Published Date : 2022-09-16
Published Date : 2022-09-16
Updated On : 2023-06-27
Pages : 163
Thelansis’s “Chimeric Antigen Receptor (CAR) T-Cell Therapy Market Outlook, Competitive Landscape, and Market Forecast Report – 2022 To 2032" covers disease overview, drug utilization, prescription share analysis, competitive landscape, clinical practice, regulatory landscape, patient share, market uptake, market forecast, and key market insights under the potential Chimeric Antigen Receptor (CAR) T-Cell Therapy treatment modalities options for eight major markets (USA, Germany, France, Italy, Spain, UK, Japan, and China).
Chimeric Antigen Receptor (CAR) T-cell therapy is an advanced immunotherapy used to treat certain types of cancer. It involves genetically modifying a patient's T-cells to express a chimeric antigen receptor on their surface, allowing them to recognize and attack cancer cells expressing specific antigens.
The CAR T-cell therapy process includes the following:
The market for CAR T-cell therapy has been rapidly growing due to its high success rates in treating blood cancers and its potential in other malignancies. Pharmaceutical and biotech companies have invested significantly in developing CAR T-cell therapies and conducting clinical trials to expand their scope. EMA and FDA have approved CAR T-cell therapies for different indications. Tisagenlecleucel (Kymriah) and axicabtagene ciloleucel (Yescarta) were the first CAR T-cell therapies to receive approval for certain forms of leukemia and lymphoma.
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 | LCAR-B38M CAR-T Cell | Nanjing Legend Biotech Co. | Phase 2 |
2 | AUTO1 | Autolus Limited | Phase 2 |
3 | IVIG | Takeda | Phase 2 |
4 | JNJ-68284528 | Janssen Research & Development, LLC | Phase 3 |
5 | Pembrolizumab | Merck Sharp & Dohme LLC | Phase 2 |
6 | Cevostamab | Genentech, Inc. | Phase 2 |
7 | ALLO-647 | Allogene Therapeutics | Phase 2 |
8 | PHE885 | Novartis Pharmaceuticals | Phase 2 |
9 | NKTR-255 | Nektar Therapeutics | Phase 2 |
10 | GC012F | Gracell Biopharmaceuticals, Inc. | 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. Chimeric Antigen Receptor (CAR-T) – Key Findings Summary |
1.1. Commercial Potential |
1.1.1. Market potential |
1.1.2. Therapeutic practices |
1.1.3. Market outlook |
1.2. Commercial findings |
1.2.1. CAR-T market scenario 2022 |
1.2.2. CAR-T market scenario 2027 |
1.2.3. CAR-T market scenario 2032 |
2. Chimeric Antigen Receptor (CAR-T) Overview |
2.1. Introduction to CAR-T |
2.2. Pathogenesis |
2.3. Technology and platform |
2.4. Applications |
2.5. Risk Factors |
2.6. Therapeutic evolutions |
2.7. Clinical practice |
2.8. CAR-T adoption and clinical practice |
2.8.1. Treatment landscape for CAR-T in US |
2.8.2. Treatment landscape for CAR-T in EU-5 |
2.8.3. Treatment landscape for CAR-T in Japan |
2.8.4. Treatment landscape for CAR-T in China |
2.9. Treatment Goals for CAR-T |
2.10. Referral Patterns for CAR-T |
2.10.1. Referral Scenario in US |
2.10.2. Referral Scenario in EU-5 |
2.10.3. Referral Scenario in Japan |
2.10.4. Referral Scenario in China |
2.11. CAR-T Healthcare burden |
2.11.1. CAR-T Healthcare burden in US |
2.11.2. CAR-T Healthcare burden in EU-5 |
2.11.3. CAR-T Healthcare burden in Japan |
2.11.4. CAR-T Healthcare burden in China |
2.12. Current unmet Needs |
2.13. Market Opportunity for CAR-T |
2.14. Payer’s Expectations from CAR-T |
2.15. KOL Comments on CAR-T current and upcoming/expected clinical practices |
3. Market Outlook
|
3.1. US CAR-T Market Forecast 2022-2032 |
3.1.1. Market Progression (Futuristic) |
3.1.2. Market Trends and Expectations |
3.1.2.1. Worst Case Scenario |
3.1.2.2. Base Case Scenario |
3.1.2.3. Best Case Scenario |
3.1.3. Drivers and Barriers |
3.2. UK CAR-T Market Forecast 2022-2032 |
3.2.1. Market Progression (Futuristic) |
3.2.2. Market Trends and Expectations |
3.2.2.1. Worst Case Scenario |
3.2.2.2. Base Case Scenario |
3.2.2.3. Best Case Scenario |
3.2.3. Drivers and Barriers |
3.3. France CAR-T Market Forecast 2022-2032 |
3.3.1. Market Progression (Futuristic) |
3.3.2. Market Trends and Expectations |
3.3.2.1. Worst Case Scenario |
3.3.2.2. Base Case Scenario |
3.3.2.3. Best Case Scenario |
3.3.3. Drivers and Barriers |
