Surgical wounds account for the vast majority of skin injuries. We estimate that there are approximately 100 million surgical incisions per year, growing at 3.1% CAGR, that require some wound management treatment. About 16 million operative procedures were performed in acute care hospitals in the USA. Approximately 80% of surgical incisions use some form of closure product: sutures, staples, and tapes. Many employ hemostasis products, and use fabric bandages and surgical dressings.
Surgical procedures generate a preponderance of acute wounds with uneventful healing and a lower number of chronic wounds, such as those generated by wound dehiscence or postoperative infection. Surgical wounds are most often closed by primary intention, where the two sides across the incision line are brought close and mechanically held together. Overall the severity and size of surgical wounds will continue to decrease as a result of the continuing trend toward minimally invasive surgery.
Surgical wounds that involve substantial tissue loss or may be infected are allowed to heal by secondary intention where the wound is left open under dressings and allowed to fill by granulation and close by epithelialization. Some surgical wounds may be closed through delayed primary intention where they are left open until such time as it is felt it is safe to suture or glue the wound closed.
Traumatic wounds occur at the rate of 50 million or more every year worldwide. They require cleansing and treatment with low-adherent dressings to cover the wound, prevent infection, and allow healing by primary intention. Lacerations are a specific type of trauma wound that are generally minor in nature and require cleansing and dressing for a shorter period. There are approximately 20 million lacerations a year as a result of cuts and grazes; they can usually be treated in the doctors’ surgery, outpatient medical center or hospital A&E departments.
Burn wounds can be divided into minor burns, medically treated, and hospitalized cases. Outpatient burn wounds are often treated at home, at the doctor’s surgery, or at outpatient clinics. As a result, a large number of these wounds never enter the formal health service system. According to the World Health Organization (WHO), globally about 11 million people are burned each year severely enough to require medical treatment. We estimate that approximately 3.5 million burns in this category do enter the outpatient health service system and receive some level of medical attention. In countries with more developed medical systems, these burns are treated using hydrogels and advanced wound care products, and they may even be treated with consumer-based products for wound healing.
Medically treated burn wounds usually receive more informed care to remove heat from the tissue, maintain hydration, and prevent infection. Advanced wound care products are used for these wounds. There are approximately 6.0 million burns such as this that are treated medically every year.
Hospitalized burn wounds are rarer and require more advanced and expensive care. These victims require significant care, nutrition, debridement, tissue grafting and often tissue engineering where available. They also require significant follow-up care and rehabilitation to mobilize new tissue, and physiotherapy to address changes in physiology. Growth rates within the burns categories are approximately 1.0% per annum.
Chronic wounds generally take longer to heal, and care is enormously variable, as is the time to heal. There are approximately 7.4 million pressure ulcers in the world that require treatment every year. Many chronic wounds around the world are treated sub-optimally with general wound care products designed to cover and absorb some exudates. The optimal treatment for these wounds is to receive advanced wound management products and appropriate care to address the underlying defect that has caused the chronic wound; in the case of pressure ulcers a number of advanced devices exist to reduce pressure for patients. There are approximately 9.7 million venous ulcers, and approximately 10.0 million diabetic ulcers in the world requiring treatment. Chronic wounds are growing in incidence due to the growing age of the population, and the growth is also due to increasing awareness and improved diagnosis. Growth rates for pressure and venous ulcers are 6%–7% in the developed world as a result of these factors.
Diabetic ulcers are growing more rapidly due mainly to increased incidence of both Type I and maturity-onset diabetes in the developed countries around the world. The prevalence of diabetic ulcers is rising at 9% annually. Every year 5% of diabetics develop foot ulcers and 1% require amputation. The recurrence rate of diabetic foot ulcers is 66%; the amputation rate rises to 12% with subsequent ulcerations. At present, this pool of patients is growing faster than the new technologies are reducing the incidence of wounds by healing them.
Wound management products are also used for a number of other conditions including amputations, carcinomas, melanomas, and other complicated skin cancers, all of which are on the increase.
