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PUBLISHER: Mellalta Meets LLP | PRODUCT CODE: 1634467

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PUBLISHER: Mellalta Meets LLP | PRODUCT CODE: 1634467

BCG Unresponsive High Grade Non-Muscle Invasive Bladder Cancer | Primary Research (KOL's Insight) | Market Intelligence | Epidemiology & Market Forecast-2035

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After resection of high-grade non-invasive bladder cancer (NMIBC), Bacille Calmette-Guerin (BCG) is a well-established therapy to stop or postpone tumor recurrence. In terms of non-invasive intramuscular injection (NMIBC) at the time of diagnosis, bladder cancer ranks second among urological malignancies with 70-80 %of cases. Every year, approximately 275,000 cases of bladder cancer are discovered worldwide, and 108,000 people pass away from the condition. 90% of bladder cancers in industrialized nations are TCC. Squamous cell carcinomas are the most common type of bladder cancer in developing nations, particularly those in the Middle East and Africa, and they are typically brought on by schistosome infection. Patients must have high-grade or resistant tumors (no disease-free period) and have received one induction cycle (6 weeks) and one maintenance cycle (3 weeks) before being deemed unresponsive to BCG.

Description

After high-grade non-invasive bladder cancer (NMIBC) is removed, the treatment Bacille Calmette-Guerin (BCG) is known to prevent or postpone tumor recurrence. In terms of non-invasive intramuscular injection (NMIBC) at the time of diagnosis, bladder cancer ranks second among urological malignancies at 70-80%. Patients with high-risk NMIBC (T1/Tis, high-grade/G3 or CIS) present a challenge due to their increased risk of progression and recurrence. However, many patients experience relapses or make advancements while receiving BCG or afterward. It has been one of the most challenging urological tumors to treat in the decades since the development of BCG. For high-risk NMIBC (non-muscle invasive bladder cancer), intravenous immunotherapy in the form of BCG slows the progression of the disease. regarding the administration of BCG, its duration, schedule, and the time it takes for a tumor to recur after BCG therapy.

BCG Unresponsive High Grade Non-Muscle Invasive Bladder Cancer (Epidemiology)

Each year, about 108,000 people die from bladder cancer and about 275,000 people are diagnosed with the condition globally. Ninety% of bladder cancers in developed nations are TCC. The majority of bladder cancers in developing nations, particularly in the Middle East and Africa, are squamous cell carcinomas, and the majority of these cancers develop as a result of schistosome infection. According to estimates, urothelial carcinoma is the most prevalent type of urinary tract cancer in China. The highest incidence of SCC is observed in schistosomiasis-endemic regions of Africa, especially in Sudan and Egypt, where CSC makes up two-thirds to three-quarters of all bladder malignancies. Recent studies from Egypt have demonstrated that this trend has reversed as a result of improved schistosomiasis control in the region, but the situation has remained the same in other regions of Africa. Egypt's shift to TCC, which has a stronger association with smoking, is thought to be influenced by rising smoking rates.

BCG Unresponsive High Grade Non-Muscle Invasive Bladder Cancer -Current Market Size & Forecast Trends

The market for BCG-unresponsive high-grade non-muscle invasive bladder cancer is projected to grow significantly, with an estimated value of approximately USD 3.9 billion in 2023, expected to reach around USD 5.4 billion by 2034, reflecting a CAGR of about 3.09%. This growth is driven by increasing incidence rates of bladder cancer, the introduction of new therapies such as N-803 and TAR-200, and rising awareness leading to earlier diagnosis and management. However, challenges such as limited treatment options, regulatory hurdles, and economic burdens associated with care persist, necessitating ongoing innovation and support to enhance patient outcomes in this therapeutic area.

Patients must have high-grade or resistant tumors and have received one induction cycle (6 weeks) and one maintenance cycle (3 weeks) before being deemed unresponsive to BCG. The only accepted course of treatment for legitimate patients whose tumors returned within six months of the last BCG exposure and did not respond to BCG was radical cystectomy. Although some show efficacy in specific patient subgroups, no medication or intravenous therapy has shown long-term effectiveness in real patients who do not respond to BCG. The options available to patients with high-grade tumor recurrence must balance the risk of invasive and metastatic disease against the potential benefit of bladder salvage after the administration of the appropriate dose of BCG.

