Market will help devise strategies to help get ahead of competitors.
• Detailed analysis ranking of class-wise potential current and emerging therapies under the analyst view section to provide visibility around leading classes.
• Highlights include access and reimbursement policies for current therapies, barriers to accessibility for expensive off-label therapies, and patient assistance programs.
• To understand Key Opinion Leaders’ perspectives around the accessibility, acceptability, and compliance-related challenges of existing treatment to overcome barriers in the future.
• Detailed insights on the unmet needs of the existing Non Muscle Invasive Bladder Cancer Diagnostics Market will help upcoming Non Muscle Invasive Bladder Cancer Companies strengthen their development and launch strategies.

Access Exclusive Insightful Articles, Videos and Informative Infographics to Stay Informed:- 

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