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.

Wound management: Novel technologies, high growth, high volume, MANY companies

Wound management technologies span an incredible spectrum of technologies — bandages, tapes, dressings (bioactive, antimicrobial, non-adherent…), sutures, staples, bioengineered skin & substitutes, negative pressure, ultrasound, pulsed electromagnetic therapy, growth factors, gene therapy…

Wound management is an old medical practice, and wounds have not changed in nature other than the mix prevalence of different wound types. Yet, the volume of all wounds, and the need to improve they may be managed, support development of many new technology and changes in clinical practice. In turn, this drives and sustains an unusually large number of competitors.

Source: MedMarket Diligence, LLC; Report #S251.

 

Below is a list, drawn from the forthcoming December 2015 report (#S251) from MedMarket Diligence global wound management market, of companies that are sufficiently large or active or noteworthy for us to have specifically profiled in our report. The true number of companies in wound (and detailed but not “profiled” in our report) is in the hundreds.

3M Health Care, ACell, Acelity L.P. Inc., AcryMed Inc., Agennix Incorporated, AGT Sciences Ltd, Alliqua Biomedical, AlloSource, Altrika Ltd, Amniox Medical, Inc., Anika Therapeutics, Argentum Medical, Avita Medical, B. Braun Melsungen AG, Biopharm GmbH, Biotime, Inc., Bio-Tissue, Inc., BSN medical, Cardium Therapeutics, CliniMed Limited, Coloplast Group, Covalon Technologies, Ltd., ConvaTec Inc., Cook Biotech, Inc., Covidien, Cytogenix, Cytomedix, Derma Sciences, Inc., DeRoyal Industries Inc., Devon Medical, Diapulse Corporation of America, Eqalix, Inc., E-QURE Corporation, Euroderm AG, Gentell Inc, Geritrex Corp., Hartmann Group, Hollister Incorporated, Imbed Biosciences, Inc., Integra LifeSciences, Inc., Kendall (Covidien), Kinetic Concepts, Inc. (KCI), Kuros Biosurgery AG, Laboratoires URGO, LifeCell Corporation, Lohmann & Rauscher International GmbH and Co. KG, Macrocure, Medline Industries, Microban International Ltd., MicroVas Technologies, Inc, MiMedx, Mölnlycke Health Care AB, NovaBay Pharmaceuticals, Oculus Innovative Sciences, Organogenesis Inc, Osiris Therapeutics, Perry Baromedical, Prospera, ReliaMed, RXi Pharmaceuticals, SafeBlood Technologies, Sanofi Biosurgery (formerly Genzyme Biosurgery), SANUWAVE Health, Inc., Shire Regenerative Medicine, Smith & Nephew plc, Sorbion GmbH & Co., KG, Soluble Solutions, LLC, Spiracur, Inc., Systagenix Wound Management (US), Inc., TEI Biosciences, Tissue Regeneration Technologies, LLC, Tissue Regenix Group plc., UDL Laboratories, Uluru, Inc., ViroMed Co., Ltd., Vomaris Innovations, Inc., Wound Management Technologies, Inc.

The 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” (see link for details), provides a current and forecast assessment (to 2024) of the worldwide market for wound management.

 

European market share analysis, interbody fusion devices, 2014

Screen Shot 2015-11-23 at 11.01.03 AM

Source: MedMarket Diligence, LLC; “Global Market for Medical Device Technologies in Spine Surgery, 2014-2021: Established and Emerging Products, Technologies and Markets in the Americas, Europe, Asia/Pacific and Rest of World” (Report #M540).

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.

 

White Paper: Lasers and electrosurgery sees sales grow by $96 million and $199 million respectively

Ablation is not a new technology, nor is it a recent addition to the tools available to clinicians (electrosurgery dates back a hundred years or more), but is still evolving in both the practice of medicine and surgery and the medtech industry. New technology developments, changes in clinical practice and growth and migration of the technologies globally are characteristics of ablation as a worldwide market with significant change and opportunity.

New ablation technologies have arisen at different times over the past 50 years, accentuated by the emergence of sophisticated instrumentation and devices designed to very precisely apply their inherent energy toward specific clinical applications. This has been and will continue to be a pattern in the ablation market, as manufacturers develop new instruments and methods to refine the delivery of ablation toward specific clinical applications. Consequently, revenues will continue to shift from one modality to another in the pursuit of improved clinical outcomes.

