Relapsed or Refractory T-Cell Acute Lymphoblastic Leukemia – Market Outlook, Epidemiology, Competitive Landscape, and Market Forecast Report – 2023 To 2033

Relapsed or Refractory T-Cell Acute Lymphoblastic Leukemia Market Outlook and Forecast

Relapsed or Refractory T-Cell Acute Lymphoblastic Leukemia – Market Outlook, Epidemiology, Competitive Landscape, and Market Forecast Report – 2023 To 2033

Published Date : 2023-05-13

Updated On : 2024-04-15

Pages : 159

Relapsed or Refractory T-Cell Acute Lymphoblastic Leukemia Market Outlook

Thelansis’s “Relapsed or Refractory T-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 T-Cell Acute Lymphoblastic Leukemia treatment modalities options for eight major markets (USA, Germany, France, Italy, Spain, UK, Japan, and China).

Relapsed or Refractory T-Cell Acute Lymphoblastic Leukemia Overview

T-cell acute lymphoblastic leukemia (T-ALL) constitutes 15% to 25% of newly diagnosed cases of acute lymphoblastic leukemia (ALL) in children and adolescents. Despite intensive treatment, t-ALL and T-LL are differentiated by a higher occurrence of residual leukemia cells in the bone marrow. While some patients achieve remission, others experience a drop in normal blood cell counts followed by a return of leukemia cells to the bone marrow. Recurrences of T-ALL typically occur within two years of diagnosis, posing significant challenges for treatment, with survival rates dropping as low as 25%. Treatment for T-ALL normally involves intense combination chemotherapy, yielding relatively high overall survival rates, especially among pediatric patients. However, despite the favorable response rates to initial therapy, approximately 20% of pediatric and 40% of adult patients will experience a relapse.

  • In the USA, the incidence of ALL is 1.8 per 100,000 across all age groups and 5 per 100,000 for individuals aged 0 to 19.

Geography Covered:

North America- the United States and Canada

Europe- EU5 (Germany, France, Italy, Spain, and the United Kingdom)

Other countries- Japan & China

Study Period: 2023-2033

Current Clinical Practice and Treatment Algorithm

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.

KOL Insights:

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

Market Forecast: Patient Based Forecast Model (MS. Excel Based Automated Dashboard)

- 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

NPV/ IRR Calculator-

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.

Competitive Landscape:

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.

Clinical Trial Assessment-

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.

Unmet Medical Needs Overview-

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.

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Relapsed or Refractory T-Cell Acute Lymphoblastic Leukemia Competitive Landscape

S. no Asset Company Stage
1 WU-CART-007 Wugen, Inc. Phase 1
2 CD7 CAR-T Guangzhou Bio-gene Technology Co., Ltd Phase 1
3 RD13-02 cell infusion Nanjing Bioheng Biotech Co., Ltd. Phase 1
4 BEAM-201 Beam Therapeutics Inc. Phase 1
5 AUTO1 Autolus Limited Phase 2
6 CPX-351 Jazz Pharmaceuticals Phase 2
7 TC-110 T Cells TCR2 Therapeutics Phase 1
8 UCART22 Cellectis S.A. Phase 1
9 BT-007 CD7 CAR-T cells Bioceltech Therapeutics, Ltd. Phase 1
10 CD7CAR T cells iCell Gene Therapeutics 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

Relapsed or Refractory T-Cell Acute Lymphoblastic Leukemia Market Forecast: Patient Based Forecast Model (MS. Excel Based Automated Dashboard)

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.

Relapsed or Refractory T-Cell Acute Lymphoblastic Leukemia Market Forecast

1.       Relapsed or Refractory T-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 T-Cell Acute Lymphoblastic Leukemia market scenario 2023
                     1.2.2. Relapsed or Refractory T-Cell Acute Lymphoblastic Leukemia market scenario 2028
                     1.2.3. Relapsed or Refractory T-Cell Acute Lymphoblastic Leukemia market scenario 2033

2.       Relapsed or Refractory T-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 T-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 T-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 T-Cell Acute Lymphoblastic Leukemia management
         2.16.  Market Opportunity for Relapsed or Refractory T-Cell Acute Lymphoblastic Leukemia
         2.17. KOL Comments on current and upcoming/expected treatment practices in Relapsed or Refractory T-Cell Acute Lymphoblastic Leukemia

3.       Epidemiology

         3.1.    Epidemiology Overview
         3.2.    Epidemiology by Geography
                     3.2.1.  Relapsed or Refractory T-Cell Acute Lymphoblastic Leukemia Epidemiology in US (2023-2033)
                             3.2.1.1.              Incidence of Relapsed or Refractory T-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 T-Cell Acute Lymphoblastic Leukemia Epidemiology in EU-5 (2023-2033)
                             3.2.2.1.              Incidence of Relapsed or Refractory T-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 T-Cell Acute Lymphoblastic Leukemia Epidemiology in Japan (2023-2033)
                             3.2.3.1.              Incidence of Relapsed or Refractory T-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 T-Cell Acute Lymphoblastic Leukemia Epidemiology in China (2023-2033)
                             3.2.4.1.              Incidence of Relapsed or Refractory T-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 T-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 T-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 T-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 T-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 T-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 T-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 T-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 T-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 T-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 T-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 T-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 T-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