Tissue Engineering and Cell Therapy Market Outlook

The market for tissue engineering and cell therapy products is set to grow 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.

An overview (map) of the spectrum of clinical applications in tissue engineering and cell therapy is shown below:

Source: Report #S520

Cell therapy is defined as a process whereby new cells are introduced into tissue as a method of treating disease; the process may or may not include gene therapy. Forms of cell therapy can include: transplantation of autologous (from the patient) or allogeneic (from a donor) stem cells , transplantation of mature, functional cells, application of modified human cells used to produce a needed substance, xenotransplantation of non-human cells used to produce a needed substance, and transplantation of transdifferentiated cells derived from the patient’s differentiated cells.

Once considered a segment of biomaterial technologies, tissue engineering has evolved into its own category and now comprises a combination of cells, engineering and suitable biochemical and physiochemical factors to improve or replace biological functions. These include ways to repair or replace human tissue with applications in nearly every medical specialty. Regenerative medicine is often synonymous with tissue engineering but usually focuses on the use of stem cells.

Tissue engineering and cell therapy may be considered comprised of bioengineered products that are themselves cells or are actively stimulating cell growth or regeneration. These often comprise a combination of biotechnology, medical device and pharmaceutical technologies.

Researchers have been examining tissue engineering and cell therapy for roughly 30 years. While some products in some specialties (such as wound care) have reached market, many others are still in research and development stages. In recent years, large pharmaceutical and medical device companies have provided funding for smaller biotech companies in the hopes that some of these products and therapies will achieve a highly profitable, commercial status. In addition, some companies have been acquired by larger medical device and pharmaceutical companies looking to bring these technologies under their corporate umbrellas. Many of the remaining smaller companies received millions of privately funded dollars per year in research and development. In many cases it takes at least ten years to bring a product to the point where human clinical trials may be conducted. Because of the large amounts of capital to achieve this, several companies have presented promising technologies only to close their doors and/or sell the technology to a larger company due to lack of funds.

The goal of stem cell research is to develop therapies to treat human disease through methods other than medication. Key aspects of this research are to examine basic mechanisms of the cell cycle (including the expression of genes during the formation of embryos) as well as specialization and differentiation into human tissue, how and when the differentiation takes place and how differentiated cells may be coaxed to differentiate into a specific type of cell. In the differentiation process, stem cells are signaled to become a specific, specialized type of cell when internal signals controlled by a cell’s genes are interspersed across long strands of DNA and carry coded instructions for all the structures and functions of a cell. In addition, cell differentiation may be caused externally by use of chemicals secreted by other cells, physical contact with neighboring cells and certain molecules in the microenvironment.

The end goal of stem cell research is to develop therapies that will allow the repair or reversal of diseases that previously were largely untreatable or incurable.. These therapies include treatment of neurological conditions such as Alzheimer’s and Parkinson’s, repair or replacement of damaged organs such as the heart or liver, the growth of implants from autologous cells, and even regeneration of lost digits or limbs.

In a developing human embryo, a specific layer of cells normally become precursor cells to cells found only in the central nervous system or the digestive system or the skin, depending on the cell layer and the elements of the embryo that direct cell differentiation. Once differentiated, many of these cells can only become one kind of cell. However, researchers have discovered that adult body cells exist that are either stem cells or can be coaxed to become stem cells that have the ability to become virtually any type of human cell, thus paving the way to engineer adult stem cell that can bring about repair or regeneration of tissues or the reversal of previously incurable diseases.

Another unique characteristic of stem cells is that they are capable of self-division and self-renewal over long periods of time. Unlike muscle, blood or nerve cells, stem cells can proliferate many times. When exposed to ideal conditions in the laboratory, a relatively small sample of stem cells can eventually yield millions of cells.

There are five primary types of stem cells: totipotent early embryonic cells (which can differentiate into any kind of human cell); pluripotent blastocyst embryonic stem cells, which are found in an embryo seven days after fertilization and can become almost any kind of cell in the body; fetal stem cells, which appear after the eighth week of development; multipotent umbilical cord stem cells, which can only differentiate into a limited number of cell types; and unspecialized adult stem cells, which exist in already developed tissue (commonly nerves, blood, skin, bone and muscle) of any person after birth.

tissue-cell-2012-2018

Source: MedMarket Diligence, LLC; Report #S520, “Tissue Engineering & Cell Therapy Worldwide 2009-2018.”

