Non-muscle Invasive Bladder Cancer (NMIBC)—Market Insights, Epidemiology and Market Forecast–2030

DelveInsight’s ‘Non-muscle Invasive Bladder Cancer (NMIBC)—Market Insights, Epidemiology and Market Forecast–2030’ report delivers an in-depth understanding of the NMIBC, historical and forecasted epidemiology as well as the NMIBC market trends in the United States, EU5 (Germany, Spain, Italy, France, and United Kingdom) and Japan.
The NMIBC market report provides current treatment practices, emerging drugs, and market share of the individual therapies, current and forecasted 7MM NMIBC market size from 2017 to 2030.The report also covers current NMIBC treatment practice/algorithm, market drivers, market barriers and unmet medical needs to curate the best of the opportunities and assesses the underlying potential of the market.
Geography Covered
• The United States
• EU5 (Germany, France, Italy, Spain, and the United Kingdom)
• Japan

Study Period: 2017–2030
Non-muscle Invasive Bladder Cancer (NMIBC) Disease Understanding and Treatment Algorithm
Non-muscle Invasive Bladder Cancer (NMIBC) Overview
Non-muscle invasive bladder cancer (NMIBC) is cancer found in the tissue that lines the inner surface of the bladder. The bladder muscle is not involved.
NMIBC, formerly known as superficial bladder cancer, is a common, heterogeneous disease associated with high rates of recurrence and that often requires lifelong surveillance.
The bladder is a vessel that stores urine produced by the kidneys before excretion. The bladder itself is made up of several tissue layers. The first two layers include the urothelial and the lamina propria layers. The urothelial or mucosal layer makes contact with the bladder contents, while the lamina propria, or submucosal layer, and connects the urothelial layer to the underlying smooth muscle. Bladder cancer is a common malignancy arising from the urothelial cells and is responsible for considerable morbidity and mortality. The most common symptom of bladder cancer is hematuria, which occurs in 80–90% of patients. Approximately 70% of newly diagnosed cases of bladder cancer are NMIBC, meaning that they are confined to the urothelial and lamina propria layers of the bladder. Among NMIBCs, around 70% present as Ta lesions (papillary tumor confined to the urothelium), 20% as T1 lesions (tumor invades the lamina propria), and 10% as carcinoma in situ (CIS) (flat, high-grade tumor confined to the urothelial layer).
Non-muscle Invasive Bladder Cancer (NMIBC) Diagnosis
NMIBC is usually diagnosed with cystoscopic evaluation. Upon diagnosis, the location, number, and morphology of the tumors are recorded. Urinary cytology and upper tract imaging is performed to assess for extravesical urothelial tumors and staging purposes. The common diagnosis method used include cystoscopy, urine cytology, imaging, rigid cystoscopy (Transurethral resection of bladder tumor (TURBT) and blue light cytoscopy).
Non-muscle Invasive Bladder Cancer (NMIBC) Treatment
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. Transurethral resection of bladder tumor (TURBT) with or without intravesical therapy, such as mitomycin C (MMC) or Bacillus Calmette-Guerin (BCG, is the current standard of treatment for NMIBC. Intravesical BCG is commonly used as an adjuvant treatment after TURBT for intermediate-high-risk NMIBC. Local and systemic side effects are common with BCG and can lead to discontinuation of therapy in up to 20% of patients. However, up to 50% of patients fail BCG, significantly increasing the risk of progression and death. Patients who have failed BCG therapy require radical cystectomy with urinary diversion or chemotherapy and radiation, both of which are associated with considerable morbidity.
