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Abstract, Snapshot, Market Analysis & Market Definition: Global Urothelial Cancer Drugs MarketThe global urothelial cancer drugs market size was valued at USD 855 million in 2017 and is expected to exhibit a CAGR of 22.9% during the forecast period. U.S. held the dominant share among the seven major markets.Market growth is largely attributed to factors such as availability of novel drugs, presence of a strong pipeline, rise in incidence of urothelial cancer due to growing geriatric population, unorganized lifestyle, and rising public awareness. Urothelial carcinoma or transitional cell carcinoma is a malignant neoplasm occurring from urothelium. The disease is the ninth most common malignancy in the world, with approximately 2.5 million patients and 420,000 newly diagnosed cases each year. Bladder transitional cell carcinoma (TCC) accounted for approximately 90% of all urinary cancer cases. Urothelial cancer is clinically divided into three categories: non-muscle invasive bladder cancer (NMIBC, early stage), muscle invasive disease (MIBC, mid stage), and metastatic disease (late stage). At diagnosis, approximately 70% of cases are non-muscle invasive disease, 20% are at the muscle invasive stage, and 10% at the advanced stage. Approximately 59% of bladder cancer cases occur in developed regions such as North America and Europe.The economic and human toll of urothelial cancer represents a highly disproportionate health burden. The disease has the highest lifetime cost of care per patient among all tumors in U.S. due to its high relapse rate and invasive lifelong monitoring including cystoscopy follow-ups.
Market Segmentation, Outlook & Viewpoint: Global Urothelial Cancer Drugs Market
Treatment Class Market Segmentation & Outlook (Revenue, USD Million, 2019 - 2029)
Key Players, Recent Developments & Regional Insights: Global Urothelial Cancer Drugs MarketEarly stage of urothelial cancer is generally treated with transurethral resection (TURBT), followed by intravesical therapy to reduce recurrence. Partial or radical cystectomy may be recommended in high-grade cancer, multiple tumor sites, or large tumor size at time of diagnosis. However, relapse rates after surgical resection is high. The standards of care are generic chemotherapeutics, Bacillus Calmette-Guerin (BCG) immunotherapy, and mitomycin C for NMIBC and Gemcitabine-Cisplatin for muscle invasive disease and metastatic disease. The treatment landscape for patients with urothelial cancer has undergone multiple changes in the past year, due to development of PD-1/PD-L1 inhibitors. Combination regimens, particularly checkpoint inhibitors, are likely to become first-line treatment to target key unmet market-needs such as curbing tumour resistance, enhancing progression-free survival, and bettering quality of life.There remain plenty of opportunities for BCG-intolerant or ineligible patients in the non-muscle invasive bladder cancer (NMIBC) setting.
Pipeline InsightsDisease progression and recurrence rates remain high among patients with aggressive carcinoma in-situ (CIS) classification. The future urothelial cancer treatment landscape has a high probability of gaining an array of first-in-class therapies and it is anticipated that several novel treatments will gain approvals during the forecast period. The potential for the use of immunotherapies in adjuvant and neoadjuvant settings is now the subject of several clinical trials. These treatments will be used in conjunction with standard therapies to provide patients with safer and effective treatment options. Innovative treatments such as CAR-T therapies and viral therapy continue to generate interest as potential treatment of urothelial cancer.
Country InsightsThe U.S. dominated the urothelial cancer drugs market in 2017, followed by Germany. U.S. is estimated to retain its leading position in 2023, followed by Japan. Presence of a large target population, increased adoption of novel therapeutics, and impending product launches during the forecast period will fuel the market. China offers strong opportunity for market expansion. Factors such as high unmet clinical needs and presence of a large target population are expected to propel the market in this region. Several local players are currently evaluating products as second/third-line treatments in Phase II trials and are well positioned to be launched in the China market in the upcoming years.