Developmental Timescales

Tissue engineering and cellular therapy products take years of research and many millions of dollars (averaging about $300 million, according to some reports) before they make it over the hurdles of clinical trials and into actual market launch. More than one small biotech company has burned through its money too quickly and been unable to attract enough investment to keep the doors open. The large pharmaceutical and medical device companies are watching development carefully, and have frequently made deals or entered into alliances with the biotechs, but they have learned to be cautious about footing the bill for development of a product that, in the end, may never sell.

For many of the products in development, product launch is likely to occur within five years. Exceptions include skin and certain bone and cartilage products, which are already on the market. Other products are likely to appear on the European market before launch in the United States, due to the presence of (so far) less stringent product review and approval laws in the European Union.

Even when the products are launched, take-up will be far from 100% of all patients with that particular condition. Initially, tissue engineering and cell therapy products will go to patients suffering from cancers and other life-threatening conditions, who, for example, are unable to wait any longer for a donor organ. Patients who seem to be near the end of their natural lives likely will not receive these treatments. Insurance coverage will certainly play a key role as well in the decision about who receives which treatments and when. But most importantly, physicians will be selecting who among their patients will be treated; the physicians learn about the treatments by using them, by observing the patient’s reactions, and by discussing their experiences with colleagues. In other words, the application of tissue engineering and cellular therapy will progress in a manner similar to the introduction of any new technology: through generally conservative usage by skilled, highly trained physicians dedicated to providing their patients with the best possible treatment without causing them additional harm.

 

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Pharmaceutical research in obesity

The challenges in the treatment of obesity are in providing practical, long-term solutions to a condition that is growing rapidly and is associated with numerous co-morbidities that include diabetes, hypertension (and other cardiovascular diseases), gastroesophageal reflux disease (GERD), osteoarthritis, fatty liver disease, obstructive sleep apnea, and cancer, among others.

Obesity is most commonly addressed, from a clinical solution, in device- and non-device-related bariatric surgery and a very limited number of drugs. Roux-en-Y and other gastric bypass procedure volumes have seen steady increases over the past few years as these procedures have been aggressively marketed and third party reimbursement has become more common.  Obesity device sales (lap-band and others) have grown, and will continue to grow, steadily.

As with most surgeries, however, there are morbidities associated with the procedures, whether or not devices are employed and long-term success has not been high enough to displace demand for pharmaceutical solutions.  Development of pharmaceuticals for obesity has been aggressive, but fraught with uncertainty in the regulatory process that, until only in mid-2011, seemed to make approval to be a moving target, if not unreachable.

Beyond the revived approval process now in play for drugs by Vivus, Orexigen, and Arena, pharmaceutical development in the field of obesity is focusing on several major areas:

  • Melanocortin receptor system
  • Cannabinoid receptor agonists
  • GLP-1 analogs
  • Methionine aminopeptidase 2 (MetAP2) inhibitor
  • Appetite suppression drugs (Arena’s lorcaserin, NeuroSearch’s Tesofensine, Shionogi’s Velneperit)
  • Malabsorption drugs
  • Satiety drugs
  • Combination drugs

We track the market for all obesity drugs and devices on the market and in development in our Report #S835, “Products, Technologies and Markets Worldwide for the Clinical Management of Obesity, 2011-2019.”

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The Obesity Drug Opportunity Remains

Memory is as fleeting in the marketplace as are the FDA's policies. So, when it comes to considering the potential for developing drugs in the treatment of obesity, it should not be a surprise that the obesity market rises and falls in synchrony with the whims of the FDA.

In mid 2010, the thrust was on for obesity drug manufacturers.  Rising prevalence, a heightened sensitivity that obesity is a lynchpin for a litany of healthcare costs and an implicit recognition that a drug will always be less invasive than a gastric bypass were the forces collectively responsible for obesity drug development.  Then, from that black box that drives FDA policy came a conclusion a la fen-phen that obesity drugs are inherently dangerous.  Hence, by early 2011, Motley Fool reports:

Obesity drugs with safety issues are as common as celebrities getting fired for saying (or tweeting) something stupid. The Food and Drug Administration wants a cardiovascular safety trial before it'll approve Orexigen's (Nasdaq: OREX  ) Contrave. Arena Pharmaceuticals' (Nasdaq: ARNA  ) lorcaserin has potential cancer issues. And VIVUS (Nasdaq: VVUS  ) is dealing with the potential for its combination drug, Qnexa, to cause cleft lip in babies whose mothers take the drug.

They, without so much as a mea culpa, in September 2011, the FDA turns around and relaxes its demands for safety data.  Obesity drugs now have a seemingly shorter path to approval than it seemed a scant month ago. Stocks of Arena Pharmaceuticals, Orexigen and Vivus are back on the rise (not where they were, mid-2010) but headed back in that direction.

