Acute Stroke Therapeutics and a $1.7+ Billion Neurointerventional Worldwide Market; MMD Report

Stroke is a costly condition with a growing patient population targeted neurointerventional treatments that will account for hundreds of millions in sales over the next five years, according to a recent MedMarket Diligence report.

Acute stroke therapeutics 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. These therapeutic technologies will account for $323 million in new revenue from 2015 to 2019, according to the recently published MedMarket Diligence report, “Emerging Global Market for Neurointerventional Technologies in Stroke, 2014-2019”, details

“Stroke is associated with costly long-term care, especially for a patient population that is typically older and more susceptible to its complications, but neurointerventional treatment have succeeded in both making a positive clinical impact and securing respectable revenue streams for manufacturers,” says Patrick Driscoll of MedMarket Diligence. These technologies will continue to develop and improve over the next five years, but much growth will also come from the penetration by these technologies in non-U.S. markets, where relative use is lower and shows untapped potential.

Stroke is a life-threatening medical condition characterized by a sudden catastrophic breakdown in the brain-supporting cerebrovascular system and blood supply, which, in many instances, is followed by an irreversible injury to the brain cells and severe neurological impairment or death.

Notwithstanding the remarkable progress in medical science and technology and associated improvements in clinical practices, stroke continues to constitute the major public health problem in the U.S. and overseas.

The $1.5 billion global market for acute stroke management is revealed in detail in the MedMarket Diligence report #C310, “Emerging Global Market for Neurointerventional Technologies in Stroke, 2014-2019”, (see http://mediligence.com/c310/). The report is a detailed market and technology assessment and forecast of the products and technologies in the management of acute stroke. The report describes the epidemiology, etiology and management of hemorrhagic stroke, ischemic stroke, subarachnoid hemorrhage, and transient ischemic attack, characterizing the patient populations, their current clinical management, and trends in clinical management as new techniques and technologies are expected to be developed and emerge. The report details the currently available products and technologies, and the manufacturers offering them. The report details the products and technologies under development and markets for each in the treatment of acute stroke. The report provides a current and forecast to 2019 by region /country for the U.S., Western Europe, the major Asia-Pacific states (China, India, and Japan), and the rest of world. The report profiles the most top companies in this industry, providing status and forecast data on their current products, current market position, and products under development.

The report is described in detail at http://mediligence.com/c310/ and may be ordered for immediate download from https://shop.mediligence.com/index.php/downloads/c310/.

 

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.
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Source: MedMarket Diligence, LLC; Report #C310.

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Source: MedMarket Diligence, LLC; Report #C310.

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.

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Source: Medtech Startups Database

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

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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:

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Source: Medtech Startups Database

 

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.

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Source: MedMarket Diligence, LLC; Report #M540.

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).

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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.

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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.

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Source: Report #M540

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Source: Report #M540

Neurointerventional Treatments for Acute Stroke

Stroke is a life-threatening medical condition characterized by a sudden catastrophic breakdown in the brain-supporting cerebrovascular system and blood supply, which, in many instances, is followed by an irreversible injury to the brain cells and severe neurological impairment or death.

Notwithstanding the remarkable progress in medical science and technology and associated improvements in clinical practices, stroke continues to constitute the major public health problem in the U.S. and overseas. According to the World Health Organization (WHO), OECD, and governments’ data, approximately 14 million to 16 million people worldwide  suffered a stroke in 2014, of which roughly 75% of the cases (10.5 – 12.0 million) represented first attacks and 25% (or 3.5 to 4.0 million cases) were qualified as recurrent attacks. Based on the same sources, about 5 million acute stroke episodes result in death within one year globally, which makes it the third most common cause of death, behind diseases of the heart and cancer.

Stroke is also a leading cause of serious and lasting disability and long-term institutionalized care.

Acute stroke – also known as “cerebrovascular accident” – represents a catastrophic manifestation of accumulated circulatory disorders that affect the vasculature of the brain. The two major subdivision of stroke are ischemia or lack of blood and oxygen supply typically resulting from occlusion of cerebral arteries, and hemorrhage or leakage of blood outside the normal cerebral vessel conduit. Both types of stroke cause necrosis of certain groups of brain cells, which leads to irreversible impairment of various neurological functions in about 22% to 25% of patients and death within one year in another 20% to 25% of stroke caseloads.

Acute stroke is managed by a broad scope of prophylactic, palliative and curative treatment regimens that are typically employed in some combinations during the preventive, acute and rehabilitation phases of stroke-related care delivery.

Treatments for acute stroke are the subject of the MedMarket Diligence report #C310, “Emerging Global Market for Neurointerventional Technologies in Stroke, 2014-2019” (see details)

Although sales are low now, one of the fast(er) growing areas in the neurointerventional management of stroke is technologies to provide closure of the left atrial appendage, a vestige of the embryonic left atrium which, for patients with atrial fibrillation, can result in the formation of blood clots in the relatively stagnant pooled blood in the appendage.

