- In catheterization, a doctor can poke a hole in your leg and fix your heart.
- Radiosurgery can destroy a tumor and leave adjacent tissue untouched, touching the body only with energy.
- A doctor thousands of miles away can do surgery on you via telepresence and robotic instrumentation.
- Medical device implants like stents have been developed to simply dissolve over time.
- Doctors can see cancer via live imaging during operations to ensure that they excise it all.
- Type 1 diabetics may soon be able to so easily manage their condition, via combined insulin pump / glucometer that they may almost forget they have diabetes (or cell therapy may cure them!), while Type 2 diabetics will grow in number and cost to manage.
- Organs are already being printed, as are other tissue implants.
- Neuroprosthetics, exoskeletons and related technologies are enabling wheelchair-bound and other physically challenged people to walk upright, allowing amputees to control prosthetics with their mind,
- Almost two-thirds of the 7,000 medical device firms in the United States have fewer than 20 employees — Medtronic employs all the rest. (OK, that’s an exaggeration.)
- Science fiction continues to drive the imagination of medtech innovators. Decentralized diagnostics — very small, efficient devices in the hands of a doctor that will rapidly assist in diagnoses and expedite the process of intervention — are becoming pervasive, ideally embodied in the fictional “tricorder” in Star Trek.
The top fundings for medical technology companies in August 2015 totaled a modest $335.1 million.
See the 2016 global reports:
Surgical Sealants, Glues, Hemostats, 2015-2022. details
Global Dynamics of Cardiovascular Surgical and Interventional Procedures, 2015–2022. details
Fundings for August 2016 were led by the $93 million funding of CVRx, followed by the $49 million funding of Auris Surgical Robots, and the $30 million funding of VytronUS. See link for the complete list.
For a comprehensive list of medtech fundings since 2009, see link.
In August 2016, MedMarket Diligence will be releasing Report #C500, “Global Dynamics of Surgical and Interventional Cardiovascular Procedures, 2015-2022”. The report details prevalence, incidence, and caseload for the following procedures, forecast to 2022, and examines the clinical practice trends, technologies emerging on the market, and the dynamics leading to trends in procedures utilization and technology adoption.
Surgical and interventional procedures included:
- Coronary artery bypass graft (CABG) surgery
- Coronary angioplasty and stenting
- Lower extremity arterial bypass surgery
- Percutaneous transluminal angioplasty (PTA) with and without bare metal and drug-eluting stenting
- Peripheral drug-coated balloon angioplasty
- Peripheral atherectomy
- Surgical and endovascular aortic aneurysm repair
- Vena cava filter placement
- Endovenous ablation
- Mechanical venous thrombectomy
- Venous angioplasty and stenting
- Carotid endarterectomy
- Carotid artery stenting
- Cerebral thrombectomy
- Cerebral aneurysm and AVM surgical clipping
- Cerebral aneurysm and AVM coiling & flow diversion
- Left Atrial Appendage closure
- Heart valve repair and replacement surgery
- Transcatheter valve repair and replacement
- Congenital heart defect repair
- Percutaneous and surgical placement of temporary and permanent mechanical cardiac support devices
- Pacemaker implantation
- Implantable cardioverter defibrillator placement
- Cardiac resynchronization therapy device placement
- Standard SVT & VT ablation
- Transcatheter AFib ablation
In very general terms, the category “cardiovascular diseases” (CVD) refers to a variety of acute and chronic medical conditions resulting in the inability of cardiovascular system to sustain an adequate blood flow and supply of oxygen and nutrients to organs and tissues of the body. The CVD conditions could be manifested by the obstruction or deformation of arterial and venous pathways, distortion in the electrical conducting and pacing activity of the heart, and impaired pumping function of the heart muscle, or some combination of circulatory, cardiac rhythm, and myocardial disorders
The scope of this report covers surgical and interventional therapeutic procedures commonly used in the management of acute and chronic conditions affecting myocardium and vascular system. The latter include ischemic heart disease (and its life threatening manifestations like AMI, cardiogenic shock, etc.); heart failure; structural heart disorders (valvular abnormalities and congenital heart defects); peripheral artery disease (and limb and life threatening critical limb ischemia); aortic disorders (AAA, TAA and aortic dissections); acute and chronic venous conditions (such as deep venous thrombosis, pulmonary embolism and chronic venous insufficiency); neurovascular pathologies associated with high risk of hemorrhagic and ischemic stroke (such as cerebral aneurysms and AVMs, and high-grade carotid/intracranial stenosis); and cardiac rhythm disorders (requiring correction with implantable pulse generators/IPG or arrhythmia ablation).
