Traditional and Advanced Wound Product Types

Wound management technologies have been under development for hundreds of years. The current state of product and technology development is now largely represented by thirteen different product categories described with their specific typical applications (1)Specific companies and products are detailed in “Wound Management to 2026”, report S254.

Wound Management Technologies By Type

Wound product categoryDescriptionPotential applicationsProduct and Manufacturer Examples
Traditional GauzeInexpensive, common, breathable, usually dries out the wound, may stick to wound causing damage when removedMay be used to secure a dressing in place, or directly over any wound type to keep it clean while allowing aeration.See link
Traditional AdherentDry, inexpensive, common, non-absorbent, will not stick to wound. Usually uses a wide mesh material with a finer mesh or foam, nonstick material.Applied directly to wound; used for large surface wounds such as abrasions or burns. Indicated when a good granulation bed has developed.

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Traditional Non-AdherentConforms to wound, keeps wound bed moist, will not stick to the surface of wound.Light to moderately exudative wounds, burns.

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FilmAvailable as adhesive, thin transparent polyurethane film, and as a dressing with a low adherent pad attached to the film.Clean, dry wounds, minimal exudate; also used to cover and secure underlying absorptive dressing, and on hard-to-bandage locations, such as heel.

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FoamPolyurethane foam dressing available in sheets or in cavity filling shapes. Some foam dressings have a semipermeable, waterproof layer as the outer layer of the dressingEnables a moist wound environment for healing. Used to clean granulating wounds with moderate to severe exudation.

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HydrogelColloids that consist of polymers that expand in water. Available in gels, sheets, hydrogel impregnated dressings.Provides moist wound environment to add moisture to dry wound, aids in cell migration, reduces pain, helps to rehydrate eschar. Used on dry, sloughy or necrotic wounds.

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HydrocolloidMade of hydroactive or hydrophilic particles attached to a hydrophobic polymer. The hydrophilic particles absorb moisture from the wound, convert it to a gel at the interface with the wound. Conforms to wound surface; waterproof and bacteria proof.Gel formation at wound interface provides moist wound environment. Dry necrotic wounds, or for wounds with minimal exudate. Also used for granulating wounds.

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AlginateA natural polysaccharide derived from seaweed; available in a range of sizes, as well as in ribbons and ropes.Because highly absorbent, used for wounds with copious exudate. Can be used in rope form for packing exudative wound cavities or sinus tracts.

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AntimicrobialBoth silver and honey are used as antimicrobial elements in dressings.Silver: Requires wound to be moderately exudative to activate the silver, in order to be effective

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CollagenAvailable in several forms, including gels, pads, pastes, particles, sheets, solutions, and are derived from bovine, porcine or avian sources. Collagen dressings are often used for PUs, VLUs, skin donor sites and surgical wounds, arterial ulcers, DFUs, second-degree burns and trauma wounds.

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NPWTComputerized vacuum device applies continuous or intermittent negative or sub-atmospheric pressure to the wound surface. NPWT accelerates wound healing, reduces time to wound closure. Comes in both stationary and portable versions.May be used for traumatic acute wound, open amputations, open abdomen, etc. Seems to increase burn wound perfusion. Also used in management of DFUs. Contraindicated for arterial insufficiency ulcers. Contraindicated if necrotic tissue is present in over 30% of the wound.

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Bioengineered Skin & Skin SubstitutesBio-engineered skin and soft tissue substitutes may be derived from human tissue (autologous or allogeneic), xenographic, synthetic materials, or a composite of these materials.Burns, trauma wounds, DFUs, VLUs, pressure ulcers, postsurgical breast reconstruction, bullous diseases

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Growth FactorsOften derived from human placenta from a healthy delivery (i.e. amniotic tissue allografts) and amniotic fluid components.May be used for any type of wound, but most often used for chronic, non-healing wounds such as DFUs and VLUs, and potentially with second-degree burns.

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Source: MedMarket Diligence, LLC; Report S254.

References   [ + ]

1. Specific companies and products are detailed in “Wound Management to 2026”, report S254

Factors Affecting Wound Healing… (more)

In addition to the factors we detailed in a past post, we show here a number of frameworks used by clinicians to properly assess the condition of wounds and the wound healing process, providing a systematic way to optimize wound healing.

