Acute Lymphocytic Leukemia – Opportunity Analysis and Forecasts to 2029

Acute Lymphocytic Leukemia (ALL) is a rare blood malignancy that affects the bone marrow and peripheral blood and originates from either B- or T-cells. While high long term overall survival (OS) rates have been achieved with the use of chemotherapy in children, outcomes in adults are suboptimal and outcomes for patients with T-ALL specifically have always been dismal. Prior to 2015, the main treatment options comprised various chemotherapy regimens and tyrosine kinase inhibitors (TKIs) such as Novartis’ Gleevec/Glivec (imatinib) or Bristol-Myers Squibb’s Sprycel (dasatinib) for patients with Ph+ ALL.

The global market is expected to grow from $1.46B in 2019 to $2.26B in 2029 at a CAGR of 4.4%. The introduction of five new pipeline agents and label expansions for currently approved agents are key drivers of this market growth. Also, China moving away from generic chemotherapies and adopting more effective and premium-priced agents will contribute significantly to this market’s expansion. However, the market value already shows signs of congestion and there are key patent expiries that will prohibit growth.

KEY QUESTIONS ANSWERED

Five late-stage pipeline agents are expected to enter the Acute Lymphocytic Leukemia market from 2020 onwards. What impact will these agents have on the market? Which of these drugs will have the highest peak sales, and why?

What are the current unmet needs in Acute Lymphocytic Leukemia, which pipeline agents are positioned to counter these unmet needs? What are the opportunities for R&D?

How has the introduction of Kymriah shaped the relapsed/refractory care? How will the competition fare?

What is the expected future uptake of monoclonal antibodies in ALL across the 8MM?

Scope

Overview of Acute Lymphocytic Leukemia including epidemiology, pathophysiology, symptoms, diagnosis, and treatment guidelines.

Topline Acute Lymphocytic Leukemia market revenue, annual cost of therapy, and major pipeline product sales in the forecast period.

Key topics covered include current treatment and pipeline therapies, unmet needs and opportunities, and the drivers and barriers affecting Acute Lymphocytic Leukemia therapeutics sales in the 8MM.

Pipeline analysis: Comprehensive data split across different phases, emerging novel trends under development, and detailed analysis of late-stage pipeline drugs (Phase II – III).

Analysis of the current and future market competition in the global Acute Lymphocytic Leukemia therapeutics market. Insightful review of the key industry drivers and challenges. Each trend is independently researched to provide qualitative analysis of its implications.

Key Highlights

The main drivers of growth include the anticipated approval and launch of five pipeline therapies, in addition to label expansions of currently marketed therapies across the 8MM during the forecast period.

The main barriers to growth in the 8MM are key patent expiries of kinase inhibitors during the forecast period and a lack of industrial investment for niche patient populations such as T-ALL due to the low incidence of ALL.

Among the late-stage pipeline products and marketed agents, CAR-T cell therapies and asparaginase enzymes are expected to generate the greatest revenues over the forecast period.

The most important unmet needs in the ALL market include: Improved overall survival after relapse, replacement of the toxic stem cell transplant procedure and improved outcomes for T-ALL patients.

Reasons to buy

The report will enable you to:

Develop and design your in-licensing and out-licensing strategies, using a detailed overview of current pipeline products and technologies to identify companies with the most robust pipelines.

Develop business strategies by understanding the trends shaping and driving the global Acute Lymphocytic Leukemia therapeutics market.

Drive revenues by understanding the key trends, innovative products and technologies, market segments, and companies likely to impact the global Acute Lymphocytic Leukemia market in the future.

Formulate effective sales and marketing strategies by understanding the competitive landscape and by analyzing the performance of various competitors.

Identify emerging players with potentially strong product portfolios and create effective counter-strategies to gain a competitive advantage.

Track drug sales in the global Acute Lymphocytic Leukemia therapeutics market from 2019-2029.

Organize your sales and marketing efforts by identifying the market categories and segments that present maximum opportunities for consolidations, investments and strategic partnerships.

Companies mentioned

Acrotech Biopharma

Amgen

Ariad

Autolus Therapeutics

Bristol Myers Squibb

Chipscreen Biosciences

Genentech/Roche

Gilead

Incyte

Jazz Pharmaceuticals

Johnson & Johnson

Novartis

Pfizer

Servier Pharmaceuticals

Takeda

Table of Contents

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

List of Tables

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

List of Figures

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

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