A significant feature of all wounds is the likelihood of pathological infection occurring. Surgical wounds are no exception, and average levels of infection of surgical wounds are in the range of 7%–10%, depending upon the procedure. These infections can be prevented by appropriate cleanliness, surgical discipline and skill, wound care therapy, and antibiotic prophylaxis. Infections usually lead to more extensive wound care time, the use of more expensive products and drugs, significantly increased therapist time, and increased morbidity and rehabilitation time. A large number of wounds will also be sutured to accelerate closure, and a proportion of these will undergo dehiscence and require aftercare for healing to occur.
For the detailed coverage of wounds, wound management products, companies, and markets, see report #S251, “Worldwide Wound Management to 2024”.
Congenital heart abnormalities – which occur in an estimated 1.1% to 1.3% of infants born in the U.S. and worldwide each year – constitute leading cause of birth defect-related deaths. To-date, clinicians have identified and documented almost four dozens distinctive heart defects in newly born ranging from relatively simple and easily correctible abnormalities to complex and multiple anatomical malformations.
The most commonly encountered congenital heart abnormalities accounting for the majority of all diagnosed cases include: ventricular septal defect (VSD); tetralogy of Fallot (TOF); transposition of great vessels (TGV); atrioventricular septal defect (ASD); and coarctation of aorta (COA).
Selection of treatment protocols for congenital heart defects depends on the morphology of the abnormality and its immediate and long-term impact on cardiopulmonary function and patient’s prognosis (threat to survival).
Many asymptomatic patients with minor defects (typically representing unresolved inheritance from normal fetal development, such as trans-septal conduits that are supposed to close at birth) might be put on a “watchful waiting” regime.
Some symptomatic and functionally compromising congenital heart defects can be treated with minimally invasive percutaneous (transcatheter) techniques. To-date, percutaneous repair tools have been developed and clinically tested for several common congenital myocardial abnormalities including: patent ductus arteriosus (PDA), atrial septal defect, ventricular septal defect and patent foramen ovale (PFO). In all instances, the primary objective of the transcatheter approach was to reduce morbidity, mortality and costs associated with the procedure by achieving septal repair or closure via endovascular implantation of specially-configures occluding or sealing devices.
In cases involving complex, debilitating and life threatening congenital myocardial abnormalities (such as Tetralogy of Fallot, transposition of great vessels, etc.) one or several corrective open heart surgeries represent the only route to patient survival. Such surgeries are typically performed during the first year of infant’s life and carry a 5% risk of mortality, on average.
Source: MedMarket Diligence, LLC; Report #C500, “Global Dynamics of Cardiovascular Surgical and Interventional Procedures, 2015-2022.”
Based on the available industry data and MedMarket Diligence estimates, in 2015, approximately 387 thousand congenital heart defect repair procedures were performed worldwide, of which less invasive transcatheter interventions accounted for about 24.3% and open heart corrective surgeries for the remaining 75.7%.
For the period 2015 to 2022, the cumulative global volume of congenital heart defect repair procedures is projected to grow 1.9% per annum to approximately 444 thousand percutaneous and surgical interventions in the year 2022. The usage of transcatheter procedures can be expected to experience significantly faster 9.0% average annual growth (partially at the expense of corrective open heart surgeries for septal defects), reflecting mostly accelerated transition to minimally invasive percutaneous septal defect repair in APAC and ROW market geographies (where the latter techniques currently used only in 15% to 22% of corresponding procedures, compared to 60% to 75% in Western Europe and the U.S.).
An important determinant of “where medicine will be” in 2035 is the set of dynamics and forces behind healthcare delivery systems, including primarily the payment method, especially regarding reimbursement. It is clear that some form of reform in healthcare will result in a consolidation of the infrastructure paying for and managing patient populations. The infrastructure is bloated and expensive, unnecessarily adding to costs that neither the federal government nor individuals can sustain. This is not to say that I predict movement to a single payer system — that is just one perceived solution to the problem. There are far too many costs in healthcare that offer no benefits in terms of quality; indeed, such costs are a true impediment to quality. Funds that go to infrastructure (insurance companies and other intermediaries) and the demands they put on healthcare delivery work directly against quality of care. So, in the U.S., whether Obamacare persists (most likely) or is replaced with a single payer system, state administered healthcare (exchanges) or some other as-yet-unidentified form, there will be change in how healthcare is delivered from a cost/management perspective.