The main treatments for when the cancer cells are found only in the bladder’s inner lining (non-muscle-invasive bladder cancer) are surgery, intravesical immunotherapy (BCG) and intravesical chemotherapy. Surgery, on its own or combined with other treatments, is used in most cases. Most people with non-muscle-invasive bladder cancer have an operation called transurethral resection of bladder tumor (TURBT). Cystoscopic tumor resection is preferred in the patients wherein there is a removal of any cancer cells that can be seen at transurethral resection of bladder tumor (TURBT). Moreover, Keytruda (pembrolizumab) is the only approved drug for the treatment of patients with Bacillus Calmette-Guerin (BCG)-unresponsive, high-risk, non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors who are ineligible for or have elected not to undergo cystectomy.
DelveInsight’s NMIBC market report gives a thorough understanding of NMIBC by including details such as disease definition, causes, mechanism, biomarkers, and diagnosis.
Non-muscle Invasive Bladder Cancer Epidemiology
The disease epidemiology covered in the report provides historical as well as forecasted epidemiology include Prevalent cases of Bladder Cancer, Diagnosed Prevalent cases of Bladder cancer, Diagnosed Prevalent cases of NMIBC, Age-specific Diagnosed Prevalence of NMIBC, Tumor (T) stage-specific Diagnosed Prevalence of NMIBC, Grade-specific Diagnosed Prevalence of NMIBC, and Risk-specific Diagnosed Prevalence of NMIBC scenario of NMIBC in the 7MM covering the United States, EU5 countries (Germany, Spain, Italy, France and the United Kingdom) and Japan from 2017 to 2030.
Key Findings
This section provides glimpses of the NMIBC epidemiology in the 7MM.
• In the 7MM, the total diagnosed prevalent population of NMIBC was estimated to be 533,263 cases in 2017, which is expected to increase in the forecast period
• The United States accounted for the maximum diagnosed prevalent population among the 7MM in 2017.
• In EU5 countries, Germany accounted for the highest diagnosed cases of NMIBC while United Kingdom had the lowest diagnosed prevalent population in 2017.
• In the United States, there were 6,841, 58,791, 125,919 and 22,234 cases for >44, 45–64, 65-–84 and >85 years, in 2017 which is expected to rise in the forecast period.
• There are different stages in which NMIBC is classified which include Ta (lowest stage), Stage Tis and Stage T1. Over half of patients with low-grade Ta cancers will have a tumor recurrence. In 2017, the diagnosed prevalent population of stage Ta, low grade NMIBC was 134,684 and stage Ta, high grade NMIBC was 14,965 in the United States.
• In 2017, the diagnosed prevalent population of high risk NMIBC was 26,366 and low risk NMIBC was 48,325 in Japan.
Country wise-NMIBC Epidemiology
The epidemiology segment also provides the NMIBC epidemiology data and findings across the United States, EU5 (Germany, France, Italy, Spain, and the United Kingdom), and Japan.
Non-muscle Invasive Bladder Cancer Drug Chapters
This segment of the NMIBC report encloses the detailed analysis of the mid- and late-stage (Phase-III and Phase-II) pipeline drugs. It also helps to understand the clinical trial details, expressive pharmacological action, agreements and collaborations, approval and patent details of each included drug and the latest news and press releases.
Non-muscle Invasive Bladder Emerging Drugs
Adstiladrin: FKD Therapies Oy/Ferring Pharmaceuticals
FKD Therapies is conducting a phase III clinical developmental trial to assess the capability of Adstiladrin (nadofaragene firadenovec/Syn3) for the treatment of high-grade, BCG unresponsive NMIBC subjects. Recombinant IFN alpha2b has pleiotropic effects that contribute to antitumor activity in NMIBC. Adstiladrin is a non-replicating adenovirus vector harbouring the human IFN alpha2b gene. When combined with the excipient Syn3, intravesical administration of the rAd-IFN results in transduction of the virus into the epithelial cell lining in the bladder. The IFN alpha2b gene is incorporated into the cellular DNA resulting in the synthesis and expression of large amounts of IFN alpha2b protein.
Keytruda: Merck
Keytruda is developed by Merck and marketed in the United States which is 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 anti-tumor immune response. The drug is also in trial for Europe and Japan.

