PUBLISHER: DelveInsight | PRODUCT CODE: 1415500
PUBLISHER: DelveInsight | PRODUCT CODE: 1415500
DelveInsight's "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.
Study Period: 2020-2034.
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 the 7MM market covering the United States, EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan from 2020 to 2034.
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.
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-Guerin (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.
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 naive to BCG treatment.
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 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.
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) 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 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.
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.
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.
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)
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 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.
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.
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.