Acute Lymphocytic Leukemia – Opportunity Analysis and Forecasts to 2029

1 Table of Contents

1.1 List of Tables

1.2 List of Figures

2 Acute Lymphocytic Leukemia: Executive Summary

2.1 The Acute Lymphocytic Leukemia Market Will Grow at a

4.4% Rate During 2019–2029

2.2 Label Expansions and New CAR-T Cell Products Drive Improvements in Acute Lymphocytic Leukemia Care

2.3 Improved Overall Survival After Relapse and Stem Cell Transplant Replacements Remain Key Unmet Needs

2.4 CAR-T Cells Shape the Future of the Acute Lymphocytic Leukemia Market

2.5 What Do Physicians Think?

3 Introduction

3.1 Catalyst

3.2 Related Reports

3.3 Upcoming Related Reports

4 Disease Overview

4.1 Etiology and Pathophysiology

4.1.1 Etiology

4.1.2 Pathophysiology

4.2 Classification and Subtypes

5 Epidemiology

5.1 Disease Background

5.2 Risk Factors and Comorbidities

5.3 Global and Historical Trends

5.4 Forecast Methodology

5.4.1 Sources Used and Not Used

5.4.2 Forecast Assumptions and Methods

5.5 Epidemiological Forecast for ALL (2019–2029)

5.5.1 Diagnosed Incident Cases of ALL

5.5.2 Age-Specific Diagnosed Incident Cases of ALL

5.5.3 Sex-Specific Diagnosed Incident Cases of ALL

5.5.4 Diagnosed Incident Cases of B-Cell and T-Cell ALL

5.5.5 Five-Year Diagnosed Prevalent Cases of ALL

5.6 Discussion

5.6.1 Epidemiological Forecast Insight

5.6.2 Coronavirus Disease 2019 (COVID-19) Impact

5.6.3 Limitations of the Analysis

5.6.4 Strengths of the Analysis

6 Current Treatment Options

6.1 Overview

7 Unmet Needs and Opportunity Assessment

7.1 Overview

7.2 Agents for T-ALL and Infant ALL

7.3 More Tolerable Curative Regimens

7.4 Improving Overall Survival After Relapse

7.5 Improved CAR-T Cells and HSCT Replacements

7.6 More Convenient Regimens

8 R&D Strategies

8.1 Overview

8.1.1 Label Expansions in Earlier Lines of Therapy

8.1.2 Improved CAR-T Cells

8.1.3 Improved Asparaginase Products

8.2 Clinical Trials Design

8.2.1 Flexible Criteria Based on the Patient Population and Unmet Need

8.2.2 Pharmacokinetics as the Critical Endpoint for Asparaginases

8.2.3 Significant Contribution of Public Funding

9 Pipeline Assessment

9.1 Overview

9.2 Innovative Early Stage Approaches

9.3 Other Drugs in Development

10 Pipeline Valuation Analysis

10.1 Clinical Benchmark of Key Pipeline Drugs

10.2 Commercial Benchmark of Key Pipeline Drugs

10.3 Competitive Assessment

10.4 Top-Line 10-Year Forecast

10.4.1 US

10.4.2 5EU

10.4.3 Japan

10.4.4 China

11 Appendix

11.1 Bibliography

11.2 Abbreviations

11.3 Methodology

11.3.1 Forecasting Methodology

11.3.2 Diagnosed Patients

11.3.3 Percent Drug-Treated Patients

11.3.4 Drugs Included in Each Therapeutic Class

11.3.5 Launch and Patent Expiry Dates

11.3.6 General Pricing Assumptions

11.3.7 Individual Drug Assumptions

11.3.8 Generic Erosion

11.3.9 Pricing of Pipeline Agents

11.3.10 Pipeline Innovation Analysis

11.4 Primary Research – KOLs Interviewed for This Report

11.4.1 KOLs

11.5 Primary Research – Prescriber Survey

11.6 About the Authors

11.6.1 Analyst

11.6.2 Therapy Area Director

11.6.3 Epidemiologist

