According to Millennium Research Group (MRG), the global authority on medical technology market intelligence, a number of novel devices are poised to enter the United States obesity intervention device market in the next few years. These devices are being developed to fill the gap between pharmacotherapy and bariatric surgery. In particular, patients who are class I obese (those with a body mass index between 30 and 35), or overweight and suffering from comorbidities or prediabetes cannot be effectively treated by either of these traditional options.
Intragastric balloons and gastric stimulation devices are two implantable device types that are front-runners to gain approval over the next few years. Several intragastric balloons have already obtained CE mark approval, and some companies, such as ReShape Medical and Obalon Therapeutics, are in the midst of conducting clinical trials in the US and are seeking to gain Food and Drug Administration (FDA) approval in the near future. Likewise, as of 2013 there were two gastric stimulators seeking FDA approval: EnteroMedics' VBLOC Maestro Rechargeable System and IntraPace's abiliti. The Maestro is anticipated to become available to the US market by the middle of 2014, and the abiliti may arrive two to three years afterwards.
"Beyond the gastric band and laparoscopy instruments used for bariatric surgery, there are a number of novel products set to enter the US market, although in order to obtain FDA approval, these products will need significant research and development funding," said MRG Analyst Jason Lau. "For instance, the EndoBarrier Therapy duodenojejunal bypass sleeve by GI Dynamics is particularly promising because GI Dynamics is a public company with significant resources to invest in large-scale development and a multicenter clinical trial.
Aspire Bariatrics' implanted AspireAssist product is also likely to see approval in the near future because this product is similar to other devices on the market; equivalency with preexisting products is a strong advantage for devices in development." However, pharmaceutical companies will also launch new products targeted at treating obesity in the next few years. Because pharmaceuticals are used before medical devices or surgery in the treatment algorithm and because they are covered by insurance in a number of cases, these new pharmaceuticals will pose significant competition for emerging obesity intervention devices going forward.
Millennium Research Group's US Markets for Obesity Intervention Devices 2014 report includes unit, procedure, average selling price and revenue information, along with market drivers and limiters and a competitive landscape for gastric bands, internal closure devices, surgical devices and emerging implanted devices in the United States.