Wound management technology projections

{Below is a summary of the products and technologies addressed in 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."}

Wound management technologies are comprised of a remarkably diverse range of product types.  Dressings alone can be divided into multiple types, including film dressings, hydrocolloids, foam dressings, alginate dressings, hydrogels, non-adherent dressings, and antimicrobial dressings. Other wound products include cleansing and debridement products, tissue engineered products, pharmacological products, (including pain control, antibiotics, growth factors, non-growth factor modulators, gene therapy, and scarring modulators), physical treatments (like pressure devices, hydrotherapy, electrical stimulation, electromagnetic stimulation, ultraviolet therapy, hyperbaric oxygen therapy, mechanically assisted wound closure devices, ultrasound, laser and information systems. Some of these product categories are well established; others are in development.

Film Dressings. Film dressings are a vital segment of the advanced wound management market. The potential for film dressings in moist wound healing is a concept that is now over 20 years old. Due to the age of many of the strong brands in this segment, key patents on technologies and the delivery/application systems are expiring. This will erode premium prices, which have been maintained by creating new and differentiating application systems and the strong branding that is associated with them. Companies with strong know-how coupled with highly integrated low-cost manufacturing, and strong brand awareness will retain share in the marketplace.

Overall, despite increased competition and price pressure, this market segment will continue to demonstrate positive growth resulting from continued adoption of moist wound healing principles and switching from general non-occlusive dressings to advanced products such as films. The market for transparent film dressings is mature, and although individual products may provide a number of separate features, such as different moisture vapor transmission rates (MVTRs), they are purchased as commodities by buying groups. Given acceptable delivery systems, films compete on price. Global sales of film dressings are significant, but relatively stable, with price competition limiting sales growth to around 5% per year.

Hydrocolloid Dressings. The market for hydrocolloids grew rapidly in the 1980s and 1990s due to the products’ convenience and the fact that they can be left on some wounds for up to five days, together with widespread experience in their use, significant clinical support, and intensive marketing, that have helped grow sales volume over the years. Clinician customers developed a high awareness of these hydrocolloid brands and effectively substituted them for traditional fabric dressings once they had adopted the rationale for advanced wound care using moist wound healing. Major players in this segment of the market encouraged the use of hydrocolloids for all moist wound healing applications.

Hydrocolloids are used extensively in long-term care sites where wear time and ease of use are determining factors in dressing selection and in hospitals where they are popular with opinion leaders. However, hydrocolloids are now starting to lose ground in the face of competition from newer types of dressings with superior benefits. Sales of hydrocolloids are growing at a modest rate, but will nonetheless reach well over $1 billion by the year 2017. ConvaTec, Coloplast, and other strong players will find it increasingly difficult to defend these brands from advancing generic hydrocolloid equivalents produced by lower cost manufacturers with generic cost bases. In addition, there is a growing customer recognition that hydrocolloids have been superseded by other technologies (for example, foam dressings) for some wounds.

Foam Dressings. The ability to outperform hydrocolloids in highly exuding wounds, lack of dressing debris, and moderate cost have made foam dressings one of the fastest growing segments in the advanced wound care market. Foams are expected to maintain an aggressive market growth rate into the immediate future as these products take share from hydrocolloids due to their superior handling characteristics, and as they erode traditional gauze dressing usage. 

Alginate Dressings. Alginate dressings are popular in the home care and extended care markets where high absorption capacity is used to reduce the number and expense of skilled visits. In deeper wounds, alginates conform to the wound bed and contain exudates better than foam dressings. As with other advanced wound dressings, the alginate market is experiencing pricing pressure due to the continued cost consciousness of many individual country’s health care systems, and the generic nature of these materials and lack of proprietary intellectual property. Use of alginate dressings is especially common on moderate-to-highly exuding wounds. Alginates were quickly categorized as devices and reimbursed in the USA, UK, France and Germany, leading to strong growth in these countries. The relatively strong support for these products by expert wound care clinicians and the need for management of highly exudative wounds led to high sales growth in the mid 1990s. The alginate dressings market segment will grow at a healthy annual compound annual growth rate through 2017; in 2008, companies generated more than a half billion dollars from alginate dressings sales.

