Category Archives: market data

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Cellular Growth Factors in the Wound Management Market

From a previous post on growth factors in wound management, we highlight this due to a recent burst of activity in research leading to commercial products.


Extensive research has demonstrated that wound fluid is rich in growth factors. Growth factors are naturally occurring proteins found primarily in platelets and macrophages. They are needed for normal wound healing to promote growth and migration of fibroblasts, endothelial cells and keratinocytes. The functions of growth factors include; attraction of cells to the wound site (chemotaxis), stimulation of cell division/ proliferation (mitogenic competence/progressive), differentiation of cells into specific phenotypes (transformation), and stimulation of cells to perform functions or secrete other growth factors. Growth factors bind to receptors on the cell surface where they activate cellular proliferation and/or differentiation. There are a number of growth factors which are involved in wound healing at different points in time. Many are quite versatile and capable of stimulating cellular division in different cell types; others are specific to a particular cell type.

Growth factors applied to wound management fall into the following categories:

 

Growth
Factor
Sources
Effects
Epidermal growth factor (EGF)Activated macrophages. Salivary glands. KeratinocytesKeratinocyte and fibroblast mitogen. Keratinocyte migration. Granulation tissue formation
Transforming growth factor-? (TGF-?)Activated macrophages. T-lymphocytes. KeratinocytesHepatocyte and epithelial cell proliferation. Expression of antimicrobial peptides. Expression of chemotactic cytokines
Hepatocyte growth factor (HGF)Mesenchymal cellsEpithelial and endothelial cell proliferation. Hepatocyte motility
Vascular endothelial growth factor (VEGF)Mesenchymal cellsVascular permeability. Endothelial cell proliferation
Platelet derived growth factor (PDGF)Platelets. Macrophages. Endothelial cells. Smooth muscle cells. KeratinocytesGranulocyte, macrophage, fibroblast and smooth muscle cell chemotaxis. Granulocyte, macrophage and fibroblast activation. Fibroblast, endothelial cell and smooth muscle cell proliferation. Matrix metalloproteinase, fibronectin and hyaluronan production. Angiogenesis. Wound remodeling. Integrin expression regulation
Fibroblast growth factor 1 and 2 (FGF-1, FGF2)Macrophages. Mast cells. T-lymphocytes. Endothelial cells. FibroblastsFibroblast chemotaxis. Fibroblast and keratinocyte proliferation. Keratinocyte migration. Angiogenesis. Wound contraction. Matrix (collagen fibers) deposition
Transforming growth factor-? (TGF-?)Platelets. T-lymphocytes. Macrophages. Endothelial cells. Keratinocytes. Smooth muscle cells. FibroblastsGranulocyte, macrophage, lymphocyte, fibroblast and smooth muscle cell chemotaxis. TIMP synthesis. Angiogenesis. Fibroplasia. Matrix metalloproteinase production inhibition. Keratinocyte proliferation
Keratinocyte growth factor (KGF)KeratinocytesKeratinocyte migration, proliferation and differentiation

Source: MedMarket Diligence, LLC; Report #S249

The emergence and rapid adoption of growth factors in wound management is testimony to the expectation that they will hasten wound healing and result in better outcomes, lowered cost or both. While the market for growth factors in wound management is largely represented by the U.S. market (as with most advanced medical technologies), economics, technology diffusion and other forces will lead to more rapid growth in the use of these products in Asia/Pacific (in particular, China will see strong growth, given that powerhouse country’s propensity to bypass progressive development in favor of very rapid adoption of new technologies).

Distribution of Wound Growth Factor Markets, 2013 & 2021

GF-pie-2013-2021

Source: MedMarket Diligence, LLC; Report #S249

Feel free to contact us directly if you have further questions on the wound management market.

Over $24 Billion in Spent on Plastic Surgery Worldwide

And that’s just the product sales including implants, fillers, and other products used for aesthetics and reconstruction. It doesn’t include the physician fees, the outpatient site fees and other money spent.

There are two parts to this, of course. Plastic surgery has two faces — reconstruction and aesthetics, the first medically-indicated and the second elective.  Of course, the surgical reconstruction of anatomy and outward appearance to restore what has been lost to disease or trauma (the medically-indicated side of plastic surgery) has  benefitted greatly by the expertise and medtech innovation of aesthetics (the elective side).  Because of this, the market for products in plastic surgery has elements of both the traditional medtech market (reimbursement, economy-independed funding) and consumer markets (elective products, sensitivity to general economic conditions).

Overall, the market for these products is growing at a compound average of 7.9%, which is a strong but not extraordinarily high growth rate for a medtech market. Within it, of course, there is wide variation in the growth rates of plastic surgery product sales. Below is illustrated the aesthetics and reconstructive surgery products market from 2013 to 2018.

