Six Key Trends in Sealants, Glues, Hemostats Markets to 2022

From July 2016 published Report #S290.

Here are six key trends we see in the global market for surgical sealants, glues, and hemostats:

  1. Aggressive development of products (including by universities, startups, established competitors), regulatory approvals, and new product introductions continues in the U.S., Europe, and Asia/Pacific (mostly Japan, Korea) to satisfy the growing volume of surgical procedures globally.
  2. Rapid adoption of sealants, glues, hemostats in China will drive much of the global market for these products, but other nations in the region are also big consumers, with more of the potential caseload already tapped than the rising economic China giant. Japan is a big developer and user of wound product consumer. Per capital demand is also higher in some countries like Japan.
  3. Flattening markets in the U.S. and Europe (where home-based manufacturers are looking more at emerging markets), with Europe in particular focused intently on lowering healthcare costs.
  4. The M&A, and deal-making that has taken place over the past few years (Bristol-Myers Squibb, The Medicines Company, Cohera Medical, Medafor, CR Bard, Tenaxis, Mallinckrodt, Xcede Technologies, etc.) will continue as market penetration turns to consolidation.
  5. Growing development on two fronts: (1) clinical specialty and/or application specific product formulation, and (2) all purpose products that provide faster sealing, hemostasis, or closure for general wound applications for internal and external use.
  6. Bioglues already hold the lead in global medical glue sales, and more are being developed, but there are also numerous biologically-inspired, though not -derived, glues in the starting blocks that will displace bioglue shares. Nanotech also has its tiny fingers in this pie, as well.

See Report #S290, “Worldwide Sealants, Glues, and Hemostats Markets, 2015-2022”.

USA and Asia/Pacific Size Versus Growth in Sealants, Glues, Hemostats

The market dynamics in Asia/Pacific stand apart from those in the U.S. In the case of surgical sealants, glues, and hemostats, what stands out is the Size versus Growth metric.

Much of the potential in China, in particular, remains untapped (low volume, high growth), while in the U.S., these markets are more well established and, therefore, more penetrated.

Below are the size/growth “bubbles” for, alternating, the U.S. and Asia/Pacific.

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Source: MedMarket Diligence, LLC; Report #S290.

Surgical Procedures with Potential for Sealants, Glues, Hemostats

See the published report #S290, “Worldwide Markets for Medical and Surgical Sealants, Glues, and Hemostats, 2015-2022: Established and Emerging Products, Technologies and Markets in the Americas, Europe, Asia/Pacific and Rest of World”.

Sealants, glues, and hemostats must offer benefit to be adopted in clinical practice, or surgical procedures. Benefits can fall into a number of categories. These range from preventing serious complications from surgery (blood loss), improved patient outcomes (fewer complications, reduction in repeats), reductions in procedure time or other time- or cost-saving benefits, or improved aesthetic and perceived benefits. See these detailed below.

Criteria for Adjunctive Use of Hemostats, Sealants, Glues and Adhesion Prevention Products in Surgery

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Source: MedMarket Diligence, LLC; Report#S192.

We have assessed surgical sealants, glues, and hemostats for their potential in general surgery, aesthetics, neurology, urological, gastroenterology, orthopedics, and cardiovascular medicine.

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Source: MedMarket Diligence, LLC; Report #S192, “Worldwide Surgical Sealants, Glues, and Wound Closure Markets, 2013-2018”.


See the published report #S290, “Worldwide Markets for Medical and Surgical Sealants, Glues, and Hemostats, 2015-2022: Established and Emerging Products, Technologies and Markets in the Americas, Europe, Asia/Pacific and Rest of World”.

Surgical Sealants and Glues in the Balance of Wound Closure

Sealants and glues are emerging as important adjunctive tools for sealing staple and suture lines, and some of these products also are being employed as general hemostatic agents to control bleeding in the surgical field. Manufacturers have also developed surgical sealants and glues that are designed for specific procedures – particularly those in which staples and sutures are difficult to employ or where additional reinforcement of the internal suture/staple line provides an important safety advantage.Suture-line-pixelated

Surgical sealants are made of synthetic or naturally occurring materials and are commonly used with staples or sutures to help completely seal internal and external incisions after surgery. In this capacity, they are particularly important for lung, spinal, and gastrointestinal operations, in which leaks of air, cerebrospinal fluid, or blood through the anastomosis can cause numerous complications. Limiting these leaks results in reduced mortality rates, less post-operative pain, shorter hospital stays for patients, and decreased health care costs.

