Market Scope

Over 35 million US and 100 million worldwide annual surgeries are driving positive ambulatory and laparoscopic surgical trends

According to MedMarket Diligence, LLC, approximately 114 million surgical and procedure-based wounds occur annually worldwide, including 36 million from surgery in the US, which can benefit from sealants and/or hemostatic* agents.2

These figures are consistent with internal estimates, derived from published data3,4,5 

Trends that support the increasing demand in “biomaterials” include:

  • ambulatory same day surgery volume growth +5% (inpatient volume is -1%)
  • laparoscopic procedure volume growth
  • operating room time reduction
    - according to MedMarket Diligence, a $115 hemostat that saves four minutes in operating time pays for itself, and these “products can often save anywhere from five minutes to two hours, depending on the procedure.”
  • surgeons are expected to meet greater challenges

Target market size and trends

Use of hemostatic agents and sealants is increasing. The market achieved $2B in 2010 worldwide sales and was projected to reach $4B in 20156.  Current projections now indicate sales may exceed $4B in 2013 and $7B in 2017. Over two-thirds of these sales are for hemostats, but a greater sealant growth rate is projected due to a relative paucity of products and an even larger unmet need.

The most useful hemostatic agents can cost upwards of $500/application. Yet a relatively small percent of surgeons use them, often citing their limitations. Supported by views of thought-leaders, improved products would see better uptake, thus growing the already large market.

Another trend is the shift over the past two decades to performing surgery in the less expensive outpatient setting. While this trend continues, bleeding risks force many otherwise straightforward cases to be performed in the hospital inpatient setting, which typically provides greater support for significant potential complications.

The biggest trend is to perform surgery less invasively. Less invasive procedures produce shorter recovery times, faster discharges, less scarring, less pain and less need for pain medications. Open surgery has moved to laparoscopic surgery (25% of procedures). Traditional laparoscopic surgery (three openings) is slowly moving to single-port laparoscopic surgery (one opening), which is more difficult to perform. While still in its infancy, there is a move afoot to advance the techniques of NOTES (natural orifice translumenal endoscopic surgery), which is a method of performing surgery without creating openings in the exterior of the body, by using natural orifices to reach the intended surgical destination instead.

The implication of these trends is that physicians need more advanced materials that are precisely deliverable, easily controlled, maintain a clear field of vision, and work reliably and promptly. Furthermore, the concern of leaking anastomosis in a patient who underwent laparoscopic surgery is prevalent. Some suggest that one of the main hurdles to the uptake of NOTES is concern over leaks after the “opening inside the orifice” is closed.  Many physicians stated they could use our product in the majority of their laparoscopic procedures, especially as prophylaxis against leaks that occur after the patient has moved to a post-operative environment.

2 2012 MedMarket Diligence, LLC, Report #S190, “Worldwide Surgical Sealants, Glues, Wound Closure and Anti-Adhesion Markets, 2010-2017″.
3 Cullen KA, Hall MJ, Golosinskiy A. Ambulatory Surgery in the United States, 2006. National health statistics reports; no 11. Revised. Hyattsville, MD: National Center for Health Statistics. 2009.
4 U.S. Surgical Procedure Volumes. 2009, Windhover Information, Inc. #A607
5 Proprietary data
6 Source: MedMarket Diligence, LLC; Report #S180, “Worldwide Surgical Sealants, Glues, Wound Closure and Anti-Adhesion Markets, 2008-2015.”

*Hemostasis or haemostasis (from the Ancient Greek: αἱμόστασις haimóstasis "styptic (drug)") is the process of stopping bleeding, or preventing blood from leaking from damaged blood vessels and tissues. (The opposite of hemostasis is hemorrhage.)

**Laparoscopic surgery, also called minimally invasive surgery (MIS), or keyhole surgery, is a modern surgical technique in which operations are performed through small incisions (usually 0.5–1.5 cm) as opposed to the larger incisions needed in open surgery. Keyhole surgery makes use of images displayed on TV monitors to magnify the surgical elements.