Published Date : 2024-07-18
Published Date : 2024-07-18
Updated On : 2025-01-10
Pages : 157
Thelansis’s “Muscle-Invasive Bladder Cancer (MIBC) Market Outlook, Epidemiology, Competitive Landscape, and Market Forecast Report – 2024 To 2034" covers disease overview, epidemiology, drug utilization, prescription share analysis, competitive landscape, clinical practice, regulatory landscape, patient share, market uptake, market forecast, and key market insights under the potential Muscle-invasive bladder cancer treatment modalities options for eight major markets (USA, Germany, France, Italy, Spain, UK, Japan, and China).
Muscle-invasive bladder cancer (MIBC) is a form of bladder cancer that penetrates the detrusor muscle, which is the thick muscle layer within the bladder wall. This type of cancer is more aggressive and has a higher likelihood of spreading to other parts of the body compared to non-muscle-invasive bladder cancer. MIBC is typically classified as stage 2 or beyond in bladder cancer staging. MIBC development begins when abnormal cells in the bladder grow uncontrollably, forming tumors that invade the muscle layer. These tumors can further spread to nearby tissues, lymph nodes, and distant organs such as the lungs, liver, and bones. The exact cause of MIBC is not fully understood, but smoking is identified as a significant risk factor, contributing to nearly half of bladder cancer cases. Other risk factors include genetic predispositions, exposure to certain chemicals, and chronic bladder inflammation. Symptoms of MIBC often include blood in the urine, frequent or painful urination, and a persistent urge to urinate even when the bladder is empty. Advanced stages may present additional symptoms such as fatigue, unintended weight loss, and swelling in the lower extremities. Diagnosis typically involves imaging tests, cystoscopy, and biopsy to confirm the presence and extent of the cancer.
North America- the United States and Canada
Europe- EU5 (Germany, France, Italy, Spain, and the United Kingdom)
Other countries- Japan & China
This section of the study covers country-specific current clinical practice, the standard of care, and significant limitations around addressing the unmet needs. Retrospective analysis and bench-marking of clinical study outcomes are presented in terms of Pre-treatment & post-treatment clinical and demographic patient characteristics. Essentially, this section will cover the evolution of the current competitive landscape and its impact on the future treatment paradigm.
KOLs across 8 MM markets from the center of Excellence/ Public/ Private hospitals participated in the study. Insights around current treatment landscape, epidemiology, clinical characteristics, future treatment paradigm, and Unmet needs
- Data Inputs with sourcing
- Market Event and Product Event
- Country-specific Forecast Model
- Market uptake and patient share uptake
- Attribute Analysis
- Analog Analysis
- Disease burden and pricing scenario
- Summary and Insights
Optimization of cash flow/ revenue flow concerning all fixed and variable investments throughout the product development process. The rate of return on an investment is a critical indicator to ensure the profitability and break-even of the project.
The competitive landscape includes country-specific approved as well as pipeline therapies. Any asset/product-specific designation or review such as Orphan drug designation, Fast track, Priority Review, Breakthrough Therapy Designation, Rare Pediatric Disease Designation, and Accelerated Approval are tracked and supplemented with analyst commentary.
Detailed clinical trial data analysis and critical product positioning include trial design, primary outcomes, secondary outcomes, dosing and schedules, inclusion and exclusion criteria, recruitment status and essentially covers the reported adverse events. Majorly the trial analysis helps determine the potential of the critical assets and their probable filing and launch date.
This report presents the most important clinical unmet needs in the treatment, according to Thelansis research and analysis. Other essential unmet needs identified through our study include decreased cost burden on patients, improved administration convenience, and improved patient compliance.
