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

 

Established to emerging, commodity to advanced in wound management

Wound management is about as diverse a market as there can be in medtech. Wounds can be acute or chronic, surgically created or arising from trauma or disease, treated with technology as simple as a piece of gauze or as complex as a hyperbaric oxygen chamber or negative pressure would therapy technology.  The manufacturers range from producers of largely commodity-like dressings to devices to equipment to growth factors and other biotech products.

Simultaneously, the nature of patient populations, clinical practices, market development, economics and technology adoption vary widely around the world, resulting in considerable variation in the sales of traditional products all the way up through the most advanced products in wound management.

As an example, below are illustrations of the 2011 to 2020 forecast for the range of wound management products in the U.S. and a different set of markets, the Rest of Asia/Pacific (excluding Japan and Korea); predominantly China, India and Australia.

The distribution of product sales in wound management, on a relative basis, is very different in the U.S. than in the Rest of Asia/Pacific due in large part to the tendency for advanced technologies to be first introduced in well developed markets, like the U.S., Europe, Japan and others and later migrated to the “emerging” markets. T

The U.S. graph illustrates the decreasing/increasing share of each technology’s sales relative to all others.

Screen Shot 2014-05-20 at 3.23.43 PM

Source: MedMarket Diligence, LLC; Report #S249

For the Rest of Asia/Pacific Market, a different picture emerges, with interesting variations per product segment.

 

 

Screen Shot 2014-05-20 at 3.23.58 PM

Source: MedMarket Diligence, LLC; Report #S249

However, to put the relative differences into a meaningful context, one has to look at the absolute sales in the different markets. And, to show the very real, stark difference between the U.S. and Rest of Asia/Pacific markets for wound management products, we have plotted both on the same scale, with the max given for both as $12,000 million in sales.

 

 

Screen Shot 2014-05-20 at 3.24.16 PM

Source: MedMarket Diligence, LLC; Report #S249

Screen Shot 2014-05-20 at 3.29.56 PM

Source: MedMarket Diligence, LLC; Report #S249

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.

 

Spine Surgery Geographic Markets

Technologies employed in the treatment of spine disorders and trauma have varying levels of acceptance globally.  These variations in the overall balance of different surgical spine technologies arise from the plethora of differences in local markets, even on a per capita basis.

Considering two very well developed markets — the USA and Germany — one would expect to see very similar levels of utilization of spine surgery technologies. The reality, however, is that the clinical practices, demographics, reimbursement schemes, regulatory environment, presence of locally active manufacturers and distributers and other characteristics differ enough so that the two countries have noticeably different markets for spine surgery products as represented by each country’s segmentation of the total market by spine surgery technology type. See below:

Source: MedMarket Diligence, LLC; Report #M520, “Worldwide Spine Surgery: Products, Technologies, Markets and Opportunities 2010-2020”.

[Note: The MedMarket Diligence Report #M520 details the worldwide spine surgery market by the Americas (USA, Canada, Mexico, Brazil), European Union (United Kingdom, Germany, France, Italy, Spain, Rest of Europe), Asia-Pacific (Japan, China, India, Australia/New Zealand) and Rest of World.]

Worldwide Spine Surgery Devices Market

For active or potential participants developing or marketing devices for use in spine surgery, there is no better reference source than MedMarket Diligence’s comprehensive, worldwide report on the spine surgery market.  Produced in mid-2011, the report, “Worldwide Spine Surgery: Products, Technologies, Markets & Opportunities, 2010-2020” (described in detail at link) accurately forecasts the status of the current (2012) market and provides a compelling case for its forecasts of individual technology and geographic markets through 2020.

(This report is now available at a 30% discount. Just order online and at checkout enter the coupon code “1262720736”.)