Screen Shot 2014-04-07 at 1.57.15 PM

MedMarket Diligence, LLC; Report #S710

 

Use of Surgical Sealants for Cranial and Spinal Dura

Surgical sealants have an enormous range of applications in the treatment of acute and chronic wounds, but while the majority of sealant revenues derives from their use in the hemostasis, closure and sealant of tissues to prevent blood loss…

Screen Shot 2014-04-07 at 9.44.39 AM

 

Source: MedMarket Diligence, LLC; Report #S190

… a different niche use of sealants is stopping cerebrospinal fluid leaks and other dural wound treatments associated with cranial and spinal procedures. These include their use in:

  • Cranial and spinal dural plastic surgery to prevent CSF fistulas.
  • Dural plastic surgery in residual cavities following tumor removal.
  • Dural lacerations in hemilaminectomy operations

Of this, most of the use is currently in cranial applications, but use in spinal applications is growing considerably faster:

Screen Shot 2014-04-07 at 9.44.53 AM

Source: MedMarket Diligence, LLC; Report #S190

 

 

 

Medtech fundings in April 2014

Fundings for medical technology in April 2014 stand at $494 million, led by the $101.4 million raised by TriVascular Technologies in its IPO. Below is a list of the month’s top fundings to date:

Company funding Product/technology
TriVascular Technologies, Inc., has raised $101.4 million in an initial public offering, according to the company Technologies for the treatment of abdominal aortic aneurysms
HALT Medical, Inc., has rasied $92.8 million in two separate rounds of funding ($29.47 million and $63.34 million) according to two regulatory filings Radiofrequency thermal ablation of uterine fibroids
Holaira, Inc., has raised $42 million in a Series D round of funding according to press reports Catheter based device to treat COPD
Titan Medical, Inc., has raised $25.6 million in a public offering according to the company Robotic systems for minimally invasive surgery
Tendyne Holdings, Inc., has raised $25 million in a round of funding according to press reports Transcatheter aortic valve implant for treatment of mitral valve regurgitation
Vapotherm, Inc., has raised $24 million in a round of funding according to press reports Ventilation systems for patients in respiratory distress

For the complete list of medtech fundings during April 2014, see link.

For a full list of the fundings in medtech, by month, since 2009, see link.

Fundings in Medtech 2009-2014: A Contrarian View

Since 2008, medtech has taken a lot of hits. Indeed, when the capital crunch hit, medtech was not viewed as the safest place for investment by a suddenly very risk averse world. Blue chip stock, high volume, low growth, STABLE markets became the norm for a lot of money. But, after a short while, it became apparent that medtech was hardly junk bonds or penny stock, especially considering the battle-hardened innovators of medtech who continued to seize on innovations that provided treatment where there once wasn’t, that accelerated healing, that measurably improved outcomes, that resulted in real cost savings to health systems and insurers, that, in other words, met DEMAND.

So, money came back to medtech. I tracked it then, and I track it now, month by month, funding by funding, company by company. Was it coming back in the pollyanna-esque windfalls of biotech and pharma? No, and I don’t think it ever has or ever will — nor should it. Biotech seems to perennially able to tap the “hope springs eternal” deep pockets of venture capital that can regularly draw individual fundings of $50 million, $75 million or $100 million. Pharmaceuticals don’t seem to go to the VC well as often, but when they do, their funding rounds are no less spectacular.

Medtech excels at crafting plain and simple solutions to disease, suffering, high healthcare costs and clinical need. Not every solution is a blockbuster — in fact, there are more than a few 510(k) products that should probably just be called “me, too”, since they do not distinguish themselves independently, at least not from a clinical or technology standpoint. But medtech has proven its ability to keep pushing the treatment envelope by innovating a little further to gain a bit more edge on outcome or cost or both.

So, medtech regularly pulls in $5 million, $10 million, $25 million at at time — frequently less, but not infrequently more.

My Contrarian View. But let me highlight again that medtech is a moving target and not everyone is thinking apples to your oranges.  What I consider medtech is, at its root, technologies that were traditionally represented as medical device treatments for disease and trauma. (And, yes, so I don’t have to answer this later on, by “medical device” I mean implants, instruments, instrumentation, even capital equipment.)  But medtech is not only medical device, for it is also (at least by my authoritarian definition, since this is my blog, but it is read by many in this field), anything and everything (within reason) that is either adjunctive to medical devices like drug delivery, like biomaterial-based implants/grafts, drug/device hybrids, tissue engineering and cell therapy (this latter is perhaps at the fringe of medtech, bordering on pure biotech).

Where’s the boundary of medtech? In my mind, it is anything and everything that competes with markets that have in the past and are to some extent still served by medical devices, equipment and supplies. For the sake of repetition, this is the definition I have posted on the medtech fundings I report on month by month in this blog (and in the online spreadsheets linked here):

What is “medtech”?: We view medical technology (medtech) as principally medical devices and equipment, but also all technologies that are directly competitive with or complementary to technologies represented by therapeutic or diagnostic medical devices/equipment.

