Published Date : 2023-09-13
Published Date : 2023-09-13
Updated On : 2024-06-28
Pages : 159
Thelansis’s “Advanced or Metastatic Non-Small-Cell Lung Cancer (NSCLC) 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 or Metastatic Non-Small-Cell Lung Cancer treatment modalities options for eight major markets (USA, Germany, France, Italy, Spain, UK, Japan, and China).
Lung cancer remains the predominant cause of cancer-related mortality globally among both males and females. The majority of lung cancer cases are classified as non-small cell lung cancer (NSCLC), accounting for approximately 85% of cases. The most prevalent histological subtypes within NSCLC include adenocarcinoma (AC), squamous cell carcinoma (SCC), and large cell neuroendocrine carcinoma (LCNEC). Advanced NSCLC, also referred to as metastatic NSCLC, is characterized by the spread of the cancer from the lungs to other parts of the body, rendering it incurable. In the United States, NSCLC represents the most common form of lung cancer and frequently metastasizes to the bones, brain, liver, skin, lymph nodes, or adrenal glands. However, it can disseminate to any region of the body. Molecular subtyping has become increasingly critical in managing advanced and metastatic NSCLC (stage IV), as genotype-driven therapies, commonly known as targeted therapies, have become the standard of care for a significant subset of patients. These therapeutic advancements have led to unprecedented improvements in patient outcomes. Historically, the estimated median overall survival for patients with stage IV NSCLC was between 6 and 10 months. Advanced NSCLC can be categorized into two forms: locally advanced and metastatic. Locally advanced NSCLC, also referred to as stage III NSCLC, occurs when cancer has spread to lymph nodes further away from the chest but has not metastasized to distant organs. This stage may involve larger tumors compared to stage II NSCLC. Metastatic NSCLC, or stage IV NSCLC, is defined by the spread of cancer to distant organs, such as the contralateral lung, brain, or liver. Current standard practice in the treatment of metastatic NSCLC includes the use of tyrosine kinase inhibitors (TKIs) targeting anaplastic lymphoma kinase (ALK), particularly in ALK-positive patients confirmed through the standard fluorescence in situ hybridization (FISH) technique, or in ROS1-positive patients. Alectinib has emerged as the preferred first-line treatment due to its superior progression-free survival (PFS) compared to crizotinib in direct comparisons.
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 | Trastuzumab Deruxtecan | AstraZeneca | Phase 3 |
2 | Lazertinib and Amivantamab | Janssen Research & Development, LLC | Phase 3 |
3 | Utidelone and Docetaxel | Beijing Biostar Pharmaceuticals Co., Ltd. | Phase 3 |
4 | Furmonertinib | ArriVent BioPharma, Inc. | Phase 3 |
5 | HS-10365 capsules | Jiangsu Hansoh Pharmaceutical Co., Ltd. | Phase 2 |
6 | DZD9008 | Dizal Pharmaceuticals | Phase 3 |
7 | D-1553 | Chia Tai Tianqing Pharmaceutical Group Co., Ltd. | Phase 3 |
8 | Domvanalimab and Zimberelimab | Gilead Sciences | Phase 3 |
9 | Divarasib, Sotorasib and Adagrasib | Hoffmann-La Roche | Phase 3 |
10 | Repotrectinib | Bristol-Myers Squibb | Phase 3 |
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. Advanced or Metastatic Non-Small-Cell Lung Cancer (NSCLC) – 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 or Metastatic Non-Small-Cell Lung Cancer (NSCLC) market scenario 2023 |
1.2.2. Advanced or Metastatic Non-Small-Cell Lung Cancer (NSCLC) market scenario 2028 |
1.2.3. Advanced or Metastatic Non-Small-Cell Lung Cancer (NSCLC) market scenario 2033 |
2. Advanced or Metastatic Non-Small-Cell Lung Cancer (NSCLC) 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 or Metastatic Non-Small-Cell Lung Cancer (NSCLC) |
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 or Metastatic Non-Small-Cell Lung Cancer (NSCLC) 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 or Metastatic Non-Small-Cell Lung Cancer (NSCLC) management |
2.16. Market Opportunity for Advanced or Metastatic Non-Small-Cell Lung Cancer (NSCLC) |
2.17. KOL Comments on current and upcoming/expected treatment practices in Advanced or Metastatic Non-Small-Cell Lung Cancer (NSCLC) |
3. Epidemiology |
3.1. Epidemiology Overview |
3.2. Epidemiology by Geography |
3.2.1. Advanced or Metastatic Non-Small-Cell Lung Cancer (NSCLC) Epidemiology in US (2023-2033) |
3.2.1.1. Incidence of Advanced or Metastatic Non-Small-Cell Lung Cancer (NSCLC) |
3.2.1.2. Diagnosed cases |
3.2.1.3. Treatable Patient Pool |
3.2.1.4. Epidemiology Trends |
3.2.2. Advanced or Metastatic Non-Small-Cell Lung Cancer (NSCLC) Epidemiology in EU-5 (2023-2033) |
3.2.2.1. Incidence of Advanced or Metastatic Non-Small-Cell Lung Cancer (NSCLC) |
3.2.2.2. Diagnosed cases |
3.2.2.3. Treatable Patient Pool |
3.2.2.4. Epidemiology Trends |
3.2.3. Advanced or Metastatic Non-Small-Cell Lung Cancer (NSCLC) Epidemiology in Japan (2023-2033) |
3.2.3.1. Incidence of Advanced or Metastatic Non-Small-Cell Lung Cancer (NSCLC) |
3.2.3.2. Diagnosed cases |
3.2.3.3. Treatable Patient Pool |
3.2.3.4. Epidemiology Trends |
3.2.4. Advanced or Metastatic Non-Small-Cell Lung Cancer (NSCLC) Epidemiology in China (2023-2033) |
3.2.4.1. Incidence of Advanced or Metastatic Non-Small-Cell Lung Cancer (NSCLC) |
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 or Metastatic Non-Small-Cell Lung Cancer (NSCLC) 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 or Metastatic Non-Small-Cell Lung Cancer (NSCLC) 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 or Metastatic Non-Small-Cell Lung Cancer (NSCLC) 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 or Metastatic Non-Small-Cell Lung Cancer (NSCLC) 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 or Metastatic Non-Small-Cell Lung Cancer (NSCLC) 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 or Metastatic Non-Small-Cell Lung Cancer (NSCLC) 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 or Metastatic Non-Small-Cell Lung Cancer (NSCLC) 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 or Metastatic Non-Small-Cell Lung Cancer (NSCLC) 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 or Metastatic Non-Small-Cell Lung Cancer (NSCLC) |
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 or Metastatic Non-Small-Cell Lung Cancer (NSCLC) 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 or Metastatic Non-Small-Cell Lung Cancer (NSCLC) |
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 or Metastatic Non-Small-Cell Lung Cancer (NSCLC) 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 |