Category Archives: surgery

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Worldwide Surgical Sealants, Glues, Wound Closure and Anti-Adhesion Market, Forecast to 2017

Potential for the Use of Hemostats, Sealants, Glues and Adhesion Prevention Products, Worldwide

This report details the complete range of sealants & glues technologies used in traumatic, surgical and other wound closure, including tapes, sutures/staples/mechanical closure, hemostats, fibrin sealants/glues and medical adhesives and anti-adhesion products. The report details current clinical and technology developments, with data on products in development (detailing market status) and on the market; market size and forecast; competitor market shares; competitor profiles; and market opportunity. The report provides full year actual data from 2011. The report provides a worldwide forecast to 2017 of the markets for these technologies, with emphasis on the market impact of new technologies through the forecast period. The report provides specific forecasts and shares of the worldwide market by segment for Americas (detail for U.S., Rest of North America and Latin America), Europe (detail for United Kingdom, German, France, Italy, Spain, Rest of Europe), Asia/Pacific (detail for Japan, Korea, Rest of Asia/Pacific) and Rest of World. The report provides background data on the surgical, disease and traumatic wound patient populations targeted by current technologies and those under development, and the current clinical practices in the management of these patients, including the dynamics among the various clinical specialties or subspecialties vying for patient population and facilitating or limiting the growth of technologies. The report establish the current worldwide market size for major technology segments as a baseline for and projecting growth in the market through 2017. The report assesses and projects the composition of the market as technologies gain or lose relative market performance over this period. The report profiles 122 active companies in this industry, providing data on their current products, current market position and products under development.

See description, table of contents and list of exhibits at http://www.mediligence.com/rpt/rpt-s190.htm Published February 2012..

Advice to forward-looking medtech manufacturers (and their competitors)

trainWill Rogers said, “Even if you are on the right track, you’ll get run over if you just sit there.” The current challenge for medtech manufacturers is that, as a result of a wide range of forces, trends and developments, the train that threatens to run them over has gotten a whole lot faster. Below is a short list of perspectives that is needed by medtech manufacturers and their competitors in order to stay ahead of the train.

  • Focus on your competitors’ solutions, not their products. Stent manufacturers (and this is just an example) are not competing only against stent manufacturers; they are also competing against drug-eluting balloon angioplasty, atherectomy, percutaneous myocardial revascularization, atherosclerotic plaque-reducing drugs, myocardial stem cell therapy and other device, drug, biotech and other options.  The focus is on the disease and all the alternative ways to treat it (even preventing it). And it bears reminding that a duty of your market intelligence is to keep a watchful eye on the broadest possible definition of potential competitors – gene therapy, holistic medicine, eastern medicines.
  • Be careful where you draw the line on your product’s features. There are many choices to be made in designing and engineering a medical product. The more you build into the product (being resorbable, being intelligent, having biocompatibility coating, having embedded drug(s), etc.), the more benefits you can potentially claim, but the more arduous the engineering, testing and regulatory approval will be.  The traditional advantage medical devices have over drugs has been that devices are “inert”, accomplishing their therapeutic endpoint without the large scale side effects possible with systemically active drugs.  The more devices are imbued with drugs, made of resorbable material or have any kind of interactive capability with the tissue around them, the more likely will be occurrence of adverse effects.
  • Directly or indirectly, your product must be viewed as lowering healthcare cost. In real terms, a product that demonstrably lowers costs compared to alternatives has a decided advantage. However, your product has only to give the appearance of saving money, or at least clearly suggests that it will not raise healthcare costs. Directly, if you can point to units per patient and average selling price and you can point to explicit cost saving compared to currently used products, you’ve gained an advantage. Short of that, you can gain advantage if you can make a defensible cast that your product leads to indirect cost savings such as in less trauma, less collateral damage, faster healing times and similar.
  • “Zero invasiveness” is the target. Expect increasing numbers of percutaneous and “natural orifice” procedures at the expense of not only open surgical procedures but also laparoscopic procedures. Too many surgical and interventional formats, and support systems for them, have been developed that signal the end of the need for invasive procedures.  And whether the procedure is done laparoscopically, endoscopically, percutaneously, or even radiosurgically, the need to cut, resect/excise or otherwise physically alter anatomy or morphology to address pathology will be obviated by, and be less attractive than, effective non-surgical/non-interventional approaches.
  • “Personalized medicine” may be largely theoretical, or at least largely unrealized, BUT the potential to be able to predetermine when therapies will or will not work is too significant in its implications to ignore. (Looking at this another way, I recently spoke with a pharmaceutical colleague who noted that blood markers in patients with a particular condition could help them screen out 97% of the diagnosed patients for whom their therapy would be ineffective.  Their conclusion was not that the drug was 97% ineffective but that, for 3% of the diagnosed population, the drug would be highly effective and therefore highly profitable.)
  • The pace of change is accelerating. Developments in material sciences, the growth in applied understanding of basic life sciences, the emergence of “paradigm-shifting” industries like stem cell and tissue regeneration, the rewards being reaped by genome sequencing, the integration of advanced information technologies in drug discovery, simulated device prototype testing and other advances are dramatically shortening the gap between idea and market introduction, reducing product life cycles (accelerating obsolescence) and increasing the intensity of competition for all manufacturers.

