Methodology

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Technologies, Products and Trends in the
Worldwide Soft Tissue Securement Market

April 2003

Report #M450

· 350 pages   · 50 Exhibits   · 109 Company Profiles   · Pub. Date April 2003   · Report #M450

This report details the current and projected market for the full range of products for soft tissue securement including adhesion prevention, glues, sealants, soft tissue anchors, hemostats and others. The report examines the clinical and technology developments underlying this huge and evolving worldwide market, with data on products in development and on the market; market size and forecast; competitor market shares; competitor profiles; and market opportunity. 

Table of Contents

Executive Summary

Surgical Closure and Securement ‑ An Important Healthcare Segment

Background

Demographics

Patient Driven Product Selection

Mechanisms of Repair

Commercial Imperatives

Industry Consolidation

Clinical Caseload

Market Segmentation and Dynamics

New Applications for Adjunctive Products for Surgical Closure and Securement

Benefits of Adjunctive Products for Surgical Closure and Securement

History of Use: Adjunctive Products for Surgical Closure and Securement

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

1.1.1          Skin Surface Tissues and Organs

1.1.2          Internal Tissues and Organs

1.2       Wound Classification and Types

1.2.1          Surgical Wounds

1.2.1.1       Cardiovascular

1.2.1.1.1          Introduction

1.2.1.1.2          Coronary Heart Disease

1.2.1.1.3          Myocardial Infarction

1.2.1.1.4          Congestive Heart Failure

1.2.1.1.5          Dysfunctional Heart Valves

1.2.1.1.6          Peripheral Vascular Disorders

1.2.1.1.7          Abnormal Aortic Aneurysms

1.2.1.1.8          Drivers of Caseloads for Cardiac Surgery

1.2.1.2       Neurological

1.2.1.2.1          Introduction

1.2.1.2.2          Stroke

1.2.1.2.3          Parkinson’s

1.2.1.2.4          Epilepsy

1.2.1.2.5          Traumatic Injury

1.2.1.2.6          Peripheral nerve treatment

1.2.1.2.7          Neurology Drivers

1.2.1.3       Orthopaedic

1.2.1.3.1          Introduction

1.2.1.3.2          Cartilage Repair

1.2.1.3.3          Ligament Damage

1.2.1.3.4          Other Joints

1.2.1.3.5          Bone Graft Materials

1.2.1.3.6          Vertebral Disc Repair

1.2.1.3.7          Drivers of Orthopedic Surgery

1.2.1.4       Urological

1.2.1.4.1          Introduction

1.2.1.4.2          Incontinence

1.2.1.4.3          Drivers of Urological Surgery

1.2.1.5       Skin

1.2.1.5.1          Introduction

1.2.1.5.2          Burns

1.2.1.5.3          Pressure Ulcers

1.2.1.5.4          Diabetic Ulcers

1.2.1.5.5          Venous Ulcers

1.2.1.5.6          Plastic Surgery

1.2.1.6       Fibrin Glue and Sealants as a Vital Tools in the Surgeon’s Armamentarium

1.2.1.7       Uses of High Strength Glues in Surgical Applications

1.2.2          Uses of Resorbable Biomaterials in the Clinic

Section 2:        Science, Technology, Development, Clinical and Regulatory Challenges

