Peripheral Vascular Stenting to 2020

First introduced about two decades ago as a bailout technique for suboptimal or failed iliac angioplasty, peripheral vascular stenting gradually emerged as a valuable and versatile tool for a variety of primary and adjuvant applications within non-coronary vasculature.

Today, peripheral vascular stenting techniques are commonly employed in the management of the most prevalent occlusive circulatory disorders and other pathologies affecting abdominal and thoracic aortic tree and lower extremity arterial bed. Stents are also increasingly used in the management of the debilitating conditions like venous outflow obstruction associated with deep venous thrombosis and chronic venous insufficiency.

Peripheral vascular systems include lower extremity bare metal and drug-eluting stents for treatment of symptomatic PAD and critical limb ischemia resulting from iliac, femoropopliteal and infrapopliteal occlusive disease; stent-grafting devices used in endovascular repair of abdominal and thoracic aortic aneurysms; as well as a subset of indication-specific and multipurpose peripheral stents used in recanalization of iliofemoral and iliocaval occlusions resulting in CVI.

In 2015, these peripheral stenting systems were employed in ovet 1.5 million revascularization procedures worldwide, of which lower extremity arterial stenting accounted for 81% of such interventions, followed by abdominal aortic aneurysm and thoracic aortic aneurym endovascular repairs.

Clinicians in the U.S. performed 34.1% of worldwide covered peripheral arterial and venous procedures,  followed by the major Western European countries (33.1%), major Asian-Pacific states (24.4%), and the rest-of-the-world with 8.4% of peripheral stent-based interventions.

During the forecast period, the global volume of peripheral arterial and venous stenting procedures is projected to grow an average of 5.5% and 6.2% per annum, generating over $4,620 million in cumulative product revenues in the year 2020.

The largest relative and absolute dollar gains in all covered product segments can be expected in Asian-Pacific market geography based on rapid transition to modern interventional radiology practices and availability of funding in China. Similar, but somewhat slower growth trends might be observes in the ROW zone, albeit from a much lower base.

Highly mature U.S. and Western European markets are likely to register relatively modest advances both in corresponding procedure volumes and device sales.

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Source: MedMarket Diligence, LLC; Report #V201, “Global Market Opportunities in Peripheral Arterial and Vascular Stents, Forecast to 2020” publishing February 2016).

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Source: MedMarket Diligence, LLC; Report #V201

 

Forecasts for neurointerventions in acute stroke

Over the past two decades, one could witness the advent and significant expansion of the neurointerventional armamentarium targeting management of acute stroke. In mid-1990s, endovascular coiling embolization tools and techniques for treatment of cerebral aneurysms and AVMs (arterio-venous malformations) were introduced as a less invasive alternative to craniotomy-based surgery in primary prevention of hemorrhagic stroke. Several years later, these techniques were supplemented with coil-containing stents, which enabled treatment of large, giant, and wide-neck aneurysms. The latter was followed by the launch of stent-based flow diversion systems, which allowed clinicians to hemoisolate such aneurysms without tedious and risky coil packing of the rupture-prone aneurysmal sac.

In primary ischemic stroke prevention, development of embolically-protected carotid stenting and left atrial appendage closure techniques provided clinicians with an option of using non-inferior transcatheter tools instead of customary surgical interventions.

Finally, a recent launch of the novel stent-based cerebral thrombectomy systems manifested a qualitative breakthrough in emergent treatment of acute cerebral ischemia, where marginally effective and severely caseloads restrictive intravenous tPA therapy represented the only available therapeutic option.

Presently, endovascular techniques are increasingly seen and used by practicing clinicians as preferred therapeutic modalities in prophylaxis and treatment of acute stroke and are likely to expand their role in the years to come.

