UPDATE: See February 2012 Report #S190, “Worldwide Surgical Sealants, Glues, Wound Closure and Anti-Adhesion Markets, 2010-2017.
Historically, closure of surgical incisions has been achieved through an ever-evolving portfolio of suture, staple and tape products. In the early 1990s, physicians involved in sports medicine were the first non-military practitioners to adopt cyanoacrylate glues to achieve immediate closure of small cuts and lacerations, and an awareness of this opportunity developed in large multinational manufacturers of sutures and staples. Joint development efforts were commenced at Davis and Geck/U.S. Surgical (now Covidien), and Ethicon (subsidiary of Johnson & Johnson), and in a number of companies manufacturing cyanoacrylates, which ultimately resulted in topical cyanoacrylate closure products being launched around the world during the 1990s.
Manufacturers of Sutures, Staples, Clips and Other Closure
The need to control bleeding during new surgical procedures has led to an increased use of biological hemostats and sealants. Made from human fibrin as well as thrombin, collagen and gelatine 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).
The use of fibrin and other hemostats expanded rapidly in the 1980s in Japan, driven by the strong cultural desire to avoid the need for blood transfusions. In addition, regulatory barriers to launching homologous pooled plasma-derived products in Europe were not as stringent as those imposed by the U.S. FDA in the late 1980s and 1990s. As a result, the scientific literature from Asia and Europe records many novel and experimental uses for sealant and hemostasis products across all surgical disciplines from ENT to major open heart surgery.
In addition to commercial sources of sealant products, surgical centers in all regions of the world also prepare autologous fibrin for surgical procedures in efforts to save on commercial product costs and to avoid potential for product-borne infection. Delays to the introduction of fibrin-based products in the United States led to a pent-up unmet need, which was addressed in the 1990s by the preparation of autologous fibrin in medical centers prior to surgical operations.
Updated Source: Worldwide Surgical Sealants, Glues, Wound Closure and Anti-Adhesion Market, 2010-2017; MedMarket Diligence, LLC