Worldwide Surgical Sealants, Glues and Wound Closure Market, 2007-2011

Table of Contents

Executive Summary

• Introduction
• Demographic trends
• Consumer Driven Product Selection
• Mechanisms of Tissue Repair
• Commercial Imperatives
• Industry Consolidation
• Clinical Caseload
• Market Segmentation and Dynamics
• New Surgical Techniques Drive Market Opportunity
• The Uses of Adjunctive Surgical Closure and Securement Products
• Product Development History
• Evolution of Commercial Markets for Sealants and Adhesives
• Company Strategies - Overview

Section 1: CLINICAL NEED, CASELOAD, AND PROCEDURE VOLUME

• 1.1 Anatomy and Physiology of Tissue Repair
• 1.2 The Skin
• 1.3 Internal Tissues and Organs
• 1.4 Wound Classification and Types
  • 1.4.1 Classification by Morphology and Severity
  • 1.4.2 Wound Classification by Cause
  • 1.4.3 Surgical Wounds
• 1.5 Caseload
• 1.6 Cardiovascular
  • 1.6.1 Coronary Heart Disease
  • 1.6.2 Dysfunctional Heart Valves
  • 1.6.3 Peripheral Vascular Disorders
  • 1.6.4 Abnormal Aortic Aneurysms
  • 1.6.5 Drivers of Caseloads for Cardiac Surgery
• 1.7 Neurological
• 1.8 Stroke
  • 1.8.1 Parkinson' s Disease
  • 1.8.2 Epilepsy
  • 1.8.3 Traumatic Injury
  • 1.8.4 Peripheral nerve treatment
  • 1.8.5 Neurology Drivers
• 1.9 Orthopaedic
  • 1.9.1 Hip Replacements
  • 1.9.2 Knee Replacements
  • 1.9.3 Cartilage Repair
  • 1.9.4 Ligament Damage
  • 1.9.5 Bone Grafting
  • 1.9.6 Vertebral Disc Repair
  • 1.9.7 Drivers of Orthopedic Surgery
• 1.10 Urological
  • 1.10.1 Incontinence
  • 1.10.2 Drivers of Urological Surgery
• 1.11 Skin
  • 1.11.1 Burns
  • 1.11.2 Pressure Ulcers
  • 1.11.3 Diabetic Ulcers
  • 1.11.4 Venous Ulcers
  • 1.11.5 Plastic Surgery
• 1.12 The Role of Modern Sealant, Securement and Hemostatic Products in Surgery
  • 1.12.1 Fibrin Sealants
  • 1.12.2 High Strength Glues

Section 2: SCIENCE, TECHNOLOGY, DEVELOPMENT, CLINICAL AND REGULATORY CHALLENGES

• 2.1 Tissue Healing
  • 2.1.1 Hemostasis
  • 2.1.2 Proliferation and Maturation
  • 2.1.3 Factors that affect healing
• 2.2 Product Development
• 2.3 Development Timelines
  • 2.3.1 Collagen and thrombin combination
  • 2.3.2 Polyethylene glycol polymer (PEG)
  • 2.3.3 Albumin cross-linked with glutaraldehyde
  • 2.3.4 Delivery Systems
• 2.4 Cost Effectiveness
• 2.5 Regulatory challenges
  • 2.5.1 Approval Processes
  • 2.5.2 History of Product Development
  • 2.5.3 Regulatory Aspects

Section 3: PRODUCTS, TECHNOLOGIES, AND FORECAST OPPORTUNITY

• 3.1 Overview
• 3.2 Development Timeline
• 3.3 Sutures and Staples
  • 3.3.1 Competitors and Products
• 3.4 Suppliers
  • 3.4.1 Product Development
  • 3.4.2 Market Analysis and Forecast
• 3.5 Tapes
  • 3.5.1 Competitors and Products
  • 3.5.2 Products in Development
  • 3.5.3 Market Analysis and Forecast
• 3.6 Hemostats
  • 3.6.1 Competitors and Products
  • 3.6.2 Products in Development
  • 3.6.3 Market Analysis and Forecasts
• 3.7 Fibrin and other Sealant Products
  • 3.7.1 Competitors and Products
  • 3.7.2 Products in Development
  • 3.7.3 Fibrin and Sealant Market and Competitive Activity
  • 3.7.4 High-Strength Medical Adhesives
  • 3.7.5 Competitors and Products
  • 3.7.6 Products in Development
  • 3.7.7 Market Analysis and Forecasts
• 3.8 Post-Surgical Adhesion Prevention
  • 3.8.1 Competitors and Products
  • 3.8.2 Products in Development
  • 3.8.3 Market Analysis and Forecasts
• 3.9 Wound Closure and Securement Markets: Global and Regional Analysis
  • 3.9.1 Americas
    • 3.9.1.1 USA
    • 3.9.1.2 Latin America
  • 3.9.2 Japan
  • 3.9.3 Europe
  • 3.9.4 Rest of World
• 3.10 Worldwide Markets By Country and Segment

