Published Date : 2023-08-25
Published Date : 2023-08-25
Updated On : 2024-06-18
Pages : 157
Thelansis’s “Advanced Metastatic Triple-Negative Breast Cancer (TNBC) 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 Advanced Metastatic Triple-Negative Breast Cancer treatment modalities options for eight major markets (USA, Germany, France, Italy, Spain, UK, Japan, and China).
Advanced Metastatic Triple-Negative Breast Cancer (TNBC) is a distinct and immensely complex form of breast cancer. Among all subtypes of breast cancers, TNBC has a comparatively high rate of relapse, a high rate of distant metastasis, and poor overall survival after standard chemotherapy. TNBC is a heterogeneous disease encompassing a variety of biomarkers or genomic signatures; it accounts for 12% of all breast cancers in the USA. 1- and 2- year survival rates are 75% and 55%, respectively. Prognosis is poor in the advanced stages – median survival of 13.3 months following diagnosis of metastatic TNBC. •Emerging therapies are expected to drive patient stratification for biomarker-defined and pathway-specific (subtyping) patient subgroups - an opportunity for a novel agent in relevant specific segments. TNBC is a clinicopathologic, not intrinsic (genomically defined) subgroup, as neither overexpressing ER and PR nor being HER2+ (IHC and/or FISH). Neither hormonal (endocrine) nor HER2-targeted therapies are indicated Potential for FastTrack/ breakthrough designation with promising outcomes in the biomarker-driven patient segment; Several PARP inhibitors are in trials; veliparib+carboplatin followed by chemotherapy showed pCR: 52% vs. 26% (chemotherapy alone) 40% of TNBC show overexpression of GPNMB; unusual activity with glembatumumab, a GPNMB-targeting AD Biomarker-driven segments have been identified within TNBC, with POC. A better understanding of these would enable personalized treatment with improved patient outcomes. p53, PTEN, and PIK3CA are most frequently mutated in TNBC (>10%).
Geography Covered
North America- the United States and Canada
Europe- EU5 (Germany, France, Italy, Spain, and the United Kingdom)
Other countries- Japan & China
Study Period: 2023-2033
Current Clinical Practice and Treatment Algorithm
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
Market Forecast: Patient Based Forecast Model (MS. Excel Based Automated Dashboard)
- 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
NPV/ IRR Calculator-
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.
Competitive Landscape:
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.
Clinical Trial Assessment-
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.
Unmet Medical Needs Overview-
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 | Abemaciclib | Eli Lilly and Company | Phase 2 |
2 | AZD5363 | AstraZeneca | Phase 2 |
3 | Ladiratuzumab vedotin and Pembrolizumab | Seagen Inc. | Phase 2 |
4 | Atezolizumab | Hoffmann-La Roche | Phase 3 |
5 | 9MW2821 | Mabwell (Shanghai) Bioscience Co., Ltd. | Phase 2 |
6 | Sacituzumab Govitecan-hziy | Gilead Sciences | Phase 3 |
7 | Leronlimab | CytoDyn, Inc. | Phase 1/2 |
8 | CB-839 | Calithera Biosciences, Inc | Phase 2 |
9 | SKB264 | Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. | Phase 3 |
10 | KN046 | Jiangsu Alphamab Biopharmaceuticals Co., Ltd | Phase 1/2 |
Continued...
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.
COUNTRY | No. Of KOLs |
USA | 17 |
GERMANY | 4 |
UK | 5 |
SPAIN | 4 |
FRANCE | 4 |
ITALY | 4 |
JAPAN | 5 |
CHINA | 5 |
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. Advanced Metastatic Triple-Negative Breast Cancer (TNBC) – 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. Advanced Metastatic Triple-Negative Breast Cancer (TNBC) market scenario 2023 |
1.2.2. Advanced Metastatic Triple-Negative Breast Cancer (TNBC) market scenario 2028 |
1.2.3. Advanced Metastatic Triple-Negative Breast Cancer (TNBC) market scenario 2033 |
2. Advanced Metastatic Triple-Negative Breast Cancer (TNBC) 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 Advanced Metastatic Triple-Negative Breast Cancer (TNBC) |
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. Advanced Metastatic Triple-Negative Breast Cancer (TNBC) 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 Advanced Metastatic Triple-Negative Breast Cancer (TNBC) management |
2.16. Market Opportunity for Advanced Metastatic Triple-Negative Breast Cancer (TNBC) |
2.17. KOL Comments on current and upcoming/expected treatment practices in Advanced Metastatic Triple-Negative Breast Cancer (TNBC) |
3. Epidemiology |
3.1. Epidemiology Overview |
3.2. Epidemiology by Geography |
3.2.1. Advanced Metastatic Triple-Negative Breast Cancer (TNBC) Epidemiology in US (2023-2033) |
3.2.1.1. Incidence of Advanced Metastatic Triple-Negative Breast Cancer (TNBC) |
3.2.1.2. Diagnosed cases |
3.2.1.3. Treatable Patient Pool |
3.2.1.4. Epidemiology Trends |
3.2.2. Advanced Metastatic Triple-Negative Breast Cancer (TNBC) Epidemiology in EU-5 (2023-2033) |
3.2.2.1. Incidence of Advanced Metastatic Triple-Negative Breast Cancer (TNBC) |
3.2.2.2. Diagnosed cases |
3.2.2.3. Treatable Patient Pool |
3.2.2.4. Epidemiology Trends |
3.2.3. Advanced Metastatic Triple-Negative Breast Cancer (TNBC) Epidemiology in Japan (2023-2033) |
3.2.3.1. Incidence of Advanced Metastatic Triple-Negative Breast Cancer (TNBC) |
3.2.3.2. Diagnosed cases |
3.2.3.3. Treatable Patient Pool |
3.2.3.4. Epidemiology Trends |
3.2.4. Advanced Metastatic Triple-Negative Breast Cancer (TNBC) Epidemiology in China (2023-2033) |
3.2.4.1. Incidence of Advanced Metastatic Triple-Negative Breast Cancer (TNBC) |
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 Advanced Metastatic Triple-Negative Breast Cancer (TNBC) 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 Advanced Metastatic Triple-Negative Breast Cancer (TNBC) 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 Advanced Metastatic Triple-Negative Breast Cancer (TNBC) 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 Advanced Metastatic Triple-Negative Breast Cancer (TNBC) 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 Advanced Metastatic Triple-Negative Breast Cancer (TNBC) 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 Advanced Metastatic Triple-Negative Breast Cancer (TNBC) 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 Advanced Metastatic Triple-Negative Breast Cancer (TNBC) 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 Advanced Metastatic Triple-Negative Breast Cancer (TNBC) 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 Advanced Metastatic Triple-Negative Breast Cancer (TNBC) |
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 Advanced Metastatic Triple-Negative Breast Cancer (TNBC) 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 Advanced Metastatic Triple-Negative Breast Cancer (TNBC) |
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 Advanced Metastatic Triple-Negative Breast Cancer (TNBC) 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 |