Currently, only the Watchman LAA Closure System is approved in the U.S. for left atrial appendage closure, but sales are now projected to grow at 13% annually through 2019. Consequently, the make-up of the market will change considerably from 2014 to 2019:

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Source: MedMarket Diligence, LLC; Report #C310 (published September 2015).

Coverage in 2015 global spine surgery technology report

The MedMarket Diligence report, “Global Market For Medical Device Technologies in Spine Surgery, 2014-2021” (link), is a detailed market and technology assessment and forecast of the products and technologies in the management of diseases and disorders of the spine. The report describes the diseases and disorders of the spine, characterizing the patient populations, their current clinical management, and trends in clinical management as new techniques and technologies are expected to be developed and emerge. The report details the currently available products and technologies, and the manufacturers offering them. The report details the products and technologies under development and markets for each in spine surgery. The report provides the current and forecast market to 2021, by region/country, of procedures and manufacturer revenues.

Technologies covered:

  • Cervical implants
  • Thoracolumbar implants
  • Minimally invasive implants
  • Non-fusion implants
  • Orthobiologics

Geographic market detail:

  • North America — United States, Canada
  • Europe — Germany, France, Spain, Italy, United Kingdom
  • Asia/Pacific — Japan, India, China
  • Central and Latin America
  • Rest of World

Selected (published report includes over 100 companies) list of companies included in the report:

  • Accel Spine
  • Advanced Spine Fixation Systems Inc
  • Aesculap
  • Alphatec Spine (Scient’x Groupe S.A.)
  • Apollo
  • Argomedical AG
  • Baumer S.A.
  • Beijing Montagne Medical Device Co.
  • Biedermann Motech GmbH & Co. KG
  • Biomatlante
  • Biotech GmbH
  • Biotechni
  • BIOTEK – Chetan Meditech Pvt. Ltd
  • Bonovo Orthopedics Inc
  • coLigne AG
  • DePuy Synthes
  • Dieter Marquardt Medizintechnik GmbH
  • ESKA Implants AG
  • Exactech Spine
  • Gerraspine AG
  • Globus Medical
  • Graftys
  • Integra LifeSciences
  • Japan Medical Dynamic Marketing (MDM) INC
  • K2M
  • Kyocera Medical Corporation
  • LDR Medical
  • Medicrea
  • Medtronic Spinal and Biologics
  • Medyssey Spine Ltd (Zimmer)
  • Nakashima Medical Co. Ltd
  • Norer Medical Group (Xinrong Best Medical Instrument Co. Limited)
  • NuVasive
  • Onur MEDiKAL San. Ve Tic Ltd. Sti.
  • Orthopaedic & Spine Development
  • Osteotech
  • Seohancare co. ltd
  • Solco Biomedical
  • Sozhou Kangli
  • Spineart
  • Spinelab Ltd.
  • Stryker Spine
  • Surgival-Grupo Cosias
  • Ulrich GmbH & Co.KG
  • Wright Medical Technology
  • Zimmer Biomet

For complete details on this report, including ordering online, see link.

The Future (Ours) is in China for Medtech

The importance of China in the global economy became apparent this week, with the ups and downs of its economic state tripping the hair trigger that financial markets have for the huge nation’s growth market.

But in hard terms, what does that mean? As an example, look at spine surgery technology and compare the forecasted growth in sales in China not against the much lower U.S. market but against other high-growth Asia-Pacific markets such as India and Japan. Below is the balance of spine surgery technology sales (encompassing cervical fusion, thoracolumbar implants, minimally invasive spinal fusion, interbody fusion, and orthobiologics) for 2014 and forecasted for 2021 for China, India, and Japan.

Spine Surgery Sales by Country, 2014 & 2021

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Source: MedMarket Diligence, LLC; Report #M540

The relative growth of the market in China is apparent in the change of pie slice sizes, but in hard numbers, Japan’s annual sales in 2021 will be $243 million higher than they were in 2014, but by comparison, China’s 2021 spine surgery sales will be $536 million higher than in 2014.

It is evident that China has made great advances in the quality and quantity of research work and in the development of its medical industry and the provision of healthcare in China. According to the International Monetary Fund, the gross domestic product of China was over $8,230 billion in 2012, making China’s economy the second largest economy in the world. China’s life sciences markets have shown particularly aggressive growth in absolute terms, with sales of the country’s reagents and analytical laboratory instruments showing annual growth in the 15% to 20% range. The Chinese pharmaceutical market is growing at 13.1% through 2020 (Source: McKinsey) and projected growth in the in vitro diagnostics market in China is at 10%.

The overall size and growth in China’s medtech market, including spine surgery, demands a business strategy to gain sales there, since no other market worldwide is expected to drive so much new revenue.