Based on the industry reporting and other estimates, in 2014, approximately 227.3 thousand cerebral endovascular therapeutic procedures were performed worldwide. Prophylaxis of ischemic stroke via carotid artery stenting and left atrial appendage (LAA) closure with contributed 91.2 thousand and 11.9 thousand interventions (or 40.1% and 5.2%, accordingly), followed by transcatheter embolization of intracranial aneurysm and AVM for hemorrhagic stroke prevention with 90.5 thousand interventions (or 39.8%), and cerebral thrombectomy-based emergent treatment of acute cerebral ischemia with 33.7 procedures (or 14.8% of the total).

Geographically, Western Europe and the U.S. accounted for the largest shares of corresponding cerebrovascular interventions in 2014, with 35.7% and 35.0%, accordingly, followed by major APAC states with 19% and rest-of-the-world with the remaining 10.3% of the total procedures performed.

Source: MedMarket Diligence, LLC; Report #C310.

 

Spine Surgery is Led By the U.S. and Thoracolumbar Fusion

From, “Global Market For Medical Device Technologies in Spine Surgery, 2014-2021”, Report #M540.

Spine surgery remains a uniquely American pastime, based at least on sales of technologies including spinal fusion, minimally invasive spine surgical technologies, and orthobiologics used for spine.

The patient demand and associated utilization rates, prices, reimbursement and other drivers make the U.S. an even bigger than it is in most medtech markets. And globally, as well as in the U.S., thoracolumbar fusion drives the most sales.

 


 

From, “Global Market For Medical Device Technologies in Spine Surgery, 2014-2021”, Report #M540.

Global Wound Management Market: Segment Size, Growth to 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 categoryProduct examplesDescriptionPotential applications
FilmHydrofilm, Release, Tegaderm, BioclusiveComes 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.
FoamPermaFoam
PolyMem
Biatain
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 dressingFacilitates a moist wound environment for healing. Used to clean granulating wounds which have minimal exudate.
HydrogelHydrosorb Gel Sheet, Purilon, Aquasorb, DuoDerm, Intrasite Gel, GranugelColloids 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.
HydrocolloidCombiDERM, Hydrocoll, Comfeel, DuoDerm CGF Extra Thin, Granuflex, Tegasorb, Nu-DermMade 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.
AlginateAlgiSite, Sorbalgon Curasorb, Kaltogel, Kaltostat, SeaSorb, TegagelA 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.
AntimicrobialBiatain Ag
Atrauman Ag
MediHoney
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
NPWDSNa
V.A.C. Ulta
PICO
Renasys (not in USA)
Prospera PRO series
Invia Liberty
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 SubstitutesAlloDerm, 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, TransCyteBio-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.

 

Top Growth Wound Care Product Sales By Country

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:

  • Traditional Adhesive Dressings
  • Traditional Gauze
  • Traditional Non-Adherent
  • Film
  • Foam
  • Hydrogel
  • Hydrocolloid
  • Alginate
  • Antimicrobial
  • 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.

Source: MedMarket Diligence, LLC; Report #S251.

 

Leaders in the global wound management market

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.

 

Global wound market highlights

Highlights from the 2015 MedMarket Diligence 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” —

Wound management is a large global market (almost $15 billion currently) driven by high and sustained volume of traumatic, surgical, and other chronic and acute wound types. Simple wound dressings with little technology development continue to more than adequately serve a large swath of wound caseload and will continue to generate 1-2% in annual growth through 2024.

However, while a great deal of wound management products provide unsophisticated but effective wound care — and this is particularly why these products sell much better outside well developed western markets — the growing cost of wounds that do not heal fast enough, or at all, has been compounded by changes in wound incidence arising from increased obesity, the aging population, and other forces, creating demand for more sophisticated wound solutions. Enter the array of advanced wound care products like innovative wound dressing materials and components, bioengineered skin and other skin substitutes, biological wound growth factors, and others. These products have been projected to grow at an annual rate of up to 16% annually. The result is a steady erosion of the share of the global market represented by simple dressings and bandages.

