Country and Regional Variability in Growth of Wound Management Sales

As illustrated in a previous post, wound management products are a spectrum from the simple to the complex:

Source: MedMarket Diligence Report #S254.

Generally, the longer the product has been around (e.g., gauze), the less complex it is compared to emerging technologies…

…BUT simpler is easy to adopt and, with well established sales, growth on a percentage basis will be low (see area in red)..’

Generally, new technologies incorporate rarer materials, have more complex construction, and may cost considerably more…

…BUT complex technologies may be far more effective clinically than older technologies and may allow treatment where no older technology could, and with low initial sales (penetrated potential), growth on a percentage bases will be high (see area in green).

Country and Regional Variation in Growth Rates

While this size-to-growth dynamic exists for most product types, the dynamic varies from one geographic region to the next. The time point at which a particular product/technology starts to be more rapidly adopted — or the rate at which use of  established products are use starts to decline — can vary considerably from country to country.

As a result, there will be variability in sales growth rates for a product in one country/region versus another.

For example, the 2017 to 2026 compound annual growth rate in sales of Alginates in wound management range from a low of 5.3% in one country to a high of 24.3% in another country. (If you make alginates, in which country would YOU like to compete?)

Regionally, as in USA versus Europe versus Asia/Pacific, etc., there is less variation in growth rates for any given product in that region. For alginates:

  • country-to-country variation in CAGR: 19%
  • region-to-region variation in CAGR: 7.8%

In other words, the difference between the countries with the highest and lowest CAGRs for alginate sales is 19%, while the difference between regions shows one region with a 7.8% higher CAGR for alginates than the lowest growth region.

Source: MedMarket Diligence, LLC; Report #S254.

Before chasing after that high growth rate, it is important to know the underlying volume. (Sales of $1 in year 1 and $2 in year 2 is a 100% growth rate, but it’s absolute growth of only $1.)


See the full REPORT, “Wound Management to 2026” details or order online. Please also see the forecast and market share data available separately from the report.

 

USA slipping behind Asia/Pacific markets in wound care sales

We present data from our 2016 to 2026 forecast of the global market for wound management products. (Data available, full report this month.)

At a glimpse, you can see the overall trend in global wound management, including the relative size of each market. (The four regional sales charts are shown on the same scale to illustrate this.)  Most notably, the USA dominance of this global market is fading, as aggregate Asia/Pacific sales of all wound products will eclipse USA sales within the forecast period.

Wound Management Worldwide, 2016-2026, By Region

 

 

 

 

 


Source: MedMarket Diligence, LLC; Report #S254.

Looking at just the aggregate of all wound product types, Asia/Pacific relative sales are squeezing out shares in every other region.Source: MedMarket Diligence, LLC; Report #S254.

When we then look specifically at the USA versus Asia/Pacific, it illustrates that by 2020, Asia/Pacific’s sales of wound management products will eclipse those of the U.S., making it the largest regional wound management market.

Source: MedMarket Diligence, LLC; Report #S254.

Next in sealants, glues, hemostats…and why?

From July 2016 published Report #S290.

The demand for surgical sealants, glues, and hemostats is directly related to the clinical caseload and procedure volumes, while product choice is dependent upon the surgeon’s training and experience with the products, the particular situation, and product availability. Availability is influenced by several factors. For example, must the product be prepared before use, or is it ready to use off the shelf? Is it refrigerated, requiring warming prior to use, or is the product able to be stored at room temperature? Availability also depends on whether the hospital or healthcare facility will stock the product, which in turn depends on the product’s cost and whether it fits into the facility’s budget and formulary. Sealants, glues and hemostats are used about 25% of the time in many (but not all) procedures, since sutures remain the most familiar and least expensive products for wound closure. However, the products addressed in this report could well find use in over 100 million procedures globally.