Download a White Paper on tissue ablation at link.

See “The Future of Tissue Ablation Products to 2020″ at link.

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.”

Medtech Startups, 2010-2015

From 2010 to present (Oct 2015), as included in the Medtech Startups Database, MedMarket Diligence identified 442 new (under one year old) medical technology startups whose businesses encompass, alone or in combination, medical devices, diagnostics, biomaterials, and the subset of both biotech and pharma that is in direct competition with medical devices, including tissue engineering and cell therapy. Of these, 74% were founded in the U.S., 5% were founded in Israel, and the rest were founded in 18 other countries.

Companies in the database have been categorized by clinical and/or technology area of focus, with multiple categories possible (e.g., minimally invasive and orthomusculoskeletal and surgery). Below is the composition of the companies identified from Jan. 2010 to Oct. 2015.

Screen Shot 2015-10-06 at 4.50.10 PM

Source: Medtech Startups Database

Below is a graphic on the companies by country. The U.S. (not shown) led with 327 companies.

Screen Shot 2015-10-06 at 4.17.30 PM

Source: Medtech Startups Database

In the U.S., the breakdown by state, other than California and its 466 companies (excluded only to show states with significantly lower numbers), is as follows:

Screen Shot 2015-10-06 at 5.13.08 PM

Source: Medtech Startups Database

 

Wound Sealing and Closure Markets by Country: Germany and United Kingdom

(Note: See the August 2016 Report #S290.)


Population differences represent a major difference between countries in the relative demand for medical products, but there remain many other differences in drivers and limiters of sales.

The markets for wound closure encompassing sutures & staples, vascular closure devices, surgical hemostats, surgical tapes, and surgical sealants & glues show distinct sensitivities country-by-country as a result of differences in:

  • Practice patterns
  • Cultural differences in perception of “wounds”
  • Reimbursement
  • Regulatory
  • Perception of new technology
  • Economics

For example, the two graphics below illustrate the wound closure markets in Germany and the United Kingdom. To have fully compared the markets in these two countries aside from differences in population, we might have presented per capita values in the sales, but even without doing so it is clear that relative sizes and growth rates in the two countries are sufficiently different to warrant attention in local efforts to market these products.

Screen Shot 2015-10-06 at 8.13.22 AM

Source: “Worldwide Surgical Sealants, Glues, and Wound Closure Markets, 2013-2018”, Report #S192; published by MedMarket Diligence, LLC. (Note: This report has been superceded by the August 2016 Report #S290.)

Cerebral Endovascular Embolization Cases, Procedures Growth

In 2014, endovascular embolization techniques were employed in approximately 90.5 thousand cerebral aneurysm and AVM repair procedures worldwide, of which aneurysm targeting interventions accounted for about 89.2%, with the rest contributed by AVMs hemoisolation.

During the forecast period, the total global volume of transcatheter neurovascular embolization procedures is projected to grow 4% per annum to an estimated 109.9 thousand interventions in the year 2019. The largest absolute and relative gains in cerebral embolization procedure volumes are expected in the largest Asian-Pacific states (mostly China) and the Rest-of-the-World, where low relative usage of endovascular techniques (30-35% versus 65-75% in the U.S. and Europe) will continue to support their increasing penetration of clinical practices and serve as the primary locomotive of growth in the corresponding global product market.

Largely mature U.S. and West European market geographies are likely to register considerably more modest advances in cerebral embolization procedure volumes.  Below is compared the growth rates to 2019 for cerebral endovascular embolization in the major Asia-Pacific countries (Japan, India, and China) to the same in Western Europe.

Screen Shot 2015-10-05 at 9.41.24 AM

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

 

Clinical procedure trends in the management of acute stroke

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).

Screen Shot 2015-10-04 at 3.11.46 PM
Source Report #C310

The 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.

At right are the key metrics in the management of acute stroke in the U.S., Western Europe, Asia/Pacific and the rest of the world, as detailed in the MedMarket Diligence report #C310.

Procedures in the management of acute stroke are detailed in the MedMarket Diligence report #C310, with current/forecast procedure volumes for carotid artery stenting, embolization of cerebral aneurysm & AVM, left atrial appendage closure, and cerebral thrombectomy.

Screen Shot 2015-10-04 at 3.20.41 PM

Source Report #C310