Market Drivers: U.S. and European Cell Therapy, Tissue Engineering

Tissue engineering and cell therapy comprise a market for regenerative products that is expected to grow worldwide from $6.9 billion in 2009 to almost $32 billion by 2018. This market spans many specialties, the biggest of which is therapies for degenerative and traumatic orthopedic and spine applications. Other disorders that will benefit from cell therapies include cardiac and vascular disease, a wide range of neurological disorders, diabetes, inflammatory diseases, and dental decay and/or injury. Key factors expected to influence the market for regenerative medicine are continued political actions, government funding, clinical trials results, industry investments, and an increasing awareness among both physicians and the general public of the accessibility of cell therapies for medical applications.

There are key market drivers affecting the relative growth of cell therapy and tissue engineering in specific regions or countries. One historical driver has been the dynamics of stem cell research in the United States. The unavailability of additional stem cells due to President Bush’s Presidential Executive Order in 2001 (since rescinded in 2009 by President Obama) had the affect of decelerating the number of new embryonic stem cell research projects launched, thus postponing the optimistic timeline anticipated by some researchers. This directly delayed the commercialization of products based on embryonic stem cell research, which had the effect of dampening the overall U.S. market.  Simultaneously, this also drove increased research and development of the science (if not technologies as well) in areas outside the U.S., especially in the EU. While this distinction between the U.S. and Europe does not account for all the market size and growth differences, it is a distinct, identifiable cause.  (The U.S. also has in many respects a more mature — or at least more penetrated cell/tissue market — and the EU is simply catching up.)

Below for comparison is the relative U.S. and European share of the cell therapy and tissue engineering market in 2009 and 2019.

Source: MedMarket Diligence, LLC; Report #S520.

Ablation Technologies Market to Reach $10 Billion in 2010, According to a New MedMarket Diligence Report

PRLog (Press Release) – Jun 09, 2010 – The practice of surgery has long employed energy-based technologies to excise, cut, ablate, cauterize, destroy or otherwise manipulate tissue to produce therapeutic results. Various energy modalities — from cryotherapy to microwave to radiofrequency to ultrasound to radiation and others — have proven their ability to effect healthy or diseased tissue with more effective outcomes than other physical methods (e.g., the scalpel) can allow. These effects and outcomes include: 

  • destruction of diseased (e.g., cancerous) tissue preferentially over healthy tissue
  • simultaneous cutting and hemostasis of the surgical wound
  • creating lesions, as in treatment of atrial fibrillation, that block aberrant electrical pathways
  • sculpting of tissue as in laser vision correction
  • a wide range of other applications

The number and diversity of clinical applications in ablation is driven by the diversity of the different energy modalities: 

  • Microwave
  • Ultrasound
  • Electrical
  • Radiation
  • Radiofrequency
  • Hydromechanical
  • Cryotherapy
  • Thermal
  • Light

Products and technologies in ablation include capital equipment, instruments and disposable probes and other products. It is a robust area in which manufacturers aggressively develop and release new product configurations that improve upon patient outcomes and capture growing share of caseload. 

While there is a concentration of some ablation modalities for specific types of treatment (e.g., radiation has long been a predominant treatment in cancer), the modalities that compete with one another for caseload varies considerably from one clinical application to the next.  Therefore, a consideration of the market for any one of these modalities is not complete without also examining the competition presented by other modalities on a case-by-case basis. 

MedMarket Diligence's report (described at http://mediligence.com/rpt/rpt-a145.htm) on the Ablation Technologies Worldwide Market details the global market for ablation technologies, encompassing discussion of the specific tissue effects of each modality, the current and emerging surgical procedures, the products and technologies under development, the growing list of active manufacturers and developers and the worldwide market, by country/region for ablation technologies by modality. 

This 488 page report, with 123 tabular and graphic exhibits, is a detailed market and technology assessment and forecast of the products and technologies in the ablation market for treatment of soft tissues via energy-based modalities, including electrosurgery, radiosurgery, gamma knife, brachytherapy, cryogenic therapy, fluidjet therapy (hydrotherapy), microwave ablation, radiofrequency ablation, laser, thermal ablation, and ultrasonic ablation. 

