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Non-Muscle Invasive Bladder Cancer (NMIBC) Market Insight, Epidemiology And Market Forecast - 2034

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    Report

  • 265 Pages
  • August 2024
  • Region: Global
  • DelveInsight
  • ID: 5144523

Key Highlights

  • In 2023, the total market size for NMIBC in the 7MM was approximately USD 2.35 billion. This 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 this field.
  • Among all risks, high-risk NMIBC accounted for the highest market size of in the 7MM, i.e., nearly USD 1.60 billion in 2023.
  • The current treatment regimen includes surgery, intravesical immunotherapy (BCG), and intravesical chemotherapy.
  • There are only three drugs approved by the FDA for treating NMIBC in the United States. KEYTRUDA (pembrolizumab) was approved in 2020, ADSTILADRIN (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 NMIBC.
  • The pipeline of NMIBC 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 NMIBC pipeline, the companies are currently focusing on something other than the Low-Risk NMIBC segment. However, a large number of companies are preparing to enter the high and intermediate Risk NMIBC.
  • 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 NMIBC 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-NMIBC segment. Urogen's treatments are likely to be already well-known by the time Cretostimogene and ADSTILADRIN join the IR-NMIBC segment.
  • The growing array of novel therapeutic agents for individuals with NMIBC 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.
The "Non-muscle Invasive Bladder Cancer - Market Insights, Epidemiology, and Market Forecast - 2034" report delivers an in-depth understanding of Non-muscle invasive bladder cancer, 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 market report provides current treatment practices, emerging drugs, non-muscle invasive bladder cancer 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 practices/algorithms and unmet medical needs to curate the best of the opportunities and assess the underlying potential of the market.

Geography Covered

  • The United States
  • EU4 (Germany, France, Italy, and Spain) and the United Kingdom
  • Japan

Study Period: 2020-2034

Non-muscle Invasive Bladder Cancer Disease Understanding and Treatment Algorithm

Non-muscle Invasive Bladder Cancer Overview

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. NMIBC 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, NMIBC 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 diagnosis of NMIBC 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 NMIBC 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. 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.

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 (NMIBC) epidemiology chapter in the report provides historical as well as forecasted epidemiology segmented by the total number of prevalent cases of NMIBC, stage-specific cases of NMIBC, grade-specific cases of NMIBC, risk-specific cases of NMIBC, and age-specific cases of NMIBC in the 7MM market 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 number of prevalent cases of NMIBC, with around 616,000 in 2023; these cases are expected to increase during the forecast period.
  • In 2023, the highest number of prevalent cases of NMIBC 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 category.
  • According to the estimates, in Japan, it is observed that NMIBC was most prevalent in the 70-89 age group, accounting for approximately 60% of total cases in 2023.
  • In Japan, the highest number of stage-specific cases of NMIBC was in the Ta stage, accounting for approximately 60% in 2023.

Non-muscle Invasive Bladder Cancer Drug Chapters

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

Marketed Drugs

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

ADSTILADRIN is a gene therapy developed as a treatment for adult patients with BCG-unresponsive NMIBC. 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 for the treatment of adult patients with high-risk, BCG unresponsive NMIBC 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 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 NMIBC with CIS, with or without papillary tumors. The drug is currently being evaluated in adult patients in two clinical NMIBC trials. QUILT-3.032 is studying N-803 in combination with BCG in patients with BCG-unresponsive NMIBC CIS and Papillary Disease; QUILT-2.005 is investigating the use of N-803 in combination with BCG for patients with BCG-naïve NMIBC. As per ImmunityBio corporate presentation 2024, the company has planned to explore ANKTIVA + iBCG (recombinant BCG) for BCG Replacement NMIBC. This study will be in collaboration with the Serum Institute of India and ImmunityBio.

Emerging 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 NMIBC 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 NMIBC. 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 NMIBC 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 NMIBC.

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 NMIBC. In August 2022, the Sponsor announced the discontinuation of enrollment to Part B, which enrolled participants with BCG unresponsive NMIBC. 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 NMIBC in the first half of 2025.

Drug Class Insight

Currently, BCG is the leading standard of care in the NMIBC setting. In the emerging pipeline, checkpoint inhibitors (KEYTRUDA), gene therapy (ADSTILADRIN), 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 NMIBC patients. Checkpoint inhibitors and gene therapy are already approved in the BCG unresponsive NMIBC 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 NMIBC 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. 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 NMIBC patients, but companies are exploring drugs for intermediate and high-risk NMIBC 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 NMIBC patients. After approval, CG0070 is expected to compete with ADSTILADRIN and EG-70.

