Here are six key trends we see in the global market next in surgical sealants, glues, and hemostats:
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.
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.
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.
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.
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.
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”.
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 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)
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.
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 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
Percutaneous transluminal coronary angioplasty
Minimally invasive direct coronary artery bypass (MIDCAB)
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
Hydrogel, alginate, and antimicrobial dressings
Negative pressure wound therapy (NPWT)
Bioengineered skin substitutes
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.
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 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.
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).
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.
Market shares for sales of sealants, glues, and hemostats vary considerably from region to region globally due to the significant variations in the local market demand, rate of adoption of specific manufacturers’ products, the regulatory climate, local economies, and other factors. Consequently, manufacturers with significant share of sales in the U.S. or Europe or Asia/Pacific may have considerably lower or higher shares in other regions.
In the U.S., Ethicon and Baxter have dominant positions in sales of surgical sealants. However, in Europe and Asia/Pacific, Baxter has substantially smaller position, particularly relative to competitors like Takeda Pharmaceuticals and The Medicines Company.
In the market for hemostats, similarly, Ethicon and Baxter have dominant position in the U.S. market, but in Asia/Pacific and Europe, Baxter is subordinate to Takeda Pharmaceuticals, CryoLife, and others.
Medtech fundings for March 2017 totaled over $2 billion, led by the $1.2 billion raise by ConvaTec, the $59 million IPO of Symetics, the $50 million Series C funding of Moximed, the $45 million funding of Corindus, and the $40 million funding round of VertiFlex.
The complete list of fundings in medtech for March 2017 are shown at link. Below are the top fundings for the month.
Source: Compiled by MedMarket Diligence, LLC
For a historical list of fundings by month since 2009, see link.
The nature of graphene’s structure and its resulting traits are responsible for a tremendous burst of research focused on applications.
Find cancer cells. Research at the University of Illinois at Chicago showed that interfacing brain cells on the surface of a graphene sheet allows the ability to differentiate a single hyperactive cancerous cell from a normal cell. This represents a noninvasive technique for the early detection of cancer.
Graphene sheets capture cells efficiently. In research similar to that U. Illinois, modification of the graphene sheet by mild heating enables annealing of specific targets/analytes on the sheet which then can be tested. This, too, offers noninvasive diagnostics.
Contact lens coated with graphene. While the value of the development is yet to be seen, researchers in Korea have learned that contact lenses coated with graphene are able to shield wearers’ eyes from electromagnetic radiation and dehydration.
Cheaply mass-producing graphene using soybeans. A real hurdle to graphene’s widespread use in a variety of applications is the cost to mass produce it, but Australia’s CSIRO has shown that an ambient air process to produce graphene from soybean oil, which is likely to accelerate graphenes’ development for commercial use.
Advanced materials development teams globally are spinning out new materials that have highly specialized features, with the ability to be manufactured under tight control.
3D manufacturing leads to highly complex, bio-like materials. With applications across many industries using “any material that can be crushed into nanoparticles”, University of Washington research has demonstrated the ability to 3D engineer complex structures, including for use as biological scaffolds.
Hydrogels and woven fiber fabric. Hokkaido University researchers have produced woven polyampholyte (PA) gels reinforced with glass fiber. Materials made this way have the structural and dynamic features to make them amenable for use in artificial ligaments and tendons.
Sound-shaping metamaterial. Research teams at the Universities of Sussex and Bristol have developed acoustic metamaterials capable of creating shaped sound waves, a development that will have a potentially big impact on medical imaging.
In vitro testing models that more accurately reflect biological systems for drug testing and development will facilitate clinical diagnostics and clinical research.
Stem cells derived neuronal networks grown on a chip. Scientists at the University of Bern have developed an in vitro stem cell-based bioassay grown on multi-electrode arrays capable of detecting the biological activity of Clostridium botulinum neurotoxins.
Used for mimicking heart’s biomechanical properties. At Vanderbilt University, scientists have developed an organ-on-a-chip configuration that mimics the heart’s biomechanical properties. This will enable drug testing to gauge impact on heart function.
Used for offering insights on premature aging, vascular disease. Brigham and Women’s Hospital has developed organ-on-a-chip model designed to study progeria (Hutchinson-Gilford progeria syndrome), which primarily affects vascular cells, making this an affective method for the first time to simultaneously study vascular diseases and aging.