Hydrogels. Hydrogels are often promoted by referring to their aesthetic cooling effects, which help to reduce wound pain. Hydrogels are now perceived by clinicians as effective in encouraging autolytic debridement, and encouraging the healing of dry or minimally exuding wounds. Amorphous hydrogels and gauze-stabilized formats provide a real advantage in wound packing, and these products have been readily adopted by clinicians. In addition, hydrogels have good potential to serve as delivery systems for active agents. Competitors are actively introducing new hydrogel products to the market, and targeting alternate and home care markets. Thus, hydrogel sales are projected to grow at roughly 5% per annum from 2008 to 2017.

Approximately 50% of amorphous hydrogel products are used by clinicians to re-hydrate black necrosis or yellow slough for purposes of debridement. The other 50% of amorphous hydrogels are sold for use as a general hydration material for controlling moisture to aid moist wound healing.

Non-Adherent Dressings. Non-adherents are a vital part of the advanced wound management market. Products are used to permit less frequent changes of dressings and to allow the use of dressings that manage higher quantities of exudates but reduce the potential for these dressings to stick to the wound. They are also used in combination with traditional dressings as an alternative to more expensive advanced wound dressings. These dressings are also used as the primary contact layer for compression bandaging systems (although we have excluded sales due to this usage from our market estimates). Thus, non-adherent sales are projected to continue to grow at little better than 3% per annum through 2017.

Anti-Microbial Dressings. Anti-microbial dressings are used to manage the effects of microbial colonization and growth. Bacterial infection of wounds is a significant complication of wound repair. There is a growing concern regarding the use of antibiotic products in the wound care environment, and there are few “non-resistant-microbe-forming” antibiotic technologies on the horizon that offer potential to be launched within the next five years. In contrast to this, antimicrobial technologies are being pursued by all wound management companies, to enhance existing brands, and to address the recognized need in this area. Topical antiseptics are one option to treat patients with infected wounds; they act rapidly and locally to destroy microbes. Products fall into a number of categories, which tend to overlap with other categories of wound care products due to the product base technology used for the dressing category that inspired them. For example, Tulle Gras delivery systems have been used for some antibacterial products such as Inadine, Bactigras, and generic antibiotic impregnated products. Sales are projected to continue to grow at under 5% per annum from 2008 to 2017.

Wound Cleansers and Debriding Agents. The wound cleanser and debridement market is expected to grow at well over 5% annually, from over $400 million in 2010. The enzymatic debridement subsegment of this market is driven by the increase in the elderly population with the corresponding increase in nursing home populations and in-home health care environments where chronic wounds are prevalent. The increasing prevalence of diabetic ulcers contributes to the market potential for these agents.

Skin Replacements and Substitutes. Skin replacements and substitutes compete in the severe burn market, venous leg ulcers market, and the diabetic foot ulcer markets where their high cost is offset by their ability to save lives and/or save limbs from amputation. These products have taken some time to demonstrate clinical effectiveness and to be approved for use to heal wounds faster than alternative treatments. In addition, these products are currently significantly more expensive than alternative therapies, and publicly funded health care schemes around the world have found it difficult to accept these costs despite strong cost-effectiveness claims. It is highly likely that these products will take some time to be widely adopted. The move towards cost- effectiveness procurement practice is likely to increase uptake of these products as purchasers advance 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.

Pharmacological Products. In the field of wound management there are a large number of companies commercializing technologies in the pharmacological field. These technologies include recombinant growth factors and growth factor mixtures, gene therapy, chemical cell stimulants, natural plant extracts and other pharmaceuticals including analgesics, antibiotics, scar reduction products etc. Advanced wound care practices and dressings have focused on removal of the underlying cause of the wound, altering the physical environment, and provision of a moist wound healing environment. These efforts have greatly improved wound care by facilitating wound repair by supporting the body’s own repair and regenerative processes. Recent interest and efforts have been directed to evolving products and procedures designed to actively manipulate the wound healing process. In addition, antibiotics and analgesics have direct and beneficial application in the treatment of wounds in specific cases.

Physical Therapies. Physical modalities have been used in the attempt to encourage wound healing for centuries. Passive compression is a popular approach for the treatment of venous stasis ulcers and many of the current passive compression products have their roots in traditional practices (e.g., paste bandages). Passive compression addresses the underlying etiology of chronic venous insufficiency.

Alternatively there is a market for devices designed to remove pressure from wounds that have been caused by extended pressure on the skin surface, and this market segment has shown astronomical growth within the past 3-4 years, driven by the demonstrated ability of application of negative (i.e., sub-atmospheric) pressure to speed up and improve the healing of chronic wounds.

