Skin replacements and substitutes in wound management

Skin replacements and substitutes (see image at right: Apligraf by Organogenesis, Inc.) compete in the severe burn, venous leg ulcer, and the diabetic foot ulcer markets where their high cost is offset by their ability to save lives and/or preserve limbs from amputation. These products have taken some time to demonstrate clinical effectiveness and to be approved for use to heal wounds more quickly than alternative treatments. In addition, these products are still significantly more expensive than alternative therapies, and publicly funded health care organizations around the world have sometimes found it difficult to absorb these costs despite strong cost-effectiveness claims. It is highly likely that products will take some time to reach high acceptance levels. The move towards cost effectiveness procurement practice is likely to increase uptake of these products as they move purchasers away from decisions based on unit product cost towards outcomes assessments and data. In addition, manufacturers are developing alternative manufacturing and lower-cost product designs that should enhance the cost-effectiveness of these products over the next few years.

The tissue engineering market has reached a point of growth inflexion, enforced by a downturn in biotechnology small-cap investment, and rationalization of tissue engineering programs by large cap medical devices and pharmacological organizations. This is strongly demonstrated by the wound management tissue-engineering field. Some companies like Novartis have recognized that existing product formats and cost structures are inappropriate for the wound management customers. As a result, the partnership between Novartis and Organogenesis dissolved at a point where sales seemed to be growing rapidly. Smith & Nephew took longer to receive approval for the Dermagraft product and limited their losses by divesting.

Globally, the market for tissue engineered skin repair and replacement is a $679 million market, with the majority of the market concentrated in the U.S. and Europe, but annual sales growth in Asia/Pacific and in RoW is in excess of 20% and 15%, respectively.

Tissue engineered skin, integumentary and plastic surgery products are detailed in MedMarket Diligence Report #S247, "Worldwide Wound Management" and Report #S520, "Tissue Engineering, Cell Therapy and Transplantation".

Size and Growth of Tissue Engineering and Cell Therapy in the U.S., Europe, Asia/Pacific and Rest of World

The global market for tissue engineering and cell therapy products is set to more than quadruple from 2009 to 2018. Products in cell therapy and tissue engineering include includes bioengineered products that are themselves cells or are actively stimulating cell growth or regeneration, products that often represent a combination of biotechnology, medical device and pharmaceutical technologies.

The largest segment in the overall market for regenerative medicine technologies and products comprises orthopedic applications. Other key sectors are cardiac and vascular disease, neurological diseases, diabetes, inflammatory diseases and dental decay and injury.

Factors that are expected to influence this market and its explosive growth include political forces, government funding, clinical trial results, fluctuating industry investment and an increasing awareness among both physicians and the general public of the accessibility of cell therapies for medical applications. The reversal of the U.S. government's ban on federal funding for embryonic stem cell research has given researchers sponsored with federal funding increased access to additional lines of embryonic stem cells. This is expected to result in an increase in the number of research projects being conducted and thus possibly hasten the commercialization of certain products.

Another factor that has influenced the advancement of regenerative technologies is found in China, where the Chinese government has encouraged and sponsored cutting-edge (and some have complained ethically questionable) research. While China’s Ministry of Health has since (in May 2009) established a policy requiring proof of safety and efficacy studies for all gene and stem cell therapies, the fact remains that this research in China has spurred the advancement of (or at least awareness of) newer applications and capabilities of gene and stem cell therapy in medicine.

Meanwhile, tighter regulatory environments in other areas of Asia (particularly Japan) will serve to temper the overall growth of commercialized tissue and cell therapy–based products in that region. Nonetheless, the growth rate in the Asia/Pacific region is expected to be a healthy 20%.

Meanwhile, growth rates in Europe and other areas outside the United States and Asia/Pacific (rest of world or ROW) are expected to be roughly to growth of the market in Asia. This reflects the fact that European and developing market regulatory requirements allow products to be commercialized more rapidly in those regions. While the rate of growth in the United States for this time period is expected to be slower, this is only due to its larger size and its position ahead of other markets on the classic market growth curve.  Nonetheless, some in Europe worry that research in the United States will accelerate at a more rapid pace now that U.S. researchers have access to additional lines of stem cells. The fear is that this will allow development in regenerative medicine technologies to threaten an eclipse of the gains made in Europe in the past several years.