The report describes alternative energy-based technologies and the nature of their effect on soft tissue, the underlying basis of the technology, the requisite systems for their use (including capital equipment, devices and disposables), and their strengths and weaknesses for specific clinical applications. The report details current and anticipated target applications and assesses the current and forecast caseload for each energy-based therapeutic considering competition from any and all alternative energy-based or other therapeutics, with current and worldwide market forecasts (2009-2019) segmented by technology type and specific clinical segment. The report provides segmentation of the worldwide ablation market by both ablation technology and region/country:Americas (USA, Canada, Mexico, Brazil), Europe (Germany, United Kingdom, France, Italy, Spain, BeNeLux), Asia/Pacific (Japan, China, India, Australia) and Rest of World. The report details the current and emerging products, technologies and markets for each energy-based therapy. The report profiles over 76 key companies in this industry detailing their current products, current market position and products under development.

The report is described in detail at link.  The report may be purchased for immediate download online or may be purchased by order form.


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MedMarket Diligence provides data and insight to the medical products, investment and other industries on advanced medical technologies through focused medical technology market and assessment Reports and the Medtech Startups Database.

 

 

 

 

 

 

 

 

Patents, Cell Therapy and the European Union

Before President Barack Obama’s 2009 Executive Order that reversed the ethics-driven ban on U.S. Federal funding for human embryonic stem cell research, the European Union had a clear advantage in stem cell research. However, now that the way is clear in the United States to accelerate embryonic stem cell research there, some worry that current regulations in Europe might undermine investor confidence and thus hamper funding for research in Europe.

The ethical debate surrounding the use of embryonic stem cells impacted not only the United States, but Europe as well. In the European Union, the debate has affected patent processes there, thus affecting funding and commercialization of the technologies in question.

The Legal Protection of Biotechnological Inventions (EU Directive 98/44/EC), which governs embryonic stem cell patents among other technologies, was intended to create a consistent approach across member states that would allow Europe to fully exploit opportunities in biotechnology. According to the directive, patents may not be granted for the human body at various stages of development, including the embryo stage. Therefore, cells that can develop into a human being cannot be patented, but adult cells and those that can be developed into body parts may be patented. While the European Patent Office grants most patents in Europe, the same patents must also be enforced in individual member states, where national courts may interpret the directive differently. In some cases, resistance has mounted to granting patents on any inventions using stem cells, leading some countries to resist implementing the directive into national law.

While the EU Directive bans patents for products that use embryos for industrial or commercial purposes, a European Patent Office board of appeal ruled that stem cells cannot be patented if they are obtained only by destruction of a human embryo. Until recently, this was the only way stem cells could be obtained. As such, the patent office’s ruling effectively created a ban on patents that involve any stem cells.

However, now that stem cells can be obtained without destruction of the embryo (e.g., adult stem cells or umbilical cord blood stem cells), the way is likely cleared for patents to be granted for embryonic stem cell inventions where a stem cell bank is listed as the source.

Needless to say, the uncertainty created by the directive and subsequent rulings has made some investors wary of investing in a market where the resulting technology may remain unprotected.

In the aggregate market of cell therapy and tissue engineering (recognizing the less strict regulatory environment of tissue engineering compared to cell therapy), the European Union generates less than half the revenues of the U.S. market, but this is expected to change (see below) as Europe expands its adoption of both tissue engineering and cell therapy in clinical practice.

Source: MedMarket Diligence, LLC; Report #S520.

Technology migration in medtech markets

Western markets, including the U.S. and Europe, tend to drive the formation of new medical technology markets, which then evolve and migrate to Asia/Pacific and the rest of the world.  While this is not always the case (a notable exception is the technology and market development of fibrin and other blood-based tissue sealants technologies, which substantially took hold in Japan first), it is often the case due to the level of innovation in these markets, available capital for investment and, in no small part (and to the ire of the cost conscious) the high percent of gross domestic product spent on healthcare, especially in the U.S.

