I. INTRODUCTION, METHODOLOGY & PRODUCT DEFINITIONS
Study Reliability and Reporting Limitations
Disclaimers
Data Interpretation & Reporting Level
Quantitative Techniques & Analytics
Product Definitions and Scope of Study
II. EXECUTIVE SUMMARY
1. OUTLOOK
A Prelude
Growing Incidence and Poor Prognosis – A Fatal Concoction Creating Significant Unmet Needs
Inadequacies Marr Existing Therapeutics; Pipeline Therapies Offer Hope
Current and Future Analysis
Standard Mode of Treatment for AML – An Overview
Standard Approved Mode of Therapy for AML by Age Group
List of FDA-Approved Chemotherapy Drugs for Treatment of AML
Ballooning Elderly Population: The Vital Growth Driver for AML Therapeutics
Table 1: Global Aging Population (in Thousands) by Age Group: 1975-2050 (includes corresponding Graph/Chart)
Table 2: Global Aging Population in Select Regions/Countries: Population of 60+ Individuals in ‘000s and as a Percentage of Total Population for 2015 & 2050 (includes corresponding Graph/Chart)
Table 3: Life Expectancy at Birth in Years of People in Select Countries (2015E) (includes corresponding Graph/Chart)
Table 4: Global Life Expectancy at Birth (Years) by Geographic Region: 1950-2050 (includes corresponding Graph/Chart)
2. MARKET DYNAMICS
Growing Interest in the Genetics of AML
Targeted Therapies Hog Limelight in AML Therapeutic Pipeline
Select Major AML Therapeutics in Late-Stage Clinical Development
Select AML Therapeutics in Phase I and II Clinical Development
FLT3 – The Most Advanced Natural Target
FLT3 Kinase Inhibitors in Pipeline for AML
PIM-FLT3 Combo – A Novel Approach to AML Treatment
Midostaurin – Awaits Approval as the First Targeted Therapy
Quizartinib – A Second Generation FLT3 Inhibitor in Late Stage Clinical Development
Chemotherapy Retains Developers’ Interest; Better Chemotherapies on the Horizon
Vyxeos – The New Standard of Care in AML Treatment?
Select Benefits of Vyxeos in a Gist:
Future of Vosaroxin Shrouded in Uncertainty
Tough Battle Lies Ahead for Guadecitabine
Eyes Maintenance Therapy Market
Drug Targeting Mutant IDH2 Enzyme Enters Pivotal Trials
Immunotherapies in Development too Show Promise
Annamycin Shows Promise as a Second Line Therapy for AML
Volasertib – the First in Molecular Targeting Agents for AML to Advance in Clinical Trials
ADCs’ Clinical Trials Depict Mixed Results
Research Innovations/Findings in AML Therapeutics
Anti-CD98 Antibodies Offer Novel Approach
Inhibition of Metabolic Enzyme in AML Pathway Identified as an Promising Option
Personalized Vaccine Approach Invades AML Therapeutic R&D
Ceramide-based Therapeutic Targets Drug Resistance of AML
Fructose – Potential Target for AML Therapeutics
3. ACUTE MYELOID LEUKEMIA - THE DISEASE, EPIDEMIOLOGY, ETIOLOGY, SYMPTOMS, AND DIAGNOSIS
Understanding the Bone Marrow, and the Blood Cells
Blood Cells
White Cells
Red Cells
Platelets
Cancer – The Deadly Disease
Leukemia – A Disease of the Bone Marrow
Acute Leukemia
Chronic Leukemia
History
Acute Myeloid Leukemia
Acute Myeloid Leukemia (AML) Types
The FAB Classification of AML
WHO AML Classification
AML with Certain Genetic Abnormalities
AML with Multilineage Dysplasia
AML Related to Previous Chemotherapy or Radiation
AML Not Otherwise Specified
Undifferentiated or Biphenotypic Acute Leukemias
Focus on Select Types
NPM1 & CEBPα Mutations in AML
FLT3 Mutated AML
RAS-Activated AML
Epigenetic Mutations in AML
DNMT3 Mutations
IDH-Mutated AML
Epidemiology
Etiology of AML
Chemicals
Radiation
Smoking
Pre-existing Blood Disorders
