Analysis of global markets for sealants, glues, hemostats, anti-adhesion

Sutures and staples are at an aging stage in their product life cycle; there are numerous predicate devices, and the materials are well established and cover most of the spectrum of clinical need for suturing. However, a great number of procedure-enhancing devices have been developed in the last seven years, particularly as minimally invasive surgery and robotics have created a need for new instrumentation to secure tissue. Good examples of this are the development of stapling devices for pneumostasis and securement devices for arthroscopy. This illustrates the fact that once clinical evaluation of a new product has been completed to the satisfaction of regulatory authorities for launch of the new product, incremental developments and clinical evaluations are usually continued throughout the lifetime of the product.

The MedMarket Diligence Report #S175 on surgical sealants and related products is widely read in the industry for its comprehensive global coverage, product and company detail, market specifics and insights, benefitting readers with competitive intelligence, market awareness and opportunities. See the complete description and table of contents here.

Similarly, a number of hemostats and devices for preparation of autologous fibrin sealant have also been available for some time for prevention of blood loss (e.g., from Harvest Technologies). These materials and devices are generally approved for hemostasis, and companies have attempted to develop new physical forms, mixes, and delivery systems to speed up and improve the usefulness of these products.

Commercial forms of pooled human fibrin have been used clinically outside of the United States for many years, for reasons of preventing infection; however these products did not reach this stage of clinical evaluation in the United States for many years. In 1996, the FDA approved the clinical investigation of fibrin sealants and a number of trials commenced. These resulted in a cascade of approvals for specific indications and claims, and considerable off-label use and clinical evaluation. Fibrin sealants have been employed and reported to prevent bleeding in many types of procedures including cardiovascular (e.g., restiotomy), neurological (e.g., craniotomy), orthopedic (e.g., knee replacement), spinal (e.g., vertebral fusion), cosmetic (e.g., breast augmentation) and digestive (e.g., closure of temporary colostomy).

Alternatives to fibrin sealant have been developed and launched with specific claims and targeted at specific indications. Cyanoacrylates have been employed as external suture replacements since 1997 in the United States. These materials started life as off-label sports injury products; they were approved with limited claims, which were then expanded to include “reduced injection risk,” and general use of these products for topical application is well established; reports from major suppliers suggest that approximately 20% of the accident and emergency opportunity for treating lacerations in the United States is penetrated by cyanoacrylate glue products.  

Variables Associated With Clinical Evaluation of Closure and Securement and Related Products
 

Variable

Rapid Evaluation

Delayed Evaluation

Expense

Low cost if short follow-up, (e.g., cuts and grazes) and low-cost procedure

High cost if long-term follow-up required, (e.g., ligament repair) and high cost procedure

Follow-up period

Some procedures require short follow-up periods (e.g., hemostasis endpoints and use of cyanoacrylate on cuts)

Some procedures require at least two years follow-up (e.g., musculoskeletal sports injuries)

Surgical setting

Community care (lacerations)

Theater (surgery)

Doctor’s surgery (accidents)

Critical care (e.g., burns)

Technology

Some devices and developments have predicate devices which allow more rapid approval. Autologous products are also relatively quick to develop

New biologicals, complex mixtures of biomaterials, and new chemical entities require extensive validation and testing

Device for delivery

Can accelerate clinical approval and improve clinical efficacy

Can complicate clinical development if both device and product are new
 
Source: MedMarket Diligence, LLC; Report #S175, "Worldwide Surgical Sealants, Glues and Wound Closure, 2009-2013."

 

Manufacturers of medical and surgical sealants, glues, hemostasis, wound closure and anti-adhesion products

The MedMarket Diligence Report #S175, "Worldwide Surgical Sealants, Glues, Wound Closure and Anti-Adhesion Market, 2009-2013," 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.

Companies profiled in the report include the following:

 

3DM, Inc. (3D-Matrix, Ltd.)
3M
Abbott Vascular
AccessClosure, Inc.
Adhezion Biomedical, LLC
Advanced Medical Solutions plc
Allerderm
Angiotech Pharmaceuticals, Inc.
Anika Therapeutics, Inc.
ARC Pharmaceuticals
Arch Therapeutics, Inc.
ArthroCare Corporation
Aso LLC
Aspen Surgical Products
Atrax Medical Group
Avery Dennison
B. Braun Melsungen AG 
Bastos Viegas, s.a.
Baxter International Inc.
Bayer HealthCare
BD (Becton, Dickinson and Company)
Berlin Heart GmbH
Bernsco Surgical Supply
Biocoral Inc.
BioCore Medical Technologies, Inc.
Biogentis, Inc.
Biomet Inc.
BIOSTER a.s.
BioSyntech Canada Inc.
BSN Medical
C.R. Bard
Cardiovascular Sciences, Inc.
Carl Auffarth GmbH & Co. KG
Cardiva Medical, Inc.
Ceremed, Inc.
Chemence Ltd.
Chemopharma, s.a.
Cohera Medical, Inc.
Collagen Matrix, Inc.
Coloplast A/S
ConvaTec
Covidien Ltd.
CryoLife Inc.
CSIRO PhotoMedical Technologies
CSL Behring