S. no | Asset | Company | Stage |
1 | Pembrolizumab | Merck Sharp & Dohme LLC | Phase 3 |
2 | RC48-ADC with JS001 | RemeGen Co., Ltd. | Phase 2 |
3 | TAR-200 with Cetrelimab | Janssen Research & Development, LLC | Phase 2 |
4 | Imfinzi (durvalumab) | AstraZeneca | Phase 3 |
5 | SHR-A2102 | Suzhou Suncadia Biopharmaceuticals Co., Ltd. | Phase 2/3 |
6 | Atezolizumab | Hoffmann-La Roche | Phase 3 |
7 | Nivolumab | Bristol-Myers Squibb | Phase 3 |
8 | Sacituzumab Govitecan, Zimberelimab, and Domvanalimab | Apices Soluciones S.L. | Phase 2 |
9 | SEphB4-HSA | Vasgene Therapeutics, Inc | Phase 2/3 |
10 | Cabozantinib | Exelixis | Phase 2 |
Continued...
KOLs across 8 MM market from the center of Excellence/ Public/ Private hospitals participated in the study. Insights around current treatment landscape, epidemiology, clinical characteristics, future treatment paradigm, and Unmet needs.
COUNTRY | No. Of KOLs |
USA | 17 |
GERMANY | 4 |
UK | 4 |
SPAIN | 3 |
FRANCE | 2 |
ITALY | 3 |
JAPAN | 3 |
CHINA | 4 |
Data Inputs with sourcing, Market Event, Product Event, Country specific Forecast Model, Market uptake and patient share uptake, Attribute Analysis, Analog Analysis, Disease burden, and pricing scenario, Summary, and Insights.
1. Muscle-Invasive Bladder Cancer (MIBC) – Key Findings Summary |
1.1. Clinical findings |
1.1.1. Disease overview |
1.1.2. Therapeutic practices |
1.1.3. Future outlook |
1.2. Commercial findings |
1.2.1. Muscle-Invasive Bladder Cancer (MIBC) market scenario 2024 |
1.2.2. Muscle-Invasive Bladder Cancer (MIBC) market scenario 2029 |
1.2.3. Muscle-Invasive Bladder Cancer (MIBC) market scenario 2034 |
2. Muscle-Invasive Bladder Cancer (MIBC) Overview |
2.1. Disease Introduction |
2.2. Pathophysiology |
2.3. Signs and Symptoms |
2.4. Risk Factors |
2.5. Etiology |
2.6. Classification |
2.7. Pathogenesis |
2.8. Diagnosis |
2.9. Complications |
2.10. Treatment Algorithm |
2.10.1. Treatment in US (guidelines) |
2.10.2. Treatment in EU-5 (guidelines) |
2.10.3. Treatment in Japan (guidelines) |
2.10.4. Treatment in China (guidelines) |
2.11. Treatment Goals for Muscle-Invasive Bladder Cancer (MIBC) |
2.12. Referral Patterns |
2.12.1. Referral Scenario in US |
2.12.2. Referral Scenario in EU-5 |
2.12.3. Referral Scenario in Japan |
2.12.4. Referral Scenario in China |
2.13. Muscle-Invasive Bladder Cancer (MIBC) Prognosis |
2.14. Healthcare burden |
2.14.1. Healthcare burden in US |
2.14.2. Healthcare burden in EU-5 |
2.14.3. Healthcare burden in Japan |
2.14.4. Healthcare burden in China |
2.15. Unmet Needs in Muscle-Invasive Bladder Cancer (MIBC) management |
2.16. Market Opportunity for Muscle-Invasive Bladder Cancer (MIBC) |
2.17. KOL Comments on current and upcoming/expected treatment practices in Muscle-Invasive Bladder Cancer (MIBC) |
3. Epidemiology |
3.1. Epidemiology Overview |
3.2. Epidemiology by Geography |
3.2.1. Muscle-Invasive Bladder Cancer (MIBC) Epidemiology in US (2024-2034) |
3.2.1.1. Incidence of Muscle-Invasive Bladder Cancer (MIBC) |
3.2.1.2. Diagnosed cases |