Here are six key trends we see in the global market next in surgical sealants, glues, hemostats:

  1. Aggressive development of products (including by universities, startups, established competitors), regulatory approvals, and new product introductions continues in the U.S., Europe, and Asia/Pacific (mostly Japan, Korea) to satisfy the growing volume of surgical procedures globally.
  2. Rapid adoption of sealants, glues, and hemostats in China will drive much of the global market for these products, but other nations in the region are also big consumers, with more of the potential caseload already tapped than the rising economic China giant. Japan is a big developer and user of wound product consumer. Per capital demand is also higher in some countries like Japan.
  3. Flattening markets in the U.S. and Europe (where home-based manufacturers are looking more at emerging markets), with Europe in particular focused intently on lowering healthcare costs.
  4. The M&A, and deal-making that has taken place over the past few years (Bristol-Myers Squibb, The Medicines Company, Cohera Medical, Medafor, CR Bard, Tenaxis, Mallinckrodt, Xcede Technologies, etc.) will continue as market penetration turns to consolidation.
  5. Growing development on two fronts: (1) clinical specialty and/or application specific product formulation, and (2) all purpose products that provide faster sealing, hemostasis, or closure for general wound applications for internal and external use.
  6. Bioglues already hold the lead in global medical glue sales, and more are being developed, but there are also numerous biologically-inspired, though not -derived, glues in the starting blocks that will displace bioglue shares. Nanotech also has its tiny fingers in this pie, as well.

See Report #S290, “Worldwide Sealants, Glues, and Hemostats Markets, 2015-2022”.

Naturally sticky: Biologically-based medical glues dominate

Biologically-based medical glues, cyanoacrylate, or other synthetic. The bulk of global sales of medical glues are biologically-based, (includes fibrin, thrombogen, and others), rather than cyanoacrylate-based or other synthetic glues.

Synthetic glues

Cyanoacrylate-based glues, include those from Ethicon, Adhezion Biomedical, B. Braun, Meyer-Haake, and others. Cyanoacrylate-based glues for medical use are said to be stronger, less irritating to the skin when used externally, and more flexible than the household ‘super glue.’

Topical skin adhesives (TSAs) are used quite commonly for closing small wounds and incisions. There are two basic TSAs: 2-octyl cyanoacrylate (intended to close wounds and surgical incisions, and useful as an antibacterial barrier), and n-butyl cyanoacrylate, which is more flexible than the former, but also not as strong. Dermabond® and SurgiSeal™ are 2-octyl cyanoacrylates (OCA); Histoacryl®, Indermil®, and LiquiBand™ are n-butyl cyanoacrylates (BCA). These glues are intended for topical use only due primarily to toxicity and safety issues.

Other Synthetic Glues

Innovators are developing “other” glues from a variety of synthetic types; these glues have yet to gain more than 4% share globally. Synthetic glues may be derived from polyurethane or other polymers and may be light-activated. As yet, these synthetics have not been able to create anything more than a minor dent in bio-glue sales.

Biologically-based Medical Glues

Manufacturers of biologically-based medical glues have made these glues the most popular, accounting for almost two-thirds of medical glue revenues. However, ongoing developments mean that products are being improved and new products are being invented. These new glues may start to cannibalize from the biologically-based products.

Below is illustrated the growth of biologically-based glues by region, showing that most growth in this segment will be from Asia/Pacific markets, which are consistently demonstrating higher growth than in western markets.

Global Markets for Biologically-Based Medical Glues, 2015-2022, USD MillionsGrowth of Medical Glues by RegionSource: MedMarket Diligence, LLC; Report #S290. (Order online)

 

Cardiovascular Procedures in Emerging Markets

Cardiovascular procedures are high volume, big business in the well developed U.S, European, and Asia/Pacific markets. But much potential procedure volume has been tapped in these markets, with any appreciable growth limited to low volume, emerging procedures.

By comparison, the less-tapped emerging markets, “Rest of World” potential (i.e., non-U.S., non-Europe, non-Asia/Pacific) for growth is significant. Below is illustrated the 2016 size and growth to 2022 for the major cardiovascular procedures in the Rest of World.

Source: “Global Dynamics of Surgical and Interventional Cardiovascular Procedures, 2015-2022”, Report #C500 (MedMarket Diligence, LLC)

Wounds looking for closure: Untapped potential for sealants, glues, hemostats

Today’s surgeon has a broad range of products from which to choose for closing and sealing wounds. These include sutures, stapling devices, vascular clips, ligatures, and thermal devices, as well as a wide range of topical hemostats, surgical sealants and glues.

However, surgeons still primarily use sutures for wound closure and securement—sutures are cheap, familiar and work most of the time. Now, in addition to reaching for a stapling device, the surgeon must frequently decide at what point to augment or replace the commonly used items in favor of other products, which product is best for what procedure or condition, how much to use, and ease of use in order to achieve optimal patient outcomes. Because of budget pressures, the surgeon must also consider price when selecting a product. Of course in the USA, the product must also be FDA-approved, although the surgeon still has the choice of using a product off-label.

