Cancer is a significant opportunity for the development of tissue engineering and cell therapies, but it is more than just an opportunity currently, since many companies are active and the market for cancer cell/tissue therapies already stands at nearly $500 million.
Currently, OSI Pharmaceuticals has a commanding lead in this area, with its Tarceva being used for pancreatic and non-small cell lung carcinoma. Overall, the market is controlled by a limited number of players, but many others are in development.
The MedMarket Diligence report #S520, "Worldwide Tissue Engineering, Cell Therapy and Transplantation Market, 2009-2018", covers the developments, products, technologies, markets and companies active in the area of cell therapies and tissue engineering for cancer. Cancer types covered are the full range encompassing urology, neurology, Ob/Gyn, orthopedic/bone, gastrointestinal/gastroenterology, head & neck, hemotopoietic, and respiratory.
The global market for coronary stents is estimated to be in excess of $7 billion and projected to be growing at 6% per year. With the average age of citizens in developed countries increasing, there is an increased need to provide medical care to the average citizen. As such, an aging population translates into increasing numbers of people needing medical therapy and increasing numbers of people who need more aggressive medical therapy due to the aging process. As the population of developed countries ages, the number of percutaneous coronary interventions (PCIs) required increases as well. Currently, the incidence of PCI procedures (sometimes referred to as percutaneous translumenal coronary intervention or PTCA) is increasing at a rate of 3%–5% worldwide. Today, the vast majority of PCIs involve the implantation of one or more coronary stents.
Until the advent of coronary stents, patients with cardiovascular blockages had little choice but to either keep a close eye on their disease (“watchful waiting” with or without accompanying pharmaceutical therapy) or undergo coronary artery bypass grafting (CABG). When angioplasty was developed by Andreas Gruentzig in 1977, patients were presented with the option to undergo angioplasty in an effort to open blocked coronary arteries. While short-term benefits were usually seen with balloon angioplasty, longer-term outcomes showed many arteries re-closing and requiring repeated intervention; up to 50% of angioplasty patients were found to require further angioplasty within six months. In an effort to reduce the frequency of patients requiring reintervention, scientists and clinicians developed stents that could be left behind to hold the artery open once the PTCA balloon was withdrawn.
Drug-eluting stents (DES) were developed to release a drug (e.g., sirolimus or paclitaxel) intended to reduce the incidence of restenosis. From there, even more innovative products have been developed, such as bioactive stents or stents designed to attract a patient’s own endothelial cells to coat the stent (as in devices by OrbusNeich, Hexacath, and Miami Cardiovascular Innovations).
Other device developers have sought to create stents that will fully degrade and disappear over a period of weeks or months—of a score of companies in this area, Abbott Vascular, Biotronik and REVA Medical appear closest to market. Yet others seek to abandon the use of stents altogether, opting instead to pursue an angioplasty balloon that will leave the anti-inflammatory drugs behind without the accompanying stent, as with CE Mark approved devices by EuroCor (the DIOR catheter) and B. Braun Melsungen (the SeQuent Please catheter).
Because the ultimate therapy has not yet been found, many opportunities still exist for effective therapies to combat atherosclerosis. So far, coronary stents hold the most promise for effectively treating an aging population with an increasing incidence of coronary artery disease.
The global market for coronary stents has evolved through technology development, market introduction and even the temporary "scare" of late stage thrombosis that was suspected, but later largely diminished, in the use of DES. The market continues to evolve with progressive adoption of DES and bare metal stenting technologies, penetration of coronary artery bypass grafting caseload by PCI/stenting and the emergence of novel stent technologies like bioabsorbables as well as drug-eluting balloons and other therapeutic options. The market is also changing globally, with variability in adoption rates by region and country.
(One of the stent industry's most respected resources on the coronary stent market is the MedMarket Diligence report #C245, "Worldwide Drug-Eluting, Bare Metal and Other Coronary Stents, 2008-2017.")
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
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.
High-strength surgical glue products were approved for topical closure applications in the United States in the late 1990s. Outside the United States, high-strength glues and adhesives have been approved in some countries for a number of years and have built up a track record of use in internal surgery. With time, high-strength glues will come to be used in a wider range of procedures and enable new procedures to be performed more economically with better outcomes and reduced morbidity and mortality.
We have reviewed applications and indications of commercial products and include, for the cardiac surgery example below, a list of approved indicated procedures from the European Union, as it illustrates the growing potential for these high-strength glues once they gain universal approval and adoption within the surgical community worldwide.
Augmentation of aortic and vascular sutures.
Repair of minor epicardial lacerations without the use of sutures.
Hemostasis and reinforcement of anastomoses of coronary bypass and as an adhesive to optimize and secure the path of coronary bypasses on the heart.