The report details the current and forecast markets, with market shares, for the following spine surgery product segments:

  • Posterior Pedicle Screw Fusion Systems
  • Anterior Cervical Plate Systems
  • Anterior Thoracolumbar Plate Systems
  • Anterior Lumbar Interbody Fusion (ALIF) devices
  • Transforaminal Lumbar Interbody Fusion (TLIF) devices
  • Posterior Lumbar Interbody Fusion (PLIF) devices
  • Axial Lumbar Interbody Fusion (AxiaLIF) devices
  • Interspinous Process Spacers (ISPs)
  • Cervical Artificial Discs
  • Lumbar Artificial Discs
  • Vertebroplasty
  • Balloon Kyphoplasty
  • Allografts
  • Demineralized Bone Matrix (DBM)
  • Bone Morphogenetic Proteins (BMPs)

The report details the products and technologies under development and markets for each in spine surgery. The report provides a current and ten-year forecast by region/country of procedures, unit sales, average selling price and manufacturer revenues for, specifically, Americas (USA, Canada, Mexico, Brazil), European Union (United Kingdom, Germany, France, Italy, Spain, Rest of Europe), Asia-Pacific (Japan, China, India, Australia/New Zealand) and Rest of World. The forecasts address product- and country-specific impacts in the market of new technologies through the coming decade. The report profiles 46 key companies in this industry, providing data on their current products, current market position and products under development.

(This report is now available at a 30% discount. Just order online and at checkout enter the coupon code “1262720736”.)

 

Anterior cervical plate systems in spine surgery

Anterior cervical plate (ACP) systems are one of several types of devices used to stabilize the spine following surgery. Others may include posterior cervical plates, posterior cervical wiring, anterior cervical interbody cages or post-operative cervical braces. An ACP is a small plate that can be attached to the front of the spine. Although this is a simple procedure, it adds significant stability to the spine. Anterior plates were first developed in the 1980s, and were initially restricted to use in long or multi-level spine fusions. Now surgeons are routinely using ACPs for single-level fusions. Attaching an ACP protects the bone graft and adds additional stability, without adding much time or labor to the cervical fusion procedure itself. ACPs tend to be fairly expensive, but they also help contribute to a speedier recovery and faster return to normal activities.

Anterior cervical plate systems are virtually commodity products. The global market for these products was $923 million in 2011, and is forecast to increase with a CAGR of 3.26% to be worth over $1.2 billion by 2020.

Source: “Worldwide Spine Surgery:  Products, Technologies, Markets and Opportunities, 2010-2020.” Report #M520.

Like many device markets, the ACP market’s biggest revenue source is the USA, followed by Japan:

Source: “Worldwide Spine Surgery:  Products, Technologies, Markets and Opportunities, 2010-2020.” Report #M520.

Key competitors in this market include Aesculap Spine, Biomet, Custom Spine, DePuy, K2M, Medtronic, NuVasive, Orthofix, Stryker and Synthes.

Kyphoplasty in the European Union and Asia/Pacific

In examining medical device markets, it is useful to be able to examine current markets, forces and trends to be able to see emerging gaps in the market, which represent opportunities or challenges, depending on where your particular medtech perspective.

In reviewing a very large set of data on spine surgery across global markets, I came across the fact that in a very specific sector, kyphoplasty — in which vertebral compression fractures are treated by restoring vertebra height through balloon inflation of the collapsed vertebral space and filling the space with cement — the trends in the Europe Union are very distinct from the trends in the Asia/Pacific region encompassing Japan, China, India and Australia/New Zealand, revealing a growing disparity between the spine surgery markets in these regions.

In this example, growth in the European Union is at better than 30% annually, while the comparable growth for Asia/Pacific is just over 10%.  As a result, you can see the divergence of these two markets after about 2014, when the difference begins to result in a much larger market for kyphoplasty in the EU.  Even if one were to temper the arguments underlying this disparity in growth, a measurable difference would remain.

Source: “Worldwide Spine Surgery:  Products, Technologies, Markets and Opportunities, 2010-2020”; Report #M520.

The point to be had from this exercise is that, however speculative predicting the future may be, since multiple forces determine the future and their individual directions and intensities can only be roughly approximated, confidently knowing the relative strength of forces in different markets and applying data-driven trending can lead to very specific predictions.  Those market predictions then become meaningful because they lead to very real consequences, good or bad, for the movers and shakers in the market.