Genetic Factors
AML Symptoms
Increased Bruising or Bleeding
Repeated or Frequent Infection
Anemia
AML Diagnosis
Full Blood Count
Bone Marrow Examination
Other Tests
4. TREATMENT OVERVIEW
Chemotherapy – The First-Line Treatment for AML
Induction Therapy
Post Remission or Consolidation Therapy
Hematopoietic Stem Cell Transplantation
Treatment for Relapsed AML
Maintenance
Side-Effects of AML Treatment
Effects on Bone Marrow, Platelets, Red Cells, and White Cells
Other Common Side-Effects
Changes in Smell and Taste
Vomiting and Nausea
Changes in Bowel
Mucositis
Loss of Hair
Loss in Fertility
Early Menopause
Fatigue
Body Image
Therapies to Complement AML Medical Treatment
5. DRUG APPROVALS/CLINICAL STUDIES
Immune Pharmaceuticals to Commence REMAIN ™ Study
Precient Doses First Patient in Phase 1b/2 Clinical Trial of
Stemline Therapeutics Presents Phase 2 Trial Data of
Helsinn and MEI Pharma Announce Phase 2 Trial results of Pracinostat and azacitidine
Daiichi Sankyo Announces Safety and Efficacy Data from Phase 1 Study of
Pfizer Reveals Positive Phase 2 Study Results of glasdegib/
Teva’s Trisenox Gains EU Approval for APL
Daiichi Sankyo Begins Patient Enrollment for Phase 3 QuANTUM Trial on Quizartinib
GlycoMimetics Doses First Patient in Phase 2 of
Seattle Genetics Initiates Phase 3 Clinical Trial for Vadastuximab Talirine
ImmunoGen Begins Clinical Study of IMGN779 for Treatment of AML
Agios Pharmaceuticals Initiates Phase 1/2 Study of
in Combination with VIDAZA®
Bio-Path Announces Positive Phase II Results of BP1001
Sunesis Secures MAA Validation from EMA for Vosaroxin in AML
Agios Pharmaceuticals Initiates Phase 1b Study of
EMA Expands Indications of Celgene's VIDAZA®
Astellas Pharma Doses First Patient in Phase 3 Registration Trial of ASP2215
OXiGENE Initiates Phase 1b/2 Trial of OXi4503
Seattle Genetics Initiates Phase 1b Clinical Trial of SGN-CD33A
Agios Pharmaceuticals Announces Safety and Efficacy Data from Phase 1 Trial of
MacroGenics Doses First Patient in Phase 1 Study of MGD006
6. RECENT INDUSTRY ACTIVITY
MacroGenics Received Orphan Drug Designation for AML Drug Candidate MGD006
FDA Puts Hold on Various Phase I Vadastuximab Trials
Arog Receives Orphan Drug Designation for Crenolanib in EU
FDA Grants Priority Review to Novartis’ NDA for PKC412
Immune Pharmaceuticals Obtains FDA Assistance in Ceplene® Pivotal Trial
Jazz Pharmaceuticals Begins NDA Submission for Vyxeos™
Celgene to File NDA for
Jazz Pharmaceuticals to Acquire Celator Pharmaceuticals
Celgene and Agios Enter into Collaboration with Abbott
Celyad Enters into Exclusive Licensing Agreement with Ono
Astex Enters into Clinical Trial Collaboration with Genentech
AbbVie’s venetoclax Receives Orphan Drug Designation from EMA
Novartis Bags Breakthrough Status for Midostaurin Therapy in AML
AbbVie Obtains Breakthrough Therapy Designation for Venetoclax with HMAs in AML Treatment
FDA Clears Hybrigenics to Carry Out Phase II Trials on inecalcitol in AML Patients
Hybrigenics Gets Approval to Carry Out Phase II Trials on inecalcitol in AML Patients in France
Boehringer and Philogen Team Up to Develop AML Therapeutics
Astex Pharmaceuticals’
/guadecitabine Receives Orphan Drug Designation from FDA
Hybrigenics Obtains Orphan Drug Designation from FDA for Inecalcitol in AML Treatment
Daiichi Sankyo to Acquire Ambit Biosciences
Celgene Takes Over Rights to Blood Cancer Drugs of Agios
Karyopharm Therapeutics’ Selinexor (
) Receives Orphan Drug Designation from FDA
Otsuka Buys Rights to Dacogen® from Eisai
