Published Date : 2023-09-21
Published Date : 2023-09-21
Updated On : 2024-06-12
Pages : 158
Thelansis’s “Relapsed or Refractory B-cell Acute Lymphoblastic Leukemia 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 Relapsed or Refractory B-cell Acute Lymphoblastic Leukemia treatment modalities options for eight major markets (USA, Germany, France, Italy, Spain, UK, Japan, and China).
Current therapies for adults with newly diagnosed B-ALL have complete remission (CR) rates of 60%–90%. In relapsed or refractory (R/R) B-ALL cases, chemotherapy achieves CR rates of 31%–44% during first salvage therapy and 18%–25% during second salvage therapy. For patients who achieve a second CR after re-induction chemoimmunotherapy, allogeneic hematopoietic cell transplantation (HCT) remains the standard of care. The absence of measurable residual disease (MRD) in the marrow after intensive multi-agent cytotoxic chemotherapy is the most predictive factor for better clinical outcomes in B-ALL. Persistent MRD at the time of allogeneic HCT is associated with higher relapse rates. Historically, treatment options for R/R B-ALL were limited to conventional cytotoxic chemotherapies, resulting in CR rates of 30%–40% for the first salvage and 10%–20% for the second salvage. This has driven the development of novel therapies to improve outcomes in adult R/R ALL. Antibody-targeted therapies and chimeric antigen receptor (CAR) T-cell therapies have emerged as significant advancements in managing R/R ALL. Monoclonal antibodies targeting cell surface antigens like CD20, CD19, and CD22 work through complement-dependent cytotoxicity, antibody-dependent cell-mediated cytotoxicity, or direct phagocytosis. With nearly all precursor and mature B cells expressing CD19 and over 90% of precursor and all mature B cells expressing CD22, blinatumomab (Blincyto, Amgen) and inotuzumab ozogamicin (Besponsa, Pfizer) are highly effective antibody-targeted therapies.
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 | CLLS52 (alemtuzumab) | Cellectis Inc. | Phase 2 |
2 | Obecabtagene autoleucel (Aucatzyl) | Autolus Therapeutics | Phase 1/2 |
3 | KTE-X19 | Kite, A Gilead Company | Phase 2 |
4 | BinD19 | Shenzhen BinDeBio Ltd. | Phase 1 |
5 | TBI-1501 | Takara Bio Inc. | Phase 2 |
6 | GNR-084 | AO GENERIUM | Phase 2 |
7 | ADCT-602 | ADC Therapeutics S.A. | Phase 2 |
8 | TC-110 T Cells | TCR2 Therapeutics | Phase 1 |
9 | MB-CART19.1 | Miltenyi Biomedicine GmbH | Phase 1 |
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. Relapsed or Refractory B-cell Acute Lymphoblastic Leukemia – 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. Relapsed or Refractory B-cell Acute Lymphoblastic Leukemia market scenario 2023 |
1.2.2. Relapsed or Refractory B-cell Acute Lymphoblastic Leukemia market scenario 2028 |
1.2.3. Relapsed or Refractory B-cell Acute Lymphoblastic Leukemia market scenario 2033 |
2. Relapsed or Refractory B-cell Acute Lymphoblastic Leukemia 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 Relapsed or Refractory B-cell Acute Lymphoblastic Leukemia |
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. Relapsed or Refractory B-cell Acute Lymphoblastic Leukemia 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 Relapsed or Refractory B-cell Acute Lymphoblastic Leukemia management |
2.16. Market Opportunity for Relapsed or Refractory B-cell Acute Lymphoblastic Leukemia |
2.17. KOL Comments on current and upcoming/expected treatment practices in Relapsed or Refractory B-cell Acute Lymphoblastic Leukemia |
3. Epidemiology |
3.1. Epidemiology Overview |
3.2. Epidemiology by Geography |
3.2.1. Relapsed or Refractory B-cell Acute Lymphoblastic Leukemia Epidemiology in US (2023-2033) |
3.2.1.1. Incidence of Relapsed or Refractory B-cell Acute Lymphoblastic Leukemia |
3.2.1.2. Diagnosed cases |
3.2.1.3. Treatable Patient Pool |
3.2.1.4. Epidemiology Trends |
3.2.2. Relapsed or Refractory B-cell Acute Lymphoblastic Leukemia Epidemiology in EU-5 (2023-2033) |
3.2.2.1. Incidence of Relapsed or Refractory B-cell Acute Lymphoblastic Leukemia |
3.2.2.2. Diagnosed cases |
3.2.2.3. Treatable Patient Pool |
3.2.2.4. Epidemiology Trends |
3.2.3. Relapsed or Refractory B-cell Acute Lymphoblastic Leukemia Epidemiology in Japan (2023-2033) |
3.2.3.1. Incidence of Relapsed or Refractory B-cell Acute Lymphoblastic Leukemia |
3.2.3.2. Diagnosed cases |
3.2.3.3. Treatable Patient Pool |
3.2.3.4. Epidemiology Trends |
3.2.4. Relapsed or Refractory B-cell Acute Lymphoblastic Leukemia Epidemiology in China (2023-2033) |
3.2.4.1. Incidence of Relapsed or Refractory B-cell Acute Lymphoblastic Leukemia |
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 Relapsed or Refractory B-cell Acute Lymphoblastic Leukemia 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 Relapsed or Refractory B-cell Acute Lymphoblastic Leukemia 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 Relapsed or Refractory B-cell Acute Lymphoblastic Leukemia 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 Relapsed or Refractory B-cell Acute Lymphoblastic Leukemia 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 Relapsed or Refractory B-cell Acute Lymphoblastic Leukemia 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 Relapsed or Refractory B-cell Acute Lymphoblastic Leukemia 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 Relapsed or Refractory B-cell Acute Lymphoblastic Leukemia 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 Relapsed or Refractory B-cell Acute Lymphoblastic Leukemia 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 Relapsed or Refractory B-cell Acute Lymphoblastic Leukemia |
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 Relapsed or Refractory B-cell Acute Lymphoblastic Leukemia 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 Relapsed or Refractory B-cell Acute Lymphoblastic Leukemia |
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 Relapsed or Refractory B-cell Acute Lymphoblastic Leukemia 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 |