Vicinium: Viventia Bio/Sesen Bio
Vicinium is being investigated in phase III clinical developmental trial to assess its efficacy in treating patients with NMIBC. It was essential developed by Viventia Bio, which was the acquired by Eleven Therapeutics (subsidiary of Sesen Bio). It is a targeted fusion protein designed to overcome the fundamental efficacy and safety challenges inherent in existing antibody-drug conjugates. In August 2018, the drug received Fast Track designation from the USFDA for Vicinium for the treatment of patients with high-risk NMIBC who have previously received two courses of BCG and whose disease is now BCG-unresponsive. The current product candidates are based on the proprietary Targeted Fusion Protein Therapeutic Platform (TFPT) platform and are focused on addressing areas of unmet medical need in cancer. The novel TFPTs have been designed to overcome the efficacy and safety challenges of existing ADCs and are being developed for both local and systemic administration.

CG0070: CG Oncology
CG Oncology is developing CG0070 which has completed phase II clinical developmental trial and is planning to initiate a phase III trial for the patients with NMIBC. 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. CG0070 was designed to work in two complementary ways. First, it replicates inside the tumor’s cells with dysfunctional Rb pathways, causing tumor cell lysis and immunogenic cell death. Then, the rupture of the cancer cells can release tumor-derived antigens, along with GM-CSF, which can stimulate a systemic antitumor immune response that involves the body’s white blood cells.

N-803 (ALT-803): ImmunityBio/Altor Biosciences
ALT-803 is currently being investigated in combination with BCG in a phase II clinical trial for the treatment of patients with NMIBC. It is a novel IL-15 superagonist complex, which possesses improved pharmacokinetic properties and enhanced anti-tumour activity compared to IL-15. ALT-803 simultaneously mobilizes both the innate and adaptive arms of the immune system to elicit rapid, robust, and long-lasting responses against cancer and virally infected cells. It also potently activates NK cells and enhances antibody-dependent cell-mediated cytotoxicity (ADCC) of antibodies. It was developed by Altor Bioscience Corporation in collaboration with NantKwest but now the Altor is a part of ImmunityBio (subsidiary of NantWorks). The drug has also received Fast Track and breakthrough designations from the USFDA.

TLD-1433: Theralase
Theralase is developing a phase II drug named TLD-1433 for the treatment of NMIBC. TLD-1433 is a photodynamic compound currently in development by Theralase has proven to be highly toxic to bladder cancer cells when activated by light, producing a 100% kill rate at very low concentrations. Photo Dynamic Compounds (PDC) are cytotoxic drugs (cell-killing) when exposed to light at specific wavelengths and power levels.

