The Demand for Sealants, Glues, and Hemostats in 2016

The following is drawn from “Worldwide Markets for Medical and Surgical Sealants, Glues, and Hemostats, 2015-2022.” Report #S290.

The need for surgical sealants, glues and hemostats is directly related to the clinical caseload and procedure volumes, as well as to the adoption of these products for multiple uses, such as the use of one product for sealing, hemostasis and anti-adhesion. It is fair to say that use of these products has become routine in the surgical suite and in other clinical locations. Procedure volumes are in turn driven by demographic forces, including global aging populations, while regulatory changes will continue to influence uptake of these products.

wound-prevalance

Source: MedMarket Diligence, LLC; Report #S290.

Medical Sealants

Fibrin sealants are made of a combination of thrombin and fibrinogen. These sealants may be sprayed on the bleeding surface, or applied using a patch. Surgical sealants might be made of glutaraldehyde and bovine serum albumin, polyethylene glycol polymers, and cyanoacrylates.

Sealants are most often used to stop bleeding over a large area. If the surgeon wishes to fasten down a flap without using sutures, or in addition to using sutures, then the product used is usually a medical glue.

Hemostatic Products

The surgeon and the perioperative nurse have a variety of hemostats from which to choose, as they are not all alike in their applications and efficacy. Selection of the most appropriate hemostat requires training and experience, and can affect the clinical outcome, as well as decrease treatment costs. Some of the factors that enter into the decision-making process include the size of the wound, the amount of hemorrhaging, potential adverse effects, whether the procedure is MIS or open surgery, and others.

Active hemostats contain thrombin products which may be derived from several sources, such as bovine pooled plasma purification, human pooled plasma purification, or through human recombinant manufacturing processes. Flowable-type hemostats are made of a granular bovine or porcine gelatin that is combined with saline or reconstituted thrombin, forming a flowable putty that may be applied to the bleeding area.

Medical Glues

Sealants and glues are terms which are often used interchangeably, which can be confusing. In this report, a medical glue is defined as a product used to bond two surfaces together securely. Surgeons are increasingly reaching for medical glues to either help secure a suture line, or to replace sutures entirely in the repair of soft tissues. Medical glues are also utilized in repairing bone fractures, especially for highly comminuted fractures that often involve many small fragments. This helps to spread out the force-bearing surface, rather than focusing weight-bearing on spots where a pin has been inserted.

Thus, the surgeon has a fairly wide array of products from which to choose. The choice of which surgical hemostat or sealant to use depends on several factors, including the procedure being conducted, the type of bleeding, severity of the hemorrhage, the surgeon’s experience with the products, the surgeon’s preference, the price of the product and availability at the time of surgery. For example, a product which has a long shelf life and does not require refrigeration or other special storage, and which requires no special preparation, usually holds advantages over a product which must be mixed before use, or held in a refrigerator during storage, then allowed to warm up to room temperature before use.

 

Report: Surgical Sealants, Glues, Wound Closure and Anti-adhesion Worldwide

MedMarket Diligence (MMD) has published its 2010 report on the worldwide market for surgical sealants and related products in surgical and traumatic wound management.

The analysis by MMD reveals the size of the evolving opportunity for a diverse set of products in global markets. Based on extensive primary and secondary research, and leveraging MMD’s position as the leading source for the medtech industry on the subject, the report provides industry participants and hopefuls with invaluable data and insights.

The report is described below and at link

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 historic (from 2008), current and annual forecast to 2015 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, Korea 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 five-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 complete table of contents and list of exhibits.  The report may be ordered for immediate download from link.

Technology platforms and clinical applications overlap

Diverse technologies have a surprising number of common threads, whether in the technologies themselves or in the clinical applications.  For this reason, manufacturers need to consider that:

1. A technology platform can be the launchpad for products in clinically diverse areas. Case in point, cell therapy, which as a fundamental scientific discipline can have uses as far afield as wound management, bone repair, treatment of myocardial ischemia and others.

