U.S. MARKETS FOR BIOLOGIC AND TISSUE ENGINEERED DEVICES - CARDIOVASCULAR AND NEUROLOGICAL PRODUCTS

110 Pages | 13 Exhibits | 2015 Analysis | Forecasts Through 2020 Product Family: Market Reports




OVERVIEW:
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.).

  • 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:
EXECUTIVE SUMMARY

i. Methodology

1. TISSUE ENGINEERING AND CELLULAR THERAPY TOOLS AND TECHNIQUES

1.1 Biomaterials
	1.1.1 Biologically Derived Biomaterials
		1.1.1.1 Collagen
		1.1.1.2 Xenogenic Tissue 
	1.1.2 Genetically Engineered Biomaterials
		1.1.2.1 Deoxyribonucleic Acid Transfection Vectors
		1.1.2.2 Genetically Manipulated Cells
		1.1.2.3 Three-Dimensional Polymer Technology
		1.1.2.4 Transgenics
		1.1.2.5 Fibroblasts
		1.1.2.6 Immortalized Neural Stem Cells
		1.1.2.7 Gene Activated Matrices
	1.1.3 Hybrid Biomaterials
	1.1.4 Synthetic Biomaterials
	1.1.5 Scaffolds
	1.1.6 Vascular Grafts
1.2 Cell Culture Technology
	1.2.1 Bioreactors
		1.2.1.1 Flatbed Perfusion Systems
		1.2.1.2 Hollow Fiber Bioreactor Systems
		1.2.1.3 Cell Suspension Systems
		1.2.1.4 Disposable Bioreactors
1.3 Stem Cell Technology
	1.3.1 Cell Extraction and Expansion
1.4 Immunoisolation Technology
	1.4.1 Chimeric Immunity
	1.4.2 Cell Encapsulation Technology

2. EMERGING APPLICATIONS OF TISSUE ENGINEERING FOR CARDIOVASCULAR DISEASE MANAGEMENT

2.1 Cellular Therapy and Tissue Engineering
	2.1.1 Skeletal Myoblasts
	2.1.2 Bone Marrow-Derived Stem Cells
	2.1.3 Adipose Tissue-Derived Stem Cells
	2.1.4 Cardiac Stem Cells
	2.1.5 Human Embryonic Stem Cells
	2.1.6 Induced Pluripotent Stem Cells
2.2 Cellular Therapy Administration
2.3 Clinical Experience with Stem Cell-Based Myocardial Tissue Repair and Regeneration
2.4 Cellular Therapies for Myocardial Repair and Regeneration in Development
	2.4.1 Athersys
	2.4.2 Baxter
	2.4.3 Bioheart, Inc.
	2.4.4 Capricor Therapeutics
	2.4.5 Cytori Therapeutics
	2.4.6 Mesoblast Ltd.
	2.4.7 NeoStem
	2.4.8 Osiris Therapeutics
	2.4.9 Terumo Corporation
	2.4.10 Vericel
	2.4.11 Conceivable Regulatory Timetable
2.5 Emerging Cellular Therapies for Limb Salvage in Critical Limb Ischemia Patients
	2.5.1 Therapeutic Angiogenesis
		2.5.1.1 Growth Factor/Gene-Based Angiogenic Therapy
		2.5.1.2 Stem Cell-Based Angiogenic Therapy
		2.5.1.3 Therapeutic Angiogenesis Products in Development
			2.5.1.3.1 Biomet Biologics
			2.5.1.3.2 Harvest Technologies
			2.5.1.3.3 Pluristem Therapeutics
			2.5.1.3.4 Taxus Cardium Pharmaceuticals Group
		2.5.1.4 Conceivable Regulatory Timetable
2.6 Bioengineered Vascular Conduits
	2.6.1 Products in Development
	2.6.2 Conceivable Regulatory Timetable
2.7 Current and Emerging U.S. 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, U.S., 2017-2020
Exhibit 2-4: Estimated Growth of Potential Therapeutic Angiogenesis Cellular Therapy Caseloads, U.S., 2017-2022
Exhibit 2-5: Estimated Growth of Potential Bioengineered Vascular Graft Caseloads, U.S., 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 FOR NEUROLOGICAL DISEASE MANAGEMENT

