For over a hundred years simple wound closure was achieved through the use of well-established suturing techniques and products. Early in the 1980s the need to control bleeding during new surgical procedures led to an increased use of biological hemostats and sealants. Made from human fibrin as well as thrombin, collagen and gelatin from other species, these materials came into widespread use, particularly in Europe and Asia, led by homologous, pooled, fibrin products such as Beriplast from CSL Behring and Tisseel from Baxter. It was not until 1997 that homologous, pooled fibrin products were approved for use in the United States. The products offer significant benefits for surgical procedures where blood loss is a major factor, but are not strong enough to be used alone for wound closure; consequently they are usually used as adjuncts to suturing.
During the 1990s an opportunity for new surgical closure products was created by the introduction of many new minimally invasive procedures. The ensuing product demand was temporarily addressed with sutures and suturing/stapling devices, autologous fibrin prepared prior to the surgical procedure, bovine and porcine hemostasis products (based on thrombin, collagen and gelatin) and chemically derived cellulose products. However, these products were less than ideal for wound closure and, as a result, were largely (and are still) used for adjunctive hemostasis. The unfilled need for more advanced products, and the huge market potential, led to the creation of biotech-based companies targeting surgical closure products. In the early 1990s this market expanded with the advent of products for adhesion prevention (prevention of fibrotic repair after surgical interventions).
New products for sealing, closure, hemostasis and anti-adhesion that gained clinical and market success in the mid-to-late 1990s continue to grow in use in an expanding market, albeit with more competitors to split the market. Â (This in turn has led to a normal round of consolidations and acquisitions; see Report #S180 Exhibit ES-1.)
The result is a large market comprised of multiple segments with traditional closure and securement continuing to hold significant revenue, but fast losing hold on a market characterized by high growth in the new products.
Source: MedMarket Diligence, LLC; Report #S180, “Worldwide Surgical Sealants, Glues, Wound Closure and Anti-Adhesion Markets, 2008-2015.”