Category Archives: China

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.

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″.

 

Wound management: A $21.8 billion+ worldwide market in 2021

The worldwide market for products in wound management, as reflected in the MedMarket Diligence report #S249, encompasses twelve discrete product segments:

  • Traditional Adhesive Dressings
  • Traditional Gauze Dressings
  • Non-Adherent Dressings
  • Film Dressings
  • Foam Dressings
  • Hydrogel Dressings
  • Hydrocolloid Dressings
  • Alginate Dressings
  • Antimicrobial Dressings
  • Negative Pressure Wound Therapy Devices
  • Bioengineered Skin and Skin Substitutes
  • Wound Care Growth Factors

These segments include traditional wound care products, like dressings and bandages, but also include their more evolved forms with embedded components or constructions to enhance wound healing by shortening healing times or improving outcomes. But, wound care has also evolved to included equipment/device-mediated care as in NPWT as well as biologically-derived or engineered products in regenerative medicine.

The MedMarket Diligence report details the current and forecast wound market by product type in North and South America, the European Union, Asia/Pacific and Rest of World, and looks at markets and growth rates by product and country for the years 2012-2021.

The world market in 2012 stood at approximately $12.45 billion. By 2021, the total wound management market represented by the segments listed above is projected to be worth over $21.85 billion million, reflecting a 2013-2021 CAGR over 7%.

wound-pie-2013

Source: Report #S249.

There are some market restraints at work, primarily the high cost of the new technologies. Not all country healthcare budgets can afford advanced wound care products, even if they are proven to decrease healing times and hospital costs over the longer run. The development of substitute products threatens existing product categories, while a lack of sufficient clinical and economic evidence backing new technology hinders growth and acceptance of some of the more advanced wound management technologies. In addition, improved wound prevention and a lack of regulation on tissue engineering in the EU are also expected to hold back the development of new technologies.

In addition to market restraints, there are a number of drivers that are expected to shape this market in the years to come. One of the primary drivers is the aging of the global population. Chronic diseases, such as circulatory conditions, anemias and autoimmune diseases influence the healing process as a result of their influence on a number of bodily functions. Illnesses that cause the most significant problems include diabetes, chronic obstructive pulmonary disease (COPD), arteriosclerosis, peripheral vascular disease (PVD), heart disease, and any conditions leading to hypotension, hypovolemia, edema, and anemia. While chronic diseases are more frequent in the elderly, wound healing will be delayed in any patient with underlying illness. Happily, most wounds heal without any problems. However, chronic wounds may take months or years to fully close, or may never close. Chronic wounds adversely affect the individual’s quality of life, and are a leading cause of burgeoning healthcare costs.

Type 2 diabetes represents 85-95% of all diabetes in developed countries, and accounts for an even higher percentage in developing countries. There were 26 million diabetic patients in the US in 2012 and 285 million patients globally.   Of these patients, approximately 15% will develop a diabetic foot ulcer and 50% of these will become infected, representing an estimated 2 million patients. Diabetic foot infections are currently treated with systemic antibiotics, but the estimated failure rate of antibiotics for diabetic foot ulcers is in excess of 22%.

A patient with diabetes is at significant risk of damage to tissues caused by impaired homeostasis due to the disease process. For example there is a tendency for such tissues to develop blockages in smaller blood vessels, which reduces the ability of these vessels to provide sufficient oxygen to tissues already under stress due to compromised nutrient supply and the diabetic condition. These patients then develop arterial ulcers. They may also have a tendency to suffer from venous ulcers, due to the underlying poor condition of cells as a result of the diabetes.

The diabetic foot is the most common cause of non-traumatic lower extremity amputations in the US and Europe: there is an average of 82,000 amputations per year in the U.S., costing an estimated $1.6 billion annually. The estimated cost of foot ulcer care in the U.S. ranges from $4,595 per ulcer episode to more than $28,000 and the total annual cost of foot ulcer care in the US has been estimated to be as high as $5 billion.

Pressure, or decubitus, ulcers are another of the most common types of chronic wounds. The treatment of pressure ulcers places a major burden on healthcare systems worldwide, with an emerging additional cost of litigation increasing in importance over recent years. Healthcare practitioners need to be aware of both the direct and indirect costs and consider how the implementation of prevention protocols may offer cost savings in the longer term. The cost of a dressing for example as a prevention tool is minimal in comparison to the costs of treating an established pressure ulcer.

Following are a few hard numbers on the true financial cost of pressure ulceration:

  • The estimated cost to the US hospital sector is $11 billion per annum
  • The estimated cost to the UK national health service is estimated at £1.4-£2.1 billion annually (4% of total NHS expenditure)
  • Lawsuits remain common in both acute and long term care — with high payments in certain cases
  • The average cost to treat an individual with an unstageable ulcer or a deep tissue injury is estimated to be $43,180
  • The average length of stay in hospital is almost three times longer for chronic wounds
  • The mean hospital cost for management of pressure ulcers in the U.S. is $14,426. In comparison, the same cost in Korea is identified as $3,000-$7,000.

The cost of treating chronic wounds is one element driving the development and utilization of advanced wound care technologies. Other drivers are the aging of the population, and the obesity epidemic, which is expected to produce a wave of diabetics in the years to come.

Worldwide Wound Management Market, Segment Size & Growth, 2013-2021

wound-bubbles-2013-2021

Source: Report #S249.

