Acute Myeloid Leukemia (AML) – Opportunity Analysis and Forecasts to 2029
All the vital news, analysis, and commentary curated by our industry experts.
Acute myeloid (or myelogenous or myelocytic) leukemia (AML) is a malignancy of the hematopoietic system caused by abnormal proliferation or differentiation of myeloid progenitors in the bone marrow and peripheral blood. AML is relatively rare and has a poor prognosis, particularly in elderly patients. Until recently, chemotherapy and hypomethylating agents were the only treatment options, but since 2017 this has changed with the introduction of premium-priced novel therapies.
The global AML market is expected to grow from $1.4B in 2019 to $5.1B in 2029 at a compound annual growth rate (CAGR) of 13.6%. This dramatic growth is driven by the launch of 16 new pipeline agents in the 7MM and 12 in China, by the introduction of currently US-exclusive agents in the 5EU and Asia, and by label expansions in the US. As the 5EU and Asia move from generic chemotherapies to combinational regimens with branded agents, the value of the market will see significant gains.
KEY QUESTIONS ANSWERED
Sixteen late-stage pipeline agents are going to enter the Acute Myeloid 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 Myeloid Leukemia, which pipeline agents are positioned to counter these unmet needs? What are the opportunities for R&D?
How has the introduction of Venclexta shaped the elderly patient first-line therapy segment? How will the competition fare?
What is the future impact of immunotherapies in AML?
Overview of Acute Myeloid Leukemia including epidemiology, pathophysiology, symptoms, diagnosis, and treatment guidelines.
Topline Acute Myeloid 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 Myeloid 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 III).
Analysis of the current and future market competition in the global Acute Myeloid Leukemia therapeutics market. Insightful review of the key industry drivers and challenges. Each trend is independently researched to provide qualitative analysis of its implications.
The main drivers of growth include the anticipated approval and launch of 16 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 the high price of premium priced therapeutics entering the market and the limited adoption of new agents by hematologists in smaller hospitals.
Among the late-stage pipeline products and marketed agents, targeted therapies, IDH1/2 inhibitors and FLT3 inhibitors are expected to generate the greatest revenues over the forecast period.
The most important unmet needs in the AML market include: Translating remission to long-term survival, treatment options upon relapse, improved options for older patients, improving outcomes for secondary AML and improving outcomes after transplant.
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 Myeloid Leukemia therapeutics market.
Drive revenues by understanding the key trends, innovative products and technologies, market segments, and companies likely to impact the global Acute Myeloid 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 Myeloid 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.
Bristol Myers Squibb
SELLAS Life Sciences
Table of Contents
1 Table of Contents
1.1 List of Tables
1.2 List of Figures
2 Acute Myeloid Leukemia: Executive Summary
2.1 The Acute Myeloid Leukemia Market Size Will Grow at a
13.6% Rate During 2019–2029
2.2 Recent Approvals and Novel Agents Drive Competition in the First-Line Induction Setting but the Relapsed/Refractory Market Remains Underserved
2.2.1 Key Drug Developers in Acute Myeloid Leukemia
2.3 Poor Long-Term Survival Remains an Unmet Need and Provides Opportunity for New Market Entrants
2.4 Increased Adoption of Targeted Therapies and Introduction of Immunotherapies Poised to Change the Treatment Paradigm
2.5 What Do Physicians Think?
3.2 Related Reports
3.3 Upcoming Related Reports
4 Disease Overview
4.1 Etiology and Pathophysiology
4.2 Classification or Staging Systems
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 AML (2019–2029)
5.5.1 Diagnosed Incident Cases of AML
5.5.2 Age-Specific Diagnosed Incident Cases of AML
5.5.3 Sex-Specific Diagnosed Incident Cases of AML
5.5.4 Diagnosed Incident Cases of AML by Risk Group
5.5.5 Diagnosed Incident Cases of Secondary AML
5.5.6 Diagnosed Incident Cases of APL
5.5.7 Five-Year Diagnosed Prevalent Cases of AML
5.6.1 Epidemiological Forecast Insight
5.6.2 Coronavirus Disease 2019 (COVID-19) Impact
5.6.3 Limitations of Analysis
5.6.4 Strengths of Analysis
6 Current Treatment Options
7 Unmet Needs and Opportunity Assessment
7.2 Outcomes in Secondary AML
7.3 Translating Complete Response to Durable, Five-Year Survival
7.4 Treatments in the Second Line and Beyond
7.5 Improved Options for Older Patients
7.6 Improved Outcomes after Transplant
8 R&D Strategies
8.1.1 Improved Cytotoxic Agents
8.1.2 Exploiting AML Vulnerabilities
8.1.3 Next-Generation Targeted Therapies
8.1.4 Revisiting Immunotherapies
