The main medical markets for sealants, glues, hemostasis and anti-adhesion in Latin America are Brazil and Mexico, followed by Argentina.
Brazil, despite its size (population 196 million), is not a lucrative medical market because of the wide economic disparity between the wealthy and poor segments of the population. The state-run Unified Health System (SUS) covers 75% of the population but only 42% of total health care expenditure is in the public sector. Private health care covers 17.5 million subscribers, less than 10% of the population. Thus conventional, low-cost closures (sutures, staples, tapes) dominate the market and more expensive novel closures (sealants and glues) have relatively modest market shares. The same is true of Argentina, which is still recovering from a severe economic depression in the 1990s. Mexico, the eighth biggest trading market in the world, operates a health care system under which 60%–70% of the population are covered by public insurance schemes. In terms of expenditure on medical products, Mexico occupies a position between that of developed and developing economies, and this is reflected in the shares of the wound closure market represented by premium-priced and commodity product groups.
Below is illustrated the segmentation of the sealants, glues, hemostasis and anti-adhesion products market in the major countries of Latin America. As is evident from the graphic, glues and sealants have gained a significant share of the sutures and staples market. How much more share glues and sealants can gain is dependent upon caseload conversion with existing products, new products developed and, to a significant degree, penetration of the sutures and staples markets by products from major manufacturers whose distribution capabilities are establ
Different options for closing wounds, initiating hemostasis and other related applications are emerging in markets outside the well-developed medical markets in Europe, Japan and the U.S.
Below is an example of a novel hemostatic agent, Ankaferd Bloodstopper, a plant-based agent that has been developed by the Istanbul, Turkey, company, Ankaferd Health Products Ltd.
Currently only registered for sale in Turkey and Bosnia/Herzegovina, since the product has not received CE Mark, the question remains whether the product will make it in Western Europe or the U.S., not least of which due to its interesting origin and the fact that its mechanism of action has not yet been elucidated. From "Today’s Zaman" (25 January 2009):
The inventor of this miraculous product, Hüseyin Cahit FÄ±rat, is, interestingly enough, not a medical doctor. He studied economics and was involved in business and journalism but has been engaged in the healing effects of herbs and worked on the formula of ABS for 30 years. Speaking to Sunday’s Zaman in an interview, FÄ±rat said ABS comprises a standardized mixture of galangal, nettles, grape leaves, licorice and thyme, which are mixed together under laboratory conditions. "Although ABS has been confirmed again and again to stop bleeding, the basic mechanism of action for the hemostatic effects of ABS still cannot be explained," he says.
It is worth noting that, for an analogous product, fibrin sealants, the initial market success was not in Europe or the U.S., but Japan, due in part to the social stigma in Japan associated with bleeding and, on the other side, to concerns in the U.S. (not so much for Europe) regarding potential blood-borne viral transmission associated with fibrin sealants.
MedMarket Diligence has published a report on surgical sealants, glues, hemostasis, anti-adhesion and other products. See Report #S175.
Skin securement has always been an essential final step in surgical procedures. In early years, the skin surface was sutured; in recent years a number of advances have been made, including new tapes, sutures, staples, hemostats, and glues.
Approximately 24,000 burn victims in the United States received skin grafts every year. These represent the very worst burn cases; in fact, approximately 25% of this group will die from their injuries. Glues and sutures are used to secure skin grafts in place and hemostats are used to prevent bleeding and to prepare the new skin for repair. Skin grafts provide an immediate covering for the patient that prevents further cell death, stimulates repair, and reduces fluid loss through the burnt skin. Products in this category may also be required to treat the skin after donor site material is taken from an intact region on the patient’s skin for skin grafting. Advances in sealant, hemostat, and closure technologies offer the potential to accelerate repair by creating the right environment to accelerate the healing process and provide better repair.
About 1.5 million pressure ulcer patients were treated in the United States in 2008. These wounds develop in immobile patients who often suffer from underlying biochemical deficiencies that lead to inadequate skin healing. Prevalence is highest in the old and infirm, and incidence is increasing in line with aging of the population. Sealants, hemostats, and closure products provide opportunities for a radical surgical method to treat these life-threatening wounds, which normally would be treated with conservative (though often sophisticated) wound healing products designed to reduce points of pressure, mask smell and absorb excess moisture while the body repairs itself. The strongest opportunity for use of surgically oriented products for repair of pressure ulcers is among young paraplegics and short-term acute care patients who are immobilized but otherwise healthy (approximately 5% of all pressure ulcers).
Diabetes causes many abnormalities in tissue biochemistry and nutrition, many of which lead to impaired tissue healing. In addition, diabetes leads to conditions of hypoxia and peripheral neuropathy that can directly cause ulcers. Approximately 800,000 diabetics in the United States have diabetic foot ulcers; closure and securement products offer a surgical route to aiding repair that may offer potential to accelerate repair in a number cases.
There are approximately one million venous ulcer patients in the United States today. Prevalence is increasing in line with aging demographics exacerbated by a sedentary lifestyle. Venous ulcers are caused by underlying vascular and venous flow abnormalities, which can often be treated by knowledgeable application of pressure bandaging and, in some cases, appropriate topical wound care. However, this treatment is largely symptomatic and many physicians believe surgical intervention to repair the underlying vascular abnormalities is required to effect a cure and avoid tissue breakdown. Sealants, hemostats, and closure products offer a surgical route to aiding repair that may offer potential to accelerate repair in a number cases.
About 2 million cosmetic augmentation procedures are performed in the United States every year. The most popular procedures are liposuction (455,000) and breast augmentation (365,000). Most of the latter use synthetic materials and biomaterials for augmentation purposes. Other procedures where sealant products may be relevant include rhinoplasty (200,000), abdominoplasty (170,000) and eyelid surgery (230,000).
Adjunctive products for securement and closure offer potential to improve surgical procedure, reduce infections, and improve aesthetic and physiological properties of newly repaired tissues, as well as offering more rapid rehabilitation and the avoidance of donor site morbidity in approximately 27,000 of these operations involving the use of donated tissue from another region of the patient’s body.