Published Date : 2022-10-10
Published Date : 2022-10-10
Updated On : 2023-07-02
Pages : 155
Thelansis’s “CAR T-Cell Therapy Opportunity within Mantle Cell Lymphoma 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 CAR T-Cell Therapy Opportunity within Mantle Cell Lymphoma treatment modalities options for eight major markets (USA, Germany, France, Italy, Spain, UK, Japan, and China).
Mantle cell lymphoma (MCL) is a mature B-cell subtype of Non-Hodgkin lymphoma (NHL), characterized by translocation, primarily caused by an excessive expression of Cyclin D1. Although with the progress in our knowledge of the causes of MCL and available treatments for MCL, this cancer is still incurable. Poor prognostic indicators, such as age, male gender, rapid disease progression, significant nodal involvement, elevated serum lactate dehydrogenase level, increased expression of Ki-67, and TP53 mutation, are associated with an unfavorable outcome. The symptoms of MCL are similar to NHL, including lymphadenopathy, lymphocytosis, splenic enlargement, growth in Waldeyer's ring and tonsils, lymphomatous polyposis, and bone marrow infiltration. Interestingly, some patients may remain asymptomatic despite lymphocytosis. MCL can affect various extranodal sites, including the kidneys, soft tissues, skin, and the central nervous system (CNS). Non-nodal leukemic MCL often presents as asymptomatic indolent or 'smouldering' MCL. Advanced immunotherapy utilizing chimeric antigen receptor (CAR)-T cells shows promise in treating B-cell malignancies and MCL. Targeting B-cell antigens on the cell surface has proven effective in recurrent (R/R) MCL, as observed in other B-cell cancers. The USFDA has approved brexucabtagene autoleucel (Tecartus, KTE-X19), a novel CAR T-cell therapy, for use in MCL patients who have not responded to previous treatments or have experienced a relapse.
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 | Tazemetostat Pill | Epizyme, Inc. | Phase 1 |
| 2 | Interferon-Beta-1a (FP-1201) | Faron Pharmaceuticals Ltd | Phase 2 |
| 3 | SYNCAR-001 | Synthekine | Phase 1 |
| 4 | Zilovertamab vedotin | Merck Sharp & Dohme LLC | Phase 2 |
| 5 | Chimeric Antigen Receptor T-Cell Therapy | Mustang Bio | Phase 2 |
| 6 | Nivolumab | Bristol-Myers Squibb | Phase 2 |
| 7 | CD19-targeted Chimeric Antigen Receptor (CAR) T Cells | Shanghai Ming Ju Biotechnology Co., Ltd. | Phase 2 |
| 8 | Autologous chimeric antigen receptor T cell transfusing agent targeting CD22 | PersonGen BioTherapeutics (Suzhou) Co., Ltd. | Phase 1 |
| 9 | ONCT-808 | Oncternal Therapeutics, Inc | Phase 2 |
| 10 | BAFFR-CAR T cells | PeproMene Bio, Inc. | Phase 1 |
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. CAR T-Cell Therapy Opportunity within Mantle Cell Lymphoma – 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-Cell Therapy Opportunity within Mantle Cell Lymphoma market scenario 2022 |
| 1.2.2. CAR T-Cell Therapy Opportunity within Mantle Cell Lymphoma market scenario 2027 |
| 1.2.3. CAR T-Cell Therapy Opportunity within Mantle Cell Lymphoma market scenario 2032 |
2. CAR T-Cell Therapy Opportunity within Mantle Cell Lymphoma Overview |
| 2.1. Introduction to CAR T-Cell Therapy Opportunity within Mantle Cell Lymphoma |
| 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-Cell Therapy Opportunity within Mantle Cell Lymphoma adoption and clinical practice |
| 2.8.1. Treatment landscape for CAR T-Cell Therapy Opportunity within Mantle Cell Lymphoma in US |
| 2.8.2. Treatment landscape for CAR T-Cell Therapy Opportunity within Mantle Cell Lymphoma in EU-5 |
| 2.8.3. Treatment landscape for CAR T-Cell Therapy Opportunity within Mantle Cell Lymphoma in Japan |
| 2.8.4. Treatment landscape for CAR T-Cell Therapy Opportunity within Mantle Cell Lymphoma in China |
| 2.9. Treatment Goals for CAR T-Cell Therapy Opportunity within Mantle Cell Lymphoma |
| 2.10. Referral Patterns for CAR T-Cell Therapy Opportunity within Mantle Cell Lymphoma |
| 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-Cell Therapy Opportunity within Mantle Cell Lymphoma Healthcare burden |
| 2.11.1. CAR T-Cell Therapy Opportunity within Mantle Cell Lymphoma Healthcare burden in US |
| 2.11.2. CAR T-Cell Therapy Opportunity within Mantle Cell Lymphoma Healthcare burden in EU-5 |
| 2.11.3. CAR T-Cell Therapy Opportunity within Mantle Cell Lymphoma Healthcare burden in Japan |
| 2.11.4. CAR T-Cell Therapy Opportunity within Mantle Cell Lymphoma Healthcare burden in China |
| 2.12. Current unmet Needs |
| 2.13. Market Opportunity for CAR T-Cell Therapy Opportunity within Mantle Cell Lymphoma |
| 2.14. Payer’s Expectations from CAR T-Cell Therapy Opportunity within Mantle Cell Lymphoma |
| 2.15. KOL Comments on CAR T-Cell Therapy Opportunity within Mantle Cell Lymphoma current and upcoming/expected clinical practices |
3. Market Outlook
|
