Metabolic syndrome and obesity

Below is an excerpt from "Products, Technologies and Markets Worldwide for the Clinical Management of Obesity, 2011-2019" (Report #S835, MedMarket Diligence, LLC).

Metabolic syndrome (MetS) is a combination of medical disorders that increase the risk of developing cardiovascular disease and diabetes. It affects one in five people, and prevalence increases with age. Some studies estimate the prevalence in the USA to be up to 25% of the population. MetS is composed of an array of factors including insulin resistance, obesity, dyslipidemia, hypertension, and greater risk for diabetes, heart disease and stroke. These are all related to obesity, although recent research indicates that these may be related to the body’s attempts to protect organs from excess fat.

In a review in the March 9th, 2010 issue of Trends in Endocrinology and Metabolism, Roger Unger, MD, University of Texas Southwestern at Dallas, suggested that obesity may not be all bad: it may be the body’s way of storing lipids in a less harmful manner, i.e. in fat tissue, in order to protect the body’s organs from the toxic effects of excess lipids. When the lipids become too numerous for the fat tissue to handle, then those fats spill over into places where they can produce toxic effects. These effects trigger the cascade of symptoms known as metabolic syndrome.

The body’s resistance to leptin, known for its appetite-suppressing abilities, is at the center of the shift from protective obesity to metabolic syndrome. Leptin is also responsible for partitioning fat in the body; but as fat stores grow, this partitioning can only go so far before resistance sets in, and the fat starts being stored in and harming other organs. The researchers found that most humans develop leptin resistance as they pass their reproductive years, meaning that everyone needs to watch their diet and exercise, or start on the path to MetS.

Definitions of MetS differ. There are no well-accepted criteria for diagnosing the metabolic syndrome. The WHO criteria (1999) require the presence of diabetes mellitus, impaired glucose tolerance, and impaired fasting glucose or insulin resistance, in addition to at least two of the following:

  • Blood pressure: ≥ 140/90 mmHg
  • Dyslipidemia: triglycerides (TG): ≥ 1.695 mmol/L and high-density lipoprotein cholesterol (HDL-C) ≤ 0.9 mmol/L (male), ≤ 1.0 mmol/L (female)
  • Central obesity: waist:hip ratio > 0.90 (male); > 0.85 (female), or body mass index > 30 kg/m2
  • Microalbuminuria: urinary albumin excretion ratio ≥ 20 µg/min or an albumin:creatinine ratio ≥ 30 mg/g

The criteria proposed by the American Heart Association’s National Cholesterol Education Program (NCEP) are widely used. The American Heart Association and the National Heart, Lung, and Blood Institute recommend that the metabolic syndrome be identified as the presence of three or more of these components:

  • Elevated waist circumference:
    • Men — Equal to or greater than 40 inches (102 cm)
    • Women — Equal to or greater than 35 inches (88 cm)
  • Elevated triglycerides: Equal to or greater than 150 mg/dL (1.7 mmol/L)
  • Reduced HDL (“good”) cholesterol:
    • Men — Less than 40 mg/dL (1.03 mmol/L)
    • Women — Less than 50 mg/dL (1.29 mmol/L)
  • Elevated blood pressure: Equal to or greater than 130/85 mm Hg or use of medication for hypertension
  • Elevated fasting glucose: Equal to or greater than 100 mg/dL (5.6 mmol/L) or use of medication for hyperglycemia

Report #S835 on the worldwide market for obesity drugs and devices is described below and a link:

This report is a detailed market and technology assessment and forecast of the products and technologies in the clinical management of obesity (bariatrics). The report describes the current and projected patient population in obesity, detailing their incidence worldwide, with available incidence by country for the U.S., major European countries, major countries in Asia/Pacific (including Japan, China, India and Australia), the clinical practices in their management to encompass surgical approaches, medical supervised severely restricted diets, drug therapies, OTC treatments, biopharmaceuticals, non-pharmacologic approaches and weight maintenance approaches. The report describes clinical trends in the management of the obese. The report details the products on the market and the status of those in development for bariatric surgery, drug therapy, gastric stimulation devices, brain stimulation devices, combination therapies and genetic therapy and other therapies under development, and will provide current and worldwide market forecasts (2009-2019) separately for pharmaceuticals (with separate segment forecast data for satiety, malabsorption, appetite suppression and combination drugs) and devices (with separate segment forecast data for stomach restriction artificial fullness, malabsorption, gastric emptying and appetite suppression), with current (2009) market shares of the leading competitors in each segment. (The report addresses the challenges to obesity drug approval, such as the FDA's February 2011 rejection of Orexigen's Contrave, and considers the realistic prospects for obesity drugs and their changing opportunities to succeed in the U.S. and international markets.) The report profiles the 45 leading competitors, detailing current and potential position in the market, their products and their market strengths and likelihood of future success.

Ablation technologies energized for growth

"Ablation" may be generally described as a therapeutic destruction and/or sealing of tissue, whether to destroy diseased tissue, remove necrotic tissue, create a lesion to produce a therapeutic effect (as in treatment of atrial fibrillation) or to otherwise dissect tissue for therapeutic benefit.

[See "Ablation Technologies Worldwide Market 2009-2019". Report #A145]

As a fundamental tissue effect, ablation can in principle be accomplished by a large range of alternative modalities or energy types, but the practical application of ablation to different clinical practices has emerged from the constraints that specific target tissue types put forth — minimizing collateral tissue damage, creating ideal lesion types, limitations of the surgical approach that lend greater or lesser advantage to one modality compared to others, etc.

