Designed for use in burn and wound patients to either temporarily cover or permanently replace areas of missing skin, skin replacements and substitutes include allografts (made from donated human tissue); autografts (made from the patient’s own tissue); dermal, epidermal, and multilayer human skin equivalents that may use autologous, donor, or synthetic materials for cell repopulation at the burn or wound site; as well as xenografts (made from animal tissue).  Active wound repair modulators are designed to modify the biochemical environment of a chronic wound, affecting the wound’s angiogenesis, bioburden, cell proliferation, exudate, growth factors, inflammatory mediators, microcirculation, moisture balance, and proteases.

In 2004, the United States (U.S.) market for tissue-engineered skin replacements/substitutes and active wound repair modulators, was valued at approximately $195 million.  During the forecast period covered by this report, sales are expected to increase at a compound annual rate of 9.5%, reaching approximately $481 million in the year 2014.

This report from Medtech Insight includes analyses of products, competitors, current and forecast markets, opportunities in the U.S. skin replacements/substitutes and active wound repair modulators market, as well as technologies.  Topics discussed in this report include allografts, autografts, extrinsic and intrinsic factors affecting wound closure, gene therapy agents, growth factors, major wound types, the physiology of wound closure, and xenografts.

TABLE OF CONTENTS AND LIST OF EXHIBITS

EXECUTIVE SUMMARY

i.   Tissue-Engineered Skin Replacements/Substitutes

ii.   Active Wound Repair Modulators

Exhibit ES-1:  2005, Skin Replacement Product Types

Exhibit ES-2:  Tissue-Engineered Skin Replacements/Substitutes, Market Forecast, 2004-2014

Exhibit ES-3:  Growth Factors, Market Forecast, 2004-2014

1. CLINICAL ISSUES IN WOUND MANAGEMENT

1.1 Physiology of Wound Closure

1.1.1 Layers of the Skin and Supporting Structures

1.1.1.1 Epidermis

1.1.1.2 Dermis

1.1.1.3 Subcutaneous Tissue

1.1.1.4 Fascia

1.1.1.5 Muscle

1.1.1.6 Bone

1.1.2 Wound Closure Process

1.1.2.1 Hemostasis

1.1.2.2 Inflammation

1.1.2.3 Proliferation

1.1.2.4 Remodeling Phase

1.2 Factors Affecting Wound Closure

1.2.1 Extrinsic Factors

1.2.1.1 Desiccation

1.2.1.2 Hydration

1.2.1.3 Infection

1.2.1.4 Maceration

1.2.1.5 Medications and Other Treatment Modalities

1.2.1.6 Necrotic Tissue and Debris

1.2.1.7 Oxygen

1.2.1.8 Stress

1.2.1.9 Temperature

1.2.1.10 Wound Creation and Depth

1.2.1.11 Wound Closure Techniques

1.2.1.12 Other Extrinsic Factors

1.2.2 Intrinsic Factors

1.2.2.1 Body Build

1.2.2.2 Chronic Illness and Age

1.2.2.3 Nutrition

1.2.3 Complications of Wound Healing

1.2.3.1 Bleeding

1.2.3.2 Scarring

1.3 Major Wound Types

1.3.1 Amputation

1.3.2 Arterial Ulcers

1.3.3 Burns

1.3.4 Diabetic Ulcers

1.3.5 Pressure Ulcers

1.3.6 Surgical Wounds

1.3.7 Traumatic Wounds

1.3.8 Venous Ulcers

1.4 Incidence of Major Wound Types

Exhibit 1-1: The Skin’s Layers and Supporting Structures

Exhibit 1-2: Phases of the Wound Closure Process

Exhibit 1-3: Intrinsic and Extrinsic Factors Affecting Wound Closure

Exhibit 1-4: Major Wound Types, by Cause

Exhibit 1-5: Stages of Burn Wounds

Exhibit 1-6: Stages of Pressure Ulcers

Exhibit 1-7: 2002, Inpatient and Outpatient Surgery, Procedure Volumes

Exhibit 1-8: 2004, Incidence of Major Wound Types

2. TISSUE-ENGINEERED SKIN REPLACEMENTS/SUBSTITUTES

2.1 Allografts

2.2 Autografts

2.3 Xenografts

2.4 Autologous and Tissue-Engineered Skin Replacements/Substitutes

2.4.1 Epidermal Equivalent Products

2.4.2 Dermal Equivalent Products

2.4.3 Multilayer Equivalent Products

2.5 Market Forecast

2.6 Competitive Analysis

Exhibit 2-1: 2005, Skin Replacement Product Types

Exhibit 2-2: 2005, Selected Current and Emerging Tissue-Engineered Skin Replacements/Substitutes

Exhibit 2-3: Tissue-Engineered Skin Replacements/Substitutes, Market Forecast, 2004-2014

Exhibit 2-4: 2004, Tissue-Engineered Skin Replacements/Substitutes Market, Share by Supplier

3. ACTIVE WOUND REPAIR MODULATORS

3.1 Growth Factors

3.1.1 Growth Factor Classification

3.1.1.1 Fibroblast Growth Factor

3.1.1.2 Transforming Growth Factor

3.1.1.3 Epidermal Growth Factor

3.1.1.4 Platelet-Derived Growth Factor

3.1.1.5 Insulin-Like Growth Factor

3.1.1.6 Keratinocyte Growth Factor

3.1.1.7 Vascular Endothelial Growth Factor

3.1.1.8 Autologous Growth Factor

3.1.1.8.1 Biomet

3.1.1.8.2 Cytomedix

3.1.1.8.3 Harvest Technologies

3.1.1.8.4 Medtronic

3.1.1.8.5 PlasmaSeal/Hanuman Medical

3.1.1.9 Summary of Angiogenic Growth Factors

3.1.2 Competitors and Products

3.1.3 Market Forecast

3.2 Gene Therapy Agents

3.3 Other Active Wound Repair Modulators and Pharmaceuticals

3.3.1 Antibiotics and Anti-Infectives

3.3.2 Hormones

3.3.3 Matrix Metalloproteinase Enzyme Inhibitors

3.3.4 Neuropeptides in Diabetic Wounds

3.3.5 Stem Cells

3.3.6 Other Products

Exhibit 3-1: Selected Growth Factors in Development for Wound Healing Applications

Exhibit 3-2: 2005, Selected Angiogenic Growth Factors

Exhibit 3-3: Growth Factors, Market Forecast, 2004-2014

Exhibit 3-4: Preclinical Gene Therapy Studies, 1998-2004

4. COMPANY PROFILES

4.1   Biomet, Inc.

4.2   Ethicon, Inc./Johnson & Johnson

4.3   Genentech, Inc.

4.4   Genzyme Biosurgery, Inc./Genzyme Corporation

4.5   Healthpoint Ltd./DFB Pharmaceuticals, Inc.

4.6   Integra LifeSciences, Inc./Integra LifeSciences Holdings Corporation

4.7   LifeCell Corporation

4.8   Organogenesis, Inc.

4.9   Ortec International, Inc.

4.10 RegeneRx Biopharmaceuticals, Inc.

4.11 Smith & Nephew plc

4.12 TEI Biosciences Inc.

APPENDIX:  COMPANY LISTING

Copyright 2005, Medtech Insight, LLC