$3,750.00
The scope of this report includes tissue-engineered skin replacements and substitutes (i.e., epidermal equivalents, dermal equivalents, and multilayer equivalents) and active wound repair modulators.
The scope of this report includes tissue-engineered skin replacements and substitutes (i.e., epidermal equivalents, dermal equivalents, and multilayer equivalents) and active wound repair modulators (i.e., growth factors, gene therapy, and other active wound repair modulators and pharmaceuticals such as new classes of antibiotics and anti-infectives, hormones, matrix metalloproteinase enzyme inhibitors, neuropeptides in diabetic wounds, stem cells, and numerous other types of peptides and pharmaceuticals).
1. CLINICAL ISSUES IN WOUND MANAGEMENT…………………………………. 1-1
1.1 Physiology of Wound Closure ………………………………………………….. 1-1
1.1.1 Layers of the Skin and Supporting Structures ………………. 1-2
1.1.1.1 Epidermis …………………………………………………. 1-2
1.1.1.2 Dermis……………………………………………………… 1-5
1.1.1.3 Hypodermis ………………………………………………. 1-5
1.1.1.4 Fascia………………………………………………………. 1-6
1.1.1.5 Muscle……………………………………………………… 1-6
1.1.1.6 Bone………………………………………………………… 1-6
1.1.2 Wound Closure Process……………………………………………. 1-7
1.1.2.1 Hemostasis ………………………………………………. 1-7
1.1.2.2 Inflammation……………………………………………… 1-9
1.1.2.3 Proliferation …………………………………………….. 1-10
1.1.2.4 Remodeling Phase…………………………………… 1-11
1.2 Factors Affecting Wound Closure……………………………………………. 1-12
1.2.1 Intrinsic Factors……………………………………………………… 1-14
1.2.1.1 Age and Chronic Illness ……………………………. 1-14
1.2.1.2 Body Composition ……………………………………. 1-15
1.2.1.3 Nutritional Status……………………………………… 1-15
1.2.2 Extrinsic Factors…………………………………………………….. 1-16
1.2.2.1 Ambient Temperature……………………………….. 1-16
1.2.2.2 Desiccation/Hydration ………………………………. 1-16
1.2.2.3 Infection………………………………………………….. 1-17
1.2.2.4 Maceration ……………………………………………… 1-17
1.2.2.5 Medication and Other Treatment Modalities…. 1-17
1.2.2.6 Necrotic Tissue and Debris ……………………….. 1-18
1.2.2.7 Oxygen…………………………………………………… 1-18
1.2.2.8 Stress …………………………………………………….. 1-18
1.2.2.9 Wound Creation and Depth……………………….. 1-19
1.2.2.10 Wound Closure Techniques ………………………. 1-19
1.2.2.11 Other Extrinsic Factors……………………………… 1-20
1.2.3 Complications of Wound Healing ……………………………… 1-20
1.2.3.1 Scarring………………………………………………….. 1-20
1.2.3.2 Bleeding …………………………………………………. 1-21
1.3 Wound Types ………………………………………………………………………. 1-21
1.3.1 Illness-Related Wounds…………………………………………… 1-21
1.3.1.1 Etiology ………………………………………………….. 1-21
1.3.1.1.1 Arterial Ulcers ………………………. 1-23
1.3.1.1.2 Diabetic Ulcers……………………… 1-23
1.3.1.1.3 Venous Ulcers ……………………… 1-24
1.3.1.2 Epidemiology…………………………………………… 1-25
1.3.2 Pressure Ulcers……………………………………………………… 1-25
1.3.2.1 Etiology ………………………………………………….. 1-25
1.3.2.2 Epidemiology…………………………………………… 1-27
1.3.3 Surgical Wounds ……………………………………………………. 1-27
1.3.3.1 Etiology ………………………………………………….. 1-29
1.3.3.2 Epidemiology…………………………………………… 1-31
1.3.4 Traumatic Wounds …………………………………………………. 1-31
1.3.4.1 Etiology ………………………………………………….. 1-31
1.3.4.1.1 Abrasions, Contusions,
and Lacerations ……………………. 1-31
1.3.4.1.2 Amputations…………………………. 1-35
1.3.4.1.3 Burns ………………………………….. 1-35
1.3.4.2 Epidemiology…………………………………………… 1-39
Exhibit 1-1: The Skin’s Layers and Supporting Structures …………………………….. 1-3
Exhibit 1-2: Phases of the Wound Closure Process……………………………………… 1-8
Exhibit 1-3: Intrinsic and Extrinsic Factors Affecting Wound Closure …………….. 1-13
Exhibit 1-4: Illness-Related Wounds, Facts and Figures,
1996-2006, and 2009 ……………………………………………………………. 1-22
Exhibit 1-5: Pressure Ulcers, Facts and Figures, 1996-2006, and 2009 ………… 1-26
Exhibit 1-6: Stages of Pressure Ulcers……………………………………………………… 1-28
Exhibit 1-7: Surgical Wounds, Facts and Figures, 1996-2006, and 2009……….. 1-30
Exhibit 1-8: Lacerations and Other Types of Traumatic Wounds,
Facts and Figures, 1996-2006, and 2009…………………………………. 1-32
Exhibit 1-9: Amputations, Facts and Figures, 1996-2006, and 2009……………… 1-33