In the areas of sealants, hemostats and glues, there is room for both improvement and additional products.  There are a number of products already on the market, but the fact is that there is no one product that meets all needs in all situations and procedures. There are few products that stand out from the rest, apart, perhaps, from DermaBond® and BioGlue®. There are unmet needs, and companies having the necessary technology, or which may acquire and further develop the technology, can enter this market and launch novel items. These products have yet to significantly tap the potential for wound management and medical/surgical procedures.

Note: Log10 scale; Chronic wounds includes pressure, venous/arterial and diabetic ulcers.

Source: MedMarket Diligence, LLC; Report #S290.

Sealants, Fibrin and Others

Numerous variants of fibrin sealant exist, including autologous products. “Other” sealants refers to thrombin, collagen & gelatin-based sealants.

Fibrin sealants are used in the US in a wide array of applications; they are used the most in orthopedic surgeries, where the penetration rate is thought to be 25-30%. Fibrin sealants can, however, be ineffective under wet surgical conditions. The penetration rate in other surgeries is estimated to be about 10-15%.

Fibrin-based sealants were originally made with bovine components. These components were judged to increase the risk of developing bovine spongiform encephalopathy (BSE), so second-generation commercial fibrin sealants (CSF) avoided bovine-derived materials. The antifibrinolytic tranexamic acid (TXA) was used instead of bovine aprotinin. Later, the TXA was removed, again due to safety issues. Today, Ethicon’s (JNJ) Evicel is an example of this product, which Ethicon says is the only all human, aprotinin free, fibrin sealant indicated for general hemostasis. Market growth in the Sealants sector is driven by the need for improved biocompatibility and stronger sealing ability—in other words, meeting the still-unsatisfied needs of physician end-users.

High Strength Medical Glues

Similar to that of sealants, the current market penetration of glues in the US is thought to be about 25% of eligible surgeries. There are several strong points in favor of the use of medical glues: their use can significantly reduce healthcare costs, for example by reducing time in the surgical suite, reducing the risk of a bleed, which may mean a return trip to the OR, and general ease of use. Patients seem to prefer the glues over receiving sutures for an external wound, as glues can provide a suture-free method of closing wounds. In addition, if glues are selected over sutures, the physician can avoid the need (and cost) of administering local anesthesia to the wound site.

Hemostats

Hemostats are normally used in surgical procedures only when conventional bleeding control methods are ineffective or impractical. The hemostat market offers opportunities as customers seek products that better meet their needs. Above and beyond having hemostats that are effective and reliable, additional improvements that they wish to see in hemostat products include: laparoscopy-friendly; work regardless of whether the patient is on anticoagulants or not; easy to prepare and store, with a long shelf life; antimicrobial; transparent so that the surgeon continues to have a clear field of view; and non-toxic; i.e. preferably not made from human or animal materials.


Drawn from, “Worldwide Markets for Medical and Surgical Sealants, Glues, and Hemostats, 2015-2022:  Established and Emerging Products, Technologies and Markets in the Americas, Europe, Asia/Pacific and Rest of World.” Report #S290.

Bioengineered skin and skin substitutes in wound management

Bioengineered skin was developed because of the need to cover extensive burn injuries in patients who no longer had enough skin for grafting. Not so long ago, a patient with third degree burns over 50% of his body surface usually died from his injuries. That is no longer the case. Today, even someone with 90% total body surface area burn has a good chance of surviving. With the array of bioengineered skin and skin substitutes available today, such products are also finding use for chronic wounds, in order to prevent infection, speed healing and provide improved cosmetic results.

Estimated Worldwide Wound Prevalence by Etiology, 2015

Source: MedMarket Diligence, LLC; Report #S251, “Wound Management to 2024.” (See pending Report #S254.)

Skin used in wound care may be autograft (from the patient’s own body, as is often the case with burn patients), allograft (cadaver skin), xenogeneic (from animals such as pigs or cows), or a combination of these. Bioengineered skin substitutes are synthetic, although they, too, may be combined with other products. It consists of an outer epidermal layer and (depending on the product) a dermal layer, which are embedded into an acellular support matrix. This product may be autogenic, or from other sources. Currently most commercial bioengineered skin is sheets of cells derived from neonatal allogenic foreskin. This source is chosen for several reasons: because the cells come from healthy newborns undergoing circumcision, and therefore the tissue would have been discarded anyway; foreskin tissue is high in epidermal keratinocyte stem cells, which grow vigorously; and because allergic reactions to this tissue is uncommon.

