The NMIBC market is gaining momentum, with ~13 therapies anticipated to enter key markets by 2034. DelveInsight projects that three critical drugs will secure billion-dollar markets across the 7MM by 2034, highlighting the significant potential in the NMIBC space. This growth is driven by the demand for new treatment options, the high treatment costs, the focus on various patient segments, and the increasing prevalence of NMIBC.
LAS VEGAS, Sept. 23, 2024 /PRNewswire/ -- Non-muscle-invasive bladder cancer (NMIBC) is a type of bladder cancer where the tumor remains confined to the bladder's innermost lining layer, without spreading into the muscle. This early-stage form constitutes a large portion of bladder cancer cases. NMIBC usually features superficial tumor growth and is commonly associated with papillary tumors or carcinoma in situ.
Based on DelveInsight's assessment in 2023, the total prevalent cases of NMIBC in the 7MM were nearly1.5 million. These cases are expected to increase by 2034. Among cases categorized by risk level, the highest number belonged to the intermediate-risk category.
The current treatment plan involves surgery, intravesical immunotherapy (BCG), and intravesical chemotherapy. For intermediate- or high-risk NMIBC, the standard approach typically includes Transurethral Resection of Bladder Tumor (TURBT) followed by adjuvant BCG immunotherapy, which is considered the gold standard for reducing tumor recurrence and preventing progression to more advanced stages. Stage 0 bladder cancer is usually treated with TURBT and fulguration, followed by intravesical therapy within 24 hours. In some cases, no further treatment is required. Cystoscopy is then performed every 3 to 6 months to monitor for cancer recurrence.
Furthermore, the FDA has approved just three drugs for treating NMIBC: KEYTRUDA, approved in 2020, ADSTILADRIN, approved in 2022, and the most recent, ANKTIVA, approved in April 2024. All three are only approved for use in the United States.
Learn more about the FDA-approved NMIBC drugs @ Drugs for NMIBC Treatment
In early 2020, the FDA authorized the use of intravenous KEYTRUDA for treating BCG-unresponsive NMIBC with carcinoma in situ (CIS), including cases with or without papillary tumors, for patients who are not candidates for or prefer not to have radical cystectomy. This approval was based on one of the two parts of the multicenter Phase II trial (KEYNOTE-057), which evaluated the effectiveness of KEYTRUDA in treating BCG-unresponsive NMIBC with CIS.
The next significant drug approved for NMIBC was ADSTILADRIN by Ferring. ADSTILADRIN is a gene therapy designed for adult patients with BCG-unresponsive NMIBC. This treatment uses a non-replicating adenovirus vector to deliver the interferon alfa-2b gene and is administered via catheter into the bladder every three months. The European Medicines Agency has classified it as an Advanced Therapy Medicinal Product (ATMP).
In December 2022, the US FDA approved ADSTILADRIN for adults with high-risk, BCG-unresponsive NMIBC, including those with carcinoma in situ (CIS), with or without papillary tumors. In April 2024, Ferring Pharmaceuticals and SK Pharmteco announced a partnership to expand the commercial manufacturing capacity for ADSTILADRIN to ensure a consistent long-term supply.
The latest therapy approved by the FDA is ImmunityBio's ANKTIVA (N-803) in combination with BCG. ANKTIVA is a novel IL-15 superagonist composed of an IL-15 mutant (IL-15N72D) linked to an IL-15 receptor a/IgG1 Fc fusion protein. In April 2024, the US FDA approved ANKTIVA combined with BCG for treating patients with BCG-unresponsive NMIBC with CIS, regardless of the presence of papillary tumors.
The drug is currently being tested in two clinical trials for NMIBC: QUILT-3.032, which evaluates ANKTIVA with BCG in BCG-unresponsive NMIBC with CIS and Papillary Disease, and QUILT-2.005, which investigates ANKTIVA with BCG for BCG-naïve NMIBC patients.
Before the COVID pandemic exacerbated the supply chain issues, there was already a shortage of BCG, which has traditionally been the primary treatment for high-risk NMIBC. The ongoing BCG deficit has compelled doctors to explore other treatment options for patients with high-risk NMIBC, such as a combination of the chemotherapy drugs gemcitabine and docetaxel. Recently, a partnership between the Serum Institute of India and ImmunityBio, aimed at providing traditional BCG and developing an improved recombinant BCG, has bolstered efforts to address and mitigate the current BCG supply shortage for NMIBC.
To know more about NMIBC treatment options, visit @ New Treatment for NMIBC
The NMIBC pipeline is robust with so many companies working in the domain. Various potential NMIBC unresponsive to BCG therapies that are projected to enter during the forecast period include Johnson & Johnson's TAR-200, CG Oncology's CG0070, Fidia Farmaceutici's ONCOFID P-B, Theralase Technologies' Ruvidar, Protara Therapeutics' TARA-002, enGene's EG-70, Astellas Pharma's PADCEV (enfortumab vedotin), Prokarium's ZH9, and others.
