Healthcare systems move billions in global wound care sales, yet chronic wounds still are a chronic problem. Despite the legion of products developed for wound care, from dressings to bioengineered skin, the obesity- and age-driven increase in chronic slow-healing and non-healing wounds plague healthcare systems globally. Results according to MedMarket Diligence’s biennial, 2018 Wound Management report (#S254).
BIDDEFORD, Maine – April 1, 2018 – PRLog — Research and routine clinical practice in wound management have advanced the science to better understand and address chronic wounds, but much work remains for research and manufacturing to impact the growing caseload.
Chronic wounds represent a large but still underestimated problem for health systems globally and industry needs to step up in response, according to MedMarket Diligence, LLC.
“Our recent research shows that chronic wounds, which have long been no secret to clinicians, epidemiologists, and product manufacturers as a growing health problem, are actually even more prevalent and costly than has been previously reported,” says Patrick Driscoll of MedMarket Diligence, who has tracked wounds in clinical practice and industry for 25 years.
Care of chronic wounds is a significant, global burden on healthcare systems. In the USA alone, it is estimated that at least 6.7 million people suffer with chronic wounds, requiring treatment in excess of $20-50 billion per year (estimates vary according to the definitions). A report from the UK suggests, based on National Health System (NHS) data, that chronic wound prevalence in developed countries is about 6% and that care of chronic wounds accounts for around 3-5.5% of total healthcare spending in those countries. (Phillips CJ, et al. Estimating the costs associated with the management of patients with chronic wounds using linked routine data. Int Wound J. 2015. doi: 10.1111/iwj.12443.)
Definitions help clinicians determine whether a wound is healing or not. For example, for venous leg ulcers (VLUs), if the wound has not shown at least a 40% reduction in wound size in about four weeks, then additional therapies are called for. A non-healing foot ulcer is generally defined to be any ulcer that is unresponsive to standard therapies and persists after four weeks of standard care. Once a foot ulcer occurs, unfortunately some 60% of patients end up moving into the chronic non-healing category. Many diabetics develop foot ulcers.
Chronic wounds and burns continue to present challenging clinical problems. For example, chronic wounds may present with persistent infections, inflammation, hypoxia, non-responsive cells at the wound edge, the need for regular debridement, etc. For DFUs, it is important for the patient to continuously wear an offloading device such as a special boot. Additionally, the practitioner must carefully debride not only the necrotic tissue in the wound bed, but the wound edges. Cells at the wound edge seem to be unresponsive to typical healing signals, and therefore must be removed to promote and support proper healing.
To the person with a chronic wound, the condition represents pain, social and psychological debilitation and usually a financial load. To society, wound care—and especially the treatment of difficult-to-heal wounds—may represent great human suffering, social discomfort, days lost from work, mental health problems, recurrent infections and great economic burden and the human burden of wound care. Having a chronic wound not only necessitates physical care of the wound, including cleaning, disinfecting, irrigating, and changing dressings; it also impacts the emotional and psychological health of the patient. Depression can set in due to a lower quality of life and dependence on others for care of the wound, as well as for overall assistance, both physical and financial. Wounds may cause odors or may have visible drainage, staining clothing and triggering feelings of embarrassment and shame. These in turn may lead to isolation due to decreased mobility and the fear of being a burden on family and friends. To make things worse, increased stress can slow the progress of wound healing.
In caring for a chronic wound, the dressing costs are only part of the picture; the less visible costs include such items as nursing care, medications for pain and infections, and hospitalization. Hospitalization is a leading cost driver for wound care, accounting for at least 50% of the global economic burden. Nursing time to properly care for the patient with a chronic wound can be lengthy, and this is time that could be spent with other patients. In a new report published in the December 2017 online version of the International Society for Pharmacoeconomics and Outcomes Research’s (ISPOR) Value in Health journal (An Economic Evaluation of the Impact, Cost, and Medicare Policy Implications of Chronic Nonhealing Wounds. Nussbaum, Samuel R. et al. Value in Health, Volume 21 , Issue 1 , 27 – 32) (see the study), the researchers found that the costs related to wound care in the Medicare population (USA) were much higher than originally estimated, and that care took place primarily in outpatient settings. For the calendar year 2014, there is considerable variation in the estimates originating from different sources:
“Total Medicare spending estimates for all wound types ranged from $28.1 to $96.8 billion. Including infection costs, the most expensive estimates were for surgical wounds ($11.7, $13.1, and $38.3 billion), followed by diabetic foot ulcers ($6.2, $6.9, and $18.7 billion,). The highest cost estimates in regard to site of service were for hospital outpatients ($9.9–$35.8 billion), followed by hospital inpatients ($5.0–$24.3 billion).”