Adstiladrin: FKD Therapies
FKD Therapies is conducting a phase III clinical developmental trial to assess the capability of Adstiladrin/Instiladrin for the treatment of high-grade, BCG unresponsive NMIBC subjects. Recombinant IFN alpha2b has pleiotropic effects that contribute to antitumor activity in NMIBC. Instiladrin is a non-replicating adenovirus vector harbouring the human IFN alpha2b gene. When combined with the excipient Syn3, intravesical administration of the rAd-IFN results in transduction of the virus into the epithelial cell lining in the bladder. The IFN alpha2b gene is incorporated into the cellular DNA resulting in the synthesis and expression of large amounts of IFN alpha2b protein. The USFDA validated FKD’s Biologics License Application (BLA) and granted Priority Review for adstiladrin, which previously received Fast Track and Breakthrough Therapy Designations.
Products detail in the report…
Non-muscle Invasive Bladder Cancer Market Outlook
The current treatment regimen includes surgery, intravesical immunotherapy (BCG) and intravesical chemotherapy. Intermediate- or high-risk NMIBC is generally treated with transurethral resection of bladder tumor (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 is only one approved drug for the treatment of NMIBC namely Keytruda (pembrolizumab) which is approved 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.
There are two types of intravesical therapy, namely immunotherapy and chemotherapy. BCG is the most common intravesical immunotherapy for treating early-stage bladder cancer. It is used to help keep cancer from growing, prevents it from relapse. BCG is a germ that is related to the one that causes tuberculosis (TB), but it does not usually cause serious disease.
The NMIBC market outlook of the report helps to build a detailed comprehension of the historic, current and forecasted NMIBC market trends by analyzing the impact of current therapies on the market, unmet needs, drivers and barriers, and demand of better technology.
This segment gives a thorough detail of NMIBC market trend of each marketed drug and late-stage pipeline therapy by evaluating their impact based on the annual cost of therapy, inclusion and exclusion criteria’s, mechanism of action, compliance rate, growing need of the market, increasing patient pool, covered patient segment, expected launch year, competition with other therapies, brand value, their impact on the market and view of the key opinion leaders. The calculated market data are presented with relevant tables and graphs to give a clear view of the market at first sight. According to DelveInsight, NMIBC 7MM market is expected to change in the study period 2017–2030.
Key Findings
This section includes a glimpse of the NMIBC 7MM market.
• The market size of NMIBC in the seven major markets was USD 1,454.00 Million in 2017.
• According to Delveinsight estimates, the United States accounts for the largest market size of NMIBC, in comparison to Japan and EU5 (Germany, Italy, Spain, France, the UK).
• Among the EU5 countries, Germany had the highest market size in 2017.
• Expected Launch of potential therapies may increase market size in the coming years, assisted by an increase in diagnosed prevalent population of high-risk NMIBC. Owing to the positive outcomes of the upcoming products during the developmental stage by key players such as Viventia Bio/Sesen Bio, FKD Therapies Oy/Ferring Pharmaceuticals, CG Oncology, ImmunityBio/Altor Biosciences, Theralase, Merck have a potential to create a significant positive shift in the high-risk NMIBC Market Size
• Among 7MM, Japan accounts for the third-highest market size during the forecast period 2017–2030, at a CAGR of 5.75 %.
Market Outlook for Seven Major Markets
This section provides the total NMIBC market size and market size by therapies in the United States, Germany, France, Italy, Spain, the United Kingdom and Japan.
Non-muscle Invasive Bladder Cancer Drugs Uptake
This section focusses on the rate of uptake of the potential drugs that are expected to get launched in the market during the study period 2017–2030. The analysis covers NMIBC market uptake by drugs; patient uptake by therapies; and sales of each drug.
This helps in understanding the drugs with the most rapid uptake, reasons behind the maximal use of new drugs and allow the comparison of the drugs on the basis of market share and size which again will be useful in investigating factors important in market uptake and in making financial and regulatory decisions.
Non-muscle Invasive Bladder Cancer Development Activities
The report provides insights into different therapeutic candidates in phase II, and phase III stage. It also analyzes key players involved in developing targeted therapeutics.
Pipeline Development Activities
The report covers the detailed information of collaborations, acquisition and merger, licensing and patent details for NMIBC emerging therapies.
Competitive Intelligence Analysis
We perform competitive and market intelligence analysis of the NMIBC market by using various competitive intelligence tools that include–SWOT analysis, PESTLE analysis, Porter’s five forces, BCG Matrix, Market entry strategies, etc. The inclusion of the analysis entirely depends upon the data availability.
Scope of the Report
• The report covers the descriptive overview of NMIBC, explaining its causes, signs and symptoms, pathogenesis and currently available therapies.
• Comprehensive insight has been provided into the NMIBC epidemiology and treatment.
• Additionally, an all-inclusive account of both the current and emerging therapies for NMIBC is provided, along with the assessment of new therapies, which will have an impact on the current treatment landscape.
• A detailed review of NMIBC market; historical and forecasted is included in the report, covering the 7MM drug outreach.
• The report provides an edge while developing business strategies by understanding trends shaping and driving the 7MMNMIBCmarket.
Report Highlights
• NMIBC market is anticipated to increase at a CAGR of 7.98% for the study period 2017–2030.
• The United States accounted for more than half (50.69%) of the market share in the 7MM.
• Adstiladrin is projected to lead the market with the largest market share in 2030.
• In the coming years, NMIBC market is set to change due to the rising awareness of the disease, and incremental healthcare spending across the world; which would expand the size of the market to enable the drug manufacturers to penetrate more into the market.
• The companies and academics are working to assess challenges and seek opportunities that could influence NMIBC R&D. The therapies under development are focused on novel approaches to treat/improve the disease condition.
• Major players are involved in developing therapies for NMIBC. Launch of emerging therapies will significantly impact the NMIBC market.
• Our in-depth analysis of the pipeline assets across different stages of development (phase III and phase II), different emerging trends and comparative analysis of pipeline products with detailed clinical profiles, key competitors, launch date along with product development activities will support the clients in the decision-making process regarding their therapeutic portfolio by identifying the overall scenario of the research and development activities.
NMIBC Report Insights
• Patient Population
• Therapeutic Approaches
• Sciatica Pipeline Analysis
• Sciatica Market Size and Trends
• Market Opportunities
• Impact of upcoming Therapies
NMIBC Report Key Strengths
• Eleven Years Forecast
• 7MM Coverage
• NMIBC Epidemiology Segmentation
• Key Cross Competition
• Highly Analyzed Market
• Drugs Uptake
NMIBC Report Assessment
• Current Treatment Practices
• Unmet Needs
• Pipeline Product Profiles
• Market Attractiveness
• Market Drivers and Barriers