The report offers current assessment and projected procedural dynamics (2015 to 2022) for primary market geographies (e.g., United States, Largest Western European Countries, and Major Asian States) as well as the rest-of-the-world.
The cited procedural assessments and forecasts are based on the systematic analysis of multiplicity of sources including (but not limited to):
- latest and historic company SEC filings, corporate presentations, and interviews with product management and marketing staffers;
- data released by authoritative international institutions (such as OECD and WHO), and national healthcare authorities;
- statistical updates and clinical practice guidelines from professional medical associations (like AHA, ACC, European Society of Cardiology, etc.);
- specialty presentations at major professional conferences (e.g., TCT, AHA Scientific Sessions, EuroPCR, etc.);
- publications in major medical journals (JAMA, NEJM, British Medical Journal, etc.) and specialty magazines (CathLab Digest, EP Digest, Endovascular Today, etc.);
- findings from relevant clinical trials;
- feedbacks from leading clinicians (end-users) in the field on device/procedure utilization trends and preferences; and
- policy papers by major medical insurance carriers on uses of particular surgical and interventional tools and techniques, their medical necessity and reimbursement.
Surgical and Interventional Procedures Covered in the report include:
- Coronary artery bypass graft (CABG) surgery;
- Coronary angioplasty and stenting;
- Lower extremity arterial bypass surgery;
- Percutaneous transluminal angioplasty (PTA) with and without bare metal and drug-eluting stenting;
- Peripheral drug-coated balloon angioplasty;
- Peripheral atherectomy;
- Surgical and endovascular aortic aneurysm repair;
- Vena cava filter placement
- Endovenous ablation;
- Mechanical venous thrombectomy;
- Venous angioplasty and stenting;
- Carotid endarterectomy;
- Carotid artery stenting;
- Cerebral thrombectomy;
- Cerebral aneurysm and AVM surgical clipping;
- Cerebral aneurysm and AVM coiling & flow diversion;
- Left Atrial Appendage closure;
- Heart valve repair and replacement surgery;
- Transcatheter valve repair and replacement;
- Congenital heart defect repair;
- Percutaneous and surgical placement of temporary and permanent mechanical cardiac support devices;
- Pacemaker implantation;
- Implantable cardioverter defibrillator placement;
- Cardiac resynchronization therapy device placement;
- Standard SVT & VT ablation; and
- Transcatheter AFib ablation
In 2016, cumulative worldwide volume of the aforementioned CVD procedures is projected to approach 15.05 million surgical and transcatheter interventions. This will include:
- Roughly 4.73 million coronary revascularization procedures via CABG and PCI (or about 31.4% of the total),
- Close to 4 million percutaneous and surgical peripheral artery revascularization procedures (or 26.5% of the total);
- About 2.12 million cardiac rhythm management procedures via implantable pulse generator placement and arrhythmia ablation (or 14.1% of the total);
- Over 1.65 million CVI, DVT, and PE targeting venous interventions (representing 11.0% of the total);
- More than 992 thousand surgical and transcatheter heart defect repairs and valvular interventions (or 6.6% of the total);
- Close to 931 thousand acute stroke prophylaxis and treatment procedures (contributing 6.2% of the total);
- Over 374 thousand abdominal and thoracic aortic aneurysm endovascular and surgical repairs (or 2.5% of the total); and
- Almost 254 thousand placements of temporary and permanent mechanical cardiac support devices in bridge to recovery, bridge to transplant, and destination therapy indications (accounting for about 1.7% of total procedure volume).
During the forecast period, the total worldwide volume of covered cardiovascular procedures is forecast to expand on average by 3.7% per annum to over 18.73 million corresponding surgeries and transcatheter interventions in the year 2022. The largest absolute gains can be expected in peripheral arterial interventions (thanks to explosive expansion in utilization of drug-coated balloons in all market geographies), followed by coronary revascularization (supported by continued strong growth in Chinese and Indian PCI utilization) and endovascular venous interventions (driven by grossly underserved patient caseloads within the same Chinese and Indian market geography).
The latter (venous) indications are also expected to register the fastest (5.1%) relative procedural growth, followed by peripheral revascularization (with 4.0% average annual advances) and aortic aneurysm repair (projected to show a 3.6% average annual expansion).