“DIMES”, “TIME” and “DIDNT HEAL”

“DIMES” focuses on providing an efficient use of resources in the management of chronic wounds.

The DIMES Acronym for Treatment Planning and Products

Source: MedMarket Diligence, LLC Report S254; GS Schultz, et al. Wound bed preparation: a systematic approach to wound management. Wound Repair Regen. 2003 Mar;11 Suppl 1:S1-28.)

 

“TIME” is focused specifically on wound bed preparation, a key determinant of wound healing.

TIME Acronym for Wound Bed Preparation

Source: MedMarket Diligence, LLC Report S254; GS Schultz, et al. Wound bed preparation: a systematic approach to wound management. Wound Repair Regen. 2003 Mar;11 Suppl 1:S1-28.)

 

“DIDNT HEAL” is similarly intended to be a useful mnemonic regarding key wound healing factors.

Source: MedMarket Diligence, LLC Report S254.


March 2018: Worldwide Wound Management, Forecast to 2026″. Report #S254.

Wound Care Market Shares Worldwide

Analyzing data from Report #S254 ,”Wound Management to 2026″, we present the distribution of top competitors’ sales in each segment in 2017. Smith & Nephew, Johnson & Johnson, and 3M dominate the global wound management, with varying dominance between them — or by other companies — in each segment.

Source: MedMarket Diligence, LLC; Report #s254. (Publishing March 2018)

S&N leads the global market, following closely by JNJ. Both companies are active in multiple segments of wound management. S&N has lower traditional wound management product sales (simple dressings and bandages) and higher sales of “advanced” wound management products. J&J does $800 million more sales in traditional dressings, gauze and bandages than S&N, but lesser involvement in newer wound technologies such as NPWT, bioengineered skin, and growth factors.

Source: MedMarket Diligence, LLC; Report #s254. (Publishing March 2018)

 

Country and Regional Variability in Growth of Wound Management Sales

As illustrated in a previous post, wound management products are a spectrum from the simple to the complex:

Source: MedMarket Diligence Report #S254.

Generally, the longer the product has been around (e.g., gauze), the less complex it is compared to emerging technologies…

…BUT simpler is easy to adopt and, with well established sales, growth on a percentage basis will be low (see area in red).

Generally, new technologies incorporate rarer materials, have more complex construction, and may cost considerably more…

…BUT complex technologies may be far more effective clinically than older technologies and may allow treatment where no older technology could, and with low initial sales (penetrated potential), growth on a percentage bases will be high (see area in green).

Country and Regional Variation in Growth Rates

While this size-to-growth dynamic exists for most product types, the dynamic varies from one geographic region to the next. The time point at which a particular product/technology starts to be more rapidly adopted — or the rate at which use of  established products are use starts to decline — can vary considerably from country to country.

As a result, there will be variability in sales growth rates for a product in one country/region versus another.

For example, the 2017 to 2026 compound annual growth rate in sales of Alginates in wound management range from a low of 5.3% in one country to a high of 24.3% in another country. (If you make alginates, in which country would YOU like to compete?)

Regionally, as in USA versus Europe versus Asia/Pacific, etc., there is less variation in growth rates for any given product in that region. For alginates:

country-to-country variation in CAGR: 19%
region-to-region variation in CAGR: 7.8%

In other words, the difference between the countries with the highest and lowest CAGRs for alginate sales is 19%, while the difference between regions shows one region with a 7.8% higher CAGR for alginates than the lowest growth region.

Source: MedMarket Diligence, LLC; Report #S254.

Before chasing after that high growth rate, it is important to know the underlying volume. (Sales of $1 in year 1 and $2 in year 2 is a 100% growth rate, but it’s absolute growth of only $1.)


See the full REPORT, “Wound Management to 2026” details or order online. Please also see the forecast and market share data available separately from the report.

 

USA slipping behind Asia/Pacific markets in wound care sales

We present data from our 2016 to 2026 forecast of the global market for wound management products (report #S254, published March 2018). 


At a glimpse, you can see the overall trend in global wound management, including the relative size of each market. (The four regional sales charts are shown on the same scale to illustrate this.)  Most notably, the USA dominance of this global market is fading, as aggregate Asia/Pacific sales of all wound products will eclipse USA sales within the forecast period.

