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Surgical Sealants, Glues and Wound Closure 2009-2013

Worldwide Surgical Sealants, Glues, Wound Closure and Anti-Adhesion Markets, 2009-2013

· 314 pages   · 75 Exhibits   · 135 Company Profiles   · Report #S175   · Published December 2008

This report details the complete range of sealants & glues technologies used in traumatic, surgical and other wound closure, from tapes, sutures and staples to hemostats, fibrin sealants/glues and medical adhesives. The report details current clinical and technology developments in this huge and rapidly growing worldwide market, with data on products in development and on the market; market size and forecast; competitor market shares; competitor profiles; and market opportunity. 

This report is a market and technology assessment and forecast of products in wound closure. The report details the current and emerging products, technologies and markets involved in wound closure and sealing using sutures and staples, tapes, hemostats, fibrin and sealant products and medical adhesives. The report provides a worldwide current and annual forecast to 2013 of the markets for these technologies, with particular emphasis on the market impact of new technologies through the coming decade.  The report provides specific forecasts and shares of the worldwide market by segment for the U.S., Europe (United Kingdom, German, France, Italy, BeNeLux), Latin America, Japan and Rest of World.

The report provides background data on the surgical, disease and traumatic wound patient populations targeted by current technologies and those under development, and the current clinical practices in the management of these patients, including the dynamics among the various clinical specialties or subspecialties vying for patient population and facilitating or limiting the growth of technologies.

The report establishes the current worldwide market size for major technology segments as a baseline for and projecting growth in the market over a ten-year forecast. The report also assesses and projects the composition of the market as technologies gain or lose relative market performance over this period.

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

1.5.1         Cardiovascular

1.5.1.1         Coronary Heart Disease

1.5.1.2         Dysfunctional Heart Valves

1.5.1.3         Peripheral Vascular Disorders

1.5.1.4         Abnormal Aortic Aneurysms

1.5.1.5         Drivers of Caseloads for Cardiac Surgery

1.5.2         Neurological

1.5.2.1         Stroke

1.5.2.2         Parkinson’s Disease

1.5.2.3         Epilepsy

1.5.2.4         Traumatic Injury

1.5.2.5         Peripheral Nerve Treatment

1.5.2.6         Neurology Drivers

1.5.3         Orthopedic

1.5.3.1         Hip Replacements

1.5.3.2         Knee Replacements

1.5.3.3         Cartilage Repair

1.5.3.4         Ligament Damage

1.5.3.5         Bone Grafting

1.5.3.6         Vertebral Disc Repair

1.5.3.7         Drivers of Orthopedic Surgery

1.5.4         Urological

1.5.4.1         Incontinence

1.5.4.2         Drivers of Urological Surgery

1.5.5         Skin

1.5.5.1         Burns

1.5.5.2         Pressure Ulcers

1.5.5.3         Diabetic Ulcers

1.5.5.4         Venous Ulcers

1.5.5.5         Plastic Surgery

1.6         The Role of Modern Sealant, Securement and Hemostatic Products in Surgery

1.6.1         Fibrin Sealants

1.6.2         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, Staples, and Other Mechanical Closure Devices

3.3.1         Competitors and Products

3.3.2         Suppliers

3.3.3         Product Development

3.3.4         Market Analysis and Forecast

3.4         Tapes

3.4.1         Competitors and Products

3.4.2         Products in Development

3.4.3         Market Analysis and Forecast

3.5         Hemostats

3.5.1         Competitors and Products

3.5.2         Products in Development

3.5.3         Market Analysis and Forecasts

3.6         Fibrin and Other Sealant Products

3.6.1         Competitors and Products

3.6.2         Products in Development

3.6.3         Fibrin and Sealant Market and Competitive Activity

3.7         High-Strength Medical Adhesives

3.7.1         Competitors and Products

3.7.2         Products in Development

3.7.3         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         United States

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         3DM, Inc. (3D-Matrix, Ltd.)