3.1 Types of Cells Used for Cellular Therapies in Development
	3.1.1 Bone Marrow-Derived Stem Cells
	3.1.2 Adipose Tissue-Derived Stem Cells
	3.1.3 Embryonic Stem Cells
	3.1.4 Induced Pluripotent Stem Cells
	3.1.5 Mesenchymal Stem Cells
	3.1.6 Neural Stem Cells
3.2 Emerging Stem Cell-Based Therapies for Alzheimer's Disease
	3.2.1 Cellular Therapies in Development for Alzheimer's Disease
		3.2.1.1 Chinese Academy of Military Medical Sciences
		3.2.1.2 Medipost
		3.2.1.3 Neuralstem
		3.2.1.4 StemCells, Inc.
	3.2.2 Conceivable Regulatory Timetable
3.3 Emerging Stem Cell-Based Therapies for Parkinson's Disease
	3.3.1 Cellular Therapies for Parkinson's Disease in Development
		3.3.1.1 Bundang CHA Hospital
		3.3.1.2 Fondazione IRCCS Ca'Granda, Ospedale Maggiore Policlinico
		3.3.1.3 Instituto de Medicina Regenerativa/Ageless Regenerative Institute
		3.3.1.4 International Stem Cell Corporation
		3.3.1.5 Neuralstem
	3.3.2 Conceivable Regulatory Timetable
3.4 Emerging Stem Cell-Based Therapies for Spinal Cord Injury
	3.4.1 Spinal Cord Injury Cellular Therapies in Development
		3.4.1.1 Bukwang Pharmaceutical
		3.4.1.2 The General Hospital of Chinese Armed Police Forces
		3.4.1.3 Hospital Sao Rafael
		3.4.1.4 Neuralstem
		3.4.1.5 Neurogen Brain and Spine Insitute
		3.4.1.6 Pharmicell
		3.4.1.7 StemCells, Inc.
		3.4.1.8 Translational Biosciences
	3.4.2 Conceivable Regulatory Timetable
3.5 Emerging Stem Cell-Based Therapies for Post-Ischemic Stroke
	3.5.1 Stem Cell Therapies for Ischemic Stroke in Development
		3.5.1.1 Athersys
		3.5.1.2 Ecron Acunova
		3.5.1.3 International Stem Cell Corporation
		3.5.1.4 Pharmicell
		3.5.1.5 ReNeuron, Ltd.
		3.5.1.6 SanBio
		3.5.1.7 Stemedica
		3.5.1.8 Stempeutics
		3.5.1.9 University of Irvine
	3.5.2 Conceivable Regulatory Timetable
3.6 Potential U.S. Market for Neurological Disease-Related Cellular Therapy Products

Exhibit 3-1: Estimated Growth of Potential Early-Stage Alzheimer's Cellular Therapy Caseloads, U.S., 2015-2020
Exhibit 3-2: Estimated Growth of Early-Stage Parkinson's Disease Cellular Therapy Caseloads, U.S., 2015-2020
Exhibit 3-3: Estimated Growth of Potential Spinal Cord Injury Cellular Therapy Caseloads, U.S., 2015-2020
Exhibit 3-4: Estimated Growth of Potential Ischemic Stroke Cellular Therapy Caseloads, U.S., 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


COMPANIES COVERED:

  1. Athersys
  2. Baxter/Baxter International
  3. Bioheart, Inc.
  4. Biomet Biologics/ Biomet
  5. Biosense Webster/Johnson & Johnson
  6. Bukwang Pharmaceutical
  7. Capricor Therapeutics/Johnson & Johnson
  8. Celladon
  9. Cytograft Tissue Engineering, Inc.
  10. Cytori Therapeutics
  11. Ecron Acunova
  12. Harvest Technologies
  13. Humacyte
  14. International Stem Cell Corporation
  15. Johnson & Johnson
  16. Medipost
  17. Mesoblast Ltd.
  18. NeoStem
  19. Neuralstem
  20. Nuo Therapeutics
  21. Osiris Therapeutics
  22. Pharmicell
  23. Pluristem Therapeutics
  24. ReNeuron, Ltd.
  25. StemCells, Inc.
  26. Stemedica
  27. Stempeutics
  28. Terumo Interventional Systems/Terumo Corporation
  29. Translational Biosciences
  30. Vericel
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