From the clinical practice and technology side, there will be enormous changes to healthcare. Here are examples of what I see from tracking trends in clinical practice and medical technology development:
Cancer 5 year survival rates will, for many cancers, be well over 90%. Cancer will largely be transformed in most cases to chronic disease that can be effectively managed by surgery, immunology, chemotherapy and other interventions. Cancer and genomics, in particular, has been a lucrative study (see The Cancer Genome Atlas). Immunotherapy developments are also expected to be part of many oncology solutions. Cancer has been a tenacious foe, and remains one we will be fighting for a long time, but the fight will have changed from virtually incapacitating the patient to following protocols that keep cancer in check, if not cure/prevent it.
Diabetes Type 1 (juvenile onset) will be managed in most patients by an “artificial pancreas”, a closed loop glucometer and insulin pump that will self-regulate blood glucose levels. OR, stem cell or other cell therapies may well achieve success in restoring normal insulin production and glucose metabolism in Type 1 patients. The odds are better that a practical, affordable artificial pancreas will developed than stem or other cell therapy, but both technologies are moving aggressively and will gain dramatic successes within 20 years.
Developments in the field of the “artificial pancreas” have recently gathered considerable pace, such that, by 2035, type 1 blood glucose management may be no more onerous than a house thermostat due to the sophistication and ease-of-use made possible with the closed loop, biofeedback capabilities of the integrated glucometer, insulin pump and the algorithms that drive it, but that will not be the end of the development of better options for type 1 diabetics. Cell therapy for type 1 diabetes, which may be readily achieved by one or more of a wide variety of cellular approaches and product forms (including cell/device hybrids) may well have progressed by 2035 to become another viable alternative for type 1 diabetics.
Diabetes Type 2 (adult onset) will be a significant problem governed by different dynamics than Type 1. A large body of evidence will exist that shows dramatically reduced incidence of Type 2 associated with obesity management (gastric bypass, satiety drugs, etc.) that will mitigate the growing prevalence of Type 2, but research into pharmacologic or other therapies may at best achieve only modest advances. The problem will reside in the complexity of different Type 2 manifestation, the late onset of the condition in patients who are resistant to the necessary changes in lifestyle and the global epidemic that will challenge dissemination of new technologies and clinical practices to third world populations.
Despite increasing levels of attention being raised to the burden of type 2 worldwide, including all its sequellae (vascular, retinal, kidney and other diseases), the pace of growth globally in type 2 is still such that it will represent a problem and target for pharma, biotech, medical device, and other disciplines.
Cell therapy and tissue engineering will offer an enormous number of solutions for conditions currently treated inadequately, if at all. Below is an illustration of the range of applications currently available or in development, a list that will expand (along with successes in each) over the next 20 years.
Cell therapy will have deeply penetrated virtually every medical specialty by 2035. Most advanced will be those that target less complex tissues: bone, muscle, skin, and select internal organ tissues (e.g., bioengineered bladder, others). However, development will have also followed the money. Currently, development and use of conventional technologies in areas like cardiology, vascular, and neurology entails high expenditure that creates enormous investment incentive that will drive steady development of cell therapy and tissue engineering over the next 20 years, with the goal of better, long-term and/or less costly solutions.