Section 4: Company Profiles

• 4.1 Advanced Medical Solutions plc
• 4.2 Angiotech Pharmaceuticals Inc
• 4.3 Anika Therapeutics Inc.
• 4.4 ARC Pharmaceuticals
• 4.5 Baxter International Inc.
• 4.6 Berlin Heart AG
• 4.7 Biocoral Inc.
• 4.8 Biovascular
• 4.9 Biomet Inc.
• 4.10 B. Braun Melsungen AG
• 4.11 Chemence Limited
• 4.12 Closure Medical Corporation
• 4.13 Collagen Matrix Inc.
• 4.14 Confluent Surgical Inc.
• 4.15 CryoLife Inc.
• 4.16 Consortium Service Management Group (CSMG)
• 4.17 CuraMedical BV
• 4.18 Ethicon (Johnson & Johnson)
• 4.19 Ethicon
• 4.20 FibroGen, Inc.
• 4.21 Fidia Advanced Biopolymers
• 4.22 Focal Inc. (Genzyme Biosurgery)
• 4.23 FzioMed Inc.
• 4.24 GEM srl
• 4.25 Genzyme Biosurgery Inc.
• 4.26 Glustitch Inc.
• 4.27 Haemacure Corporation
• 4.28 Harvest Technologies Corporation
• 4.29 HemCon, Inc.
• 4.30 Incisive Surgical, Inc.
• 4.31 Integra Life Sciences Holdings Corp.
• 4.32 Kensey Nash Corporation
• 4.33 King Pharmaceuticals
• 4.34 Lifecore Biomedical, Inc.
• 4.35 Marine Polymer Technologies
• 4.36 Medafor, Inc.
• 4.37 Nycomed Pharma
• 4.38 Omrix Biopharmaceuticals Inc.
• 4.39 Organogenesis Inc.
• 4.40 Ortec
• 4.41 Pharming Group NV
• 4.42 PlasmaSeal
• 4.43 Polyganics
• 4.44 Smith & Nephew plc
• 4.45 Spiration Inc.
• 4.46 Synovis Life Technologies
• 4.47 Thermogenesis Corporation
• 4.48 Tissuemed Ltd
• 4.49 Tyco International Inc.
• 4.50 US Surgical Corp.
• 4.51 Vivolution
• 4.52 ZLB Behring