| 3.1. US CAR T-Cell Therapy Opportunity within Mantle Cell Lymphoma 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-Cell Therapy Opportunity within Mantle Cell Lymphoma 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-Cell Therapy Opportunity within Mantle Cell Lymphoma 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-Cell Therapy Opportunity within Mantle Cell Lymphoma 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-Cell Therapy Opportunity within Mantle Cell Lymphoma 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-Cell Therapy Opportunity within Mantle Cell Lymphoma 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-Cell Therapy Opportunity within Mantle Cell Lymphoma 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-Cell Therapy Opportunity within Mantle Cell Lymphoma 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-Cell Therapy Opportunity within Mantle Cell Lymphoma
|
| 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-Cell Therapy Opportunity within Mantle Cell Lymphoma
|
| 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-Cell Therapy Opportunity within Mantle Cell Lymphoma |
| 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-Cell Therapy Opportunity within Mantle Cell Lymphoma 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 |
Head – Business Development and Partnering
Mr. Pankaj Negi has joined Thelansis as Practice Head; Business Development and Partnering, since Jan 2020. A dynamic professional with 12+ years of diverse experience across Pharmaceuticals/ Healthcare/ Life sciences with specialized in sales & marketing and Business Development.
Mr. Pankaj is holding a Master’s degree in “Pharma Management” from the Rajiv Gandhi University of Health Science, Bangalore, India and has expertise in Content Marketing, Content Management systems, Customer Relationship Management, online marketing, advertising, promotion, and Search Engine Optimization. Creating and implementing client-centered, successful campaigns, aimed at improving brand awareness and presence.
Vice President – Delivery, Scientific CI
Mukesh Kumar has joined us as Vice President – Delivery & Innovations, Scientific CI Practice, since August 2019. Prior to joining us, Dr. Mukesh holding a Postdoctoral Fellow with a demonstrated history of working in hard-core research for more than 15 years on both small molecule and biologics within the oncology and neurology segment.
Skilled in Recombinant DNA, Phage Display Technology, Antibodies, ImmunoOncology (K-RAS, Check-Point, Oncolytic), and Immunotherapeutic (RNA andProtein/huMab-based) products, Cancer-stem Cells, Chemoresistance, Real-TimePolymerase Chain Reaction (qPCR), and SDS-PAGE. Strong research professional with a Ph.D. focused on Recombinant Antibody-mediated tumor targeting. Dr.Mukesh has several citations on Synergistic increase in efficacy of a combination of 2-deoxy-D-glucose and cisplatin in normoxia and hypoxia: switch from autophagy to apoptosis, Membrane, Fusion Mediated Targeted Cytosolic DrugDelivery Through scFv Engineered Sendai Viral Envelopes, and Drug combination targeting hypoxia-induced chemoresistance and stemness in glioma cells.
Director – Practice Head, Competitive Intelligence, Market Access, and Pricing
Mr. Peeyush Potdar is working at Thelansis as Practice Head; Competitive Intelligence, Market Access, and Pricing Analytics, since Dec 2017. With 12+ years of rich experience in providing business consulting and research support across competitive intelligence, BD&L activities, KOL management, business research, and analytics services, he has been involved in the development of syndicated therapy area specialized reports in Orphan & ultra-orphan indications and conducting market intelligence assignments on different verticals such as Pharmaceuticals, Medical Devices and Health Insurance.
Mr. Peeyush is holding an MBA degree in “Pharma Management” from the National Institute of Pharmaceutical Education & Research (NIPER), Mohali, India and has expertise in scientific research as well as in commercialization and lifecycle management for innovative and mature assets. He has a good competency in building AI/ ML-based analytics platforms for tracking global conferences, social media analytics, and for conducting patient outcomes research.
Director – Global Relationship and Partnering US
Ms. Martina is working with us as Director – Global Relationship and Partnering US, since October 2019. Prior to joining us, Ms. Martina holding a Master’s Degree in Public Health from Boston University School of Public Health with more than 8 years of experience in B2B and B2C sales. Highly motivated and accomplished sales and marketing professional with a proven history of success in creating the road map and driving business development globally.
Part of US Leadership team and heading Business Development for Thelansis Knowledge Partner for both US and EU Region. Business Development opportunity identification, Engaging with the client and providing them with innovative business solutions.
Director – Global Relationship and Partnering EU