3.2.1.3. Treatable Patient Pool |
3.2.1.4. Epidemiology Trends |
3.2.2. Muscle-Invasive Bladder Cancer (MIBC) Epidemiology in EU-5 (2024-2034) |
3.2.2.1. Incidence of Muscle-Invasive Bladder Cancer (MIBC) |
3.2.2.2. Diagnosed cases |
3.2.2.3. Treatable Patient Pool |
3.2.2.4. Epidemiology Trends |
3.2.3. Muscle-Invasive Bladder Cancer (MIBC) Epidemiology in Japan (2024-2034) |
3.2.3.1. Incidence of Muscle-Invasive Bladder Cancer (MIBC) |
3.2.3.2. Diagnosed cases |
3.2.3.3. Treatable Patient Pool |
3.2.3.4. Epidemiology Trends |
3.2.4. Muscle-Invasive Bladder Cancer (MIBC) Epidemiology in China (2024-2034) |
3.2.4.1. Incidence of Muscle-Invasive Bladder Cancer (MIBC) |
3.2.4.2. Diagnosed cases |
3.2.4.3. Treatable Patient Pool |
3.2.4.4. Epidemiology Trends |
3.3. Epidemiology Trends (World-wide) |
4. Market Outlook |
4.1. US Muscle-Invasive Bladder Cancer (MIBC) Market Forecast 2024-2034 |
4.1.1. Market Progression (Futuristic) |
4.1.2. Market Trends and Expectations |
4.1.2.1. Worst case scenario |
4.1.2.2. Base Case Scenario |
4.1.2.3. Best Case Scenario |
4.1.3. Drivers and Barriers |
4.2. UK Muscle-Invasive Bladder Cancer (MIBC) Market Forecast 2024-2034 |
4.2.1. Market Progression (Futuristic) |
4.2.2. Market Trends and Expectations |
4.2.2.1. Worst case scenario |
4.2.2.2. Base Case Scenario |
4.2.2.3. Best Case Scenario |
4.2.3. Drivers and Barriers |
4.3. France Muscle-Invasive Bladder Cancer (MIBC) Market Forecast 2024-2034 |
4.3.1. Market Progression (Futuristic) |
4.3.2. Market Trends and Expectations |
4.3.2.1. Worst case scenario |
4.3.2.2. Base Case Scenario |
4.3.2.3. Best Case Scenario |
4.3.3. Drivers and Barriers |
4.4. Germany Muscle-Invasive Bladder Cancer (MIBC) Market Forecast 2024-2034 |
4.4.1. Market Progression (Futuristic) |
4.4.2. Market Trends and Expectations |
4.4.2.1. Worst case scenario |
4.4.2.2. Base Case Scenario |
4.4.2.3. Best Case Scenario |
4.4.3. Drivers and Barriers |
4.5. Italy Muscle-Invasive Bladder Cancer (MIBC) Market Forecast 2024-2034 |
4.5.1. Market Progression (Futuristic) |
4.5.2. Market Trends and Expectations |
4.5.2.1. Worst case scenario |
4.5.2.2. Base Case Scenario |
4.5.2.3. Best Case Scenario |
4.5.3. Drivers and Barriers |
4.6. Spain Muscle-Invasive Bladder Cancer (MIBC) Market Forecast 2024-2034 |
4.6.1. Market Progression (Futuristic) |
4.6.2. Market Trends and Expectations |
4.6.2.1. Worst case scenario |
4.6.2.2. Base Case Scenario |
4.6.2.3. Best Case Scenario |
4.6.3. Drivers and Barriers |
4.7. Japan Muscle-Invasive Bladder Cancer (MIBC) Market Forecast 2024-2034 |
4.7.1. Market Progression (Futuristic) |
4.7.2. Market Trends and Expectations |
4.7.2.1. Worst case scenario |
4.7.2.2. Base Case Scenario |
4.7.2.3. Best Case Scenario |
4.7.3. Drivers and Barriers |
4.8. China Muscle-Invasive Bladder Cancer (MIBC) Market Forecast 2024-2034 |
4.8.1. Market Progression (Futuristic) |
4.8.2. Market Trends and Expectations |
4.8.2.1. Worst case scenario |
4.8.2.2. Base Case Scenario |
4.8.2.3. Best Case Scenario |
4.8.3. Drivers and Barriers |