The development of advanced wound care dressings, devices and biologics is helping to change this situation. Although these advanced products may seem (or may be) expensive, they end up saving money for health care systems by healing wounds more rapidly.
The wound care industry remains quite fragmented, with about eight companies holding leading market shares, but with possibly thousands of small cap companies around the world that are also manufacturing and marketing various wound care products. The Traditional Wound Care space remains attractive, in part since gauze dressings are relatively easy to manufacture and are also still the most commonly-used wound dressing. Even a small company can invent a novel twist to a dressing and experience a rise in profits and inroads into the market.
Low to medium industry concentration. As the traditional and advanced market shares diagrams below demonstrate, there are five to eight major players in Traditional and Advanced Wound Care Markets.
While these firms account for about 79% and 73% of the total markets, respectively, a significant portion of these markets are covered by hundreds or thousands of Other companies. This low to medium level of concentration means that smaller companies, or large companies looking to break into Wound Care, are able to do so more easily than if, say, three companies controlled 95% of the market.
Johnson & Johnson is estimated to be the Traditional Wound Care market leader with about 26% share, followed by Smith & Nephew, 3M Health Care and Hartmann. Medline Industries is estimated to account for about 8%, while Others account for about 21% of this market.
Breaking into the Advanced Wound Care markets presents a somewhat greater challenge. Here, the leading companies have invested heavily in R&D to gain strategic competitive advantage, as well as to create improved products for patients. Smith & Nephew is holds an estimated 21% of this market, followed by Acelity and Johnson & Johnson with 11% each, and Mölnlycke, 3M Health Care, Hartmann, Cardinal Health and ConvaTec accounting for smaller shares. Here again, Others accounts for at least 27% of this market.
Opportunities exist in both Traditional and Advanced Wound Care, especially if a company is in the position of acquiring part or all of an existing wound care company, and if the company can then invest in the development of its new products. If points of distribution overlap, then so much the better.
Relatively low barriers to entry. Good news for companies wishing to break into wound care: barriers to entry into the traditional wound dressing segments (Adherents, Gauze and Non-Adherent Dressings) are relatively low, while demand remains strong. Typically, once a company is established in a traditional segment, it may either plow revenues into research and development, or it may acquire companies to more easily break into new product segments and markets. Many companies in wound care have followed just this path to gain market share and make an impact in the industry.
The clinical driver of sales in wound care is the prevalence of different wound types and the associated cost to manage them. While surgical wounds made by primary intent as part of surgical procedures (e.g., excision of skin lesion, appendectomy, coronary artery bypass graft, etc.) represent the biggest source of wounds, the biggest focus on reining in costs in medtech is slow-healing, chronic wounds, such as ulcers.
We have projected the global prevalence for the most common wound types through 2026, shown below.
In addition to the factors we detailed in a past post, we show here a number of frameworks used by clinicians to properly assess the condition of wounds and the wound healing process, providing a systematic way to optimize wound healing.
“DIMES”, “TIME” and “DIDNT HEAL”
“DIMES” focuses on providing an efficient use of resources in the management of chronic wounds.
The DIMES Acronym for Treatment Planning and Products
Source: MedMarket Diligence, LLC Report S254; GS Schultz, et al. Wound bed preparation: a systematic approach to wound management. Wound Repair Regen. 2003 Mar;11 Suppl 1:S1-28.)
“TIME” is focused specifically on wound bed preparation, a key determinant of wound healing.
TIME Acronym for Wound Bed Preparation
Source: MedMarket Diligence, LLC Report S254; GS Schultz, et al. Wound bed preparation: a systematic approach to wound management. Wound Repair Regen. 2003 Mar;11 Suppl 1:S1-28.)
“DIDNT HEAL” is similarly intended to be a useful mnemonic regarding key wound healing factors.
Clinical protocols for the treatment of specific wounds can vary considerably from country to country. Venous stasis ulcers, which account for approximately 4% of wounds and 75% of leg ulcers, are treated with short stretch compression bandages in Germany, elastic adhesive bandages in Italy, high compression bandages in France and multi-layer compression systems in the UK. As in the US, the routine use of strong antiseptics is discouraged in the UK and Germany but still prevalent in East European countries as well as the Netherlands and Italy.
The quest for standardized modern approaches to wound healing is aided by groups such as the European Wound Management Association and European Tissue Repair Society, which encourage pan-European dialogue on issues pertaining to wound care. Such organizations have had significant effect on the development of US wound care policy and practices.
