Category Archives: Americas

Effective technologies for wound hemostasis, sealing and closure

See the pending 2014 Report #S192, “Worldwide Surgical Sealants, Glues, Wound Closure and Anti-Adhesion Markets, 2013-2020″.

Tourniquet, pressure and sutures have been used for controlling excessive bleeding during surgical procedures for many hundreds of years. Fibrin sealants represented a revolution in local hemostatic measures for both bleeding and nonbleeding disorders. Fibrin sealant has the potential to provide life-saving control of excessive bleeding in many critical surgical operations and during a number of elective procedures. The terms “sealant” and “glue” are frequently used interchangeably in the surgical context, but there is actually a difference in adhesive strength between sealants, pioneered by fibrin products (sometimes homemade) and the later, stronger glues of which cyanoacrylate-based products are the most common.

In order for a sealant to be effective, the product should meet several parameters, depending upon the application. Among these are:

  • Ability to close the wound
  • Strength of bond
  • Speed of curing
  • Protection of the wound from infection
  • Low surface friction
  • Breathability in order to aid healing
  • Lack of adverse side effects to skin and internal tissues
  • Cost-effectiveness
  • Ease of handling

Fibrin and other sealant products have been approved and used outside the United States for many years and their use has created strong awareness of their surgical and economic benefits in Europe, Latin America and Asia. As a result, many such products have been marketed in these regions for 20 years or more, and have been developed for a variety of surgical uses. In the U.S., these products were initially approved as hemostatic adjuncts to suturing. They are increasingly being used for sealing of tissues, but their use beyond simple hemostasis (i.e., as sealants and low-strength glues) lags that of markets outside the U.S.

Despite the development of novel sutures (e.g., resorbable), endoscopically applied clips and other innovations, fibrin sealants will remain a versatile option available to surgeons to achieve hemostasis and sealing of wounds (alone or adjunctively with sutures/staples). Their clinical track record, biocompatibility and ready availability match high demand. Their limitation in adhesive strength, however, does put some limit on their sales potential, since significant demand exists for tight sealing and strong bonding of tissues under stress, such as in lung and bowel resections, cardiovascular and other anastomoses and adhesion of muscle, that go beyond what fibrin sealants can achieve. For this reason, other naturally-occuring “bioglues” are under development that will achieve tighter tissue bonds than fibrin sealants, but without the toxic effects of cyanoacrylates (“superglues”).

There are more than 30 companies worldwide developing fibrin sealants and driving a market that will exceed $2.2 billion by 2017.

sealants-regional-forecast

 Source: MedMarket Diligence, LLC; Report #S190. (This report is being updated by the pending 2014 Report #S192.)

For complete analysis of the global market for fibrin sealants, see the MedMarket Diligence Report #S190, “Worldwide Surgical Sealants, Glues, Wound Closure and Anti-Adhesion Markets, 2010-2017.”

Wound technologies being adopted at varying rates globally

The success of specific wound management products in the market ensues from their ability to produce clinical outcome in environments where there are clinical, economic and other incentives for that success.  The different technologies are used in different healthcare systems/countries/markets with different patient demographics, practice patterns and other variables, resulting in widely variable levels of market success.

Gauze dressings, bioengineered skin, alginates, negative pressure devices, cellular growth factors, hydrogels, antimicrobial dressings — all of these products (and more) represent the practice of wound management for the entire spectrum of wound types and severities.

Practice patterns, regulatory requirements, price pressures, healthcare delivery system gatekeepers, demographics, cultural sensitivities — the net effect of these forces and others dictate the size and outlook of the markets for different wound management products in global markets.

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It’s no surprise, then, that product sales are growing (or declining) at different rates in different regions of the world, but the data is clear on this. MedMarket Diligence researched and published this data in its global wound management market Report #S249, which details the clinical practice of wound management, the products on the market and in development, the current and forecast markets for each worldwide and regionally and the competitors vying for market presence now and in the future.  Research from primary and secondary sources, the global wound market data illustrated above (which is also detailed by country) and presented in Report #S249 is a compelling read for market participants.

