Published Date : 2021-09-10
Published Date : 2021-09-10
Updated On : 2022-03-18
Pages : 169
Thelansis’s “Relapsed / Refractory B-Acute Lymphocytic Leukemia (ALL) 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 Relapsed / Refractory B-Acute Lymphocytic Leukemia (ALL) treatment modalities options for eight major markets (USA, Germany, France, Italy, Spain, UK, Japan, and China).
B-Cell Acute lymphoblastic leukemia (ALL) is a type of blood cancer in which many abnormal, immature lymphocytes known as blasts begin to multiply in the bone marrow. Lymphocytes are white blood cells that play a role in the immune response. B-ALL is characterized by the expression of various B–cell-specific antigens, which often include PAX-5, CD19, CD20, CD22, CD24, and CD79a. B-cell ALL is primarily a childhood disease, with approximately 75% of cases being children aged <6 years, however, the majority of the B-Cell ALL occurs in the <15 years of age; also, the peak of the incidence is seen in people around 40 years. Approximately 20% to 30% of adult acute lymphoblastic leukemias (ALLs) and 5% of pediatric ALLs harbor the Ph-chromosome. This genetic alteration confers a poor prognosis, as defined by shorter remission duration and shorter survival, and higher rates of resistance to standard chemotherapy. CNS involvement is more common in relapsed adult patients. In children, the overall complete remission rate is greater than 95%, and in adults, the rate is 60-85 percent. Relapse occurs in 15 to 20% of children with B-cell ALL, and the prognosis becomes less favorable. Adults with B-cell ALL have a relapse rate of approximately 50%, and a poor prognosis is expected, with a median survival of fewer than six months after 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 | AUTO3 (CD19/22 CAR T cells | Autolus Limited | Phase 1 |
2 | Blinatumomab | Amgen | Phase 2 |
3 | ADCT-602 | ADC Therapeutics S.A. | Phase 1 |
4 | TBI-1501 | Takara Bio Inc. | Phase 1 |
5 | Anti-CD123 ADC IMGN632 | LLS PedAL Initiative, LLC | Phase 1 |
6 | Ibrutinib | Pharmacyclics LLC. | Phase 2 |
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.
COUNTRY | No. Of KOLs |
USA | 18 |
GERMANY | 4 |
UK | 5 |
SPAIN | 4 |
FRANCE | 4 |
ITALY | 4 |
JAPAN | 5 |
CHINA | 5 |
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 / Refractory B-Acute Lymphocytic Leukemia (ALL) – 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 / Refractory B-Acute Lymphocytic Leukemia (ALL) market scenario 2021 |
1.2.2. Relapsed / Refractory B-Acute Lymphocytic Leukemia (ALL) market scenario 2025 |
1.2.3. Relapsed / Refractory B-Acute Lymphocytic Leukemia (ALL) market scenario 2032 |
2. Relapsed / Refractory B-Acute Lymphocytic Leukemia (ALL) 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 / Refractory B-Acute Lymphocytic Leukemia (ALL) |
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 / Refractory B-Acute Lymphocytic Leukemia (ALL) 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 / Refractory B-Acute Lymphocytic Leukemia (ALL) management |
2.16. Market Opportunity for Relapsed / Refractory B-Acute Lymphocytic Leukemia (ALL) |
2.17. KOL Comments on current and upcoming/expected treatment practices in Relapsed / Refractory B-Acute Lymphocytic Leukemia (ALL) |
3. Epidemiology |
3.1. Epidemiology Overview |
3.2. Epidemiology by Geography |
3.2.1. Relapsed / Refractory B-Acute Lymphocytic Leukemia (ALL) Epidemiology in US (2021-2032) |
3.2.1.1. Incidence of Relapsed / Refractory B-Acute Lymphocytic Leukemia (ALL) |
3.2.1.2. Diagnosed cases |
3.2.1.3. Treatable Patient Pool |
3.2.1.4. Epidemiology Trends |
3.2.2. Relapsed / Refractory B-Acute Lymphocytic Leukemia (ALL) Epidemiology in EU-5 (2021-2032) |
3.2.2.1. Incidence of Relapsed / Refractory B-Acute Lymphocytic Leukemia (ALL) |
3.2.2.2. Diagnosed cases |
3.2.2.3. Treatable Patient Pool |
3.2.2.4. Epidemiology Trends |
3.2.3. Relapsed / Refractory B-Acute Lymphocytic Leukemia (ALL) Epidemiology in Japan (2021-2032) |
3.2.3.1. Incidence of Relapsed / Refractory B-Acute Lymphocytic Leukemia (ALL) |
3.2.3.2. Diagnosed cases |
3.2.3.3. Treatable Patient Pool |
3.2.3.4. Epidemiology Trends |
3.2.4. Relapsed / Refractory B-Acute Lymphocytic Leukemia (ALL) Epidemiology in China (2021-2032) |
3.2.4.1. Incidence of Relapsed / Refractory B-Acute Lymphocytic Leukemia (ALL) |
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 / Refractory B-Acute Lymphocytic Leukemia (ALL) 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 Relapsed / Refractory B-Acute Lymphocytic Leukemia (ALL) 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 Relapsed / Refractory B-Acute Lymphocytic Leukemia (ALL) 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 Relapsed / Refractory B-Acute Lymphocytic Leukemia (ALL) 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 Relapsed / Refractory B-Acute Lymphocytic Leukemia (ALL) 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 Relapsed / Refractory B-Acute Lymphocytic Leukemia (ALL) 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 Relapsed / Refractory B-Acute Lymphocytic Leukemia (ALL) 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 Relapsed / Refractory B-Acute Lymphocytic Leukemia (ALL) 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 Relapsed / Refractory B-Acute Lymphocytic Leukemia (ALL) |
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 / Refractory B-Acute Lymphocytic Leukemia (ALL) 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 / Refractory B-Acute Lymphocytic Leukemia (ALL) |
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 / Refractory B-Acute Lymphocytic Leukemia (ALL) 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 |