Naturally sticky: Biologically-based medical glues dominate

Medical glues are either biologically-based, cyanoacrylate, or other synthetic. The bulk of global sales of medical glues are biologically-based, (includes fibrin, thrombogen, and others), cyanoacrylate-based glues, and other synthetic glues.

Cyanoacrylate-based glues, include those from Ethicon, Adhezion Biomedical, B. Braun, Meyer-Haake, and others. Cyanoacrylates provide strong adhesion, but biologically-based glues have found more applications, both topically and internally. “Other” glues are of a variety of synthetic types; these glues have yet to gain more than 4% share globally.

Below is illustrated the growth of biologically-based glues by region, showing that most growth in this segment will be from Asia/Pacific markets, which are consistently demonstrating higher growth than in western markets.

Global Markets for Biologically-Based Medical Glues, 2015-2022, USD MillionsSource: MedMarket Diligence, LLC; Report #S290. (Order online)

 

What’s next in sealants, glue, hemostats…and why?

From July 2016 published Report #S290.

Here are six key trends we see in the global market next in surgical sealants, glues, and hemostats:

  1. Aggressive development of products (including by universities, startups, established competitors), regulatory approvals, and new product introductions continues in the U.S., Europe, and Asia/Pacific (mostly Japan, Korea) to satisfy the growing volume of surgical procedures globally.
  2. Rapid adoption of sealants, glues, hemostats in China will drive much of the global market for these products, but other nations in the region are also big consumers, with more of the potential caseload already tapped than the rising economic China giant. Japan is a big developer and user of wound product consumer. Per capital demand is also higher in some countries like Japan.
  3. Flattening markets in the U.S. and Europe (where home-based manufacturers are looking more at emerging markets), with Europe in particular focused intently on lowering healthcare costs.
  4. The M&A, and deal-making that has taken place over the past few years (Bristol-Myers Squibb, The Medicines Company, Cohera Medical, Medafor, CR Bard, Tenaxis, Mallinckrodt, Xcede Technologies, etc.) will continue as market penetration turns to consolidation.
  5. Growing development on two fronts: (1) clinical specialty and/or application specific product formulation, and (2) all purpose products that provide faster sealing, hemostasis, or closure for general wound applications for internal and external use.
  6. Bioglues already hold the lead in global medical glue sales, and more are being developed, but there are also numerous biologically-inspired, though not -derived, glues in the starting blocks that will displace bioglue shares. Nanotech also has its tiny fingers in this pie, as well.

See Report #S290, “Worldwide Sealants, Glues, and Hemostats Markets, 2015-2022”.

Medtech fundings for June 2017

Fundings in medical technology for June 2017 stand at $503 million to date, led by the $140 million debt funding of Spectranetics, followed by the $57 million funding of Bonesupport, the $52 million debt funding of Accuray and the $42 million funding of Micell Technologies.

Below are the top medtech fundings thus far for June 2017:

Source: Compiled by MedMarket Diligence, LLC

For the complete list of medtech fundings for June 2017, see link.

For a historical listing of medtech fundings by month since 2008, see link.

Cardiovascular procedure volumes in the rest of the world

Cardiovascular procedures are high volume, big business in the well developed U.S, European, and Asia/Pacific markets. But much potential procedure volume has been tapped in these markets, with any appreciable growth limited to low volume, emerging procedures.

By comparison, the less-tapped “Rest of World” potential (i.e., non-U.S., non-Europe, non-Asia/Pacific) for growth is significant. Below is illustrated the 2016 size and growth to 2022 for the major cardiovascular procedures in the Rest of World.

Source: “Global Dynamics of Surgical and Interventional Cardiovascular Procedures, 2015-2022”, Report #C500 (MedMarket Diligence, LLC)

The reasons behind the growth in surgical sealants, glues, hemostats

Surgical sealants, glues, and hemostats are now a routine part of closing and managing wounds, with their use determined by demand from patients, surgeons, and healthcare systems that has in turn been enabled by innovations from technology development.

From our global analysis of sealants, glues, and hemostats, here are the elements that determine the forecast for their sales:

  • Product adoption trends, driven by better formulations, especially for use in MIS and other applications
  • Growth in different formulations developed for different clinical applications
  • Geographic market growth patterns and trends
  • Patient preferences
  • Growth in minimally invasive surgical procedures
  • Growth in products designed to work in MIS procedures
  • Growth rates driven by growing clinical utility
  • Surgeon preferences and adoption rate
  • Geographic market shifts (slowing growth rates in the U.S. and burgeoning growth in A/P, especially China due to its effort to modernize its healthcare system)
  • Demographically driven population shifts — age-related demand
  • Growth in surgical procedure volumes in MIS and other applications
  • Growth in the # of procedures performed in ambulatory surgical centers and doctors offices

 

Companies in the Market

Companies focused on wound closure find plenty of competition. Below is a selected list of current companies active in this field. M&A and even new startups will mold this list over the next five years.