See Report #S520.

Report: Worldwide Tissue Engineering & Cell Therapy Market at $6.9 billion

Our research into the products, technologies, companies and markets for tissue engineering and cell therapy has revealed that the 2009 market was at $6.9 billion. The market has grown dramatically, in commercialized products and company activity, over the past few years and is on an accelerated growth rate as technology hurdles are overcome and clinical acceptance is gained in a wide range of applications spanning cardiology, neurology, orthpedics/musculoskeletal/spine, urology, skin/integumentary, dental/oral, organ replacement and preservation, ophthalmology, general/gastroenterology/gynecology, cancer and cord blood & cell banking.


Worldwide Tissue Engineering & Cell Therapy Market, by Segment, 2009

Source: MedMarket Diligence, LLC, Report #S520

The report, described at link, details the activities, products and markets for these applications represented by almost 150 active companies.  The report may be purchased for download at link.  Until February 28, 2010, we're offering 10% off the purchase price of this report. Just order the report online and on checkout enter the coupon code "1266865321" to receive the 10% discount.

Wound Care Markets: Country-Specific Patterns, Drivers, Opportunities

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.

From MedMarket Diligence Report #S247,  "Worldwide Wound Management, 2008-2017: Established and Emerging Products, Technologies and Markets in the U.S., Europe, Japan and Rest of World."

European drug-eluting stent market trends

The European market for drug-eluting stents is demonstrating its maturity in terms of numbers of competitors, the upward sales growth driven by increasing unit sales rather than premium pricing and other considerations.

Source: MedMarket Diligence, LLC; Report #C245

This illustrates the challenge for manufacturers to differentiate their products and pursue innovations that can command premium pricing, a challenge that is becoming increasingly difficult as healthcare reform emerges.

The similar curves for the next major alternative to drug-eluting stents — bioabsorbable stents — show markedly different trends, those illustrative of an emerging, growth market.  In the 2013 to 2017 timeframe, bioabsorbable stents will gradually begin to make inroads into the European DES market.  These include products under development by Abbott Vascular, Amaranth Medical, Inc., Arterial Remodeling Technologies (ART), Arterius Ltd., Bioabsorbable Therapeutics, Inc. (BTI), Bioring SA, Biotronik, Boston Scientific, Elixir Medical, EuroCor (owned by Opto Circuits), ICON Interventional, Kyoto Medical Planning Co., Ltd., and REVA Medical.

Europe’s $1.2 billion wound closure products market

Although market growth in some Eastern European countries that have recently joined the EU is more rapid than in the west, the major European markets in terms of size are still Germany, United Kingdom, France, Italy and Spain. The market for advanced wound closure and securement products is relatively mature in Europe and the scope for vigorous growth is correspondingly lower than in the United States.

With a population of 82 million, Germany is the leading European medical market and the wound closure and securement segment represents almost 6% of the global market, with advanced products in widespread use. One of the main companies in the field, B. Braun, is headquartered here, as is Meyer-Haake (makers of Epiglu); CSL Behring (formerly Aventis-Behring) also has a strong presence. American companies such as Ethicon and Covidien are also well represented.

Source: MedMarket Diligence, LLC; from "Worldwide Surgical Sealants, Glues and Wound Closure, 2009-2013"Report #S175.

Cardiac surgery indications of high strength glues (Europe)

High-strength surgical glue products were approved for topical closure applications in the United States in the late 1990s. Outside the United States, high-strength glues and adhesives have been approved in some countries for a number of years and have built up a track record of use in internal surgery. With time, high-strength glues will come to be used in a wider range of procedures and enable new procedures to be performed more economically with better outcomes and reduced morbidity and mortality.

We have reviewed applications and indications of commercial products and include, for the cardiac surgery example below, a list of approved indicated procedures from the European Union, as it illustrates the growing potential for these high-strength glues once they gain universal approval and adoption within the surgical community worldwide. 