Non-muscle Invasive Bladder Cancer Market Outlook

NMIBC 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 NMIBC 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 NMIBC.

The current 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 NMIBC: 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 NMIBC patients in real-world clinical practice reveals significant trends. Approximately a quarter of physicians' NMIBC caseload comprised BCG-unresponsive patients for whom BCG therapy was no longer a viable option. Furthermore, about a third of the NMIBC 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.

NMIBC pipeline possesses potential drugs in mid and late-stage developments for low and high-risk NMIBC to be launched in the near future. The major drugs in the pipeline for high-risk NMIBC 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 landscape showcases the challenges and shifting paradigms in managing BCG-unresponsive NMIBC 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 total market size in the US for NMIBC 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 therapies, the highest revenue is expected to be generated by Cretostimogene Grenadenorepvec ± KEYTRUDA.
  • In terms of risk, low-risk NMIBC, intermediate-risk NMIBC, 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 companies are focusing on the BCG-unresponsive NMIBC 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 NMIBC patient segment, owing to the BCG shortage and lack of approved 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 drugs expected to be launched in the market during 2024-2034. The landscape of NMIBC 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 NMIBC, 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 report provides insights into therapeutic candidates in Phase III, Phase II, and Phase I. It also analyzes key players involved in developing targeted therapeutics. 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).

Pipeline Development Activities

The 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 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 treatment 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.

The 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 market trends. This will support the clients in potential upcoming novel treatments by identifying the overall scenario of the market and the unmet needs.

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 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.

Market Access and Reimbursement

NMIBC 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).

Detailed market access and reimbursement assessment will be provided in the final report.

Scope of the Report

  • The report covers a segment of critical events, an executive summary, and a descriptive overview of non-muscle invasive bladder cancer, 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 market, historical and forecasted market size, market share by therapies, detailed assumptions, and rationale behind our approach is included in the report, covering the 7MM drug outreach.
  • The 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 Report Insights

  • Patient Population
  • Therapeutic Approaches
  • Non-muscle Invasive Bladder Cancer Pipeline Analysis
  • Non-muscle Invasive Bladder Cancer Market Size and Trends
  • Existing and Future Market Opportunity

Non-muscle Invasive Bladder Cancer Report Key Strengths

  • Eleven Years Forecast
  • The 7MM Coverage
  • Non-muscle Invasive Bladder Cancer Epidemiology Segmentation
  • Key Cross Competition
  • Drugs Uptake and Key Market Forecast Assumptions

Non-muscle Invasive Bladder Cancer Report Assessment

  • Current Treatment Practices
  • Unmet Needs
  • Pipeline Product Profiles
  • Market Attractiveness
  • Qualitative Analysis (SWOT and Analyst Views)

FAQs

  • What was the size of the Non-muscle invasive bladder cancer market, the market size by therapies, and the 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 unmet needs of non-muscle invasive bladder cancer? 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 NMIBC market by 2024?
  • What are the current options for the treatment of non-muscle invasive bladder cancer? What are the current guidelines for treating non-muscle invasive bladder cancer in the 7MM?
  • What are the recent novel therapies, targets, mechanisms of action, and technologies being developed to overcome the limitations of existing therapies?
  • What is the market size of non-muscle invasive bladder cancer by low, intermediate and high risk?
  • Which segment is most explored under high-risk NMIBC (Naïve, unresponsive, and recurrent)?

Reasons to Buy

  • The 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 prevalence, evolution in diagnosis, and factors contributing to the change in the epidemiology of the disease during the forecast years.
  • Understand the existing market opportunities in varying geographies and the growth potential over the coming years.
  • Identifying upcoming solid players in the 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 market will help upcoming players strengthen their development and launch strategies.

