Category Archives: Americas

Applications, global markets in tissue engineering and cell therapy

Screen Shot 2014-04-17 at 7.37.44 AMThe market for tissue engineering and cell therapy products is set to grow from a respectable $8.3 billion in 2010 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.

Cell-tissue-applications

Factors that are expected to influence this market and its explosive growth include political forces, government funding, clinical trial results, industry investments (or lack thereof), and an increasing awareness among both physicians and the general public of the accessibility of cell therapies for medical applications. Changes in the U.S. government’s federal funding of embryonic stem cell research has given a potentially critical mass of researchers increased access to additional lines of embryonic stem cells. This is expected to result in an increase in the number of research projects being conducted and thus possibly hasten the commercialization of certain products.

regional-forecast

Source: Report #S520, “Tissue Engineering, Cell Therapy and Transplantation: Products, Technologies & Market Opportunities, Worldwide, 2009-2018.”

Another factor that has influenced the advancement of regenerative technologies is found in China, where the Chinese government has encouraged and sponsored cutting-edge (and some have complained ethically questionable) research. While China’s Ministry of Health has since (in May 2009) established a policy requiring proof of safety and efficacy studies for all gene and stem cell therapies, the fact remains that this research in China has spurred the advancement of (or at least awareness of) newer applications and capabilities of gene and stem cell therapy in medicine.

Meanwhile, stricter regulations in other areas of Asia (particularly Japan) will serve to temper the overall growth of commercialized tissue and cell therapy–based products in that region. Nonetheless, the growth rate in the Asia/Pacific region is expected to be a very robust 20% annually.


MedMarket Diligence’s Report #S520 remains the most comprehensive and credible study of the current and project market for products and technologies in cell therapy and tissue engineering.

The Aesthetics & Reconstructive Surgery Products Global Market

Global medical aesthetic products are to achieve sales of more than $6.5 billion in 2013. Through 2018 the market is expected to reach a value of about $10.7 billion. Europe has been witnessing relatively a slower growth of 6.6% per year. Declining purchasing power, particularly in southern Europe affects the European market and this geographical segment is estimated at $1.84 billion in 2013 to reach $1.94 billion in 2018. The U.S. and the Latin America markets will have a CAGR close to 10%. The U.S. and Latin America will experience a growth respectively of 9.2% and 10% in line with global trends. The U.S. market still represents 45% of the global market.

Screen Shot 2014-04-15 at 7.27.04 AMThe Asia/Pacific region will have an overall CAGR of more than 14.1%. Asia will experience the strongest growth through 2018 and exceed the level of the European market in 2018 to $2.24 billion. Overall, the annual growth of the world market between 2013 and 2018 should be 10% to $10.7 billion.

The injectable products (botulinum toxin and fillers mainly hyaluronic acid) constitute the top market segment in value and will have a CAGR of 10.8% until 2018, thus confirming their constant development potential. Since 2012, the toxins market marginally exceeded the dermal fillers market in the world but with a few exceptions such as Europe. The main markets for injectable products by decreasing order are the U.S., E.U., Asia and South America.

The energy-based devices (laser, radiofrequency, ultrasounds) will have an average CAGR of 10.3% until 2018. The sub-segment of body contouring devices will have an average CAGR of 12.1% until 2018. It should represent as nearly half of the activity-based equipment energy by 2018. The main markets for energy-based devices by decreasing order are the U.S., E.U. Asia and South America.

The cosmeceuticals (active cosmetics) will follow the same trend as the injectable products. The major markets for active cosmetics in decreasing order are the U.S., Asia, South America and the E.U. The market for active cosmetics in 2013 and 2018 will be $1,026 million and $1,677 million respectively. The breast implants will have a reduced progression of 5.2% per year until 2018. The major markets for breast implants by decreasing order are the U.S., South America, E.U. and Asia. The 2013 and 2018 market for breast implants will be about $1,066 and $1,370 million respectively. The two most popular cosmetic surgery procedures are still, in the world as well as for each geographical area, the liposuction and the breast augmentation with prosthetic implants. Breast implants experienced a slowdown of about 9% mainly due to concerns about the safety of their components, but this suspicion seems to disappear gradually in recent months.