There are also a great number of devices that are designed to immobilize limbs to avoid weight-bearing behavior, and sophisticated footwear and devices for diagnosing neuropathy. In addition, devices exist to manipulate pressure around limbs to maintain and improve venous blood flow. There are devices designed to accelerate healing through the use of physical treatments including ultrasound, electrical, magnetic, hyperbaric, and pressure relief.

Taken together, these physicial treatment modalities commanded sales almost $2 billion in 2010 and annual growth at double digits for the period 2008–2017.

Tissue Engineered Products. Skin replacements are designed to replace missing skin, including the skin’s structures and biologic functions. Skin replacements may be from the patient’s own skin, from a human cadaver, or from an alternate species; or the skin replacement may be made from biomaterials or biodegradable synthetic materials with or without cells grown as tissue engineered constructs in culture. These tissue engineered products provide the matrix alone, epidermal tissue equivalent, dermal tissue equivalent, or a multi-layer human skin equivalent that includes both dermal and epidermal tissues. In addition this category includes some emergency burn cover products that are synthetic and biosynthetic dressings. These products have been used for some time as a temporary covering for severely burnt patients when insufficient graft material is available and the patient will otherwise die if the burns are not covered to reduce fluid loss and prevent infection. When skin for autografting is available, the temporary dressing is removed and graft is performed. This skin replacement category of products is receiving considerable R&D attention as biotechnology companies strive to develop replacement engineered skin to repair chronic wounds.


MedMarket Diligence report #S247:

The report details the current and projected market for wound management products, including dressings, closure devices, debridement, pharmacological products, tissue engineered products and others. Particular emphasis is placed on advanced and leading edge developments (i.e., those approaching wound management from novel perspective) such as growth factors, stem cells, gene therapy and other approaches, while baseline data (current and forecast market size and current competitor market shares) is provided for established segments — multiple dressings types (film, foam, alginate, antibacterial, non-adherent), hydrogels, hydrocolloids, pharmaceuticals, and physical treatments. The report details the clinical and technology developments underlying the huge and evolving worldwide wound care market, with data on products in development and on the market; market size and forecast; competitor market shares; competitor profiles; and market opportunity. Separate size, growth and competitor data are presented for the U.S., leading western European countries, Japan and the Rest of World category. The report profiles leading and emerging companies, with data on products, technologies and positions in the advanced wound care market. The report establishes the current worldwide market size for major technology segments as a baseline for and projecting growth in the market over a ten-year forecast and assesses and projects the composition of the market as technologies gain or lose relative market performance over this period.

Se also the related report $S180, "Worldwide Surgical Sealants, Glues, Wound Closure and Anti-Adhesion Markets, 2010-2015."

Emerging diabetes treatment options

Research in the diabetes field has taken two main directions: improving current therapies, and exploring radical new approaches. Improvements in current therapy include making glucose monitoring and insulin delivery less invasive and more patient-friendly, and many significant advances have been made in this context in the past two decades. Among these have been the development of insulin pumps and of non- or minimally-invasive techniques for sampling blood. New, fast-acting forms of insulin have been introduced. There has been considerable research in non-injection dosage forms for insulin, and the first inhaled insulin product has recently been approved. This could herald a new era in insulin therapy.

Another ground-breaking development will be the successful development of an “artificial pancreas.” This is the term used to describe a system in which continuous glucose monitoring is linked electronically to continuously variable insulin delivery, effectively making diabetes control automatic and freeing the patient to get on with his/her life. The technology behind an artificial pancreas is still being developed but it is at an advanced stage.

More radical approaches to diabetes mellitus, also the subject of vigorous research, include ways of replacing the whole cumbersome business of glucose testing and insulin administration. Transplantation of healthy pancreatic islets into diabetic patients has been explored, but the problems of rejection are a significant hurdle. More promising is the modification of adult or embryonic stem cells so that they develop into pancreatic beta-cells capable of being implanted in the patient and serving as a replacement for the insulin-secreting cells that have been destroyed.

Further in the future are developments based on genetic manipulation. Several gene anomalies have been identified as related to the development of type 1 diabetes in particular, and these may present targets for intervention to prevent the disease from developing.

For more details, see link.