Table of Contents

1. Key Insights2. Report Introduction3. Executive Summary of NMIBC
4. NMIBC Market Overview at a Glance
4.1. Market Share (%) Distribution by Risk (Low, Intermediate and High) in 2024 in the 7MM
4.2. Market Share (%) Distribution by Risk (Low, Intermediate and High) in 2034 in the 7MM
5. NMIBC Drug Development Overview by Phase and ROA6. Key Events7. Epidemiology and Market Forecast Methodology
8. Disease Background and Overview: NMIBC
8.1. Introduction
8.2. Sign and Symptoms
8.3. Clinical Stages of NMIBC
8.4. Grading
8.5. The Risk Stratification of NMIBC
8.6. Diagnosis of NMIBC
8.6.1. Cystoscopy
8.6.2. Urinary Cytology - Urinary Molecular Marker Tests
8.6.3. Transurethral resection of bladder tumors (TURBT)
8.6.4. Urinary Biomarkers
8.6.4.1. Potential Application of Urinary Cytology and Markers
8.7. Treatment
8.7.1. TURBT
8.7.2. Intravesical Therapy
8.7.2.1. Intravesical Immunotherapy (BCG)
8.7.2.2. Intravesical Chemotherapy
8.7.3. Surgery to Remove the Bladder
8.7.3.1. Partial Cystectomy (removal of part of the bladder)
8.7.3.2. Radical Cystectomy (removal of the whole bladder)
8.7.3.3. Urinary Diversion after Bladder Removal
9. Guidelines
9.1. American Urological Association (AUA)/Society of Urologic Oncology (SUO) Guidelines for NMIBC: 2024
9.2. NCCN Guidelines (2024)
9.3. European Association of Urology (EAU) Guidelines on Non-muscle-invasive Bladder Cancer (2024)
9.3.1. Diagnosis
9.3.2. Disease Management
9.3.2.1. Recommendation for Adjuvant Therapy in TaT1 Tumors and for Therapy of Carcinoma in Situ
9.3.2.2. Recommendations for the Treatment of TaT1 Tumors and Carcinoma In Situ According to Risk Stratification
9.4. Treatment Algorithm
10. Epidemiology and Patient Population
10.1. Key Findings
10.2. Assumptions and Rationale
10.3. Total Prevalent Cases of Bladder Cancer in the 7MM
10.4. Total Prevalent Cases of NMIBC in the 7MM
10.5. The United States
10.5.1. Total Prevalent Cases of NMIBC in the United States
10.5.2. Stage-specific Cases of NMIBC in the United States
10.5.3. Grade-specific Cases of NMIBC in the United States
10.5.4. Risk-specific Cases of NMIBC in the United States
10.5.5. Age-specific Cases of NMIBC in the United States
10.6. EU4 and the UK
10.6.1. Total Prevalent Cases of NMIBC in EU4 and the UK
10.6.2. Stage-specific Cases of NMIBC in EU4 and the UK
10.6.3. Grade-specific Cases of NMIBC in EU4 and the UK
10.6.4. Risk-specific Cases of NMIBC in EU4 and the UK
10.6.5. Age-specific Cases of NMIBC in EU4 and the UK
10.7. Japan
10.7.1. Total Prevalent Cases of NMIBC in Japan
10.7.2. Stage-specific Cases of NMIBC in Japan
10.7.3. Grade-specific Cases of NMIBC in Japan
10.7.4. Risk-specific Cases of NMIBC in Japan
10.7.5. Age-specific Cases of NMIBC in Japan
11. Patient Journey
12. Marketed Drugs
12.1. Key Competitors
12.2. ANKTIVA (N-803/ALT-803): ImmunityBio
12.2.1. Product Description
12.2.2. Regulatory Milestone
12.2.3. Other Developmental Activities
12.2.4. Clinical Development
12.2.4.1. Clinical Trial Information
12.2.5. Safety and Efficacy
12.3. ADSTILADRIN (nadofaragene firadenovec): Ferring Pharmaceuticals/FKD Therapies Oy
12.3.1. Product Description
12.3.2. Regulatory Milestones
12.3.3. Other Developmental Activities
12.3.4. Clinical Development
12.3.4.1. Clinical Trial Information
12.3.5. Safety and Efficacy
12.4. KEYTRUDA (pembrolizumab): Merck
12.4.1. Product Description
12.4.2. Regulatory Milestones
12.4.3. Other Developmental Activities
12.4.4. Clinical Development
12.4.4.1. Clinical Trial Information
12.4.5. Safety and Efficacy
13. Emerging Drugs
13.1. Key Cross Competition
