Wound Closure Technologies Fragmented, But Growing through 2018

Wounds have been closed and secured through the use of sutures and bandages since ancient times, using equipment ranging from threads made of a variety of organic materials, to tight wrappings. In the modern medical age, suture materials have evolved through a succession of stages from non-resorbable, to resorbable, to stapling devices. Surgeons still primarily use sutures for wound closure and securement—sutures are cheap, familiar and work most of the time. However, it is important to discuss this class of products and their relationship with adjunctive measures, and with newer products under development.

There are six major device markets in the field of wound closure:

  • Sutures and Staples
  • Vascular Closure Devices
  • Surgical Sealants and Glues
  • Surgical Hemostats
  • Cyanoacrylate Glues for External Closure
  • External Closure Tapes and Strips

The markets for some segments in wound closure, especially sutures and staples, surgical tape, hemostats, and sealants and glues, are highly fragmented. There are literally hundreds of companies with products that fall into the wound closure arena. Barriers to entry are low for some segments, such as medical tapes, sutures and staples, and high for others, such as fibrin and others. In addition, many companies purchase from the original equipment manufacturers (OEM), and rebrand the products to sell under their own name. While this may obscure who the market leaders are, there no little doubt, however, that the overall market leader for the products in wound closure is Johnson & Johnson (JNJ), which markets devices that fall under six of the seven product categories. JNJ is followed by Covidien and B. Braun/Aesculap, which together make up the three largest players in this space.

Global Market Shares in Wound Closure 2014

Screen Shot 2015-02-23 at 4.02.15 PM

Source: MedMarket Diligence, LLC; Report #S192.

Growth in this market is still driven by new technologies with potential to not only penetrate well-established wound closure technologies but also gain procedure volume in novel applications. Below is illustrated the relative compound annual growth rates in sales of each of the major types of wound closure technologies.

Sales Growth in Wound Closure Types, 2014-2018

Screen Shot 2015-02-23 at 4.08.14 PM

Source: MedMarket Diligence, LLC; Report #S192.

Surgical Sealants and Glues Sales Growth

Aside from demonstrating clinical utility in wound sealing and closure on their own, sealants and glues are emerging as important adjunctive tools for sealing staple and suture lines, and some of these products also are being employed as general hemostatic agents to control bleeding in the surgical field. Manufacturers have also developed surgical sealants and glues that are designed for specific procedures – particularly those in which staples and sutures are difficult to employ or where additional reinforcement of the internal suture/staple line provides an important safety advantage.

Sales of surgical sealants and glues have become as common in some surgical procedures as sutures and staples in well developed markets (U.S., Europe and Japan), but their use continues to expand in both stand alone and adjunctive use with other wound closure. Emerging markets, especially in Asia will drive nearly double these growth rates. All told, the global surgical sealants and glues market will eclipse $2 billion by 2018 on compound annual growth of 9.4%.

Screen Shot 2015-01-27 at 2.45.11 PMSource: MedMarket Diligence, LLC; Report #S192.

 

Surgical Sealants and Glues in the Balance of Wound Closure

Sealants and glues are emerging as important adjunctive tools for sealing staple and suture lines, and some of these products also are being employed as general hemostatic agents to control bleeding in the surgical field. Manufacturers have also developed surgical sealants and glues that are designed for specific procedures – particularly those in which staples and sutures are difficult to employ or where additional reinforcement of the internal suture/staple line provides an important safety advantage.Suture-line-pixelated

Surgical sealants are made of synthetic or naturally occurring materials and are commonly used with staples or sutures to help completely seal internal and external incisions after surgery. In this capacity, they are particularly important for lung, spinal, and gastrointestinal operations, in which leaks of air, cerebrospinal fluid, or blood through the anastomosis can cause numerous complications. Limiting these leaks results in reduced mortality rates, less post-operative pain, shorter hospital stays for patients, and decreased health care costs.

Although some form of suturing wounds has been used for thousands of years, sutures and staples can be troublesome. There are procedures in which sutures are too large or clumsy to place effectively, and locations in which it is difficult for the surgeon to suture. Moreover, sutures can lead to complications, such as intimal hyperplasia, in which cells respond to the trauma of the needle and thread by proliferating on the inside wall of the blood vessel, causing it to narrow at that point. This increases the risk of a blood clot forming and obstructing blood flow. In addition, sutures and staples may trigger an immune response, leading to inflamed tissue, which also increases the risk of a blockage. Finally, as mentioned above, sutured and stapled internal incisions may leak, leading to dangerous post-surgical complications.

These are some of the reasons why surgical adhesives are becoming increasingly popular, both for use in conjunction with suture and staples and on a stand-alone basis. As a logical derivative, surgeons want a sealant product that is strong, easy-to-use and affordable, while being biocompatible and resorbable. In reality, it is difficult for manufacturers to meet all of these requirements, particularly with biologically active sealants, which tend to be pricey. Thus, for physicians, there is usually a trade-off to consider when deciding whether or not to employ these products.

Screen Shot 2014-12-29 at 9.28.14 AMClosure of general surgical wounds (internal or external) is largely accomplished by a combination of surgical tapes, sutures & staples and, increasingly, surgical sealants and glues. For the reasons discussed, the rates of technology development and adoption among these causing a relative but not absolute decline of sutures and staples revenues worldwide.

Surgical sealants, glues, and hemostats can be divided into several different categories based on their primary components and/or their intended use. From a practical standpoint, they may be subdivided by composition into products containing biologically active agents, products made from natural and synthetic (nonactive) components, and nonactive scaffolds, patches, sponges, putties, powders, and matrices used as surgical hemostats.