Selected new medical technologies with big potential impact

One of our readers at nursingschools.net sent along an interesting set of medical technologies that are good examples of new and evolving technologies impacting patient care.  

  • Faster MRIs. Cutting MRI imaging time seven-fold will yield great research and clinical benefits.
  • Water fleas as new human testing models.  Genetic homology with humans may make these valuable human test subject.
  • Molecular imaging. Bridging the gap between molecular biology and imaging to elucidate molecular level precursors to organ failure.
  • Magnetic molecules. Room temperature control of the magnetic state of molecules may lead to a variety of medical and non-medical applications.
  • Bioengineered blood vessels.  Faster graft generation, better than synthetic.  (This has also been the subject of tissue engineering in our Report #S520.) 
  • STEM microscopes. High-speed, 3D recording of individual neurons firing could dramatically improve understanding of neural pathologies.
  • Blurring man/machine. Brainwave control of machines. (See also "2045: The Year Man Becomes Immortal", Time Magazine.)
  • Laser biopsies. Painless, noninvasive.
  • Wireless heart monitoring.  Potential for earlier detection of heart failure events to  dramatically reduce readmissions.

For the full review of these advances at nursingschools.net see link.

Cell-based options for diabetes treatment

From "Diabetes Management: Products, Technologies, Markets and Opportunities Worldwide 2009-2018", Report #D510.

 

At the forefront of those technologies seeking to reverse diabetes or at least target the underlying disease are the cell-based options to restore normoregulated blood glucose levels. These include pancreas transplants, islet cell transplants and a number of stem cell transplant options.

Pancreas Transplants

Pancreas transplantation has been widely practiced for some years and has been successful in a majority of patients. It is not appropriate for all diabetics as it is, for example, too invasive for children, and cost is a major deterrent. Also, immune rejection of the transplanted organ is a constant threat which must be counteracted by daily immunosuppressant drugs. Another major problem is the shortage of available organs for transplantation compared with the much larger demand.

Pancreas-alone transplants are performed when there is normal or near-normal kidney function. This option may be recommended for patients who have frequent insulin reactions or poor blood glucose control despite best efforts to manage the disease. Most transplant recipients are 55 years or younger, have type 1 diabetes and are healthy enough to undergo the procedure. About 95% of pancreas transplantation are performed in patients with renal disease or who had a previous functioning kidney transplant. In the United States, roughly 1,200 people receive pancreas transplantations each year. If insulin treatment and monitoring strategies are working, a transplant is unlikely to be a better option. According to pancreas transplantation results reported to the Scientific Registry of Transplant Recipients of the United Network for Organ Sharing and the International Pancreas Transplant Registry, survival rates for recipients of a simultaneous pancreas-kidney (SPK, i.e., from the same donor) transplant were 85%–95%. Compared to diabetic patients receiving just a kidney, long-term patient and kidney graft survival improved for patients who also received a pancreas. Survival rates were 78%–83% for those patients who received only a pancreas or a pancreas some time after a kidney transplant.

As such, roughly 75% of all pancreas transplants are performed along with a kidney transplant (in an SPK procedure) in diabetic patients with renal failure. (About 15% of pancreas transplantation are performed after a previously successful kidney transplantation and 10% consist of pancreas alone in nonuremic patients with very labile and problematic diabetes.) The strategy is to give the patient a healthy kidney and pancreas that is unlikely to contribute to diabetes-related kidney damage in the future. This dual transplant appears to contribute to better survival rates for both organs. After five years, the survival rate for the pancreas in a simultaneous transplant is 70%, while the organ survival rate for other pancreas transplants is only 52%. 

Islet Cell Transplants

Islet cell transplantation (ICT) may eventually become an effective diabetes therapy by replacing whole pancreas transplantations, but at this point, it is experimental and not yet as efficient as pancreas transplantation. ICT involving just those parts of the pancreas, called islets, where insulin is produced. Theoretically, the process is based on the enzymatic isolation of the pancreatic islets from an organ procured from a cadaver donor. The islets obtained are injected into the liver in the recipient via percutaneous catheterization of the portal venous system. This procedure allows the selective transplantation of the insulin-producing cell population, thus avoiding open surgery as well as the transplantation of the exocrine pancreas with related morbidity.