The advice for any medtech manufacturer — or, for that matter, any manufacturer of a product competing against a “medtech” product — is that they must continually address the view of their competitive landscape to recognize and be prepared to respond to real and perceived competition, trends, forces and opportunities.

Growth of established and advanced wound closure products globally

Sutures and staples are fairly low tech methods to close wounds.  Sutures in one form or another (mostly sheep intestines) have been in use for hundreds of years and staples have been in practice since the early 1900s. At the other end of the extreme are high strength medical adhesives or surgical glues, which are still largely in their infancy.

But the impact of these products in the market for wound closure varies by country and the local nature of medical practice, the impact of culture on the management of wounds, the economic climate and a large number of other factors.

Below is illustrated, for comparison, the compound annual growth rate in sales of sutures/staples versus high strength adhesives/glues.  What is clear is that the more rapid growth of high strength adhesives reflects the fact that their potential is a long way from being fully penetrated.  What is not as clear from growth rates is the relative size of the markets — or the absolute sales volume associated with the growth rates given.  Sutures and staples still represent an enormous ($5.5 billion) global market while high strength glues are less than a quarter of this.

CAGRs-sealants-high-strength

Source: MedMarket Diligence, LLC; Report #S190.

The complete picture — growth and current revenues — is represented in the sales by country, which (for the sake of this snapshot) is illustrated below in summary by geographic region.

regional-sealant-sales-2012

Source: MedMarket Diligence, LLC; Report #S190.


“Surgical Sealants, Glues, Sutures, Other Wound Closure and Anti-Adhesion, Worldwide Markets, 2012-2017″, Report #S190 from MedMarket Diligence, details the current and forecast market by country for the range of products in wound closure and related wound applications including tapes, sutures/staples/mechanical closure, hemostats, fibrin sealants/glues and high-strength medical adhesives and anti-adhesion products.

Growth in posterior pedicle screw fusion systems in spine surgery

Posterior pedicle screw fusion systems are used extensively in spine surgery; eight or more screws may be used in a single procedure.

The posterior pedicle screw fusion system will continue to be used in spine surgery for the foreseeable future. Industry managers believe that, even as new treatments come on to the market, spinal fusion will continue to be the gold standard treatment for degenerative disc disease unresponsive to conservative measures.

The global market for posterior pedicle screw fusion systems was nearly $3 billion 2012, and is forecast to reach a value of almost $6 billion by 2020. The average selling price (ASP) is expected to drop over this period, due largely to strong competition and the sheer number of companies manufacturing and selling these devices.

pedicle-screw

Source: MedMarket Diligence, LLC: Report #M520.