Geographically, Asian-Pacific (APAC) market geography accounts for slightly larger share of the global CVD procedure volume than the U.S. (29.5% vs 29,3% of the total, followed by the largest Western European states (with 23.9%) and ROW geographies (with 17.3%). Because of the faster growth in all covered categories of CVD procedures, the share of APAC can be expected to increase to 33.5% of the total by the year 2022, mostly at the expense of the U.S. and Western Europe.
Source: MedMarket Diligence, LLC; Report #C500.
However, in relative per capita terms, covered APAC territories (e.g., China and India) are continuing to lag far behind developed Western states in utilization rates of therapeutic CVD interventions with roughly 1.57 procedures per million of population performed in 2015 for APAC region versus about 13.4 and 12.3 CVD interventions done per million of population in the U.S. and largest Western European countries.
See “Global Dynamics of Surgical and Interventional Cardiovascular Procedures, 2015-2022”, Report #C500 (publishing August 2016).
An important determinant of “where medicine will be” in 2035 is the set of dynamics and forces behind healthcare delivery systems, including primarily the payment method, especially regarding reimbursement. It is clear that some form of reform in healthcare will result in a consolidation of the infrastructure paying for and managing patient populations. The infrastructure is bloated and expensive, unnecessarily adding to costs that neither the federal government nor individuals can sustain. This is not to say that I predict movement to a single payer system — that is just one perceived solution to the problem. There are far too many costs in healthcare that offer no benefits in terms of quality; indeed, such costs are a true impediment to quality. Funds that go to infrastructure (insurance companies and other intermediaries) and the demands they put on healthcare delivery work directly against quality of care. So, in the U.S., whether Obamacare persists (most likely) or is replaced with a single payer system, state administered healthcare (exchanges) or some other as-yet-unidentified form, there will be change in how healthcare is delivered from a cost/management perspective.
From the clinical practice and technology side, there will be enormous changes to healthcare. Here are examples of what I see from tracking trends in clinical practice and medical technology development:
- Cancer 5 year survival rates will, for many cancers, be well over 90%. Cancer will largely be transformed in most cases to chronic disease that can be effectively managed by surgery, immunology, chemotherapy and other interventions. Cancer and genomics, in particular, has been a lucrative study (see The Cancer Genome Atlas). Immunotherapy developments are also expected to be part of many oncology solutions. Cancer has been a tenacious foe, and remains one we will be fighting for a long time, but the fight will have changed from virtually incapacitating the patient to following protocols that keep cancer in check, if not cure/prevent it.
- Diabetes Type 1 (juvenile onset) will be managed in most patients by an “artificial pancreas”, a closed loop glucometer and insulin pump that will self-regulate blood glucose levels. OR, stem cell or other cell therapies may well achieve success in restoring normal insulin production and glucose metabolism in Type 1 patients. The odds are better that a practical, affordable artificial pancreas will developed than stem or other cell therapy, but both technologies are moving aggressively and will gain dramatic successes within 20 years.
Developments in the field of the “artificial pancreas” have recently gathered considerable pace, such that, by 2035, type 1 blood glucose management may be no more onerous than a house thermostat due to the sophistication and ease-of-use made possible with the closed loop, biofeedback capabilities of the integrated glucometer, insulin pump and the algorithms that drive it, but that will not be the end of the development of better options for type 1 diabetics. Cell therapy for type 1 diabetes, which may be readily achieved by one or more of a wide variety of cellular approaches and product forms (including cell/device hybrids) may well have progressed by 2035 to become another viable alternative for type 1 diabetics.
- Diabetes Type 2 (adult onset) will be a significant problem governed by different dynamics than Type 1. A large body of evidence will exist that shows dramatically reduced incidence of Type 2 associated with obesity management (gastric bypass, satiety drugs, etc.) that will mitigate the growing prevalence of Type 2, but research into pharmacologic or other therapies may at best achieve only modest advances. The problem will reside in the complexity of different Type 2 manifestation, the late onset of the condition in patients who are resistant to the necessary changes in lifestyle and the global epidemic that will challenge dissemination of new technologies and clinical practices to third world populations.
Despite increasing levels of attention being raised to the burden of type 2 worldwide, including all its sequellae (vascular, retinal, kidney and other diseases), the pace of growth globally in type 2 is still such that it will represent a problem and target for pharma, biotech, medical device, and other disciplines.