One of the most well established markets for cell therapy and tissue engineering products, and second only to orthopedics, is in the area of skin or integumentary applications — treatment of burns, diabetic and venous ulcers and plastic and reconstructive surgery.  As an example of the trend of U.S. markets driving innovation, the market for cell/tissue products in skin applications has been dominated by the U.S., and the recent past trend in reported revenues geographically, which is certainly going to continue, is that the U.S. will represent a progressively smaller share of this global market.

Source: MedMarket Diligence, LLC; Report #S520.

U.S., Europe lead cell/tissue therapeutics markets

Worldwide sales of cell therapy and tissue engineering products eclipsed $6.9 billion in 2009 on pace to reach $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. 

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. Specifically, President Obama’s repeal of a Presidential Executive Order has given researchers sponsored with Federal funding 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.

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 healthy 20% (CAGR 2009–2018), as shown below.

 

 

Source: Report #S520, MedMarket Diligence, LLC

Skin replacements and substitutes in wound management

Skin replacements and substitutes (see image at right: Apligraf by Organogenesis, Inc.) compete in the severe burn, venous leg ulcer, and the diabetic foot ulcer markets where their high cost is offset by their ability to save lives and/or preserve limbs from amputation. These products have taken some time to demonstrate clinical effectiveness and to be approved for use to heal wounds more quickly than alternative treatments. In addition, these products are still significantly more expensive than alternative therapies, and publicly funded health care organizations around the world have sometimes found it difficult to absorb these costs despite strong cost-effectiveness claims. It is highly likely that products will take some time to reach high acceptance levels. The move towards cost effectiveness procurement practice is likely to increase uptake of these products as they move purchasers away 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.

The tissue engineering market has reached a point of growth inflexion, enforced by a downturn in biotechnology small-cap investment, and rationalization of tissue engineering programs by large cap medical devices and pharmacological organizations. This is strongly demonstrated by the wound management tissue-engineering field. Some companies like Novartis have recognized that existing product formats and cost structures are inappropriate for the wound management customers. As a result, the partnership between Novartis and Organogenesis dissolved at a point where sales seemed to be growing rapidly. Smith & Nephew took longer to receive approval for the Dermagraft product and limited their losses by divesting.

Globally, the market for tissue engineered skin repair and replacement is a $679 million market, with the majority of the market concentrated in the U.S. and Europe, but annual sales growth in Asia/Pacific and in RoW is in excess of 20% and 15%, respectively.


Tissue engineered skin, integumentary and plastic surgery products are detailed in MedMarket Diligence Report #S247, "Worldwide Wound Management" and Report #S520, "Tissue Engineering, Cell Therapy and Transplantation".

Size and Growth of Tissue Engineering and Cell Therapy in the U.S., Europe, Asia/Pacific and Rest of World

The global market for tissue engineering and cell therapy products is set to more than quadruple from 2009 to 2018. Products in cell therapy and tissue engineering include 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.

Factors that are expected to influence this market and its explosive growth include political forces, government funding, clinical trial results, fluctuating industry investment and an increasing awareness among both physicians and the general public of the accessibility of cell therapies for medical applications. The reversal of the U.S. government's ban on federal funding for embryonic stem cell research has given researchers sponsored with federal funding 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.

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, tighter regulatory environments 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 healthy 20%.

Meanwhile, growth rates in Europe and other areas outside the United States and Asia/Pacific (rest of world or ROW) are expected to be roughly to growth of the market in Asia. This reflects the fact that European and developing market regulatory requirements allow products to be commercialized more rapidly in those regions. While the rate of growth in the United States for this time period is expected to be slower, this is only due to its larger size and its position ahead of other markets on the classic market growth curve.  Nonetheless, some in Europe worry that research in the United States will accelerate at a more rapid pace now that U.S. researchers have access to additional lines of stem cells. The fear is that this will allow development in regenerative medicine technologies to threaten an eclipse of the gains made in Europe in the past several years.


See Report #S520.