8.2 Clinical Trials Design
8.2.1 Important Trials
8.2.2 Primary and Secondary Endpoints
8.2.3 Comparison Arm
8.2.4 Choice of Patients
8.2.5 Future Trends
9 Pipeline Assessment
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
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
11.4 Primary Research – KOLs Interviewed for This Report
11.5 Primary Research – Prescriber Survey
11.6 About the Authors
11.6.2 Therapy Area Director
11.6.4 Managing Epidemiologist
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
Table 1: Acute Myeloid Leukemia: Key Metrics in the 8MM
Table 2: Clinically Relevant Segmentation of AML Patients
Table 3: Risk Factors for AML
Table 4: Treatment Guidelines for Acute Myeloid Leukemia
Table 5: Leading Treatments for Acute Myeloid Leukemia, 2020
Table 6: Comparison of Therapeutic Classes in Development for Acute Myeloid Leukemia, 2019–2029
Table 7: Innovative Early-Stage Approaches for Acute Myeloid Leukemia, 2020
Table 8: Drugs in Development (US/Global) for Acute Myeloid Leukemia, 2020
Table 9: Clinical Benchmarking of Key Pipeline Products (Intensive Induction Regimens)
Table 10: Clinical Benchmarking of Key Pipeline Products (Lower-intensity regimens)
Table 11: Clinical Benchmarking of Key Pipeline Products (Relapsed/Refractory Regimens)
Table 12: Commercial Benchmarking of Key Pipeline Products (Intensive Induction Regimens)
Table 13: Commercial Benchmarking of Key Pipeline Products (Lower-intensity regimens)
Table 14: Commercial Benchmark of Key Pipeline Products (Relapsed/Refractory Regimens)
Table 15: Key Events Impacting Sales for Acute Myeloid Leukemia in the US, 2019–2029
Table 16: Acute Myeloid Leukemia Market – Global Drivers and Barriers, 2019–2029
Table 17: Key Historical and Projected Launch Dates for Acute Myeloid Leukemia
Table 18: Key Historical and Projected Patent Expiry Dates for Acute Myeloid Leukemia
Table 19: US Annual Cost of Therapy for the Most Common Chemotherapies in Acute Myeloid Leukemia
Table 20: High-Prescribing Physicians (non-KOLs) Surveyed, By Country
Figure 1: Global Sales Forecast by Country for Acute Myeloid Leukemia in 2019 and 2029
Figure 2: Competitive Assessment of Key Pipeline Intensive Induction Regimens Benchmarked Against the SOC, 7+3
Figure 3: Competitive Assessment of Key Pipeline Low-Intensity Regimens Benchmarked Against the SOC, Venclexta + Low-Intensity Regimen
Figure 4: Competitive Assessment of Key Pipeline Relapse/Refractory Regimens Benchmarked Against the SOC, FLAG-IDA
Figure 5: Comparison of Normal and Leukemia Blood Cell Differentiation
Figure 6: 8MM, Diagnosed Incidence of AML, Men and Women, Ages 18 Years and Older, 2009–2019
Figure 7: Sources Used to Forecast the Diagnosed Incident Cases of AML
Figure 8: Sources Used to Forecast the Diagnosed Incident Cases of AML by Risk Group
Figure 9: Sources Used to Forecast the Diagnosed Incident Cases of Secondary AML
Figure 10: Sources Used to Forecast the Diagnosed Incident Cases of APL
Figure 11: Sources Used to Forecast the Five-Year Diagnosed Prevalent Cases of AML
Figure 12: 8MM, Diagnosed Incident Cases of AML, Men and Women, Ages ≥18 Years, 2019
Figure 13: 8MM, Diagnosed Incident Cases of AML by Age Group, Men and Women, 2019
Figure 14: 8MM, Diagnosed Incident Cases of AML by Sex, Ages ≥18 Years, 2019
Figure 15: 8MM, Diagnosed Incident Cases of AML by Risk Group, Men and Women, Ages ≥18 Years, 2019
Figure 16: 8MM, Diagnosed Incident Cases of Secondary AML, Men and Women, Ages ≥18 Years, 2019
Figure 17: Diagnosed Incident Cases of APL, 8MM, Men and Women, Ages ≥18 Years, 2019 and 2029
Figure 18: 8MM, Five-Year Diagnosed Prevalent Cases of AML, Men and Women, Ages ≥18 Years, 2019
Figure 19: Current Treatment Algorithm of Acute Myeloid Leukemia
Figure 20: Unmet Needs and Opportunities in Acute Myeloid Leukemia
Figure 21: Overview of the Development Pipeline in Acute Myeloid Leukemia
Figure 22: Key Phase II and III Trials for Promising Injectable Pipeline Agents
Figure 23: Key Phase II and III Trials for Promising Oral Pipeline Agents
Figure 24: Competitive Assessment of Key Pipeline Intensive Induction Regimens Benchmarked Against the SOC, 7+3
Figure 25: Competitive Assessment of Key Pipeline Low-Intensity Regimens Benchmarked Against the SOC, Venclexta + Low-Intensity Regimen
Figure 26: Competitive Assessment of Key Pipeline Relapsed/Refractory Regimens Benchmarked Against the SOC, FLAG-IDA
Figure 27: Global (8MM) Sales Forecast by Country for Acute Myeloid Leukemia in 2019 and 2029
Figure 28: Global Sales Forecast by Class for Acute Myeloid Leukemia in 2019 and 2029
Figure 29: Sales Forecast by Class for Acute Myeloid Leukemia in the US in 2019 and 2029
Figure 30: Sales Forecast by Class for Acute Myeloid Leukemia in the 5EU in 2019 and 2029
Figure 31: Sales Forecast by Class for Acute Myeloid Leukemia in Japan in 2019 and 2029
Figure 32: Sales Forecast by Class for Acute Myeloid Leukemia in China in 2019 and 2029
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