In 2009, four companies (Johnson and Johnson, Kinetic Concepts Inc., Hill-Rom and Smith & Nephew) were responsible for about 60 percent of total market revenue. However, mergers, acquisitions and sales of intellectual property have rapidly changed the market share picture. By the end of 2012, more than half of the global wound care market was held by Johnson and Johnson, 3M, Smith & Nephew, and Systagenix. In addition, competition on price has driven down prices in the well established (i.e., traditional wound care) markets, while novel technologies are taking hold with introductory revenues and generating high, early stage growth rates.


For the complete analysis of the worldwide wound management market, see “Wound Management, Worldwide Market and Forecast to 2021: Established and Emerging Products, Technologies and Markets in the Americas, Europe, Asia/Pacific and Rest of World” (Report #S249).

Plastic Surgery Utilization Worldwide

The popularity of plastic surgery — whether for aesthetic or reconstructive procedures — is growing worldwide, driving the development and sale of a wide range of medical products.

The highest utilization of plastic surgery worldwide is in China, followed closely by India. Yes, of course, this is purely population-driven, with the #1 and #2 countries by population having the highest absolute volume of plastic surgery procedures. But, on a relative basis, compensating for those countries’ huge populations, the highest per capita utilization of plastic surgery is…anyone? Anyone? Buehler?

The highest per capita utilization of plastic surgery is actually in South Korea, followed by Greece, followed by Italy, followed by the U.S. Below is tabulated the plastic surgery procedure volumes (medical or surgical) by country for the top 25 countries:

Plastic Surgery Procedures by Country, 2011

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Source: MedMarket Diligence, LLC; Report #S710.

Global and regional growth rates for wound care product sales

Manufacturers of wound care products, from traditional dressings and bandages to growth factors and bioengineered skin, see variable sales growth driven by different levels of new product adoption, variations in clinical practices, and other technology, reimbursement, regulatory, economic and other forces that vary by geography across the globe. The balance of sales across multiple wound care product types can be radically different from country to country and region to region.

Emerging from the 2013 analysis (Report #S249) by MedMarket Diligence are the current and forecast wound care product sales resulting from the net effect, region by region, of these multiple forces. Below is illustrated the high growth country/product segments in wound management, reflecting the rapid adoption of new technologies such as growth factors and bioengineered skin, as well as older products such as alginates that are gaining sales in rapidly developing economies.

wound-country-high

Source: MedMarket Diligence, LLC; Report #S249, “Wound Management, Worldwide Market and Forecast to 2021: Established and Emerging Products, Technologies and Markets in the Americas, Europe, Asia/Pacific and Rest of World.”

At the other end of the extreme are those very well established products growing at less than anemic rates in countries where the economy is not as robust and/or where the growth has been superseded by sales of more novel products. Conventional dressings and bandages offer considerably less demand than do growth factors, bioengineered skin and skin substitutes and similar new products.

wound-country-low

Source: MedMarket Diligence, LLC; Report #S249

Of course, growth of sales in wound management products (and any product) is defined as the percentage change in sales volume over time. Smaller markets (typically soon after they have formed as a result of their initial commercialization) tend to grow on a percentage basis much faster. Indeed, a $1 dollar sale in year 1 followed by a $2 sale in year 2 represents a 100% growth rate, while a $1 increase in sales from year 1 to year 2 for a $100 million market represents virtually zero growth. Conversely, a 1% increase in a $1.75 billion market is a $17.5 million increase. This is indeed obvious, but must be kept in mind when considering the growth rates discussed above.

Wound management technologies, worldwide growth

The global wound care market is expected to always be represented by sizeable share of basic products in wound dressings and bandages, which for the majority of wound types have clearly proven to be cost effective in producing acceptable time-to-healing and other clinical outcomes. However, advanced wound products to address complex wound types – many of which may simply evolve from otherwise simple wounds that have been neglected – are increasingly demonstrating their potential for accelerating the pace and therefore reducing the cost of wound healing.

But factors other than cost-consciousness are driving the advanced wound care market. Patients’ desire for less scarring, as well as an increased awareness of infection issues, drive the development of advanced dressings and biomaterials that reduce bacteria and heal wounds faster. An aging world population and lifestyle changes that contribute to disease frequency also factor into the market’s continued growth.

Still, there are some market restraints, primarily the high cost of new technologies, which therefore must demonstrate better outcomes and/or lower long-term costs. Development of substitute products threatens existing product categories, while a lack of sufficient clinical and economic evidence backing new technology hinders growth and acceptance of some more advanced wound management technologies. Improved wound prevention and a lack of regulation on tissue engineering in the EU are also expected to withhold the development of new technologies.

A high number of manufacturers competing for market share have also driven down prices. In 2009, the top wound care companies included Johnson and Johnson, Kinetic Concepts Inc. (KCI), Hill-Rom and Smith & Nephew. These four companies were responsible for 60 percent of total market revenue in 2009. However, mergers, acquisitions and sales of intellectual property can rapidly change the market share picture. In June 2009, Hill-Rom sold its intellectual property relating to negative pressure wound therapy to KCI. By end 2012, about 56% of the wound care market was held by Johnson and Johnson, 3M, Smith & Nephew, and Systagenix.

Below is illustrated the global market for traditional and advanced products in wound management, with the compound growth rate in sales of individual product types ranging from a low of under 3% to a high of 19% through the forecast period (i.e., to 2021).

wound-2012-2021

Source: MedMarket Diligence, LLC; Report #S249, “Wound Management, Worldwide Market and Forecast to 2021:  Established and Emerging Products, Technologies and Markets in the Americas, Europe, Asia/Pacific and Rest of World”.