Table of Contents
ONE: EXECUTIVE SUMMARY
Overview and Scope of Study
Methodology
Glossary of Terms
Size and Growth of the Market
TWO: STEM CELLS: AN INTRODUCTION
Overview
Types of Stem Cells
Adult Stem Cells
Human Embryonic Stem Cells
Stem Cell Harvesting
Harvesting Adult Stem Cells
Peripheral Blood Apheresis
Bone Marrow Stem Cells
Cord Blood Stem Cells
Harvesting Embryonic Stem Cells
Transplantation of Stem Cells
Stem Cell Transplant Approaches
Autologous Transplantation
Allogeneic Transplantation
Graft-versus-host Disease
Drug Research Applications
THREE: REGULATORY LANDSCAPE AND RESEARCH POLICY
Overview of Stem Cell Regulation
The Ethical Side of Stem Cell Research
U.S. Regulation
Fast Track, Breakthrough Therapy, Accelerated Approval and Priority Review
Fast Track
Breakthrough Therapy
Accelerated Approval
Priority Review
United States: State and Federal Initiatives on Embryonic Stem Cells
Research Funding
State ‘Right to Try’ Laws
For-Profit Stem Cell Clinics
Regulatory Actions
Canada: Stem Cell Research Guidelines
European Union: Member States’ Regulatory Position on Human Embryonic Stem
Cell Research
United Kingdom: Initiatives on Embryonic Stem Cells
Portugal: Changes in Embryonic Stem Cell Research
Asia: A Vibrant Market for Stem Cell Research
China: Stem Cell Research Policies
Singapore: An Emerging Market
South Korea: An Active Stem Cell Market
Stem Cell Developers by Country of Operation
FOUR: DEVELOPMENT PROFILES AND ANALYSIS
Overview
The Embryonic Research and Development Approach
Stem Cell Technology Patents
Development Programs
Aastrom Biosciences, Inc.
Advanced Cell Technology
AlloCure, Inc.
Anterogen Co., Ltd.
Antria, Inc.
apceth GmbH & Co. KG
Arteriocyte, Inc.
Athersys, Inc.
Baxter International
BioCardia, Inc.
Bioheart, Inc.
BrainStorm Cell Therapeutics, Inc.
Capricor Therapeutics, Inc.
Celgene Cellular Therapeutics
Cytomedix, Inc.
Cytori Therapeutics, Inc.
Gamida Cell Ltd.
GlaxoSmithKline plc
Histogenics Corporation
International Stem Cell Corporation
ISTO Technologies, Inc.
Medipost Co., Ltd.
Mesoblast Ltd.
NeoStem, Inc.
Neuralstem, Inc.
Pharmicell Co., Ltd.
Pluristem Therapeutics, Inc.
ReNeuron Group plc
SanBio, Inc.
StemCells, Inc.
Stemedica Cell Technologies, Inc.
Stempeutics Research Pvt. Ltd.
Targazyme, Inc.
TiGenix NV
ViaCyte, Inc.
Developer Market Performance: Projected 2025
FIVE: THERAPEUTIC APPLICATIONS: CURRENT AND POTENTIAL STEM CELL SEGMENTS
Overview
Disease Stats
Diseases of the Blood and Blood-Forming Organs
Aplastic Anemia
Sickle-Cell Disease
Diseases of the Circulatory System
Cardiovascular Disease
Atherosclerosis
Congestive Heart Failure
Critical Limb Ischemia
Myocardial Infarction
Diseases of the Endocrine and Metabolic System and Immunity Disorders
Diabetes
Graft-versus-host Disease
Primary Immune Deficiency
Systemic Lupus Erythematosus
Diseases of the Eye
Macular Degeneration
Diabetic Retinopathy
Blindness
Diseases of the Gastrointestinal System
Intestinal Diseases
Crohn’s Disorders
Liver Failure
Liver Transplantation
Diseases of the Musculoskeletal System and Connective Tissue Disorders
Arthritis
Osteoarthritis
Rheumatoid Arthritis
Orthopedic Surgery
Osteoporosis
Neoplasms
Bladder Cancer
Brain Cancer
Glioblastoma
Neuroblastoma
Breast Cancer
Cervical Cancer
Colorectal Cancer
Esophageal Cancer
Kidney
Leukemia
Liver Cancer
Lung Cancer
Lymphoma
Non-Hodgkin’s Lymphoma
Hodgkin’s Lymphoma
Melanoma
Multiple Myeloma
Ovarian Cancer
Pancreatic Cancer
Prostate Cancer
Stomach Cancer
Diseases of the Nervous System
Alzheimer’s Disease
Amyotrophic Lateral Sclerosis