The technologies representing the range of alternative ablation types are grouped into nine sectors:

  • Electrical
  • Radiation
  • Light
  • Radiofrequency
  • Ultrasound
  • Cryotherapy
  • Thermal (other than cryotherapy)
  • Microwave
  • Hydromechanical

In 2010, given its long history in medicine, radiation represented the largest share of global revenues of energy-based ablation devices, followed by light (essentially laser) with 19% and ultrasound with 15%. The total market is forecast to grow at a compound annual growth rate (2010-2019) of 11.2%. 

Despite the economic slowdown of 2008-2009, the energy-based ablation devices market continued growing vigorously and is expected to continue to grow at a strong rate over the next five+ years. The total CAGR of 11.2% is deceptively modest, because these figures reflect the combined market sizes and growth rates of nine sectors. Those nine sectors, or modalities, vary widely in size and growth rates: from thermal, with an estimated CAGR of under 3%, to cryotherapy with a CAGR approaching 19.5%. Four of the modalities are forecast to experience compound annual growth rates equal to or exceeding 11%.

Electrical and electrocautery devices have long been a mainstay of the surgeon’s toolbox, and they will continue to be used for the foreseeable future. Some estimates say that as much as 80% of all surgical procedures make use of one of these devices. Key among the advantages offered by these products is the ability, depending upon the procedure, to assist the surgeon to conduct a procedure rapidly—often more quickly than with a cold scalpel. Electrical ablation is used in a wide array of surgical procedures, including colon resection, hysterectomy and gastric bypass, to name a few.
Radiation devices cause destruction of target tissues by disruption of cellular mechanisms, often with surgical precision, without ever cutting the skin. These systems have advanced to a high-tech level unforeseen even ten years ago.

Radiation ablating equipment includes traditional radiotherapy machines, image-guided radiotherapy (IGRT) and intensity-modulated radiotherapy (IMRT). Over the last ten years or so, radiologists have been moving towards more advanced treatment techniques, such as those utilizing multiple or non-coplanar beams, 3-dimensional conformal radiotherapy (3DRT) and IMRT, to treat tumors. Physicians view the accuracy of computed tomography-based 3-dimensional target delineation, which provides more detailed targeting than does 2-dimensional design, as another very attractive treatment option.

Light-based or laser devices use high-intensity light to shrink or destroy tumors. Various lasers have different effects on different tissues, depending on the laser’s wavelength. Lasers commonly used for medical and/or aesthetic purposes include Erbium:YAG, ruby, CO2, and neodymium:YAG-laser (Nd:YAG). Also in this category are femtosecond and excimer lasers. Femtosecond lasers allow extreme precision in surgery. The possibilities for its use now include but are not limited to femtosecond keratoplasty, astigmatic keratoplasty, and keratoconus. Excimer lasers typically produce ultraviolet light, and are used in LASIK eye surgery.

Radiofrequency energy is characterized by a specific frequency measurable in Hz. Medical devices that emit RF energy produce a change in the electrical charges of the treated tissue, creating an electron movement. Electrosurgical cutting uses sharply focused, intense heat at the surgical site to cut the tissue. By holding the electrode a small distance away from the tissue, the surgeon can produce the most intense heat over a very short amount of time. This results in vaporization of the tissue and the desired cutting effect. Vessel sealing and ligating devices usually utilize electrical energy combined with pressure to seal vessels and to cut off small bits of tissue.

Ultrasound energy relies on the fact that as an acoustic wave propagates through tissue, part of it is absorbed and converted to heat. Focusing sound waves allows concentrated energy deposition to occur deep in tissue, allowing precisely localized heating and thermal coagulation while sparing intervening tissue. High intensity focused ultrasound, or HIFU, treats a precisely defined portion of the targeted tissue. Because this technology can achieve precise ablation of diseased tissue, it is often referred to as ‘HIFU surgery’, or ‘non-invasive HIFU surgery.’

Cryotherapy uses extreme cold to freeze and destroy the target tissue, such as a cancerous tumor. It is applied in a freeze-thaw process. The cryotherapy probes, needles or catheters are carefully positioned in place using ultrasound guidance, then the freezing agent, argon gas, is allowed to circulate through the cryotherapy probes, causing an ice ball to form in the tissue at the tip of the probes. The tissue is frozen rapidly, then thawed slowly and completely, and then is put through a second freeze-thaw cycle. It is the intensity of the freezing that determines the ultimate response of the targeted tissue, which may range from chilled to inflammation to cell death. Different cell types show different sensitivities to freezing, a fact which can be used for therapeutic purposes. For example, prostate cancer cells demonstrate different susceptibilities to freezing than do other tissues, a difference that has been linked to the presence of the androgen receptor.

Thermal ablation devices may be engineered to produce a variety of temperatures in tissues, depending upon the intended usage. These temperatures may range from 39 – 40 °C up to as high as 80 – 90 °C, under well-controlled conditions. When hyperthermia is used, there is evidence of a number of processes taking place, which can include enhancement of the anti-tumor effects of radiation and of various drugs; induction of immunological processes; induction of gene expression and protein synthesis; and general changes to the tumor’s environment which make the tumor more accessible to some therapies. Above 43°C, the heat itself has a cytotoxic effect on the cells.

Microwave hyperthermia is a non-ionizing form of radiation therapy. Low levels of microwave energy are used to vigorously vibrate water molecules in tissue to quickly and effectively heat the tissue to a physical penetration depth defined by the microwave frequency. Microwave has also been shown to improve the results of radiation therapy for the treatment of some recurrent and progressive tumors. The resulting hyperthermia destroys cancer cells by raising the tumor temperature to a ‘high fever’ range. Recent research appears to show that cancer cells may be particularly vulnerable to microwave-induced hyperthermia due to their high acidity. Microwave energy disrupts the stability of the cellular proteins and kills the cells.