4.2         3M

4.2.1         Products

4.2.1.1         Steri-Strip and Other Wound Closure Products

4.2.2         Financial

4.3         Abbott Vascular

4.3.1         Products

4.3.1.1         Perclose A-T, Perclose ProGlide and Prostar XL

4.3.1.2         StarClose

4.3.1.3         Chito-Seal

4.3.2         Financials

4.4         AccessClosure, Inc.

4.4.1         Product

4.4.1.1         Mynx

4.5         Adhezion Biomedical, LLC

4.6         Advanced Medical Solutions plc

4.6.1         Products

4.6.1.1         LiquiBand

4.6.2         Financials

4.7         Allerderm

4.8         Angiotech Pharmaceuticals, Inc.

4.8.1         Products

4.8.1.1         CoSeal

4.8.1.2         Vitagel

4.8.1.3         Adhibit

4.8.1.4         Quill

4.8.1.5         LOOK Sutures

4.8.1.6         Sharpoint

4.8.2         Financials

4.9         Anika Therapeutics, Inc.

4.9.1         Products

4.9.1.1         Incert-S

4.9.2         Financials

4.10       ARC Pharmaceuticals

4.10.1         Product

4.10.1.1       ARCAD

4.11       Arch Therapeutics, Inc.

4.12       ArthroCare Corporation

4.12.1         Products

4.12.1.1       MagnumWire

4.12.2         Financials

4.13       Aso LLC

4.14       Aspen Surgical Products

4.15       Atrax Medical Group

4.16       Avery Dennison

4.17       B. Braun Melsungen AG

4.17.1         Products

4.17.1.1       Histoacryl

4.17.1.2       Lysostypt

4.17.1.3       Gelita Local Hemostat

4.17.2         Financials

4.18       Bastos Viegas, s.a.

4.19       Baxter International Inc.

4.19.1         Products

4.19.1.1       Tisseel/Tissucol

4.19.1.2       FloSeal

4.19.1.3       CoSeal

4.19.1.4       TissuFleece E

4.19.1.5       ARTISS

4.19.2         Financials

4.20       Bayer HealthCare

4.21       BD (Becton, Dickinson and Company)

4.21.1         Products

4.21.1.1       Autoclip

4.22       Berlin Heart GmbH

4.22.1         Products

4.22.1.1       Gluetiss

4.23       Bernsco Surgical Supply

4.24       Biocoral Inc.

4.24.1         Products

4.24.1.1       Autologous Biological Glue

4.25       BioCore Medical Technologies, Inc.

4.26       Biogentis, Inc.

4.26.1         Products

4.26.1.1       SkinLink

4.27       Biomet Inc.

4.27.1         Product

4.27.1.1       GPS III System

4.27.1.2       Pro Osteon/BioPlex (Interpore Cross)

4.28       BIOSTER a.s.

4.29       BioSyntech Canada Inc.

4.30       BSN Medical

4.31       C.R. Bard

4.31.1         Bard Medical

4.31.2         Davol Inc.

4.31.3         Financials

4.32       Cardiovascular Sciences, Inc.

4.33       Carl Auffarth GmbH & Co. KG

4.34       Cardiva Medical, Inc.

4.35       Ceremed, Inc.

4.36       Chemence Ltd.

4.37       Chemopharma, s.a.

4.38       Cohera Medical, Inc.

4.38.1         Products

4.38.1.1       TissuGlu

4.39       Collagen Matrix, Inc.

4.39.1....... Products

4.39.1.1       Porous Collagen Dental Dressings

4.39.1.2       Collatene Fibrillar Collagen Dental Dressing

4.40       Coloplast A/S

4.41       ConvaTec

4.42       Covidien Ltd.

4.42.1         Products

4.42.1.1       DuraSeal

4.42.1.2       SprayGel

4.42.1.3       Indermil (Syneture)

4.42.1.4       PleuraSeal

4.42.1.5       VascuSeal

4.42.1.6       SprayShield

4.42.2         Financials

4.43       CryoLife Inc.

4.43.1         Products

4.43.1.1       BioGlue Surgical Adhesive

4.43.1.2       BioFoam Adhesive

4.43.1.3       Hemostase MPH

4.43.2         Financials

4.44       CSIRO PhotoMedical Technologies

4.44.1         Products

4.44.1.1       PhotoSeal

4.45       CSL Behring