Initial experience with ICT was only modestly promising. The immunosuppression regimen was similar to the one used in solid organ transplantation, based on high dose steroids and calcineurin inhibitors, both of which are agents with diabetogenic effects. Results improved markedly with improved manipulation of the islets and changes in immunosuppression strategy using sirolimus, tacrolimus and daclizumab. This protocol was initiated by investigators at the University of Alberta in Edmonton, Canada. Generally, their protocol requires two islet cell infusions in order to attain the critical cell mass necessary to achieve insulin-independency. The changes in treatment were adopted as the Edmonton Protocol, which is used now in several transplant centers worldwide.

Stem Cell Transplants

Stem cell research allows scientists to explore how to control and direct stem cells so they can grow into other cells, such as insulin-producing beta cells found in the pancreas. Creating new beta cells could lead to cure for type 1 diabetes as they would serve as a replenishable source of cells for islet cell transplantation. They could also provide an additional means for controlling type 2 diabetes.

The American Diabetes Association strongly supports all forms of stem cell research to find effective diabetes therapies, examples of which include embryonic stem cells, cord blood stem cells and adult stem cells.

Researchers have made several advances to demonstrate the potential of human embryonic stem cell (hESC) research and are beginning to understand how this research could benefit diabetes. Already, many of the genes involved in pancreatic development have been identified, and recent discoveries have allowed scientists to overcome the difficult task of getting stem cells to produce the necessary proteins in the correct sequence that will allow them to become insulin-producing islet cells.

Due to the ongoing ethical challenges raised by the use of embryos for stem cell therapies (despite the rescinded funding ban on federally funded embryonic stem cell research), alternatives that avoid these issue have been, and will continue to be investigated aggressively, including cord blood cells and adult stem cells.  Cord blood is obtained from the umbilical cord at childbirth after the cord has been detached from the newborn. This blood contains stem cells, including hematopoietic cells, which can be used in the research of many types of therapies, including diabetes. This includes such studies as the regeneration of islet cells.  Adult stem cells hold promise, particularly as autologously-derived cells that can be directed to differentiate into pancreatic islet cells that, due to their autologous sourcing, will avoid immunogenic response and its complications (and cost) in treatment.

Report #D510 details the status of programs and products in the development for cell-based therapies for diabetes.

Medical technologies seizing opportunity in clinical applications

A great many medical technologies are seizing opportunity in healthcare as a result of a wide range of advances.  Here are a few we wish to highlight:

  • RFID devices
    Radiofrequency devices are in a growth phase as device manufacturers recognize the potential to monitor device location and performance.  RFID potential includes tags enabling the secure tracking of instruments (and sponges) during surgery, patient tracking in healthcare facilities, glucose-sensing RFID implants for diabetes and many others.
  • Neurostimulation
    Technologies to approach clinical challenges by harnessing and manipulating the patient’s own nervous system — for reduction of pain, control of incontinence, even spinal cord stimulation for treatment of congestive heart failure and others are opening up a whole new field of clinical intervention.  Driven by companies like Medtronic and others, the field is poised for dramatic growth in clinical applications and device markets.
  • Interventional (percutaneous) technologies
    Catheters used to represent little more than tubes to drain fluids, but have evolved to remotely deliver and deploy a remarkable range of devices from stents, to heart valves to vena caval filters and many others.  Taking advantage of the highly prevalent skillsets of interventional cardiologists, new interventional technologies are pushing the boundaries of procedures that can be performed without incision.  And as clinicians’ skills increase, manufacturers are further developing interventional technologies that can access ever-smaller vasculature, such as via radial arteries instead of femoral.
  • Natural orifice transluminal endoscopic surgery (NOTES)
    The relentless drive to make surgical procedures less traumatic has driven surgeons away from even the relatively inconsequential laparoscopic incision to a growing volume of surgical procedures that can be performed entirely endoscopically using the patient’s “natural orifice”.  As a practical matter, NOTES is effectively a natural result of the continued development of endscopy, but the drive to eliminate external incisions and further reduce trauma, combined with great advances in endoscope and endoscopic instrumentation development, is accelerating the shift away from traditional surgery and toward truly least invasive surgery.
  • Biomaterials
    No longer are medical devices inert, structural implants, but they have become biocompatible, bioerodible/biodegradable and provide other functions including drug delivery, stimulation of cell migration and others.  The science of engineering polymers and other unique materials is complementing advances in understanding and control of cell and tissue biology to produce a dramatic increase in the functional interface between device and disease.
  • Nanotechnology
    Whether commercialized as nanocoatings or as nanoparticles to provide targeting or drug delivery or a host of other “very small” functions, nanotechnology applications in medicine are proliferating.  The applications are too numerous to mention, revealing that there is in reality little in common between many different nanotechnologies, other than size.
  • Adult and other non-embryonic stem cells
    When the ethical challenge of embryonic stem cells caused federally funded research to be put on hold, the incentive was raised for research to ferret out the potential of adult stem cells, cord blood cells and other sources of stem cells, many of which may ultimately avoid both the ethical challenge and the tendency of embryonic cells to become cancerous. Nonetheless, the potential of embryonic remains (as does the ethical risk), but adult stem cells may prove more pragmatic in the long run.