- Cell therapy and tissue engineering will offer an enormous number of solutions for conditions currently treated inadequately, if at all. Below is an illustration of the range of applications currently available or in development, a list that will expand (along with successes in each) over the next 20 years.
Cell therapy will have deeply penetrated virtually every medical specialty by 2035. Most advanced will be those that target less complex tissues: bone, muscle, skin, and select internal organ tissues (e.g., bioengineered bladder, others). However, development will have also followed the money. Currently, development and use of conventional technologies in areas like cardiology, vascular, and neurology entails high expenditure that creates enormous investment incentive that will drive steady development of cell therapy and tissue engineering over the next 20 years, with the goal of better, long-term and/or less costly solutions.
- Gene therapy will be an option for a majority of genetically-based diseases (especially inherited diseases) and will offer clinical options for non-inherited conditions. Advances in the analysis of inheritance and expression of genes will also enable advanced interventions to either ameliorate or actually preempt the onset of genetic disease.
As the human genome is the engineering plans for the human body, it is a potential mother lode for the future of medicine, but it remains a complex set of plans to elucidate and exploit for the development of therapies. While genetically-based diseases may readily be addressed by gene therapies in 2035, the host of other diseases that do not have obvious genetic components will resist giving up easy gene therapy solutions. Then again, within 20 years a number of reasonable advances in understanding and intervention could open the gate to widespread “gene therapy” (in some sense) for a breadth of diseases and conditions –> Case in point, the recent emergence of the gene-editing technology, CRISPR, has set the stage for practical applications to correct genetically-based conditions.
- Drug development will be dramatically more sophisticated, reducing the development time and cost while resulting in drugs that are far more clinically effective (and less prone to side effects). This arises from drug candidates being evaluated via distributed processing systems (or quantum computer systems) that can predict efficacy and side effect without need of expensive and exhaustive animal or human testing.The development of effective drugs will have been accelerated by both modeling systems and increases in our understanding of disease and trauma, including pharmacogenomics to predict drug response. It may not as readily follow that the costs will be reduced, something that may only happen as a result of policy decisions.
- Most surgical procedures will achieve the ability to be virtually non-invasive. Natural orifice transluminal endoscopic surgery (NOTES) will enable highly sophisticated surgery without ever making an abdominal or other (external) incision. Technologies like “gamma knife” and similar will have the ability to destroy tumors or ablate pathological tissue via completely external, energy-based systems.
By 2035, technologies such as these will measurably reduce inpatient stays, on a per capita basis, since a significant reason for overnight stays is the trauma requiring recovery, and eliminating trauma is a major goal and advantage of minimally invasive technologies (e.g., especially the NOTES technology platform). A wide range of other technologies (e.g., gamma knife, minimally invasive surgery/intervention, etc.) across multiple categories (device, biotech, pharma) will also have emerged and succeeded in the market by producing therapeutic benefit while minimizing or eliminating collateral damage.
Information technology will radically improve patient management. Very sophisticated electronic patient records will dramatically improve patient care via reduction of contraindications, predictive systems to proactively manage disease and disease risk, and greatly improve the decision-making of physicians tasked with diagnosing and treating patients.There are few technical hurdles to the advancement of information technology in medicine, but even in 2035, infotech is very likely to still be facing real hurdles in its use as a result of the reluctance in healthcare to give up legacy systems and the inertia against change, despite the benefits.
- Personalized medicine. Perfect matches between a condition and its treatment are the goal of personalized medicine, since patient-to-patient variation can reduce the efficacy of off-the-shelf treatment. The thinking behind gender-specific joint replacement has led to custom-printed 3D implants. The use of personalized medicine will also be manifested by testing to reveal potential emerging diseases or conditions, whose symptoms may be ameliorated or prevented by intervention before onset.
- Systems biology will underlie the biology of most future medical advances in the next 20 years. Systems biology is a discipline focused on an integrated understanding of cell biology, physiology, genetics, chemistry, and a wide range of other individual medical and scientific disciplines. It represents an implicit recognition of an organism as an embodiment of multiple, interdependent organ systems and its processes, such that both pathology and wellness are understood from the perspective of the sum total of both the problem and the impact of possible solutions.This orientation will be intrinsic to the development of medical technologies, and will increasingly be represented by clinical trials that throw a much wider and longer-term net around relevant data, staff expertise encompassing more medical/scientific disciplines, and unforeseen solutions that present themselves as a result of this approach.Other technologies being developed aggressively now will have an impact over the next twenty years, including medical/surgical robots (or even biobots), neurotechnologies to diagnose, monitor, and treat a wide range of conditions (e.g., spinal cord injury, Alzheimer’s, Parkinson’s etc.).