4.45.1         Products

4.45.1.1       Beriplast P Combi-Set (Fibrin Sealant)

4.45.1.2       Beriplex P/N, Confidex

4.45.1.3       Fibrogammin P

4.45.1.4       Haemocomplettan P

4.45.1.5       Kybernin P

4.46       CSMG Technologies, Inc.

4.46.1         Live Tissue Connect, Inc.

4.47       CuraMedical BV

4.47.1         Products

4.47.1.1       Curacel

4.47.1.2       Curacoll

4.47.1.3       Curaspon

4.48       Cypress Medical Products

4.49       Derma Sciences, Inc.

4.50       Distrex Ibérica S.A.

4.51       DuPont Applied BioSciences

4.52       Entegrion, Inc.

4.52.1         Products

4.52.1.1       Stasilon FR

4.52.1.2       Stasix

4.52.1.3       Resusix

4.53       FibroGen, Inc.

4.54       Fidia Advanced Biopolymers

4.54.1         Products

4.55       Flamel Technologies SA

4.56       Forticell Bioscience

4.56.1         Products

4.56.1.1       Fibrin MB

4.57       FzioMed Inc.

4.57.1         Products

4.57.1.1       Oxiplex/SP Gel

4.57.1.2       MediShield

4.57.1.3       Intercoat

4.57.1.4       Laresse Dermal Filler

4.58       Gelita Medical BV

4.58.1         Products

4.58.1.1       Gelita-Spon

4.58.1.2       Gelitacel

4.58.1.3       Geli Putty

4.59       GEM srl

4.60       Genzyme Biosurgery Inc.

4.60.1         Products

4.60.1.1       Sepraflm

4.60.1.2       Seprapack and Sepragel ENT

4.60.1.3       SeprameshIP

4.60.1.4       Epicel

4.60.1.5       FocalSeal

4.60.2         Financial

4.61       GluStitch, Inc.

4.61.1         Products

4.61.1.1       GluStitch

4.61.1.2       GluSeal

4.61.1.3       PeriAcryl

4.61.1.4       GluShield

4.61.1.5       GluSite

4.62       Graceduty Company Limited

4.63       GramsMed, LLC

4.64       Haemacure Corporation

4.64.1         Products

4.64.1.1       Hemaseel HMN

4.64.1.2       Hemaseel Thrombin

4.64.2         Financial Data

4.65       HAPTO Biotech Israel Ltd.

4.66       Hartmann Group

4.67       Harvest Technologies Corporation

4.68       HemCon Medical Technologies, Inc.

4.68.1         Products

4.68.1.1       HemCon Bandage

4.68.1.2       ChitoFlex

4.68.1.3       HemCon Dental Dressing

4.68.1.4       KytoStat

4.68.1.5       m•doc

4.69       Hemostasis, LLC

4.70       HyperBranch Medical Technology, Inc.

4.71       Incisive Surgical, Inc.

4.72       Innovasa Corporation

4.73       Integra Lifesciences Corporation

4.73.1         Products

4.73.2         Financials

4.74       I-Therapeutix, Inc.

4.75       Johnson & Johnson

4.75.1         Ethicon, Inc. and Ethicon Endo-Surgery, Inc.

4.75.1.1       Evicel/Quixil

4.75.1.2       Dermabond

4.75.1.3       Omnex

4.75.1.4       Gynecare Interceed

4.75.1.5       Hemostasis Products

4.75.1.6       Surgical Sutures and Skin Closures

4.75.2         DePuy Spine

4.75.3         Financials

4.76       Kaketsuken (Chemo-Sero-Therapeutic Research Institute)

4.77       Kensey Nash Corporation

4.77.1         Product

4.77.1.1       Angio-Seal

4.78       Kimberly-Clark Health Care

4.78.1         Products

4.78.1.1       InteguSeal

4.78.2         Financials

4.79       Kinetic Concepts, Inc.

4.80       King Pharmaceuticals, Inc.

4.80.1         Products

4.80.1.1       Thrombin-JMI

4.80.2         Financials

4.81       Kookbo Chemicals Co., Ltd. (KB Chem.)

4.82       Laboratoires Urgo (Urgo Medical)

4.83       Lewis Medical Supplies

4.84       LifeBond Ltd.

4.85       Lifecore Biomedical, Inc.

4.86       Lohmann & Rauscher

4.87       Marine Polymer Technologies

4.88       Medafor, Inc.

4.89       Medi Surgichem Pvt. Ltd.