Adhesys Medical, Adhezion Biomedical LLC, Advanced Medical Solutions, Arch Therapeutics, B. Braun Melsungen AG, Baxter, Cellphire, Chemence Medical, Cohera Medical, Connexicon Medical Ltd., Covalon Technologies, Covidien (Medtronic), CR Bard, CryoLife, CSL Behring, Endomedix, Entegrion, Ethicon (JNJ), Gecko Biomedical, Grifols International, Hyperbranch Medical, Integra LifeSCiences, LifeBond, Mallinckrodt, Medline Industries, Meyer-Haake GmbH, Ocular Therapeutics, Pfizer, Sealantis, Suneris.

The cumulative result of all these forces, drivers, and trends is a market with significant growth in some geographic markets and specific products. One need only consider the hemostat market to recognize these trends.

Source: MedMarket Diligence, LLC; Report #S290; Order online.

Medtech fundings for May 2017

Medtech fundings for May 2017 came in at a total $579 million, led by the $76.5 million raised by Outset Medical, the $57.7 million funding by CVRx, the $49 million raised by Intrinsic Therapeutics, the $46 million by Magenta Therapeutics and the $45 million by Advanced Cardiac Therapeutics.

Below are the top funding for the month. The complete list of fundings are shown at link (refresh your browser for updates during the month).

Source: Compiled by MedMarket Diligence, LLC.

For a historical listing of medtech fundings by month since 2009, see link.

Bioengineered skin and skin substitutes in wound management

Bioengineered skin was developed because of the need to cover extensive burn injuries in patients who no longer had enough skin for grafting. Not so long ago, a patient with third degree burns over 50% of his body surface usually died from his injuries. That is no longer the case. Today, even someone with 90% total body surface area burn has a good chance of surviving. With the array of bioengineered skin and skin substitutes available today, such products are also finding use for chronic wounds, in order to prevent infection, speed healing and provide improved cosmetic results.

Skin used in wound care may be autograft (from the patient’s own body, as is often the case with burn patients), allograft (cadaver skin), xenogeneic (from animals such as pigs or cows), or a combination of these. Bioengineered skin substitutes are synthetic, although they, too, may be combined with other products. It consists of an outer epidermal layer and (depending on the product) a dermal layer, which are embedded into an acellular support matrix. This product may be autogenic, or from other sources. Currently most commercial bioengineered skin is sheets of cells derived from neonatal allogenic foreskin. This source is chosen for several reasons: because the cells come from healthy newborns undergoing circumcision, and therefore the tissue would have been discarded anyway; foreskin tissue is high in epidermal keratinocyte stem cells, which grow vigorously; and because allergic reactions to this tissue is uncommon.

Bioengineered skin and skin substitutes are on the market and in development by LifeCell (Acelity), Organogenesis, Smith & Nephew, Organogenesis, Vericel Corporation (formerly Aastrom Biosciences), Mölnlycke Health Care, Integra LifeSciences, Smith & Nephew, Stratatech Corporation, A-Skin, University Children’s Hospital, Zurich; EuroSkinGraft.

The market may become more crowded as growth in the adoption of these products draws more competitors. Bioengineered skin and skin substitutes will drive more revenue than any other segment of the broader wound management market.

Growth in Advanced Wound Market Segments, 2014 to 2024

Competitors’ positions in bioengineered skin are variable based on their geographic presence. See shares in the U.S., the UK, and Germany for bioengineered skin & skin substitutes.

 

Source: MedMarket Diligence, LLC; Report #S251, “Wound Management to 2024.”

 

Source: MedMarket Diligence, LLC; Report #S251, “Wound Management to 2024.”

Source: MedMarket Diligence, LLC; Report #S251, “Wound Management to 2024.”

 

The rise and fall of medical technologies

When does one recognize that horse-and-buggy whips are in decline and auto-mobiles are on the rise?

When does one recognize that a new technology is a definite advance over established ones in the treatment of particular disease, in cost or quality?

Technologies go through life cycles.

A medical technology is introduced that is found effective in the management of a disease. Over time, the technology is improved upon marginally, but eventually a new technology, often radically different, emerges that is more effective or better (cheaper, less invasive, easier to use). It enters the market, takes market share from and grows, only to be later eclipsed by a new (apologies) “paradigm”. Each new technology, marginal or otherwise, advances the limit of what is possible in care.

Predicting the marginal and the more radical innovation is necessary to illustrate where medicine is headed, and its impact. Many stakeholders have interest in this — insurance companies (reimbursing technologies or covering the liabilities), venture capitalists, healthcare providers, patients, and the medical technology companies themselves.

