PUBLISHER: DelveInsight | PRODUCT CODE: 1415497
PUBLISHER: DelveInsight | PRODUCT CODE: 1415497
DelveInsight's "Non-muscle Invasive Bladder Cancer - Market Insights, Epidemiology, and Market Forecast - 2032" 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.
Study Period: 2019-2032.
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-Guerin (BCG) immunotherapy or chemotherapy. Surveillance through regular cystoscopies and adherence to guidelines are essential to monitor and manage this condition effectively.
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.
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-Guerin (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.
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.
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.
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.
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 naive to BCG treatment (NCT03711032).
Detailed emerging therapies assessment will be provided in the final report.
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.
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.
Detailed market assessment will be provided in the final report.
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.
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)
The report covers information on collaborations, acquisitions and mergers, licensing, and patent details for Non-muscle invasive bladder cancer emerging therapy.
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.
DelveInsight's 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.
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.
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.