Published Date : 2023-08-25
Published Date : 2023-08-25
Updated On : 2024-06-11
Pages : 153
Thelansis’s “Metastatic Clear Cell Renal Cell Carcinoma (RCC) Market Outlook, Epidemiology, Competitive Landscape, and Market Forecast Report – 2023 To 2033" 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 Metastatic Clear Cell Renal Cell Carcinoma treatment modalities options for eight major markets (USA, Germany, France, Italy, Spain, UK, Japan, and China).
Renal cell carcinoma (RCC), the 8th most common malignancy affecting adults, accounts for between 3% and 4% of new cancer cases in the United States. The classic clinical presentation of flank pain, hematuria, and a palpable flank mass are comparatively uncommon (5–10% of cases). However, clinical symptomatology may be relatively nonspecific. For example, anorexia, tiredness, weight loss, or fever of unknown origin. The clear cell histologic subtype remains the most common, representing approximately 70% of all renal tumors and an even more significant proportion of patients with metastatic RCC (>80%). The vast majority of clear cell RCC is characterized by biallelic loss of function of the von Hippel Lindau (VHL) tumor suppressor gene. Prognosis is generally reflected in staging severity, with the lower-stage disease associated with longer survival rates. The prediction is noticeably adversely affected by the spread of the tumor beyond the renal fascia and into the retroperitoneum (TNM T3a and higher) · The more common sites of metastases as reported in stage IV disease (TNM T4 or N1+ M1 disease) are the lung (69%), bone (43%), liver (34%), lymph nodes (22%), adrenal gland (19%), brain (7%), and thyroid, skin, and bladder (< 1% each)
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 | MLN0128 and MLN1117 | Millennium Pharmaceuticals, Inc. | Phase 2 |
2 | Sitravatinib, Nivolumab and Ipilimumab | Mirati Therapeutics Inc. | Phase 1 |
3 | ADI-270 | Adicet BioAdicet Bio | Phase 1 |
4 | 68Ga-NYM005 injection | Norroy Bioscience Co., LTD | Phase 1 |
5 | Orellanine | Oncorena AB | Phase 1/2 |
6 | ALLO-316 | Allogene Therapeutics | Phase 1 |
7 | XL092 | Exelixis | Phase 3 |
8 | Pembrolizumab and Lenvatinib | Merck Sharp & Dohme LLC | Phase 2 |
9 | Lenvatinib and Everolimus | Eisai Inc. | Phase 2 |
10 | Cabozantinib | Ipsen | 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. Metastatic Clear Cell Renal Cell Carcinoma (RCC) – 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. Metastatic Clear Cell Renal Cell Carcinoma (RCC) market scenario 2023 |
1.2.2. Metastatic Clear Cell Renal Cell Carcinoma (RCC) market scenario 2028 |
1.2.3. Metastatic Clear Cell Renal Cell Carcinoma (RCC) market scenario 2033 |
2. Metastatic Clear Cell Renal Cell Carcinoma (RCC) 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 Metastatic Clear Cell Renal Cell Carcinoma (RCC) |
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. Metastatic Clear Cell Renal Cell Carcinoma (RCC) 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 Metastatic Clear Cell Renal Cell Carcinoma (RCC) management |
2.16. Market Opportunity for Metastatic Clear Cell Renal Cell Carcinoma (RCC) |
2.17. KOL Comments on current and upcoming/expected treatment practices in Metastatic Clear Cell Renal Cell Carcinoma (RCC) |
3. Epidemiology |
3.1. Epidemiology Overview |
3.2. Epidemiology by Geography |
3.2.1. Metastatic Clear Cell Renal Cell Carcinoma (RCC) Epidemiology in US (2023-2033) |
3.2.1.1. Incidence of Metastatic Clear Cell Renal Cell Carcinoma (RCC) |
3.2.1.2. Diagnosed cases |
3.2.1.3. Treatable Patient Pool |
3.2.1.4. Epidemiology Trends |
3.2.2. Metastatic Clear Cell Renal Cell Carcinoma (RCC) Epidemiology in EU-5 (2023-2033) |
3.2.2.1. Incidence of Metastatic Clear Cell Renal Cell Carcinoma (RCC) |
3.2.2.2. Diagnosed cases |
3.2.2.3. Treatable Patient Pool |
3.2.2.4. Epidemiology Trends |
3.2.3. Metastatic Clear Cell Renal Cell Carcinoma (RCC) Epidemiology in Japan (2023-2033) |
3.2.3.1. Incidence of Metastatic Clear Cell Renal Cell Carcinoma (RCC) |
3.2.3.2. Diagnosed cases |
3.2.3.3. Treatable Patient Pool |
3.2.3.4. Epidemiology Trends |
3.2.4. Metastatic Clear Cell Renal Cell Carcinoma (RCC) Epidemiology in China (2023-2033) |
3.2.4.1. Incidence of Metastatic Clear Cell Renal Cell Carcinoma (RCC) |
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 Metastatic Clear Cell Renal Cell Carcinoma (RCC) Market Forecast 2023-2033 |
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 Metastatic Clear Cell Renal Cell Carcinoma (RCC) Market Forecast 2023-2033 |
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 Metastatic Clear Cell Renal Cell Carcinoma (RCC) Market Forecast 2023-2033 |
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 Metastatic Clear Cell Renal Cell Carcinoma (RCC) Market Forecast 2023-2033 |
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 Metastatic Clear Cell Renal Cell Carcinoma (RCC) Market Forecast 2023-2033 |
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 Metastatic Clear Cell Renal Cell Carcinoma (RCC) Market Forecast 2023-2033 |
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 Metastatic Clear Cell Renal Cell Carcinoma (RCC) Market Forecast 2023-2033 |
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 Metastatic Clear Cell Renal Cell Carcinoma (RCC) Market Forecast 2023-2033 |
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 Metastatic Clear Cell Renal Cell Carcinoma (RCC) |
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 Metastatic Clear Cell Renal Cell Carcinoma (RCC) 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 Metastatic Clear Cell Renal Cell Carcinoma (RCC) |
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 Metastatic Clear Cell Renal Cell Carcinoma (RCC) 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 |