Discover which therapies are expected to grab major NMIBC market share @ NMIBC Market Report
CG0070 is an oncolytic immunotherapy that uses a modified adenovirus type 5 backbone with a cancer-specific promoter and a GM-CSF transgene to target and destroy bladder tumor cells with a faulty Rb pathway. Its effectiveness as a standalone treatment for NMIBC after the failure of BCG therapy has been demonstrated in previous studies, V0046 and BOND-002.
Ongoing Phase III trials (BOND-003) are investigating its potential further. At the AUA 2024 annual meeting, updated results from BOND-003 Cohort C were presented. CG0070 is also being evaluated in a Phase II CORE-001 study, in collaboration with Merck, which combines CG0070 with KEYTRUDA for treating high-grade NMIBC that does not respond to BCG. Positive results from this study were shared at ASCO 2024, supporting further exploration of CG0070 with checkpoint inhibitors in an upcoming CORE-008 trial for high-risk NMIBC.
In addition to this, other new treatments such as TAR-002, Ruvidar, and ONCOFID P-B are anticipated to enter the NMIBC market. ONCOFID P-B is a chemotherapy-based option developed by Fidia Farmaceutici, which is currently in Phase III trials. enGene's non-viral plasmid-based therapy EG-70 is expected to compete with viral therapies from companies like Ferring Pharmaceuticals, CG Oncology, Istari Oncology, and Vaxiion Therapeutics, offering a safety advantage by reducing the risk of immune response. The design of EG-70, which is user-friendly and non-viral, is likely to fit well into current treatment practices without requiring changes from urologists.
Discover more about drugs for NMIBC in development @ NMIBC Clinical Trials
The segment of patients who have never used BCG has been tough to access because BCG has long been the only major treatment available for NMIBC. However, any new drug that can exceed BCG's complete response rate (CRR) could gain a significant edge in this area. The ongoing BCG shortage highlights the need for alternative therapies and additional BCG strains for high-risk, BCG-naïve disease.
This scarcity has opened the door for key players in the NMIBC market to enter a field traditionally dominated by BCG. Leading companies like Merck (KEYTRUDA + BCG), ImmunityBio (ANKTIVA + BCG), Roche (TECENTRIQ + BCG), Pfizer (Sasanlimab + BCG), and AstraZeneca (IMFINZI + BCG) are focusing on combining their drugs with BCG to improve treatment efficacy rather than trying to replace BCG entirely.
Several promising treatments for IR-NMIBC are also currently in development. Companies like Urogen, CG Oncology, Johnson & Johnson, and Ferring Pharmaceuticals are concentrating on therapies for intermediate-risk NMIBC. DelveInsight predicts that, due to its first-mover advantage, Urogen's treatments (UGN-102 and UGN-103) will likely be widely recognized by the time CG0070 and ADSTILADRIN enter the IR-NMIBC market.
The anticipated launch of these emerging therapies for NMIBC are poised to transform the market landscape in the coming years. As these cutting-edge therapies continue to mature and gain regulatory approval, they are expected to reshape the NMIBC market landscape, offering new standards of care and unlocking opportunities for medical innovation and economic growth.
DelveInsight estimates that the total market size for NMIBC is expected to grow from USD 2.6 billion in 2023 with a significant CAGR of 15% by 2034. Among all risks, high-risk NMIBC accounted for the highest market size in the 7MM, i.e., nearly USD 1.6 billion in 2023. This growth can be attributed to the introduction of upcoming therapies along with improved diagnosis.
While the goal is to start with BCG-unresponsive high-risk NMIBC patients, there is opportunity to expand growth into other market segments, such as intermediate NMIBC and BCG-naive. Majority of company's eyeing High-Risk NMIBC pool, however, the broader market potential lies with BCG-naive patients, and Intermediate NMIBC.
DelveInsight's latest published market report titled as Non-Muscle Invasive Bladder Cancer (NMIBC) Market Insight, Epidemiology And Market Forecast - 2034 will help you to discover which market leader is going to capture the largest market share. The report provides comprehensive insights into the NMIBC country-specific treatment guidelines, patient pool analysis, and epidemiology forecast to help understand the key opportunities and assess the market's underlying potential. The NMIBC market report proffers epidemiological analysis for the study period 2020-2034 in the 7MM segmented into:
- Total Number of Prevalent Cases of NMIBC
- Stage-specific Cases of NMIBC
- Grade-specific Cases of NMIBC
- Risk-specific Cases of NMIBC
- Age-specific Cases of NMIBC
The report provides an edge while developing business strategies by understanding trends shaping and driving the 7MM NMIBC market. Highlights include:
- 11-year Forecast
- 7MM Analysis
- Epidemiology-based Market Forecasting
- Historical and Forecasted Market Analysis upto 2034
- Emerging Drug Market Uptake
- Peak Sales Analysis
- Key Cross Competition Analysis
- Industry Expert's Opinion
- Access and Reimbursement
Download this NMIBC market report to assess the epidemiology forecasts, understand the patient journeys, know KOLs' opinions about the upcoming treatment paradigms, and determine the factors contributing to the shift in the NMIBC market. Also, stay abreast of the mitigating factors to improve your market position in the NMIBC therapeutic space.
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