7. FOCUS ON SELECT PLAYERS
AbbVie Inc. (USA)
Actinium Pharmaceuticals, Inc. (USA)
Agios Pharmaceuticals, Inc. (USA)
Amgen Inc. (USA)
Astellas Pharma Inc. (Japan)
Astex Pharmaceuticals, Inc. (USA)
Celgene Corporation (USA)
CTI BioPharma Corp. (USA)
Cyclacel Pharmaceuticals, Inc. (USA)
Daiichi Sankyo Company Limited (Japan)
F. Hoffmann-La Roche AG (Switzerland)
Immune Pharmaceuticals Inc. (USA)
Janssen-Cilag Limited (UK)
Jazz Pharmaceuticals plc (Ireland)
MEI Pharma, Inc. (USA)
Merus N.V. (The Netherlands)
Novartis AG (Switzerland)
Pfizer Inc. (USA)
Seattle Genetics, Inc. (USA)
Stemline Therapeutics, Inc. (USA)
Sunesis Pharmaceuticals, Inc. (USA)
Tolero Pharmaceuticals, Inc. (USA)
8. GLOBAL MARKET PERSPECTIVE
Table 5: World Recent Past, Current and Future Analysis for Acute Myeloid Leukemia (AML) Therapeutics by Geographic Region/Country - US, Canada, Japan, Europe and Rest of World Markets Independently Analyzed with Annual Sales Figures in US$ Thousand for Years 2015 through 2022 (includes corresponding Graph/Chart)
Table 6: World Historic Review for Acute Myeloid Leukemia (AML) Therapeutics by Geographic Region/Country - US, Canada, Japan, Europe and Rest of World Markets Independently Analyzed with Annual Sales Figures in US$ Thousand for Years 2009 through 2014 (includes corresponding Graph/Chart)
Table 7: World 14-Year Perspective for Acute Myeloid Leukemia (AML) Therapeutics by Geographic Region/Country - Percentage Breakdown of Dollar Sales for US, Canada, Japan, Europe and Rest of World Markets for Years 2009, 2016 and 2022 (includes corresponding Graph/Chart)
III. MARKET
1. THE UNITED STATES
A. Market Analysis
Current & Future Analysis
Rising Elderly Population: Key Growth Driver
Table 8: Aging Population in the US (2015 & 2030): 60 Years and Above Population (in Thousands) and Percentage Share of Overall Population (includes corresponding Graph/Chart)
Table 9: North American Elderly Population by Age Group (1975-2050) (includes corresponding Graph/Chart)
A Peek into Incidence and Mortality Statistics of AML
Table 10: New Cases of Leukemia in the US by Type: 2017E (includes corresponding Graph/Chart)
Table 11: Incidence and Mortality of AML in the US by Gender: 2017E (includes corresponding Graph/Chart)
Low Survival Rates Create Huge Unmet Need for Therapeutics
Table 12: 5-Year Survival Rate of Various Leukemias in the US (2016) - Survival Rate Percentage for Acute Myeloid Leukemia (AML), Chronic Myeloid Leukemia (CML), Acute Lymphoblastic Leukemia (ALL), and Chronic Lymphoblastic Leukemia (CLL) (includes corresponding Graph/Chart)
Table 13: 5-Year Survival Rates (%) of Various Pediatric Cancers in the US (1975-79 & 2003-2009) - Survival Rates of Acute Lymphocytic Leukemia (ALL), Acute Myeloid Leukemia (AML), and Lymphomas and Reticuloendothelial Neoplasms (includes corresponding Graph/Chart)
Robust R&D Activity Hint at Better Prospects
Product Approvals/Clinical Studies
Strategic Corporate Developments
Key Players
B. Market Analytics
Table 14: US Recent Past, Current and Future Analysis for Acute Myeloid Leukemia (AML) Therapeutics Market - Analyzed with Annual Sales Figures in US$ Thousand for Years 2015 through 2022 (includes corresponding Graph/Chart)
Table 15: US Historic Review for Acute Myeloid Leukemia (AML) Therapeutics Market - Analyzed with Annual Sales Figures in US$ Thousand for Years 2009 through 2014 (includes corresponding Graph/Chart)
2. CANADA
A. Market Analysis
Current & Future Analysis
Aging Population and Rising Incidence Drives Growth