4.90       MedTrade Products, Ltd.

4.91       Meyer-Haake GmbH Medical Innovations

4.92       Mölnlycke Health Care AB

4.93       Morris Innovative

4.94       Motex Healthcare Corp.

4.95       Myco Medical

4.96       NeatStitch Ltd.

4.97       Neose Technologies Inc. (Novo Nordisk)

4.98       Nycomed

4.98.1         Products

4.99       Omrix Biopharmaceuticals Inc.

4.99.1         Products

4.99.1.1       Evicel/Quixil

4.99.1.2       Fibrin Patch

4.99.1.3       Evithrom

4.99.1.4       Adhexil

4.99.2         Financials

4.100    Pac-Kit Safety Equipment

4.101    Pfizer Inc.

4.101.1         Product

4.101.1.1    Gelfoam

4.101.2         Financials

4.102    Pharming Group NV

4.102.1         Financials

4.103    Plasma Technologies, Inc.

4.104    PlasmaSeal

4.105    Pluromed, Inc.

4.106    Polyganics

4.107    Polyheal Ltd.

4.108    ProFibrix BV

4.109    Progressive Surgical, Ltd.

4.110    Protein Polymer Technologies, Inc.

4.111    Radi Medical Systems AB

4.111.1         Products

4.111.1.1    FemoSeal

4.112    Resorba Wundversorgung GmbH & Co. KG

4.113    Scapa Group plc

4.114    Scion Cardio-Vascular, Inc.

4.115    Sea Run Holdings

4.116    Seton

4.117    Smith & Nephew plc

4.118    Starch Medical, Inc.

4.118.1         Products

4.118.1.1    PerClot

4.118.1.2    StarFoam

4.118.1.3    SuperClot

4.119    Stereoplast Ltd.

4.120    Sutura, Inc.

4.120.1         Products

4.120.1.1    SuperStitch

4.121    Synovis Life Technologies

4.122    SyntheMed, Inc.

4.123    Teleflex Medical

4.123.1         Products

4.123.1.1    Deknatel Sutures

4.123.1.2    Weck

4.123.2         Financial

4.124    ThermoGenesis Corporation

4.124.1         Products

4.124.1.1    CryoSeal FS System

4.124.1.2    Thrombin Processing Device (TPD)

4.125    Therus Corporation

4.126    Thrombotargets Corp.

4.126.1         Products

4.126.1.1    TT-103MH

4.127    Tissuemed Ltd.

4.127.1         Products

4.128    TraumaCure, Inc.

4.128.1         Products

4.128.1.1    WoundStat

4.129    TyRx Pharma Inc.

4.130    Vascular Solutions, Inc.

4.131    Vectura Group plc

4.131.1         Product

4.131.1.1    Adept

4.132    Vivostat A/S

4.132.1         Products

4.132.1.1    Vivostat

4.133    Z-Medica Corporation

4.134    Zimmer

4.135    ZymoGenetics, Inc.

4.135.1         Products

4.135.1.1    Recothrom

4.135.2         Financials

APPENDIX: LIST OF COMPANIES

List of Exhibits

Exhibit ES-1: Recent Acquisitions in the Securement Segment

Exhibit ES-2: Introducers 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, 2006–2013

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: Prevalence of Different Wound Types, 2008

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, Worldwide

Exhibit 1-8: Potential for Cardiovascular Applications, Prevalence of Applicable Surgical Applications

Exhibit 1-9: Potential for Neurological Applications, Prevalence of Applicable Disorders

Exhibit 1-10: Potential for Orthopedic Applications, Frequency of Major Surgical Interventions

Exhibit 1-11: Potential for Urological Applications, Prevalence of Applicable Disorders

Exhibit 1-12: Potential for Dermal Repair, Prevalence of Applicable Disorders

Exhibit 1-13: Applications of Fibrin and Other Sealants

Exhibit 1-14: Surgical Procedures Using Fibrin and Other Sealant Products (2009–2013)

Exhibit 1-15: Surgical Indications for High-Strength Glues (Europe, 2008)

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: Manufacturers of Surgical Sutures, Staples, Clips, and Other Mechanical Closure Devices

