Non-Muscle Invasive Bladder Cancer - Market Insights, Epidemiology, and Market Forecast - 2032

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.
• As patients often require long-term BCG maintenance therapy and ongoing disease surveillance to monitor recurrence and progression, the financial burden of disease to healthcare systems is high.
• 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.
• Potent ICI-based gene therapies can alter the disease trajectory, halting its advancement to advanced stages - an impactful stride in managing NMIBC. Their potential to fulfill approval criteria further underscores their pivotal role in advancing NMIBC treatment.
• 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.
• Radical cystectomy is the gold standard treatment for MIBC, and early radical cystectomy is the preferred treatment in patients with very high-risk NMIBC. Early radical cystectomy is also recommended for BCG-unresponsive disease. While the high-risk characteristics prompting eligibility for radical cystectomy differ between guidelines. Studies evaluating the benefits of early radical cystectomy have not differentiated BCG-naïve patients from those who have failed BCG. The benefit of early radical cystectomy in BCG-naïve patients, therefore, remains unclear.
• Several clinical trials are actively pursuing the development of an innovative bladder-sparing approach tailored for very high-risk BCG-naïve NMIBC and BCG-unresponsive NMIBC. The continuous dedication to overcoming clinical limitations in bedside management is crucial for elevating the standard of patient care in NMIBC.
• 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 predominant used BCG strain.
• There is need for adherence to surveillance guidelines, particularly in patients with high-risk NMIBC.
• By 2032, Japan will account the total market of Non-muscle invasive bladder cancer around USD 600 million.

This 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 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 2019 to 2032, 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

• Japan

Study Period: 2019-2032

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.

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.

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 Japan from 2019 to 2032.

• According to the estimates, Japan accounted for around 185,400 total prevalent cases of NMIBC in 2022. These cases are expected to increase during the forecast period, i.e., 2023-2032.
• 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 ~60% of total cases in 2022.
• In Japan, stage-specific cases of NMIBC were highest in the Ta stage, accounting for ~60% in 2022.

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-stage (Phase III) 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.

Emerging Drugs

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

ADSTILADRIN (nadofaragene firadenovec-vncg) 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. Currently, the company is evaluating nadofaragene firadenovec in the Phase III trial for Japanese subjects (NCT05704244) 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. 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 (NCT03711032).

Drug Class Insight

Currently BCG is the main standard of care in NMIBC setting. In the emerging pipeline Checkpoint inhibiotrs, gene therapies, Oncolytic Immunotherapy, and others are different class that are showing positive results in NMIBC patients. Checkoint inhibitors and gene therapy is already approved in BCG unresponsive NMIBC patient pool.

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.

Radiation therapy as a standalone treatment proves ineffective in addressing bladder cancer. The preferred approach involves removing as much of the tumor as possible through Transurethral Resection of Bladder Tumor (TURBT). The treatment’s effectiveness is significantly enhanced when combined with radiation and anticancer drugs. A Japanese survey conducted by the Japan Radiation Cancer Research Group between 2002 and 2006 highlighted that among 159 bladder cancer patients undergoing radiation therapy, 47% received radiation therapy alone, while another 47% underwent radiation therapy in conjunction with systemic chemotherapy. Additionally, 21% received chemotherapy, and 32% received radiotherapy combined with intravesical chemotherapy. The 5-year overall survival rates for these treatments were 26%, 67%, and 64%, respectively, underscoring the suboptimal outcomes associated with radiation therapy as a sole intervention.

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.

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 Japan for Non-muscle invasive bladder cancer was estimated to be nearly USD 200 million in 2022, which is expected to grow during the forecast period.
• Globally, various strains of BCG vaccine, including TICE, Connaught, Tokyo, and Russian strains, are employed. But in Japan, the Tokyo strain holds prominence as the most commonly utilized BCG strain.
• Maintenance BCG (mBCG) is not considered a standard treatment option in Japan, and its utilization is less preferred, with concerns primarily centered around potential side effects.

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 2023-2032. 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 (2023-2032)

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 Japan. 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 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

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).

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 Japan 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 Japan 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

• Ten Years Forecast
• Japan 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 2022, and what would it look like by 2032? 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 Japan concerning the patient population with Non-muscle invasive bladder cancer?
• How much market share will PDL1 capture by 2032?
• 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 Japan?
• 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.