Sealants, Glues, Hemostats, Anti-Adhesion: An Evolved Market

In a forthcoming report on advanced technologies associated with the acute phase of wound management — specifically, hemostasis, closure and sealing — MedMarket Diligence will be revealing the state of the art and the industry for fibrin and other surgical sealants; cyanoacrylate and other synthetic and naturally-occurring high strength glues; a wide range of products providing hemostasis; products that prevent the formation of post-surgical adhesions; and the increasingly varied types of physical wound closure, including sutures, staples, clips, tapes, and other mechanical wound closure types.

Our analysis in 2012 illustrated the scope and depth to which these advanced wound closure products had penetrated the realm of many areas of clinical practice that, up to a scan decade ago, had been dominated for a millennia by simple physical methods to manage acute wounds — sutures and tapes. Below is an illustration of the size and growth in e sales of these products, showing that the advanced products are being adopted at accelerated rates, yet a sizable volume of wound closure remains in the hands of very traditional closure (sutures/staples).

Size and Growth of Surgical Securement Product Segments Worldwide 2010-2019

Source: “Worldwide Surgical Sealants, Glues, Wound Closure and Anti-Adhesion Markets, 2008-2015.”  Published by MedMarket Diligence, LLC. See updated Report S192.

Of course, the field of sutures and staples is not exactly stagnant, devoid of innovation. Sutures, staples and clips innovation have been driven by the commensurate innovation in surgical technique. Traditional surgery via laparotomy has long since been revolutionized by laparoscopy, and endoscopic procedures in general have become the standard for minimizing surgical trauma and faster recovery. The endoscopic format has demanded new suturing and stapling technologies, and industry stalwarts like Ethicon, Covidien and others have been happy to provide the solutions.  And even more recently, natural orifice transluminal endoscopic surgery (NOTES) procedures are pushing the minimally invasive principle to a greater extreme.

Wound market CAGRs by segment and region, worldwide

Gauze dressings, bioengineered skin, alginates, negative pressure devices, cellular growth factors, hydrogels, antimicrobial dressings — all of these products (and more) represent the practice of wound management for the entire spectrum of wound types and severities. Practice patterns, regulatory requirements, price pressures, healthcare delivery system gatekeepers, demographics, cultural sensitivities — all of these, and more, combine in the forces that dictate the size and outlook of the markets for different wound management products in global markets.

Screen Shot 2014-05-13 at 9.20.35 AM

It’s no surprise, then, that product sales are growing (and in some cases declining) at different rates in different regions of the world, but the data is clear on this. MedMarket Diligence researched and published this data in its global wound management market Report #S249, which details the clinical practice of wound management, the products on the market and in development, the current and forecast markets for each worldwide and regionally and the competitors vying for market presence now and in the future.

Researched from primary and secondary sources, the global wound market data illustrated above (which is also detailed by country) and presented in Report #S249, “Worldwide Wound Management, Forecast to 2021: Established and Emerging Products, Technologies and Markets in the Americas, Europe, Asia/Pacific and Rest of World.”

 

The Staying Power of Spine Surgery Markets

While medtech over the past five years has seen continued pressure on prices, increased oversight on physician-manufacturer relationships, reduced med/surg procedure volumes, continued regulatory challenges and the real or perceived negative impacts of the Affordable Care Act, the business of spine surgical technologies remains one of the most steadfast oases of innovation and price stability.

The continued growth of spine surgery owes itself to a number of key drivers:

  • The ageing population worldwide
  • Increasing incidence of obesity
  • A growing middle class in developing countries, with the ability to pay out of pocket for spine surgery
  • Improving worldwide economy
  • Technological device enhancements, leading to improved surgical results
  • Developments in minimally invasive spine surgery (MISS) devices driving a strong increase in MISS, with its numerous advantages
  • In the US, improvements in reimbursement as clinical trials demonstrate the efficacy of treatments using the devices
  • US healthcare reform leading to medical insurance coverage for more people, allowing those suffering from intractable back pain to receive surgical treatment

(The last, of course, is debatable, since medical device manufacturers are not yet convinced that a 3.2% excise tax is supported by the anticipated boost in patient population. The jury is still out on this and, in any case, prospects for the 3.2% tax being repealed are slim, despite repeated efforts.)

Consequently, the worldwide aggregate spine surgery market has a 2012 to 2020 compound growth rate of 7.7%, with individual segments within it growing at a low of 2.3% to a high of 35.0%.