Coating of perianeurysmatic tissue in ventricular aneurysm surgery.
Reinforcement of sutures and patch adhesion in reduction of the left ventricle.
As an adhesive to secure the dissection plane in acute aortic dissections.
As a hemostatic agent in the prevention of bleeding of proximal and distal anastomoses in acute aortic dissections.
As an adhesive for gluing patches for dissected aorta reinforcement.
As a hemostatic agent on anastomoses in aortic valve surgery, particularly in the presence of calcific or atheromatous aortas.
Hemostasis and reinforcement of sutures after aortic aneurysm repair.
In re-operations, as a hemostatic adhesive on lacerations of the ventricle caused by re-sternotomy or the presence of adhesions.
Other specific surgery indications are provided in report S175, "Worldwide Surgical Sealants, Glues, Wound Closure and Anti-Adhesion Markets, 2009-2013" for each of the following surgical fields:
Digestive tract endoscopy
Interventional radiology and vascular neuroradiology
Pediatric cardiac surgery
The unmet need for non-toxic, high-strength, resorbable glues is clearly demonstrated by adoption of existing glue products outside of the United States in these multiple clinical indications.
Below is a brief profile of Adhezion Biomedical, LLC, one of the companies active in the surgical sealants and glues market and profiled in the MedMarket Diligence report #S175. We occasionally highlight companies whose products, in our opinion, are poised to make an impact on medtech markets.
Founded in 2001, Adhezion Biomedical (formerly Spartan Medical Products, LLC) is a private company developing and producing cyanoacrylate-based medical adhesives. The company’s SurgiSeal, DermaSeal, and FloraGuard products are based on the company’s proprietary OctylFlex technology and can bond skin tissue, replace sutures, staples and bandages, or be a protective barrier to prevent infection as an anti-microbial surgical sealant. The highly flexible products are biodegradable, do not require refrigeration or blending and dry quickly. SurgiSeal and FloraGuard have achieved CE Mark approval in Europe and 510(k) status in the United States. The company has received FDA approval for an OTC product in the United States.
Adhezion Biomedical received its first patent in 2003 and in 2006 received 510(k) and CE Mark approval for a consumer wound-care adhesive. In January 2008, Adhezion received 510(k) approval for the professional version of its topical wound closure adhesive and in February 2008, the company received FDA approval to begin clinical trials of this technology.
In March 2008, Adhezion Biomedical raised $3 million in a Series A financing from Originate Ventures to fund growth and product development.
Hemostats have been used for over a hundred years to stop bleeding in surgical and traumatic wounds. Primarily these products were first introduced to prevent hematomas during surgery with the aim of preventing resultant infections. During the 1980s and 1990s, the popularity of hemostats increased rapidly as surgeons tried to avoid excessive use of blood transfusions for reasons of economy and the threat of disease transmission. Products were launched during this period by many of the large medical device manufacturers.
The value of hemostasis lies in its ability to quickly improve patient clinical status and/or improve surgeons’ ability to do so by clearing the surgical field in order to assess traumatic wounds or facilitate surgical procedures. Hemostats also play a less technically challenging role than providing closure of wounds, which is offered instead by a variety of sealants and glues. Consequently, the barriers to entry for this market are relatively low — and getting lower, as many companies are developing formulations of collagen and gelatin for introduction in world markets. (Components of hemostats on the market and under development also include thrombin, fibrin, synthetics and others.) However, a number of proprietary products and formulations still face significant regulatory hurdles associated with their development and manufacture.
There are some well established companies controlling the current market, among King Pharmaceuticals, Ethicon, and Pfizer, with many competitors vying for increasingly larger shares of this market.
Products for the treatment of wounds can be divided into categories using a number of different classification systems. For the sake of analysis (as applied in the MMD report #S247), products and technologies in wound management can be divided generally into traditional products (simple bandages, dressings and closures) and advanced wound management. The advanced area includes film dressings, hydrocolloids, foam dressings, alginate dressings, hydrogels, non-adherent dressings, antimicrobial dressings, 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 very well established; others are in development.
The rate of development (product, technology and market) varies considerably among these different segments, and the overall market is in a state of growth. Below is a snapshot of the composition of the advanced wound management market in 2007.
Advanced Wound Management Market by Product Segment
Source: MedMarket Diligence, LLC; forecast to 2017 in pending report #S247.
Products, technologies, markets and companies are the focus of recent medtech global market reports from MedMarket Diligence:
"Worldwide Wound Management Market, 2008-2017", Report #S247 (September 2009)
This report details the complete range of products and technologies used in wound management and wound care, from dressings, bandages, hydrogels, tissue engineered products, physical treatments and others. The report details current clinical and technology developments in this huge worldwide market with high growth sectors, with data on products in development and on the market; market size and forecast; competitor market shares; competitor profiles; and market opportunity.