4.9. Key Expected Milestones (world-wide) Impacting the Market |
5. Competitive Landscape |
5.1. Pipeline Therapies Overview |
5.1.1. Phase III Therapies |
5.1.1.1. Current Status |
5.1.1.2. Trial details, results |
5.1.1.3. Approval Timeline |
5.1.1.4. Likelihood of approval |
5.1.1.5. Expected Product Positioning |
5.1.1.2. All other Phase III Therapies ….. |
5.1.1.3. Attribute Analysis of Phase III molecules |
5.1.2. Phase II and Phase I/II Therapies |
5.1.2.1. Current Status |
5.1.2.2. Trial details, results |
5.1.2.3. Approval Timelines |
5.1.3. List of active Pre-clinical Therapies |
5.1.3.1. Status in Muscle-Invasive Bladder Cancer (MIBC) |
5.1.3.2. Company positioning |
5.1.3.2. All other pre-clinical therapies |
5.1.4. List of Inactive/discontinued assets |
5.1.4.1. Business impact of discontinuations on current pipeline |
5.1.5. Potential winners from Muscle-Invasive Bladder Cancer (MIBC) Pipeline |
5.1.5.1. Potential Blockbusters across the pipeline |
6. Regulatory/Approval Scenario |
6.1. Regulatory/Approval Framework in US |
6.1.1. Policy Framework |
6.1.2. Payer Expectations |
6.2. Regulatory/Approval Framework in UK |
6.2.1. Policy Framework |
6.2.2. Payer Expectations |
6.3. Regulatory/Approval Framework in France |
6.3.1. Policy Framework |
6.3.2. Payer Expectations |
6.4. Regulatory/Approval Framework in Germany |
6.4.1. Policy Framework |
6.4.2. Payer Expectations |
6.5. Regulatory/Approval Framework in Italy |
6.5.1. Policy Framework |
6.5.2. Payer Expectations |
6.6. Regulatory/Approval Framework in Spain |
6.6.1. Policy Framework |
6.6.2. Payer Expectations |
6.7. Regulatory/Approval Framework in Japan |
6.7.1. Policy Framework |
6.7.2. Payer Expectations |
6.8. Regulatory/Approval Framework in China |
6.8.1. Policy Framework |
6.8.2. Payer Expectations |
7. Clinical Trial Assessment – Current and Future Paradigm |
7.1. Distribution of Primary Endpoints across trials |
7.2. Distribution of Secondary Endpoints across trials |
7.3. Evolution and acceptance of surrogate endpoints |
7.4. Key Investigator initiated trials |
7.5. Attrition analysis |
7.5.1. Suspended/Discontinued Assets |
7.5.2. Failed Trials, Reasons and Business Impact |
7.5.3. Terminated Trials, Reasons and Business Impact |
7.5.4. Withdrawn Trials, Reasons and Business Impact |
7.6. Trial enrollment scenario and challenges |
7.7. Clinical Trial Guidance (across geographies) |
8. Thelansis Commentary |
8.1. Key Unmet needs in Muscle-Invasive Bladder Cancer (MIBC) |
8.2. Possible Best-case Clinical Trial Strategies |
8.3. Possible Best Case Targeted Product Profile (TPP) |
8.4. Possible Best-case Market positioning strategies |
8.5. Possible Best-case Market Access Strategies |
8.6. Possible Best-case LCM Strategies |
8.7. Overall View on Muscle-Invasive Bladder Cancer (MIBC) Market in Dollar Value |
9. Report Methodology |
9.1. Secondary research |
9.2. Primary research |
9.3. Data collation |
9.4. Insight Generation |
10. About Thelansis |
10.1. Our Capabilities |
10.2. Our Services |
10.3. Our Contacts |
10.4. Disclaimer |