The proliferation of different wound care products and strategies leads to confusion and uncertainty over the best practice options. Clinical comparisons between treatment modalities have been minimal, with reliance on small, product-focused studies that often omit the wider context under which wounds are treated. Users of wound care products rely on manufacturers for performance data and increasingly turn to the larger manufacturers for staff education and wound care treatment protocols that will naturally include the use of the large number of products in the manufacturer’s line. In many countries in Europe, testing procedures have been developed by government-supported cross-company working panels that meet regularly to define specific protocols for testing products. These tests gradually become adopted by manufacturers as first lines of evaluation for new technologies.
The emerging use of electronic devices for wound documentation and assessment is expected to allow the comparison of large numbers of wounds undergoing different integrated approaches to wound care and begin to differentiate those activities that provide the most benefit to wound healing. As in the rest of the world, studies need to become larger, more standardized and complete to allow scientific comparison of products and practices that include multiple product classes and the management of the underlying conditions that create chronic wounds.
In addition, electronic devices for recording individual patient data are becoming available. These devices are important to ensure continuity of treatment, particularly in the home environment where several visiting nurses may see a single patient over a period of weeks. Without a good monitoring tool a complex and inconsistent mix of products and strategies could be applied.
See the newest global wound management market report (published December 2012), Report #S249, “Wound Management, Worldwide Market and Forecast to 2020: Established and Emerging Products, Technologies and Markets in the Americas, Europe, Asia/Pacific and Rest of World.”
In results presented in a poster session at the 24th Annual Clinical Symposium on Advances in Skin and Wound Care (San Antonio, TX), the Advanced Wound Management Division of Smith & Nephew highlighted that gauze-based negative pressure wound therapy (NPWT) can achieve the same treatment goals as foam-based NPWT, which are a reduction in wound dimension, exudate, and improvement in granulation tissue.
One of the most dramatic, and perhaps surprising, recent developments in the advanced wound management sector has been the meteoric rise of negative pressure wound therapy (NPWT) technology, spearheaded by the V.A.C. approach developed by Kinetic Concepts Inc. (KCI). This has driven growth in the “physical treatment” market segment to exceed $1.2 billion. In 1989, Mark Chariker and Katherine Jeter developed a technique utilizing standard surgical dressings and wall suction to create a “vacuum” that aided in wound healing. In 1997, Dr. Michael Morykwas and Dr. Lewis Argenta studied the use of suction applied to polyurethane foam in wounds. Shortly after, KCI launched its product, the V.A.C.® and later received Medicare B approval. In early September 2009, Kinetic Concepts received Japanese regulatory approval to begin selling the V.A.C. device in that country. The company expects sales to commence in the first half of 2010.
Further innovations into the use of closed wound suction were made by BlueSky Medical with the Versatile One® System. Then in 2007, Smith & Nephew acquired BlueSky Medical and brought all that company’s products under the Smith & Nephew umbrella. Since the purchase of BlueSky, S&N has devoted considerable resources to contest KCI’s hold on the lion’s share of the market for NPWT devices.
More details on the study and its results from Smith & Nephew are given here. The trial was a prospective, multi-center clinical evaluation assessed 131 non-grafted patients at 21 centers in the United States, Canada, United Kingdom, Saudi Arabia and the United Arab Emirates.
Following on the post, What medtech company isn’t globally focused?, the premise of which is that opportunities are too large globally to focus on one geographic, especially considering the competition, it is important to understand how the dynamics of each market can come to be understood in juxtaposition with each other. Each market has its own demographics, its own clinical practice patterns, its unique rates of technology adoption.
For example, companies who market products in the U.S. can find opportunities in non-U.S. markets by understanding the differences in the drivers and limiters in those non-U.S. markets.
Consider the wound management market in Japan.
It is estimated that more than 1 million people in Japan are treated for wounds every day. There are roughly 5,500 new cases of diabetes every year. There are now roughly 8.2 million Japanese suffering from diabetes with a total 18.7 million people including pre-diabetic subjects, according to The Japan Diabetes Society.
The potential market opportunity offered by the caseload of decubitus ulcers may be gauged from the fact that the total of infirm elderly is expected to be 3.5 million in 2010. Among elderly individuals who are bedridden, 75% have been in this situation for more than one year and 53% for more than three years.
Other important differences exist between Japan and other countries, but the above give a glimpse of how the wound management market in Japan can be understood on the basis of the underlying drivers in its market.
Below is a segmentation of Japanese advanced wound management market in 2008 and 2017. Like other well developed markets, Japan illustrates similar shifts — but in different relative rates — toward or away from the use of specific wound management technologies.
