$3,750.00
U.S. Markets for Biologic and Tissue Engineered Devices – Cardiovascular and Neurological Products, March 2015
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:
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.
EXECUTIVE SUMMARY…………………………………………………………………………. ES-1
i. Methodology……………………………………………………………………….. ES-2
1. TISSUE ENGINEERING AND CELLULAR THERAPY TOOLS AND TECHNIQUES…………………………………………………………………………………. 1-1
1.1 Biomaterials…………………………………………………………………………… 1-1
1.1.1 Biologically Derived Biomaterials ……………………………….. 1-1
1.1.1.1 Collagen …………………………………………………… 1-2
1.1.1.2 Xenogenic Tissue………………………………………. 1-2
1.1.2 Genetically Engineered Biomaterials…………………………… 1-2
1.1.2.1 Deoxyribonucleic Acid Transfection Vectors ….. 1-3
1.1.2.2 Genetically Manipulated Cells ……………………… 1-3
1.1.2.3 Three-Dimensional Polymer Technology ………. 1-3
1.1.2.4 Transgenics………………………………………………. 1-4
1.1.2.5 Fibroblasts………………………………………………… 1-4
1.1.2.6 Immortalized Neural Stem Cells…………………… 1-4
1.1.2.7 Gene Activated Matrices …………………………….. 1-5
1.1.3 Hybrid Biomaterials ………………………………………………….. 1-5
1.1.4 Synthetic Biomaterials………………………………………………. 1-6
1.1.5 Scaffolds…………………………………………………………………. 1-6
1.1.6 Vascular Grafts………………………………………………………… 1-9
1.2 Cell Culture Technology ………………………………………………………… 1-10
1.2.1 Bioreactors ……………………………………………………………. 1-10
1.2.1.1 Flatbed Perfusion Systems ……………………….. 1-11
1.2.1.2 Hollow Fiber Bioreactor Systems ……………….. 1-12
1.2.1.3 Cell Suspension Systems………………………….. 1-12
1.2.1.4 Disposable Bioreactors …………………………….. 1-13
1.3 Stem Cell Technology …………………………………………………………… 1-13
1.3.1 Cell Extraction and Expansion………………………………….. 1-13
1.4 Immunoisolation Technology………………………………………………….. 1-15
1.4.1 Chimeric Immunity………………………………………………….. 1-16
1.4.2 Cell Encapsulation Technology ………………………………… 1-16
2. EMERGING APPLICATIONS OF TISSUE ENGINEERING FOR CARDIOVASCULAR DISEASE MANAGEMENT ………………………………… 2-1
2.1 Cellular Therapy and Tissue Engineering…………………………………… 2-2
2.1.1 Skeletal Myoblasts …………………………………………………… 2-3 2015 Medtech Insight i #A427
U.S. Markets for Biologic and Tissue Engineered
Devices – Cardiovascular and Neurological Products Table of Contents
2.1.2 Bone Marrow-Derived Stem Cells ………………………………. 2-4
2.1.3 Adipose Tissue-Derived Stem Cells ……………………………. 2-4
2.1.4 Cardiac Stem Cells…………………………………………………… 2-6
2.1.5 Human Embryonic Stem Cells……………………………………. 2-6
2.1.6 Induced Pluripotent Stem Cells ………………………………….. 2-8
2.2 Cellular Therapy Administration ……………………………………………….. 2-8
2.3 Clinical Experience with Stem Cell-Based Myocardial Tissue Repair and Regeneration…………………………………………………………………. 2-12
2.4 Cellular Therapies for Myocardial Repair and Regeneration in Development ……………………………………………………………………….. 2-13
2.4.1 Athersys ……………………………………………………………….. 2-15
2.4.2 Baxter…………………………………………………………………… 2-15
2.4.3 Bioheart, Inc. …………………………………………………………. 2-16
2.4.4 Capricor Therapeutics …………………………………………….. 2-16
2.4.5 Cytori Therapeutics ………………………………………………… 2-17
2.4.6 Mesoblast Ltd. ……………………………………………………….. 2-18
2.4.7 NeoStem ………………………………………………………………. 2-19
2.4.8 Osiris Therapeutics ………………………………………………… 2-20
2.4.9 Terumo Corporation ……………………………………………….. 2-21