Hydromechanical ablation is energy-based tissue destruction accomplished via mechanical means, such as extracorporeal shock wave lithotripsy devices, or jets of water or saline. In extracorporeal shock wave lithotripsy, the lithotriptor uses an external hydromechanical energy source to break up the stone with minimal collateral damage. The successive shock wave pressure pulses result in direct shearing forces which fragment the stones. Water jet surgery, a form of dissection which has been used successfully for several years, employs the kinetic energy of the water jet to separate different tissue types by their varying elasticity and firmness. In hepatic surgery, for example, the device can selectively differentiate between liver parenchyma, blood vessels and bile ducts. This modality does not cause thermal damage to tissue and can sculpt, ablate and cauterize bleeders.


The above is excerpted from Report #A145, published 2010 by MedMarket Diligence, LLC.

Metabolic/Bariatric Surgery Types

Gastric bypass surgery is currently considered the gold standard for surgical treatment of obesity. Studies have shown that patients tend to experience 50-80% excess weight loss (EWL) over a two year period following surgery. In addition, gastric bypass offers sustainable weight loss, and has a better record in this regard than does gastric banding.

Weight regain is not unknown, however, and has been reported to be as high as 25-30%, depending on the type of procedure and the patient’s dedication to changing. Patients must follow significant, permanent diet and lifestyle modifications following surgery, which is one reason that patients are usually required to undergo psychiatric testing and counseling prior to having the surgery. If weight is regained, then factors such as psychiatric challenges, the patient’s degree of adherence to the new diet, and general health must all be reviewed. Once these have been dealt with, then surgical revision may be considered.

Bariatric surgery falls into one of three categories, depending upon the type of procedure: restrictive, malabsorptive or a combination of these. ‘Restrictive’ refers to restricting the size of the stomach, so that the patient feels full on less food. This may be achieved using gastric stapling, gastric banding or by surgically removing a large part of the stomach. ‘Malabsorptive’ surgery involves making significant surgical changes to the digestive tract by bypassing most of the stomach and intestines, thereby shortening the absorptive surface area of the bowel. Because so much absorptive area is lost, the patient must take vitamins and minerals for the rest of his or her life.

In the US and European Union, bariatric surgeons generally perform the following major procedures:

  • Gastric bypass, including a variation known as vertical banded gastroplasty (VBG); the latter is both malabsorptive and restrictive.
  • Roux-en-Y (vertical division)
  • Sleeve gastrectomy independent of biliopancreatic diversion.
  • Biliopancreatic diversion with duodenal switch (both malabsorptive and restrictive)
  • Gastric banding (restrictive)

These may be performed using either open surgery or laparoscopically, but are usually done via laparoscope. 

See Report #S835 for complete analysis of obesity treatment options.

Products and markets for the advanced closure and securement of wounds

{Below is drawn from MedMarket Diligence Report #S180.}

Products for the advanced closure and securement of wounds are not fundamentally changing the practice of surgery, but their advantages are sufficient to drive strong adoption rates in a wide range of clinical specialties.  In particular, these products provide for rapid and efficient closure of surgical wounds, and internal securement of tissues to reduce pain and accelerate rehabilitation. Appropriate use of these products can reduce risk of infection, and can optimize the repair process to enhance the speed and strength of tissue repair, as well as reducing complications such as those resulting from post-surgical adhesions.  For this reason, they represent a $10 billion annual market that has nowhere to go but up.

Sutures and Staples. Sutures are medical devices made out of woven or single filament fibers of steel, synthetic polymer or natural biomaterials that are used to secure cuts, lacerations, and incisions in the surface or internal tissues. Staples are rigid or semi-rigid suture-like materials delivered through a closure device and consisting of single- or multi-filament fibers of steel, synthetic polymer or natural biomaterials that are used to secure cuts, lacerations, and incisions in the surface or internal tissues. Sutures are one of the most well-established technologies in surgery and staples have emerged to represent almost a market extension of sutures in terms of clinical application and market dynamics. Long-term development in the sutures market will be affected by technical innovation but no major breakthroughs are anticipated in this regard. However, established and new niche entrants are expanding suturing business to take advantage of profit premiums available in specialist anchoring, stapling, endoscopic and tissue engineering segments.

Tapes. Tapes are fabric and polymer-based medical devices that are used to secure cuts, lacerations, and incisions in the surface of the skin as an adjunct to wound closure. The global market for adhesive tapes is roughly $250 million, but with annual growth at only 3%, the only real stimulus to growth is the gradual increase in numbers of relevant surgical procedures.

Hemostats. A hemostat reacts in the presence of blood to establish the normal cascade of factors that arrest bleeding. These products can be added to a bleeding field during surgery to prevent further bleeding, and are mostly dependent on a full complement of normal factors in the patient’s blood. Global hemostat sales are well over $1 billion annually and will see double digit growth over the next few years fueled by increased incidence of surgery, greater adoption of these products within the European surgical environment, and the need for improved hemostasis products during minimally invasive surgical procedures.

Sealants. A sealant will prevent leakage of fluid and/or gas from a surgical incision (such as pulmonary gases or spinal fluids). These products will often hold back pressurized fluids from normal vascular activity. Although their efficiency does not normally require the full complement of active clotting factors in blood to be within normal levels, these products (e.g., fibrin sealants) normally also have some hemostatic activity. Like other advanced technologies in wound closure and management, especially emerging ones that have yet to fully penetrate the readily available caseload, the sealant market growth rate is in double digit annually. The success of synthetic and biological sealants will be based on the uniqueness of procedure-based benefits, which enable niche high added-value segments to be created. Although these products offer potential for active delivery and adjunctive repair with sutures, their scope will be more limited than the stronger cyanoacrylate technologies.