The breadth and depth of advances in medicine over the next 20 years will be extraordinary, since many doors have been recently opened as a result of advances in genetics, cell biology, materials science, systems biology and others — with the collective advances further stimulating both learning and new product development.
See the 2016 report #290, “Worldwide Markets for Medical and Surgical Sealants, Glues, and Hemostats, 2015-2022.”
Medtech fundings for June 2016 stand at $607 million, led by the $172.5 million post-IPO sale of Nevro’s convertible notes, the $75 million IPO (to happen in June) of OrthoPediatrics, and the $50 million funding of Clearside Biomedical.
Below are fundings for the month, thus far. Please revisit this post (and refresh your browser) for updates by month-end.
For a complete list of fundings during June 2016.
Worldwide, an enormous number of wounds are driving a $15 billion market that will soon pass $20 billion. What is driving wound sales is the continued growth and prevalence of different wound types targeted by medical technologies ranging from bandages to bioengineered skin, physical systems like negative pressure wound therapy, biological growth factors, and others.
Most attention in wound management is focused on improving conventional wound healing in difficult clinical situations, especially for chronic wounds, in the expansion of wound management technologies to global markets, and in the application of advanced technologies to improve healing of acute wounds, especially surgical wounds.
Global Prevalence of Wound Types, 2015
Total Wound Care Market as Percent of Entire Market, 2024
The content of this post is drawn from the complete Report #S251, “Worldwide Wound Management, Forecast to 2024: Established and Emerging Products, Technologies and Markets in the Americas, Europe, Asia/Pacific and Rest of World”. For separate coverage of sealants, glues, and hemostats in wound management, see Report #S290.
The World Market for Wound Management Report encompasses twelve product segments:
- Traditional Adhesive Dressings
- Traditional Gauze Dressings
- Traditional Non-Adherent Dressings
- Film Dressings
- Foam Dressings
- Hydrogel Dressings
- Hydrocolloid Dressings
- Alginate Dressings
- Antimicrobial Dressings
- Negative Pressure Wound Therapy Devices
- Bioengineered Skin & Skin Substitutes
- Wound Care Growth Factors
The report examines North and South America, the European Union, Asia/Pacific and Rest of World, and looks at markets and growth rates by product and country for the years 2014-2024. The world market in 2024 for the total wound management market represented by the segments listed above is projected to be worth over $22 billion, with segments growing at widely variable rates, with lowest sales growth in traditional adhesive bandages and the highest sales growth in bioengineered skin and skin substitutes
Source: MedMarket Diligence, LLC; Report #S251.
Below are representative examples of each type of wound management product.
|Dressing category||Product examples||Description||Potential applications|
|Film||Hydrofilm, Release, Tegaderm, Bioclusive||Comes as adhesive, thin transparent polyurethane film, and as a dressing with a low adherent pad attached to the film.||Clean, dry wounds, minimal exudate; also used to cover and secure underlying absorptive dressing, and on hard-to-bandage locations, such as heel.|
|Polyurethane foam dressing available in sheets or in cavity filling shapes. Some foam dressing have a semipermeable, waterproof layer as the outer layer of the dressing||Facilitates a moist wound environment for healing. Used to clean granulating wounds which have minimal exudate.|
|Hydrogel||Hydrosorb Gel Sheet, Purilon, Aquasorb, DuoDerm, Intrasite Gel, Granugel||Colloids which consist of polymers that expand in water. Available in gels, sheets, hydrogel-impregnated dressings.||Provides moist wound environment for cell migration, reduces pain, helps to rehydrate eschar. Used on dry, sloughy or necrotic wounds.|
|Hydrocolloid||CombiDERM, Hydrocoll, Comfeel, DuoDerm CGF Extra Thin, Granuflex, Tegasorb, Nu-Derm||Made of hydroactive or hydrophilic particles attached to a hydrophobic polymer. The hydrophilic particles absorb moisture from the wound, convert it to a gel at the interface with the wound. Conforms to wound surface; waterproof and bacteria proof.||Gel formation at wound interface provides moist wound environment. Dry necrotic wounds, or for wounds with minimal exudate. Also used for granulating wounds.|
|Alginate||AlgiSite, Sorbalgon Curasorb, Kaltogel, Kaltostat, SeaSorb, Tegagel||A natural polysaccharide derived from seaweed; available in a range of sizes, as well as in ribbons and ropes.||Because highly absorbent, used for wounds with copious exudate. Can be used in rope form for packing exudative wound cavities or sinus tracts.|