Multiple Sclerosis
Parkinson’s Disease
Diseases of the Respiratory System
Asthma
COPD
Diseases of the Skin and Subcutaneous Tissues
Chronic Skin Wounds
Burn Skin Wounds
SIX: STEM CELL MARKET SUMMARY AND OUTLOOK
Overview
Stem Cell Forecast Analysis
Stem Cell Market Analysis by Disease Classification
Disease Summary
Stem Cell Outlook in Circulatory / Cardiovascular Diseases
Stem Cell Outlook in Atherosclerosis
Stem Cell Outlook in Heart Failure
Stem Cell Outlook in Critical Limb Ischemia
Stem Cell Outlook in Myocardial Infarction
Stem Cell Outlook in Metabolic / Endocrine Diseases and Immunology Disorders . 178
Stem Cell Market Outlook: Diabetes
Stem Cell Outlook in Graft-versus-host Disease
Stem Cell Outlook in Systemic Lupus Erythematosus
Stem Cell Outlook in Digestive Disorders
Stem Cell Outlook in Crohn’s Disease
Stem Cell Outlook in Liver Failure
Stem Cell Outlook in Musculoskeletal Diseases
Stem Cell Outlook in Osteoarthritis
Stem Cell Outlook in Osteoporosis
Stem Cell Outlook in Orthopedic Trauma
Stem Cell Outlook in Rheumatoid Arthritis
Stem Cell Outlook in Cancer
Stem Cell Outlook by Cancer Type
Bladder Cancer Focus
Esophageal Cancer Focus
Leukemia Focus
Lymphoma Focus
Melanoma Focus
Multiple Myeloma Focus
Stem Cell Outlook in Nervous System Disorders
Stem Cell Outlook in Alzheimer’s Disease
Stem Cell Outlook in Amyotrophic Lateral Sclerosis
Stem Cell Outlook in Multiple Sclerosis
Stem Cell Outlook in Parkinson’s Disease
Stem Cell Outlook in Skin Disorders
Stem Cell Outlook in Wound Healing
Stem Cell Outlook in Wrinkles and Aging Skin Conditions
Stem Cells in Other Areas of Focus
Asthma Outlook
Chronic Obstructive Pulmonary Disease Outlook
Incontinence Outlook
Macular Degeneration Outlook
Male Infertility Outlook
Tooth Regeneration Outlook
Conclusion
APPENDIX: INDUSTRY PARTICIPANTS
LIST OF EXHIBITS
ONE: EXECUTIVE SUMMARY
Figure 1-1
Stem Cell Therapeutics Market Value, 2010 to 2025
TWO: STEM CELLS: AN INTRODUCTION
Table 2-1
Compare and Contrast: Adult vs. Embryonic Stem Cells
THREE: REGULATORY LANDSCAPE AND RESEARCH POLICY
Table 3-1
NIH Funding Trends for Stem Cell Research, Actual FY 2002 – 2013 and Estimated
FY 2014 – 2015
Table 3-2
European Union Member State Positions on Human Embryonic Stem Cell Research
Figure 3-1
Distribution of Stem Cell Developers by Registered Country
FOUR: DEVELOPMENT PROFILES AND ANALYSIS
Figure 4-1
Distribution of Stem Cell Development Projects by Broad Indication
Figure 4-2
Number of Stem Cell Development Projects by Developer
Table 4-1
Phase III Developments in Stem Cell Therapies, Selected Projects
Table 4-2
Phase II Developments in Stem Cell Therapies, Selected Projects
Table 4-3
Phase I Developments in Stem Cell Therapies, Selected Projects
Table 4-4
Preclinical Developments in Stem Cell Therapies, Selected Projects
Figure 4-3
Aastrom Biosciences Stem Cell Pipeline Overview
Figure 4-4
Advanced Cell Technology Stem Cell Pipeline Overview
Figure 4-5
AlloCure Stem Cell Pipeline Overview
Figure 4-6
Anterogen Stem Cell Pipeline Overview
Figure 4-7
Antria Stem Cell Pipeline Overview
Figure 4-8
apceth Stem Cell Pipeline Overview
Figure 4-9
Arteriocyte Stem Cell Pipeline Overview
Figure 4-10
Athersys Stem Cell Pipeline Overview
Figure 4-11
Baxter International Stem Cell Pipeline Overview
Figure 4-12
BioCardia Stem Cell Pipeline Overview
Figure 4-13
Bioheart Stem Cell Pipeline Overview
Figure 4-14
BrainStorm Cell Therapeutics Stem Cell Pipeline Overview
Figure 4-15
Capricor Therapeutics Stem Cell Pipeline Overview
Figure 4-16
