Wounds have been closed and secured through the use of suture materials since ancient Egyptian times. In the modern medical age, suture materials have evolved through a succession of stages from non-resorbable, to resorbable, to stapling devices. Since sutures still represent the majority of products used for wound closure and securement, it is important to consider this class of products and their potential that is associated with adjunctive measures, and with newer products under development.
There are six main categories of closure and securement products:
- Sutures, Staples, and Other Mechanical Closure Devices
- Medical Tapes
- Fibrin and Other Sealants
- High-Strength Medical Adhesives
- Post-Surgical Adhesion Prevention
Development Timeline. 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).
The world market for these closure and securement product is currently worth more than $9.7 billion. This total market is growing at a steady 6.7% compound annual rate, though growth rates for individual regions vary. For example, France is 5.3%, the Americas are close to 7%, and Europe overall is 6.0%. Average growth in the world closure and securement products market also reflects differing conditions in individual countries, ranging between 3% CAGR for less developed economies and 7.7% for the United States. Growth in specific wound closure technologies markets ranges from a low of under 3% to almost 15% annually.
Even though there is therefore a dramatic amount of change expected in this market over the next five years, given the different growth rates, there is still a substantial amount of "untapped" demand evident in the well established wound closure markets — sutures, staples, tapes and mechanical closure.
Source: MedMarket Diligence Report #S180.