Global Dynamics of Surgical and Interventional Cardiovascular Procedures, 2015-2022. See Report #C500.
Publishing July 2016
This report covers surgical and interventional therapeutic procedures commonly used in the management of acute and chronic conditions affecting myocardium and vascular system. The latter include ischemic heart disease (and its life threatening manifestations like AMI, cardiogenic shock, etc.); heart failure; structural heart disorders (valvular abnormalities and congenital heart defects); peripheral artery disease (and limb and life threatening critical limb ischemia); aortic disorders (AAA, TAA and aortic dissections); acute and chronic venous conditions (such as deep venous thrombosis, pulmonary embolism and chronic venous insufficiency); neurovascular pathologies associated with high risk of hemorrhagic and ischemic stroke (such as cerebral aneurysms and AVMs, and high-grade carotid/intracranial stenosis); and cardiac rhythm disorders (requiring correction with implantable pulse generators/IPG or arrhythmia ablation).
The report offers current assessment and projected procedural dynamics (2015 to 2022) for primary market geographies (e.g., United States, Largest Western European Countries, and Major Asian States) as well as the rest-of-the-world.
Medical technology is, for many of its markets, being forced to look for growth from more sources, including emerging markets. Manufacturers are able to gain better margins through innovation, but their success varies by clinical application.
Cardiology. A demanding patient base (it’s life or death). Be that as it may, there are few new or untapped markets, only the opportunity for new technologies to displace existing markets. Interventional technologies are progressively enabling treatment of larger patient populations, but much growth will still be from emerging markets.
Wound management. Even the most well-established markets will see growth from innovation. The wound market just needs less growth to be happy, since small percentage growth becomes very large by volume. And yet, some of the most significant growth in the long run will be for more advanced
Surgery. Every aspect of surgery seems to be subject to attempts to improve upon it. Robotics, endoscopy, transcatheter, single-port, incisionless, natural orifice. Interventional options are increasing the treatable patient population, and it seems likely that continued development (e.g., materials, including biodegradables, use of drug or other coatings, including cells) will yield more routine procedures for more and different types of conditions, many of which have been inadequately served, if it all.
Orthopedics. Aging populations demanding more agility and mobility will drive orthopedic procedures and device use. Innovation still represents some upside, but more from 3D printing than other new technologies being introduced to practice.
Tissue/Cell Therapy. This is a technology opportunity (and represents radical innovation for most clinical areas), but it is also a set of target clinical applications, since tissues/cells are being engineered to address tissue or cell trauma or disease. Growth is displacing existing markets with new technology, such as bioengineered skin, tendons, bladders, bone, cardiac tissue, etc. These are fundamentally radical technologies for the target applications.
Below is my conceptual opinion on the balance of growth by clinical area coming from routine innovation (tweaks, improvements), radical innovation (whole new “paradigms” like cell therapy in cardiology), and emerging market growth (e.g., China, S. America).
Even excluding the three traditional wound care dressing segments, the advanced wound care market is enormous — over the next ten years, it will grow at a compound annual growth rate of at least 7.7%, and is forecast to reach nearly $16 billion by 2024. This market is being driven by several inter-related factors: the increasing percentage of the aged (65years old and over) in country populations, the fact that people are living longer, obesity, the virtually epidemic rise of Type 2 diabetes, government policies intended to curb healthcare spending, and an increasingly sedentary population. The latter trend is seen especially in developed countries, but is also on the rise in less-developed countries as their economic standing improves and the middle class grows in numbers.
Certain product segments are forecast to have stronger growth than others. Sales of bioengineered skin & skin substitutes for wound care will increase at a CAGR of at least 15%, while sales of foam and hydrocolloid dressings will be growing at high single-digit rates, respectively.
From Report S251 (see global analysis and the above detail for Americas (with detail for U.S., Rest of North America and Latin America), Europe (United Kingdom, Germany, France, Spain, Italy, and Rest of Europe), Asia/Pacific (Japan, Korea, and Rest of Asia/Pacific) and Rest of World.
Do you wish to see excerpts from “Worldwide Wound Management, Forecast to 2024: Established and Emerging Products, Technologies and Markets”?
It was once quite convenient for manufacturers of deluxe medical widgets to worry only about other manufacturers of deluxe medical widgets. Manufacturers must now widen their perspective to consider current and future competition (and opportunity) from whatever direction it may come. –> Just thought I might chime in and suggest that, if you do make such widgets, it might be a good idea to maybe throw at least an occasional sidelong glance at biotech. (Most of you are, great, but some of you think biotech is too far away to compete…)
Organ Bioengineering is years away and poses little challenge to medical devices …FALSE. Urinary bladders have been engineered for pediatric applications. Bioengineered skin (the “integumentary” organ) is now routinely bioengineered for burns, chronic wounds, and other wound types. Across a wide range of tissue types (bone, cardiac, smooth muscle, dermal, etc.) scientists — clinicians — have rapidly developed technologies to direct the construction and reconstruction of these tissues and restore their structure and function.