 

 

 

 

 

 


Source: MedMarket Diligence, LLC; Report #S254.

Looking at just the aggregate of all wound product types, Asia/Pacific relative sales are squeezing out shares in every other region.Source: MedMarket Diligence, LLC; Report #S254.

When we then look specifically at the USA versus Asia/Pacific, it illustrates that by 2020, Asia/Pacific’s sales of wound management products will eclipse those of the U.S., making it the largest regional wound management market.

Source: MedMarket Diligence, LLC; Report #S254.

Changes in Fortunes for Wound Management Products

Over the 2017 to 2026 period, the compound annual growth rate for the entire wound management market will approach 6%, a respectable rate of growth for an established market, though not quite high enough to encourage investment in the market as a whole.

Of course, the total wound market is comprised of a number of VERY large, slow-growing segments, like traditional adhesive dressings, gauze dressings, and non-adherent dressings, which have annual sales at $3.8 billion, $3.2 billion, and $1.3 billion, respectively.

The large volume, slow growth of the aggregate masks growth in the following segments:

  • Bioengineered skin and skin substitutes
  • Alginates
  • Foam dressings
  • Growth factors

These wound care segments have had, and will continue to have, annual growth rates at or near double-digit through 2026.

The end result of variable growth rates is that the 2026 Wound Care Market (worldwide), by comparison to 2017, will show the following changes (up/down) in each segment’s share of the total market.

Source: MedMarket Diligence, LLC; Report #S254 (publishing Mar. 2018).

The future of medicine in 2037

In the post below from 2016, we wrote of what we can expect for medicine 20 years into the future. We review and revise it anew here.

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 the Affordable Care Act (“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.  -[Editor’s note: After multiple attempts by the GOP to “repeal and replace”, the strengths of Obamacare have outweighed its weaknesses in the minds of voters who have thus voiced their opinions to their representatives, many seeking reelection in 2018.]

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.
    [Editor’s note: Immunology has surged in a wide range of cancer-related research yielding new weapons to cure cancer or render it to routine clinical management.]
  • 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. [Editor’s note: Our view of this stands, as artificial pancreases are maturing in development and reaching markets. Cell therapy still offers the most “cure-like” result, which is likely to happen within the next 20 years.]

  • Diabetes Type 2 (adult onset) will be a significant problem, governed as it is 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. [Editor’s note: the burden of Type 2 on people, families, communities, and governments globally should motivate policy, legislation, and other action, but global initiatives have a long way to travel.]

  • 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, more 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. [Editor’s note: CRISPR and other gene-editing techniques have accelerated the pace at which practical and affordable gene-therapies will reach the market.]
  • 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). [Editor’s note: We are revising our optimism about drug development being more sophisticated and streamlined. To a measurable degree, “distributed processing systems” have proven far more exciting in principle than practice, since results — marketable drugs derived this way — have been scant. We remain optimistic as a result of the rapid emergence of artificial intelligence (AI) and deep learning, which have have very credible promise to impact swaths of industry, especially in medicine.]
    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. [Editor’s note: In the late 1980s, laparoscopy revolutionized surgery for its less invasiveness. Now, NOTES procedures and external energy technologies (e.g., gamma knife) have now proven to be about as minimally invasive as medical devices can be. To be even less invasive will require development of drugs (including biotechs) that succeed as therapeutic alternatives to any kind of surgery.]

    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. [Editor’s note: Before AI and other systems will truly have an impact, IT and its policy for healthcare in the next 10 years will solve the problem of health data residing inertly behind walls that hinder efficient use of the rich, patient-specific knowledge that physicians and healthcare systems might use to improve the quality and cost of care.]
  • 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 Reports:

Report #290, “Worldwide Markets for Medical and Surgical Sealants, Glues, and Hemostats, 2015-2022.”

Report #S254, “Wound Management to 2026.”

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.”

 

MedMarket Future: Developments in Growth Technologies

Proliferation of graphene applications

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.

Materials

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.

Organ-on-a-chip

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.

Investment in medtech and biotech: Outlook

Medtech and biotech investment is driven by an expectation of returns, but rapid advances in technology simultaneously drive excitement for their application while increasing the uncertainty in what is needed to bring those applications in the market.