Below is the global market opportunity for obesity drugs that remains unchanged as a result of the FDA turnaround.

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

One cannot say that an opportunity exists irrespective of the stance of the FDA, at least not anyone who witnessed, as Motlely Fool called FDA bullying.  In the U.S., regardless of the latent demand or the amount of efficacy sans safety data, the FDA is a gatekeeper.  Even without the obesity drug barricade that the FDA erected, then has seemingly started tearing down, the capricious, unpredictable and, most of all, drawn-out regulatory approval process has been driving manufacturers elsewhere — the EU, even though it is far more Europe than it is Union, is still a well developed western market, and even South America, with its proximity to U.S. distribution systems, has become very attractive.

Demand for drug treatments for obesity remains high — in some ways it may be even higher than had the FDA not become such a barrier. In a free market economy, even as flawed as that model may seem in today's debt-riddled, recessionary world, demand remains a driver that seems to have much more staying power than anyone previously considered.

 

 

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Obesity Treatment Options Maintaining Steady State… Of Change

Obesity rates are approaching 30% in developed countries, while a recognition of obesity's direct and indirect costs are driving development of treatment options.  Given the size of the problem and its increasing prevalence and costs, one can readily conclude that the problem of obesity remains largely untouched.  A variety of drugs and devices have been developed and are either on the market or the subject of aggressive industry effort to get them introduced.  Thus far, the bulk of the success has come from obesity devices, including "restrictive" devices and "artificial fullness" devices.  

Based on the resilient drivers of drug and device development in obesity, the treatment options available and the manufacturer revenues that are generated will tap into that steady state of demand to result in a rapidly changing market picture for drugs and devices.  Accordingly, a substantial shift in obesity treatment options is going to happen over even just the next four years.

Below is illustrated the distribution of the obesity treatment market across options available in 2011 and in 2015.  

Obesity Treatment Market, Drugs and Devices, 2011 and 2015

 

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

In the aggregate, drug options, which currently only represent 45% of revenues, will rise to 65% by 2015 with the introduction of several drugs and drug types.  This will mean only a relative reduction in the device market — indeed, select obesity device categories will be increasing at better than 60% annually — since the aggregate market continues to grow as more demand is addressed by drugs and devices.

With Vivus announcing that it has reached agreement with the Endocrine and Metabolic Division of the FDA on an early resubmission of its QNEXA new drug application for the treatment of obesity and, separately, with Arena Pharmaceuticals indicating that it plans to resubmit by year end 2011 its application for Lorcaserin, which was turned down by the FDA in 2010, the obesity drug market will be the major contender in obesity treatments that many expected it to be, despite the FDA's initial resistance.

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Obesity Treatment Device Market Outlook

The market for obesity devices in the U.S. is currently dominated by restrictive devices, including primarily adjustible gastric banding (e.g., Allergan's Lap-Band) but also Ethicon Endo-Surgery, Helioscopie, AMI GmbH, Bariatric Solutions GmbH, Cousin Biotech and others.

The future market for these products will also be largely represented by restrictive devices, but in the period from 2011 to 2019 a number of other obesity treatment devices will be added in other categories including artificial fullness devices, malabsorption devices, gastric emptying devices, and appetite suppression devices.

Us-obesity-device-2011-2019

 

Shown graphically (and drawn from Report #S835) is the current and 2019 U.S. market for devices in the treatment of obesity. As is shown, appetite suppression devices will by 2019 represent the secondmost significant type of obesity device.


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

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Until September 30, 2011, get any MedMarket Diligence report (any option: single user, site license or global license) for 20% off.  Order online (or any "online order" link) and use coupon code 1315780157 on checkout to receive a 20% discount.

 

New obesity treatments to hit market

Given the dramatically increasing rates of obesity prevalence and the resulting size of the potential market for treatment of diabetes — by surgery, drugs, devices or combinations of these — manufacturers of drugs and devices are working furiously to develop treatment options that can face an increasingly rigorous set of requirements by the FDA to gain approval.  Even recent adverse regulatory decisions or market withdrawals of obesity drugs have not quelled the drive for more effective treatment options.

As a result, a number of specific market introductions and market success are expected to take place in the 2011 to 2019 time frame (we identify specific developments in the 2011 global obesity report).  Much of the revenue expected by 2019 will come from newly introduced spanning drugs, combination drugs and devices.

See below for our estimate of the 2011 and 2019 breakdown of the obesity treatment market.