Glues/adhesives. Glues and adhesives (e.g., cyanoacrylate glues) are used to attach organs, structures, or tissues to each other or to effect repair. These materials can be enhanced by incorporating additional hemostatic or sealant properties, such as Angiotech’s Vitagel (a combination of collagen and thrombin) and Nycomed’s Tachocomb (a combination of thrombin, collagen and fibrin). The market for glues and adhesives (often referred to as “high strength” glues and adhesives) is growing at a rate only slightly less than sealants due to some regulatory constraints and technology limitations the prevent their more widespread use. Nonetheless this even modestly strong growth will be sustained over the next decade, fueled by increased incidence of surgery, greater adoption of these cyanoacrylate and newer adhesive products for internal surgical applications, and the need for improved, fast-acting and easy-to-use products for use in minimally invasive procedures. In addition, it is becoming recognized that these products have a role to play in reducing infection and improving cosmesis of surgical wounds to the surface of the skin and this will also drive the value of this attractive market segment.

Anti-adhesion. Abnormal joining of two organs or tissues occurring after inflammation, especially post-surgery. Adhesion-prevention products are medical devices or substances made from synthetic polymer or natural biomaterials that are manufactured into gels, fabrics, films, and dried solids that are used to avoid the formation of post-surgical adhesions (PSA). World sales of post-operative adhesion prevention products are building at a critical mass at near double digit rates annually, with the total to soon eclipse $1 billion annually. Growth in post-surgical adhesion product sales is driven by innovations that yield greater utility and effectiveness data, increased incidence of surgery, the greater adoption of these products generally, and specifically their growing use in minimally invasive surgical procedures.

For a complete analysis of the wound closure and securement market, see MedMarket Diligence report #S180, "Worldwide Surgical Sealants, Glues, Wound Closure and Anti-Adhesion Markets, 2008-2015." 

Wound management technology projections

{Below is a summary of the products and technologies addressed in MedMarket Diligence report #S247, "Worldwide Wound Management, 2008-2017: Established and Emerging Products, Technologies and Markets in the U.S., Europe, Japan and Rest of World."}

Wound management technologies are comprised of a remarkably diverse range of product types.  Dressings alone can be divided into multiple types, including film dressings, hydrocolloids, foam dressings, alginate dressings, hydrogels, non-adherent dressings, and antimicrobial dressings. Other wound products include cleansing and debridement products, tissue engineered products, pharmacological products, (including pain control, antibiotics, growth factors, non-growth factor modulators, gene therapy, and scarring modulators), physical treatments (like pressure devices, hydrotherapy, electrical stimulation, electromagnetic stimulation, ultraviolet therapy, hyperbaric oxygen therapy, mechanically assisted wound closure devices, ultrasound, laser and information systems. Some of these product categories are well established; others are in development.

Film Dressings. Film dressings are a vital segment of the advanced wound management market. The potential for film dressings in moist wound healing is a concept that is now over 20 years old. Due to the age of many of the strong brands in this segment, key patents on technologies and the delivery/application systems are expiring. This will erode premium prices, which have been maintained by creating new and differentiating application systems and the strong branding that is associated with them. Companies with strong know-how coupled with highly integrated low-cost manufacturing, and strong brand awareness will retain share in the marketplace.

Overall, despite increased competition and price pressure, this market segment will continue to demonstrate positive growth resulting from continued adoption of moist wound healing principles and switching from general non-occlusive dressings to advanced products such as films. The market for transparent film dressings is mature, and although individual products may provide a number of separate features, such as different moisture vapor transmission rates (MVTRs), they are purchased as commodities by buying groups. Given acceptable delivery systems, films compete on price. Global sales of film dressings are significant, but relatively stable, with price competition limiting sales growth to around 5% per year.

Hydrocolloid Dressings. The market for hydrocolloids grew rapidly in the 1980s and 1990s due to the products’ convenience and the fact that they can be left on some wounds for up to five days, together with widespread experience in their use, significant clinical support, and intensive marketing, that have helped grow sales volume over the years. Clinician customers developed a high awareness of these hydrocolloid brands and effectively substituted them for traditional fabric dressings once they had adopted the rationale for advanced wound care using moist wound healing. Major players in this segment of the market encouraged the use of hydrocolloids for all moist wound healing applications.

Hydrocolloids are used extensively in long-term care sites where wear time and ease of use are determining factors in dressing selection and in hospitals where they are popular with opinion leaders. However, hydrocolloids are now starting to lose ground in the face of competition from newer types of dressings with superior benefits. Sales of hydrocolloids are growing at a modest rate, but will nonetheless reach well over $1 billion by the year 2017. ConvaTec, Coloplast, and other strong players will find it increasingly difficult to defend these brands from advancing generic hydrocolloid equivalents produced by lower cost manufacturers with generic cost bases. In addition, there is a growing customer recognition that hydrocolloids have been superseded by other technologies (for example, foam dressings) for some wounds.

Foam Dressings. The ability to outperform hydrocolloids in highly exuding wounds, lack of dressing debris, and moderate cost have made foam dressings one of the fastest growing segments in the advanced wound care market. Foams are expected to maintain an aggressive market growth rate into the immediate future as these products take share from hydrocolloids due to their superior handling characteristics, and as they erode traditional gauze dressing usage. 