3.4. Germany CAR-T Market Forecast 2022-2032 |
3.4.1. Market Progression (Futuristic) |
3.4.2. Market Trends and Expectations |
3.4.2.1. Worst Case Scenario |
3.4.2.2. Base Case Scenario |
3.4.2.3. Best Case Scenario |
3.4.3. Drivers and Barriers |
3.5. Italy CAR-T Market Forecast 2022-2032 |
3.5.1. Market Progression (Futuristic) |
3.5.2. Market Trends and Expectations |
3.5.2.1. Worst Case Scenario |
3.5.2.2. Base Case Scenario |
3.5.2.3. Best Case Scenario |
3.5.3. Drivers and Barriers |
3.6. Spain CAR-T Market Forecast 2022-2032 |
3.6.1. Market Progression (Futuristic) |
3.6.2. Market Trends and Expectations |
3.6.2.1. Worst Case Scenario |
3.6.2.2. Base Case Scenario |
3.6.2.3. Best Case Scenario |
3.6.3. Drivers and Barriers |
3.7. Japan CAR-T Market Forecast 2022-2032 |
3.7.1. Market Progression (Futuristic) |
3.7.2. Market Trends and Expectations |
3.7.2.1. Worst Case Scenario |
3.7.2.2. Base Case Scenario |
3.7.2.3. Best Case Scenario |
3.7.3. Drivers and Barriers |
3.8. China CAR-T Market Forecast 2022-2032 |
3.8.1. Market Progression (Futuristic) |
3.8.2. Market Trends and Expectations |
3.8.2.1. Worst Case Scenario |
3.8.2.2. Base Case Scenario |
3.8.2.3. Best Case Scenario |
3.8.3. Drivers and Barriers |
3.9. Key Expected Milestones (world-wide) Impacting the Market |
4. Competitive Landscape
|
4.1. Pipeline Therapies Overview |
4.2. Phase III/ II Profiles |
4.2.1. All Other Company (All Other Product) Profile |
4.2.1.1. Current Status |
4.2.1.2. Trial details, results (Targeted Disease Segments) |
4.2.1.3. Approval Timeline |
4.2.1.4. Likelihood of approval (KOL Comments) |
4.3. Phase I Profiles |
4.3.1. All Other Company (All Other Product) Profile |
4.3.1.1. Current Status |
4.3.1.2. Trial details, results (Targeted Disease Segments) |
4.3.1.3. Approval Timeline |
4.3.1.4. Likelihood of approval (KOL Comments) |
4.4. Preclinical/Phase I ready Therapies |
4.4.1. All Other Product (All Other Company) Profile |
4.4.1.1. Current Status (Targeted Disease Segments) |
4.4.1.2. Competitive Benchmarking |
4.4.1.3. Company Profile |
4.5. Attrition analysis |
4.5.1. Discontinued and Assets with No Development Reported |
4.5.2. Reasons and class-effect of discontinuations |
5. Regulatory/Approval Scenario for CAR-T
|
5.1. Regulatory/Approval Framework in US |
5.1.1. Policy Framework |
5.1.2. Payer Expectations |
5.2. Regulatory/Approval Framework in UK |
5.2.1. Policy Framework |
5.2.2. Payer Expectations |
5.3. Regulatory/Approval Framework in France |
5.3.1. Policy Framework |
5.3.2. Payer Expectations |
5.4. Regulatory/Approval Framework in Germany |
5.4.1. Policy Framework |
5.4.2. Payer Expectations |
5.5. Regulatory/Approval Framework in Italy |
5.5.1. Policy Framework |
5.5.2. Payer Expectations |
5.6. Regulatory/Approval Framework in Spain |
5.6.1. Policy Framework |
5.6.2. Payer Expectations |
5.7. Regulatory/Approval Framework in Japan |
5.7.1. Policy Framework |
5.7.2. Payer Expectations |
5.8. Regulatory/Approval Framework in China |
5.8.1. Policy Framework |
5.8.2. Payer Expectations |
6. Clinical Trial Assessment – Current and Future Paradigm of CAR-T
|
6.1. Distribution of Primary Endpoints across trials |
6.2. Distribution of Secondary Endpoints across trials |
6.3. Evolution and acceptance of surrogate endpoints |
6.4. Key Investigator initiated trials |
6.5. Attrition analysis |
6.5.1. Suspended/Discontinued Assets |
6.5.2. Failed Trials, Reasons and Business Impact |
6.5.3. Terminated Trials, Reasons and Business Impact |
6.5.4. Withdrawn Trials, Reasons and Business Impact |
6.6. Trial enrollment scenario and challenges |
6.7. Clinical Trial Guidance (across geographies) |
7. Thelansis Commentary
|
7.1. Key Unmet needs in CAR-T |
7.2. Possible Best-case Clinical Trial Strategies |
7.3. Possible Best Case Targeted Product Profile (TPP) |
7.4. Possible Best-case Market Positioning Strategies |
7.5. Possible Best-case Market Access Strategies |
7.6. Possible Best-case LCM Strategies |
7.7. Overall View on CAR-T Market in Dollar Value |
8. Report Methodology
|
8.1. Secondary research |
8.2. Primary research |
8.3. Data collation |
8.4. Insight Generation |
9. About Thelansis
|
9.1. Our Capabilities |
9.2. Our Services |
9.3. Our Contacts |
9.4. Disclaimer |