Cell Biology. Of course cells are engineered into tissues as part of the science of tissue engineering, but combine this with advances in engineering not just between cells but between cells AND within cells and (…sound of my head exploding). With the sum of the understanding and capacity to control we have gained over cellular processes over the past few decades now rapidly accelerating, medical science is fast approaching the point at which it can dictate outcomes for cell, tissues, organs, organ systems, and humans (I am not frightened, but excited, with caution). Our understanding and proficiency gained in manipulating processes from cell division to pluripotency to differentiation to senescence to death OR NOT has profound consequences for fatal, debilitating, incurable, devastating, costly, and nearly every other negative superlative you can conceive.
CRISPR*: This is a new, relatively simple, but extraordinary tool allowing researchers or, more importantly, physicians to potentially swap out defective genes with healthy ones. See Nature. (* clustered regularly interspersed short palindromic repeats)
Biotech has, over its history, often succeeded in getting attention, but has had less success justifying it, leaving investors rudely awakened to its complexities. It has continued, however, to achieve legitimately exciting medical therapeutic advances, if only as stepping stones in the right direction, like mapping the human genome, the development of polymerase chain reaction (“PCR”), and biotech-driven advances in molecular biology, immunology, gene therapy, and others, with applications ripe for exploitation in many clinical specialties, Sadly, the agonizing delay between advanced and “available now” has typically disappointed manufacturers, investors, clinicians and patients alike. CRISPR and other tools already available (see Genetic Engineering News and others) are poised to increase the expectations – and the pace toward commercialization – in biotechnology.
Vaccines and Infectious Disease: Anyone reading this who has been under a rock for lo these many years, blissfully ignorant of SARS, Ebola, Marburg, MRSA, and many other frightening acronyms besides HIV/AIDS (more than enough for us already) should emerge and witness the plethora of risks we face (and self-inflict through neglect), any one of which might ultimately overwhelm us if not medically then economically in their impacts. But capitalists (many altruistic) and others have come to the rescue with vaccines such as for malaria and dengue-fever and, even, one for HIV that is in clinicals.
Critical Mass, Synergies, and Info Tech. Biotechnology is succeeding in raising great gobs of capital (if someone has a recommended index/database on biotech funding, let me know?). Investors appear to be forgetful increasingly confident (in the 1990s, I saw big layoffs in biotech because of ill-advised investments, but that was then…) that their money will result in approved products with protected intellectual property and adequate reimbursement and manageable costs in order to result in attractive financials. The advances in biological and medical science alone are not enough to account for this, but such advances are almost literally being catalyzed by information technologies that make important connections faster, yielding understanding and new opportunities. The net effect of individual medically-related disciplines (commercial or academic) advancing research more efficiently as a result of info tech and info sharing/synergies between disciplines is the expected burst of medical benefits ensuing from biotech. (Take a look also at Internet of DNA.)
Very decided shifts are taking place in the wound management market as advanced wound technologies take up caseload from traditional technologies like gauze and others. It becomes evident that traditional products once representing above average sales are now projected to be below average (gauze) as are even a moderately new technology, “negative pressure wound therapy devices” (NPWD), while bioengineered skin and skin substitutes will represent “above average”.
Global Wound Management Market, Above/Below Average Sectors, 2015 & 2024
Despite the tepid growth of traditional wound management products, they remain very large markets that even the most aggressively growing segments will require time to match that volume. Bioengineered skin and skin substitutes are moving fast in that direction.
Global CAGR 2016-2024 for Wound Management Segments
Whether sales growth arises by a preferred adoption of one technology over another or by better than average economic conditions — or both, sales of wound management products are driven by technology adoption rates that vary by country, clinical practice patterns, reimbursement and other variables.
We assessed current and forecast sales for the following products:
Traditional Adhesive Dressings
Negative Pressure Wound Therapy
Bioengineered Skin & Skin Substitutes
For all product segments but the traditional adhesive, gauze, and non-adherent wound care products (which were assessed only at the global level), we assessed growth in each of the following countries/regions: Americas (USA, Rest of North America, Latin America), Europe (United Kingdom, Germany, Italy, France, Spain, Rest of Europe), Asia/Pacific (Japan, Korea, Rest of Asia/Pacific), and Rest of World.