|Both silver and honey are used as antimicrobial elements in dressings.||Silver: Requires wound to be moderately exudative to activate the silver, in order to be effective|
Renasys (not in USA)
Prospera PRO series
|Computerized vacuum device applies continuous or intermittent negative or sub-atmospheric pressure to the wound surface. NPWT accelerates wound healing, reduces time to wound closure. Comes in both stationary and portable versions.||May be used for traumatic acute wound, open amputations, open abdomen, etc. Seems to increase burn wound perfusion. Also used in management of DFUs. Contraindicated for arterial insufficiency ulcers. Not to be used if necrotic tissue is present in over 30% of the wound.|
|Bioengineered Skin and Skin Substitutes||AlloDerm, AlloMax, FlexHD, DermACELL, DermaMatrix, DermaPure, Graftjacket Regenerative Tissue Matrix, PriMatrix, SurgiMend PRS, Strattice Reconstructive Tissue Matrix, Permacol, EpiFix, OASIS Wound Matrix, Apligraf, Dermagraft, Integra Dermal Regeneration Template, TransCyte||Bio-engineered skin and soft tissue substitutes may be derived from human tissue (autologous or allogeneic), xenographic, synthetic materials, or a composite of these materials.||Burns, trauma wounds, DFUs, VLUs, pressure ulcers, postsurgical breast reconstruction, bullous diseases|
Source: MedMarket Diligence, LLC; Report #S251.
There are some market restraints at work, primarily the high cost of the new technologies. Not all country healthcare budgets can afford advanced wound care products, even if they are proven to decrease healing times and hospital costs over the longer run. The development of substitute products threatens existing product categories, while a lack of sufficient clinical and economic evidence backing new technology hinders growth and acceptance of some of the more advanced wound management technologies.
In addition, improved wound prevention and a lack of regulation on tissue engineering in the EU are also expected to hold back the development of new technologies. In addition to market restraints, there are a number of drivers that are expected to shape this market in the years to come. One of the primary drivers is the aging of the global population. Chronic diseases, such as circulatory conditions, anemias and autoimmune diseases influence the healing process as a result of their influence on a number of bodily functions. Illnesses that cause the most significant problems include diabetes, chronic obstructive pulmonary disease (COPD), arteriosclerosis, peripheral vascular disease (PVD), heart disease, and any conditions leading to hypotension, hypovolemia, edema, and anemia. While chronic diseases are more frequent in the elderly, wound healing will be delayed in any patient with underlying illness. Happily, most wounds heal without any problems. However, chronic wounds may take months or years to fully close, or may never close. Chronic wounds adversely affect the individual’s quality of life, and are a leading cause of burgeoning healthcare costs. Type 2 diabetes represents 85-95% of all diabetes in developed countries, and accounts for an even higher percentage in developing countries. There were 26 million diabetic patients in the US in 2012 and 285 million patients globally. Of these patients, approximately 15% will develop a diabetic foot ulcer and 50% of these will become infected, representing an estimated 2 million patients. Diabetic foot infections are currently treated with systemic antibiotics, but the estimated failure rate of antibiotics for diabetic foot ulcers is in excess of 22%. A patient with diabetes is at significant risk of damage to tissues caused by impaired homeostasis due to the disease process. For example there is a tendency for such tissues to develop blockages in smaller blood vessels, which reduces the ability of these vessels to provide sufficient oxygen to tissues already under stress due to compromised nutrient supply and the diabetic condition. These patients then develop arterial ulcers. They may also have a tendency to suffer from venous ulcers, due to the underlying poor condition of cells as a result of the diabetes. The diabetic foot is the most common cause of non-traumatic lower extremity amputations in the US and Europe: there is an average of 82,000 amputations per year in the U.S., costing an estimated $1.6 billion annually. The estimated cost of foot ulcer care in the U.S. ranges from $4,595 per ulcer episode to more than $28,000 and the total annual cost of foot ulcer care in the US has been estimated to be as high as $5 billion.