A variable number of pedicles screws are used in each procedure but this number on average will remain the same through 2020.  Consequently, with prices being squeezed, unit growth will outpace dollar volume sales growth.

The global leader for posterior pedicle screw fusion systems is Zimmer, followed by Medtronic, with the two companies controlling almost 75% of the market. There are many smaller companies in this market, and all of these are targeting the same customers, creating intense pricing pressure for devices that are generally ‘me-too’ and leading to consolidation as manufacturers hit their lowest limits on cost.

 

Wound healing physiology

Skin_layers.svgWhen body tissue is damaged by trauma, surgery, hypoxia, or other destructive processes, it quickly reacts to protect itself and begin the process of healing. Clean surgical wounds closed by primary intention heal rapidly and do not usually require additional medical intervention and support. Chronic wounds and those left to heal by secondary intention will require more attention from the medical team. Most of the literature describing the phases of wound healing has been written following investigation of clean, acute wounds, and the sequence and timing of the events described thus only relates to acute wounds. It is assumed that the chronic wound follows a similar wound-healing course with the timing of events delayed or prolonged compared with acute wounds.

All wounds must pass through three recognized physiological processes in order to achieve healing: the inflammatory phase, proliferative phase, and maturation phase. It is useful to view the stages of wound healing as distinct events with endpoints or goals that must be achieved in the proper sequence for healing to succeed. In reality, there is overlap between the phases, and an individual wound may be in several phases at the same time. When all the stages have been accomplished over the entire wound surface, complete wound healing is achieved.

Unlike acute or surgical wounds, which heal by “primary intent” – the joining of the wound edges by sutures, staples, or adhesive strips – skin ulcers and severe burns heal by “secondary intent,” through the formation of granulation tissue, contraction of the wound, and epithelialization. A normal wound heals in approximately 21 days in organized phases of inflammation, proliferation, and remodeling, but chronic wounds often stall between the inflammatory and proliferation stages, creating wounds that can last for months or even years.

Wound physiology is divided into three phases: defensive, proliferative, and maturation; each phase must be allowed to occur without impediment for healing to be complete. The defensive phase occurs from the time of injury to three days and is characterized by hemostasis and inflammation. The clotting cascade is initiated, and white blood cells mobilize to defend and protect the area from bacterial invasion. Vasodilatation and serous exudate facilitate the removal of debris and deliverance of nutrients to injured tissue. Proliferation lasts from day two until the area is healed and features granulation, contraction, and epithelialization. Granulation includes neoangiogenesis and collagen formation. Granular tissue is pale pink to beefy red, glistening, and has a rough surface due to blood vessels and collagen deposits Contraction occurs as a result of myofibroblasts pulling collagen toward the cell body, and epithelialization is the migration of epithelial cells to resurface the area. Maturation is the last phase of healing, and involves scar remodeling after wound closure and may take years. Maturation sees a scar change from red to purple/pink to white, and from bumpy to flat.

Wound management priorities include: 1) reducing or eliminating causative factors (pressure, shear, friction, moisture, circulatory impairment, and/or neuropathy), 2) providing systemic support for healing (blood, oxygen, fluid, nutrition, and/or antibiotics), and, 3) applying the appropriate topical therapy (remove necrotic tissue or foreign body, eliminate infection, obliterate dead space, absorb exudate, maintain moist environment, protect from trauma and bacterial invasion, and provide thermal insulation).

The diversity of wounds and wound care products complicates the dressing selection process; many wounds have several options for dressings that are effective. Matching wound characteristics with dressing features is one important goal in the healing process. For example, a heavily exudating wound needs an absorptive dressing, and a wound with necrotic eschar needs a dressing that facilitates debridement. Dressings fall into several categories: gauze, hydrogel, hydrocolloid, transparent film, alginate, foam, and accessory products such as enzymes, growth factors, biological dressings, compression devices, support surfaces, and methods for securing dressings.