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

Medical technology platforms with high growth potential

Specific technologies and broad technology platforms have tremendous potential for market growth based on combinations of recent technology advancement, changes in clinical practice, current forces in the market and other criterial. 

  • Biotech solutions to traditional medical device technologies.  The thrust of medical technology is, and has been for a long time, to make it as effective as possible while being the least possible invasive.  Taken to the extreme, instead of implanting a device, such as a suture or a staple, the almost perfect solution would to be to close wounds with no device at all.  Hence, surgical sealants, fibrin glues and other medical/surgical adhesives, hemostats and related biologicals (and even non-biologicals like cyanoacrylates), having proven themselves clinically and offering very low adoption hurdles, represent a huge opportunity in the medtech market.
     
  • Ablation and other high energy technologies.  What used to be handled by scalpel when my father did general surgery, is now increasingly being accomplished using energy-driven modalities that provide other tissue effects that a sharp metal blade alone could never do.  These technologies are therefore growing in both the penetration of traditional surgical procedures and their expansion to new clinical applications.
     
  • Nanotech and microelectromechanical systems (MEMS).  It is actually a gross oversimplification to use a word like "nanotech" and imply that you are talking about one type of technology.  The only thing common to nanotech is size; every manner of material, construction, function and clinical benefit is part of this area.  The pace of development is striking.
     
  • Drug-device hybrids.  Just a few of the applications of combining drugs and devices in a single device include localized drug-delivery that avoids toxic, systemic dosages and vastly improved biocompatibility of existing devices. These two options alone represent multiple enormous markets.  Now, naked metal (or other) implants seem almost barbaric.
     
  • Bioresorbable materials.   Polymer and other materials technologies are enabling the development of implants and other devices that conveniently go away when they are no longer needed.  Already a significant market force in areas like bone growth in orthopedics, bioresorbable stents and other implants are proving their worth in cardiology and urology. 
     
  • Atherosclerotic plaque-reversing drugs.  When Pfizer divested itself of Esperion Therapeutics, it did not bode the end of this striking new drug approach to atherosclerosis, it simply illustrated the persistent challenge of drug development.  Here, it should be kept in mind that, the bigger the potential payout, based on huge clinical need (e.g., drug solution to the device intensive treatment of coronary artery disease), the more likely it is only a matter of time before the product reaches the market.  The jury is out on the "when" part, not the "if".
     
  • Rational therapeutics.  This is the holy grail thinking behind the development of many, many biotech products.  If one can develop a cure — a direct resolution of the underlying biological defect or deficiency in disease — and not just the symptoms, then one has changed the market in paradigm ways.  The hurdle and the payoffs are huge.
     
  • Tissue engineering technologies.  We have begun to be able to develop tissue engineered organs of increasing complexity — skin, bladders and rudimentary pancreases — and the benefits of these are in applications too numerous to mention..
     
  • RFID.  There is little, really, that is sophisticated about radiofrequency identification devices,  but their rapid integration into medical technologies of a wide range (tagging surgical instruments so they don’t get left behind, implants that enable external identification or even status, other types) will extend the utility and value of medical devices.
     
  • Noninvasive glucose monitoring.  Optimizing care for diabetes means, at a minimum, very frequent (5-10) checks per day of blood glucose.  This many finger pricks per year by the total number of diabetics globally (a rapidly growing number at that) who clearly would benefit from noninvasive monitoring reveals the value of this opportunity.  Capturing that opportunity means the combined success of both technology and cost.
     
  • Infection control.  This area is a top area, not for the sigificant technologies that have been developed, but the enormous demand for them.  Between rapidly emerging problems like methicillin-resistant staph aureus (MRSA), the resurgence of tuberculosis, the enormous costs of nosocomial infections and other infection-related challenges, infection control is an enormous, global opportunity.
     
  • Spine surgery.   The nature of the human spine, constructed of bone that needs to be both flexible and strong, demands device-intensive solutions.  The growing patient population of active, older adults is ratcheting the pressure on technologies to be less invasive, provide greater range of motion, last longer, cost less — all of which drives innovation in spine surgical technologies.
     
  • Obesity treatment technologies.  Technology solutions to the increasingly prevalant problem of obesity are imperfect, but still are frequently better solutions for the obese than an alternative that may ultimately also encompass heart disease, diabetes, stroke and other problems.  Diverse drug and device alternatives have been developed and the trend in obesity incidence will simply drive their continued development. 

Other forces are at work driving the above technologieis including, of course, cost containment, the integration of information technologies in both medical product and development process and the globalized economy.

(While the above list  is separately a White Paper that I have written, and periodically re-write to reflect new stuff being developed, I find it interesting and worthwhile to revisit frequently and discuss in this blog.)


