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

Key Highlights

• NMIBC is a clinically heterogeneous group of cancers with a wide range of recurrence and progression probabilities that depend on several clinical and pathologic factors.
• The current treatment regimen includes surgery, intravesical immunotherapy (BCG), and intravesical chemotherapy.
• The standard care treatment for intermediate- and high-risk NMIBCs is a transurethral resection of the bladder tumor (TURBT) followed by intravesical Bacillus Calmette-Guerin (BCG) instillations with induction and maintenance therapy for up to 3 years.
• There are only two approved drugs for the treatment of NMIBC, namely KEYTRUDA (pembrolizumab) and ADSTILADRIN (nadofaragene firadenovec-vncg), which were approved in 2020 and 2022, respectively by the FDA. Since then, both drugs have been approved in the United States only.
• 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.
• Gene therapy is an option with promising potential in HR-NMIBC. Oncolytic viral therapy is becoming more popular, particularly with the FDA's approval of nadofaragene firadenovec-vcng.
• TLD-1433, combined with the TLC-3200 medical laser system, pioneers a personalized Ruthenium-based PhotoDynamic compound for BCG-unresponsive NMIBC, including CIS and papillary Ta or T1 tumors. This groundbreaking technology innovates NMIBC treatment and marks a transformative shift in medical technology paradigms.
• Protara‘s TARA-002 exhibits a strong mechanism of action and offers clear advantages in overcoming the challenges related to BCG manufacturing.
• TOKYO-172 is a predominantly used BCG strain in Japan.
• 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.
• The pipeline of NMIBC is strong with promising therapies like CG0070 (CG Oncology), Anktiva (ImmunityBio), Sasanlimab (Pfizer), EG-70 (enGene), UGN-102 (Urogen), Ruvidar/TLD-1433 (Theralase) and others.
• In 2023, in the 7MM the total diagnosed prevalent cases of NMIBC were ~1,500,000.

This Non-muscle Invasive Bladder Cancer - Market Insights, Epidemiology, and Market Forecast - 2034 report delivers an in-depth understanding of the Non-muscle invasive bladder cancer, historical and forecasted epidemiology as well as the Non-muscle invasive bladder cancer market trends in the United States, EU4 (Germany, France, Italy, and Spain) and 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 Bacillus Calmette-Guérin (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(s). 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.

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

Non-muscle Invasive Bladder Cancer Treatment

High-risk, non-muscle-invasive bladder cancer 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 Bacillus Calmette-Guérin (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. Transurethral resection of bladder tumors (TURBT), a surgical approach, is frequently performed to remove visible cancer cells, ensuring comprehensive management.

Further details related to treatment will be provided in the report...

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 cases in 2023, with around 600,000 prevalent cases, these cases are expected to increase during the forecast period.
• Among EU4 and the UK, the total prevalent cases of NMIBC was maximum in Italy, while the lowest number of cases were in France in 2023.
• 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, stage-specific cases of NMIBC were highest 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 for emerging drugs and their respective drug candidates include Ferring Pharmaceuticals/FKD Therapies Oy (ADSTILADRIN), Merck Sharp & Dohme (KEYTRUDA), and others. The drug chapter also helps understand 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 vector enters the cells of the bladder wall, releasing the active gene to do its work. The internal gene/DNA machinery of the cells picks up the gene and translates its DNA sequence, resulting in the cells secreting high quantities of interferon alfa-2b protein, a naturally occurring protein the body uses to fight cancer. This novel gene therapy approach turns the patient's bladder wall cells into interferon microfactories, enhancing the body's natural defenses against cancer). 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, Bacillus Calmette-Guérin (BCG) unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors. Currently, the company is evaluating nadofaragene firadenovec in the Phase III trial for Japanese subjects with high-grade, BCG unresponsive NMIBC.

KEYTRUDA (pembrolizumab): Merck Sharp & Dohme

Pembrolizumab is the active ingredient of KEYTRUDA, a humanized monoclonal antibody that binds to the programmed cell death-1 (PD-1) receptor and blocks its interaction with PD-L1 and PD-L2, releasing PD-1 pathway-mediated inhibition of the immune response, including antitumor immune response. Binding the PD-1 ligands, PD-L1 and PD-L2, to the PD-1 receptor on T cells inhibits T-cell proliferation and cytokine production. Upregulation of PD-1 ligands occurs in some tumors, and signaling through this pathway can inhibit active T-cell immune surveillance of tumors. In January 2020, the US FDA approved KEYTRUDA for the treatment of patients with BCG-unresponsive, high-risk, NMIBC with carcinoma in situ (CIS) with or without papillary tumors who are ineligible for or have elected not to undergo cystectomy. Currently, the company is evaluating pembrolizumab in combination with BCG in the Phase III trial for participants with high-risk NMIBC that is either persistent or recurrent following BCG induction or that is naïve to BCG treatment.