Many more technologies are arising from advances in basic scientific research and from the highly innovative development by medical device and other technology companies than have been mentioned here, but this provides a sampling of the technologies that are seizing opportunity as a result of advances in scientific application that meets clinical demand.

Recent medtech market insights

It occurred to me that in my position performing, directing and reviewing market research on a global scale that it would be worthwhile to highlight recent insights that have come to me regarding the global medical technology market.  Some of these insights, of course, may only be meaningful to me (and those who have a perspective on medtech markets similar to mine), but I hope that some insights may be useful to some of my niche audiences in medtech.   Keep in mind that some of the insights I have come from proprietary sources, whose identities I am not able to reveal (lest they elect to no longer do business with me!), but I will nonetheless reveal as much non-proprietary information as I can.

  • The global economy is down from two years ago, but is measurably if not significantly up from one year ago.  I gauge this based on the overall level of business we directly receive and the feedback my authors receive from researching medtech companies. This should be no surprise to anyone who reads other business news on a regular basis.
     
  • U.S. markets, for a number of reasons, seem to be lagging markets in the global economy in this period of economic recovery. If I simply use the measure of the number of medtech company inquiries to us originating from U.S. versus OUS companies, I have seen a clear trend that started with a global decline in 2008 followed by a flat 2009 followed by a steady growth in inquiries from OUS companies in 2010 and relative smattering of U.S. company inquiries.  Why this is so may be the subject of countless speculation, but one reason, I believe [insert personal insight here] is that OUS companies (whose pockets weren't so deep as those in the US) felt the hit of the global recession  before the US companies and they sooner ran out of patience waiting for markets to rebound, electing instead to move forward on product development, market development and other initiatives.    
     
  • The trend of OUS emerging from the global recession before the US is one that runs counter to the other truth I see, which is that the U.S. is almost universally a market leader (with the exception of areas like cell therapy, in which academia and business OUS has been more than happy to push forward in research while the U.S. vacillates between right- and left-wing politics).  Almost without fail, I continue to see the most advanced technologies emerging principally from US rather than OUS companies.
     
  • There has been more activity emerging from China and (rogue island) Taiwan in medtech over the past two years than I have ever seen.  This activity — purchase of market research, formation of companies or commercialization in general — has a concentration in academic organizations or institutes apparently seeking to commercialize research discoveries originating from "pure" research.
     
  • Hope springs eternal in the U.S.  Despite two full years of economic woes in the U.S., a surprisingly steady stream of new medtech companies continue to be founded, as entrepreneurs commit to the commercialization of technologies they see warranting the rigorous development, clinical testing, FDA and other hurdles en route to the market.  But to temper the idea that in the US there is a greater abundance of adventurous entrepreneurs, I must note that a remarkable number of new companies in the US recently have been started by serial entrepreneurs, who have so often previously run the gauntlet demanded of startups  that they are fully prepped to make new runs with new technologies. 
     
  • Minimally invasive is minimally invasive (is better).  Lower long term cost is better. With few real "untapped" clinical targets being the subject of new medtech development, the vast majority of activity is clearly centered around improvements in care that lend to the argument of better clinical outcomes and/or reduced cost of patient care.  The thrust of R&D is on yielding advantages that reduce invasiveness, speed the treatment process and/or time to healing or simply provide competitive clinical costs at or lower than alternatives.
     
