Next in sealants, glues, hemostats…and why?

From July 2016 published Report #S290.

The demand for surgical sealants, glues, and hemostats is directly related to the clinical caseload and procedure volumes, while product choice is dependent upon the surgeon’s training and experience with the products, the particular situation, and product availability. Availability is influenced by several factors. For example, must the product be prepared before use, or is it ready to use off the shelf? Is it refrigerated, requiring warming prior to use, or is the product able to be stored at room temperature? Availability also depends on whether the hospital or healthcare facility will stock the product, which in turn depends on the product’s cost and whether it fits into the facility’s budget and formulary. Sealants, glues and hemostats are used about 25% of the time in many (but not all) procedures, since sutures remain the most familiar and least expensive products for wound closure. However, the products addressed in this report could well find use in over 100 million procedures globally.

Here are six key trends we see in the global market next in surgical sealants, glues, 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, and 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”.

Naturally sticky: Biologically-based medical glues dominate

Biologically-based medical glues, cyanoacrylate, or other synthetic. The bulk of global sales of medical glues are biologically-based, (includes fibrin, thrombogen, and others), rather than cyanoacrylate-based or other synthetic glues.

Synthetic glues

Cyanoacrylate-based glues, include those from Ethicon, Adhezion Biomedical, B. Braun, Meyer-Haake, and others. Cyanoacrylate-based glues for medical use are said to be stronger, less irritating to the skin when used externally, and more flexible than the household ‘super glue.’

Topical skin adhesives (TSAs) are used quite commonly for closing small wounds and incisions. There are two basic TSAs: 2-octyl cyanoacrylate (intended to close wounds and surgical incisions, and useful as an antibacterial barrier), and n-butyl cyanoacrylate, which is more flexible than the former, but also not as strong. Dermabond® and SurgiSeal™ are 2-octyl cyanoacrylates (OCA); Histoacryl®, Indermil®, and LiquiBand™ are n-butyl cyanoacrylates (BCA). These glues are intended for topical use only due primarily to toxicity and safety issues.

Other Synthetic Glues

Innovators are developing “other” glues from a variety of synthetic types; these glues have yet to gain more than 4% share globally. Synthetic glues may be derived from polyurethane or other polymers and may be light-activated. As yet, these synthetics have not been able to create anything more than a minor dent in bio-glue sales.

Biologically-based Medical Glues

Manufacturers of biologically-based medical glues have made these glues the most popular, accounting for almost two-thirds of medical glue revenues. However, ongoing developments mean that products are being improved and new products are being invented. These new glues may start to cannibalize from the biologically-based products.

Below is illustrated the growth of biologically-based glues by region, showing that most growth in this segment will be from Asia/Pacific markets, which are consistently demonstrating higher growth than in western markets.

Global Markets for Biologically-Based Medical Glues, 2015-2022, USD MillionsGrowth of Medical Glues by RegionSource: MedMarket Diligence, LLC; Report #S290. (Order online)