Exhibit 1-10: Burns, Facts and Figures, 1996-2006, and 2009 ………………………. 1-34
Exhibit 1-11: Classification of Burns, by Mechanism of Injury ………………………… 1-36
Exhibit 1-12: Classification of Burns, by Extent of Injury ……………………………….. 1-38
2. TISSUE-ENGINEERED SKIN REPLACEMENTS AND SUBSTITUTES….. 2-1
2.1 Allografts ………………………………………………………………………………. 2-1
2.2 Autografts……………………………………………………………………………… 2-2
2.3 Xenografts …………………………………………………………………………….. 2-4
2.4 Autologous and Tissue-Engineered
Skin Replacements/Substitutes………………………………………………… 2-5
2.4.1 Epidermal Equivalent Products ………………………………….. 2-6
2.4.2 Dermal Equivalent Products………………………………………. 2-8
2.4.3 Multilayer Equivalent Products …………………………………… 2-9
2.5 Market Forecast …………………………………………………………………… 2-11
2.6 Competitive Analysis …………………………………………………………….. 2-17
Exhibit 2-1: 2013, Selected Current and Emerging Tissue-Engineered
Skin Replacements and Substitutes………………………………………… 2-12
Exhibit 2-2: Tissue-Engineered Skin Replacements and Substitutes,
Market Forecast, 2011-2016 ………………………………………………….. 2-18
Exhibit 2-3: 2011, Tissue-Engineered Skin Replacements and Substitutes
Market, Share by Supplier ……………………………………………………… 2-20
3. ACTIVE WOUND REPAIR MODULATORS………………………………………… 3-1
3.1 Growth Factors………………………………………………………………………. 3-1
3.1.1 Growth Factor Classification………………………………………. 3-3
3.1.1.1 Fibroblast Growth Factors …………………………… 3-4
3.1.1.2 Transforming Growth Factors………………………. 3-7
3.1.1.3 Epidermal Growth Factors…………………………… 3-7
3.1.1.4 Platelet-Derived Growth Factors ………………….. 3-8
3.1.1.5 Insulin-Like Growth Factors…………………………. 3-9
3.1.1.6 Keratinocyte Growth Factors……………………….. 3-9
3.1.1.7 Vascular Endothelial Growth Factors ………….. 3-10
3.1.1.8 Autologous Growth Factors……………………….. 3-10
3.1.1.8.1 Arteriocyte Medical Systems…… 3-11
3.1.1.8.2 Biomet…………………………………. 3-11
3.1.1.8.3 Cytomedix……………………………. 3-11
3.1.1.8.4 Harvest Technologies/Terumo… 3-11
3.1.1.9 Summary of Angiogenic Growth Factors……… 3-12
3.1.2 Competitors and Products……………………………………….. 3-12
3.1.3 Market Forecast …………………………………………………….. 3-15
3.2 Gene Therapy Agents …………………………………………………………… 3-18
3.3 Stem Cells …………………………………………………………………………… 3-20
3.3.1 Types of Stem Cells ……………………………………………….. 3-21
3.3.1.1 Embryonic Stem Cells ………………………………. 3-22
3.3.1.2 Adult Stem Cells………………………………………. 3-24
3.3.1.3 Cord Blood Stem Cells ……………………………… 3-26
3.3.2 The Role of Stem Cells in Wound Healing …………………. 3-27
3.3.3 Market Status ………………………………………………………… 3-28
3.4 Other Active Wound Repair Modulators and Pharmaceuticals…….. 3-28
3.4.1 Antibiotics and Anti-Infectives…………………………………… 3-28
3.4.2 Hormones……………………………………………………………… 3-29
3.4.3 Matrix Metalloproteinase Enzyme Inhibitors……………….. 3-29
3.4.4 Neuropeptides in Diabetic Wounds …………………………… 3-30
3.4.5 Other Products ………………………………………………………. 3-31
Exhibit 3-1: Selected Growth Factors in Development for
Wound Healing Applications…………………………………………………….. 3-5
Exhibit 3-2: The Angiogenesis Process…………………………………………………….. 3-13
Exhibit 3-3: 2012, Selected Angiogenic Growth Factors ……………………………… 3-14
Exhibit 3-4: Growth Factors, Market Forecast, 2011-2016 …………………………… 3-19
4. COMPANY PROFILES…………………………………………………………………….. 4-1
4.1 Biomet, Inc. …………………………………………………………………………… 4-1
4.2 Forticell Bioscience, Inc…………………………………………………………… 4-1
4.3 Genentech, Inc./F. Hoffmann-La Roche LTD ……………………………… 4-2
4.4 Genzyme Corporation/Sanofi SA ……………………………………………… 4-3
4.5 Integra LifeSciences, Inc./
Integra LifeSciences Holdings Corporation ………………………………… 4-3
4.6 LifeCell Corporation/Kinetic Concepts, Inc. ………………………………… 4-4
4.7 Organogenesis, Inc. ……………………………………………………………….. 4-6
4.8 Smith & Nephew PLC……………………………………………………………… 4-6
4.9 TEI Biosciences, Inc……………………………………………………………….. 4-9
APPENDIX: COMPANY LISTING……………………………………………………………… A-1
Figure: Tissue-Engineered Skin Replacements and Substitutes, Market Forecast, 2011-2016
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