2. A disease state can sometimes be targeted by many very different technologies.  Examples include that wound management can be accomplished by tissue engineering, sutures, fibrin-based surgical glues, cyanoacrylate-based surgical glues, dressings and others.

The driver behind technologies having multiple clinical applications is, of course, that companies wish to maximize their ROI.  

The driver behind single disease states being the target of multiple alternative technologies is cost — healthcare systems (in principle, anyway) seek the most competitive options for treating specific patient populations, and this driver has been gaining momentum over the past ten years due to “managed care” efforts as well as aggressive, cost-focus innovators creating technologies that displace market share with convincingly better patient outcomes compared to alternative technologies.


MedMarket Diligence publishes medical technology market reports on a wide range of clinical and technology subjects (of course, sometimes overlapping). See list.

(This post was done via the Palm Pre WebOS app Po’ster by Gabriele Nizzoli.) 

Product development trend in surgical sealants, glues, hemostats

During the 19th century, surgeons began to experiment with materials designed to achieve hemostasis: gelatin, collagen, natural fabrics, and thrombin and fibrin materials. In the early 1980s today’s commercial products began to appear. They were rapidly adopted in Japan where bleeding is an extremely emotive issue, and also in Europe where local regulatory requirements allowed a sequential roll-out of product introductions. In the United States, early FDA concerns associated with disease transmission led to delayed launch of products derived from human sources. These regulatory delays, plus the perceived high cost of products and surgeons’ concerns regarding disease transmission risk, drove surgeons and hospitals to continue to look for alternative hemostats, sealants and glues. As a result, to this day there is a tendency for hospitals to continue to prepare autologous fibrin (from the patient’s own blood taken before surgery) and to use a number of inferior hemostasis products.

 U.S. FDA Approved Uses of Sealants, Glues, and Hemostats
 

 

Hemostats

Sealants

Adhesives

Cardiovascular

X

Orthopaedic

X

Neurological

√*

Gastrointestinal

X

Paediatric

X

Thoracic

X

Pulmonary

X

Skin

x

 

*Specific indication (few procedures per year) approved 

Source: MedMarket Diligence, LLC; Report #S175, "Worldwide Surgical Sealants, Glues and Wound Closure, 2009-2013."

Topical high-strength glues were first used by the military and to achieve immediate repair of sports injuries during professional sports like ice hockey, boxing and American football and basketball. These products became the subject of collaborative efforts between innovative suppliers and major suture manufacturing and marketing companies, keen to evolve their product portfolios to include next-generation closure materials.

During the 1990s, many technology-based companies began to target the huge unmet closure and sealant market and extensive literature appeared, advising practitioners on specific methodology to create the ideal autologous fibrin sealant product and on applying these products to surgical indications. In addition, a number of specialist societies were established to support and advise on the process of preparing and using hospital-derived fibrin sealants.

There were also a growing number of companies developing medical devices and equipment specifically designed to allow the preparation of autologous fibrin sealant for surgical applications. All this effort led to a number of products being approved for use in the major surgical indications (Exhibit 1-7). In 2006, sealant products were used in over three million surgical procedures. This represents up to 5 million units of commercially available fibrin sealant products, and approximately four million units of autologous fibrin prepared by hospitals. The autologous fibrin material, prepared using commercial medical devices, was used in approximately 70,000 surgical operations worldwide and represents a new market that has developed over the last five years. Similarly, the use of high-strength glues for wound closure evolved since 1992 in Europe and since 1998 in the United States and Japan. High-strength adhesives were used on approximately 6 million cuts, grazes and minor incisions in 2006. This usage is growing rapidly driven by greater awareness and cost-effectiveness.
 

Wound closure, sealants, other securement sales in the Americas

Taken together, the Americas represent some 60% of the global market for surgical securement (sealants, glues, hemostasis, wound closure, anti-adhesion), led by the United States with more than 50%. The relative success of each product type varies between these markets, dominated by traditional sutures and staples, but with sealants rapidly penetrating and gaining share.

securement-americas

Source:  Report #S175, "Worldwide Surgical Sealants, Glues and Wound Closure Market, 2009-2013."