13.2. TECENTRIQ (atezolizumab): Hoffmann-La Roche
13.2.1. Product Description
13.2.2. Other Developmental Activities
13.2.3. Clinical Development
13.2.3.1. Clinical Trial Information
13.2.4. Safety and Efficacy
13.3. Sasanlimab (PF-06801591): Pfizer
13.3.1. Product Description
13.3.2. Other Developmental Activities
13.3.3. Clinical Development
13.3.3.1. Clinical Trial Information
13.4. IMFINZI (durvalumab): AstraZeneca
13.4.1. Product Description
13.4.2. Other Developmental Activities
13.4.3. Clinical Development
13.4.3.1. Clinical Trial Information
13.5. UGN-102 (mitomycin): UroGen Pharma
13.5.1. Product Description
13.5.2. Other Developmental Activities
13.5.3. Clinical Development
13.5.3.1. Clinical Trial Information
13.5.4. Safety and Efficacy
13.6. UGN-103: UroGen Pharma
13.6.1. Product Description
13.6.2. Other Developmental Activities
13.6.3. Clinical Development
13.6.3.1. Clinical Trial Information
13.7. TAR-200: Johnson & Johnson
13.7.1. Product Description
13.7.2. Other Developmental Activity
13.7.3. Clinical Development
13.7.3.1. Clinical Trial Information
13.7.4. Safety and Efficacy
13.8. CG0070 (cretostimogene grenadenorepvec): CG Oncology
13.8.1. Product Description
13.8.2. Other Developmental Activities
13.8.3. Clinical Development
13.8.3.1. Clinical Trial Information
13.8.4. Safety and Efficacy
13.9. TAR-210 (intravesical erdafitinib): Johnson & Johnson
13.9.1. Product Description
13.9.2. Clinical Development
13.9.2.1. Clinical Trial Information
13.9.3. Safety and Efficacy
13.10. ONCOFID P-B: Fidia Farmaceutici
13.10.1. Product Description
13.10.2. Clinical Development
13.10.2.1. Clinical Trial Information
13.10.3. Safety and Efficacy
13.11. Ruvidar (TLD-1433): Theralase Technologies
13.11.1. Product Description
13.11.2. Other Developmental Activities
13.11.3. Clinical Development
13.11.3.1. Clinical Trial Information
13.11.4. Safety and Efficacy
13.12. BALVERSA (erdafitinib): Johnson & Johnson
13.12.1. Product Description
13.12.2. Clinical Development
13.12.2.1. Clinical Trial Information
13.12.3. Safety and Efficacy
13.13. TARA-002: Protara Therapeutics
13.13.1. Product Description
13.13.2. Other Developmental Activities
13.13.3. Clinical Development
13.13.3.1. Clinical Trial Information
13.13.4. Safety and Efficacy
13.14. EG-70: enGene
13.14.1. Product Description
13.14.2. Other Developmental Activities
13.14.3. Clinical Development
13.14.3.1. Clinical Trial Information
13.14.4. Safety and Efficacy
13.15. Belzupacap Sarotalocan (AU-011): Aura Biosciences
13.15.1. Product Description
13.15.2. Other Developmental Activities
13.15.3. Clinical Development
13.15.3.1. Clinical Trial Information
13.16. PADCEV (Enfortumab vedotin): Astellas Pharma/Pfizer
13.16.1. Product Description
13.16.2. Other Developmental Activities
13.16.3. Clinical Development
13.16.3.1. Clinical Trial Information
13.16.4. Safety and Efficacy
14. NMIBC: The 7MM Analysis
14.1. Key Findings
14.2. Market Outlook
14.2.1. BCG Shortage
14.3. Conjoint Analysis
14.1. Key Market Forecast Assumptions
14.1.1 . Cost Assumptions and Rebates
14.1.2. Pricing Trends
14.1.3. Analogue Assessment
14.1.4 . Launch Year and Therapy Uptakes
14.1.5. Intermediate-risk NMIBC
14.1.6. High-risk NMIBC
14.1.6.1. High-risk BCG Naïve NMIBC
14.1.6.2. High-risk BCG Unresponsive NMIBC
14.1.6.3. High-risk BCG Recurrent
14.2. Total Market Size of NMIBC in the 7MM
14.3. Total Market Size of NMIBC by Risk in the 7MM
14.4. Total Market Size of NMIBC by Therapies in the 7MM
14.5. Low-risk NMIBC
14.5.1. The United States
14.5.2. EU4 and the UK
14.5.3. Japan
14.6. Intermediate-risk NMIBC