2.1       Tissue Healing

2.2       Development, Clinical, Regulatory  and Cost-Effectiveness Challenges

2.2.1          Development

2.2.2          Delivery Systems

2.2.3          Cost Effectiveness

2.2.4          Clinical

2.2.5          Regulatory

Section 3:        Products, Technologies, and Forecast Opportunity

3.1       Overview

3.2       Sutures and Staples

3.2.1          Competitors and Products

3.2.2          Products in Development

3.2.3          Market Analysis and Forecast

3.3       Tapes

3.3.1          Competitors and Products

3.3.2          Products in Development

3.3.3          Market Analysis and Forecast

3.4       Hemostats

3.4.1          Competitors and Products

3.4.2          Products in Development

3.4.3          Market Analysis and Forecasts

3.5       Fibrin and Sealant Products

3.5.1          Competitors and Products

3.5.2          Products in Development

3.5.3          Fibrin and Sealant Market and Competitive Activity

3.6       Medical Adhesives

3.6.1          Competitors and Products

3.6.2          Products in Development

3.6.3          Market Analysis and Forecasts

3.7       Post-Surgical Adhesion Prevention

3.7.1          Competitors and Products

3.7.2          Products in Development

3.7.3          Market Analysis and Forecasts

3.8       Resorbable Soft Tissue Anchors and Devices

3.8.1          Competitors and Products

3.8.2          Products in Development

3.8.3          Market Analysis and Forecasts

Section 4:        Company Profiles

3D Matrix Inc.

Aaron Medical Industries (Bovie Medical)

Advanced Materials Design

Advanced Medical Solutions

Anika Therapeutics Inc.

Alliance Pharmaceuticals Inc.

ARC Pharmaceuticals

Arthrex Inc.

Aventis Behring

Axya Medical Inc.

Bard Medical Division / C.R. Bard, Inc.

Baxter International Inc.

Becton Dickinson and Company

Biocomposites Inc.

Biocoral Inc.

Biomet Inc.

Bionx Implants (CONMED)

Biosyntech

Biota Ltd.

Biovascular (Synovis Life Technologies)

B. Braun Melsungen AG

Chemence Limited

Closure Medical Corporation

Cohesion Technologies Inc.

CollaGenex Pharmaceuticals

Collagen Matrix Inc

Collgard Biopharmaceuticals

Confluent Surgical Inc.

CONMED Corporation

Cook Group Ltd

CryoLife, Inc.

CSMG (Consortium Service Management Group)

CuraMedical BV

Datascope Corporation

Durect Corporation

Johnson & Johnson (Ethicon, DePuy, Mitek)

Encelle, Inc.

Envisiontec GmbH

Fehling Medical AG/Berlin Heart

FibroGen, Inc.

Fidia Advanced Biopolymers

Flamel Technologies SA

Focal Inc.

Fusion Medical Technologies Inc.

FzioMed Inc.

GEM SRI

Genzyme Biosurgery Inc.

Gliatech, Wright Medical Inc.

Glustitch Inc.

Haemacure Corporation

HAPTO Biotech

Harvest Technologies Corporation

HemCon, Inc.

Inion Ltd.

Integra Life Sciences

Interface Biologics

Interpore Cross International

Instrument Makar

IsoTis NV

Isto Technologies, Inc.

Kaketsuken

Kensey Nash Corporation

Keratec

King Pharmaceuticals

Kinetic Concepts Inc.

Lifecell Corporation

Lifecore Biomedical, Inc.

Life Medical Sciences Inc.

MacroPore Biosurgery Inc.

Marine Polymer Technologies

Medafor, Inc.

MedLogic Global Corporation

NanoMatrix, Inc.

Nycomed Pharma

Omrix biopharmaceuticals S.A.

Onux Medical Inc.

Organogenesis Inc.

Ortec International Inc.

Osteobiologics, Inc.

Osteotech, Inc.

Plasmaseal

Polyganics

Poly-Med, Inc.

Proctor and Gamble

Protein Polymer Technologies Inc.

PPL Therapeutics Ltd

Regen Inc.

Regeneration Technologies, Inc.

Scaffix International

Sciperio Inc.

Smith & Nephew plc

Spiration Inc.

Surgical Dynamics

Surgical Sealants Inc.

TEI Biosciences Inc.

Therics

Thermogenesis Corporation

Tissuemed Ltd

TiGenix N.V.

Triage Medical, Inc.

Tyco International Inc.