"Drug-Eluting, Bare and Other Coronary Stents Worldwide Market, 2008-2017", Report #C245 (May 2009)
This report details the worldwide market for the use of alternative stent devices (cardiac stents or heart stents) in the treatment of coronary artery disease. The report assesses the treatment of coronary artery disease by alternative treatment methodologies (percutaneous intervention with or without stenting, coronary artery bypass grafting alternatives and other medical/surgical treatment options), with estimated current/forecast caseload across treatment types. The report details currently approved coronary stents, providing data on current and forecast impact on the market. The report also details the current state of product development in bare stents, drug-coated or drug-eluting stents and bioabsorbable stents in coronary applications and details the products under development, the anticipated timeline and impact of their market introduction. The report assesses the current and ten-year forecast global market for coronary stents, with segmentation by U.S., Europe, Asia/Pacific and Rest of World. The report provides competitor market shares by these geographic regions. The leading and key emerging coronary stent manufacturers are profiled with current product offerings, development status and market strengths/advantages.
"Worldwide Surgical Sealants, Glues and Wound Closure Market, 2009-2013", Report #S175 (Jan. 2009)
This report details the complete range of sealants & glues technologies used in traumatic, surgical and other wound closure, from tapes, sutures and staples to hemostats, fibrin sealants/glues and medical adhesives. The report details current clinical and technology developments in this huge and rapidly growing worldwide market, with data on products in development and on the market; market size and forecast; competitor market shares; competitor profiles; and market opportunity.
Translation: Drug-eluting stents are to bare metal stents as bare metal stents were to percutaneous transluminal coronary angioplasty alone.
In the September 1 post on the meta-analysis by researchers at Tuft Medical Center, we noted the overall findings in general terms of the value of drug-eluting stents compared to bare metal stents. It is worthwhile to provide the slightly more detailed conclusions of the authors:
"As a new technology, drug-eluting stents have now emerged as an important innovation in reducing coronary restenosis. To provide a precise estimate of their clinical benefit and to explore sources of statistical heterogeneity, we performed a meta-analysis of randomized controlled trials involving currently available drug-eluting stents using a DerSimonian and Laird random effects model. Our meta-analysis found no significant reduction in mortality or MI-free survival from the use of drug-eluting stents. However, drug-eluting stents clearly reduced the risk of restenosis by 23% and the risk for target lesion revascularization by 11% in the primary analysis. This is similar in magnitude to the benefit found for stents compared to balloon angioplasty. The need for revascularization after DES was 3.7% that is similar to the 3.8% observed after coronary artery bypass grafting and much lower than the 21% with bare-metal stents."
I have engaged in debate (I might actually call it "baiting") wtih those who have instead favored coronary artery bypass graft (CABG) surgery, which I view as a waning procedure compared to percutaneous methods (like angioplasty with stenting) that revascularize with minimal trauma to achieve clinically competitive outcomes. I would argue that the most minimally invasive procedure is ultimately likely to resemble a percutaneous one anyway. Indeed, if one were to project the future evolution of CABG, it would traverse a course from thoracotomy to endoscopy (thoracoscopy) to an intraluminal procedure (which garners negative feedback from surgeons; but, of course, when speaking with surgeons, I expect their answers to be geared toward the scalpel).
By comparison, drug-eluting stents are on a course toward an analogously less invasive option, which I envision as first, atherosclerosis-reducing drugs and, probably ultimately, gene therapy that preemptively addresses the incidence of atherosclerosis. Right now, that is fantasy, but not by much.
See also the MedMarket Diligence report #C245 on the global market for coronary stents.
Wound management demands globally are as considerable as the range and diversity of therapeutic options to deal with them. Surgical, traumatic, burn, ulcer and other wound types are highly prevalent, growing in caseload and expensive when they fail to promptly heal. New products are steadily impacting the market, while development continues on many fronts including novel wound closure, debridement, dressings, physical therapies and others. MedMarket Diligence's 2009 report, "Worldwide Wound Management, 2009-2018: Established and Emerging Products, Technologies and Markets in the U.S., Europe, Japan and Rest of World" (see link) is a thorough analysis of the current and forecast market for these products.
See report description:
This report details the complete range of products and technologies used in wound management and wound care, from dressings, bandages, hydrogels, tissue engineered products, physical treatments and others. The report details current clinical and technology developments in this huge worldwide market with high growth sectors, with data on products in development and on the market; market size and forecast; competitor market shares; competitor profiles; and market opportunity. (Continued at link.)