Table 16: Aging Population in Canada (2015 & 2030): 60 Years and Above Population (in Thousands) and Percentage Share of Overall Population
B. Market Analytics
Table 17: Canadian Recent Past, Current and Future Analysis for Acute Myeloid Leukemia (AML) Therapeutics Market - Analyzed with Annual Sales Figures in US$ Thousand for Years 2015 through 2022 (includes corresponding Graph/Chart)
Table 18: Canadian Historic Review for Acute Myeloid Leukemia (AML) Therapeutics Market - Analyzed with Annual Sales Figures in US$ Thousand for Years 2009 through 2014 (includes corresponding Graph/Chart)
3. JAPAN
A. Market Analysis
Current & Future Analysis
Aging Population Drives Market Growth
Table 19: Aging Population in Japan (2015 & 2030): 60 Years and Above Population (in Thousands) and Percentage Share of Overall Population (includes corresponding Graph/Chart)
Product Approvals/Clinical Trials
Strategic Corporate Developments
Key Players
B. Market Analytics
Table 20: Japanese Recent Past, Current and Future Analysis for Acute Myeloid Leukemia (AML) Therapeutics Market - Analyzed with Annual Sales Figures in US$ Thousand for Years 2015 through 2022 (includes corresponding Graph/Chart)
Table 21: Japanese Historic Review for Acute Myeloid Leukemia (AML) Therapeutics Market - Analyzed with Annual Sales Figures in US$ Thousand for Years 2009 through 2014 (includes corresponding Graph/Chart)
4. EUROPE
A. Market Analysis
Current & Future Analysis
Changing Demographics to Propel Market Growth
Table 22: European Population By Age Group (2013, 2020 & 2040): Percentage Share Breakdown of Age Groups 0-19, 20-39, 40-59, 60-79, and 80+ (includes corresponding Graph/Chart)
Product Approvals/Clinical Trials
Strategic Corporate Development
B. Market Analytics
Table 23: European Recent Past, Current and Future Analysis for Acute Myeloid Leukemia (AML) Therapeutics by Geographic Region/Country - France, Germany, Italy, UK and Rest of European Markets Independently Analyzed with Annual Sales Figures in US$ Thousand for Years 2015 through 2022 (includes corresponding Graph/Chart)
Table 24: European Historic Review for Acute Myeloid Leukemia (AML) Therapeutics by Geographic Region/Country - France, Germany, Italy, UK and Rest of European Markets Independently Analyzed with Annual Sales Figures in US$ Thousand for Years 2009 through 2014 (includes corresponding Graph/Chart)
Table 25: European 14-Year Perspective for Acute Myeloid Leukemia (AML) Therapeutics by Geographic Region/Country - Percentage Breakdown of Dollar Sales for France, Germany, Italy, UK and Rest of European Markets for Years 2009, 2016 and 2022 (includes corresponding Graph/Chart)
4a. FRANCE
A. Market Analysis
Current & Future Analysis
Strategic Corporate Development
B. Market Analytics
Table 26: French Recent Past, Current and Future Analysis for Acute Myeloid Leukemia (AML) Therapeutics Market - Analyzed with Annual Sales Figures in US$ Thousand for Years 2015 through 2022 (includes corresponding Graph/Chart)
Table 27: French Historic Review for Acute Myeloid Leukemia (AML) Therapeutics Market - Analyzed with Annual Sales Figures in US$ Thousand for Years 2009 through 2014 (includes corresponding Graph/Chart)
4b. GERMANY
A. Market Analysis
Current & Future Analysis
Strategic Corporate Development
B. Market Analytics
Table 28: German Recent Past, Current and Future Analysis for Acute Myeloid Leukemia (AML) Therapeutics Market - Analyzed with Annual Sales Figures in US$ Thousand for Years 2015 through 2022 (includes corresponding Graph/Chart)