Factors affecting healing include tissue perfusion and oxygenation, presence or absence of infection, nutrition, medications, underlying disease, mobility and sensation, and age. Circulation and adequate oxygen saturation deliver nutrients for wound healing and gas exchange. All wounds disrupting the integument are contaminated, but not necessarily infected. Bacteria compete with tissues for nutrients, prolonging the inflammatory stage and delay collagen synthesis and epithelialization. Vitamin C, the B vitamins, zinc, and copper are necessary for collagen synthesis. Vitamin A combats the effects of steroids and protein is needed for collagen and skin growth. Steroids and immunosuppressive drugs suppress the inflammatory phase thus slowing the entire healing process. Underlying chronic disease(s) also competes for nutrients, increases risk of infection, and stresses the healing process. Limited mobility and/or sensation contribute to wound formation and impair the perception of wound presence or complications.

Debridement is necessary when necrotic eschar or fibrinous slough is present in the wound base. Necrotic eschar is thick, leathery, devitalized, black tissue, and slough is white or yellow tenuous tissue. Methods of debridement are described as sharp (surgical), mechanical (dressings), autolytic (dressings) and enzymatic (enzymes). Sharp debridement is indicated for extensive necrosis or for large wounds. Mechanical and autolytic debridement are indicated for many pediatric wounds and is accomplished with dressings. Mechanical debridement is done with a wet to dry dressing using woven gauze; as wet fibers dry, tissue adheres to the fiber and is removed when the dressing is removed. Autolytic debridement is also indicated for many pediatric wounds and is done with an occlusive dressing that retains moisture on the wound and allows white blood cells and enzymes to break down necrotic tissue. Hydrocolloids, transparent films, and hydrogels are effective for autolytic debridement. Enzymatic debridement is indicated when selective debridement is desired because enzymes only work on necrotic tissue. Enzymatic preparations contain fibrinolysin, collagenase, papain or trypsin in a cream or ointment base. Enzymatic debridement is slow, but effective, and instructions for using enzymes must be followed closely.

Wound cleansing removes dressing residue, microbes, and cellular debris (may include healing tissue). Cleansing products need to be safe for healing tissue and effective at removing debris. The adage “don’t put anything in a wound you wouldn’t put in your eye” are safe words to work by. Many topical cleansing agents and antiseptics are cytotoxic, and it is imperative to weigh the risks of cytotoxicity against the benefits of cleansing effectiveness and antimicrobial activity. Normal saline is safe, effective, readily available, and inexpensive. Wound irrigation pressure needs to be high enough to remove debris and low enough to avoid traumatizing tissue. Pressures ranging from 4-15 pounds per square inch (psi) are effective for cleaning. For example, a 60cc catheter tip syringe delivers 4.2 psi, a 35cc syringe with a 19 guage needle delivers 8.0 psi, and a Water Pik at its highest setting delivers >50 psi. Frequency of wound cleansing varies with wound characteristics and dressing selection, but once a day cleansing is a minimum4,5. Clean versus sterile technique for dressing changes is constantly debated with varying outcomes and supporting arguments. Most importantly, consider the host system defenses and type of wound when deciding whether to use a clean or sterile technique for dressing changes and cleansing.

Wound assessment involves many parameters, but the following indices should be included in continued documentation of wound healing: size (length, width, depth), extent of tissue involvement (partial or full thickness; stage of pressure ulcer), presence of undermining or tracts, anatomic location, type of tissue in base (viable or nonviable), color (red, yellow, black categories), exudate, edges, presence of foreign bodies, condition of surrounding skin, and duration2. Photography is useful for documenting progress and should include a measuring scale and date.

For Inflammatory Phase, Proliferative Phase, Angiogenesis and Maturation Phase, see Report #S249.


Drawn from Report #S249: “Wound Management, Worldwide Market and Forecast to 2021: Established and Emerging Products, Technologies and Markets in the Americas, Europe, Asia/Pacific and Rest of World.”