Emerging Drugs

TECENTRIQ (atezolizumab): Hoffmann-La Roche

TECENTRIQ is a monoclonal antibody designed to bind with a protein called PD-L1 expressed on tumor cells and tumor-infiltrating immune cells, blocking its interactions with both PD-1 and B7.1 receptors. By inhibiting PD-L1, TECENTRIQ enables the activation of T cells. The drug is a cancer immunotherapy that has the potential to be used as a foundational combination partner with other immunotherapies, targeted medicines, and various chemotherapies across a broad range of cancers. Currently the drug is being evaluated in Phase III of clinical development. As per Roche's pipeline, the company is anticipating expected filing for TECENTRIQ plus BCG induction and maintenance for high-risk NMIBC in 2026+.

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. Healthy cells produce a protein called PD-L1 that binds to PD-1, inactivating T-cells. It is an immunotherapy for several types of cancer. However, some tumors have adapted to T-cell checkpoints by producing PD-L1 to prevent the immune system from identifying and destroying them. When PF-06801591 binds to PD-1 on T-cells, it prevents PD-L1 found on cancer cells from binding to PD-1. This allows T-cells to destroy cancer cells. As per Pfizer's 2023 second quarter report, the company is anticipating the potential launch of sasanlimab for NMIBC in >2024.

Drug Class Insight

Currently, BCG is the main standard of care in the NMIBC setting. In the emerging pipeline checkpoint inhibitors, gene therapies, Oncolytic Immunotherapy, 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) stand as a formidable weapon in cancer immunotherapy, designed to fortify the body's natural defense against cancer cells. These inhibitors work by precisely targeting immune checkpoints - proteins present in both immune and cancer cells. Particularly, they disrupt the interaction between immune checkpoints like programmed cell death protein 1 (PD-1) and cytotoxic T-lymphocyte-associated antigen 4 (CTLA-4) and their corresponding ligands on cancer cells. This interruption eliminates inhibitory signals, essentially releasing the brakes on the immune system. As a result, immune cells can more effectively pinpoint and attack cancer cells, leading to enhanced anti-tumor responses. Immune checkpoint inhibitors have proven remarkably successful in treating various cancer types, spanning melanoma, lung cancer, kidney cancer, and bladder cancer. However, the responses to these inhibitors can vary based on individual factors and the specific type of cancer. A prime example is pembrolizumab, a drug honing in on the PD-1 checkpoint, approved for treating melanoma, non-small cell lung cancer, head and neck squamous cell carcinoma, and other cancer types.

Interferon alpha (IFNa) gene therapy

Interferon alpha (IFNa) gene therapy is emerging as a promising treatment avenue for patients grappling with NMIBC. Clinical efficacy has been observed in utilizing adenoviral vectors expressing IFNa, particularly in cases of BCG-unresponsive bladder cancer (BLCA). However, challenges such as transient transgene expression and adenoviral immunogenicity may curtail therapeutic effectiveness. Lentiviral vectors, offering stable transgene expression and lower immunogenicity, present a viable alternative. In a syngeneic BLCA model, intravesical therapy employing LV-IFNa/Syn3 demonstrated a substantial enhancement in survival. Molecular analysis of treated tumors unveiled the upregulation of apoptotic pathways and immune-cell-mediated death pathways, underscoring the significant strides made in this therapeutic approach.

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 to this, there are only two approved drugs for the treatment of NMIBC, namely KEYTRUDA (pembrolizumab) and ADSTILADRIN (nadofaragene firadenovec-vncg), which were approved in 2020 and 2022, respectively by the FDA. Since then, both drugs have been approved in the United States 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.

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 wider adoption of biomarker-driven approaches for improved patient outcomes.

Key Findings

• The total market size in the US for NMIBC was estimated to be USD 1,700 million in 2023, which is expected to grow during the forecast period (2024-2034).
• The total market size in EU4 and the UK for NMIBC was estimated to be nearly USD 800 million in 2023, which is expected to grow during the forecast period.
• Many companies are focusing on BCG unresponsive NMIBC patient population. They're exploring various treatments such as oncolytic virus (CG0070), PD-1 inhibitors (Sasanlimab, OPDIVO, and others), interleukin inhibitor (Anktiva), non-viral plasmid-based therapy (EG-70), and more.
• Globally, various strains of BCG vaccine, including TICE, Connaught, Tokyo, and Russian strains, are employed. However in Japan, the Tokyo strain holds prominence as the most commonly utilized BCG strain.

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.

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 Ferring Pharmaceuticals/FKD Therapies Oy, Roche, and Merck 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.

This 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

The publisher performs Qualitative and market Intelligence analysis using various approaches, such as SWOT analysis and Analyst views. In the SWOT analysis, strengths, weaknesses, opportunities, and threats in terms of disease diagnosis, patient awareness, patient burden, competitive landscape, cost-effectiveness, and geographical accessibility of therapies are provided. These pointers are based on the Analyst's discretion and assessment of the patient burden, cost analysis, and existing and evolving treatment landscape.

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 provides assistance 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 key 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 the emerging therapies and the elaborative 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 Non-muscle invasive bladder cancer market size, the market size by therapies, 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 PDL1 capture by 2034?
• 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 patient share in Non-muscle invasive bladder cancer?

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 strong upcoming 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 of access and reimbursement policies of current therapies, barriers to accessibility of 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 so that the upcoming players can strengthen their development and launch strategy.