Gene therapy will be an option for a majority of genetically-based diseases (especially inherited diseases) and will offer clinical options for non-inherited conditions. Advances in the analysis of inheritance and expression of genes will also enable advanced interventions to either ameliorate or actually preempt the onset of genetic disease. As the human genome is the engineering plans for the human body, it is a potential mother lode for the future of medicine, but it remains a complex set of plans to elucidate and exploit for the development of therapies. While genetically-based diseases may readily be addressed by gene therapies in 2035, the host of other diseases that do not have obvious genetic components will resist giving up easy gene therapy solutions. Then again, within 20 years a number of reasonable advances in understanding and intervention could open the gate to widespread “gene therapy” (in some sense) for a breadth of diseases and conditions –> Case in point, the recent emergence of the gene-editing technology, CRISPR, has set the stage for practical applications to correct genetically-based conditions.
Drug development will be dramatically more sophisticated, reducing the development time and cost while resulting in drugs that are far more clinically effective (and less prone to side effects). This arises from drug candidates being evaluated via distributed processing systems (or quantum computer systems) that can predict efficacy and side effect without need of expensive and exhaustive animal or human testing.The development of effective drugs will have been accelerated by both modeling systems and increases in our understanding of disease and trauma, including pharmacogenomics to predict drug response. It may not as readily follow that the costs will be reduced, something that may only happen as a result of policy decisions.
Most surgical procedures will achieve the ability to be virtually non-invasive. Natural orifice transluminal endoscopic surgery (NOTES) will enable highly sophisticated surgery without ever making an abdominal or other (external) incision. Technologies like “gamma knife” and similar will have the ability to destroy tumors or ablate pathological tissue via completely external, energy-based systems. By 2035, technologies such as these will measurably reduce inpatient stays, on a per capita basis, since a significant reason for overnight stays is the trauma requiring recovery, and eliminating trauma is a major goal and advantage of minimally invasive technologies (e.g., especially the NOTES technology platform). A wide range of other technologies (e.g., gamma knife, minimally invasive surgery/intervention, etc.) across multiple categories (device, biotech, pharma) will also have emerged and succeeded in the market by producing therapeutic benefit while minimizing or eliminating collateral damage.
Information technology will radically improve patient management. Very sophisticated electronic patient records will dramatically improve patient care via reduction of contraindications, predictive systems to proactively manage disease and disease risk, and greatly improve the decision-making of physicians tasked with diagnosing and treating patients.There are few technical hurdles to the advancement of information technology in medicine, but even in 2035, infotech is very likely to still be facing real hurdles in its use as a result of the reluctance in healthcare to give up legacy systems and the inertia against change, despite the benefits.
Personalized medicine. Perfect matches between a condition and its treatment are the goal of personalized medicine, since patient-to-patient variation can reduce the efficacy of off-the-shelf treatment. The thinking behind gender-specific joint replacement has led to custom-printed 3D implants. The use of personalized medicine will also be manifested by testing to reveal potential emerging diseases or conditions, whose symptoms may be ameliorated or prevented by intervention before onset.
Systems biology will underlie the biology of most future medical advances in the next 20 years. Systems biology is a discipline focused on an integrated understanding of cell biology, physiology, genetics, chemistry, and a wide range of other individual medical and scientific disciplines. It represents an implicit recognition of an organism as an embodiment of multiple, interdependent organ systems and its processes, such that both pathology and wellness are understood from the perspective of the sum total of both the problem and the impact of possible solutions.This orientation will be intrinsic to the development of medical technologies, and will increasingly be represented by clinical trials that throw a much wider and longer-term net around relevant data, staff expertise encompassing more medical/scientific disciplines, and unforeseen solutions that present themselves as a result of this approach.Other technologies being developed aggressively now will have an impact over the next twenty years, including medical/surgical robots (or even biobots), neurotechnologies to diagnose, monitor, and treat a wide range of conditions (e.g., spinal cord injury, Alzheimer’s, Parkinson’s etc.).
The breadth and depth of advances in medicine over the next 20 years will be extraordinary, since many doors have been recently opened as a result of advances in genetics, cell biology, materials science, systems biology and others — with the collective advances further stimulating both learning and new product development.
See the 2016 report #290, “Worldwide Markets for Medical and Surgical Sealants, Glues, and Hemostats, 2015-2022.”
