European market share analysis, interbody fusion devices, 2014

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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 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.

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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

 

Technology advances in spine surgery

Manufacturers, clinicians and others focusing on technology advancement in spine surgery are not developing radical innovations, but are making enough incremental improvements in a number of ways that result in growth in the industry.  Most improvements fall into a number of categories:

Screen Shot 2015-09-14 at 7.29.36 AMNew materials technologies: Historically, spinal fusion instrumentation was fabricated from metallic biomaterials, including stainless steel and titanium alloy, because of their strength and fatigue resistance. However, one key drawback of these metallic implants is incompatibility with diagnostic imaging, including MRI and CT scans, which are crucial for visualizing changes to the spinal cord and vital soft tissue structures of the spine. To overcome these issues a variety of new materials such as biocompatible carbon fiber-reinforced (CFR) thermoplastic materials and implantable polyetheretherketone (PEEK) polymers were examined as an alternative to the traditional materials. In addition to biocompatibility, biostability and compatibility with diagnostic imaging, these advanced thermoplastic polymers provide a range of mechanical properties that are well suited to the demanding environment of spinal implants.

Implantable PEEK polymers are available today in an array of formulations, ranging from unfilled grades with varying molecular weight, to image-contrast and carbon fiber-reinforced grades. The first implantable unfilled PEEK polymer–PEEK-OPTIMA was pioneered in 1999 by United Kingdom-based Invibio Biomaterial Solutions. Introduced by Invibio in 2007 to provide controlled visibility through X-ray, CT and MRI technologies, image-contrast grades offer tailored opacity that allows for easier post-operative device placement verification by surgeons and clear assessment of the healing site. Also launched by Invibio in 2007, carbon fiber-reinforced (CFR) grades provide significantly increased strength and stiffness as well as a modulus similar to that of cortical bone.

The CD HORIZON LEGACY PEEK Rod from Medtronic Sofamor Danek and the EXPEDIUM™ PEEK Rod System from DePuy Spine, Inc., are examples, in which these polyetheretherketone (PEEK) polymers are radiolucent and have the ability to reduce scatter and artifact from CT and MRI images. [Picture source: MRI scan via Shutterstock]

Screen Shot 2015-09-14 at 7.24.36 AMComputer aided fixation of spinal implants: A number of proprietary techniques are being developed that provide computer or robotic alignment for the placement of spinal implants. Current research ensures that further developments will occur resulting in more extensive use of computer aided fixation. [Picture source: NIH]

 

percutaneous spineMinimally invasive spine surgery: Manufacturers have development technologies in percutaneous and endoscopic approaches to spine surgery that are having (and will continue to have) a significant impact on patients, clinical practice and the market for spine products.  It is producing all the expected benefits of less invasiveness — less traumatic surgery results in shorter recovery times and better outcomes and opens up spine surgery to more elderly, infirm and other patients for whom traditional spine surgery would be contraindicated. [Image: Handbook of Minimally Invasive and Percutaneous Spine Surgery; allamericanspeakers.com]

 

Screen Shot 2015-09-14 at 7.19.47 AMVariable axis screw systems: A variable axis screw system is a pedicular screw system that features a variable-axis head, which offers a ±25 degrees of angulation. The system also offers a pre-contoured rod. The contoured rod, along with the angulation available in the screw head, alleviates the need for rod contouring. The screw also features a pre-assembled head and double lead thread. The pre-assembled head reduces the steps required for construct assembly and the double lead thread increase the speed of screw insertion and construct assembly so that the overall operative time can be shortened. [Picture source: DePuy Synthes]

Products, technologies, markets, companies and opportunities in the spine surgery industry are the focus of the MedMarket Diligence Report #M540, “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.” The next five purchasers of this report (any option) will receive a 25% discount off the published price online by entering the coupon code “spinepricectomy”.