The above topics are covered in various MedMarket Diligence reports.  See our list of titles.

 

 

 

Ablation: An Energized Market

The post below has been superceded by the 2010 analysis, "Ablation Technologies Worldwide Market 2009-2019".  See link for details.  See also "Japanese Ablation Market", "Cryotherapy and Cryosurgery", and "Radiofrequency ablation devices".

(See July 2010 report #A145, "Ablation Technologies Worldwide Market, 2009-2019," from MedMarket Diligence, LLC.  May be purchased online.)

Energy-based therapies generate sales of $13 billion in the United States alone, with probably another $12 billion in other developed markets worldwide. This represents around 13% of the total medical device market, and it is growing at 11% per annum—twice the growth rate for medical devices overall.

Several kinds of energy are used for medical purposes, including electrical energy, radiation, thermal and light (see chart, “Energy-Based Therapies by Modality”). When the market is analyzed by function, it emerges that the fastest-growing area within this dynamic sector is ablation therapies: a segment that includes devices using electrical, radiofrequency, thermal and other forms of energy. A Market of $25 Bln and Growing The total market for energy-based therapies is estimated at $25 billion, of which 60% is in the United States and the rest mainly concentrated in developed economies around the world. Ablation therapies consist of several market segments. Arrhythmia ablation generates sales estimated at $60 million in the United States and $50 million internationally; ablation products for cancer therapy are valued at $225 million, of which $125 million are generated in the United States. Thus ablation therapies for these two leading indications—almost all consisting of RF devices and consumables—generated sales around $335 million in 2007. In fact, total RF ablation therapy sales are estimated at $1.5 billion worldwide. Also, this sector is growing much faster than the energy sector overall—annual rates are in the range 25%–30%. Demographic Factors—Growth of the market for ablation therapies is based partly on dynamic changes in demographics. The baby boomer generation (i.e., the 78 million Americans born between 1946 and 1964) represents about one-third of the U.S. population and a similar proportion of the population of other developed countries. These maturing citizens have both the economic means and the demand for therapies that can extend their active lives and delay the visible signs of aging. Pushing the growth of energy therapies beyond basic changes in demographics are the unique benefits that they offer. They are typically less invasive and are generally employed without the need for an implant. The therapies can be precisely metered and can be repeated. Emerging energy modalities have the potential to grow at significant, double-digit rates over the next decade as delivery systems evolve. Technological Change—The ablation market is also driven by technological innovation. First-generation ablation devices and catheters have been supplanted by more sophisticated newcomers. Some of the improvements are incremental, other represent more fundamental innovation. Typical is the recent introduction by VNUS Medical Technologies of the ClosureFAST catheter, an endovenous radio frequency (RF) ablation catheter that is designed to heat, shrink and close diseased saphenous veins (large leg veins) in three to five minutes. VNUS claims treatment is as fast as laser ablation devices and causes minimal pain and bruising. The entire procedure, from insertion of the catheter to removal, can be completed in approximately 16 minutes—less than half the time required for previous RF-based procedures. The ClosureFAST catheter received FDA clearance in August 2006, and is now in general distribution.

A Handful of Companies Dominate

The energy-based medical device industry is led by a small group of companies: Medtronic, which has 30% share; St. Jude Medical, with 12%, and Varian Medical Systems, with 10%. A fourth strong presence was, until a few months ago, Boston Scientific, which had acquired Guidant, one of the pioneers in the field. However, Boston’s cardiac and vascular surgery business has been absorbed by the Swedish group Getinge (see MedMarkets, January 2008, “MedTech Companies Refine Therapies for Cardiac Ablation“) and is being marketed under the Maquet Cardiovascular name. Boston Scientific has retained its Blazer, Chilli, Steerocath and Maestro ablation systems for cardiac applications. In terms of ablation therapies, different market contenders make their appearance. Valleylab, a division of Covidien, is a leader in the field of RF ablation for general surgery. In the arrhythmia ablation segment, the Johnson & Johnson company Biosense Webster has a significant share, competing with CryoCath Technologies, AtriCure, Getinge and St. Jude Medical.

