Tag Archives: market data

Applications, global markets in tissue engineering and cell therapy

Screen Shot 2014-04-17 at 7.37.44 AMThe market for tissue engineering and cell therapy products is set to grow from a respectable $8.3 billion in 2010 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.

Cell-tissue-applications

Factors that are expected to influence this market and its explosive growth include political forces, government funding, clinical trial results, industry investments (or lack thereof), and an increasing awareness among both physicians and the general public of the accessibility of cell therapies for medical applications. Changes in the U.S. government’s federal funding of embryonic stem cell research has given a potentially critical mass of researchers increased access to additional lines of embryonic stem cells. This is expected to result in an increase in the number of research projects being conducted and thus possibly hasten the commercialization of certain products.

regional-forecast

Source: Report #S520, “Tissue Engineering, Cell Therapy and Transplantation: Products, Technologies & Market Opportunities, Worldwide, 2009-2018.”

Another factor that has influenced the advancement of regenerative technologies is found in China, where the Chinese government has encouraged and sponsored cutting-edge (and some have complained ethically questionable) research. While China’s Ministry of Health has since (in May 2009) established a policy requiring proof of safety and efficacy studies for all gene and stem cell therapies, the fact remains that this research in China has spurred the advancement of (or at least awareness of) newer applications and capabilities of gene and stem cell therapy in medicine.

Meanwhile, stricter regulations in other areas of Asia (particularly Japan) will serve to temper the overall growth of commercialized tissue and cell therapy–based products in that region. Nonetheless, the growth rate in the Asia/Pacific region is expected to be a very robust 20% annually.


MedMarket Diligence’s Report #S520 remains the most comprehensive and credible study of the current and project market for products and technologies in cell therapy and tissue engineering.

The drug and device trends in the treatment of obesity

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

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

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

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

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.

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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