MedMarket Diligence has tracked technology developments and trends in © 2018, MedMarket Diligence, LLC -- advanced medical technologies, inclusive of medical devices and the range of other technologies — in biotech, pharma, others — that impact, drive, limit, or otherwise affect markets for the management of disease and trauma. This broader perspective on new developments and a deeper understanding of their limitations is important for a couple of reasons:

  1. Healthcare systems and payers are demanding competitive cost and outcomes for specific patient populations, irrespective of technology type — it’s the endpoint that matters. This forces medical devices into de facto competition with biotech, pharma, and others.
  2. Medical devices are becoming increasingly intelligent medical devices, combining “smart” components, human-device interfaces, integration of AI in product development and products.
  3. Medical devices are rarely just “medical devices” anymore, often integrating embedded drugs, bioresorable materials, cell therapy components, etc.
  4. Many new technologies have dramatically pushed the boundaries on what medicine can potentially accomplish, from the personalized medicine enabled by genomics, these advances have served to create bigger gaps between scientific advance and commercial reality, demanding deeper understanding of the science.

The rapid pace of technology development across all these sectors and the increasing complexity of the underlying science are factors complicating the development, regulatory approval, and market introduction of advanced technologies. The unexpected size and number of the hurdles to bring these complex technologies to the market have been responsible for investment failures, such as:

  • Theranos. Investors were too ready to believe the disruptive ideas of its founder, Elizabeth Holmes. When it became clear that data did not support the technology, the value of the company plummeted.
  • Juno Therapeutics. The Seattle-based gene therapy company lost substantial share value after three patients died on a clinical trial for the company’s cell therapy treatments that were just months away from receiving regulatory approval in the US.
  • A ZS Associates study in 2016 showed that 81% of medtech companies struggle to receive an adequate return on investment

As a result, investment in biotech took a correctional hit in 2016 to deflate overblown expectations. Medtech, for its part, has seen declining investment, especially at early stages, reflecting an aversion to uncertainty in commercialization.

Below are clinical and technology areas that we see demonstrating growth and investment opportunity, but still represent challenges for executives to navigate their remaining development and commercialization obstacles:

  • Cell therapies
    • Parkinson’s disease
    • Type I diabetes
    • Arthritis
    • Burn victims
    • Cardiovascular diseases
  • Diabetes
    • Artificial pancreas
    • Non-invasive blood glucose measurement
  • Tissue engineering and regeneration
    • 3D printed organs
  • Brain-computer and other nervous system interfaces
    • Nerve-responsive prosthetics
    • Interfaces for patients with locked-in syndrome to communicate
    • Interfaces to enable (e.g., Stentrode) paralyzed patients to control devices
  • Robotics
    • Robotics in surgery (advancing, despite costs)
    • Robotic nurses
  • Optogenetics: light modulated nerve cells and neural circuits
  • Gene therapy
    • CRISPR
  • Localized drug delivery
  • Immuno-oncology
    • Further accelerated by genomics and computational approaches
    • Immune modulators, vaccines, adoptive cell therapies (e.g., CAR-T)
  • Drug development
    • Computational approaches to accelerate the evaluation of drug candidates
    • Organ-on-a-chip technologies to decrease the cost of drug testing

Impact on investment

  • Seed stage and Series A investment in med tech is down, reflecting an aversion to early stage uncertainty.
  • Acquisitions of early stage companies, by contrast, are up, reflecting acquiring companies to gain more control over the uncertainty
  • Need for critical insight and data to ensure patient outcomes at best costs
  • Costs of development, combined with uncertainty, demand that if the idea’s upside potential is only $10 million, then it’s time to find another idea
  • While better analysis of the hurdles to commercialization of advanced innovations will support investment, many medtech and biotech companies may opt instead for growth of established technologies into emerging markets, where the uncertainty is not science-based

 

Below is illustrated the fundings by category in 2015 and 2016, which showed a consistent drop from 2015 to 2016, driven by a widely acknowledged correction in biotech investment in 2016.

*For the sake of comparing other segments, the wound fundings above exclude the $1.8 billion IPO of Convatec in 2016.

Source: Compiled by MedMarket Diligence, LLC.