S-curves illustrate the rise in performance or demand over time for new technologies and show the timing and relative impact of newer technologies when they emerge. Importantly, the relative timing and impact of emerging technologies can be qualitatively and quantitatively predicted. Historic data is extremely useful predicting the rise and fall of specific medical technologies in specific disease treatment.

Following are two examples of diseases with multiple technologies arcing through patient demand over time.

  • Ischemic Heart Disease Past, Current, and Future Technologies
    • Open bypass
    • Percutaneous transluminal coronary angioplasty
    • Minimally invasive direct coronary artery bypass (MIDCAB)
    • Percutaneous CABG
    • Stem-cell impregnated heart patches

The treatment of ischemic heart disease, given the seriousness of the disease and its prevalence, has a long history in medicine and within the past fifty years has a remarkable timeline of innovations. Ischemia is condition in which inadequate blood flow to an area due to constriction of blood vessels from inflammation or atherosclerosis can cause cell death. In the case of cardiac ischemia, in which the coronary arteries that supply the heart itself with blood are occluded, the overall cell death can result in myocardial infarction and death.

The effort to re-establish adequate blood flow to heart muscle has evolved from highly invasive surgery in which coronary artery bypass graft (CABG) requires cutting through the patient’s sternum and other tissues to access the heart, then graft arteries and/or veins to flow to the poorly supplied tissue, to (2) minimally invasive, endoscope procedures that do not require cutting the sternum to access the heart and perform the graft and significantly improve healing times and reduced complications, to as illustrated, multiple technologies rise and fall over time with their impacts and their timing considered.

Technology S-Curves in the Management of Ischemic Heart Disease

(Note: These curves are generally for illustrative purposes only; some likely dynamics may not be well represented in the above. Also note that, in practice, demand for old technologies doesn’t cease, but declines at a rate connected to the rise of competing technologies, so after peaking, the S-curves start a descent at various rates toward zero. Also, separately note that the “PTCA” labeled curve corresponds to percutaneous transluminal coronary angioplasty, encompassing the percutaneous category of approaches to ischemic heart disease. PTCA itself has evolved from balloon angioplasty alone to the adjunctive use of stents of multiple material types with or without drug elution and even bioabsorbable stents.)
Source: MedMarket Diligence, LLC

Resulting Technology Shifts

Falling: Open surgical instrumentation, bare metal stents.
Rising and leveling: thoracoscopic instrumentation, monitors
Rising later: stem-cells, extracellular matrices, atherosclerosis-reducing drugs
Rising even later: gene therapy

The minimally invasive technologies enabled by thoracoscopy (used in MIDCAB) and catheterization pulled just about all the demand out of open coronary artery bypass grafting, though the bare metal stents used initially alongside angioplasty have also been largely replaced by drug-eluting stents, which also may be replaced by drug-eluting balloon angioplasty. Stem cells and related technologies used to deliver them will later represent new growth in treatment of ischemia, at least to some degree at the expense of catheterization (PTCA and percutaneous CABG). Eventually, gene therapy may prove able to prevent the ischemia to develop in the first place.

  • Wound Management Past, Current, and Future Technologies
    • Gauze bandages/dressings
    • Hydrogel, alginate, and antimicrobial dressings
    • Negative pressure wound therapy (NPWT)
    • Bioengineered skin substitutes
    • Growth factors

Another great example of a disease or condition treated by multiple evolving technologies over time is wound management, which has evolved from simple gauze dressings to advanced dressings, to systems like negative pressure wound therapy, hyperbaric oxygen and others, to biological growth factors to bioengineered skin and skin substitutes.

Technology S-Curves in the Management of Ischemic Heart Disease

Source: MedMarket Diligence, LLC

Resulting Technology Shifts

Falling: Traditional gauze and other simple dressings
Falling: NPWT, hyperbaric oxygen
Rising: Advanced wound dressings, bioengineered skin, growth factors

Wound management has multiple technologies concurrently available, rather than sequential (when one largely replaces the other) over time. Unsurprisingly, traditional dressings are in decline. Equipment-related technologies like NPWT and hyperbaric oxygen are on the wane as well. While wound management is not a high growth area, advanced dressings are rising due to their ability to heal wounds faster, an important factor considering that chronic, slow-healing wounds are a significant contributor to high costs. Bioengineered skin is patient-specific, characterized by faster healing and, therefore, rising.

Medtech fundings for April 2017

Medtech fundings for April 2017 stand at $524 million, led by the $120 million credit facility secured by Endologix, followed by $40 million raised by Cardiovascular Systems, $36 million by ALung Technologies, $32 million by Frequency Therapeutics, and $30 million by ProTom International.