Companies:
• Adstiladrin(nadofaragenefiradenovec/Syn3): FKD Therapies Oy/Ferring Pharmaceuticals
• Keytruda: Merck
• Vicinium: Viventia Bio/Sesen Bio
• CG0070: CG Oncology
• N-803 (ALT-803): ImmunityBio/Altor Biosciences
• TLD-1433: Theralase

 
Key Questions
Market Insights:
• What was the NMIBC market share (%) distribution in 2017 and how it would look like in 2030?
• What would be the NMIBC total market size as well as market size by therapies across the 7MMduring the forecast period (2020–2030)?
• What are the key findings pertaining to the market across the 7MM and which country will have the largest NMIBC market size during the forecast period (2020–2030)?
• At what CAGR, the NMIBC market is expected to grow at the 7MM level during the forecast period (2020–2030)?
• What would be the NMIBC market outlook across the 7MM during the forecast period (2020–2030)?
• What would be the NMIBC market growth until 2030, and what will be the resultant market size in the year 2030?
• How would the market drivers, barriers and future opportunities affect the market dynamics and subsequent analysis of the associated trends?
Epidemiology Insights:
• What is the disease risk, burden and unmet needs of NMIBC?
• What is the historical NMIBC patient pool in the United States, EU5 (Germany, France, Italy, Spain, and the UK) and Japan?
• What would be the forecasted patient pool of NMIBC at the 7MM level?
• What will be the growth opportunities across the 7MM with respect to the patient population pertaining to NMIBC?
• Out of the countries mentioned above, which country would have the highest prevalent population of NMIBC during the forecast period (2020–2030)?
• At what CAGR the population is expected to grow across the 7MM during the forecast period (2020–2030)?
Current Treatment Scenario, Marketed Drugs and Emerging Therapies:
• What are the current options for the treatment of NMIBC along with the approved therapy?
• What are the current treatment guidelines for the treatment of NMIBC in the US and Europe?
• What are the NMIBC marketed drugs and their MOA, regulatory milestones, product development activities, advantages, disadvantages, safety and efficacy, etc.?
• How many companies are developing therapies for the treatment of NMIBC?
• How many therapies are developed by each company for the treatment of NMIBC?
• How many emerging therapies are in the mid-stage and late stage of development for the treatment of NMIBC?
• What are the key collaborations (Industry–Industry, Industry–Academia), Mergers and acquisitions, licensing activities related to the NMIBC therapies?
• What are the recent novel therapies, targets, mechanisms of action and technologies developed to overcome the limitation of existing therapies?
• What are the clinical studies going on for NMIBC and their status?
• What are the key designations that have been granted for the emerging therapies for NMIBC?
• What are the 7MM historical and forecasted market of NMIBC?
Reasons to buy
• The report will help in developing business strategies by understanding trends shaping and driving the NMIBC.
• To understand the future market competition in the NMIBC market and Insightful review of the key market drivers and barriers.
• Organize sales and marketing efforts by identifying the best opportunities for NMIBC in the US, Europe (Germany, Spain, Italy, France, and the United Kingdom) and Japan.
• Identification of strong upcoming players in the market will help in devising strategies that will help in getting ahead of competitors.
• Organize sales and marketing efforts by identifying the best opportunities for NMIBC market.
• To understand the future market competition in the NMIBC market.