· 322 pages
· 75 Exhibits
· 136 Company Profiles
· Report #S175
· Published January 2009
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 surgical sealants,
glues, hemostasis, other wound closure and anti-adhesion. 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, medical adhesives and products
to prevent surgical adhesions. 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
4.3
Abbott Vascular
4.4
AccessClosure, Inc.
4.5
Adhezion Biomedical, LLC
4.6
Advanced Medical Solutions plc
4.7
Allerderm
4.8
Angiotech Pharmaceuticals, Inc.
4.9
Anika Therapeutics, Inc.
4.10 ARC
Pharmaceuticals
4.11 Arch
Therapeutics, Inc.
4.12 ArthroCare
Corporation
4.13 Aso LLC
4.14 Aspen
Surgical Products
4.15 Atrax
Medical Group
4.16 Avery
Dennison
4.17 B. Braun
Melsungen AG
4.18 Bastos
Viegas, s.a.
4.19 Baxter
International Inc.
4.20 Bayer
HealthCare
4.21 BD (Becton,
Dickinson and Company)
4.22 Berlin Heart
GmbH
4.23 Bernsco
Surgical Supply
4.24 Biocoral
Inc.
4.25 BioCore
Medical Technologies, Inc.
4.26 Biogentis,
Inc.
4.27 Biomet Inc.
4.28 BIOSTER a.s.
4.29 BioSyntech
Canada Inc.
4.30 BSN Medical
4.31 C.R. Bard
4.32
Cardiovascular Sciences, Inc.
4.34 Carl
Auffarth GmbH & Co. KG
4.35 Cardiva
Medical, Inc.
4.36 Ceremed,
Inc.
4.37 Chemence
Ltd.
4.38 Chemopharma,
s.a.
4.39 Cohera
Medical, Inc.
4.40 Collagen
Matrix, Inc.
4.41 Coloplast
A/S
4.42 ConvaTec
4.43 Covidien
Ltd.
4.44 CryoLife
Inc.
4.45 CSIRO
PhotoMedical Technologies
4.46 CSL Behring
4.47 CSMG
Technologies, Inc.
4.48 CuraMedical
BV
4.49 Cypress
Medical Products
4.50 Derma
Sciences, Inc.
4.51 Distrex
Ibérica S.A.
4.52 DuPont
Applied BioSciences
4.53 Entegrion,
Inc.
4.54 FibroGen,
Inc.
4.55 Fidia
Advanced Biopolymers
4.56 Flamel
Technologies SA
4.57 Forticell
Bioscience
4.58 FzioMed Inc.
4.59 Gelita
Medical BV
4.60 GEM srl
4.61 Genzyme
Biosurgery Inc.
4.62 GluStitch,
Inc.
4.63 Graceduty
Company Limited
4.64 GramsMed,
LLC
4.65 Haemacure
Corporation
4.66 HAPTO
Biotech Israel Ltd.
4.67 Hartmann
Group
4.68 Harvest
Technologies Corporation
4.69 HemCon
Medical Technologies, Inc.
4.70 Hemostasis,
LLC
4.71 HyperBranch
Medical Technology, Inc.
4.72 Incisive
Surgical, Inc.
4.73 Innovasa
Corporation
4.74 Integra
Lifesciences Corporation
4.75 I-Therapeutix,
Inc.
4.76 Johnson &
Johnson (Ethicon, Ethicon Endo-Surgery, DePuy Spine)
4.77 Kaketsuken
(Chemo-Sero-Therapeutic Research Institute)
4.78 Kensey Nash
Corporation
4.79
Kimberly-Clark Health Care
4.80 Kinetic
Concepts, Inc.
4.81 King
Pharmaceuticals, Inc.
4.82 Kookbo
Chemicals Co., Ltd. (KB Chem.)
4.83 Laboratoires
Urgo (Urgo Medical)
4.84 Lewis
Medical Supplies
4.85 LifeBond
Ltd.
4.86 Lifecore
Biomedical, Inc.
4.87 Lohmann &
Rauscher
4.88 Marine
Polymer Technologies
4.89 Medafor,
Inc.
4.90 Medi
Surgichem Pvt. Ltd.
4.91 MedTrade
Products, Ltd.
4.92 Meyer-Haake
GmbH Medical Innovations
4.93 Mölnlycke
Health Care AB
4.94 Morris
Innovative
4.95 Motex
Healthcare Corp.
4.96 Myco Medical
4.97 NeatStitch
Ltd.
4.98 Neose
Technologies Inc. (Novo Nordisk)
4.99 Nycomed
.100 Omrix
Biopharmaceuticals Inc.
4.101 Pac-Kit Safety
Equipment
4.102 Pfizer Inc.
4.103 Pharming Group NV
4.104 Plasma Technologies,
Inc.
4.105 PlasmaSeal
4.106 Pluromed, Inc.
4.107 Polyganics
4.108 Polyheal Ltd.
4.109 ProFibrix BV
4.110 Progressive Surgical,
Ltd.
4.111 Protein Polymer
Technologies, Inc.
4.112 Radi Medical Systems AB
4.113 Resorba Wundversorgung
GmbH & Co. KG
4.114 Scapa Group plc
4.115 Scion Cardio-Vascular,
Inc.
4.116 Sea Run Holdings
4.117 Seton
4.118 Smith & Nephew plc
4.119 Starch Medical, Inc.
4.120 Steroplast Ltd.
4.121 Sutura, Inc.
4.122 Synovis Life
Technologies
4.123 SyntheMed, Inc.
4.124 Teleflex Medical
4.125 Tenaxis Medical, Inc.
4.126 ThermoGenesis
Corporation
4.127 Therus Corporation
4.128 Thrombotargets Corp.
4.129 Tissuemed Ltd.
4.130 TraumaCure, Inc.
4.131 TyRx Pharma Inc.
4.132 Vascular Solutions,
Inc.
4.133 Vectura Group plc
4.134 Vivostat A/S
4.135 Z-Medica Corporation
4.136 Zimmer
4.137 ZymoGenetics, Inc.
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, 2009–2013
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
Note: The report described above has been updated by
Report #S190, published
February 2012.
Patrick Driscoll
tel: +1.949.859.3401
tel: +1.949.891.1753 (google voice)
Methodology. MedMarket Diligence
Reports are produced through primary and secondary research. Data is
gathered from published sources on products and technologies on the
market and under development. Clinicians and industry representatives
are interviewed for their knowledge and insights on product development,
market development, clinical practice and trends associated with the
evolving use of technologies. Secondary data is used to corroborate and
support assessments and projections. Reports are written and researched
by industry insiders, whose familiarity with the companies, industry
dynamics and other marketplace specifics facilitate the research process
and ensure high quality and thorough reports.
Contact: Patrick Driscoll, (949)
859-3401. patrick<at>mediligence<dot>com.