Exhibit 3-2: Worldwide Sutures and Staples Market Forecast, 2006–2013

Exhibit 3-3: Worldwide Suture and Staples Market 2007, Share by Supplier

Exhibit 3-4: Companies Commercializing First Aid Technologies Often Used as Tapes for Closure

Exhibit 3-5: Worldwide Tapes Market Forecast, 2006-2013

Exhibit 3-6: Worldwide Tapes for Closure Market Share, 2007, by Supplier

Exhibit 3-7: Companies Commercializing Technologies in the Hemostat Category

Exhibit 3-8: Worldwide Hemostats Market Forecast, 2009–2013

Exhibit 3-9: Worldwide Hemostats Market Share, 2007, by Supplier

Exhibit 3-10: Companies Commercializing Technologies in the Sealants Category

Exhibit 3-11: Worldwide Sealants Market Forecast, 2006-2013

Exhibit 3-12: Worldwide Sealants Market Share, 2007, by Supplier

Exhibit 3-13: Companies Commercializing Cyanoacrylate-based High-Strength Medical Adhesives

Exhibit 3-14: Worldwide High-Strength Glues Market Forecast, 2006–2013

Exhibit 3-15: Worldwide High-Strength Glues Market Share 2007, by Supplier

Exhibit 3-16: Companies Commercializing Technologies in the Post-Surgical Adhesion Prevention Category

Exhibit 3-17: Worldwide Post-Operative Adhesion Prevention Market Forecast, 2006–2013

Exhibit 3-18: Worldwide Post Operative Adhesion Prevention Market Share, 2007, by Supplier

Exhibit 3-19:  Size and Growth of Wound Closure and Securement Market, World and Selected Countries, 2007

Exhibit 3-20: Wound Closure Market 2007, by Product Segments: The Major American Countries

Exhibit 3-21: Wound Closure Market 2007, by Product Segments: Japan

Exhibit 3-22: Wound Closure Market 2007, by Product Segments: Major European Countries

Exhibit 3-23: Wound Closure Market 2007, by Product Segments: Rest of World

Exhibit 3-24: Growth Forecast for Closure and Securement Market, 2006–2013

Exhibit 4-1: 3M, Selected Financial Data for 2007

Exhibit 4-2: Abbott Laboratories, Selected Financial Data for the First Nine Months of 2008

Exhibit 4-3: Advanced Medical Solutions’ Selected Financial Data for 2006 and 2007

Exhibit 4-4: Angiotech Pharmaceuticals’ Statement of Income for 2nd Quarter, 2008 (Ending June 30)

Exhibit 4-5: Anika Therapeutics’ Financial Results for 2006 and 2007

Exhibit 4-6: ArthroCare Corporation Financial Data

Exhibit 4-7: B. Braun Financial Data

Exhibit 4-8: Baxter International Financial Data

Exhibit 4-9: C.R. Bard, Inc. Financial Data for Nine Months Ending Sept. 30

Exhibit 4-10: Cardiovascular Sciences, Inc. Financial Data

Exhibit 4-11: Covidien, Selected Financial Data, 2007

Exhibit 4-12: CryoLife Financial Results, 2006 and 2007

Exhibit 4-13: Haemacure Corporation, Selected Financial Data

Exhibit 4-14: Integra Lifesciences, Financial Data

Exhibit 4-15: Johnson & Johnson Key Financial Data, 2006 and 2007

Exhibit 4-16: Kimberly-Clark Health Care Financial Data

Exhibit 4-17: King Pharmaceuticals Financial Data

Exhibit 4-18: Overview of Omrix’ Biosurgical Product Pipeline

Exhibit 4-19: Omrix Biopharmaceuticals Financial Data

Exhibit 4-20: Pfizer Financial Data for 2007 and 2006

Exhibit 4-21: Pharming Financial Data

Exhibit 4-22: Teleflex Inc. Financial Data

Exhibit 4-23: Vascular Solutions Financial Results

Exhibit 4-24: ZymoGenetics Financial Data, 3^rd Quarter, 2008

Worldwide Surgical Sealants, Glues, Wound Closure and Anti-Adhesion Markets, 2009-2013.  December 2008

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Revised: 12/30/08