 

Source: MedMarket Diligence, LLC; Report #S251

Wound Care Technologies: Sales Growth, Change, Global Forecast

MedMarket Diligence is hours away from publishing its 2015 report on the worldwide wound management market.

The report is entitled, “Worldwide Wound Management, Forecast to 2024: Established and Emerging Products, Technologies and Markets in the Americas, Europe, Asia/Pacific and Rest of World”. The report is described in detail at link.

The very diverse field that is wound management encompasses technologies from gauze to bioengineered skin and skin substitutes and many in between. Growth rates range from flat to over 15% annually through 2024.

Source: MedMarket Diligence, LLC; Report #S251.

The highest growth segments in medical technology sectors typically derive their high growth from modest absolute changes on very small volume and therefore rarely can sustain that growth over time. However, in wound management, the use of bioengineered skin and skin substitutes will result in the highest cumulative sales compared to all segments from 2015 to 2024 — excluding, that is, the high volume segments of traditional adhesives, gauzes, and non-adherent dressings.  Also noteworthy is the second highest cumulative sales over this period was for antimicrobial dressings, despite this segment having relatively modest growth on a percentage basis, but proceeding from significant sales in 2015 (already at over $1.5 billion).

Source: MedMarket Diligence, LLC; Report #S251.

During the forecast period, the most significant change evident in sales is the jump in the share of the market represented by bioengineered and other skin replacements, as noted above. But with compound annual growth rates (to 2024) in sales in the different wound segments ranging from near 1% to nearly 20% — for segments with 2015 sales at a low of $300 million and a high of $15 billion — there is considerable shifting of shares of the global wound market.

Source: MedMarket Diligence, LLC; Report #S251.

On a geographic basis, wound care technology migration, efforts to secure underserved patient caseload, and other forces result in growth rates that vary by country or region. The well-developed USA market therefore does not compare in uptake of both old and new technologies within growth markets like China and others in the Asia/Pacific region.

Source: MedMarket Diligence, LLC; Report #S251.

Growth in Treatment of Acute Stroke

Drawn from Report #C310, “Emerging Global Market for Neurointerventional Technologies in Stroke, 2014-2019”, published by MedMarket Diligence, LLC.

Therapeutic management of stroke encompasses a broad scope of prophylactic, palliative and curative treatment modalities that are typically employed in some combinations during the preventive, acute and rehabilitation phases of stroke-related care delivery.

Historically, prevention has been universally regarded as the best form of medicine for dealing with any disease. This old wisdom is especially true in management of acute stroke, which represents a catastrophic event with a largely predetermined clinical progression and outcome that stem from the patient’s preexisting pathologies and can be only marginally altered with available emergent therapies.

The commonly accepted, current strategy of primary and secondary stroke prevention is focused on elimination or remedying of the modifiable risk factors that have been shown to create a general predisposition or directly contribute to the onset of acute cerebral ischemia or/and hemorrhage.

Within the context of general population, this strategy is targeting alleviation of certain lifestyle risk factors (such as smoking, obesity, physical inactivity, excessive alcohol consumption, drug abuse, high-fat diet etc.), which could contribute to the development of cardiovascular and other pathologies associated with increased propensity to stroke.

In patient caseloads with preexisting medical conditions (AFib, mechanical prosthetic valves, recent AMI, stoke or TIA, hypertension, diabetes, etc.) which are characterized by a high risk of adverse vascular events potentially leading to stroke, preventive strategy is focused on reducing such risks via a strict control and monitoring of corresponding hemostatic and hemodynamic parameters.

Finally, in persons with diagnosed cerebrovascular pathologies (high grade carotid stenosis, intracranial aneurysms and AVMs) the first line preventive therapy involves their repair or eradication, when technically possible.

The scope of FDA-approved medical and interventional modalities commonly employed in preventive management of stroke includes oral anticoagulation, antiplatelet, and lipid-lowering drug therapies, cerebral aneurysm and AVM repair surgery, carotid endarterectomy, stereotactic radiosurgery, as well as endovascular embolization of intracranial aneurysms and AVMs, carotid artery stenting with embolic protection, left atrial appendage closure, along with  rarely used and likely to be abandoned intracranial stenting.