Ablation Therapy in Cardiology

Ablation therapy using RF waves is used to cure or treat a variety of cardiac arrhythmias such as supraventricular tachycardia, Wolff-Parkinson-White syndrome, ventricular tachycardia and especially atrial fibrillation. The term laser ablation is a process by which the molecular bonds of a material are dissolved by a laser; the technique is used as a part of percutaneous transluminal coronary angioplasty (PTCA) to dissolve plaque and restore patency in stenosed coronary vessels. Rotoablation, also used in PTCA, consists of inserting a tiny, diamond-tipped, drill-like device into the affected artery to remove fatty deposits or plaque. The major and fastest-growing use of ablation in cardiology is in the management of atrial fibrillation. Fibrillation is a disorder in which the orderly sequential propagation of an electrical impulse throughout the heart (which controls the heartbeat), is disrupted by multiple impulses so that the heart’s rhythm is disrupted. Atrial fibrillation involves ablating select areas of the heart’s upper chambers, which receive blood from the systemic and pulmonary circulations and pass it on to the ventricles. Before the development of ablation therapy, treatment of atrial fibrillation consisted of drugs to control the heart rhythm, and surgery in selected cases. The object of surgery was to cut away tissues in the heart that were transmitting the errant electrical impulses. This was an open-heart procedure with all the attendant risks, and recovery usually took eight weeks or more. Ablation therapy, like PTCA, is essentially noninvasive; a special ablation catheter is inserted into a peripheral vein and threaded up to the heart, where it is carefully positioned. RF pulses are then generated at the catheter tip to destroy tissue in the immediate vicinity. A series of such pulses is required to disrupt the abnormal electrical pathways.

Ablation Therapy in Cancer

A major and growing use of ablation is in the treatment of solid tumors, especially in the liver, lung, kidney and prostate. RF ablation is a minimally invasive, FDA-approved treatment for cancer. Physicians worldwide have used RF ablation to treat thousands of patients for liver/kidney tumors, and bone cancer pain. RF ablation is an image-guided technique that kills cancer cells by heating and destroying them. It is an alternative when surgery is not likely to be successful or has failed, or when other medical conditions increase the risk of surgery. In these cases, RF ablation can offer an effective treatment for small cancers; it is minimally invasive with no skin incision and there is minimal risk to the patient (who typically suffers little or no pain). The technique is cost-effective, with minimal hospital stay, and the procedure can be repeated if a new cancer appears. Liver—RF ablation has achieved excellent results in treating primary liver tumors such as hepatoma or hepatocellular carcinoma. These tumors tend to grow slowly and are usually encapsulated. The technique is especially useful for patients who are not ideal surgical candidates, who cannot undergo surgery, who have recurrent tumors or who do not respond to conventional therapies. Liver cancers most likely to be good candidates for RF ablation include tumors 4 cm diameter or smaller; cases with no more than three tumors per patient; and patients waiting for a liver transplantation who have a hepatoma. The most common metastatic disease in the liver treated by RF ablation has been colon cancer. As with primary liver cancers, results are good if the tumors are small and few, and if there is no evidence of metastatic disease elsewhere, RF ablation can also be combined with surgery to treat patients who have several tumors in different locations. Reports indicate that RF ablation results in complete cell death in the majority of hepatomas 3 cm–4 cm in size. Patients who have residual tumors can be re-treated if necessary. In patients who have metastatic colon cancer, re-treatment results are similar. Lung Cancer—Lung cancers are among the most intractable of malignancies and the mortality rate remains high. Any incremental improvement in therapy is therefore to be welcomed. RF ablation may be an alternative nonsurgical treatment for selected patients who have cancers that are limited in size (less than 3 cm in diameter) and few in number (one or two). Tumors should be separate from vital structures in the body. RF ablation may also help lung cancer patients who are not candidates for traditional surgery due to advanced disease in the lungs, poor cardiac function and/or poor pulmonary function. Kidney Cancer—Experience of RF ablation in kidney tumors is considerably less than with liver tumors. However, early results at the Mayo Clinic indicate that RF ablation is very effective for small tumors. In the Clinic’s experience with more than 70 patients, the tumor was destroyed in more than 95% of patients treated. Surgery is the treatment of choice for most kidney tumors; however, RF ablation might be considered for patients who have only one kidney, or who have other medical conditions that might prevent surgery; also for elderly patients who might have difficulty with surgery or postsurgical recovery, and in cases where the tumor is less than 4 cm in size.

Diverse Factors Drive Market Growth

The ablation device market is a buoyant one supported by a number of significant growth drivers, and its annual growth is almost certain to be in the range of 15%–25% over the next few years. The industry landscape is changing with the introduction of new technologies and the development of new indications for ablation-based therapy. This market will be strongly influenced by a new graying population who knows what it wants in terms of health care and who are intensely cost-conscious.