Note: Historic coverage of “medtech” has been limited to medical devices, supplies and equipment. We feel that such a limited definition poorly reflects the true nature of the markets that once were limited to such products. In reality, assessing the markets and competition for medical devices by ONLY considering other medical devices would result in gross underestimations of both competition and market potential. Moreover, this is reflected in both the nature of medical devices (which may be hybrid device/bio/pharm products or products that may not be “devices” at all (especially in the typical definitions defined by material type and function) but that compete head-on with devices.

So, on this more liberal definition of medtech (which some still feel is too restrictive), I can point to a steady stream of investments that has been on an upward trend for the last five years. If you disagree, feel free to come up with your own definition(s), but here is the five year trend of medtech investment:

Screen Shot 2014-04-01 at 2.49.04 PM

 

Source: MedMarket Diligence, LLC

Looked at from a seasonal standpoint, this data is shown below:

Screen Shot 2014-04-01 at 2.50.09 PM

 

Source: MedMarket Diligence, LLC

The monthly data underlying both of these charts is at link. If that is not enough data for you, then you can look at a comprehensive listing of the individual fundings behind this at link.

New Technologies at Medtech Startups, March 2014

Below is the list of new medical technologies under development at startups recently identified and included this month in the Medtech Startups Database:

  • Cardiac assist device for patients otherwise needing transplant.
  • Custom surgical implants including using 3D printing.
  • Targeted, localized drug delivery.
  • Hemostatic dressing for non-compressible hemorrhage.
  • High resolution imaging in cancer
  • Image-guided surgery
  • Autologous cell therapy delivered at the intraoperative point of care.
  • Device to harvest bone grafts
  • Device and method for self-collection of samples to screen for HPV, chlamydia, and gonorrhea.
  • Implantable neuromodulation device for the treatment of chronic pain and overactive bladder.
  • Encapsulated pancreatic cells for treatment of type 1 diabetes.
  • Embolization device.
  • Deep brain stimulation for Alzheimer’s and other cognitive disorders.
  • Magnetoencephalography (MEG) and magnetocardiography (MCG).
  • Technologies to manage core temperature in critical care and post-surgical patients
  • New method to use pulse wave velocity to measure arterial stiffness as indicator of heart attack risk.
  • Minimally invasive hip implants and other orthopedic implants.
  • Orthopaedic implants.

For a historical listing of the technologies under development at medtech startups, see link.

Wound Market Analysis, A Case Study in Understanding the Context for Opportunity

Analysis is a funny thing. If done thoroughly, accurately and carefully to represent a subject from all relevant angles, it can reveal very important considerations by those with a vested interest (e.g., in support of expensive investment).

Analysis is often driven by assumption. (“It seems to me that the relative significances of different wound management products vary from one country to another, or one region to another.”) So, analysts go looking for data that would support or reject that assumption. Here, one would be interested in the relative values of different wound product sales in different countries.

Ah, we have that data. Let’s plot the sales, as a percent of each region’s total, for the different categories of wound management products in the Americas, European Union, Asia/Pacific and Rest of World:

Screen Shot 2014-03-26 at 1.57.46 PM

 Source: MedMarket Diligence, LLC; Report #S249.

What striking results, the analyst says. Clearly, negative pressure wound therapy is much more common in the Americas than it is in the Rest of World. Other small-to-significant differences are seen in other product areas.

However, the better analyst would challenge the assumption or at least consider its relevance to important decisions (again, e.g., expensive investment).

This relative data was presented because it answered an assumption, that relative use of different wound management products varies by country/region. Of course, this is indeed true.

But that’s not the whole story.  Here, we have engaged ourselves in a careful analysis of deck chairs on top of a magnificent, unsinkable luxury liner.

The bigger picture, the more relevant context into which this analysis must fit is not simply the relative difference, but the absolute difference. If we take this question of wound product sales by geography and consider not the relative but the absolute differences, the picture changes considerably:

Screen Shot 2014-03-26 at 1.59.06 PM

Source: MedMarket Diligence, LLC; Report #S249.

Which analysis is correct?  Of, course, they both tell the truth, but neither tells the whole truth. One can gain a more comprehensive understanding by considering both and recognizing the significance of actions based on one or the other analysis.

But size and growth are not the only dimensions that factor into the potential interest by manufacturers. There is, of course, the degree to which the market is fragmented — how many competitors are carving up that high volume or high growth niche?  Here are some of the (3^3=9) combinations (of which many are possible):

  • High volume, low growth, fragmented: traditional wound dressings
  • High growth, low volume, unfragmented: growth factors
  • High growth, low volume, fragmented: bioengineered skin and skin substitutes
  • High growth, high volume, unfragmented:  ???

The opportunities available to manufacturers of wound management products clearly derive from each manufacturer’s strengths (technology, market presence, time-to-market, etc.), but the value of those opportunities and whether they should be pursued are factors that are dictated entirely by how each of those strengths match up against others in the market.  The wound management market has a highly diverse makeup of technology types, competitor types, clinical applications, clinical challenges, market forces and, ultimately, different competitive niches for product suppliers.