(Part 3) Adjunctive use of sealants, glues…

 (Continued from here)

The dynamics behind these products’ success: 

  • Significant cost-effectiveness arguments can be made for products that avoid blood transfusions or reduce the quantities of blood transfusion products required. Approximately 8 million patients worldwide would benefit directly from increased usage of hemostats, sealants and glue products to reduce bleeding during cardiovascular, orthopaedic, urologic, and other general surgical procedures. Units of blood cost approximately $180 each; however, the benefit of reducing transfusion requirement goes beyond this simple saving. Often, the real benefit is that appropriate hemostasis reduces the risk of mortality. For example, reducing blood loss during cardiovascular procedures in particular not only prevents the use of large volumes of donated blood (e.g., 5–10 units for dissection of aortic aneurysms) but significantly reduces mortality rates (which can be as high as 30% for aortic aneurysm procedures).
     
  • Adhesion-prevention products have been shown to significantly reduce post-surgical adhesions associated with gynaecological, spinal, cardiovascular and orthopedic procedures. Post-operative adhesions can severely complicate subsequent interventions by making re-entry hazardous, and impeding orientation and visibility, which can lead to damaging the surrounding tissues or vessels. There may also be increased blood loss, and significantly longer operating time required to cut through the adhesions.

 

These dynamics have collectively contributed to the worldwide growth in the market.  Below please find the aggregate worldwide market forecast for these products.

 

Worldwide Growth in the Markets for
Sealants, Glues, Wound Closure and Anti-Adhesion,
2006–2013
 
Sales

Growth

$6,795

 

$7,309

7.6%

$7,860

7.5%

$8,472

7.8%

$9,149

8.0%

$9,921

8.4%

$10,792

8.8%

$11,765

9.0%

 Source: Report #S175, published December 2008, MedMarket Diligence, LLC

Adjunctive use of sealants, glues, hemostasis and other wound closure and anti-adhesion (part 1)

There are many reasons underlying the explosive growth of the worldwide markets for surgical sealants, hemostasis, wound closure and anti-adhesion.

The market potential for products in the surgical securement field is driven by a combination of new technologies coming to market and expanding caseload for which these technologies are applicable. The potential for these products continues to grow as surgical practices improve and the benefits of new products address the requirement for fast and effective closure.

We forecast that approximately 70 million procedures around the world might benefit from products in this category in the future, and due to demographic trends and evolving surgical capabilities, this number is forecast to increase at an annualized rate of 3%–5%.  

In the coming decade we will see strong penetration of new therapies into new procedure areas and some new introductory techniques for treatment of orthopedic, cardiovascular and neurological procedures.

Below represent some of the clinical and market dynamics for these products’ success:

  • The use of products such as tapes and sutures for wound closure and securement leads to faster wound healing with less risk of contamination by debris and infectious agents, and with improved cosmetic outcomes. Failure to use these products can lead to significant complications, infections, significant delays to healing, and potentially loss of life through infection of the tissue leading to septicemia.
     
  • Hemostats, sealants and glues have been shown to aid recovery and rehabilitation after invasive surgical procedures, to reduce morbidity associated with infection rates and post-surgical adhesions, and to reduce morbidity associated with specific procedures. For example, these products may be used to reduce the risk of deep vein thromboses resulting from tourniquet application to reduce bleeding during total knee replacements.
     
  • Hemostats and sealants have been demonstrated to have substantial cost-effective benefits during many surgical operations and the cost of these products are increasingly seen as minor in comparison with the time saved during the surgical procedure alone, even without taking into account rehabilitation. These products have been shown to be highly cost-effective for topical wound closure and there are also many potential internal applications for these products.

To be continued..


See Worldwide Surgical Sealants, Glues and Wound Closure Market, 2009, published December 2008.