Although some form of suturing wounds has been used for thousands of years, sutures and staples can be troublesome. There are procedures in which sutures are too large or clumsy to place effectively, and locations in which it is difficult for the surgeon to suture. Moreover, sutures can lead to complications, such as intimal hyperplasia, in which cells respond to the trauma of the needle and thread by proliferating on the inside wall of the blood vessel, causing it to narrow at that point. This increases the risk of a blood clot forming and obstructing blood flow. In addition, sutures and staples may trigger an immune response, leading to inflamed tissue, which also increases the risk of a blockage. Finally, as mentioned above, sutured and stapled internal incisions may leak, leading to dangerous post-surgical complications.

These are some of the reasons why surgical adhesives are becoming increasingly popular, both for use in conjunction with suture and staples and on a stand-alone basis. As a logical derivative, surgeons want a sealant product that is strong, easy-to-use and affordable, while being biocompatible and resorbable. In reality, it is difficult for manufacturers to meet all of these requirements, particularly with biologically active sealants, which tend to be pricey. Thus, for physicians, there is usually a trade-off to consider when deciding whether or not to employ these products.

Screen Shot 2014-12-29 at 9.28.14 AMClosure of general surgical wounds (internal or external) is largely accomplished by a combination of surgical tapes, sutures & staples and, increasingly, surgical sealants and glues. For the reasons discussed, the rates of technology development and adoption among these causing a relative but not absolute decline of sutures and staples revenues worldwide.

Surgical sealants, glues, and hemostats can be divided into several different categories based on their primary components and/or their intended use. From a practical standpoint, they may be subdivided by composition into products containing biologically active agents, products made from natural and synthetic (nonactive) components, and nonactive scaffolds, patches, sponges, putties, powders, and matrices used as surgical hemostats.


Data drawn from MedMarket Diligence, LLC, Report #S192, “Worldwide Surgical Sealants, Glues, and Wound Closure Markets, 2013-2018.” See link.

 

Growth of High Strength Medical Adhesives

The market for high strength medical adhesives is growing, and is expected to continue to grow due to regulatory approvals and steady ongoing research and development. Active programs are currently under development in three areas for high strength surgical adhesives:

  • The use of cyanoacrylate adhesives and new application devices for new internal surgical procedures
  • New adhesive products based on existing biomaterial adhesives such as fibrin and albumin compounds
  • New polymer adhesives based on entirely new chemistries (e.g., polyurethanes, proteins from living organisms).

The global market for high-strength medical adhesives is forecast to show strong double-digit growth during the forecast period, growing from roughly $713 million in 2011 to $1.72 billion by 2017. The USA represents, by far, the largest share of the global high strength medical adhesives market, and this is not expected to change during the forecast period.

Worldwide Market for High Strength Medical Adhesives, 2010-2017

Source: MedMarket Diligence Report #S190, “Worldwide Surgical Sealants, Glues, Wound Closure and Anti-Adhesion Markets, 2010-2017.”

Although some form of suturing wounds has been used for probably thousands of years due to their ease of use and strength of closure, but sutures’ simplicity can also be limiting. There are procedures in which sutures are too large or clumsy, and locations in which it is difficult for the surgeon to suture. They can lead to complications, such as intimal hyperplasia, in which cells respond to the trauma of the needle and thread by proliferating on the inside wall of the blood vessel, causing it to narrow at that point. This increases the risk of a blood clot getting stuck and obstructing blood flow. In addition, sutures may trigger an immune response, leading to inflamed tissue that also increases the risk of a blockage. These are some of the reasons why surgical adhesives are becoming increasingly popular.

As a logical derivative, surgeons want a product that is strong, easy-to-use and affordable, while being biocompatible and resorbable. TissuGlu (Cohera Medical), a urethane adhesive suited for plastic surgery procedures, is both biocompatible and resorbable, making it ideal for internal applications. It is also strong, user-friendly, and does not contain human/animal product derivatives. TissuGlu is currently only available for sale in Germany, but the company is rapidly preparing to sell in the other major markets of the EU.

