Regional Markets for Surgical Sealants, 2015 and 2022

The fastest growth in the sales of surgical sealants over the next decade will be in the Asia-Pacific region, driven primarily by very strong healthcare market growth in China, and reaching a CAGR (2016-2022) of at least 13.97%. The growth rate in China would be even higher, but will be dampened for the time being by the lack of surgeons trained in the proper use of these products, as well as the limitations of reaching a dispersed patient population. Nonetheless, the A/P share of the global sealants market will double in the next seven years!

Below illustrates the geographic distribution of surgical sealants (fibrin and others) in 2015.

Regional Markets for Sealants, Fibrin and Other Sealant Products,
2015 & 2022, USD Millions

2015screen-shot-2016-11-11-at-8-52-44-am

2022

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Source: MedMarket Diligence, LLC; Report #S290.


Report #S290 may be purchased online for PDF download or print delivery; in single, site, or global licenses.

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.”

Global trends in spine surgery, 2015 to 2021

The global spine surgery market, which is largely stable in terms of technologies and the dominance of the U.S. market, will demonstrate the most significant change through 2021 through an increasing share of spine surgeries done minimally invasively and a noticeable shift of sales to OUS, especially to China, Japan, and India.

See the relative growth from 2015 to 2021 in the charts below (the proprietary data in axes values omitted, but the sales for North America and Asia-Pacific are presented on the same vertical scale for comparison purposes).

Source: MedMarket Diligence, LLC; Report #M540.

 

Growth in endovascular thrombectomy accelerating globally

First generation thrombectomy systems, despite their allure, have not fared well against standard medical (and tPA) therapy, since the endovascular retrieval of clots did not result in improved patient outcomes.

However, clinical trials of second generation systems and interviews with clinicians and industry support the common perception that the cumulative worldwide volume of cerebral thrombectomy procedures is projected to experience accelerated growth through 2019, resulting in an 10.8% overall average annual expansion of corresponding interventions in the to an estimated 56.2 thousand total procedures worldwide in 2019.

The fastest cerebral thrombectomy procedural gains (11.4% and 11.7% annually) are likely to be registered in major Asian state and the U.S., followed by largest Western European countries and rest of the world (9.9% and 7.8% annually).

See incidence of ischemic stroke and compound growth in thrombectomy in the major global markets.
Screen Shot 2015-10-19 at 9.06.29 AM

Source: MedMarket Diligence, LLC; Report #C310.

Screen Shot 2015-10-19 at 9.06.43 AM

Source: MedMarket Diligence, LLC; Report #C310.

Double-digit sales growth rates in spine surgery products

In many Western markets, spine surgery represents a mature market, with significant penetration of potential patients and caseload. Manufacturers have been able to produce innovations that have been able to command respectable premiums for a long time, and while they still represent some of the strongest growth rates in medical technology, overall revenue growth rates in spine surgery have been squeezed by procedure limitations and pressure on pricing.

Not so much the case in Asia/Pacific, Central/Latin America, and markets elsewhere in the world, where double digit spine surgery growth rates are the evident now, and will continue for the near future.

Below is illustrated the top growth (2014-2021) combinations of technologies and regional markets in spine surgery, in descending order.

Screen Shot 2015-10-06 at 11.10.30 AM

Source: MedMarket Diligence, LLC; Report #M540.

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

 

 

The Spine Market in China, India, & Japan, 2011-2021

The rise and growth of the spinal fusion market within China and India within the Asia Pacific region has been rapid and dramatic and reflects the spectacular growth in the economies of the emerging markets of the Asia Pacific region. It is predicted that the rise in these markets will have been so dramatic that by 2020 the Asia Pacific region will have outgrown the North American market and will have become the largest regional market.

Screen Shot 2015-10-04 at 12.16.54 PM

Source: Report #M540

Screen Shot 2015-10-04 at 11.16.39 AM

Source: Report #M540