From our examination (report #S251) of the global market for wound management products, below are the top product-country cohorts in terms of projected compounded sales growth from 2015 to 2024.
There are literally many hundreds—perhaps thousands—of companies in wound care, ranging from tiny companies operating with a couple of employees in a developing country, to large-cap market leaders with thousands of employees located in offices around the world.
The following exhibit shows that a handful of companies account for a large part of the global advanced wound care market. Acelity LP, Inc., which is a merger of Kinetic Concepts, Inc. (KCI), Systagenix, Inc. and LifeCell, is now one of the leaders in this market, and accounts for about 20% of wound care revenues. Acelity is followed by Smith & Nephew plc, which is followed by several other companies with 13% or less of the market. The hundreds of other companies fall into the 20% of “Other”. In summary, about seven companies account for approximately 80% of the advanced wound care market worldwide.
Bioengineered skin, skin substitutes, foam dressings, hydrocolloids, and growth factors are among top growth segments in a global market for advanced wound management that is otherwise modest in growth, but high in volume.
The 2016 global wound management market will hit nearly $15 billion. With sales growing at just better than 5% annually on population growth, migration of technologies to developing markets, and increased per capita utilization, the aggregate market is stably tied to persistent caseload. This regular, high volume of wound product sales supports a steady stream of innovation intended to gain even the smallest edge in share, an advantage that gains its value in real terms from the multiple of such a large global caseload.
In a market in which autografts and allografts have long been common, the development of cost-effective and safe bioengineered skin and skin substitutes is finding ready adoption in wounds of all types, but particularly burn wounds.
Due to their small base of existing sales thus far, even incremental expansion of sales in the use of biological growth factors in wound management reflects high growth through the forecast period.
Biotech need not be behind the higher growth in wound management technologies. Excellent growth prospects are also seen in foams, hydrogels, hydrocolloids, and other dressing materials.
Physical systems, including negative pressure wound devices, are not demonstrating growth prospects as good as traditional wound dressing products, let alone advanced wound products.
In short, the large global market is stable and growing at best modestly, but within this market, advanced wound management technologies’ sales are accelerating at the expense of traditional wound products. Growth in wound management is clearly coming from within.
We see three key forces underlying investment trends in medical technology:
The spectrum of competition has been broadened and sometimes isn’t even obvious.
Widely different technologies (as in treatment of coronary artery disease, see white paper) can address a clinical condition, with the solution to the problem being the focus of new investment.
New materials for devices, drug-device hybrids, biotech-driven solutions, and other innovations can create competition between very different technologies. As a result, the paradigms and truths that held true in the past, when devices only went head-to-head with devices, are no longer relevant, creating the need to better assess the competitive landscape.
Manufacturers must there develop good market awareness, as in being cognizant of all the potential source of competition, such as from companies in adjacent markets who might pivot and seize market share.
Money flows to niches in medtech where the demand for clinical utility is high.
The biggest forces driving medtech are increasing patient populations or the cost of managing them. Niches that address the challenges of an older population with unsolved painful and or costly conditions (orthopedics, chronic wounds, diabetes, bariatrics) have prominent cost targets that stimulate investment.
Patient demographics, healthcare cost/utility demands and other forces make some medtech niches very attractive, even if only as a result of technology migration (e.g., to growth geo markets).
Underserved patient populations command almost as much attention as the untapped patient populations.
There is much potential return on investment to be made in blockbuster treatments, but these can be financial sinkholes compared to less grandiose technology solutions. A motive force exists in medtech, centered around healthcare costs, that is relentlessly forcing medical technology innovators to find opportunity within existing markets, by eliminating cost (e.g., shifting care to outpatient as via minimally invasive technologies). Significant medical technology investment has already recognized the value in targeting conditions for which new technology, new clinical practices and/or simply new ways of thinking can improve the quality of life, patient costs or both.
Medtech investment is most serious when it is (1) in high dollar value, or (2) tied to the formation of companies. It reflects confidence in that sector to the degree set by the investment.
In the past five years, MedMarket Diligence has tracked the identification of over 600 companies in medtech. Below is the distribution of their focus across a large number of clinical and technology areas (multiple possible, as in “minimally invasive” and “orthomusculoskeletal”).
These companies have also been tracked through their specific investments (detailed historically at link).
Cardiology, orthopedics, and surgery are mainstay drivers of new technology development in medtech, as has been the push for minimally invasive therapies, but nanotechnology, interventional (e.g., transcatheter) technologies, biomaterials, wound management and other niches have a steady stream of new company formations.
See recent reports from MedMarket Diligence in the following clinical areas.