Global spine surgery market to shift through 2020

Driven by aging populations and technological advances leading to improved devices and less invasive surgery, and despite the current economic challenges, the overall global market for spine surgery devices is expected to see modest growth through 2020. In addition, spine surgery will increasingly be represented by minimally invasive procedures, which will be a factor in the increase in younger (under 50) patients deciding to undergo spine surgery. Then, too, many of these younger patients wish to return to the activities that may have caused their back problems in the first place. They are therefore open to undergoing spine surgery procedures, in preference to adoption of a more sedentary lifestyle.

The principal devices in spine surgery are:  posterior pedicle screw fusion systems, anterior cervical plate (ACP) systems, anterior lumbar interbody fusion (ALIF) devices, transforaminal interbody fusion (TLIF) devices, posterior lumbar interbody fusion (PLIF) devices, axial lumbar interbody fusion (AxiaLIF) devices and interspinous process spacers, cervical artificial discs, lumbar artificial discs, vertebroplasty, balloon kyphoplasty, allografts, demineralized bone matrix (DBM) and bone morphogenetic proteins (BMPs).

MedMarket Diligence’s comprehensive study of the global spine surgery market details, for all of these devices, the products on the market and in development, the active and hopeful competitors and the current and forecast markets for these products in the Americas (USA, Canada, Mexico and Brazil), the European Union (United Kingdom, Germany, France, Spain, Italy and Rest of Europe), Asia-Pacific (Japan, China, India and Australia/New Zealand) and Rest of World.

The compound annual growth rate for the entire market as defined in this study is forecast to be a modest 7% for 2011-2020, but it will be driven by higher growth in Posterior Pedicle Screw Fusion Systems and Cervical and Lumbar Artificial Discs, and lesser growth in some sectors which are of significant size, including Balloon Kyphoplasty, Allografts and DBM.  As a result, the makeup of the global spine market will be noticeably different by 2020.

Source: “Worldwide Spine Surgery:  Products, Technologies, Markets and Opportunities, 2010-2020.” Report #M520.

Ablation technology regional growth to 2019

In our analysis of the global market for the spectrum of ablation technologies — Electrical, Radiation, Light, Radiofrequency, Ultrasound, Cryotherapy, Thermal (other than cryo), Microwave, and Hydromechanical — we assessed the size and growth of sales of these technologies with specificity to a large number of regions and countries:

  • U.S.A.
  • Canada
  • Brazil
  • Mexico
  • Germany
  • United Kingdom
  • France
  • Italy
  • Spain
  • BeNeLux
  • Japan
  • China
  • India
  • Australia
  • Rest of World

Below, we illustrate, ranked from low to high, the compound annual growth rates of each geography/technology combination.  This data reflects the strong trends that exist for clinical adoption and sales growth of specific technologies, driven by the unique combination of country-specific and technology-specific forces.

Source: Report #A145, MedMarket Diligence, LLC.

Developed versus emerging markets in advanced wound management

Continuing a vein of discussion posted previously, Trickle Down Technologies in Medtech, it is worth looking at the advanced wound management products represented by hemostats (i.e., hemostatic agents, like ZMedica's QuikClot), fibrin and other sealants, high-strength medical adhesives and products for prevention of post-surgical adhesion and look at their relative size in a set of  well-developed economies like that of the Americas versus the same for emerging markets, such as represented by Asia/Pacific excluding Japan and Korea.

The point of this comparison is to illustrate that markets for advanced technologies grow first and fastest in advanced economies.  In the case of advanced wound management products, least "advanced" product is hemostats, while the most advanced is high-strength medical adhesives (even moreso than anti-adhesion products).  See below in graphics comparing in absolute terms the market segmentation (stacked column chart) and the relative size of segments (two pie charts) for the Americas and Emerging Asia/Pacific.

 

Source: MedMarket Diligence Report #S190.

Hemostats represent a relatively low hurdle to market entry, since the important functions of the product are simply to stop bleeding without being toxic.  On the other end of the spectrum is high-strength medical adhesives, which must create strong tissue adhesion without toxicity and, as has been demonstrated by toxic cyanoacrylates, this is indeed a challenge.

Having said this, despite the technical challenge, which exists independently of geographic market differences, the real challenge (beyond gaining U.S. or EU regulatory approval) is bringing the price of these advanced products down to levels can accelerate their more rapid introduction into growth markets like the emerging Asia/Pacific (see CHINA).