Report Highlights

BCG Unresponsive High Grade Non-Muscle Invasive Bladder Cancer - Current Market Trends

BCG Unresponsive High Grade Non-Muscle Invasive Bladder Cancer - Current & Forecasted Cases across the G8 Countries

BCG Unresponsive High Grade Non-Muscle Invasive Bladder Cancer - Market Opportunities and Sales Potential for Agents

BCG Unresponsive High Grade Non-Muscle Invasive Bladder Cancer - Patient-based Market Forecast to 2035

BCG Unresponsive High Grade Non-Muscle Invasive Bladder Cancer - Untapped Business Opportunities

BCG Unresponsive High Grade Non-Muscle Invasive Bladder Cancer - Product Positioning Vis-a-vis Competitors' Products

BCG Unresponsive High Grade Non-Muscle Invasive Bladder Cancer - KOLs Insight

Table of Content

1. BCG Unresponsive High Grade Non-Muscle Invasive Bladder Cancer Background

  • 1.1. BCG Unresponsive High Grade Non-Muscle Invasive Bladder Cancer Definition
  • 1.2. Signs and Symptoms
  • 1.3. Pathogenesis
  • 1.4. Clinical Manifestation
  • 1.5. BCG Unresponsive High Grade Non-Muscle Invasive Bladder Cancer biomarkers
  • 1.6. Diagnosis

2. Epidemiology Estimated and Forecast to 2035

  • 2.1. Epidemiology Research Method & Data Sources Used
  • 2.2. United States
    • 2.2.1. Incident Cases of BCG Unresponsive High Grade Non-Muscle Invasive Bladder Cancer
    • 2.2.2. Diagnosed and treatable cases of BCG Unresponsive High Grade Non-Muscle Invasive Bladder Cancer by line of therapies (LOT)
  • 2.3. United Kingdom
    • 2.3.1. Incident Cases of BCG Unresponsive High Grade Non-Muscle Invasive Bladder Cancer
    • 2.3.2. Diagnosed and treatable cases of BCG Unresponsive High Grade Non-Muscle Invasive Bladder Cancer by line of therapies (LOT)
  • 2.4. Spain
    • 2.4.1. Incident Cases of BCG Unresponsive High Grade Non-Muscle Invasive Bladder Cancer
    • 2.4.2. Diagnosed and treatable cases of BCG Unresponsive High Grade Non-Muscle Invasive Bladder Cancer by line of therapies (LOT)
  • 2.5. Germany
    • 2.5.1. Incident Cases of BCG Unresponsive High Grade Non-Muscle Invasive Bladder Cancer
    • 2.5.2. Diagnosed and treatable cases of BCG Unresponsive High Grade Non-Muscle Invasive Bladder Cancer by line of therapies (LOT)
  • 2.6. France
    • 2.6.1. Incident Cases of BCG Unresponsive High Grade Non-Muscle Invasive Bladder Cancer
    • 2.6.2. Diagnosed and treatable cases of BCG Unresponsive High Grade Non-Muscle Invasive Bladder Cancer by line of therapies (LOT)
  • 2.7. Italy
    • 2.7.1. Incident Cases of BCG Unresponsive High Grade Non-Muscle Invasive Bladder Cancer
    • 2.7.2. Diagnosed and treatable cases of BCG Unresponsive High Grade Non-Muscle Invasive Bladder Cancer by line of therapies (LOT)
  • 2.8. Japan
    • 2.8.1. Incident Cases of BCG Unresponsive High Grade Non-Muscle Invasive Bladder Cancer
    • 2.8.2. Diagnosed and treatable cases of BCG Unresponsive High Grade Non-Muscle Invasive Bladder Cancer by line of therapies (LOT)
  • 2.9. China
    • 2.9.1. Incident Cases of BCG Unresponsive High Grade Non-Muscle Invasive Bladder Cancer
    • 2.9.2. Diagnosed and treatable cases of BCG Unresponsive High Grade Non-Muscle Invasive Bladder Cancer by line of therapies (LOT)
  • 2.10. Current Unmet Needs in BCG Unresponsive High Grade Non-Muscle Invasive Bladder Cancer by line of therapies (LOT)

3. Current Treatment Paradigm

  • 3.1. Treatment/Prevention guidelines
  • 3.2. Regulatory Approvals/Indication and Current Benchmarks