 

Expanded list of companies in med/surg sealants, glues, hemostasis, anti-adhesion, wound closure

The list of companies profiled in the forthcoming MedMarket Diligence report #S175 on Surgical Sealants, Glues, Wound Closure and Anti-Adhesion has been expanded based on the additional company data gathered from the worldwide analysis.  The list now stands at 136 companies.  See below:

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
4.7 Allerderm
4.8 Angiotech Pharmaceuticals, Inc.
4.9 Anika Therapeutics, Inc.
4.10 ARC Pharmaceuticals Inc.
4.11 Arch Therapeutics (formerly Clear Nano Solutions)
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 Bard Medical Division, CR Bard
4.19 Bastos Viegas, s.a.
4.20 Baxter International Inc.
4.21 Bayer HealthCare
4.22 BD (Becton Dickinson and Company)
4.23 Berlin Heart GmbH
4.24 Bernsco Surgical Supply
4.25 Biocoral Inc
4.26 BioCore Medical Technologies, Inc.
4.27 Biogentis, Inc.
4.28 Biomet, Inc.
4.29 BIOSTER a.s.
4.30 BSN Medical
4.31 Cardiovascular Sciences, Inc.
4.32 Cardiva Medical, Inc.
4.33 Carl Auffarth GmbH & Co. KG
4.34 Ceremed, Inc.
4.35 Chemence Ltd.
4.36 Chemopharma, s.a.
4.37 Cohera Medical, Inc.
4.38 Collagen Matrix, Inc.
4.39 Coloplast A/S
4.40 ConvaTec
4.41 Covidien
4.42 CryoLife, Inc.
4.43 CSIRO PhotoMedical Technologies
4.44 CSL Behring
4.45 CSMG Technologies, Inc.
4.46 CuraMedical BV
4.47 Cypress Medical Products
4.48 DePuy, Inc.
4.49 Derma Sciences
4.50 Distrex Ibérica S.A.
4.51 Entegrion
4.52 Ethicon, Inc., Johnson & Johnson
4.53 FibroGen, Inc.
4.54 Fidia Advanced Biopolymers SpA
4.55 Flamel Technologies SA
4.56 Focal, Inc.
4.57 Forticell Bioscience
4.58 FzioMed, Inc.
4.59 Gelita Medical BV
4.60 GEM s.r.l.
4.61 Genzyme Biosurgery
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 Kaketsuken (Chemo-Sero-Therapeutic Research Institute)
4.77 Kensey Nash Corporation
4.78 Kimberly-Clark Health Care
4.79 Kinetic Concepts, Inc.
4.80 King Pharmaceuticals, Inc.
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
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.
4.98 Nycomed
4.99 Nycomed Pharma AS
4.100 Omrix Biopharmaceuticals Inc. (J&J)
4.101 Pac-Kit Safety Equipment
4.102 Pfizer Inc.
4.103 Pharming Group NV
4.104 Plasma Technologies, Inc.
4.105 PlasmaSeal LLC
4.106 Pluromed, Inc.
4.107 Polyganics, BV
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 Stereoplast Ltd.
4.121 Sutura Inc.
4.122 Synovis Life Technologies, Inc.
4.123 SyntheMed, Inc.
4.124 Teleflex Medical
4.125 ThermoGenesis Corp.
4.126 Therus Corporation
4.127 Thrombotargets Corp.
4.128 Tissuemed Ltd.
4.129 TraumaCure, Inc.
4.130 TyRx Pharma, Inc.
4.131 Vascular Solutions, Inc.
4.132 Vectura Group plc
4.133 Vivostat A/S
4.134 Zimmer
4.135 Z-Medica Corp.
4.136 ZymoGenetics, Inc.

 

Companies active in surgical glues, sealants, wound closure and anti-adhesion

The companies involved in the marketing and development of surgical sealants, glues, and other wound closure and anti-adhesion products are a robust group.  The number of competitors and the breadth and depth of their offerings are testimony to the size of the active market as well as its considerable potential.  Below is the list of companies preliminarily profiled in the pending, December 2008, report #S175, "Worldwide Surgical Sealants, Glues, Wound Closure and Anti-adhesion, 2009-2013."  The report is described here.
 