See also Report #S190: “Surgical Sealants, Glues, Sutures, Other Wound Closure and Anti-Adhesion, Worldwide Markets, 2012-2017.”

Opportunities, drivers and growth platforms in medtech

horizon_00364590The medical technology industry is characterized by its steady focus on finding and developing innovative solutions on the horizon that will meet the demands of clinicians and healthcare systems to more rapidly and effectively solve problems in the management of disease and trauma.

Given the state of the art in healthcare regarding the performance of current and potential medical technologies, there are a number of key opportunities in medtech that are driven by specific forces and are likely to be solved by one or more high value platform technologies.  These opportunities, drivers and high value platforms are listed below.

The biggest opportunities in medtech:

  • Non-toxic, high strength closure and sealing of internal wounds (GI, pulmonary, cardio, etc.)
  • Closed-loop “artificial pancreas” comprising integrated glucometer and insulin pump
  • Versatile chronic wound management to accelerate healing of multiple chronic wound types
  • Non-invasive blood glucose testing (infrared, interstitial fluid or other approach)
  • Non-invasive large molecule drug delivery (transdermal, inhaled, encapsulated, etc.)
  • Interventional surgery (catheter or natural orifice) instrumentation
  • Infection control for nosocomial vectors
  • Organ replacement and transplant (preservation, bridge-to-transplant, etc.)

Drivers

  • Untreated or underserved, growing patient population
  • Cost containment
  • Eliminating lost productivity
  • Less invasiveness for lower cost, faster healing
  • Point-of-care (home, physician office, bedside) diagnostics for comprehensive screening and detection
  • Increasing demands for devices to be specific, be clinically effective and have small or non-existent long-term footprint

High Value Platform Technologies

  • Materials technologies incorporating one or more features of biocompatibility, adaptation, cell migration, drug elution, resorption, excretion or other easy removal
  • Adult, embryonic and other pluripotent stem cells
  • Gene therapy emerging from recent innovations (e.g., type 1 diabetes)
  • Interventional surgical technologies
  • Multi-parameter (MRI, CT, ultrasound, etc.) intraoperative imaging
  • Laparoscopic and natural orifice transluminal endoscopic surgery
  • Nanotechnology drug delivery, surface modification
  • Integration/fusion of information technologies with implants

We have identified these opportunities, drivers and platforms from research in a wide range of medtech markets, considering the state of the art in clinical practice, products/technologies on or nearing entry to the market, clinician and healthcare system perspectives, and the  current/forecast sales data for products in surgery, cardiology, spine/orthopedics, cell/tissue therapy, obesity, wound management, others.

See MedMarket Diligence Reports.

 

 

Advanced wound technologies penetrating, expanding markets

Advanced medical technologies gain footing in medical technology markets by a combination of displacing caseload previously served by older, established technologies, and tapping into previously unserved (or underserved) caseload by offering new product benefits. In other words, new technologies gain sales by both penetrating existing markets and actually expanding the current market.

The global wound care market is characterized by such a shift toward advanced technologies, where the overall gain in sales of new technologies is accounted for by both the displacement of traditional product sales and the added caseload of patients previously untreated or under-treated.

Below is illustrated the shift in share of the total market arising from each of the multiple different wound management technologies. Growth in the market (and resulting decline of traditional technologies) is arising from growth factors, bio-engineered skin & skin substitutes, as well as growth in some older but still advancing technologies driving growth in foam and alginate dressings.

adv-wound-share

Source: Report #S249, “Worldwide Wound Management, 2012-2021.”

High growth spine surgery markets worldwide

Growth of sales for medical technologies can be determined almost as much by geography as by whether the market is emerging or displacing existing competitive technologies.  For this reason, we review spine surgery markets globally considering the growth of specific spine surgery technologies in specific countries.

Clearly, the geographic markets that are, in general, demonstrating the most rapid adoption of new medical technologies will show even higher rates of adoption of the newest medical technologies than in other geographies.