14.6.1. The United States
14.6.2. EU4 and the UK
14.6.3. Japan
14.7. High-risk NMIBC
14.7.1. United States
14.7.1.1. High-risk BCG Naïve NMIBC
14.7.1.2. High-risk BCG Unresponsive NMIBC
14.7.1.3. High-risk BCG Recurrent NMIBC
14.7.2. EU4 and the UK
14.7.2.1. High-risk BCG Naïve NMIBC
14.7.2.2. High-risk BCG Unresponsive NMIBC
14.7.2.3. High-risk BCG Recurrent NMIBC
14.7.3. Japan
14.7.3.1. High-risk BCG Naïve NMIBC
14.7.3.2. High-risk BCG Unresponsive NMIBC
14.7.3.3. High-risk BCG Recurrent NMIBC
15. Unmet Needs16. Swot Analysis17. KOL Views
18. Market Access and Reimbursement
18.1. United States
18.1.1. Centre for Medicare and Medicaid Services (CMS)
18.2. EU4 and the UK
18.2.1. Germany
18.2.2. France
18.2.3. Italy
18.2.4. Spain
18.2.5. United Kingdom
18.3. Japan
18.3.1. MHLW
18.4. Market Access and Reimbursement for NMIBC
18.4.1. Reimbursement of cystoscopy
19. Appendix
19.1. Abbreviations
19.2. Bibliography
19.3. Report Methodology
20. Publisher Capabilities21. Disclaimer22. About the Publisher
List of Tables
Table 1: Summary of NMIBC Market and Epidemiology (2020-2034)
Table 2: WHO Grading in 1973 and in 2004
Table 3: Risk Stratification of NMIBC According to EAU and NICE Guidelines
Table 4: Treatment Options for the Various Categories of BCG Failure
Table 5: Recommendations of EAU Guidelines
Table 6: Summary of Evidence of Management of NMIBC
Table 7: Guidelines for Adjuvant Therapy in TaT1 Tumors and for Therapy of CIS
Table 8: Guidelines for the Treatment of TaT1 Tumors and Carcinoma In Situ According to Risk Stratification
Table 9: Total Prevalent Cases of Bladder Cancer in the 7MM in Thousand (2020-2034)
Table 10: Total Prevalent Cases of NMIBC in the 7MM in Thousand (2020-2034)
Table 11: Total Prevalent Cases of NMIBC in the United States in Thousand (2020-2034)
Table 12: Stage-specific Cases of NMIBC in the United States in Thousand (2020-2034)
Table 13: Grade-specific Cases of NMIBC in the United States in Thousand (2020-2034)
Table 14: Risk-specific Cases of NMIBC in the United States in Thousand (2020-2034)
Table 15: Age-specific Cases of NMIBC in the United States in Thousand (2020-2034)
Table 16: Total Prevalent Cases of NMIBC in EU4 and the UK in Thousand (2020-2034)
Table 17: Stage-specific Cases of NMIBC in EU4 and the UK in Thousand (2020-2034)
Table 18: Grade-specific Cases of NMIBC in EU4 and the UK in Thousand (2020-2034)
Table 19: Risk-specific Cases of NMIBC in EU4 and the UK in Thousand (2020-2034)
Table 20: Age-specific Cases of NMIBC in EU4 and the UK in Thousand (2020-2034)
Table 21: Total Prevalent Cases of NMIBC in Japan in Thousand (2020-2034)
Table 22: Stage-specific Cases of NMIBC in Japan in Thousand (2020-2034)
Table 23: Grade-specific Cases of NMIBC in Japan in Thousand (2020-2034)
Table 24: Risk-specific Cases of NMIBC in Japan in Thousand (2020-2034)
Table 25: Age-specific Cases of NMIBC in Japan in Thousand (2020-2034)
Table 26: Key Cross of Marketed Therapies
Table 27: ANKTIVA, Clinical Trial Description, 2024
Table 28: ADSTILADRIN, Clinical Trial Description, 2024
Table 29: KEYTRUDA, Clinical Trial Description, 2024
Table 30: Comparison of Emerging Drugs Under Development
Table 31: TECENTRIQ , Clinical Trial Description, 2024
Table 32: Sasanlimab, Clinical Trial Description, 2024
Table 33: IMFINZI (durvalumab), Clinical Trial Description, 2024
Table 34: UGN-102, Clinical Trial Description, 2024
Table 35: UGN-103, Clinical Trial Description, 2024
Table 36: TAR-200, Clinical Trial Description, 2024
Table 37: CG0070, Clinical Trial Description, 2024
Table 38: TAR-210 (intravesical erdafitinib), Clinical Trial Description, 2024