Table 29: German Historic Review for Acute Myeloid Leukemia (AML) Therapeutics Market - Analyzed with Annual Sales Figures in US$ Thousand for Years 2009 through 2014 (includes corresponding Graph/Chart)
4c. ITALY
Market Analysis
Table 30: Italian Recent Past, Current and Future Analysis for Acute Myeloid Leukemia (AML) Therapeutics Market - Analyzed with Annual Sales Figures in US$ Thousand for Years 2015 through 2022 (includes corresponding Graph/Chart)
Table 31: Italian Historic Review for Acute Myeloid Leukemia (AML) Therapeutics Market - Analyzed with Annual Sales Figures in US$ Thousand for Years 2009 through 2014 (includes corresponding Graph/Chart)
4d. THE UNITED KINGDOM
A. Market Analysis
Current & Future Analysis
Table 32: Aging Population in the United Kingdom (2015 & 2030): 60 Years and Above Population (in Thousands) and Percentage of Population (includes corresponding Graph/Chart)
Key Player
B. Market Analytics
Table 33: UK Recent Past, Current and Future Analysis for Acute Myeloid Leukemia (AML) Therapeutics Market - Analyzed with Annual Sales Figures in US$ Thousand for Years 2015 through 2022 (includes corresponding Graph/Chart)
Table 34: UK Historic Review for Acute Myeloid Leukemia (AML) Therapeutics Market - Analyzed with Annual Sales Figures in US$ Thousand for Years 2009 through 2014 (includes corresponding Graph/Chart)
4e. REST OF EUROPE
A. Market Analysis
Current & Future Analysis
Clinical Trial Development
Strategic Corporate Development
Key Players
B. Market Analytics
Table 35: Rest of Europe Recent Past, Current and Future Analysis for Acute Myeloid Leukemia (AML) Therapeutics Market - Analyzed with Annual Sales Figures in US$ Thousand for Years 2015 through 2022 (includes corresponding Graph/Chart)
Table 36: Rest of Europe Historic Review for Acute Myeloid Leukemia (AML) Therapeutics Market - Analyzed with Annual Sales Figures in US$ Thousand for Years 2009 through 2014 (includes corresponding Graph/Chart)
5. REST OF WORLD
A. Market Analysis
Current & Future Analysis
Focus on Select Regional Markets
China
Greying Population Offers Opportunity for Growth in China
Table 37: Aging Population in China (2015 & 2030): 60 Years and Above Population (in Thousands) and Percentage of Population (includes corresponding Graph/Chart)
India
A Note on Incidence of Leukemias in India
Low Treatment Rates – A Hurdle to Market Growth
Increasing Share of Elderly in Population Uncovers Opportunities
Table 38: Aging Population in India (2015 & 2030): 60 Years and Above Population (in Thousands) and Percentage of Population (includes corresponding Graph/Chart)
Medical Tourism – A Shot in the Arm for AML Therapeutics Market
Clinical Trial Development
B. Market Analytics
Table 39: Rest of World Recent Past, Current and Future Analysis for Acute Myeloid Leukemia (AML) Therapeutics Market - Analyzed with Annual Sales Figures in US$ Thousand for Years 2015 through 2022 (includes corresponding Graph/Chart)
Table 40: Rest of World Historic Review for Acute Myeloid Leukemia (AML) Therapeutics Market - Analyzed with Annual Sales Figures in US$ Thousand for Years 2009 through 2014 (includes corresponding Graph/Chart)
IV. COMPETITIVE LANDSCAPE
Total Companies Profiled: 69 (including Divisions/Subsidiaries - 73)
The United States (40)
Canada (3)
Japan (3)
Europe (24)
- France (3)
- Germany (2)
- The United Kingdom (5)
- Spain (1)
- Rest of Europe (13)
Asia-Pacific (Excluding Japan) (1)
Middle East (2)