Pressure, or decubitus, ulcers are another of the most common types of chronic wounds. The treatment of pressure ulcers places a major burden on healthcare systems worldwide, with an emerging additional cost of litigation increasing in importance over recent years. Healthcare practitioners need to be aware of both the direct and indirect costs and consider how the implementation of prevention protocols may offer cost savings in the longer term. The cost of a dressing for example as a prevention tool is minimal in comparison to the costs of treating an established pressure ulcer. Following are a few hard numbers on the true financial cost of pressure ulceration:
- The estimated cost to the US hospital sector is $11 billion per annum
- The estimated cost to the UK national health service is estimated at £1.4-£2.1 billion annually (4% of total NHS expenditure)
- Lawsuits remain common in both acute and long term care — with high payments in certain cases
- The average cost to treat an individual with an unstageable ulcer or a deep tissue injury is estimated to be $43,180
- The average length of stay in hospital is almost three times longer for chronic wounds
- The mean hospital cost for management of pressure ulcers in the U.S. is $14,426. In comparison, the same cost in Korea is identified as $3,000-$7,000.
The cost of treating chronic wounds is one element driving the development and utilization of advanced wound care technologies. Other drivers are the aging of the population, and the obesity epidemic, which is expected to produce a wave of diabetics in the years to come.
Source: Report #S251.
Whether sales growth arises by a preferred adoption of one technology over another or by better than average economic conditions — or both, sales of wound management products are driven by technology adoption rates that vary by country, clinical practice patterns, reimbursement and other variables.
We assessed current and forecast sales for the following products:
- Trad’l Adhesive Dressings
- Trad’l Gauze
- Trad’l Non-Adherent
- Negative Pressure Wound Therapy
- Bioengineered Skin & Skin Substitutes
- Growth Factors
For all product segments but the traditional adhesive, gauze, and non-adherent wound care products (which were assessed only at the global level), we assessed growth in each of the following countries/regions: Americas (USA, Rest of North America, Latin America), Europe (United Kingdom, Germany, Italy, France, Spain, Rest of Europe), Asia/Pacific (Japan, Korea, Rest of Asia/Pacific), and Rest of World.
From our examination (report #S251) of the global market for wound management products, below are the top product-country cohorts in terms of projected compounded sales growth from 2015 to 2024.
There are literally many hundreds—perhaps thousands—of companies in wound care, ranging from tiny companies operating with a couple of employees in a developing country, to large-cap market leaders with thousands of employees located in offices around the world.
The following exhibit shows that a handful of companies account for a large part of the global advanced wound care market. Acelity LP, Inc., which is a merger of Kinetic Concepts, Inc. (KCI), Systagenix, Inc. and LifeCell, is now one of the leaders in this market, and accounts for about 20% of wound care revenues. Acelity is followed by Smith & Nephew plc, which is followed by several other companies with 13% or less of the market. The hundreds of other companies fall into the 20% of “Other”. In summary, about seven companies account for approximately 80% of the advanced wound care market worldwide.
Source: MedMarket Diligence, LLC; Report #S251.
Bioengineered skin, skin substitutes, foam dressings, hydrocolloids, and growth factors are among top growth segments in a global market for advanced wound management that is otherwise modest in growth, but high in volume.
The 2016 global wound management market will hit nearly $15 billion. With sales growing at just better than 5% annually on population growth, migration of technologies to developing markets, and increased per capita utilization, the aggregate market is stably tied to persistent caseload. This regular, high volume of wound product sales supports a steady stream of innovation intended to gain even the smallest edge in share, an advantage that gains its value in real terms from the multiple of such a large global caseload.
In a market in which autografts and allografts have long been common, the development of cost-effective and safe bioengineered skin and skin substitutes is finding ready adoption in wounds of all types, but particularly burn wounds.
Due to their small base of existing sales thus far, even incremental expansion of sales in the use of biological growth factors in wound management reflects high growth through the forecast period.
Biotech need not be behind the higher growth in wound management technologies. Excellent growth prospects are also seen in foams, hydrogels, hydrocolloids, and other dressing materials.
Physical systems, including negative pressure wound devices, are not demonstrating growth prospects as good as traditional wound dressing products, let alone advanced wound products.
In short, the large global market is stable and growing at best modestly, but within this market, advanced wound management technologies’ sales are accelerating at the expense of traditional wound products. Growth in wound management is clearly coming from within.
Advanced Wound Care Sales, 2014 & 2024
Source: MedMarket Diligence, LLC; Report #S251.