See the published report #S290, “Worldwide Markets for Medical and Surgical Sealants, Glues, and Hemostats, 2015-2022: Established and Emerging Products, Technologies and Markets in the Americas, Europe, Asia/Pacific and Rest of World”.
Sealants, glues, and hemostats must offer benefit to be adopted in clinical practice, or surgical procedures. Benefits can fall into a number of categories. These range from preventing serious complications from surgery (blood loss), improved patient outcomes (fewer complications, reduction in repeats), reductions in procedure time or other time- or cost-saving benefits, or improved aesthetic and perceived benefits. See these detailed below.
Criteria for Adjunctive Use of Hemostats, Sealants, Glues and Adhesion Prevention Products in Surgery
See the published report #S290, “Worldwide Markets for Medical and Surgical Sealants, Glues, and Hemostats, 2015-2022: Established and Emerging Products, Technologies and Markets in the Americas, Europe, Asia/Pacific and Rest of World”.
MedMarket Diligence is hours away from publishing its 2015 report on the worldwide wound management market.
The report is entitled, “Worldwide Wound Management, Forecast to 2024: Established and Emerging Products, Technologies and Markets in the Americas, Europe, Asia/Pacific and Rest of World”. The report is described in detail at link.
The very diverse field that is wound management encompasses technologies from gauze to bioengineered skin and skin substitutes and many in between. Growth rates range from flat to over 15% annually through 2024.
The highest growth segments in medical technology sectors typically derive their high growth from modest absolute changes on very small volume and therefore rarely can sustain that growth over time. However, in wound management, the use of bioengineered skin and skin substitutes will result in the highest cumulative sales compared to all segments from 2015 to 2024 — excluding, that is, the high volume segments of traditional adhesives, gauzes, and non-adherent dressings. Also noteworthy is the second highest cumulative sales over this period was for antimicrobial dressings, despite this segment having relatively modest growth on a percentage basis, but proceeding from significant sales in 2015 (already at over $1.5 billion).
During the forecast period, the most significant change evident in sales is the jump in the share of the market represented by bioengineered and other skin replacements, as noted above. But with compound annual growth rates (to 2024) in sales in the different wound segments ranging from near 1% to nearly 20% — for segments with 2015 sales at a low of $300 million and a high of $15 billion — there is considerable shifting of shares of the global wound market.
On a geographic basis, wound care technology migration, efforts to secure underserved patient caseload, and other forces result in growth rates that vary by country or region. The well-developed USA market therefore does not compare in uptake of both old and new technologies within growth markets like China and others in the Asia/Pacific region.
Wound management is an old medical practice, and wounds have not changed in nature other than the mix prevalence of different wound types. Yet, the volume of all wounds, and the need to improve they may be managed, support development of many new technology and changes in clinical practice. In turn, this drives and sustains an unusually large number of competitors.
Below is a list, drawn from the forthcoming December 2015 report (#S251) from MedMarket Diligence global wound management market, of companies that are sufficiently large or active or noteworthy for us to have specifically profiled in our report. The true number of companies in wound (and detailed but not “profiled” in our report) is in the hundreds.
The MedMarket Diligence Report #S251, “Worldwide Wound Management, Forecast to 2024: Established and Emerging Products, Technologies and Markets in the Americas, Europe, Asia/Pacific and Rest of World” (see link for details), provides a current and forecast assessment (to 2024) of the worldwide market for wound management.
Manufacturers, clinicians and others focusing on technology advancement in spine surgery are not developing radical innovations, but are making enough incremental improvements in a number of ways that result in growth in the industry. Most improvements fall into a number of categories:
New materials technologies: Historically, spinal fusion instrumentation was fabricated from metallic biomaterials, including stainless steel and titanium alloy, because of their strength and fatigue resistance. However, one key drawback of these metallic implants is incompatibility with diagnostic imaging, including MRI and CT scans, which are crucial for visualizing changes to the spinal cord and vital soft tissue structures of the spine. To overcome these issues a variety of new materials such as biocompatible carbon fiber-reinforced (CFR) thermoplastic materials and implantable polyetheretherketone (PEEK) polymers were examined as an alternative to the traditional materials. In addition to biocompatibility, biostability and compatibility with diagnostic imaging, these advanced thermoplastic polymers provide a range of mechanical properties that are well suited to the demanding environment of spinal implants.