  • Augmentation of aortic and vascular sutures.
  • Repair of minor epicardial lacerations without the use of sutures.
  • Hemostasis and reinforcement of anastomoses of coronary bypass and as an adhesive to optimize and secure the path of coronary bypasses on the heart.
  • Coating of perianeurysmatic tissue in ventricular aneurysm surgery.
  • Reinforcement of sutures and patch adhesion in reduction of the left ventricle.
  • As an adhesive to secure the dissection plane in acute aortic dissections.
  • As a hemostatic agent in the prevention of bleeding of proximal and distal anastomoses in acute aortic dissections.
  • As an adhesive for gluing patches for dissected aorta reinforcement.
  • As a hemostatic agent on anastomoses in aortic valve surgery, particularly in the presence of calcific or atheromatous aortas.
  • Hemostasis and reinforcement of sutures after aortic aneurysm repair.
  • In re-operations, as a hemostatic adhesive on lacerations of the ventricle caused by re-sternotomy or the presence of adhesions. 

Other specific surgery indications are provided in report S175, "Worldwide Surgical Sealants, Glues, Wound Closure and Anti-Adhesion Markets, 2009-2013" for each of the following surgical fields:

  • Digestive tract endoscopy
  • Neurosurgery
  • General surgery
  • Gynecological surgery
  • Urological surgery
  • Interventional radiology and vascular neuroradiology
  • Pediatric surgery
  • Pediatric cardiac surgery
  • ENT surgery

The unmet need for non-toxic, high-strength, resorbable glues is clearly demonstrated by adoption of existing glue products outside of the United States in these multiple clinical indications. 

Global wound care market segmentation, drivers

Products and technologies used in advanced wound management have found varying degrees of success in global markets, stemming from differences in clinical practices, cultures, sensitivities, demographics and other geographically-driven differences.  At the macro view, the size of the advanced wound management market by countries falls in a typical pattern based on the relative size of the populations and healthcare markets:


Source: MedMarket Diligence report #S247

The differences between these markets in their relative adoption and use of advanced wound management technologies is illustrated in the graph below, showing the percent of each country's total market that is represented by each wound product type.


Source: MedMarket Diligence report #S247.


The size of the wound care market is ultimately determined by the clinical need for advanced wound management products. That need is most clearly reflected in the prevalence of chronic wounds and burns. Current estimates put the total annual incidence of chronic wounds at almost 9 million worldwide, and there are 177 million cases of diabetes worldwide; 10%–15% of diabetic patients will develop ulcers at some point. The market for products used in the management of specific wound types are, in decreasing size, venous stasis (as in chronic venous ulcers) decubitus ulcer (e.g., bedsores), diabetic foot ulcers and lastly (despite their acute nature) burn wonds.


It should be noted that a large proportion of wound product sales are accounted for by traditional types of wound management products. It has been estimated that two-thirds of the world’s physicians are not making routine use of advanced wound management products. Perhaps surprisingly, U.S. physicians are much more conservative in their approach to advanced wound healing technologies than their European counterparts. For this reason, the European share of the AWC market is significantly higher than the U.S. share.

The implication is that there is significant market potential, if barriers such as cost and entrenched attitudes can be overcome. It is not yet widely appreciated, even in some parts of the developed world, that the relatively high initial cost of managing hard-to-heal wounds with advanced techniques is more than offset by the savings achieved with shorter treatment periods and reduction in the demand for skilled medical attention.


(From "Worldwide Wound Management, 2008-2017: Established and Emerging Products, Technologies and Markets in the U.S., Europe, Japan and Rest of World", report #S247.)

Coronary stents: Big differences in adoption globally

Market drivers that vary geographically account for some big differences in the distribution of the coronary stent market across the currently available stent types, and these differences will continue when bioabsorbable stents (and others) are introduced to the market over the next few years.

The local market forces dictating these differences include:

  • Regulatory timelines in one market that can delay new product introductions by a year or more compared to another market
  • Regulatory control that either limits or facilitates introduction of local market ("me too") stent developers.
  • Differences in clinical adoption of advanced technologies driven by local practice patterns
  • Price sensitivities that can vary considerably from one geography to the next, with the potential to severely restrict the adoption of advanced technologies and/or force price reductions


The coronary stent market illustrated distinct differences in market segmentation on the basis of geography, challenging assumptions of the expected market shares of current and potential stent manufacturers competing in each local market.  One of the most distinct differences is the relative adoption of drug-eluting stents in China (captured in Asia/Pacific, below) versus either the U.S. or Europe. 

Source: MedMarket Diligence, LLC.  Report #C245, "Worldwide Coronary Stent Market, 2008-2017."