Glues, sealants, hemostasis, anti-adhesion market growth

The market for surgical closure and securement has entered a phase in which major driving forces are the introduction of new procedures and techniques by the surgical profession, the development by the medical device industry of new wound closure devices and biomaterials, and the growing willingness of surgical specialists to use these devices in appropriate circumstances. There is now a continuum between simple closure using sutures and the use of specially designed devices and delivery systems with new bioresorbable securement materials either as supplements to conventional closure methodology or as stand-alone replacements.
Worldwide expenditure on all medical devices surpassed $180 billion in 2007, and in the field of tissue repair and surgical securement, the total market reached $7.3 billion, underpinned by product advances reflecting our improved understanding of the underlying mechanisms of tissue repair, patient demographic pressures creating an increasing caseload of procedures, and a rapidly expanding number of new products available.

The tissue closure and securement market can be regarded as a benchmark indicator for overall expansion of medical device usage. This is because surgical closure and securement products are growing to be components of all surgical procedures. These products are used for rapid and efficient closure of surgical wounds, and internal securement of tissues to reduce pain and accelerate rehabilitation. Appropriate use of these products can reduce risk of infection, and can optimize the repair process to enhance the speed and strength of tissue repair, as well as reducing complications such as those resulting from post-surgical adhesions.

Overall industry spending in the health care system has a major impact on this segment. Consolidation in healthcare buying organizations (particularly in the United States) creates a pressure for cost-effectiveness arguments and supporting clinical efficacy data, and may also limit pricing potential, often when the overall cost in a category appears to be growing uncontrollably. The shift to outpatient and community-based treatment sites and practices affects the way that products are designed, marketed and distributed. In the securement segment, hospital administrators are involved in purchasing more routine and generic surgical securement and closure products, with surgeons selecting more advanced and new technologies. In addition, the case for cost-effectiveness involves professional preferences and adoption of new procedures, as well as the potential to reduce surgical theatre time and costs.

sealant-growth-rates

Source:  MedMarket Diligence report #S175, "Worldwide Surgical Sealants, Glues, Wound Closure and Anti-Adhesion, 2009-2013."

 

Orthopedic biomaterials market growth strongest in U.S.

Growth in the U.S. market for orthopedic biomaterials is expected to be somewhat faster than in Europe and significantly greater than in the developing world, partly because new biomaterials are relatively expensive and their uptake is related, in general terms, to GDP. Newly-emerging technologies such as bone morphogenetic proteins (BMPs) are expected to grow at rates up to 30-35% per annum during the forecast period (2007-2011), although their contribution to the overall orthopaedic biomaterials market will be relatively modest, since they are starting from a small base. Overall, the U.S. market for orthopaedic biomaterials is expected to grow by approximately 12% per annum over the next five years.

The U.S. market is the best-documented of the world’s regional markets for orthopaedic biomaterials, and U.S.-specific data are to be found later in this section, under discussions of the market by surgical procedures and classes of biomaterials.

ortho-biomaterials-pie1

Source:  MedMarket Diligence Report #S625.

 

Although the "other" category is the largest category included in this overall market, and has been included because of both "biomaterials" aspect of these technologies and their clinical utility in orthopedic applications, these products are part of the larger market for sealing, adhesion, hemostasis and prevention of post-surgical adhesions.  (The market for these products are addressed separately in the MedMarket Diligence report #S175, "Worldwide Sealants, Glues and Wound Closure, 2009-2013".)

 

 

Latin American markets for surgical sealants, glues, hemostasis and ant-adhesion products

MedMarket Diligence's worldwide analysis of the markets for surgical sealants, glues, hemostasis, wound closure and anti-adhesion provides detail on growth segments of the market, both in the products/technologies and the geographic breakdown.  Below is an excerpt from Report #S175.


The main medical markets 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.

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Below is shown a graph of the major Latin American markets for these products.  As is shown, sealants and glues have gained a significant share of these markets, yet additional penetration of the sutures and staples segment by sealants/glues, potentially to a large degree, may be gained with additional product development, conversion of caseload and aggressive marketing/promotional campaigns to physicians in these markets.

latin-america2

Source: MedMarket Diligence, LLC; Report #S175

Latin American markets for surgical sealants, glues and related products

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

latin-america1

Source: MedMarket Diligence, LLC; Report #S175

 

New sealants, glues emerging from nettles, grape leaves, licorice and thyme?

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 Fırat, 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, Fırat 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.

Prevalence of dermal applications for sealants and glues

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.

Burns

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.

Pressure Ulcers

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).

Diabetic 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.

Venous Ulcers

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.

Plastic Surgery

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.

 

dermal applications of sealants

Source: MedMarket Diligence, LLC; Report #S175, "Worldwide Surgical Sealants, Glues and Wound Closure, 2009-2013."

 

Technologies at new medtech startups

Below are the products/technologies at recently identified medtech startups:

Company
City
Country
Founded
Product/Technology
Checkpoint Surgical, LLC
Cleveland, OH
USA
2008
Intraoperative nerve location and protection device.
DiFUSION Technologies, Inc.
Austin, TX
USA
2008
Medical device to prevent surgical site infections in orthopedic and spinal surgeries.
FHL Innovations, LLC
Fredericksburg, VA
USA
2007
Surgical dressings
GS Medical Co. Ltd.
Seoul
Korea
2007
Spinal implant manufacturer
IQ Medical Devices, LLC
Belmont, MA
USA
2006
Surgical irrigation and retraction systems.
Millennium Medical Technologies, Inc.
La Verne, CA
USA
2006
Autologous fluid concentrator
OmegaGenesis Corporatoin
Gilroy, CA
USA
2008
Nanotechnology biomaterials company developing angiogenic materials for use in wound management, treatment of ischemic heart disease, others.
Piezo Resonance Innovations, Inc.
Bellefonte, PA
USA
2007
Devices based on piezoelectric, magnetorestrictive and shape memory materials technologies, including a sonicator and an ophthalmic surgical device.
Seventh Sense Biosystems, Inc.
Cambridge, MA
USA
2007
Medical device company backed by Flagship Ventures, Polaris Venture Partners and Third Rock Ventures.
SPR Therapeutics
Cleveland, OH
USA
2008
Peripheral nerve stimulation for treatment of post-stroke shoulder pain.
Starch Medical, Inc.
San Jose, CA
USA
2007
Polymer-based absorbable surgical hemostats.

Source: MedMarket Diligence, LLC; Medtech Startups Database