More limited surgical procedures now are performed in the face, arm, or the internal face of thighs. The goal is primarily to make a change with a natural result. For the face it is readily associated with fat injection to recover volumes. Minimal invasive therapies enjoy a strong growth in 2013, especially with the new botulinum toxin. Alternative techniques to the toxin as cryomodulation begin to develop. The non-invasive techniques are increasingly linked to each other: toxin for the upper face and hyaluronic acid for the lower face, willingly associated with rejuvenation and retightening techniques of the skin by radio frequency and light peels. Far from being opposed to surgery, these techniques maintain surgery result. There is strong growth of surgical cosmetic procedures for men and women above 50 years old in Western countries due to the demand for anti-aging treatment and social pressure. These procedures increased from 28% to 36% between 2005 and 2011, this demand is also significant for invasive treatments and non-invasive.

From “Global Markets for Products and Technologies in Aesthetic and Reconstructive Surgery, 2013-2018″, Report #S710, published by MedMarket Diligence, LLC.

Wound Market Analysis, A Case Study in Understanding the Context for Opportunity

Analysis is a funny thing. If done thoroughly, accurately and carefully to represent a subject from all relevant angles, it can reveal very important considerations by those with a vested interest (e.g., in support of expensive investment).

Analysis is often driven by assumption. (“It seems to me that the relative significances of different wound management products vary from one country to another, or one region to another.”) So, analysts go looking for data that would support or reject that assumption. Here, one would be interested in the relative values of different wound product sales in different countries.

Ah, we have that data. Let’s plot the sales, as a percent of each region’s total, for the different categories of wound management products in the Americas, European Union, Asia/Pacific and Rest of World:

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 Source: MedMarket Diligence, LLC; Report #S249.

What striking results, the analyst says. Clearly, negative pressure wound therapy is much more common in the Americas than it is in the Rest of World. Other small-to-significant differences are seen in other product areas.

However, the better analyst would challenge the assumption or at least consider its relevance to important decisions (again, e.g., expensive investment).

This relative data was presented because it answered an assumption, that relative use of different wound management products varies by country/region. Of course, this is indeed true.

But that’s not the whole story.  Here, we have engaged ourselves in a careful analysis of deck chairs on top of a magnificent, unsinkable luxury liner.

The bigger picture, the more relevant context into which this analysis must fit is not simply the relative difference, but the absolute difference. If we take this question of wound product sales by geography and consider not the relative but the absolute differences, the picture changes considerably:

Screen Shot 2014-03-26 at 1.59.06 PM

Source: MedMarket Diligence, LLC; Report #S249.

Which analysis is correct?  Of, course, they both tell the truth, but neither tells the whole truth. One can gain a more comprehensive understanding by considering both and recognizing the significance of actions based on one or the other analysis.

But size and growth are not the only dimensions that factor into the potential interest by manufacturers. There is, of course, the degree to which the market is fragmented — how many competitors are carving up that high volume or high growth niche?  Here are some of the (3^3=9) combinations (of which many are possible):

  • High volume, low growth, fragmented: traditional wound dressings
  • High growth, low volume, unfragmented: growth factors
  • High growth, low volume, fragmented: bioengineered skin and skin substitutes
  • High growth, high volume, unfragmented:  ???

The opportunities available to manufacturers of wound management products clearly derive from each manufacturer’s strengths (technology, market presence, time-to-market, etc.), but the value of those opportunities and whether they should be pursued are factors that are dictated entirely by how each of those strengths match up against others in the market.  The wound management market has a highly diverse makeup of technology types, competitor types, clinical applications, clinical challenges, market forces and, ultimately, different competitive niches for product suppliers.

Aesthetic and Reconstructive Products Accelerating to Double Digit Growth Worldwide

Global medical aesthetic and reconstructive products, which include medical/surgical implants, materials, injectable products, energy-based devices (e.g., laser, RF), “cosmeceuticals” and other products used in aesthetic and/or reconstructive procedures, achieved sales of more than $6.5 billion in 2013. By 2018, the worldwide market for aesthetic/reconstructive products will reach $10.7 billion. The U.S. and the Latin America markets will have a CAGR close to 10%. The U.S. and Latin America will experience growth, respectively, of 9.2% and 10% in line with global trends. Of course, the global trend is largely represented by the U.S. market, which holds 45% of the total. Europe has been witnessing relatively a slower growth of 6.6% per year. Declining purchasing power, particularly in southern Europe affects the European market and this geographical segment is estimated at $1.84 billion in 2013 to reach $1.94 billion in 2018.