Table 39: ONCOFID P-B , Clinical Trial Description, 2024
Table 40: Ruvidar, Clinical Trial Description, 2024
Table 41: BALVERSA (erdafitinib), Clinical Trial Description, 2024
Table 42: TARA-002, Clinical Trial Description, 2024
Table 43: EG-70, Clinical Trial Description, 2024
Table 44: Belzupacap sarotalocan, Clinical Trial Description, 2024
Table 45: Enfortumab vedotin, Clinical Trial Description, 2024
Table 46: Treatment Outcomes with Approved Therapies for NMIBC
Table 47: Key Market Forecast Assumption of Intermediate-risk NMIBC in the United States
Table 48: Key Market Forecast Assumption of Intermediate-risk NMIBC in EU4 and the UK
Table 49: Key Market Forecast Assumption of Intermediate-risk NMIBC in Japan
Table 50: Key Market Forecast Assumption of High-risk BCG Naive NMIBC in the United States
Table 51: Key Market Forecast Assumption of High-risk BCG Naive NMIBC in EU4 and the UK
Table 52: Key Market Forecast Assumption of High-risk BCG Naive NMIBC in Japan
Table 53: Key Market Forecast Assumption of High-risk BCG Unresponsive NMIBC in the United States
Table 54: Key Market Forecast Assumption of High-risk BCG Unresponsive NMIBC in EU4 and the UK
Table 55: Key Market Forecast Assumption of High-risk BCG Unresponsive NMIBC in Japan
Table 56: Key Market Forecast Assumption of High-risk BCG Recurrent NMIBC in the United States
Table 57: Key Market Forecast Assumption of High-risk BCG Recurrent NMIBC in EU4 and the UK
Table 58: Key Market Forecast Assumption of High-risk BCG Recurrent NMIBC in Japan
Table 59: Total Market Size of NMIBC in the 7MM, USD million (2020-2034)
Table 60: Total Market Size of NMIBC by Risk in the 7MM, USD million (2020-2034)
Table 61: Total Market Size of NMIBC by Therapies in the 7MM, USD million (2020-2034)
Table 62: Market Size of low-risk NMIBC by Therapies in the US, USD million (2020-2034)
Table 63: Market Size of low-risk NMIBC by Therapies in EU4 and the UK, USD million (2020-2034)
Table 64: Market Size of low-risk NMIBC by Therapies in Japan, USD million (2020-2034)
Table 65: Market Size of Intermediate-risk NMIBC by Therapies in the US, USD million (2020-2034)
Table 66: Market Size of Intermediate-risk NMIBC by Therapies in EU4 and the UK, USD million (2020-2034)
Table 67: Market Size of Intermediate-risk NMIBC by Therapies in Japan, USD million (2020-2034)
Table 68: Market Size of High-risk BCG Naïve NMIBC in the United States, USD million (2020-2034)
Table 69: Market Size of High-risk BCG Unresponsive NMIBC in the United States, USD million (2020-2034)
Table 70: Market Size of High-risk BCG Recurrent NMIBC in the United States, USD million (2020-2034)
Table 71: Market Size of High-risk BCG Naïve NMIBC in EU4 and the UK, USD million (2020-2034)
Table 72: Market Size of High-risk BCG Unresponsive NMIBC in EU4 and the UK, USD million (2020-2034)
Table 73: Market Size of High-risk BCG Recurrent NMIBC in EU4 and the UK, USD million (2020-2034)
Table 74: Market Size of High-risk BCG Naïve NMIBC in Japan, USD million (2020-2034)
Table 75: Market Size of High-risk BCG Unresponsive NMIBC in Japan, USD million (2020-2034)
Table 76: Market Size of High-risk BCG Recurrent NMIBC in Japan, USD million (2020-2034)
List of Figures
Figure 1: Different Stages of NMIBC
Figure 2: Usage of Cystoscopy for Initial Diagnosis of NMIBC (per 100 patients, per country)
Figure 3: Diagnostic Tools Used for Initial Diagnosis of NMIBC (usage share for each diagnostic tool, per 100 patients, per country)
Figure 4: Management per NMIBC Risk Group
Figure 5: AUA/SUO Treatment Algorithm