One of the top five plastic surgery procedures performed in the United States is abdominoplasty, which has a reported post-operative complication rate of 15-52%. The most common complication is the formation of seroma. Usual methods to combat seroma formation include the placement of closed suction drains, use of compression garments around the tissue, use of progressive tension sutures, and use of fibrin sealants to reduce fluid accumulation. However, most of these methods can still lead to further complications such as leakage from drain sites, skin necrosis and inconsistent adhesion. High strength glues like TissuGlu and other products can solve this problem and garner significant caseload.

Worldwide Surgical Sealants, Glues, Wound Closure and Anti-Adhesion Markets, 2010-2017

This report details the complete range of sealants & glues technologies used in traumatic, surgical and other wound closure, including tapes, sutures, staples, mechanical closure, hemostats, fibrin sealants/glues and medical adhesives and anti-adhesion products. The report details current clinical and technology developments, with data on products in development (detailing market status) and on the market; market size and forecast; competitor market shares; competitor profiles; and market opportunity. The report provides full year actual data from 2011. The report provides a worldwide forecast to 2017 of the markets for these technologies, with emphasis on the market impact of new technologies through the forecast period. The report provides specific forecasts and shares of the worldwide market by segment for Americas (detail for U.S., Rest of North America and Latin America), Europe (detail for United Kingdom, German, France, Italy, Spain, Rest of Europe), Asia/Pacific (detail for Japan, Korea, Rest of Asia/Pacific) 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 establish the current worldwide market size for major technology segments as a baseline for and projecting growth in the market through 2017. The report assesses and projects the composition of the market as technologies gain or lose relative market performance over this period. The report profiles 122 active companies in this industry, providing data on their current products, current market position and products under development.

The report's complete description, table of contents, and list of exhibits is at link.  The report is available for purchase and immediate download at link.

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.) 

Medtech market competitor consolidation on the rise

The healthcare industry faces a less daunting period of recession compared to many industries (we’ve covered it here and here), but still faces different and tough dynamics during this period.

Although demand for healthcare is more inelastic than other products and services, new business in healthcare (development and innovation) requires financing, a particularly  scarce commodity during the recession.  Well established companies with existing revenue streams are able to draw on those streams to fund new development.  However, early stage and startup companies demand financing from 3F ( "family, friends and fools"), since they do not yet have other revenue streams.  So, an obvious polarity is set up:  big companies with money seeking innovation versus small companies with innovation but little money.

Hence, the young startup has become a very real acquisition target by established companies.

If we look at one of our favorite markets, for surgical sealants, glues, hemostats, wound closure and anti-adhesion, here is a past list of acquisitions in this arena, a robust amount of activity before the financial meltdown took place: 

 

 

Company

Year Acquired

Omrix Biopharmaceuticals

2008

Altana Pharma

2007

American Medical Instruments

2006

Berlin Heart

2006

Biomet

2006

Confluent Surgical

2006

Quill Medical

2006

Surgical Specialties

2006

Closure Medical

2005

Aventis Behring

2004

Interpore Cross

2004

Onux Medical

2004

PPL Therapeutics

2004

Cohesion

2003

Gliatech

2003

Fusion Medical Technologies

2002

Medlogic Global

2002

Focal

2001

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

In early 2009, we have already seen some struggles among young companies in this sector, such as Haemacure, in financing their operations and continued development.  Given that there are so manny active companies in this area (our report #S175 profiles over 135 companies), we anticipate in 2009 a significant amount of interest and potentially acquisitions by the well established players.

See our report #S175 table of contents, including companies profiled, for potential acquisition targets.

 

Growth, development and consolidation in the sealants, glues, wound closure and anti-adhesion industry

In the last few years, there has been a significant consolidation in the sealants, glues, wound closure and anti-adhesion industry (the "securement industry") as venture-based companies have been acquired and assimilated into larger market-based corporations with critical mass in their sales effort. This represents a welcome development for investors in leading-edge technologies, which are now being developed into marketable ventures. Examples are seen in the full range of deal structures from exclusive distribution deals and joint development agreements with exclusive marketing licenses to full acquisitions of companies.

Recent Acquisitions in the Securement Industry

sealant-consolidation1

Source: MedMarket Diligence, Report #S175.