Bioengineered skin and skin substitutes are on the market and in development by LifeCell (Acelity), Organogenesis, Smith & Nephew, Organogenesis, Vericel Corporation (formerly Aastrom Biosciences), Mölnlycke Health Care, Integra LifeSciences, Smith & Nephew, Stratatech Corporation, A-Skin, University Children’s Hospital, Zurich; EuroSkinGraft.

The market may become more crowded as growth in the adoption of these products draws more competitors. Bioengineered skin and skin substitutes will drive more revenue than any other segment of the broader wound management market.

Growth in Advanced Wound Market Segments, 2014 to 2024

Source: MedMarket Diligence, LLC; Report #S251, “Wound Management to 2024.” (See pending Report #S254.)

Competitors’ positions in bioengineered skin are variable based on their geographic presence. See shares in the U.S., the UK, and Germany for bioengineered skin & skin substitutes.

Source: MedMarket Diligence, LLC; Report #S251, “Wound Management to 2024.”

Source: MedMarket Diligence, LLC; Report #S251, “Wound Management to 2024.” (See pending Report #S254.)

Source: MedMarket Diligence, LLC; Report #S251, “Wound Management to 2024.” (See pending Report #S254.)

 

Sealants, Glues, Hemostats Makers Not Poised for Global Domination

Market shares for sales of sealants, glues, and hemostats vary considerably from region to region globally due to the significant variations in the local market demand, rate of adoption of specific manufacturers’ products, the regulatory climate, local economies, and other factors. Consequently, manufacturers with significant share of sales in the U.S. or Europe or Asia/Pacific may have considerably lower or higher shares in other regions.

In the U.S., Ethicon and Baxter have dominant positions in sales of surgical sealants. However, in Europe and Asia/Pacific, Baxter has substantially smaller position, particularly relative to competitors like Takeda Pharmaceuticals and The Medicines Company.

Source: Report #S290, MedMarket Diligence, LLC (order online)

  • In the market for hemostats, similarly, Ethicon and Baxter have dominant position in the U.S. market, but in Asia/Pacific and Europe, Baxter is subordinate to Takeda Pharmaceuticals, CryoLife, and others.

Source: Report #S290, MedMarket Diligence, LLC

In medical glues, CryoLife has risen to the fore with its BioGlue, such that it has a global leading position as well as specifically in the U.S., Europe, and Asia/Pacific.

Source: Report #S290, MedMarket Diligence, LLC

Sealants, glues, hemostats not poised for world domination

Market shares for sales of sealants, glues, and hemostats vary considerably from region to region globally due to the significant variations in the local market demand, rate of adoption of specific manufacturers’ products, the regulatory climate, local economies, and other factors. Consequently, manufacturers with significant share of sales in the U.S. or Europe or Asia/Pacific may have considerably lower or higher shares in other regions.

In the U.S., Ethicon and Baxter have dominant positions in sales of surgical sealants. However, in Europe and Asia/Pacific, Baxter has substantially smaller position, particularly relative to competitors like Takeda Pharmaceuticals and The Medicines Company.

Source: Report #S290, MedMarket Diligence, LLC

In the market for hemostats, similarly, Ethicon and Baxter have dominant position in the U.S. market, but in Asia/Pacific and Europe, Baxter is subordinate to Takeda Pharmaceuticals, CryoLife, and others.

Source: Report #S290, MedMarket Diligence, LLC

In medical glues, CryoLife has risen to the fore with its BioGlue, such that it has a global leading position as well as specifically in the U.S., Europe, and Asia/Pacific.

Source: Report #S290, MedMarket Diligence, LLC

Medtech fundings for May 2017

Medtech fundings for May 2017 stand at $367 million, led by the $76.5 million raised by Outset Medical, followed by $46.6 million by Cerus, the $46 million raised by Magenta Therapeutics, and the $45 million by Advanced Cardiac Therapeutics.

Below are the top funding for the month. The complete list of fundings are shown at link (refresh for updates during the month).

Source: Compiled by MedMarket Diligence, LLC.

For a historical listing of medtech fundings by month since 2009, see link.