It is also worth noting that we have identified seven (7) new medtech startups (McGinley Orthopaedic Innovations, KB Medical, Trice Orthopedics, Tyber Medical, Direct Spinal Therapeutics, NLT Spine, Osseus Fusion Systems) in spine surgery that have been founded in the past three years alone.

Below is illustrated the spine surgery markets in the Americas and Europe for 2012-2020.

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Source: MedMarket Diligence, LLC; Report #M520, “Worldwide Spine Surgery: Products, Technologies, Markets and Opportunities 2010-2020″.

Established to emerging, commodity to advanced in wound management

Wound management is about as diverse a market as there can be in medtech. Wounds can be acute or chronic, surgically created or arising from trauma or disease, treated with technology as simple as a piece of gauze or as complex as a hyperbaric oxygen chamber or negative pressure would therapy technology.  The manufacturers range from producers of largely commodity-like dressings to devices to equipment to growth factors and other biotech products.

Simultaneously, the nature of patient populations, clinical practices, market development, economics and technology adoption vary widely around the world, resulting in considerable variation in the sales of traditional products all the way up through the most advanced products in wound management.

As an example, below are illustrations of the 2011 to 2020 forecast for the range of wound management products in the U.S. and a different set of markets, the Rest of Asia/Pacific (excluding Japan and Korea); predominantly China, India and Australia.

The distribution of product sales in wound management, on a relative basis, is very different in the U.S. than in the Rest of Asia/Pacific due in large part to the tendency for advanced technologies to be first introduced in well developed markets, like the U.S., Europe, Japan and others and later migrated to the “emerging” markets. T

The U.S. graph illustrates the decreasing/increasing share of each technology’s sales relative to all others.

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Source: MedMarket Diligence, LLC; Report #S249

For the Rest of Asia/Pacific Market, a different picture emerges, with interesting variations per product segment.

 

 

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Source: MedMarket Diligence, LLC; Report #S249

However, to put the relative differences into a meaningful context, one has to look at the absolute sales in the different markets. And, to show the very real, stark difference between the U.S. and Rest of Asia/Pacific markets for wound management products, we have plotted both on the same scale, with the max given for both as $12,000 million in sales.

 

 

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Source: MedMarket Diligence, LLC; Report #S249

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Source: MedMarket Diligence, LLC; Report #S249

Tissue Engineering and Cell Therapy Market Outlook

The market for tissue engineering and cell therapy products is set to grow to nearly $32 billion by 2018. This figure includes bioengineered products that are themselves cells or are actively stimulating cell growth or regeneration, products that often represent a combination of biotechnology, medical device and pharmaceutical technologies. The largest segment in the overall market for regenerative medicine technologies and products comprises orthopedic applications. Other key sectors are cardiac and vascular disease, neurological diseases, diabetes, inflammatory diseases and dental decay and injury.

An overview (map) of the spectrum of clinical applications in tissue engineering and cell therapy is shown below:

Source: Report #S520

Cell therapy is defined as a process whereby new cells are introduced into tissue as a method of treating disease; the process may or may not include gene therapy. Forms of cell therapy can include: transplantation of autologous (from the patient) or allogeneic (from a donor) stem cells , transplantation of mature, functional cells, application of modified human cells used to produce a needed substance, xenotransplantation of non-human cells used to produce a needed substance, and transplantation of transdifferentiated cells derived from the patient’s differentiated cells.

Once considered a segment of biomaterial technologies, tissue engineering has evolved into its own category and now comprises a combination of cells, engineering and suitable biochemical and physiochemical factors to improve or replace biological functions. These include ways to repair or replace human tissue with applications in nearly every medical specialty. Regenerative medicine is often synonymous with tissue engineering but usually focuses on the use of stem cells.

Tissue engineering and cell therapy may be considered comprised of bioengineered products that are themselves cells or are actively stimulating cell growth or regeneration. These often comprise a combination of biotechnology, medical device and pharmaceutical technologies.

Researchers have been examining tissue engineering and cell therapy for roughly 30 years. While some products in some specialties (such as wound care) have reached market, many others are still in research and development stages. In recent years, large pharmaceutical and medical device companies have provided funding for smaller biotech companies in the hopes that some of these products and therapies will achieve a highly profitable, commercial status. In addition, some companies have been acquired by larger medical device and pharmaceutical companies looking to bring these technologies under their corporate umbrellas. Many of the remaining smaller companies received millions of privately funded dollars per year in research and development. In many cases it takes at least ten years to bring a product to the point where human clinical trials may be conducted. Because of the large amounts of capital to achieve this, several companies have presented promising technologies only to close their doors and/or sell the technology to a larger company due to lack of funds.