Alginate Dressings. Alginate dressings are popular in the home care and extended care markets where high absorption capacity is used to reduce the number and expense of skilled visits. In deeper wounds, alginates conform to the wound bed and contain exudates better than foam dressings. As with other advanced wound dressings, the alginate market is experiencing pricing pressure due to the continued cost consciousness of many individual country’s health care systems, and the generic nature of these materials and lack of proprietary intellectual property. Use of alginate dressings is especially common on moderate-to-highly exuding wounds. Alginates were quickly categorized as devices and reimbursed in the USA, UK, France and Germany, leading to strong growth in these countries. The relatively strong support for these products by expert wound care clinicians and the need for management of highly exudative wounds led to high sales growth in the mid 1990s. The alginate dressings market segment will grow at a healthy annual compound annual growth rate through 2017; in 2008, companies generated more than a half billion dollars from alginate dressings sales.

Hydrogels. Hydrogels are often promoted by referring to their aesthetic cooling effects, which help to reduce wound pain. Hydrogels are now perceived by clinicians as effective in encouraging autolytic debridement, and encouraging the healing of dry or minimally exuding wounds. Amorphous hydrogels and gauze-stabilized formats provide a real advantage in wound packing, and these products have been readily adopted by clinicians. In addition, hydrogels have good potential to serve as delivery systems for active agents. Competitors are actively introducing new hydrogel products to the market, and targeting alternate and home care markets. Thus, hydrogel sales are projected to grow at roughly 5% per annum from 2008 to 2017.

Approximately 50% of amorphous hydrogel products are used by clinicians to re-hydrate black necrosis or yellow slough for purposes of debridement. The other 50% of amorphous hydrogels are sold for use as a general hydration material for controlling moisture to aid moist wound healing.

Non-Adherent Dressings. Non-adherents are a vital part of the advanced wound management market. Products are used to permit less frequent changes of dressings and to allow the use of dressings that manage higher quantities of exudates but reduce the potential for these dressings to stick to the wound. They are also used in combination with traditional dressings as an alternative to more expensive advanced wound dressings. These dressings are also used as the primary contact layer for compression bandaging systems (although we have excluded sales due to this usage from our market estimates). Thus, non-adherent sales are projected to continue to grow at little better than 3% per annum through 2017.

Anti-Microbial Dressings. Anti-microbial dressings are used to manage the effects of microbial colonization and growth. Bacterial infection of wounds is a significant complication of wound repair. There is a growing concern regarding the use of antibiotic products in the wound care environment, and there are few “non-resistant-microbe-forming” antibiotic technologies on the horizon that offer potential to be launched within the next five years. In contrast to this, antimicrobial technologies are being pursued by all wound management companies, to enhance existing brands, and to address the recognized need in this area. Topical antiseptics are one option to treat patients with infected wounds; they act rapidly and locally to destroy microbes. Products fall into a number of categories, which tend to overlap with other categories of wound care products due to the product base technology used for the dressing category that inspired them. For example, Tulle Gras delivery systems have been used for some antibacterial products such as Inadine, Bactigras, and generic antibiotic impregnated products. Sales are projected to continue to grow at under 5% per annum from 2008 to 2017.

Wound Cleansers and Debriding Agents. The wound cleanser and debridement market is expected to grow at well over 5% annually, from over $400 million in 2010. The enzymatic debridement subsegment of this market is driven by the increase in the elderly population with the corresponding increase in nursing home populations and in-home health care environments where chronic wounds are prevalent. The increasing prevalence of diabetic ulcers contributes to the market potential for these agents.

Skin Replacements and Substitutes. Skin replacements and substitutes compete in the severe burn market, venous leg ulcers market, and the diabetic foot ulcer markets where their high cost is offset by their ability to save lives and/or save limbs from amputation. These products have taken some time to demonstrate clinical effectiveness and to be approved for use to heal wounds faster than alternative treatments. In addition, these products are currently significantly more expensive than alternative therapies, and publicly funded health care schemes around the world have found it difficult to accept these costs despite strong cost-effectiveness claims. It is highly likely that these products will take some time to be widely adopted. The move towards cost- effectiveness procurement practice is likely to increase uptake of these products as purchasers advance from decisions based on unit product cost towards outcomes assessments and data. In addition, manufacturers are developing alternative manufacturing and lower cost product designs that should enhance the cost effectiveness of these products over the next few years.

Pharmacological Products. In the field of wound management there are a large number of companies commercializing technologies in the pharmacological field. These technologies include recombinant growth factors and growth factor mixtures, gene therapy, chemical cell stimulants, natural plant extracts and other pharmaceuticals including analgesics, antibiotics, scar reduction products etc. Advanced wound care practices and dressings have focused on removal of the underlying cause of the wound, altering the physical environment, and provision of a moist wound healing environment. These efforts have greatly improved wound care by facilitating wound repair by supporting the body’s own repair and regenerative processes. Recent interest and efforts have been directed to evolving products and procedures designed to actively manipulate the wound healing process. In addition, antibiotics and analgesics have direct and beneficial application in the treatment of wounds in specific cases.

Physical Therapies. Physical modalities have been used in the attempt to encourage wound healing for centuries. Passive compression is a popular approach for the treatment of venous stasis ulcers and many of the current passive compression products have their roots in traditional practices (e.g., paste bandages). Passive compression addresses the underlying etiology of chronic venous insufficiency.

Alternatively there is a market for devices designed to remove pressure from wounds that have been caused by extended pressure on the skin surface, and this market segment has shown astronomical growth within the past 3-4 years, driven by the demonstrated ability of application of negative (i.e., sub-atmospheric) pressure to speed up and improve the healing of chronic wounds.