SECTION 4:    COMPANY PROFILES
 
4.1      3DM, Inc. (3D-Matrix, Ltd.)
4.2      Abbott Vascular
4.3      AccessClosure, Inc.
4.4      Adhezion Biomedical, LLC 
4.5      Advanced Medical Solutions 
4.6      Angiotech Pharmaceuticals, Inc.
4.7      Anika Therapeutics, Inc.
4.8      ARC Pharmaceuticals Inc.
4.9      Arch Therapeutics (formerly Clear Nano Solutions)
4.10    ArthroCare Corporation
4.11    B. Braun Melsungen AG
4.12    Bard Medical Division, CR Bard
4.13    Baxter International Inc.
4.14    Bayer Schering Pharma
4.15    BD (Becton Dickinson and Company)
4.16    Biiosyntech Inc.
4.17    Biocoral Inc
4.18    Biogentis, Inc.
4.19    BIOSTER a.s.
4.20    Cardiovascular Sciences, Inc.
4.21    Cardiva Medical, Inc.
4.22    Ceremed, Inc.
4.23    Chemence Ltd.
4.24    Cohera Medical, Inc.
4.25    Collagen Matrix, Inc.
4.26    Covidien
4.27    CryoLife, Inc.
4.28    CSIRO PhotoMedical Technologies
4.29    CSL Behring
4.30    CSMG, Inc.
4.31    CuraMedical BV
4.32    DePuy, Inc.
4.33    Entegrion
4.34    Ethicon, Inc., Johnson & Johnson
4.35    FibroGen, Inc.
4.36    Fidia Advanced Biopolymers SpA
4.37    Flamel Technologies SA
4.38    Focal, Inc.
4.39    Forticell Bioscience
4.40    FzioMed, Inc.
4.41    GEM s.r.l.
4.42    Genzyme Biosurgery
4.43    GluStitch, Inc.
4.44    Haemacure Corporation
4.45    Harvest Technologies Corporation
4.46    HemCon, Inc.
4.47    Hemostasis LLC
4.48    Henkel Loctite Corp.
4.49    HyperBranch Medical Technology, Inc.
4.50    Innovasa Corporation
4.51    Integra Lifesciences Corporation
4.52    Interpore Cross International
4.53    Isto Technologies, Inc.
4.54    I-Therapeutix, Inc.
4.55    Kaketsuken (Chemo-Sero-Therapeutic Research Institute)
4.56    Kensey Nash Corporation
4.57    Kimberly-Clark Health Care
4.58    King Pharmaceuticals, Inc.
4.59    LifeBond, Ltd.
4.60    Lifecore Biomedical Inc.
4.61    Marine Polymer Technologies
4.62    Medafor, Inc.
4.63    MedTrade Products
4.64    Meyer-Haake GmbH Medical Innovations
4.65    Morris Innovative
4.66    Neose Technologies
4.67    Nycomed Pharma AS
4.68    Omrix Biopharmaceuticals Inc.
4.69    Organogenesis, Inc.
4.70    Pharming Group NV
4.71    Plasma Technologies, Inc.
4.72    PlasmaSeal LLC
4.73    Pluromed, Inc.
4.74    Polyganics, BV
4.75    ProFibrix BV
4.76    Protein Polymer Technologies, Inc.
4.77    Radi Medical Systems AB
4.78    Scion Cardio-Vascular, Inc.
4.79    Sea Run Holdings
4.80    Smith & Nephew Plc 
4.81    Sutura Inc.
4.82    Synovis Life Technologies, Inc.
4.83    Teleflex Medical
4.84    ThermoGenesis Corp.
4.85    Therus Corporation
4.86    Thrombotargets Corp.
4.87    Tissuemed Ltd.
4.88    TraumaCure, Inc.
4.89    TyRx Pharma, Inc. 
4.90    Vascular Solutions, Inc. 
4.91    Vectura Group plc 
4.92    Vivostat A/S
4.93    Z-Medica Corp.
 
See Report #S175 for more detail.