The goal of stem cell research is to develop therapies to treat human disease through methods other than medication. Key aspects of this research are to examine basic mechanisms of the cell cycle (including the expression of genes during the formation of embryos) as well as specialization and differentiation into human tissue, how and when the differentiation takes place and how differentiated cells may be coaxed to differentiate into a specific type of cell. In the differentiation process, stem cells are signaled to become a specific, specialized type of cell when internal signals controlled by a cell’s genes are interspersed across long strands of DNA and carry coded instructions for all the structures and functions of a cell. In addition, cell differentiation may be caused externally by use of chemicals secreted by other cells, physical contact with neighboring cells and certain molecules in the microenvironment.

The end goal of stem cell research is to develop therapies that will allow the repair or reversal of diseases that previously were largely untreatable or incurable.. These therapies include treatment of neurological conditions such as Alzheimer’s and Parkinson’s, repair or replacement of damaged organs such as the heart or liver, the growth of implants from autologous cells, and even regeneration of lost digits or limbs.

In a developing human embryo, a specific layer of cells normally become precursor cells to cells found only in the central nervous system or the digestive system or the skin, depending on the cell layer and the elements of the embryo that direct cell differentiation. Once differentiated, many of these cells can only become one kind of cell. However, researchers have discovered that adult body cells exist that are either stem cells or can be coaxed to become stem cells that have the ability to become virtually any type of human cell, thus paving the way to engineer adult stem cell that can bring about repair or regeneration of tissues or the reversal of previously incurable diseases.

Another unique characteristic of stem cells is that they are capable of self-division and self-renewal over long periods of time. Unlike muscle, blood or nerve cells, stem cells can proliferate many times. When exposed to ideal conditions in the laboratory, a relatively small sample of stem cells can eventually yield millions of cells.

There are five primary types of stem cells: totipotent early embryonic cells (which can differentiate into any kind of human cell); pluripotent blastocyst embryonic stem cells, which are found in an embryo seven days after fertilization and can become almost any kind of cell in the body; fetal stem cells, which appear after the eighth week of development; multipotent umbilical cord stem cells, which can only differentiate into a limited number of cell types; and unspecialized adult stem cells, which exist in already developed tissue (commonly nerves, blood, skin, bone and muscle) of any person after birth.

tissue-cell-2012-2018

Source: MedMarket Diligence, LLC; Report #S520, “Tissue Engineering & Cell Therapy Worldwide 2009-2018.”

Developmental Timescales

Tissue engineering and cellular therapy products take years of research and many millions of dollars (averaging about $300 million, according to some reports) before they make it over the hurdles of clinical trials and into actual market launch. More than one small biotech company has burned through its money too quickly and been unable to attract enough investment to keep the doors open. The large pharmaceutical and medical device companies are watching development carefully, and have frequently made deals or entered into alliances with the biotechs, but they have learned to be cautious about footing the bill for development of a product that, in the end, may never sell.

For many of the products in development, product launch is likely to occur within five years. Exceptions include skin and certain bone and cartilage products, which are already on the market. Other products are likely to appear on the European market before launch in the United States, due to the presence of (so far) less stringent product review and approval laws in the European Union.

Even when the products are launched, take-up will be far from 100% of all patients with that particular condition. Initially, tissue engineering and cell therapy products will go to patients suffering from cancers and other life-threatening conditions, who, for example, are unable to wait any longer for a donor organ. Patients who seem to be near the end of their natural lives likely will not receive these treatments. Insurance coverage will certainly play a key role as well in the decision about who receives which treatments and when. But most importantly, physicians will be selecting who among their patients will be treated; the physicians learn about the treatments by using them, by observing the patient’s reactions, and by discussing their experiences with colleagues. In other words, the application of tissue engineering and cellular therapy will progress in a manner similar to the introduction of any new technology: through generally conservative usage by skilled, highly trained physicians dedicated to providing their patients with the best possible treatment without causing them additional harm.

 

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