(See the 2016 published report #S290, “Sealants, Glues, Hemostats, 2016-2022”.)
Sealants, glues, hemostats, and other products in wound closure and securement offer benefits that vary by clinical area, but the nature of that benefit also varies by the type of end-point (benefit) the product achieves — does it provide a life-saving benefit? A time-saving? Cost-savings? A cosmetic or aesthetic benefit?
Accordingly, by examining the volume of procedures for which closure and securement products provide which kind of benefit is crucial to understanding demand, especially between competitive products.
Below is a categorization of benefits ranging from the critical (I) to the aesthetic (IV).
Criteria for Adjunctive Use of Hemostats, Sealants, Glues and Adhesion Prevention Products in Surgery
Several events have set the stage for change in the markets for treatment of obesity. Key among them are the 2012 FDA approvals of (link) of Vivus’ Qsymia (combination of phentermine and topiramate) and Arena Pharmaceuticals’ Belviq (lorcaserin). In a market that has been dominated by surgical procedures and medical devices, the introduction of two significant pharmaceutical options has served notice that pharma is finally seizing hold of this large and growing opportunity. The potential addition of yet another obesity drug, Orexigen’s Contrave (combination of naltrexone and bupropion), will only hasten this change.
Combine the advent of obesity drugs (whether or not reimbursement is at optimum levels) with the demand-pinching force of a still somewhat hobbled economy and its impact on the significantly out-of-pocket payment for obesity surgery and device procedures and it becomes clear that the market is shifting away from device and toward pharma. Gastric bypass (e.g., Roux en-Y) will hold stronger than device treatments due to lower cost. As a result, the adjustable gastric band, such as Allergan’s Lap-Band, will see a decline in the total share of obesity surgeries. See the trend in Europe as an example:
Trend in Metabolic/Bariatric Surgery, Europe, 2003-2013
RYGB= Roux-en-Y gastric bypass AGB=Adjustable gastric band BPD/DS= Biliopancreatic diversion with duodenal switch SG=Sleeve gastrectomy
Established obesity devices such as restrictive devices (e.g., Lap-Band and transoral gastropexy) and artificial fullness devices (e.g., gastric balloon) will represent slower growth than malabsorption devices, gastric emptying devices and appetite suppression devices, but which have thus far gained little presence in the market. By comparison, appetite suppression drugs are already on the market and, with combination drugs taking off quickly, the share of the future market will be increasingly dominated by appetite suppression and combination drugs.
In a move that could be considered ironic, Allergan is looking to shed some excess weight as it looks to sell its Lap-Band business. While Lap-Band initially demonstrated extraordinary growth as the incidence and prevalence of obesity began to skyrocket (along with attention in the press), the product was also tarnished by the aggressive marketing of 1-800-GET-THIN. Lap-Band has also been a victim of the economy because many patients elect to pay for the surgery out of pocket. This is due to the fact that, while third party payers may ultimately be more inclined toward the product’s reimbursement since it may prevent or ameliorate obesity’s co-morbidities (e.g., Type 2 diabetes), current reimbursement levels do not yet reflect this. Allergan now believes that Lap-Band (which only represents only 3% of the company’s revenue) no longer exhibits attractive enough growth.
The future of obesity treatment is forecast in any case to be increasingly divided between devices and drugs.
—————— MedMarket Diligence has completed a global report on the clinical management of obesity. See link.
Qnexa, a drug in development by VIVUS, is one of several promising drugs for the treatment of obesity that received adverse FDA decisions, but which are now receiving additional consideration for potential regulatory approval in exchange for completion of results that demonstrate positive outcomes relative to specific FDA concerns.
Qnexa is an investigational, once a day, proprietary, oral, controlled-release formulation of low dose phentermine and topiramate. Vivus holds that this combination addresses the two main mechanisms that impact eating behavior: appetite and satiety.
In 2010, the FDA rejected Qnexa on the basis that evidence indicated it could cause birth defects in babies born to women who take the drug. Responding specifically to these concerns, VIVUS has submitted a new application for Qnexa with a commitment to complete a clinical trial (called the "Fortress" trial) of Qnexa to assess fetal outcomes in offspring of women exposed to topiramate during the first trimester of pregnancy. The initial results from the Fortress trial are due in December 2011.
Obesity drugs represent an enormous untapped opportunity based on their potential to produce significant weight loss without the need of bariatric surgery. The realizable market for obesity drugs, encompassing satiety drugs, malabsorption drugs, appetite suppression drugs and combination drugs (like Qnexa) will reach almost $16 billion by 2019, while devices in the management of obesity will at that same time reach only $1.7 billion.
The FDA has recently made overtures in the obesity drug market that reflect an apparent recognition that adverse regulatory decisions in 2010 against Qnexa, Arena's Lorcaserin and Orexigen's Contrave may perhaps have overreached.
The MedMarket Diligence, LLC., Report #S835, "Products, Technologies and Markets Worldwide for the Clinical Management of Obesity, 2011-2019", is a global analysis of the clinical practice, products, technologies, companies and markets in the field of obesity. The report is described in detail at http://mediligence.com/rpt/rpt-s835.htm.
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:
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.”
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.
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.
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.
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."
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.
Research in the diabetes field has taken two main directions: improving current therapies, and exploring radical new approaches. Improvements in current therapy include making glucose monitoring and insulin delivery less invasive and more patient-friendly, and many significant advances have been made in this context in the past two decades. Among these have been the development of insulin pumps and of non- or minimally-invasive techniques for sampling blood. New, fast-acting forms of insulin have been introduced. There has been considerable research in non-injection dosage forms for insulin, and the first inhaled insulin product has recently been approved. This could herald a new era in insulin therapy.
Another ground-breaking development will be the successful development and regulatory approval of an “artificial pancreas.” This is the term used to describe a system in which continuous glucose monitoring is linked electronically to continuously variable insulin delivery, effectively making diabetes control automatic and freeing the patient to get on with his/her life. The technology behind an artificial pancreas is still being developed but it is at an advanced stage. While the major components — an insulin pump and a continuous glucose monitor — are already on the market, and as a combined system by one manufacturer (Medtronic), the FDA has not approved a unified system in which the system runs autonomously by glucose readings driving insulin infusion rates. The algorithms, software and other systems necessary are likely to gain approval in only 1-2 years.
More radical approaches to diabetes mellitus, also the subject of vigorous research, include ways of replacing the whole cumbersome business of glucose testing and insulin administration. Transplantation of healthy pancreatic islets into diabetic patients has been explored, but the problems of rejection are a significant hurdle. More promising is the modification of adult or embryonic stem cells so that they develop into pancreatic beta-cells capable of being implanted in the patient and serving as a replacement for the insulin-secreting cells that have been destroyed.
Further in the future are developments based on genetic manipulation. Several gene anomalies have been identified as related to the development of type 1 diabetes in particular, and these may present targets for intervention to prevent the disease from developing.
The global market for products in the management of diabetes (monitoring, anti-diabetic drugs and insulin) is a $5 billion market currently and is growing at over 9% annually, a rate that is unlikely to slow while rates of obesity prevalence keep climbing.
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.