 

Global Growth in Spine Surgery

Spine surgery is a relatively mature market — all segments of the spine can be treated, significant share has been garnered by a few major companies, and there are no radically new technologies disrupting current market positions. Yet, trends in the patient population, the active innovation by all companies (see further, below, on market shares per region), the fact that it remains an invasive procedure (even the best minimally invasive approaches have room for improvement), and the accelerating migration of advanced spine technologies to developing non-U.S. markets are all reasons why this “mature” market is anything but stagnant.

Success in applying minimally invasive approaches to spine fusion has opened up procedure volumes for more patients, resulting in the fastest growing area of spine fusion sales. Fusion devices are strong worldwide, with the non-U.S. markets lagging in volumes, but growing at markedly faster rates.

Below is illustrated the segment growth rates for major geographic regions.

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Source: MedMarket Diligence, LLC; Report #M540

The result of the faster non-U.S. growth is that the dominance of U.S. spine surgery markets will decline over the next decade. Below is the change in the share of the global spine surgery market represented by each reach from 2014. For example,  the U.S. market will lose 6% of the global market between 2014 and 2021, while Asia-Pacific will gain roughly 5%.

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Source: MedMarket Diligence, LLC; Report #M540

A two-tier market

The big players (Medtronic, DePuy, Stryker, Zimmer-Biomet) cumulatively control a large swath of the spine surgery market, yet many millions of dollars streams to hungry and innovative smaller spine companies. For example, below is the distribution of market shares for cervical fusion globally.

cervical fusion mkt shares by region

Source: MedMarket Diligence, LLC; Report #M540

 

 

 

Global Spine Surgery Finding Double Digit Growth from Innovation, Economics, and Clinical Trends According to MedMarket Diligence Report

[August 21, 2015 — Mission Viejo  CA — MedMarket Diligence has published its 2015 global report on spine surgery. For details, see link.]

Decades of clinical research and medtech innovation have combined to offer solutions for every segment of the spine.  Economics and innovation have also made spine surgery one of the strongest growth of all medtech markets. MedMarket Diligence’s new global report on spine surgery device markets reveals opportunities for established, emerging, and potential medtech players.

Screen Shot 2015-08-24 at 2.03.50 PM

Screen Shot 2015-08-24 at 2.10.34 PMThe $9.17 billion global market for cervical fusion, thoracolumbar Implants, MIS spine fusion, interbody fusion, and orthobiologics has evolved dramatically over the last several decades as a result of significant advances in the understanding of spinal biomechanics, the proliferation of sophisticated spinal instrumentation devices, surgical advances in bone fusion techniques, refinement of anterior approaches to the spine and the emergence and development of microsurgical, minimally invasive methods and robotics. As a result of these advances it is now possible to stabilize every segment of the spine successfully, regardless of the offending pathology. The global market for spine surgery devices is detailed in the MedMarket Diligence report, “Global Market for Medical Device Technologies in Spine Surgery, 2014-2021.” See Report #M540.

“While this market may be dominated by the bigs — Medtronic, DePuy, Stryker, Zimmer-Biomet, et al. – there remains more than enough business in spine technology to attract a remarkably large number of mid-tier and smaller market participants,” says Patrick Driscoll of MedMarket Diligence. “And there are ample participants who do not accept the status quo, by aggressively innovating and introducing clinical and economic improvement in spine surgery.”

Spine fusion is the fastest growing technology in spine surgery and with growth in spine surgery being fastest in the Asia-Pacific and Central/Latin America, the growth of spine fusion in those areas is double-digit. The improvements in spine surgery and technology development have produced steady growth in volumes of surgeries, supported by reimbursement and clinical outcomes (and the increasingly active aging population). Spine surgery, with its exponential growth, has been the answer to an orthopaedic industry seeking to optimize earnings and add value for shareholders.