Urothelial Cancer Drugs Market Share InsightsSome of the key players operating in this market are Roche, Merck, Bristol-Myers Squibb, AstraZeneca, and Pfizer. Collaborations for development, broader product portfolios, and regional expansion in emerging markets are key strategic undertakings of these companies to increase their market share. The market is expected to grow increasingly crowded with several product launches during the forecast period. Merck and AstraZeneca are expected to lead the market in 2023, supported by approvals of (Imfinzi + tremelimumab) and (Keytruda + chemotherapy) regimens in early lines of treatment for both chemo-ineligible and chemo-eligible patients.It is expected that immune checkpoint blockade therapy could replace the current standard of care in bladder cancer. In Jun 2020, FDA Approves BAVENCIO as First-Line Maintenance Treatment for Patients with Locally Advanced or Metastatic Urothelial Carcinoma. First and only FDA-approved immunotherapy to demonstrate a significant overall survival benefit in the first-line setting in a Phase III study. Priority review completed under FDAs Real-Time Oncology Review (RTOR) pilot program, following receipt of Breakthrough Therapy Designation. EMD Serono, the biopharmaceutical business of Merck KGaA, Darmstadt, Germany in the US and Canada, and Pfizer Inc. (NYSE: PFE) today announced that the US Food and Drug Administration (FDA) has approved the supplemental Biologics License Application (sBLA) for BAVENCIO® (avelumab) for the maintenance treatment of patients with locally advanced or metastatic urothelial carcinoma (UC) that has not progressed with first-line platinum-containing chemotherapy.For patients that do not progress on platinum-containing chemotherapy, BAVENCIO is administered as a first-line maintenance treatment until disease progression or unacceptable toxicity. The FDA previously approved BAVENCIO under the accelerated approval program in 2017 for the treatment of patients with locally advanced or metastatic UC who have disease progression during or following platinum-containing chemotherapy, or who have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy, based on tumor response rate and duration of response. Continued approval was contingent upon verification of clinical benefit, which was demonstrated in JAVELIN Bladder 100. The FDA has now converted the accelerated approval to full approval. This approval for BAVENCIO, has the opportunity to fundamentally shift the standard of care in the first-line setting of advanced bladder cancer. The focus will be to work closely with the GU community to ensure that this novel and potentially life-changing treatment paradigm is rapidly integrated into clinical practice. The alliance is committed to providing patient access and reimbursement support through its CoverOne® program to patients who have been prescribed BAVENCIO. This program provides a spectrum of patient access and reimbursement support services intended to help US patients prescribed BAVENCIO receive appropriate access.
Key Insights Covered: Global Urothelial Cancer Drugs Market1. North America, Europe, Asia Pacific, Middle East & Africa, Latin America market size (sales, revenue and growth rate) of Urothelial Cancer Drugs industry. 2. Global major manufacturers operating situation (sales, revenue, growth rate and gross margin) of Urothelial Cancer Drugs industry. 3. Global major countries (United States, Canada, Germany, France, UK, Italy, Russia, Spain, China, Japan, Korea, India, Australia, New Zealand, Southeast Asia, Middle East, Africa, Mexico, Brazil, C. America, Chile, Peru, Colombia) market size (sales, revenue and growth rate) of Urothelial Cancer Drugs industry. 4. SWOT analysis, New Project Investment Feasibility Analysis, Upstream raw materials and manufacturing equipment & Industry chain analysis of Urothelial Cancer Drugs industry. 5. Global market size (sales, revenue) forecast by regions and countries from 2019 to 2024 of Urothelial Cancer Drugs industry.
Research Methodology: Global Urothelial Cancer Drugs Market
- Data collection and base year analysis is done using data collection modules with large sample sizes. The market data is analyzed and forecasted using market statistical and coherent models. Also market share analysis and key trend analysis are the major success factors in the market report. To know more please Request a Sample Report.
- Demand Side Primary Contributors: OEMs, Industrial Professionals, Researches, Suppliers and Distributors, Group Purchasing Organizations, Associations, Insurers, Universities, Technological Writers, Scientists, Promoters, Investors among others.
- Supply Side Primary Contributors: Product Managers, Marketing Managers, C-Level Executives, Distributors, Market Intelligence, Regulatory Affairs Managers among other
Table of Contents Chapter 1 Research Methodology 1.1. Information Procurement 1.2. Information or Data Analysis 1.2.1 Market Formulation & ValidationChapter 2 Executive SummaryChapter 3 Disease Primer and Epidemiology 3.1. Disease Primer 3.2. EpidemiologyChapter 4 Global Urothelial Cancer Drugs Market Overview 4.1 Market by Treatment Class 4.2 Market Size and Forecast 2017- 2023 4.3 Market Share Distribution, by Company 2017- 2023 4.4 Market Dynamics and Brand Strategies 4.5 Patent Expiry Analysis 4.6 Urothelial Cancer Market: Drivers and Restraints 4.6.1 Drivers 4.6.2 | read more...