There are also a great number of devices that are designed to immobilize limbs to avoid weight-bearing behavior, and sophisticated footwear and devices for diagnosing neuropathy. In addition, devices exist to manipulate pressure around limbs to maintain and improve venous blood flow. There are devices designed to accelerate healing through the use of physical treatments including ultrasound, electrical, magnetic, hyperbaric, and pressure relief.

Taken together, these physicial treatment modalities commanded sales almost $2 billion in 2010 and annual growth at double digits for the period 2008–2017.

Tissue Engineered Products. Skin replacements are designed to replace missing skin, including the skin’s structures and biologic functions. Skin replacements may be from the patient’s own skin, from a human cadaver, or from an alternate species; or the skin replacement may be made from biomaterials or biodegradable synthetic materials with or without cells grown as tissue engineered constructs in culture. These tissue engineered products provide the matrix alone, epidermal tissue equivalent, dermal tissue equivalent, or a multi-layer human skin equivalent that includes both dermal and epidermal tissues. In addition this category includes some emergency burn cover products that are synthetic and biosynthetic dressings. These products have been used for some time as a temporary covering for severely burnt patients when insufficient graft material is available and the patient will otherwise die if the burns are not covered to reduce fluid loss and prevent infection. When skin for autografting is available, the temporary dressing is removed and graft is performed. This skin replacement category of products is receiving considerable R&D attention as biotechnology companies strive to develop replacement engineered skin to repair chronic wounds.


MedMarket Diligence report #S247:

The report details the current and projected market for wound management products, including dressings, closure devices, debridement, pharmacological products, tissue engineered products and others. Particular emphasis is placed on advanced and leading edge developments (i.e., those approaching wound management from novel perspective) such as growth factors, stem cells, gene therapy and other approaches, while baseline data (current and forecast market size and current competitor market shares) is provided for established segments — multiple dressings types (film, foam, alginate, antibacterial, non-adherent), hydrogels, hydrocolloids, pharmaceuticals, and physical treatments. The report details the clinical and technology developments underlying the huge and evolving worldwide wound care market, with data on products in development and on the market; market size and forecast; competitor market shares; competitor profiles; and market opportunity. Separate size, growth and competitor data are presented for the U.S., leading western European countries, Japan and the Rest of World category. The report profiles leading and emerging companies, with data on products, technologies and positions in the advanced wound care market. The report establishes the current worldwide market size for major technology segments as a baseline for and projecting growth in the market over a ten-year forecast and assesses and projects the composition of the market as technologies gain or lose relative market performance over this period.

Se also the related report $S180, "Worldwide Surgical Sealants, Glues, Wound Closure and Anti-Adhesion Markets, 2010-2015."

Obesity drug (and other treatments) market recalibrated

Despite a December advisory panel recommending Orexigen's Contrave for approval, the FDA this month reversed itself and rejected the combination drug, citing the need for long term safety and efficacy data and adding yet another blow to the obesity drug market — at least in the U.S.  Quick to declare the obesity drug market dead as a result, some market analysts have minimized (or ignored) the untapped demand for an effective obesity drug, the non-U.S. obesity drug markets that are, indeed, influenced by the U.S. FDA, but nonetheless free to operate of their own accord and readily do, and the number of obesity drugs still in the pipeline in the U.S. (including, potentially, Contrave among them).

Nonetheless, since we provided a comprehensive analysis of the obesity drug and device market in December, in which we recognized the challenges that other obesity drugs (e.g., lorcaserin, sibutramine, etc.) had encountered, but had crossed our fingers on the potential FDA approval of Contrave, the drug's FDA-tarnished U.S. prospects prompted us to revised our forecast of the balance of the obesity market across the range of treatment options:

  • Satiety Drugs
  • Malabsorption Drugs
  • Appetite Suppression Drugs
  • Combination Drugs
  • Restrictive Devices
  • Artificial Fullness Devices
  • Mal-absorption Devices
  • Gastric Emptying Devices
  • Appetite Suppression Devices

The MedMarket Diligence Report #S835, "Products, Technologies and Markets Worldwide for the Clinical Management of Obesity, 2011-2019", has been overhauled, with revised forecasts based on the recent market developments. The report is described in detail at this link and may be ordered online for immediate download or may be ordered via order form.

Europe and Asia/Pacific to widely differ in future obesity

While it is universally true that the incidence and prevalence of obesity is increasing steadily, it is not nearly as true that the rate of growth is consistent globally and differences in these rates are compounded by differences in the market impact they have for the adoption and growth in the use of obesity treatment products.  Differences in demographics, socioeconomic trends, regulatory environments and other forces result in some starkly different pictures of obesity markets from region to region.

As an example, below are illustrated the distribution of obesity markets (figures in $ millions) by treatment type for Asia/Pacific versus Europe for both 2011 and 2019.  The economic growth of Asia/Pacific markets, particularly China and an associated growth in incidence/prevalence in obesity there will translate into a larger aggregate market for obesity treatments in 2019 for Asia/Pacific than in Europe, reversing the current picture in 2011.

Source: Report #S835, "Products, Technologies and Markets Worldwide for the Clinical Management of Obesity, 2011-2019."

A $10 billion global medtech market for ablation technologies

The world market for energy-based ablation devices includes electrical, radiation, light, radiofrequency, ultrasound, cryotherapy, thermal, microwave and hydromechanical. 

The total market in 2009 was valued at nearly $10 billion. For the market period 2010-2019, the compound annual growth rate (CAGR) for the global market is projected to be 11.2%. The CAGR is deceptively modest, because these figures reflect the combined market sizes and growth rates of nine sectors. Those nine sectors, or modalities, vary widely in growth rates: from thermal, with an estimated CAGR (’09-’19) of under 3%, to cryotherapy with a CAGR of 19.5%. The energy-based ablation devices market is growing vigorously and will continue to grow at a strong rate during the study period.

