Astellas Pharma Inc. (TSE:4503, President and CEO, Naoki Okamura) announced that the National Medical Products Administration’s Center for Drug Evaluation (CDE) had on March 27th accepted enfortumab vedotin in combination with pembrolizumab as a sBLA for previously untreated adults with locally advanced or metastatic urothelial cancer; if approved, this could be the first combo option to platinum-containing chemotherapy which is still considered frontline treatment for la/mUC. Urothelial cancer is divided into upper tract (ureter and renal pelvis) and lower urinary tract (bladder and urethra) cancers, where the disease of the lower one accounts for about 90-95% of cases of all UCs.
FDA has further expanded Opdivo indication; it was licensed as a monotherapy already but also used in other therapies such as melanoma unresectable/metastatic cases, advanced clear cell RCC, stage IV non-small cell lung carcinoma, relapsed classical Hodgkin lymphoma weight loss and dyspnoea on light exertion due to bulky mediastinal adenopathy leading to SVC syndrome; recurrent squamous cell carcinoma neck or head mostly limited only to cervical nodes which are more difficult to treat hence metastasis often occurs; UC locally advanced or metastatic; colorectal cancer with liver metastases due to microsatellite instability-high/deficient mismatch repair system.
UroGen Pharma Ltd., a biotech company focused on novel solutions for specialty as well as urothelial cancers, announced that their Investigational New Drug (IND) application for UGN-103, a next-generation novel mitomycin-based formulation designed for low-grade intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC), has been accepted by the Food and Drug Administration (FDA). The RTGel® platform technology of UroGen in making the UGN-103 formulation is a reverse-thermal hydrogel that can release drugs slowly and thus enhance drug profiles so that they would be better than existing ones. In case of approval, the production benefits associated with UGN-103 include cost advantages, supply chain efficiencies, and product convenience. For heavily recurrent LG-IR-NMIBC, a Phase 3 study using UGN-103 is planned to be initiated in 2024.
The market for drugs to treat urothelial cancer may expand quickly as people become more aware of bladder disorders and treatment options, as healthcare costs rise and the impact of bladder cancer increases. Additionally, the rising prevalence of bladder cancer worldwide supports the market's rise over the projected period. Depending on the goal of their use, chemotherapy medicines may be used singly or in combination. The most popular type of treatment used to halt or delay the proliferation of urothelial carcinoma cells is chemotherapy. It operates across the entire body to eliminate and prevent the spread of cancer cells to organs other than the original tumor. The segment is anticipated since chemotherapy is regarded as the first-line treatment for urothelial carcinoma.
When bladder tumors progress to deeper bladder layers and become challenging to treat, a problem is created. Blood in the urine, suffering, irritation in the bladder, changes in urination patterns, edema, sweating during the night, weight loss, and fever are among the common signs of urothelial cancer. The standard course of treatment for urothelial cancer is chemotherapy. Recent market approvals from significant companies present numerous prospects for industry expansion. For instance, better medicines that top drug regulatory organizations have approved will likely benefit the urothelial cancer medications market. The availability of generic medications on the market and the expensive nature of investing in research and development to create a new product are two issues that may impede the industry's growth. The high cost of treatment options restricts market expansion. The development of the market will probably be hindered by the high R&D costs resulting from producing urothelial cancer medications and the growing use of generic medications.
On a regional basis, the market is segmented into the Americas, Europe, Asia-Pacific, and the Middle East and Africa. Americas is likely to dominate the urothelial carcinoma treatment market owing to the increasing prevalence of bladder cancer, increasing investment in research and development of new bladder cancer treatment. According to the American cancer society report, about 79030 cases of bladder cancer was reported in 2017 in the US.
Europe is the second largest market for the urothelial carcinoma treatment followed by Asia-Pacific. Due to growing awareness regarding early diagnosis of bladder cancer and developed healthcare infrastructure with increasing prevalence of urothelial cancer. Asia-Pacific shows the fastest growth in the market due to the low cost of R&D. India and China are expected to be the fastest growing market for bladder cancer treatment.
The Middle East and Africa has the lowest market for urothelial carcinoma treatment due to poor medical facilities and lack of technology.
According to a study published in The Oncologist, first-line cisplatin-based chemotherapy offers those suffering from metastatic urothelial carcinoma the longest overall survival (OS) compared to other treatments. In this real-world trial, chemotherapy based on cisplatin had a median OS longer than chemotherapy based on carboplatin, immune checkpoint inhibitor (ICI) monotherapy, or nonplatinum therapy (apart from ICIs). ICI monotherapy had the highest total cost of care, while cisplatin-based chemotherapy also had the highest level of resource consumption in the healthcare system.
Intended Audience
| Report Attribute/Metric | Details |
| Â Â Market Size 2032 | Â USD 3.72 Billion |
| Â Â CAGR | Â 19.66% (2024-2032) |
| Â Â Base Year | Â Â 2023 |
| Â Â Forecast Period | Â Â 2024-2032 |
| Â Â Historical Data | Â Â 2018 |
| Â Â Forecast Units | Â Â Value (USD Billion) |
| Â Â Report Coverage | Â Â Revenue Forecast, Competitive Landscape, Growth Factors, and Trends |
| Â Â Segments Covered | Â Â Types, Treatment, And End-Users |
| Â Â Geographies Covered | Â Â North America, Europe, Asia-Pacific, and Rest of the World (RoW) |
| Â Â Key Vendors | Â Â GlaxoSmithKline plc, Genentech, Inc., Novartis AG, Dendreon, Merck KGaA, Eisai Co., Sanofi S.A., Bristol-Myers Squibb |
| Â Â Key Market Opportunities | Â Â Investment in R&D activities to come up with new cancer treatment |
| Â Â Key Market Drivers | Â Â Growing prevalence of cancer |
Frequently Asked Questions (FAQ) :
Urothelial Carcinoma, also known as transitional cell carcinoma, is a cancer of the urinary bladder that can spread to other parts of the body.
Urothelial Carcinoma is expected to exhibit a strong 19.66% CAGR over the forecast period from 2024-2032.
Growing prevalence of cancer is the major driver for the market.
Americas hold the largest share in the global Urothelial Carcinoma Market.
Leading players in the Urothelial Carcinoma Market include Sanofi, Genentech, and Novartis, among others.
Assistant Manager He holds an experience of about 7+ years in market research and business consulting, working under the spectrum of life sciences and healthcare domains. rahul conceptualizes and implements a scalable business strategy and provides strategic leadership to the clients. his expertise lies in market estimation, competitive intelligence, pipeline analysis, customer assessment, etc. in addition to the above, his other responsibility includes strategic tracking of high growth markets & advising clients on the potential areas of focus they could direct their business initiatives
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