Tag Archives: market data

The drug and device trends in the treatment of obesity

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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

Source: MedMarket Diligence, LLC; Report #S835.

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.

Source: MedMarket Diligence, LLC; Report #S835.

 

The report, “Products, Technologies and Markets Worldwide for the Clinical Management of Obesity, 2011-2019″, may be purchased online at link.

 

 

Allergan Looking to Slim Down

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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.

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MedMarket Diligence has completed a global report on the clinical management of obesity. See link.

Vertebral Compression Fracture Treatment Technologies

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From “Worldwide Spine Surgery: Products, Technologies, Markets & Opportunities, 2010-2020″, Report #M520, published 2011 by MedMarekt Diligence:

Vertebral compression fractures result primarily from osteoporosis and the consequent weakening of bones, including those in the spine. VCFs can result in tremendous back pain both in the short and long term. Because the injured vertebra is compressed and loses height, kyphotic deformity of that particular vertebra and the spine as a whole often results. Kyphosis in and of itself can produce pain long after the vertebral compression fracture has healed. As discussed earlier, several conditions can lead to osteoporosis, including estrogen deficiency, multiple myeloma, radiation therapy, and natural aging. Bones weakened either due to the primary disease process or as a result of treatment of such diseases are more prone to fracture. Common sites osteoporotic fracture include the spine, hip, and wrist.

The traditional treatment for VCFs is conservative care with back braces, bed rest, and analgesic medications for alleviating pain. Although given time the fracture eventually heals, the vertebral body remains in a collapsed, compressed state. This can result in prolonged pain, impaired function, and decreased activity. Additionally, bone and muscle loss resulting from a lack of activity can make recovery even more difficult, leading to the so-called ‘downward spiral’ of vertebral osteoporosis.

In recent years, two minimally invasive procedures have been introduced to treat VCFs: vertebroplasty and kyphoplasty. The procedures are very different, in that vertebroplasty is designed to stabilize the break, while kyphoplasty attempts to both stabilize the break and bring the collapsed vertebra back to its original height. 

Companies with products in vertebroplasty and/or kyphoplasty on the market or under development include: Alphatec, ArthroCare, AscendX, Benvenue Medical, Biomet, BoneSupport, CareFusion, Cook, DePuy Spine, Dfine, Integra Spine, Lafitt, Medtronic, Orthovita, Osseon Therapeutics, Signus, Sintea, Skeltex, Soteira, Spine Wave, SpineAlign, Stryker, Synthes, Tecres, Teknimed, Vexim.

Kyphoplasty is currently the bigger market, but trends in procedure volume, pricing and unit sales are causing the gap in global market between kyphoplasty and vertebroplasty to disappear during the forecast period.

 

Vertebro-kypho

Source: MedMarket Diligence, LLC; Report #M520.

 

 

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Pharmaceutical research in obesity

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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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Spine surgery technologies gaining/losing ground on each other

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One thing to keep in mind about the spine surgery market is that, without exception, each and every technology continues to grow from the underlying procedure volume and even if prices are declining (as they are in some cases) the resulting market is also increasing as a result of procedure volume increases.

Hence, for the sake of highlighting where the growth stands out, it is useful to see the change in each technology's share of the total market over the 2010 to 2020 period.

Below is illustrated the change in percent of total market between 2010 and 2020 for each of the key technologies in spine surgery. First among these in gaining relative share are lumbar artificial discs and posterior pedicle screw fusion systems.

 

 

Source: MedMarket Diligence, LLC; Report #M520, "Worldwide Spine Surgery: Products, Technologies, Markets and Opportunities, 2010-2020".

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Surgical sealants, glues, sutures/clips, hemostats outside the U.S.

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See the updated, published 2012 Report #S190, “Surgical Sealants, Glues, Sutures, Other Wound Closure and Anti-Adhesion, Worldwide Markets, 2012-2017.”

The world market for the securement products, encompassing wound closure/sealing, hemostasis and anti-adhesion) is currently valued at more than $9.7 billion. This total market is growing at a steady 6.7% compound annual rate, though growth rates for individual regions vary.

Average growth in the world closure and securement products market also reflects differing conditions in individual countries, ranging between 3% CAGR for less developed economies and considerably higher for the United States.

Below is illustrated the market value and compound annual growth rate of the closure and securement market for countries outside the U.S. (the U.S. dominates the world market, largely dwarfing non-U.S. markets).

 

Securement-size-growth

 

Source: MedMarket Diligence Report #S180; “Worldwide Surgical Sealants, Glues, Wound Closure and Anti-Adhesion Markets, 2008-2015.”

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The Obesity Drug Opportunity Remains

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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

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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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Steady growth in wound management products

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Wound management, with its diverse products, well established base and growth prospects, not only for the advanced product segments but also for its tradiitional products, is an attractive area for medical technologies, drawing many active market participants.

The need for effective and improved technologies for acute and chronic wounds continues to be high, driven by the demographics of the aging population, the increasing sensitivity of healthcare systems to high costs such as chronic wounds and other forces.  The industry has responded by developing and introducing more complex types of wound products focused on shortening wound healing times and costs.

The largest single category of wound management products is already in physical wound management, encompassing negative pressure wound therapy, hyperbaric oxygen, hydrotherapy, electrical stimulation, electromagnetic stimulation, ultrasound, laser and others.  This category will also demonstrate some of greatest growth in wound management over the next several years. Other areas of significant growth include the use of growth factors, and foam and alginate dressings.

Illustrated is the global wound management market by product segment for 2008 and 2017.

Wound-by-segment-2008-2017

Source: MedMarket Diligence, LLC; Report #S247.

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Technologies at medical technology startups this month

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Here's a preliminary list of the technologies at companies we have identified this month to date (16 Sept. 2011) and included in the Medtech Startups Database:

  • Hydrogel-based tissue expanders.
  • Systems to prepare tissue for prosthetic implants and grafts.
  • Implants for internal compression or distraction of, for example, bone fractures, fusions, and osteotomies.
  • Devices for heart and vascular, initially developing a catheter-delivered heart valve.
  • Imaging and microfluidics based system to detect cancer.
  • System for detecting pressure-induced ischemia to assist in prevention and treatment of pressure ulcers.
  • Fentanyl iontophoretic transdermal drug delivery system.
  • Implants and other devices for treatment of injured or damaged shoulders.

MedMarket Diligence offers an online, searchable database of medical technology company startups. Updated regularly with addition of at least 10 new companies per month, the Medtech Startups Database contains contact details, business/product/technology descriptions and other data with records searchable by keyword and categorized by clinical/technology segment. Currently the database contains approximately 1,000 medical technology startup companies spanning medical device, biotech, biomaterials, diagnostics, pharmaceuticals and other medical product companies. 

 

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.