  • Notwithstanding the prevalence of developments noted above, in reducing cost/invasiveness, there are distinct areas of new technology development that center on providing outcomes where few, if any, effective therapies existed previously.   A good point (perhaps the most salient example) is in cell therapies, deriving from autologous, embryonic or adult stem cell technologies.  Despite ongoing ethical/policy/legal battles regarding embryonic stem cells, cell therapy has moved rapidly to the foreground as one of the most significant drivers of new technologies soon to spawn therapies for previously untreated diseases.  While this field may certainly characterized as simply being en vogue, and is therefore only momentarily benefiting financially from recent attention, there are very real advances in the science and technology of cell therapies that are moving these to clinical and market fruition.

These are some of the insights I have picked up and can reveal from our market research.  It would certainly be intriguing to me to hear what readers have themselves witness that either corroborates, or refutes, what I see.

Clinical applications of tissue engineering and cell therapy

The market for tissue engineering and cell therapy products is set to grow to nearly $32 billion by 2018. This figure 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.

An overview (map) of the spectrum of clinical applications in tissue engineering and cell therapy is shown below:

Source: Report #S520

Cardiology and cardiovascular medicine applications of cell therapy

Much attention has been paid to the development of cell therapies with cardiovascular applications. According to the Institute of Cardiovascular Regeneration, more than 1,500 patients with cardiovascular diseases are treated with adult progenitor cells worldwide. Much success has been achieved in this sector and cardiovascular cell therapies are increasingly becoming viable technologies.

The primary competitors in the field of tissue engineering and cell-based therapies for cardiovascular applications are shown in the exhibit below illustrating the stages in which they have cardiology/cardiovascular applications in development.

Key Competitors in Tissue Engineering and Cell Therapies for Cardiovascular Applications

Note: See specific products in development detailed in report #S520.

Source: MedMarket Diligence, LLC; Report #S520, "Tissue Engineering, Cell Therapy and Transplantation 2010."

Market Drivers: U.S. and European Cell Therapy, Tissue Engineering

Tissue engineering and cell therapy comprise a market for regenerative products that is expected to grow worldwide from $6.9 billion in 2009 to almost $32 billion by 2018. This market spans many specialties, the biggest of which is therapies for degenerative and traumatic orthopedic and spine applications. Other disorders that will benefit from cell therapies include cardiac and vascular disease, a wide range of neurological disorders, diabetes, inflammatory diseases, and dental decay and/or injury. Key factors expected to influence the market for regenerative medicine are continued political actions, government funding, clinical trials results, industry investments, and an increasing awareness among both physicians and the general public of the accessibility of cell therapies for medical applications.

There are key market drivers affecting the relative growth of cell therapy and tissue engineering in specific regions or countries. One historical driver has been the dynamics of stem cell research in the United States. The unavailability of additional stem cells due to President Bush’s Presidential Executive Order in 2001 (since rescinded in 2009 by President Obama) had the affect of decelerating the number of new embryonic stem cell research projects launched, thus postponing the optimistic timeline anticipated by some researchers. This directly delayed the commercialization of products based on embryonic stem cell research, which had the effect of dampening the overall U.S. market.  Simultaneously, this also drove increased research and development of the science (if not technologies as well) in areas outside the U.S., especially in the EU. While this distinction between the U.S. and Europe does not account for all the market size and growth differences, it is a distinct, identifiable cause.  (The U.S. also has in many respects a more mature — or at least more penetrated cell/tissue market — and the EU is simply catching up.)

Below for comparison is the relative U.S. and European share of the cell therapy and tissue engineering market in 2009 and 2019.

Source: MedMarket Diligence, LLC; Report #S520.

Cell therapy, tissue engineering and two means to one end

The subject of "tissue engineering and cell therapy" is, by some accounts, an artificial amalgam of the two separate subjects, particularly since cell therapy per se, as a result of its inextricable link to embryonic stem cells and abortion, seems to demand (at least by some) a wholly separate consideration.  From a scientific basis, of course, there is merit in the distinction, but from an industry-driven commercial consideration of diseases, disorders and trauma to be addressed — and patients served — the amalgam of cell therapy and tissue engineering is indeed warranted. For those such as we who track the developments  and markets pursued by medical technology in an era when devices compete with and/or are complementary with drugs, biotechs, biomaterials and every other technology paradigm, it is little more than an educational but largely academic exercise to make the distinction.  Medtech markets have been dramatically characterized of late, as a result of a cost- and reform-driven fixation on clinical solutions and outcomes that are achieved by any technological route. Yes, tissue engineering, biopharmaceuticals, biomaterials and other technologies are indeed distinct in nature from cell therapies in general and stem cell therapies in particular, but neither the manufacturer nor the patient particularly care about that distinction.