Company Product Energy Modality Primary Application Market Segment
Accuray Cyberknife Radiation Tumor ablation Cancer
Atricure Coolrail Pen RF Arrhythmias Cardiovascular
Biosense Webster (Johnson & Johnson) Thermocool RF Atrial arrhythmias Cardiovascular
Cryocath Technologies Freezor Cryoablation System Thermal AV tachycardia Cardiovascular
Elekta Gamma Knife Radiation Tumor ablation Cancer
EndoCare Cryocare CS Cryogenic Prostate cancer Cancer
ERBE Erbokryo CA Cryogenic Pulmonary Cardiovascular
  ErbeJet 2 Hydro Soft tissue ablation General surgery
Ethicon EndoSurgery (Johnson & Johnson) Harmonic Scalpel Ultrasonic Soft tissue ablation General surgery
Focus Surgery Sonablate 500 Ultrasonic Prostate cancer Cancer
Galil Medical Presice Cryogenic Prostate, kidney cancer Cancer
Gynecare (Johnson & Johnson) ThermaChoice Thermal Gynecological General surgery
Gyrus (Olympus) PK Tissue Management System RF Gynecological General surgery, urology, gynecology
Healthtronics Ossatron Ultrasonic Chronic proximal plantar fasciitis Orthopedic
Hologic MammoSite Radiation Breast cancer Cancer
Imagyn isoStar Radiation Prostate cancer Cancer
Insightec ExAblate 2000 Ultrasonic Uterine fibroids Cancer
Integra LifeSciences Sonotom Ultrasonic Soft tissue ablation General surgery
Irvine Biomedical (St. Jude Medical) Therapy RF Atrial arrhythmias Cardiovascular
Maquet Critical Care (Medical Systems division of Getinge) RF 3000 RF Hepatic cancer Cancer
Medical Technologies OrthoWave Ultrasonic Chronic pain Orthopedic
Medtronic Cardioblate RF Atrial arrhythmias Cardiovascular
Mentor Best Palladium-103 Radiation Prostate cancer Cancer
Microsulis MEA Microwave Menorrhagia Gynecology
Mitek (Johnson & Johnson) VAPR II RF Arthroscopic Orthopedic
Olympus Sonosurg Ultrasonic Soft tissue ablation General surgery
OmniSonics Resolution 360 Microwave Vascular disease Cardiovascular
Oncura Rapid Strand Radiation Prostate cancer Cancer
ProSurg RF GEL RF BPH General surgery
Radionics Cool-Tip RF Soft tissue ablation Cancer
Radiotherapeutics RF 3000 RF Tumor ablation Cancer
RITA Medical Rita RF Ablation System RF Tumor ablation Cancer
Sanarus Visica Cryogenic Soft tissue ablation Benign breast tumors
SenoRx Shape Select RF Breast cancer Cancer
Siemens Sonocur Ultrasonic Lateral epicondylitis Orthopedic
Smith & Nephew Versajet Hydro Soft tissue ablation General surgery
  Vulcan RF Capsular shrinkage Orthopedic
Somatex LITT Thermal Tumor ablation Cancer
Spectranetics CVX-300 Light Ischemia Cardiovascular
Spectrasonics HIFU Ultrasonic Atrial fibrillation Cardiovascular
St. Jude Medical Epicor Ultrasonic Atrial fibrillation Cardiovascular
  Current, Promote RF Cardiac arrhythmias Cardiovascular
Theragenics Theraseed Radiation Prostate cancer Cancer
TissueLink DS 3.0 RF Hepatectomy General surgery
U.S. Surgical (Covidien) AutoSonix Ultrasonic Soft tissue ablation General surgery
Urologix Targis Ultrasonic BPH General surgery
  Prostatron Ultrasonic BPH General surgery
Valleylab CoolTip RF Nonresectable liver tumors General surgery
Varian RapidArc linear accelerator Radiation Tumor ablation Cancer
VNUS Medical Technologies ClosureFast RF Saphenous vein closure Vascular