Verigen

Vivolution

Xylos Corporation

Appendix: List of Companies

Exhibit ES-1:  Recent Acquisitions within 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:  Availability of Sealant Products From Selected Companies

Exhibit ES-5:  Availability of High Strength Glue Products From Example Companies

Exhibit ES-6:  Incidence of Two Example Surgical Procedures with High Requirement for Adjunctive Products for Surgical Closure and Securement

Exhibit ES-7:  U.S. FDA Approved Uses of Sealants, Glues, and Hemostats

Exhibit ES-8:  Synthetic and Biological Sealant Competitors (Non-Fibrin Sealants)

Exhibit ES-9:  Selected High Strength Adhesive Companies and Their Strategies

Exhibit ES-10:  Selected Sealant Product Companies and Their Strategies

Exhibit ES-11:  Worldwide Growth in the Securement and Closure Market, 2001-2012

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:  Current Uses of Adjunctive Surgical Closure and Securement  Products

Exhibit 1-5:  2002, Worldwide Wound Incidence by Etiology

Exhibit 1-6:  Criteria for Adjunctive Use of Hemostats, Sealants, High Strength Adhesives, Adhesion Prevention Products, and Soft Tissue Securement Products for Surgery

Exhibit 1-7:  Surgical Procedures with Potential Requirements for Hemostats, Sealants, High Strength Adhesives, Adhesion Prevention Products, and Soft Tissue Securement Products.

Exhibit 1-8:  Potential for Cardiovascular Applications, Incidences of Applicable Surgical Disorders (000s), 2002

Exhibit 1-9:  Potential for Neurological Applications, Incidences of Applicable Disorders (000s), 2002

Exhibit 1-10:  Potential for Orthopedic Applications, Incidence of Applicable Disorders (000s), 2002

Exhibit 1-11:  Potential for Urological Applications, Incidence of Applicable Disorders (000s), 2002

Exhibit 1-12:  Potential for Dermal Repair, Incidence of Applicable Disorders (000s), 2002

Exhibit 1-13:  Applications of Fibrin and Other Sealants:

Exhibit 1-14:  Surgical Procedures Using Fibrin and Other Sealant Products (1990-2002)

Exhibit 1-15:  Surgical Indications for High Strength Glues (Europe - 2002)

Exhibit 2-1:  Timescales for Development of Closure and Sealant Products

Exhibit 2-2 :  Variables associated with Clinical Evaluation of Closure and Securement, and Related Products

Exhibit 2-3:  Clinical Development and Approvals (USA)

Exhibit 3-1:  Companies Commercializing Technologies in the Surgical  Suture and Staples Category

Exhibit 3-2:  Worldwide Sutures and Staples, Market Forecast, 2001-2012

Exhibit 3-3:  2002, Worldwide Suture and Staples Market, Share by Supplier

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

Exhibit 3-5:  Worldwide Tapes Market Forecast, 2001-2012

Exhibit 3-6:  2002, Worldwide Tapes for Closure Market Share by Supplier

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

Exhibit 3-8:  Worldwide Hemostats Market Forecast, 2001-2012

Exhibit 3-9:  2002, Worldwide Hemostats Market Share by Supplier

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

Exhibit 3-11:  Worldwide Sealants Market Forecast, 2001-2012

Exhibit 3-12:  2002, Worldwide Sealants Market Share by Supplier

Exhibit 3-13:  Companies Commercializing Technologies in the Medical Adhesives Category

Exhibit 3-14:  Worldwide High Strength Glues Market Forecast, 2001-2012

Exhibit 3-15:  2002, Worldwide High Strength Glues Market Share by Supplier

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

Exhibit 3-17:  Worldwide Post Operative Adhesion Prevention Market Forecast, 2001-2012

Exhibit 3-18:  2002, Worldwide Post Operative Adhesion Prevention Market Share by Supplier

Exhibit 3-19:  Companies Commercializing Technologies in the Resorbable Soft Tissue Attachment Category

Exhibit 3-20:  Worldwide Soft Tissue Anchors and Devices Market Forecast, 2001-2012

Exhibit 3-21:  2002, Worldwide Soft Tissue Anchors and Devices Market Share by Supplier

Technologies, Products and Trends in the Worldwide Soft Tissue Securement Market

April 2003
 

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