2.4.10 Vericel ………………………………………………………………….. 2-21
2.4.11 Conceivable Regulatory Timetable……………………………. 2-22
2.5 Emerging Cellular Therapies for Limb Salvage in Critical Limb Ischemia Patients …………………………………………………………………. 2-27
2.5.1 Therapeutic Angiogenesis……………………………………….. 2-27
2.5.1.1 Growth Factor/Gene-Based Angiogenic Therapy …………………………………. 2-29
2.5.1.2 Stem Cell-Based Angiogenic Therapy…………. 2-31
2.5.1.3 Therapeutic Angiogenesis Products in Development …………………………………………… 2-32
2.5.1.3.1 Biomet Biologics …………………… 2-33
2.5.1.3.2 Harvest Technologies ……………. 2-33
2.5.1.3.3 Pluristem Therapeutics ………….. 2-34
2.5.1.3.4 Taxus Cardium Pharmaceuticals Group …………. 2-35
2.5.1.4 Conceivable Regulatory Timetable……………… 2-35
2.6 Bioengineered Vascular Conduits …………………………………………… 2-36
2.6.1 Products in Development ………………………………………… 2-38 2015 Medtech Insight ii #A427
U.S. Markets for Biologic and Tissue Engineered
Devices – Cardiovascular and Neurological Products Table of Contents
2.6.2 Conceivable Regulatory Timetable……………………………. 2-40
2.7 Current and Emerging U.S. Market for Cardiovascular Disease-Related Tissue Engineering and Cellular Therapy Products …………………… 2-40
Exhibit 2-1: Comparative Advantages and Disadvantages of Selected Stem Cell Grafts for Myocardial Repair and Regeneration……………………………………………… 2-9
Exhibit 2-2: Selected Myocardial Cellular Repair and Regeneration Therapies in Development……………………………………………………………………………………….. 2-23
Exhibit 2-3: Estimated Growth of Potential Myocardial Cellular Repair and Regeneration Caseloads, U.S., 2017-2020 …………………………………………………. 2-28
Exhibit 2-4: Estimated Growth of Potential Therapeutic Angiogenesis Cellular Therapy Caseloads, U.S., 2017-2022…………………………………………………………. 2-37
Exhibit 2-5: Estimated Growth of Potential Bioengineered Vascular Graft Caseloads, U.S., 2017-2022……………………………………………………………………… 2-41
Exhibit 2-6: Tissue Engineered Cardiac and Vascular Products, Expected Product Launch, by Indication……………………………………………………………………………….. 2-44
Exhibit 2-7: Tissue Engineered Cardiac and Vascular Products, Estimated Market Forecast, 2017 and 2022………………………………………………………………………….. 2-47
3. EMERGING APPLICATIONS OF TISSUE ENGINEERING FOR NEUROLOGICAL DISEASE MANAGEMENT …………………………………….. 3-1
3.1 Types of Cells Used for Cellular Therapies in Development …………. 3-1
3.1.1 Bone Marrow-Derived Stem Cells ………………………………. 3-2
3.1.2 Adipose Tissue-Derived Stem Cells ……………………………. 3-2
3.1.3 Embryonic Stem Cells ………………………………………………. 3-3
3.1.4 Induced Pluripotent Stem Cells ………………………………….. 3-4
3.1.5 Mesenchymal Stem Cells………………………………………….. 3-4
3.1.6 Neural Stem Cells ……………………………………………………. 3-5
3.2 Emerging Stem Cell-Based Therapies for Alzheimer’s Disease…….. 3-5
3.2.1 Cellular Therapies in Development for Alzheimer’s Disease…………………………………………………. 3-6
3.2.1.1 Chinese Academy of Military Medical Sciences ………………………………………. 3-6
3.2.1.2 Medipost…………………………………………………… 3-7
3.2.1.3 Neuralstem……………………………………………….. 3-7
3.2.1.4 StemCells, Inc. ………………………………………….. 3-7
3.2.2 Conceivable Regulatory Timetable……………………………… 3-8 2015 Medtech Insight iii #A427
U.S. Markets for Biologic and Tissue Engineered