Below are the top listings of medtech fundings for the month to date. For a complete listing of fundings to date, see link.

Source: Compiled by MedMarket Diligence, LLC

For a complete list of medtech fundings recorded since 2009, see link.

The global dynamics of cardiovascular surgical and interventional procedures

This is an excerpt from Report #C500, “Cardiovascular Procedures to 2022.”

Cardiovascular Procedures in 2016

• Coronary artery bypass graft (CABG) surgery;
 • Coronary angioplasty and stenting;
 • Lower extremity arterial bypass surgery;
  • Percutaneous transluminal angioplasty (PTA) with and without bare metal and drug-eluting stenting;
  • Peripheral drug-coated balloon angioplasty;
  • Peripheral atherectomy;
  • Surgical and endovascular aortic aneurysm repair;
  • Vena cava filter placement
  • Endovenous ablation;
  • Mechanical venous thrombectomy;
  • Venous angioplasty and stenting;
  • Carotid endarterectomy;
  • Carotid artery stenting;
  • Cerebral thrombectomy;
  • Cerebral aneurysm and AVM surgical clipping;
  • Cerebral aneurysm and AVM coiling & flow diversion;
  • Left Atrial Appendage closure;
  • Heart valve repair and replacement surgery;
  • Transcatheter valve repair and replacement;
  • Congenital heart defect repair;
  • Percutaneous and surgical placement of temporary and permanent mechanical cardiac support devices;
  • Pacemaker implantation;
  • Implantable cardioverter defibrillator placement;
  • Cardiac resynchronization therapy device placement;
  • Standard SVT & VT ablation; and
  • Transcatheter AFib ablation

In 2016, the cumulative worldwide volume of the most prevalent cardiac surgeries and other  cardiovascular procedures (at right) is projected to approach 15.05 million surgical and transcatheter interventions. This will include:

  • in coronart artery disease, roughly 4.73 million coronary revascularization procedures via coronary artery bypass graft (CABG) and percutaneous coronary intervention (PCI) or about 31.4% of the total),
  • close to 4 million percutaneous and surgical peripheral artery revascularization procedures (or 26.5% of the total);
  • about 2.12 million cardiac rhythm management procedures via implantable pulse generator placement and arrhythmia ablation (or 14.1% of the total);
  • over 1.65 million  chronic venous insufficiency, deep vein thrombosis, and pulmonary embolism targeting venous interventions (representing 11.0% of the total);
  • more than 992 thousand surgical and transcatheter heart defect repairs and  valve replacement or valve repair  (or 6.6% of the total);
  • close to 931 thousand acute stroke prophylaxis and treatment procedures (contributing 6.2% of the total);
  • over 374 thousand abdominal and thoracic aortic aneurysm endovascular and surgical repairs (or 2.5% of the total); and
  • almost 254 thousand placements of temporary and permanent mechanical cardiac support devices in bridge to recovery, bridge to transplant, and destination therapy indications (accounting for about 1.7% of total procedure volume).

During the period 2016 to 2022, the total worldwide volume of covered cardiovascular procedures is forecast to expand on average by 3.7% per annum to over 18.73 million corresponding surgeries and transcatheter interventions in the year 2022. The largest absolute gains can be expected in peripheral arterial interventions (thanks to explosive expansion in utilization of drug-coated balloons in all market geographies), followed by coronary revascularization (supported by continued strong growth in Chinese and Indian PCI utilization) and endovascular venous interventions (driven by grossly underserved patient caseloads within the same Chinese and Indian market geography).

The latter (venous) indications are also expected to register the fastest (5.1%) relative procedural growth, followed by peripheral revascularization (with 4.0% average annual advances) and aortic aneurysm repair (projected to show a 3.6% average annual expansion).

http://mediligence.com/c500/

Geographically, Asian-Pacific (APAC) market geography accounts for slightly larger share of the global CVD procedure volume than the U.S. (29.5% vs 29,3% of the total), followed by the largest Western European states (with 23.9%) and ROW geographies (with 17.3%). Because of the faster growth in all covered categories of CVD procedures, the share of APAC can be expected to increase to 33.5% of the total by the year 2022, mostly at the expense of the U.S. and Western Europe.

However, in relative per capita terms, covered APAC territories (e.g., China and India) are continuing to lag far behind developed Western states in utilization rates of therapeutic CVD interventions with roughly 1.57 procedures per million of population performed in 2015 for APAC region versus about 13.4 and 12.3 CVD interventions done per million of population in the U.S. and largest Western European countries.


Report #C500: “Global Dynamics of Surgical and Interventional Cardiovascular Procedures, 2015-2022.” Request excerpts.

This report may be purchased for immediate download at link.