In contrast to causes-oriented therapies used in stroke prevention, therapeutic modalities employed in the emergent management of acute stroke are focused almost exclusively on patients’ cardiopulmonary and hemodynamic support and ad hoc containment of dangerous complications and corresponding brain damage associated with stroke.

Among the life-threatening complications that commonly accompany acute cerebral hemorrhage or ischemia are cerebral edema; hydrocephalus; brain stem compression; vasospasm and pulmonary embolism.

Management of the aforementioned acute complications relies on a few proven treatment regimens, including (but not limited to):

  • medical therapy and catheter-based ventricular drainage of cerebrospinal fluid to control intracerebral pressure in patients at risk of edema, hydrocephalus or brain stem compression;
  • hypertensive hypervolemic hemodilution (or “triple-H” therapy) to treat ischemic neurological deficit from vasospasm following subarachnoid hemorrhage;
  • subcutaneous anticoagulation (with heparins or heparinoids) for prophylaxis of pulmonary embolism (which accounts for approximately 10% of deaths following stroke); and
  • elective hypothermia for temporary salvaging brain cells from necrosis due to hemorrhagic trauma or acute ischemia (although the latter technique has not been proven efficacious in clinical trials and was not endorsed in the latest, 2007 versions of the AHA hemorrhagic and ischemic stroke guidelines).

The currently available curative treatment options for acute stroke are limited to intravenous t-PA therapy (which has about 30% efficacy and is indicated for a very narrow cohort of eligible ischemic stroke patients only), investigational intra-arterial thrombolytic therapy, transcatheter cerebral thrombectomy (in patients who did not qualify for or failed t-PA therapy), and emergency craniotomy-based or endoscopic removal of stroke-related hematoma (which carries a 50% to 80% risk of mortality and is reserved for rapidly deteriorating young patients with large lobar hemorrhages).

Rehabilitation phase of stroke management relies on general physiotherapeutic techniques commonly used in patients with various physical and neurological disabilities. Prophylactics of recurrent cerebrovascular events in stroke survivors employs medical and interventional regimens referred to in the overview of primary and secondary stroke prevention.


Drawn from Report #C310, “Emerging Global Market for Neurointerventional Technologies in Stroke, 2014-2019”, published by MedMarket Diligence, LLC.

 

Growth in Neurointevention Procedure Volumes for Acute Stroke Treatment

The largest (39.8%) share of 2015 global therapeutic neurointerventional device revenues was generated in the U.S. market, followed by Western European marketplace with 32.3%, APAC markets with 18.5%, and the rest-of-the-world market segment with the remaining 9.4% of the global stroke-related neurointerventional system business.

During the forecast period, the overall worldwide volume of novel peripheral interventional and neurointerventional procedures and corresponding product sales are projected to experience a healthy growth expanding an average of 6.3% and 5.3% accordingly to over 308 thousand total interventions and $1,773.2 million in cumulative device revenues in the year 2019.

The largest absolute gains in the market can be expected in the biggest and most mature endovascular embolization system segment which is forecast to expand by $165 million to approximately $1,017 million in the year 2019.

The fastest relative advances are likely to occur in the smallest LAA closure and cerebral thrombectomy device segments which are expected to grow 16.3% and 10.1% to $121 million and $268.4 million in device revenues, respectively, in 2019.

Geography wise, underpenetrated APAC (particularly Chinese) marketplace is projected to register the fastest growth in stroke-related neuro-interventional market dollar volume, followed by the ROW market segment (albeit from a relatively low base), and highly mature U.S. and West European markets.

Source: MedMarket Diligence, LLC; Report #C310, “Emerging Global Market for Neurointerventional Technologies in Stroke, 2014-2019.”