Case in point, the spine surgery technologies demonstrating the highest growth geographically are among the newest medical technologies being introduced in rapidly growing economies:

growth-country-segments

Source: MedMarket Diligence, LLC; Report #M520, “Worldwide Spine Surgery: Products, Technologies, Markets and Opportunities 2010-2020.”

Requirements for effective surgical sealants

Tourniquet, pressure and sutures have been used for controlling excessive bleeding during surgical procedures for many hundreds of years. Fibrin sealants represented a revolution in local hemostatic measures for both bleeding and nonbleeding disorders. Fibrin sealant has the potential to provide life-saving control of excessive bleeding in many critical surgical operations and during a number of elective procedures. The terms “sealant” and “glue” are frequently used interchangeably in the surgical context, but there is actually a difference in adhesive strength between sealants, pioneered by fibrin products (sometimes homemade) and the later, stronger glues of which cyanoacrylate-based products were the leaders.

In order for a sealant to be effective, the product should meet several parameters, depending upon the application. Among these are:

  • Ability to close the wound
  • Strength of bond
  • Speed of curing
  • Protection of the wound from infection
  • Low surface friction
  • Breathability in order to aid healing
  • Lack of adverse side effects to skin and internal tissues
  • Cost-effectiveness
  • Ease of handling

Fibrin and other sealant products have been approved and used outside the United States for many years and their use has created strong awareness of their surgical and economic benefits in Europe, Latin America and Asia. As a result, many such products have been marketed in these regions for 20 years or more, and have been developed for a variety of surgical uses. In the U.S., these products were initially approved as hemostatic adjuncts to suturing. They are increasingly being used for sealing of tissues, but their use beyond hemostasis (i.e., as sealants and low-strength glues) lags that of markets outside the U.S.

There are more than 30 companies worldwide developing fibrin sealants and driving a market that will exceed $2.2 billion by 2017.

sealants-regional-forecast

 

Source: MedMarket Diligence, LLC; Report #S190.

For complete analysis of the global market for fibrin sealants, see the MedMarket Diligence Report #S190, “Worldwide Surgical Sealants, Glues, Wound Closure and Anti-Adhesion Markets, 2010-2017.”

High and low growth wound care sales by country

Wound care product sales are growing at wildly variable rates around the world, with extremes spanning from the emergence of new technologies in rapidly growing economies to the technologies with low innovation in sluggish economies.

MedMarket Diligence’s global analysis of wound care products, technologies, companies and markets reveals the full spectrum of growth rates for well established to rapidly emerging products.

Below is illustrated the high growth country/product segments in wound management, reflecting the rapid adoption of new technologies such as growth factors and bioengineered skin, as well as older products such as alginates that are gaining sales in rapidly developing economies.

wound-country-high

Source: MedMarket Diligence, LLC; Report #S249, “Wound Management, Worldwide Market and Forecast to 2021:  Established and Emerging Products, Technologies and Markets in the Americas, Europe, Asia/Pacific and Rest of World.”

At the other end of the extreme are those very well established products growing at less than anemic rates in countries where the economy is not as robust and/or where the growth has been superseded by sales of more novel products. Conventional dressings and bandages offer considerably less demand than do growth factors, bioengineered skin and skin substitutes and similar new products.

wound-country-low

Source: MedMarket Diligence, LLC; Report #S249

Of course, growth of sales in wound management products (and any product) is defined as the percentage change in sales volume over time. Smaller markets (typically soon after they have formed as a result of their initial commercialization) tend to grow on a percentage basis much faster. Indeed, a $1 dollar sale in year 1 followed by a $2 sale in year 2 represents a 100% growth rate, while a $1 increase in sales from year 1 to year 2 for a $100 million market represents virtually zero growth. Conversely, a 1% increase in a $1.75 billion market is a $17.5 million increase. This is indeed obvious, but must be kept in mind when considering the growth rates discussed above.