 

CSMG Technologies, Inc.
CuraMedical BV
Cypress Medical Products
Derma Sciences, Inc.
Distrex Ibérica S.A.
DuPont Applied BioSciences
Entegrion, Inc.
FibroGen, Inc.
Fidia Advanced Biopolymers
Flamel Technologies SA
Forticell Bioscience
FzioMed Inc.
Gelita Medical BV
GEM srl
Genzyme Biosurgery Inc.
GluStitch, Inc.
Graceduty Company Limited
GramsMed, LLC
Haemacure Corporation
HAPTO Biotech Israel Ltd.
Hartmann Group
Harvest Technologies Corporation
HemCon Medical Technologies, Inc.
Hemostasis, LLC
HyperBranch Medical Technology, Inc.
Incisive Surgical, Inc.
Innovasa Corporation
Integra Lifesciences Corporation
I-Therapeutix, Inc.
Johnson & Johnson
Kaketsuken (Chemo-Sero-Therapeutic
Research Institute)
Kensey Nash Corporation
Kimberly-Clark Health Care
Kinetic Concepts, Inc.
King Pharmaceuticals, Inc.
Kookbo Chemicals Co., Ltd. (KB Chem.)
Laboratoires Urgo (Urgo Medical)
Lewis Medical Supplies
LifeBond Ltd.
Lifecore Biomedical, Inc.
Lohmann & Rauscher
Marine Polymer Technologies
Medafor, Inc.
Medi Surgichem Pvt. Ltd.
MedTrade Products, Ltd.

Meyer-Haake GmbH Medical Innovations
Mölnlycke Health Care AB
Morris Innovative
Motex Healthcare Corp.
Myco Medical
NeatStitch Ltd.
Neose Technologies Inc. (Novo Nordisk)
Nycomed
Omrix Biopharmaceuticals Inc.
Pac-Kit Safety Equipment
Pfizer Inc.
Pharming Group NV
Plasma Technologies, Inc.
PlasmaSeal
Pluromed, Inc.
Polyganics
Polyheal Ltd.
ProFibrix BV
Progressive Surgical, Ltd.
Protein Polymer Technologies, Inc.
Radi Medical Systems AB
Resorba Wundversorgung GmbH & Co. KG
Scapa Group plc
Scion Cardio-Vascular, Inc.
Sea Run Holdings
Seton
Smith & Nephew plc
Starch Medical, Inc.
Steroplast Ltd.
Sutura, Inc.
Synovis Life Technologies
SyntheMed, Inc.
Teleflex Medical
ThermoGenesis Corporation
Therus Corporation
Thrombotargets Corp.
Tissuemed Ltd.
TraumaCure, Inc.
TyRx Pharma Inc.
Vascular Solutions, Inc.
Vectura Group plc
Vivostat A/S
Z-Medica Corporation
Zimmer
ZymoGenetics, Inc.

 

 

Proliferation of sealant/glue/hemostasis/anti-adhesion companies, developments

A truly striking amount of industry activity spanning company formation, industry consolidation, product developments and market introductions have taken place over the past two years in the markets for sealants, glues, hemostasis, wound closure and anti-adhesion.

With a relatively low barrier to entry for products with well established routes to FDA and CE Mark approval, application of products across a wide range of clinical applications, short learning curves and otherwise low resistance on the part of clinicians in adopting new products in practice, the markets for these products have been dynamic.

The report by MedMarket Diligence, pending publication in December 2008, illustrates the breadth and depth of this robust market, with nearly 100 companies profiled and active in this market.  

Globally, this is a $11+ billion market, with persistently double digit growth rate in some sectors.  The report is described below:

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.

See link for preliminary table of contents.

Fibrin sealants reducing the incidence, extent and severity of anti-adhesion

Haemacure Corporation last month disclosed the apparent clinical utility of its fibrin sealant in the prevention of post-surgical adhesion:

Haemacure Corporation (TSX : HAE), a Montreal-based specialty bio-therapeutics company developing high-value human plasma-derived protein products for commercialization, disclosed today the positive results of a second preclinical study conducted on the use of its proprietary lead product candidate, the human fibrin sealant Hemaseel(R)HMN, in preventing the formation of post-surgical adhesions in a bleeding surgical model.

In two preclinical studies, this utility was demonstrated in the statistically significant reduction in the incidence, extent and severity of post-surgical adhesions when Haemacure’s fibrin sealant was compared to Interceed(R) Absorbable Adhesion Barrier (Ethicon) and Seprafilm(R) Adhesion Barrier (Genzyme).

A collegue pointed out to me that Angiotech’s CoSeal is being investigated by Baxter for its use as both a sealant and adhesion protection product.

The topic of anti-adhesion has been addressed in prior business reports by MedMarket Diligence, including the February 2007 report and is being addressed in the Report #S175 in process, “Worldwide Surgical Sealants, Glues and Wound Closure Market, 2009-2013.”

Quite a counterintuitive idea to take a glue and use it for anti-adhesion, but the data supports it.