11.6.4 Managing Epidemiologists

11.6.5 Global Director of Therapy Analysis and Epidemiology

11.6.6 Global Head and EVP of Healthcare Operations and Strategy

11.7 About GlobalData

11.8 Contact Us

11.9 Disclaimer

Table 1: Acute Lymphocytic Leukemia: Key Metrics in the 8MM

Table 2: Classification of ALL Patients

Table 3: Risk Factors and Comorbidities for ALL

Table 4: Treatment Guidelines for ALL

Table 5: Leading Treatments for ALL, 2019

Table 6: Previous ALL Pivotal Trials with Their Respective Endpoints

Table 7: Comparison of Therapeutic Classes in Development for ALL, 2019–2029

Table 8: Innovative Early Stage Approaches for ALL, 2020

Table 9: Drugs in Development for ALL, 2020

Table 10: Clinical Benchmark of Key Marketed and Pipeline Drugs – ALL

Table 11: Commercial Benchmark of Key Pipeline Drugs – ALL

Table 12: Key Events Impacting Sales for ALL in the US, 2019–2029

Table 13: ALL Market – Global Drivers and Barriers, 2019–2029

Table 14: Key Historical and Projected Launch Dates for ALL

Table 15: Key Historical and Projected Patent Expiry Dates for ALL

Table 16: Most Commonly Used Regimens for ALL in the 8MM

Table 17: High-Prescribing Physicians (non-KOLs) Surveyed, By Country

Figure 1: Global Sales Forecast by Country for Acute Lymphocytic Leukemia in 2019 and 2029

Figure 2: Competitive Assessment of the Marketed and Pipeline Drugs Benchmarked Against the SOC Oncaspar Regimen and Blincyto

Figure 3: Comparison of Normal and Leukemia Blood Cell Differentiation

Figure 4: Agents Used to Target ALL Antigens/Pathways Specific to B- or T-cells

Figure 5: 8MM, Diagnosed Incidence of ALL, Men and Women, All Ages, 2009–2019

Figure 6: Sources Used to Forecast the Diagnosed Incident Cases of ALL

Figure 7: Sources Used to Forecast the Five-Year Diagnosed Prevalent Cases of ALL

Figure 8: 8MM, Diagnosed Incident Cases of ALL, Men and Women, All Ages, 2019

Figure 9: 8MM, Diagnosed Incident Cases of ALL by Age Group, Men and Women, 2019

Figure 10: 8MM, Diagnosed Incident Cases of ALL by Sex, All Ages, 2019

Figure 11: 8MM, Diagnosed Incident Cases of B-cell and T-Cell ALL, Men and Women, All Ages, 2019

Figure 12: 8MM, Five-Year Diagnosed Prevalent Cases of ALL, Men and Women, All Ages, 2019

Figure 13: Current Treatment Algorithm of ALL

Figure 14: Unmet Needs and Opportunities in ALL

Figure 15: Overview of the ALL Development Pipeline

Figure 16: Key Phase II/III Trials for the Promising Pipeline Agents that GlobalData Expects be Licensed for ALL in the 8MM During the Forecast Period

Figure 17: Competitive Assessment of the Marketed and Pipeline Drugs Benchmarked Against the SOC Blincyto and Oncaspar Regimen

Figure 18: Global (8MM) Sales Forecast by Country for ALL in 2019 and 2029

Figure 19: Global Sales Forecast by Class for ALL in 2019 and 2029

Figure 20: Sales Forecast by Class for ALL in the US in 2019 and 2029

Figure 21: Sales Forecast by Class for ALL in the 5EU in 2019 and 2029

Figure 22: Sales Forecast by Class for ALL in Japan in 2019 and 2029

Figure 23: Sales Forecast by Class for ALL in China in 2019 and 2029