(As defined in the MedMarket Diligence report #A145), the Americas consist of the USA, Canada, Mexico and Brazil; the European Union (EU) includes the United Kingdom, Germany, France, Spain, Italy and BeNeLux; Asia-Pacific represents Japan, China, India and Australia.

The different energy-based ablation segments vary widely in size, as shown in the following exhibit. Radiation accounted for one-third of the entire market in 2009, followed by light-based ablation (e.g., laser) with 19%. These two modalities accounted for 52% of the dollar value of the energy-based ablation device market in 2009. The CAGR (’10-’19) for radiation is about 8.1%; that of light is about 11%. 

Global Ablation Market Segments

Source: MedMarket Diligence, LLC, Report #A145, "Ablation Technologies Worldwide Market, 2009-2019: Products, Technologies, Markets, Companies and Opportunities".

Global diabetes market growth by segment, regions

The global market for products in the management of diabetes currently stands at $41 billion and is on pace to grow to over $114 billion by 2018.  Products include glucose meters, lancets, test strips, continuous blood glucose meters, insulin, insulin pumps, syringes and other insulin delivery devices and anti-diabetic drugs.  The bulk of product revenues come from three segments — test strips, insulin and anti-diabetic drugs — which will remain the largest sources of product revenues over the next ten years.  The most significant growth, however, will come from the nascent segment of continuous blood glucose monitors, which provide significantly added clinical benefit at only a modestly higher cost compared to standard blood glucose meters.

The growth in global market for diabetes products from 2010 to 2018 is illustrated by product segment below:

Source: MedMarket Diligence, LLC; Report #D510, "Diabetes Management: Products, Technologies, Markets and Opportunities Worldwide 2009-2018."

 

Currently, the U.S. remains the single largest source of product revenues in diabetes management, at roughly 37% of the global market, but that percentage will drop to 28% by 2018, primarily as a result of significant growth in Asia/Pacific, which is due in no small measure to the rapid economic development of China, which demonstrate growth in both pricing and expansion of healthcare coverage to its 23 million diabetics.

The growth in the global market for diabetes products from 2010 to 2018 is illustrated by major geographic area below:

Source: MedMarket Diligence, LLC; Report #D510.

Clinical Management of Obesity Worldwide

Publishing in November 2010:

Products, Technologies and Markets Worldwide for the Clinical Management of Obesity, 2009-2019

– 300 pages  – 95 Exhibits  – 54 Company Profiles  – February 2011  – Report #S835

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[This report description and table of contents is also available at report S835.]

This report is a detailed market and technology assessment and forecast of the products and technologies in the clinical management of obesity (bariatrics). The report describes the current and projected patient population in obesity, detailing their incidence worldwide, with available incidence by country for the U.S., major European countries, major countries in Asia/Pacific (including Japan, China, India and Australia), the clinical practices in their management to encompass surgical approaches, medical supervised severely restricted diets, drug therapies, OTC treatments, biopharmaceuticals, non-pharmacologic approaches and weight maintenance approaches. The report describes clinical trends in the management of the obese. The report details the products on the market and the status of those in development for bariatric surgery, drug therapy, gastric stimulation devices, brain stimulation devices, combination therapies and genetic therapy and other therapies under development, and will provide current and worldwide market forecasts (2009-2019) separately for pharmaceuticals (with separate segment forecast data for satiety, malabsorption, appetite suppression and combination drugs) and devices (with separate segment forecast data for stomach restriction artificial fullness, malabsorption, gastric emptying and appetite suppression), with current (2009) market shares of the leading competitors in each segment. The report profiles 60 of the leading competitors, detailing current and potential position in the market, their products and their market strengths and likelihood of future success.