Below is an excerpt from Tissue Engineering, Cell Therapy & Transplantation, 2009-2018.


Cell therapy is defined as a process whereby new cells are introduced into tissue as a method of treating disease; the process may or may not include gene therapy. Forms of cell therapy can include: transplantation of autologous (from the patient) or allogeneic (from a donor) stem cells , transplantation of mature, functional cells, application of modified human cells used to produce a needed substance, xenotransplantation of non-human cells used to produce a needed substance, and transplantation of transdifferentiated cells derived from the patient’s differentiated cells.

Once considered a segment of biomaterial technologies, tissue engineering has evolved into its own category and now comprises a combination of cells, engineering and suitable biochemical and physiochemical factors to improve or replace biological functions. These include ways to repair or replace human tissue with applications in nearly every medical specialty. Regenerative medicine is often synonymous with tissue engineering but usually focuses on the use of stem cells.

For the purposes of definition, tissue engineering and cell therapy comprise bioengineered products that are themselves cells or are actively stimulating cell growth or regeneration. These often comprise a combination of biotechnology, medical device and pharmaceutical technologies.

Researchers have been examining tissue engineering and cell therapy for roughly 30 years. While some products in some specialties (such as wound care) have reached market, many others are still in research and development stages. In recent years, large pharmaceutical and medical device companies have provided funding for smaller biotech companies in the hopes that some of these products and therapies will achieve a highly profitable, commercial status. In addition, some companies have been acquired by larger medical device and pharmaceutical companies looking to bring these technologies under their corporate umbrellas. Many of the remaining smaller companies received millions of privately funded dollars per year in research and development. In many cases it takes at least ten years to bring a product to the point where human clinical trials may be conducted. Because of the large amounts of capital to achieve this, several companies have presented promising technologies only to close their doors and/or sell the technology to a larger company due to lack of funds.

The goal of stem cell research is to develop therapies to treat human disease through methods other than medication. Key aspects of this research are to examine basic mechanisms of the cell cycle (including the expression of genes during the formation of embryos) as well as specialization and differentiation into human tissue, how and when the differentiation takes place and how differentiated cells may be coaxed to differentiate into a specific type of cell. In the differentiation process, stem cells are signaled to become a specific, specialized type of cell when internal signals controlled by a cell’s genes are interspersed across long strands of DNA and carry coded instructions for all the structures and functions of a cell. In addition, cell differentiation may be caused externally by use of chemicals secreted by other cells, physical contact with neighboring cells and certain molecules in the microenvironment.

The end goal of stem cell research is to develop therapies that will allow the repair or reversal of diseases that previously were largely untreatable or incurable.. These therapies include treatment of neurological conditions such as Alzheimer’s and Parkinson’s, repair or replacement of damaged organs such as the heart or liver, the growth of implants from autologous cells, and even regeneration of lost digits or limbs.

In a developing human embryo, a specific layer of cells normally become precursor cells to cells found only in the central nervous system or the digestive system or the skin, depending on the cell layer and the elements of the embryo that direct cell differentiation. Once differentiated, many of these cells can only become one kind of cell. However, researchers have discovered that adult body cells exist that are either stem cells or can be coaxed to become stem cells that have the ability to become virtually any type of human cell, thus paving the way to engineer adult stem cell that can bring about repair or regeneration of tissues or the reversal of previously incurable diseases.

Another unique characteristic of stem cells is that they are capable of self-division and self-renewal over long periods of time. Unlike muscle, blood or nerve cells, stem cells can proliferate many times. When exposed to ideal conditions in the laboratory, a relatively small sample of stem cells can eventually yield millions of cells.

There are five primary types of stem cells: totipotent early embryonic cells (which can differentiate into any kind of human cell); pluripotent blastocyst embryonic stem cells, which are found in an embryo seven days after fertilization and can become almost any kind of cell in the body; fetal stem cells, which appear after the eighth week of development; multipotent umbilical cord stem cells, which can only differentiate into a limited number of cell types; and unspecialized adult stem cells, which exist in already developed tissue (commonly nerves, blood, skin, bone and muscle) of any person after birth.

Source: MedMarket Diligence, LLC; Report #S520