Data drawn from MedMarket Diligence, LLC, Report #S192, “Worldwide Surgical Sealants, Glues, and Wound Closure Markets, 2013-2018.” See link.

 

New technologies at Medtech Startups, November 2014

Below is a list of the technologies under development at companies recently identified and included in the Medtech Startups Database.

  • Handheld ultrasound, MRI imaging device.
  • Needle-free injection drug delivery.
  • Lenses designed to correct imbalance between eyes and brain that cause certain migraines.
  • Continuous blood glucose monitoring in diabetes.
  • Customized prosthetic aortic valve.
  • Cystoscope-implanted, stent-like device to treat urinary obstruction associated with benign prostatic hypertrophy.
  • Endovascular treatment for abdominal aortic aneurysm.
  • Respiratory therapy device based on “high frequency chest wall oscillation” for treatment of COPD, other respiratory disorders.
  • Treatment of arrhythmia.
  • Medical device commercialization company active in cardiovascular care, tissue ablation, medical infusions, hand surgery and laparoscopic surgery.
  • Surgical visualization systems.
  • Arthroscopic bone tunneler and other orthopedic surgical instrumentation.
  • Brain stimulation to treat multiple disorders.

See link for a month-by-month listing of the technologies at companies in the Medtech Startups Database.

Advanced and basic wound closure markets in contrast globally

In a prior post, I noted the migration of advanced technologies from countries/regions with well developed medical technology markets (U.S., Europe, Japan) to countries/regions such as China, which have large economies but relatively undeveloped markets for these technologies.

To elaborate on that, one of the more advanced technologies in wound closure is for the devices used in vascular closure, represented in the majority of cases by those used for closure of femoral artery puncture following diagnostic and interventional catheterization procedures. By contrast, perhaps the most basic wound closure technology is surgical tapes.

Diagnostic and therapeutic catheterizations are advanced procedures designed to reveal and treat vascular pathologies, respectively, and require access to the vasculature through a femoral artery. Following the procedure, the prompt and effective closure of the femoral puncture is critical, given the size of the artery and the potential for its inadequate closure leading to rapid blood loss and death. The overall procedure comprises advanced technology in the catheterization and the closure that is therefore relatively common in advanced economies, such as the U.S., Europe and Japan, and relatively scarce or non-existent in markets, such as China.

By contrast, surgical tapes are the simplest form of wound closure with minimal technology. However, the caseload for use of surgical tapes is enormous, given the incidence of simple lacerations that can be addressed through surgical tapes. Given advanced alternatives to closure (sealants, glues, hemostats, etc.) in the U.S., Europe and Japan, surgical tapes have considerably lower demand than in China.

The contrast is illustrated in the two forecast graphs of global sales of surgical tapes and vascular closure devices.

Screen Shot 2014-11-24 at 8.36.49 AM

Source: Report #S192, “Worldwide Surgical Sealants, Glues, and Wound Closure Markets, 2013-2018″; MedMarket Diligence, LLC.

Screen Shot 2014-11-24 at 8.36.30 AM
Source: Report #S192; MedMarket Diligence, LLC.

 

Technology Migration in Global Wound Closure Markets

Drawn from our recent report on the global market for wound closure products, Report #S192, the distribution of the technologies on the market now, and in the future, for wound closure encompassing sutures & staples, tapes, hemostats, sealants & glues and vascular closure devices reveals the continued migration of advanced technologies (vascular closure, hemostats, glues & sealants) from western economies to the developing markets. Simultaneously, the more well established technologies (tapes, sutures & staples) are showing modest growth in western economies and robust growth in developing economies.

Below are illustrated the percentage of total worldwide market for each wound closure technology type by country/region.

Screen Shot 2014-11-10 at 10.29.31 AM

Source: MedMarket Diligence, LLC; Report #S192

Screen Shot 2014-11-10 at 10.29.41 AM

Source: MedMarket Diligence, LLC; Report #S192

Screen Shot 2014-11-10 at 10.30.22 AM

Source: MedMarket Diligence, LLC; Report #S192

Screen Shot 2014-11-10 at 10.30.58 AM

Source: MedMarket Diligence, LLC; Report #S192

Screen Shot 2014-11-10 at 10.31.08 AM

Source: MedMarket Diligence, LLC; Report #S192

New technologies at medtech startups, October 2014

Below is a list of the technologies under development at medical technology startups recently identified and included in the Medtech Startups Database.

  • Prosthetic disc nucleus in spine surgery.
  • Device and non-device technologies based on dynamics of blood flow.
  • Magnetic and fluorescent technology point-of-care device to detect heart attack.
  • Technologies for tissue reconstruction.
  • Adult stem cell therapy in orthopedics, aesthetics, and chronic diseases (diabetes, COPD, heart disease, multiple sclerosis, stroke/cerebrovascular disease).
  • Vagus nerve stimulation for neuromodulation treatment of various inflammatory autoimmune diseases.
  • Surgical devices including for endoscopic access closure.
  • Device to measure sympathetic nerve activity and produce ECG.
  • Simultaneously track electrical measures that indicate brain, heart, optical and musculoskeletal activity.
  • Needle-free pediatric withdrawal of blood.
  • Ventilation systems for improved delivery of gas, moisture and nebulized medication.
  • Broadly focused medical technology company active in osteoarthritis, cardiovascular, stroke, diabetes, infection control and spine surgery.

For a historical listing of technologies at medtech startups, see link.