Figure 6: Total Prevalent Cases of Bladder Cancer in the 7MM (2020-2034)
Figure 7: Total Prevalent Cases of NMIBC in the 7MM (2020-2034)
Figure 8: Total Prevalent Cases of NMIBC in the United States (2020-2034)
Figure 9: Stage-specific Cases of NMIBC in the United States (2020-2034)
Figure 10: Grade-specific Cases of NMIBC in the United States (2020-2034)
Figure 11: Risk-specific Cases of NMIBC in the United States (2020-2034)
Figure 12: Age-specific Cases of NMIBC in the United States (2020-2034)
Figure 13: Total Prevalent Cases of NMIBC in EU4 and the UK (2020-2034)
Figure 14: Stage-specific Cases of NMIBC in EU4 and the UK (2020-2034)
Figure 15: Grade-specific Cases of NMIBC in EU4 and the UK (2020-2034)
Figure 16: Risk-specific Cases of NMIBC in EU4 and the UK (2020-2034)
Figure 17: Age-specific Cases of NMIBC in EU4 and the UK (2020-2034)
Figure 18: Total Prevalent Cases of NMIBC in Japan (2020-2034)
Figure 19: Stage-specific Cases of NMIBC in Japan (2020-2034)
Figure 20: Grade-specific Cases of NMIBC in Japan (2020-2034)
Figure 21: Risk-specific Cases of NMIBC in Japan (2020-2034)
Figure 22: Age-specific Cases of NMIBC in Japan (2020-2034)
Figure 23: Historical phylogeny of BCG vaccine strains. Continuous passage of the original strain attenuated by Calmette and Guérin resulted in a number of diverse daughter strains
Figure 24: BCG units ordered and sold to Vizient members January 2021 to December 2022
Figure 25: Comparison of actual BCG supply to projected market volume
Figure 26: Total Market Size of NMIBC in the 7MM (2020-2034)
Figure 27: Total Market Size of NMIBC by Risk in the 7MM (2020-2034)
Figure 28: Total Market Size of NMIBC by Therapies in the 7MM (2020-2034)
Figure 29: Market Size of low-risk NMIBC by Therapies in the US (2020-2034)
Figure 30: Market Size of low-risk NMIBC by Therapies in EU4 and the UK (2020-2034)
Figure 31: Market Size of low-risk NMIBC by Therapies in Japan (2020-2034)
Figure 32: Market Size of Intermediate-risk NMIBC by Therapies in the US (2020-2034)
Figure 33: Market Size of Intermediate-risk NMIBC by Therapies in EU4 and the UK (2020-2034)
Figure 34: Market Size of Intermediate-risk NMIBC by Therapies in Japan (2020-2034)
Figure 35: Market Size of High-risk BCG Naïve NMIBC in the United States (2020-2034)
Figure 36: Market Size of High-risk BCG Unresponsive NMIBC in the United States (2020-2034)
Figure 37: Market Size of High-risk BCG Recurrent NMIBC in the United States (2020-2034)
Figure 38: Market Size of High-risk BCG Naïve NMIBC in EU4 and the UK (2020-2034)
Figure 39: Market Size of High-risk BCG Unresponsive NMIBC in EU4 and the UK (2020-2034)
Figure 40: Market Size of High-risk BCG Recurrent NMIBC in EU4 and the UK (2020-2034)
Figure 41: Market Size of High-risk BCG Naïve NMIBC in Japan (2020-2034)
Figure 42: Market Size of High-risk BCG Unresponsive NMIBC in Japan (2020-2034)
Figure 43: Market Size of High-risk BCG Recurrent NMIBC in Japan (2020-2034)
Figure 44: Health Technology Assessment
Figure 45: Reimbursement Process in Germany
Figure 46: Reimbursement Process in France
Figure 47: Reimbursement Process in Italy
Figure 48: Reimbursement Process in Spain
Figure 49: Reimbursement Process in the United Kingdom
Figure 50: Reimbursement Process in Japan

Companies Mentioned (Partial List)

A selection of companies mentioned in this report includes, but is not limited to:

  • Hoffmann-La Roche
  • Pfizer
  • AstraZeneca
  • UroGen Pharma
  • Johnson & Johnson
  • CG Oncology
  • Fidia Farmaceutici
  • Theralase Technologies
  • Protara Therapeutics
  • Aura Biosciences
  • Astellas Pharma
  • enGene