APPENDIX: LIST OF COMPANIES

• Exhibit ES-1: Recent Acquisitions in the Securement Segment
• Exhibit ES-2: Introduction of New Securement Technologies to the U.S. Market
• Exhibit ES-3: Definition of Surgical Closure and Securement Products
• Exhibit ES-4: Incidence of Two Example Surgical Procedures with High Requirement for Adjunctive Products for Surgical Closure and Securement
• Exhibit ES-5: U.S. FDA Approved Uses of Sealants, Glues, and Hemostats
• Exhibit ES-6: Synthetic and Biological Sealant Competitors (Non-Fibrin Sealants)
• Exhibit ES-7: Selected High Strength Adhesive Companies and Their Strategies
• Exhibit ES-8: Selected Sealant Product Companies and Their Strategies
• Exhibit ES-9: Worldwide Growth in the Securement and Closure Market, 2004-2014
• Exhibit 1-1: Skin Structure Illustrating Major Organelles and Skin Layers
• Exhibit 1-2: Classification of Wounds by Morphology
• Exhibit 1-3: Severity Classification of Wounds
• Exhibit 1-4: Wound classification by Etiology
• Exhibit 1-5: Incidence of Different Wound Types
• Exhibit 1-6: Criteria for Adjunctive Use of Hemostats, Sealants, Glues and Adhesion Prevention Products in Surgery
• Exhibit 1-7: Surgical Procedures with Potential for the Use of Hemostats, Sealants, Glues and Adhesion Prevention Products
• Exhibit 1-8: Potential for Cardiovascular Applications, Incidences of Applicable Surgical Disorders, 2006
• Exhibit 1-9: Potential for Neurological Applications, Incidences of Applicable Disorders (000s), 2006
• Exhibit 1-10: Potential for Orthopedic Applications, Numbers of Major Surgical Interventions, 2006
• Exhibit 1-11: Potential for Urological Applications, Incidence of Applicable Disorders, 2006
• Exhibit 1-12: Potential for Dermal Repair, Incidence of Applicable Disorders
• Exhibit 1-13: Applications of Fibrin and Other Sealants
• Exhibit 1-14: Surgical Procedures Using Fibrin and Other Sealant Products (2006-2011)
• Exhibit 1-15: Surgical Indications for High Strength Glues (Europe - 2006)
• Exhibit 2-1: Factors That Affect Wound Healing
• Exhibit 2-2: Timescales for Development of Closure and Sealant Products
• Exhibit 2-3: Variables Associated With Clinical Evaluation of Closure and Securement, and Related Products
• Exhibit 3-1: Companies Commercializing Technologies in the Surgical Suture and Staples Category
• Exhibit 3-2: Worldwide Sutures and Staples, Market Forecast, 2006-2011
• Exhibit 3-3: Worldwide Suture and Staples Market 2006, Share by Supplier
• Exhibit 3-4: Companies Commercializing First Aid Technologies Often Used as Tapes for Closure
• Exhibit 3-5: Worldwide Tapes Market Forecast, 2006-2011
• Exhibit 3-6: Worldwide Tapes for Closure Market Share, 2006, by Supplier
• Exhibit 3-7: Companies Commercializing Technologies in the Hemostat Category
• Exhibit 3-8: Worldwide Hemostats Market Forecast, 2006-2011
• Exhibit 3-9: Worldwide Hemostats Market Share, 2006, by Supplier
• Exhibit 3-10: Companies Commercializing Technologies in the Sealants Category
• Exhibit 3-11: Worldwide Sealants Market Forecast, 2006-2011
• Exhibit 3-12: Worldwide Sealants Market Share, 2006, by Supplier
• Exhibit 3-13: Companies Commercializing Cyanoacrylate-based High Strength Medical Adhesives
• Exhibit 3-14: Worldwide High Strength Glues Market Forecast, 2006-2011
• Exhibit 3-15: Worldwide High Strength Glues Market Share 2006, by Supplier
• Exhibit 3-16: Regulatory Status of Surgical Sealant Products
• Exhibit 3-17: Companies Commercializing Technologies in the Post-Operative Adhesion Category
• Exhibit 3-18: Worldwide Post Operative Adhesion Prevention Market Forecast, 2006-2011
• Exhibit 3-19: Worldwide Post Operative Adhesion Prevention Market Share, 2006, by Supplier
• Exhibit 3-20: Size and Growth of Wound Closure and Securement Market, World and Selected Countries, 2006
• Exhibit 3-21: Wound Closure Market 2006, by Product Segments: The Major American Countries
• Exhibit 3-22: Wound Closure Market 2006, by Product Segments: Japan
• Exhibit 3-23: Wound Closure Market 2006, by Product Segments: Major European Countries
• Exhibit 4-1: Advanced Medical Solutions, selected financial data for 12 months to December 31 2005 and 2004
• Exhibit 4-2: Angiotech Pharmaceuticals financial data for the quarter ending September 30th
• Exhibit 4-3: Anika Therapeutics selected financial data
• Exhibit 4-4: Baxter financial data, $millions
• Exhibit 4-5: B Braun financial data, € millions
• Exhibit 4-6: CryoLife financial results, 2005
• Exhibit 4-7: Johnson & Johnson key financial data; $ millions
• Exhibit 4-9: LifeCore Biomedical financial data
• Exhibit 4-10: Nycomed topline financial data; € millions
• Exhibit 4-11: Omrix topline financial data; $ millions
• Exhibit 4-12: Pharming financial data € 000s