The Asia/Pacific region will have an overall CAGR of more than 14.1% driven by increasing demand and, accordingly, by the expanded access to technologies and products in China and by the continued high growth in the strong economies of Japan and South Korea. Overall, Asia will experience the strongest growth in aesthetic/reconstructive product sales, eventually eclipsing the total for the European market in 2018, reaching $2.24 billion. Globally, the growth of the market from 2013 and 2018 be a 10%+ compound annual growth rate.

Global Segmentation of All Surgical and Non-Surgical
Aesthetic/Reconstructive Procedures, 2013

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Source: MedMarket Diligence, LLC; Report #S710, “Global Markets for Products and Technologies in Aesthetic and Reconstructive Surgery, 2013-2018″.

 

Sales of Sealants, Hemostasis, Other Closure a Large, Shifting Market Worldwide

Products that provide hemostasis, closure, sealing and anti-adhesion of wounds comprised long established products (e.g., tapes, sutures, etc.) as well as a variety of advanced products such as fibrin and other surgical sealants, surgical glues, hemostats and products to prevent post-surgical adhesion.  While traditional products are being innovated to keep pace with advanced products (for example, through the development of absorbable sutures), the shift of caseload and product sales away from traditional products appears unrelenting.

As a result, the balance of the competitive landscape is forecast to shift over the next few years toward advanced sealing, hemostasis, closure and anti-adhesion products.  Below is illustrated, in a combined “donut” chart, this shift from 2012 to 2017 in the share of the global market for these products.

sealants_donut_2012-2017

Source: MedMarket Diligence Report #S190, “Worldwide Surgical Sealants, Glues, Wound Closure and Anti-Adhesion Markets, 2012-2017.”

These percentage shifts may not seem significant unless one considers that the global market for these products is over $5 billion.

 

Potential for the Use of Hemostats, Sealants, Glues and Adhesion Prevention Products, Worldwide

The MedMarket Diligence Report #S190, “Worldwide Surgical Sealants, Glues, Wound Closure and Anti-Adhesion Markets, 2012-2017″, details the complete range of sealants & glues technologies used in traumatic, surgical and other wound closure, including tapes, sutures/staples/mechanical closure, hemostats, fibrin sealants/glues and medical adhesives and anti-adhesion products. The report details current clinical and technology developments, with data on products in development (detailing market status) and on the market; market size and forecast; competitor market shares; competitor profiles; and market opportunity. The report provides full year actual data from 2011. The report provides a worldwide forecast to 2017 of the markets for these technologies, with emphasis on the market impact of new technologies through the forecast period. The report provides specific forecasts and shares of the worldwide market by segment for Americas (detail for U.S., Rest of North America and Latin America), Europe (detail for United Kingdom, German, France, Italy, Spain, Rest of Europe), Asia/Pacific (detail for Japan, Korea, Rest of Asia/Pacific) and Rest of World. The report provides background data on the surgical, disease and traumatic wound patient populations targeted by current technologies and those under development, and the current clinical practices in the management of these patients, including the dynamics among the various clinical specialties or subspecialties vying for patient population and facilitating or limiting the growth of technologies. The report establish the current worldwide market size for major technology segments as a baseline for and projecting growth in the market through 2017. The report assesses and projects the composition of the market as technologies gain or lose relative market performance over this period. The report profiles 122 active companies in this industry, providing data on their current products, current market position and products under development.

See description, table of contents and list of exhibits at http://www.mediligence.com/rpt/rpt-s190.htm.

Pressure ulcers in chronic wound management

Manufacturers of medical products have a primary focus on developing products that target underserved treatment areas, reduce the cost of care, or both. In one of the largest and most long-term treatment markets — wound management — a major focus of development is therefore the technologies to accelerate and improve the outcomes in the treatment of chronic wounds, which otherwise linger in healthcare systems, generating long-term direct and indirect costs. Among the most common types of chronic wounds are pressure ulcers.

Pressure ulcers, or bedsores, are areas of local necrosis resulting from vascular insufficiency due to the prolonged application of pressure to the tissues. There is an important relationship between the magnitude of pressure applied to the capillary bed and the duration that pressure is applied. Pressure ulcers are more likely to occur under relatively low pressures over long periods of time rather than under short episodes of high pressure. A healthy adult can develop a pressure ulcer if pressure sufficient to close capillaries (25-32 mm Hg) is applied for sufficient time, such as when undergoing a lengthy surgical procedure. In the compromised or elderly patient, significantly lower pressures may lead to pressure ulcer formation.

