Published Date : 2020-10-16
Published Date : 2020-10-16
Updated On : 2022-03-25
Pages : 158
Thelansis’s “HER2 Positive Gastroesophageal Adenocarcinoma (GEA) Market Outlook, Epidemiology, Competitive Landscape, and Market Forecast Report – 2021 To 2032" 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 HER2 Positive Gastroesophageal Adenocarcinoma (GEA) treatment modalities options for eight major markets (USA, Germany, France, Italy, Spain, UK, Japan, and China).
Gastroesophageal cancer is the second most commonly diagnosed type of cancer and is responsible for more than 1.2 million deaths yearly. Adenocarcinoma is the predominant type of gastroesophageal cancer, comprising 60% to 95% of all malignant tumors. With 5-year survival rates under 30%, the prognosis of gastroesophageal cancer remains poor. HER2 positivity occurs in 15% to 30% of gastroesophageal adenocarcinomas. Gastric cancer is often diagnosed at an advanced stage, defined as unresectable locoregional or metastatic disease, which has a very poor prognosis with 5-year survival not exceeding 5–20%. Systemic chemotherapy remains the mainstay of first-line therapy, with two or three-drug combinations of fluoropyrimidine and a platinum compound, as well as docetaxel and irinotecan, being widely used.
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 | Zanidatamab | Zymeworks | Phase 3 |
2 | Trastuzumab | Celltrion | Phase 2 |
3 | Trastuzumab Deruxtecan | AstraZeneca | Phase 3 |
4 | Atezolizumab | Hoffmann-La Roche | Phase 2 |
5 | CYNK-101 | Celularity Incorporated | Phase 2 |
6 | Pembrolizumab | Merck Sharp & Dohme LLC | Phase 3 |
7 | DS-8201a | Daiichi Sankyo, Inc. | Phase 1 |
8 | tucatinib | Seagen Inc. | Phase 3 |
9 | PRS-343 | Pieris Pharmaceuticals, Inc. | Phase 2 |
10 | IMU-131 | Imugene Limited | 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. HER2 Positive Gastroesophageal Adenocarcinoma (GEA) – 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. HER2 Positive Gastroesophageal Adenocarcinoma (GEA) market scenario 2021 |
1.2.2. HER2 Positive Gastroesophageal Adenocarcinoma (GEA) market scenario 2025 |
1.2.3. HER2 Positive Gastroesophageal Adenocarcinoma (GEA) market scenario 2032 |
2. HER2 Positive Gastroesophageal Adenocarcinoma (GEA) 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 HER2 Positive Gastroesophageal Adenocarcinoma (GEA) |
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. HER2 Positive Gastroesophageal Adenocarcinoma (GEA) 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 HER2 Positive Gastroesophageal Adenocarcinoma (GEA) management |
2.16. Market Opportunity for HER2 Positive Gastroesophageal Adenocarcinoma (GEA) |
2.17. KOL Comments on current and upcoming/expected treatment practices in HER2 Positive Gastroesophageal Adenocarcinoma (GEA) |
3. Epidemiology |
3.1. Epidemiology Overview |
3.2. Epidemiology by Geography |
3.2.1. HER2 Positive Gastroesophageal Adenocarcinoma (GEA) Epidemiology in US (2021-2032) |
3.2.1.1. Incidence of HER2 Positive Gastroesophageal Adenocarcinoma (GEA) |
3.2.1.2. Diagnosed cases |
3.2.1.3. Treatable Patient Pool |
3.2.1.4. Epidemiology Trends |
3.2.2. HER2 Positive Gastroesophageal Adenocarcinoma (GEA) Epidemiology in EU-5 (2021-2032) |
3.2.2.1. Incidence of HER2 Positive Gastroesophageal Adenocarcinoma (GEA) |
3.2.2.2. Diagnosed cases |
3.2.2.3. Treatable Patient Pool |
3.2.2.4. Epidemiology Trends |
3.2.3. HER2 Positive Gastroesophageal Adenocarcinoma (GEA) Epidemiology in Japan (2021-2032) |
3.2.3.1. Incidence of HER2 Positive Gastroesophageal Adenocarcinoma (GEA) |
3.2.3.2. Diagnosed cases |
3.2.3.3. Treatable Patient Pool |
3.2.3.4. Epidemiology Trends |
3.2.4. HER2 Positive Gastroesophageal Adenocarcinoma (GEA) Epidemiology in China (2021-2032) |
3.2.4.1. Incidence of HER2 Positive Gastroesophageal Adenocarcinoma (GEA) |
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 HER2 Positive Gastroesophageal Adenocarcinoma (GEA) Market Forecast 2021-2032 |
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 HER2 Positive Gastroesophageal Adenocarcinoma (GEA) Market Forecast 2021-2032 |
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 HER2 Positive Gastroesophageal Adenocarcinoma (GEA) Market Forecast 2021-2032 |
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 HER2 Positive Gastroesophageal Adenocarcinoma (GEA) Market Forecast 2021-2032 |
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 HER2 Positive Gastroesophageal Adenocarcinoma (GEA) Market Forecast 2021-2032 |
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 HER2 Positive Gastroesophageal Adenocarcinoma (GEA) Market Forecast 2021-2032 |
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 HER2 Positive Gastroesophageal Adenocarcinoma (GEA) Market Forecast 2021-2032 |
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 HER2 Positive Gastroesophageal Adenocarcinoma (GEA) Market Forecast 2021-2032 |
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 HER2 Positive Gastroesophageal Adenocarcinoma (GEA) |
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 HER2 Positive Gastroesophageal Adenocarcinoma (GEA) 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 HER2 Positive Gastroesophageal Adenocarcinoma (GEA) |
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 HER2 Positive Gastroesophageal Adenocarcinoma (GEA) 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 |