Report: Worldwide Tissue Engineering & Cell Therapy Market at $6.9 billion

Our research into the products, technologies, companies and markets for tissue engineering and cell therapy has revealed that the 2009 market was at $6.9 billion. The market has grown dramatically, in commercialized products and company activity, over the past few years and is on an accelerated growth rate as technology hurdles are overcome and clinical acceptance is gained in a wide range of applications spanning cardiology, neurology, orthpedics/musculoskeletal/spine, urology, skin/integumentary, dental/oral, organ replacement and preservation, ophthalmology, general/gastroenterology/gynecology, cancer and cord blood & cell banking.

 

Worldwide Tissue Engineering & Cell Therapy Market, by Segment, 2009

Source: MedMarket Diligence, LLC, Report #S520

The report, described at link, details the activities, products and markets for these applications represented by almost 150 active companies.  The report may be purchased for download at link.  Until February 28, 2010, we're offering 10% off the purchase price of this report. Just order the report online and on checkout enter the coupon code "1266865321" to receive the 10% discount.


Wound Care Markets: Country-Specific Patterns, Drivers, Opportunities

Clinical protocols for the treatment of specific wounds can vary considerably from country to country. Venous stasis ulcers, which account for approximately 4% of wounds and 75% of leg ulcers, are treated with short stretch compression bandages in Germany, elastic adhesive bandages in Italy, high compression bandages in France and multi-layer compression systems in the UK. As in the US, the routine use of strong antiseptics is discouraged in the UK and Germany but still prevalent in East European countries as well as the Netherlands and Italy.

The quest for standardized modern approaches to wound healing is aided by groups such as the European Wound Management Association and European Tissue Repair Society, which encourage pan-European dialogue on issues pertaining to wound care. Such organizations have had significant effect on the development of US wound care policy and practices. 

The proliferation of different wound care products and strategies leads to confusion and uncertainty over the best practice options. Clinical comparisons between treatment modalities have been minimal, with reliance on small, product-focused studies that often omit the wider context under which wounds are treated. Users of wound care products rely on manufacturers for performance data and increasingly turn to the larger manufacturers for staff education and wound care treatment protocols that will naturally include the use of the large number of products in the manufacturer’s line. In many countries in Europe, testing procedures have been developed by government-supported cross-company working panels that meet regularly to define specific protocols for testing products. These tests gradually become adopted by manufacturers as first lines of evaluation for new technologies.

The emerging use of electronic devices for wound documentation and assessment is expected to allow the comparison of large numbers of wounds undergoing different integrated approaches to wound care and begin to differentiate those activities that provide the most benefit to wound healing. As in the rest of the world, studies need to become larger, more standardized and complete to allow scientific comparison of products and practices that include multiple product classes and the management of the underlying conditions that create chronic wounds.

In addition, electronic devices for recording individual patient data are becoming available. These devices are important to ensure continuity of treatment, particularly in the home environment where several visiting nurses may see a single patient over a period of weeks. Without a good monitoring tool a complex and inconsistent mix of products and strategies could be applied.


From 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."

European drug-eluting stent market trends

The European market for drug-eluting stents is demonstrating its maturity in terms of numbers of competitors, the upward sales growth driven by increasing unit sales rather than premium pricing and other considerations.

Source: MedMarket Diligence, LLC; Report #C245

This illustrates the challenge for manufacturers to differentiate their products and pursue innovations that can command premium pricing, a challenge that is becoming increasingly difficult as healthcare reform emerges.

The similar curves for the next major alternative to drug-eluting stents — bioabsorbable stents — show markedly different trends, those illustrative of an emerging, growth market.  In the 2013 to 2017 timeframe, bioabsorbable stents will gradually begin to make inroads into the European DES market.  These include products under development by Abbott Vascular, Amaranth Medical, Inc., Arterial Remodeling Technologies (ART), Arterius Ltd., Bioabsorbable Therapeutics, Inc. (BTI), Bioring SA, Biotronik, Boston Scientific, Elixir Medical, EuroCor (owned by Opto Circuits), ICON Interventional, Kyoto Medical Planning Co., Ltd., and REVA Medical.