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  4. > U.S. Markets for Biologic and Tissue Engineered Devices – Cardiovascular and Neurological Products

Tissue engineering, or regenerative medicine, represents a promising therapeutic possibility for the treatment of aggressive and deadly diseases. Cellular therapies for cardiovascular disease (CVD) and neurological disease represent potential billion dollar markets that could offer a viable therapeutic option for a sizable patient population that has exhausted other therapeutic alternatives. Over 35 novel cellular therapies for cardiovascular and neurological disease are currently in development internationally, and in the United States (U.S.).

Content included in this report includes:

emerging cellular therapies for cardiovascular and neurological diseases;
companies and biotech firms developing novel cellular therapies;
a prospective regulatory approval forecast for cellular therapy products currently in development for cardiovascular and neurological diseases; and,
a speculative market analysis predicting the potential overall market values for cardiovascular and neurological disease stem cell therapies.
The scope of the analysis of this report covers companies developing novel cellular therapeutics for the treatment of debilitating and deadly diseases that currently lack adequate therapeutic intervention. Cardiovascular disease-related conditions with cellular therapies in development are discussed in Chapter 2 of this report, which covers acute myocardial infarction, critical limb ischemia, heart failure, and bioengineered vascular grafts. Neurological conditions/diseases discussed in Chapter 3 of this report include Alzheimer’s disease, ischemic stroke, Parkinson’s disease, and spinal cord injury.

Table Of Contents

U.S. Markets for Biologic and Tissue Engineered Devices - Cardiovascular and Neurological Products
TABLE OF CONTENTS

EXECUTIVE SUMMARY
i Methodology

1 TISSUE ENGINEERING AND CELLULAR THERAPY TOOLS AND TECHNIQUES
11 Biomaterials
111 Biologically Derived Biomaterials
1111 Collagen
1112 Xenogenic Tissue
112 Genetically Engineered Biomaterials
1121 Deoxyribonucleic Acid Transfection Vectors
1122 Genetically Manipulated Cells
1123 Three-Dimensional Polymer Technology
1124 Transgenics
1125 Fibroblasts
1126 Immortalized Neural Stem Cells
1127 Gene Activated Matrices
113 Hybrid Biomaterials
114 Synthetic Biomaterials
115 Scaffolds
116 Vascular Grafts
12 Cell Culture Technology
121 Bioreactors
1211 Flatbed Perfusion Systems
1212 Hollow Fiber Bioreactor Systems
1213 Cell Suspension Systems
1214 Disposable Bioreactors
13 Stem Cell Technology
131 Cell Extraction and Expansion
14 Immunoisolation Technology
141 Chimeric Immunity
142 Cell Encapsulation Technology

2 EMERGING APPLICATIONS OF TISSUE ENGINEERING AND CELL TRANSPLANTATION IN CARDIOVASCULAR DISEASE MANAGEMENT
21 Cellular Therapy and Tissue Engineering
211 Skeletal Myoblasts
212 Bone Marrow-Derived Stem Cells
213 Adipose Tissue-Derived Stem Cells
214 Cardiac Stem Cells
215 Human Embryonic Stem Cells
216 Induced Pluripotent Stem Cells
22 Cellular Therapy Administration
23 Clinical Experience with Stem Cell-Based Myocardial Tissue Repair and Regeneration
24 Cellular Therapies for Myocardial Repair and Regeneration in Development
241 Athersys
242 Baxter
243 Bioheart, Inc
244 Capricor Therapeutics
245 Cytori Therapeutics
246 Mesoblast Ltd
247 NeoStem
248 Osiris Therapeutics
249 Terumo Corporation
2410 Vericel
2411 Conceivable Regulatory Timetable
25 Emerging Cellular Therapies for Limb Salvage in Critical Limb Ischemia Patients
251 Therapeutic Angiogenesis
2511 Growth Factor/Gene-Based Angiogenic Therapy
2512 Stem Cell-Based Angiogenic Therapy
2513 Therapeutic Angiogenesis Products in Development
25131 Biomet Biologics
25132 Harvest Technologies
25133 Pluristem Therapeutics
25134 Taxus Cardium Pharmaceuticals Group
2514 Conceivable Regulatory Timetable
26 Bioengineered Vascular Conduits
261 Products in Development
262 Conceivable Regulatory Timetable
27 Current and Emerging US Market for Cardiovascular Disease-Related Tissue Engineering and Cellular Therapy Products