Pressure ulcer formation is enhanced through the additional application of shearing forces, friction, and moisture.

Shearing occurs when the skin is anchored to a surface, such as a bed or chair, and restrained from sliding over the surface while the underlying tissues are forced to move. The shearing force contributes to the destruction of deep tissue through the angulation and obstruction of blood vessels and excessive stretching of tissue. Shear occurs when a patient left sitting in a bed is pulled down into a slouch by gravity. The skin will adhere to the bed linen, while the coccyx will gradually drag the underlying tissue downward. Shearing forces may result in a disruption of the dermal-epidermal junction and produce blisters. Proper and frequent repositioning of a patient can reduce both pressure and shearing forces.

Friction occurs when the adhesion to the surface is not quite sufficient to prevent sliding, but sufficient to impart resistance to motion, that results in heat and wearing away of the outer layers of the skin. A patient who has slid down toward the bottom of the bed and is dragged back to the top will experience friction on the heels and other bony prominences. For this reason patients should be lifted back into position, and sliding over the bed surface should be avoided. Dressings that protect against friction and mattress covers with a low friction coefficient are helpful.

Moisture that is in prolonged contact with the skin produces maceration and reduction in the skin’s ability to tolerate additional stress. Macerated skin has a higher friction coefficient, increasing the likelihood of damage from friction and shear. Several sources of moisture are common in hospital and nursing home situations, including perspiration and urinary and fecal incontinence. Moisture may lead to fungal infections, and fecal incontinence can generate infections by E. coli. Thus, moisture may contribute to wound formation and present complications to wound healing.

Ulcer Classification

Several pressure sore classification systems have been used since 1975, including the Shea Pressure Sore Classification (1975), and the International Association of Enterostomal Therapy (IAET) pressure ulcer classification (1987).

  • Stage I ulcers are indicated by damaged friable surface skin with considerable hidden cell death caused by continuous pressure damage usually from immobilization in a single position. Identification of signs of pain and early indications of visible damage is a significant event in that it alerts caregivers of the need for interventions to prevent more serious damage.
  • Stage II ulcers present as partial thickness wounds, which may heal with early intervention by regeneration under advanced wound care techniques.
  • Stage III ulcers are usually full-thickness pressure sores. These are often difficult to classify due to the presence of eschar that obscures visualization of the wound bed. The presence of eschar does indicate a full thickness wound but the eschar must be debrided before classification can be established.

    Early Stage III or Stage IV pressure ulcers may superficially resemble Stage I ulcers. A wound initially classified as Stage I may, therefore subsequently appear to progress to higher stages as the already damaged deeper tissues slough off or as auto-debridement occurs with moist wound healing therapy.

  • Stage IV pressure ulcers are characterized by full thickness skin loss with extensive destruction, tissue necrosis, or damage to muscle, bone, or supporting structures (e.g., tendon, joint capsule). Undermining of healthy surrounding skin and sinus tracts may also be associated with Stage IV pressure ulcers.

 

Products and markets in the treatment of chronic wounds are covered in the comprehensive global report on wound management from MedMarket Diligence. See link.

Plastic and reconstructive surgery drives a $6.5 billion global products market

Plastic and reconstructive surgery, whether for reconstructive procedures following traumatic, cancer or other clinically indicated condition or simply for cosmetic purposes, is performed over 6 million times annually worldwide.

The highest volume procedures, despite being limited by their need to be financed out-of-pocket, are cosmetic procedures. However, the demand for cosmetic procedures has stimulated an industry that is increasingly being leveraged for the benefit of clinically-indicated (read: reimbursed) reconstructive procedures.

Below is illustrated the top aesthetic and reconstructive procedures globally.

Screenshot 2014-01-22 13.10.33

Source: ISAPS International Survey on Aesthetic/Cosmetic Procedures Performed in 2011; MedMarket Diligence, LLC.

These procedures are the basis of a $6.5 billion global market aesthetic and reconstructive products, as detailed in the 2013 MedMarket Diligence Report #S710, “Global Markets for Products and Technologies in Aesthetic and Reconstructive Surgery, 2013-2018″.