4. KOLs Insight (US, EU, JP, CH)

  • 4.1. Unmet Needs
  • 4.2. Analysis of the progress in terms of approvals & current pipeline
  • 4.3. Impact on the treatment algorithm and product positioning
  • 4.4. Relevance of new targets/platforms/ Therapy Uptake Share %
  • 4.5. Physicians Preferences for the new pharmacological agents

5. What's New in 2024/2025

6. Future Treatment Paradigm

  • 6.1. BCG Unresponsive High Grade Non-Muscle Invasive Bladder Cancer Competitor Landscape and Approvals Anticipated
  • 6.2. Future Treatment Algorithms and Competitor Positioning
  • 6.3. Key Data Summary for Emerging Treatment

7. Late Phase Therapies Strategic Considerations in BCG Unresponsive High Grade Non-Muscle Invasive Bladder Cancer

8. Total Market Forecast

  • 8.1. Key Summary Findings
    • 8.1.1. G8 total Market for BCG Unresponsive High Grade Non-Muscle Invasive Bladder Cancer 2022-2035 (USD Million)
    • 8.1.2. G8 total Market for BCG Unresponsive High Grade Non-Muscle Invasive Bladder Cancer by Therapies 2022-2035 (USD Million)

9. Market Forecast by Country

  • 9.1. United States
    • 9.1.1. United States Market for BCG Unresponsive High Grade Non-Muscle Invasive Bladder Cancer 2022-2035 (USD Million)
    • 9.1.2. United States Market for BCG Unresponsive High Grade Non-Muscle Invasive Bladder Cancer by Therapies 2022-2035 (USD Million)
  • 9.2. Germany
    • 9.2.1. Germany Market for BCG Unresponsive High Grade Non-Muscle Invasive Bladder Cancer 2022-2035 (USD Million)
    • 9.2.2. Germany Market for BCG Unresponsive High Grade Non-Muscle Invasive Bladder Cancer by Therapies 2022-2035 (USD Million)
  • 9.3. France
    • 9.3.1. France Market for BCG Unresponsive High Grade Non-Muscle Invasive Bladder Cancer 2022-2035 (USD Million)
    • 9.3.2. France Market for BCG Unresponsive High Grade Non-Muscle Invasive Bladder Cancer by Therapies 2022-2035 (USD Million)
  • 9.4. Italy
    • 9.4.1. Italy Market for BCG Unresponsive High Grade Non-Muscle Invasive Bladder Cancer 2022-2035 (USD Million)
    • 9.4.2. Italy Market for BCG Unresponsive High Grade Non-Muscle Invasive Bladder Cancer by Therapies 2022-2035 (USD Million)
  • 9.5. Spain
    • 9.5.1. Spain Market for BCG Unresponsive High Grade Non-Muscle Invasive Bladder Cancer 2022-2035 (USD Million)
    • 9.5.2. Spain Market for BCG Unresponsive High Grade Non-Muscle Invasive Bladder Cancer by Therapies 2022-2035 (USD Million)
  • 9.6. United Kingdom
    • 9.6.1. United Kingdom Market for BCG Unresponsive High Grade Non-Muscle Invasive Bladder Cancer 2022-2035 (USD Million)
    • 9.6.2. United Kingdom Market for BCG Unresponsive High Grade Non-Muscle Invasive Bladder Cancer by Therapies 2022-2035 (USD Million)
  • 9.7. Japan
    • 9.7.1. Japan Market for BCG Unresponsive High Grade Non-Muscle Invasive Bladder Cancer 2022-2035 (USD Million)
    • 9.7.2. Japan Market for BCG Unresponsive High Grade Non-Muscle Invasive Bladder Cancer by Therapies 2022-2035 (USD Million)
  • 9.8. China
    • 9.8.1. China Market for BCG Unresponsive High Grade Non-Muscle Invasive Bladder Cancer 2022-2035 (USD Million)
    • 9.8.2. China Market for BCG Unresponsive High Grade Non-Muscle Invasive Bladder Cancer by Therapies 2022-2035 (USD Million)

10. Market Drivers and Barriers

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Jeroen Van Heghe

Manager - EMEA

+32-2-535-7543

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Christine Sirois

Manager - Americas

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