Exhibit 2-1: Comparative Advantages and Disadvantages of Selected Stem Cell Grafts for Myocardial Repair and Regeneration
Exhibit 2-2: Selected Myocardial Cellular Repair and Regeneration Therapies in Development
Exhibit 2-3: Estimated Growth of Potential Myocardial Cellular Repair and Regeneration Caseloads, US, 2017-2020
Exhibit 2-4: Estimated Growth of Potential Therapeutic Angiogenesis Cellular Therapy Caseloads, US, 2017-2022
Exhibit 2-5: Estimated Growth of Potential Bioengineered Vascular Graft Caseloads, US, 2017-2022
Exhibit 2-6: Tissue Engineered Cardiac and Vascular Products, Expected Product Launch, by Indication
Exhibit 2-7: Tissue Engineered Cardiac and Vascular Products, Estimated Market Forecast, 2017 and 2022


3 EMERGING APPLICATIONS OF TISSUE ENGINEERING AND CELL TRANSPLANTATION IN NEUROLOGICAL DISEASE MANAGEMENT
31 Types of Cells Used for Cellular Therapies in Development
311 Bone Marrow-Derived Stem Cells
312 Adipose Tissue-Derived Stem Cells
313 Embryonic Stem Cells
314 Induced Pluripotent Stem Cells
315 Mesenchymal Stem Cells
316 Neural Stem Cells
32 Emerging Stem Cell-Based Therapies for Alzheimer's Disease
321 Cellular Therapies in Development for Alzheimer's Disease
3211 Chinese Academy of Military Medical Sciences
3212 Medipost
3213 Neuralstem
3214 StemCells, Inc
322 Conceivable Regulatory Timetable
33 Emerging Stem Cell-Based Therapies for Parkinson's Disease
331 Cellular Therapies for Parkinson's Disease in Development
3311 Bundang CHA Hospital
3312 Fondazione IRCCS Ca'Granda, Ospedale Maggiore Policlinico
3313 Instituto de Medicina Regenerativa/Ageless Regenerative Institute
3314 International Stem Cell Corporation
3315 Neuralstem
332 Conceivable Regulatory Timetable
34 Emerging Stem Cell-Based Therapies for Spinal Cord Injury
341 Spinal Cord Injury Cellular Therapies in Development
3411 Bukwang Pharmaceutical
3412 The General Hospital of Chinese Armed Police Forces
3413 Hospital Sao Rafael
3414 Neuralstem
3415 Neurogen Brain and Spine Insitute
3416 Pharmicell
3417 StemCells, Inc
3418 Translational Biosciences
342 Conceivable Regulatory Timetable
35 Emerging Stem Cell-Based Therapies for Post-Ischemic Stroke
351 Stem Cell Therapies for Ischemic Stroke in Development
3511 Athersys
3512 Ecron Acunova
3513 International Stem Cell Corporation
3514 Pharmicell
3515 ReNeuron, Ltd
3516 SanBio
3517 Stemedica
3518 Stempeutics
3519 University of Irvine
352 Conceivable Regulatory Timetable
36 Potential US Market for Neurological Disease-Related Cellular Therapy Products

Exhibit 3-1: Estimated Growth of Potential Early-Stage Alzheimer's Cellular Therapy Caseloads, US, 2015-2020
Exhibit 3-2: Estimated Growth of Early-Stage Parkinson's Disease Cellular Therapy Caseloads, US, 2015-2020
Exhibit 3-3: Estimated Growth of Potential Spinal Cord Injury Cellular Therapy Caseloads, US, 2015-2020
Exhibit 3-4: Estimated Growth of Potential Ischemic Stroke Cellular Therapy Caseloads, US, 2015-2020
Exhibit 3-5: Tissue Engineered Neurological Disease Products, Expected Product Launch, by Indication
Exhibit 3-6: Tissue Engineered Neurological Disease Products, Estimated Market Forecast, 2020

APPENDIX: COMPANY LISTING

BIBLIOGRAPHY

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