The terms “sealant” and “glue” tend to be used interchangeably in the surgical context, but in fact there is 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.
Fibrin sealants represented a revolution in local hemostatic measures for both bleeding and nonbleeding disorders. Tourniquet, pressure and sutures have been used for controlling excessive bleeding during surgical procedures for hundreds of years. 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. It is used for local hemostasis and as an augmenting material during arterial bleeding. It has been applied to every organ except eyeballs. It has been shown to be very useful for local hemostasis, a valuable tool for adhesion, sealing, anastomosis, vascular and nerve grafts, and many other procedures.
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 up to 20 years and have been developed for a variety of surgical uses. While in the United States these products were approved initially as hemostatic adjuncts to suturing, they are increasingly being used for sealing of tissues, yet their use beyond hemostasis (i.e., as sealants and low-strength glues) lags that of markets outside the United States.
For the vast majority of surgical procedures, sutures and staples remain the most common methods of closure, but often they are sub-optimal. They do not have inherent sealing capabilities, and therefore cannot stop air and fluid leakage (for example in lung resection) and fluid leakage at the wound site. Furthermore, friable tissues such as the liver, brain or spleen, are fragile and often cannot support sutures or staples. Therefore, other means of wound closure are required for repair of these tissues.
Applications of Fibrin and Other Sealants
Local hemostatic measures for both surgical and trauma cases
Surgery in patients with bleeding disorders (e.g., hemophilia, severe thrombocytopenia) and non-bleeding cases with suspected fluid oozing
Surgery in nonsuturable organs (e.g., brain, liver, lung, pancreas, thymus) or to repair unhealthy tissue (e.g., irradiated bowel or tissue of elderly patients)
Cardiovascular, microvascular surgery and vascular grafts (e.g., aneurysm repair, coronary bypass, etc.)
Skin grafts, particularly plastic surgery
Surgery of small or difficult to reach organs (e.g., tympanoplasty, ENT, eye)
Sealing of body cavities, fistulae, pneumothorax, cranium, etc.
Anastomosis of gastrointestinal, tract and other ductal organs
Below is a brief profile of Adhezion Biomedical, LLC, one of the companies active in the surgical sealants and glues market and profiled in the MedMarket Diligence report #S175. We occasionally highlight companies whose products, in our opinion, are poised to make an impact on medtech markets.
Founded in 2001, Adhezion Biomedical (formerly Spartan Medical Products, LLC) is a private company developing and producing cyanoacrylate-based medical adhesives. The company’s SurgiSeal, DermaSeal, and FloraGuard products are based on the company’s proprietary OctylFlex technology and can bond skin tissue, replace sutures, staples and bandages, or be a protective barrier to prevent infection as an anti-microbial surgical sealant. The highly flexible products are biodegradable, do not require refrigeration or blending and dry quickly. SurgiSeal and FloraGuard have achieved CE Mark approval in Europe and 510(k) status in the United States. The company has received FDA approval for an OTC product in the United States.
Adhezion Biomedical received its first patent in 2003 and in 2006 received 510(k) and CE Mark approval for a consumer wound-care adhesive. In January 2008, Adhezion received 510(k) approval for the professional version of its topical wound closure adhesive and in February 2008, the company received FDA approval to begin clinical trials of this technology.
In March 2008, Adhezion Biomedical raised $3 million in a Series A financing from Originate Ventures to fund growth and product development.
Hemostats have been used for over a hundred years to stop bleeding in surgical and traumatic wounds. Primarily these products were first introduced to prevent hematomas during surgery with the aim of preventing resultant infections. During the 1980s and 1990s, the popularity of hemostats increased rapidly as surgeons tried to avoid excessive use of blood transfusions for reasons of economy and the threat of disease transmission. Products were launched during this period by many of the large medical device manufacturers.
The value of hemostasis lies in its ability to quickly improve patient clinical status and/or improve surgeons’ ability to do so by clearing the surgical field in order to assess traumatic wounds or facilitate surgical procedures. Hemostats also play a less technically challenging role than providing closure of wounds, which is offered instead by a variety of sealants and glues. Consequently, the barriers to entry for this market are relatively low — and getting lower, as many companies are developing formulations of collagen and gelatin for introduction in world markets. (Components of hemostats on the market and under development also include thrombin, fibrin, synthetics and others.) However, a number of proprietary products and formulations still face significant regulatory hurdles associated with their development and manufacture.
There are some well established companies controlling the current market, among King Pharmaceuticals, Ethicon, and Pfizer, with many competitors vying for increasingly larger shares of this market.