Devices – Cardiovascular and Neurological Products Table of Contents
3.3 Emerging Stem Cell-Based Therapies for Parkinson’s Disease…….. 3-8
3.3.1 Cellular Therapies for Parkinson’s Disease in Development ……………………………………………………… 3-11
3.3.1.1 Bundang CHA Hospital …………………………….. 3-11
3.3.1.2 Fondazione IRCCS Ca’Granda, Ospedale Maggiore Policlinico …………………………………. 3-11
3.3.1.3 Instituto de Medicina Regenerativa/Ageless Regenerative Institute ………………………………. 3-12
3.3.1.4 International Stem Cell Corporation ……………. 3-12
3.3.1.5 Neuralstem……………………………………………… 3-13
3.3.2 Conceivable Regulatory Timetable……………………………. 3-13
3.4 Emerging Stem Cell-Based Therapies for Spinal Cord Injury………. 3-13
3.4.1 Spinal Cord Injury Cellular Therapies in Development …. 3-16
3.4.1.1 Bukwang Pharmaceutical………………………….. 3-16
3.4.1.2 The General Hospital of Chinese Armed Police Forces…………………………………………… 3-16
3.4.1.3 Hospital Sao Rafael………………………………….. 3-17
3.4.1.4 Neuralstem……………………………………………… 3-17
3.4.1.5 Neurogen Brain and Spine Insitute……………… 3-17
3.4.1.6 Pharmicell ………………………………………………. 3-18
3.4.1.7 StemCells, Inc. ………………………………………… 3-18
3.4.1.8 Translational Biosciences………………………….. 3-19
3.4.2 Conceivable Regulatory Timetable……………………………. 3-19
3.5 Emerging Stem Cell-Based Therapies for Post-Ischemic Stroke …. 3-20
3.5.1 Stem Cell Therapies for Ischemic Stroke in Development ……………………………………………………… 3-22
3.5.1.1 Athersys …………………………………………………. 3-22
3.5.1.2 Ecron Acunova………………………………………… 3-24
3.5.1.3 International Stem Cell Corporation ……………. 3-24
3.5.1.4 Pharmicell ………………………………………………. 3-24
3.5.1.5 ReNeuron, Ltd. ………………………………………… 3-25
3.5.1.6 SanBio……………………………………………………. 3-25
3.5.1.7 Stemedica ………………………………………………. 3-26
3.5.1.8 Stempeutics…………………………………………….. 3-26
3.5.1.9 University of Irvine……………………………………. 3-27
3.5.2 Conceivable Regulatory Timetable……………………………. 3-27 2015 Medtech Insight iv #A427
U.S. Markets for Biologic and Tissue Engineered
Devices – Cardiovascular and Neurological Products Table of Contents
3.6 Potential U.S. Market for Neurological Disease-Related Cellular Therapy Products …………………………………………………………………. 3-28
Exhibit 3-1: Estimated Growth of Potential Early-Stage Alzheimer’s Cellular Therapy Caseloads, U.S., 2015-2020…………………………………………………………… 3-1
Exhibit 3-2: Estimated Growth of Early-Stage Parkinson’s Disease Cellular Therapy Caseloads, U.S., 2015-2020…………………………………………………………. 3-10
Exhibit 3-3: Estimated Growth of Potential Spinal Cord Injury Cellular Therapy Caseloads, U.S., 2015-2020……………………………………………………………………… 3-16
Exhibit 3-4: Estimated Growth of Potential Ischemic Stroke Cellular Therapy Caseloads, U.S., 2015-2020……………………………………………………………………… 3-22
Exhibit 3-5: Tissue Engineered Neurological Disease Products, Expected Product Launch, by Indication……………………………………………………………………………….. 3-31
Exhibit 3-6: Tissue Engineered Neurological Disease Products, Estimated Market Forecast, 2020………………………………………………………………………………………… 3-35
APPENDIX: COMPANY LISTING……………………………………………………………… A-1
BIBLIOGRAPHY ……………………………………………………………………………………… B-1
Exhibit 2-3: Estimated Growth of Potential Myocardial Cellular Repair and Regeneration Caseloads, U.S., 2017-2020
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