Preliminary Table of Contents

EXECUTIVE SUMMARY

SECTION 1: CLINICAL BACKGROUND OF OBESITY
1.1 Clinical Diagnosis of Obesity
1.1.1 Body Mass Index Scale
1.1.2 Measuring BMI vs. Measuring Adiposity
1.1.3 Classification of Obesity
1.1.4 Overweight, Obesity, Morbid Obesity, Super Obesity
1.1.5 Genetic Testing for Obesity
1.2 Obesogenic Influences
1.2.1 Dietary Changes Over the Last Twenty Years
1.2.2 Sedentary Lifestyles
1.2.3 Ongoing Research into Causes
1.3 Metabolic Pathways of Energy Homeostasis
1.3.1 Role of the Hypothalamus
1.3.2 Role of the Stomach
1.3.3 Role of the Small Intestine
1.3.4 Role of the Pancreas
1.3.5 Role of Adipose Tissue, An Endocrine Organ
1.3.6 Other Peptides
1.3.7 Obesity as Survival Mechanism
1.4 Co-Morbidities of Overweight and Obesity
1.4.1 Metabolic Syndrome
1.4.2 Effects of Obesity on Immune Function
1.4.3 Racial Differences in Co-morbidities
1.4.4 Type 2 Diabetes and Insulin Resistance
1.4.5 Hypertension
1.4.6 Dyslipidemia
1.4.7 Depression
1.4.8 Osteoarthritis
1.4.9 Asthma
1.4.10 Sleep apnea
1.4.11 Obesity and Cancer
1.5 Global Incidence and Prevalence of Obesity
1.5.1 By Geographic Region
1.5.1.1 USA, Canada, Mexico, Brazil
1.5.1.2 European Union
1.5.1.3 Asia-Pacific
1.5.2 By Age Group
1.5.2.1 Incidence and Prevalence among Children
1.5.2.2 Incidence and Prevalence among Elderly
1.5.3 Incidence and Prevalence of Morbid Obesity
SECTION 2: THE IMPACT OF OBESITY
2.1 Costs Related to Treating Obesity and Co-Morbidities
2.1.1 Current Healthcare Expenses
2.1.2 Breaking the Bank: Predictions of Future Healthcare Expenses
2.1.3 Healthcare Reform and Obesity
2.2 Impact on Businesses
2.2.1 Increased Health Insurance Costs
2.2.2 Increase in Workers’ Compensation Costs
2.2.3 Debate: Pay Employees to Lose Weight?
2.3 Legislating Prevention and Weight Loss
2.3.1 Changing Society: Educating Children as well as Adults
2.3.2 Pressure on the Food Industry
SECTION 3: CLINICAL APPROACHES TO THE TREATMENT OF OVERWEIGHT AND OBESITY
3.1 Role of Behavior Modification and Lifestyle Changes
3.1.1 Behavior Modification Programs: Decidedly Mixed Success
3.1.2 Medically Supervised Low Calorie and Very Low Calorie Diets (LCDs and VLCDs)
3.1.3 Why Diets Usually Fail
3.2 Pharmaceutical Treatment of Obesity: Past, Present and Future Drugs
3.2.1 The Bloom is Off the Rose: Promising Drugs Which Have Failed, and Why
3.2.2 Drugs Currently on the Market
3.2.2.1 Appetite Suppression Drugs
3.2.2.2 Malabsorption Drugs
3.2.2.3 Satiety Drugs
3.2.2.4 Combination Drugs
3.2.3 Areas of Pharmaceutical Research
3.2.3.1 Melanocortin Receptor System
3.2.4 Drugs in the Pipeline—But Will They Hold Up?
3.2.4.1 Appetite Suppression Drugs
3.2.4.2 Malabsorption Drugs
3.2.4.3 Satiety Drugs
3.2.4.4 Combination Drugs
3.2.5 Safety: The Major Diet Drug Hurdle
3.2.6 After ‘Phen-Fen’ Experience, Will Physicians Prescribe Off-Label Combinations?
3.3 Non- Pharmaceutical Options for Treating Obesity
3.3.1 Permanent Surgical Modification
3.3.2 Surgical Revision of Bariatric Procedures
3.3.3 Short-Term Surgical/Device Solutions
3.3.4 Invasive Devices to Treat Obesity
3.3.4.1 Devices to Restrict Stomach Volume
3.3.4.2 Artificial Fullness Devices
3.3.4.3 Malabsorption Devices
3.3.4.4 Devices to Control Gastric Emptying
3.3.4.5 Appetite Suppressive Devices
SECTION 4: MARKET ASSESSMENT
4.1 Global Market for the Treatment of Obesity
4.1.1 Pharmaceuticals
4.1.1.1 Satiety
4.1.1.2 Malabsorption
4.1.1.3 Appetite Suppression
4.1.1.4 Combination Drugs
4.1.2 Devices
4.1.2.1 Stomach Restriction
4.1.2.2 Artificial Fullness
4.1.2.3 Malabsorption
4.1.2.4 Gastric Emptying
4.1.2.5 Appetite Suppression
4.2 Market Shares of Leading Companies
4.2.1 Leading Pharmaceutical Companies
4.2.2 Leading Device Companies
4.3 Americas Market for the Treatment of Obesity
4.3.1 USA
4.3.2 Canada
4.3.3 Mexico
4.3.4 Brazil
4.4 European Market for the Treatment of Obesity
4.4.1 United Kingdom
4.4.2 France
4.4.3 Germany
4.4.4 Italy
4.4.5 Spain
4.4.6 Rest of Europe
4.5 Asia-Pacific Markets for the Treatment of Obesity
4.5.1 Japan
4.5.2 India
4.5.3 China
4.5.4 Australia
4.5.5 Russia
4.6 ROW Markets for the Treatment of Obesity
4.7 Market Drivers and Restraints
4.7.1 Drivers
4.7.2 Restraints
4.8 Marketing Opportunities
SECTION 5: COMPANY PROFILES
5.1 Abbott Laboratories
5.2 Allergan
5.3 Amylin Pharmaceuticals
5.4 Arena Pharmaceuticals
5.5 AstraZeneca
5.6 BAROnova Therapeutics
5.7 BaroSense
5.8 Covidien
5.9 CR Bard, Inc.
5.10 Eli Lilly & Company
5.11 EndoGastric Solutions
5.12 EndoSphere
5.13 EndoVx
5.14 EnteroMedics
5.15 Ethicon Endo-Surgery (JNJ)
5.16 Gelesis, Inc.
5.17 GI Dynamics
5.18 GlaxoSmithKline
5.19 Helioscopie
5.20 Interleukin Genetics
5.21 IntraPace
5.22 Merck
5.23 Nestlé Healthcare Nutrition
5.24 NeuroSearch A/S
5.25 Novo Nordisk
5.26 Orexigen
5.27 Pfizer
5.28 ReShape Medical
5.29 Rhythm Pharmaceuticals
5.30 SafeStitch Medical, Inc.
5.31 Sanofi Aventis
5.32 Satiety
5.33 Scientific Intake, LLC
5.34 Silhouette Medical, Inc.
5.35 Spatz FGIA, Inc.
5.36 USGI Medical
5.37 ValenTx, Inc.
5.38 Verva Pharmaceuticals Ltd.
5.39 Vivus, Inc.
APPENDIX I: CLINICAL TRIALS
APPENDIX II: APPENDIX
Company Contact Details
Terms and Abbreviations Used in this Report