The MedMarket Diligence report, “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) 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 a current and forecast assessment by region/country of procedures and manufacturer revenues for, specifically, Americas (United States, Rest of North America, Latin America), European Union (United Kingdom, Germany, France, Italy, Spain, Rest of Europe), Asia-Pacific (Japan, China, India, Rest of Asia/Pacific) and Rest of World. The forecast addresses the product- and country-specific impacts in the market of new technologies through the coming decade.

The report profiles 38 of the most notable current and emerging companies in this industry, providing data on their current products, current market position and products under development. The products and activities of numerous additional startup and emerging companies are also detailed in the report.

The report is described in detail at http://mediligence.com/m540/ and may be ordered for immediate download from https://mediligence.com/store/page51.html.


Until August 28, 2015, Report #M540 is available for $500 off the list price. See Spine Surgery 2015 (M540) $500 off early release

Global Markets for Medical Devices in Spine Surgery, Forecast to 2021

The market for spinal implants and associated spinal fusion products has evolved dramatically over the last several decades as a result of significant advances in the understanding of spinal biomechanics, the proliferation of sophisticated spinal instrumentation devices, surgical advances in bone fusion techniques, refinement of anterior approaches to the spine and the emergence and development of microsurgical, minimally invasive methods and robotics. As a result of these advances it is now possible to stabilize every segment of the spine successfully, regardless of the offending pathology.

Prior to these developments, the orthopedic industry had traditionally regarded spinal surgery as a “Cinderella” segment that — far from being a major market segment — was almost regarded as a service area supporting a relatively small number of highly specialized surgeons focusing on the clinical issues associated with the vertebral column. In contrast, by the beginning of the new millennia it became clear that an orthopaedic industry seeking to provide optimized earnings and value to share holders had identified this area as a major unmet need in which the demand to resolve an increasingly wide range of spinal conditions was growing exponentially.

In response to these developments, and in recognition that the market for spinal implants and associated spinal fusion products was and is growing, orthopedic companies have realigned their strategic approach by:

  • Providing greater resources to further product development.
  • Expanding of sales and marketing resources
  • Growing new and emerging geographic regions

It is anticipated that, collectively, these elements will further open the door to the development of implantable devices that can identically reproduce the elements of the spine that need to be reinforced or replaced by artificial. Accordingly, use of spinal fusion and instrumentation is anticipated to increase in the foreseeable future and continue to represent a better than average growth area in medtech.

 

 

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Source: MedMarket Diligence, LLC; Report #M540


MedMarket Diligence, LLC, has completed an analysis entitled, “Global Market For Medical Device Technologies in Spine Surgery, 2014-2020”. The report (#M540) will be published August 21, 2015, and will be downloadable in PDF and available in print for single, site, and global licenses. The report is described in detail, with a complete table of contents and list of exhibits, at link.

What is spine surgery?

What is spine surgery? Specifically it’s:

  • Anterior Lumbar Interbody Fusion (ALIF)
  • Anterior Cervical Corpectomy
  • Anterior Cervical Discectomy and Fusion (ACDF)
  • Axial Lumbar Interbody Fusion (AXiaLIF)
  • Cervical Laminaplasty
  • Cervical Posterior Foraminotomy
  • Direct Lateral Interbody Fusion (DLIF)
  • Discectomy
  • Endoscopic Surgery
  • eXtreme Lateral Interbody Fusion (XLIF)
  • Foraminotomy and Foraminectomy
  • Intradiscal Electrothermal Therapy (IDET)
  • Kyphoplasty
  • Laminectomy
  • Laminoplasty
  • Laminotomy
  • LASER Surgery
  • Microdiscectomy (Minimally Invasive Technique)
  • Oblique Lumbar Interbody Fusion (PLIF)
  • Posterior Lumbar Interbody Fusion (PLIF)
  • Scoliosis Correction
  • Spinal Decompression
  • Spinal Fusion
  • Spinal Instrumentation
  • Spinal Osteotomy
  • Thoracoscopic Release
  • Transforamenal Lumbar Interbody Fusion (TLIF)

These represent the range of options to address diseases and trauma of the spine. To varying degrees, these procedures can require multiple instruments and/or implants and other products, which encompass the following:

  • Cervical interbody cages or spacers
  • Anterior cervical plates
  • Artificial cervical discs
  • Thoracolumbar plate systems
  • Interbody fusion devices
  • Thoracolumbar screw/rod systems
  • Minimally invasive implants
  • Artificial disc replacement implants
  • Interspinous implants
  • Demineralized bone matrix
  • Synthetic bone graft substitutes

See pending Report #M540.