Implantable PEEK polymers are available today in an array of formulations, ranging from unfilled grades with varying molecular weight, to image-contrast and carbon fiber-reinforced grades. The first implantable unfilled PEEK polymer–PEEK-OPTIMA was pioneered in 1999 by United Kingdom-based Invibio Biomaterial Solutions. Introduced by Invibio in 2007 to provide controlled visibility through X-ray, CT and MRI technologies, image-contrast grades offer tailored opacity that allows for easier post-operative device placement verification by surgeons and clear assessment of the healing site. Also launched by Invibio in 2007, carbon fiber-reinforced (CFR) grades provide significantly increased strength and stiffness as well as a modulus similar to that of cortical bone.
The CD HORIZON LEGACY PEEK Rod from Medtronic Sofamor Danek and the EXPEDIUM™ PEEK Rod System from DePuy Spine, Inc., are examples, in which these polyetheretherketone (PEEK) polymers are radiolucent and have the ability to reduce scatter and artifact from CT and MRI images. [Picture source: MRI scan via Shutterstock]
Computer aided fixation of spinal implants: A number of proprietary techniques are being developed that provide computer or robotic alignment for the placement of spinal implants. Current research ensures that further developments will occur resulting in more extensive use of computer aided fixation. [Picture source: NIH]
Minimally invasive spine surgery: Manufacturers have development technologies in percutaneous and endoscopic approaches to spine surgery that are having (and will continue to have) a significant impact on patients, clinical practice and the market for spine products. It is producing all the expected benefits of less invasiveness — less traumatic surgery results in shorter recovery times and better outcomes and opens up spine surgery to more elderly, infirm and other patients for whom traditional spine surgery would be contraindicated. [Image: Handbook of Minimally Invasive and Percutaneous Spine Surgery; allamericanspeakers.com]
Variable axis screw systems: A variable axis screw system is a pedicular screw system that features a variable-axis head, which offers a ±25 degrees of angulation. The system also offers a pre-contoured rod. The contoured rod, along with the angulation available in the screw head, alleviates the need for rod contouring. The screw also features a pre-assembled head and double lead thread. The pre-assembled head reduces the steps required for construct assembly and the double lead thread increase the speed of screw insertion and construct assembly so that the overall operative time can be shortened. [Picture source: DePuy Synthes]
Products, technologies, markets, companies and opportunities in the spine surgery industry are the focus of the MedMarket Diligence Report #M540, “Global Market for Medical Device Technologies in Spine Surgery, 2014-2021: Established and Emerging Products, Technologies and Markets in the Americas, Europe, Asia/Pacific and Rest of World.” The next five purchasers of this report (any option) will receive a 25% discount off the published price online by entering the coupon code “spinepricectomy”.
(See the 2016 published report #S290, “Sealants, Glues, Hemostats, 2016-2022”.)
Of late, I have needed to re-emphasize the difference between absolute and relative growth in medtech markets (and its importance). So, here it is again, this time regarding surgical sealants and other wound closure products.
The lowest relative rate of growth in this industry is the well-established sutures and staples segment. Sales of these products globally, even supported by innovations in bioresorbables and laparoscopic delivery technologies, are only growing at a 5.6% compound annual growth rate from 2013 to 2018. By comparison, growth of sales of surgical glues and sealants is at 9.4% for 2013-2018.
But from an absolute sales growth point of view, sales of sutures and staples will go from $5.2 billion to $6.9 billion, or absolute growth of $1.7 billion. Simultaneously, the relatively high growth in surgical glues and sealants translates to the absolute growth from 2013 to 2018 of only $0.9 billion.
Obviously, both absolute and relative growth are of interest.