Links Accuray (Sunnyvale, CA; http://www.accuray.com) AngioDynamics (Queensbury, NY; http://www.angiodynamics.com) AtriCure (West Chester, OH; http://www.atricure.com) AutoSuture (See Covidien) Biosense Webster (Diamond Bar, CA; http://www.biosensewebster.com) Boston Scientific (Natick, MA; http://www.bsci.com) Covidien (Mansfield, MA; http://www.covidien.com) CryoCath Technologies (Montreal, Quebec, Canada; http://www.cryocath.com) DePuy Mitek (Westwood, MA; http://www.mitek.com) Elekta (Stockholm, Sweden; http://www.elekta.com) Endocare (Irvine, CA; http://endocare.com) ERBE Elektromedizin (Tubingen, Germany; http://www.erbe-med.com) Ethicon Endo-Surgery (Cincinatti, OH; http://ethiconendo.com) Focus Surgery (Indianapolis, IN; http://www.focus-surgery.com) Galil Medical (Yokneam, Israel; http://www.galilmedical.com) Getinge (Getinge, Sweden; http://www.getinge.com) Gynecare (Somerville, NJ; http://www.gynecare.com) Gyrus Group (Reading, England; http://www.gyrusacmi.com) HealthTronics (Austin, TX; http://www.healthtronics.com) Hologic (Bedford, MA; http://www.hologic.com) InSightec (Tirat Carmel, Israel; http://www.insightec.com) Integra LifeSciences (Plainsboro, NJ; http://www.integra-ls.com) Integra Radionics (Burlington, MA; http://www.radionics.com) Irvine Biomedical (See St. Jude Medical) Johnson & Johnson (New Brunswick, NJ; http://www.jnj.com) Maquet Cardiovascular (Solna, Sweden; http://www.maquet.com) Medtronic (Minneapolis, MN; http://www.medtronic.com) Mentor (Santa Barbara, CA; http://www.mentorcorp.com) Microsulis (Waltham, MA; http://www.microsulis.com) MTS (Konstanz, Germany; http://www.mts-medical.com) Olympus Surgical Orangeburg, NY; http://www.olympussurgical.com) OmniSonics (Wilmington, MA; http://www.omnisonics.com) Oncura (Plymouth Meeting, PA; http://www.oncura.com) ProSurg (San Jose, CA; http://prosurg.com) RITA Medical (See AngioDynamics) Salient Surgical Technologies (Dover, NJ: http://www.tissuelink.com) Sanarus Medical (Pleasanton, CA; http://www.sanarus.com) SenoRx (Aliso Viejo, CA; http://www.senorx.com) Siemens Medical Solutions (Malvern, PA; http://www.smed.com) Smith & Nephew (London, U.K.; http://www.smith-nephew.com) Somatex Medical Technologies (Teltow, Germany; http://www.somatex.com) Spectranetics (Colorado Springs, CO; http://www.spectranetics.com) Spectrasonics (Wayne, PA; http://www.spectrasonics.com) St. Jude Medical (St. Paul, MN; http://www.sjm.com) Theragenics (Buford, GA; http://www.theragenics.com) TissueLink Medical (see Salient Surgical Technologies) U.S. Surgical (See Covidien) Urologix (Minneapolis, MN; http://www.urologix.com) Valleylab (Boulder, CO; http://www.valleylab.com) Varian Medical Systems (Palo Alto, CA; http://www.varian.com) VNUS Medical Technologies (San Jose, CA; http://www.vnus.com)


Report #A125, "Ablation Technologies Worldwide", may be purchased online or via Google Checkout (below).

 

 

 

 

 

 

Obesity Management Products Segment Sales Growth

[Editor's note: The global market for products in the management of obesity has been analyzed in the 2011 Report #S835, which supersedes the content discussed below.]

 

The revenues to be had from the clinical management of obesity, whether derived from pharmaceutical or device sales, are forecast to see double-digit growth through 2015. Although revenues have been dampened by the FDA’s negative reaction to Sanofi-Aventis’ application for rimonabant, there are other drug compounds in late stages of testing which may prove to be blockbuster drugs, and should see launch during the forecast period. Allergan’s LapBand device will soon be facing competition from Ethicon Endo-Surgery’s version, and other devices should soon be providing surgeons and patients with yet other alternatives to bypass surgery and adjustable gastric banding. Below are shown the absolute and relative growth rates in drug and device revenues for the clinical management of obesity.

Obesity Segment Growth

 

Obesity Relative Segment Growth

The increase in sales is based upon the net effect of a number of factors, including:

  • Increasing attention paid by governments, public health systems, physicians and patients to the enormity of the obesity problem and to its growth rate
  • The introduction of new medical devices via regulatory approval in the US and EU, and their subsequent acceptance by physicians and their patients
  • Regulatory approvals and market launch of new, more effective drugs with relatively more acceptable adverse side effects
  • Increase in the number of overweight, obese and morbidly obese individuals worldwide, and an increase in the percentage of eligible patients who seek treatment
  • Increased reimbursement for surgery, pharmaceutical treatments, and combinations thereof.

The relative growth of revenues for drugs and devices are driven by the projected penetration of new products, with shifts anticipated in the forecast period to 2015. _________________ From Report #S825, "Worldwide Market for the Clinical Management of Obesity, 2007."  >>> See the 2011 report #S835.