Wound management technologies, worldwide growth

The global wound care market is expected to always be represented by sizeable share of basic products in wound dressings and bandages, which for the majority of wound types have clearly proven to be cost effective in producing acceptable time-to-healing and other clinical outcomes. However, advanced wound products to address complex wound types – many of which may simply evolve from otherwise simple wounds that have been neglected – are increasingly demonstrating their potential for accelerating the pace and therefore reducing the cost of wound healing.

But factors other than cost-consciousness are driving the advanced wound care market. Patients’ desire for less scarring, as well as an increased awareness of infection issues, drive the development of advanced dressings and biomaterials that reduce bacteria and heal wounds faster. An aging world population and lifestyle changes that contribute to disease frequency also factor into the market’s continued growth.

Still, there are some market restraints, primarily the high cost of new technologies, which therefore must demonstrate better outcomes and/or lower long-term costs. 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 more advanced wound management technologies. Improved wound prevention and a lack of regulation on tissue engineering in the EU are also expected to withhold the development of new technologies.

A high number of manufacturers competing for market share have also driven down prices. In 2009, the top wound care companies included Johnson and Johnson, Kinetic Concepts Inc. (KCI), Hill-Rom and Smith & Nephew. These four companies were responsible for 60 percent of total market revenue in 2009. However, mergers, acquisitions and sales of intellectual property can rapidly change the market share picture. In June 2009, Hill-Rom sold its intellectual property relating to negative pressure wound therapy to KCI. By end 2012, about 56% of the wound care market was held by Johnson and Johnson, 3M, Smith & Nephew, and Systagenix.

Below is illustrated the global market for traditional and advanced products in wound management, with the compound growth rate in sales of individual product types ranging from a low of under 3% to a high of 19% through the forecast period (i.e., to 2021).

wound-2012-2021

Source: MedMarket Diligence, LLC; Report #S249, “Wound Management, Worldwide Market and Forecast to 2021:  Established and Emerging Products, Technologies and Markets in the Americas, Europe, Asia/Pacific and Rest of World”.

Reference reports in Ophthalmology, Coronary Stents and Tissue Engineering

MedMarket Diligence has added three previously published, comprehensive analyses of  medtech markets to its Reference Reports listings. The markets covered in the three reports are:

  • Ophthalmology Diagnostics, Devices and Drugs (see link)
  • Coronary Stents: Drug-Eluting, Bare, Bioresorbable and Others (see link)
  • Tissue Engineering, Cell Therapy and Transplantation (see link)

Termed “Reference Reports”, these detailed studies were initially completed typically within the past five years. They now serve as exceptional references to those markets, since fundamental data about each of these markets has remained largely unchanged. Such data includes:

  • Disease prevalence, incidence and trends (including credible forecasts to the present)
  • Clinical practices and trends in the management of the disease(s)
  • Industry structure including competitors (most still active today)
  • Detailed appendices on procedure data, company directories, etc.

Arguably, a least one quarter of every NEW medtech report contains background data encompassing the data listed above.  Therefore, the MedMarket Diligence reports have been priced in the single user editions at $950 each, which is roughly one quarter the price of a full report.

See links above for detailed report descriptions, tables of contents, lists of exhibits and ordering. If you have further questions, feel free to contact Patrick Driscoll at (949) 859-3401 or (toll free US) 1-866-820-1357.

See the comprehensive list of MedMarket Diligence reports at link.