Celgene Cellular Therapeutics Stem Cell Pipeline Overview
Figure 4-17
Cytomedix Stem Cell Pipeline Overview
Figure 4-18
Cytori Therapeutics Stem Cell Pipeline Overview
Figure 4-19
Gamida Cell Stem Cell Pipeline Overview
Figure 4-20
GlaxoSmithKline Stem Cell Pipeline Overview
Figure 4-21
Histogenics Stem Cell Pipeline Overview
Figure 4-22
International Stem Cell Corporation Stem Cell Pipeline Overview
Figure 4-23
ISTO Technologies Stem Cell Pipeline Overview
Figure 4-24
Medipost Stem Cell Pipeline Overview
Figure 4-25
Mesoblast Stem Cell Pipeline Overview
Figure 4-26
NeoStem Stem Cell Pipeline Overview
Figure 4-27
Neuralstem Stem Cell Pipeline Overview
Figure 4-28
Pharmicell Stem Cell Pipeline Overview
Figure 4-29
Pluristem Therapeutics Stem Cell Pipeline Overview
Figure 4-30
ReNeuron Stem Cell Pipeline Overview
Figure 4-31
SanBio Stem Cell Pipeline Overview
Figure 4-32
StemCells Stem Cell Pipeline Overview
Figure 4-33
Stemedica Cell Technologies Stem Cell Pipeline Overview
Figure 4-34
Stempeutics Research Stem Cell Pipeline Overview
Figure 4-35
Targazyme Stem Cell Pipeline Overview
Figure 4-36
TiGenix Stem Cell Pipeline Overview
Figure 4-37
ViaCyte Stem Cell Pipeline Overview
Figure 4-38
Stem Cell Therapeutics: Sales by Select Developer, Projected 2025
FIVE: THERAPEUTIC APPLICATIONS: CURRENT AND POTENTIAL STEM CELL SEGMENTS
Table 5-1
Global Prevalence of Selected Medical Conditions with Potential Stem Cell Therapy Benefits
Table 5-2
Leukemia Overview by Type
Figure 5-1
Distribution of Leukemia Cases by Type
Table 5-3
Types of Primary Lung Cancer
Table 5-4
Classification of Non-Hodgkin’s Lymphomas
Table 5-5
Malignant Conditions of the Skin
SIX: STEM CELL MARKET SUMMARY AND OUTLOOK
Figure 6-1
Stem Cell Therapeutics Market Value, 2010 to 2025
Figure 6-2
Stem Cell Therapeutics Market by Disease Classification, 2010 – 2025 (Skin & Subcutaneous Tissue, Nervous System, Neoplasms, Musculoskeletal System and Connective Tissue, Digestive System, Endocrine / Metabolic / Immunology, Circulatory System, Other Systems)
Figure 6-3
Stem Cell Therapeutics Market Distribution by Disease Classification, 2025
Table 6-1
Population Affected by Select Diseases and Conditions by Type
Figure 6-4
Global Prevalence of Selected Medical Conditions, Over 100 Million Affected, with
Potential Stem Cell Therapy Benefits
Figure 6-5
Circulatory / Cardiovascular Stem Cell Therapeutics Market Outlook, 2010 – 2025
Figure 6-6
Endocrine / Metabolic and Immunology Stem Cell Therapeutics Market Outlook,
2010 – 2025
Table 6-2
World Diabetes Prevalence by Country
Figure 6-7
World Diabetes Prevalence by Country
Figure 6-8
Digestive Disorder Stem Cell Therapeutics Market Outlook, 2010 – 2025
Figure 6-9
Musculoskeletal Disease Stem Cell Therapeutics Market Outlook, 2010 – 2025
Figure 6-10
Estimated World Prevalence of Rheumatoid Arthritis by Select Region
Figure 6-11
Cancer Stem Cell Therapeutics Market Outlook, 2010 – 2025
Table 6-3
World Cancer Incidence by Selected Types of Cancer, 2012 and 2025, All Races,
All Ages, Both Genders
Figure 6-12
Estimated and Projected World Cancer Incidence by Selected Types of Cancer, 2012
and 2025
Figure 6-13
Nervous System Disorder Stem Cell Therapeutics Market Outlook, 2010 – 2025
Figure 6-14
Estimated World Prevalence and Incidence of Alzheimer’s Diseases by Region
Table 6-4
Estimated World Prevalence of Multiple Sclerosis by Selected Countries
Figure 6-15
Estimated World Prevalence of Multiple Sclerosis by Selected Countries
Figure 6-16
Skin Disorder Stem Cell Therapeutics Market Outlook, 2010 – 2025