According to Millennium Research Group (MRG), the global authority on medical technology market intelligence, efforts to streamline the regulatory approval process in Japan have resulted in the recent entry of numerous devices in the Japanese peripheral vascular (PV) device market, and more products, such as drug-coated balloons and infrapopliteal stents, are expected to enter in the next few years.
The femoropopliteal (fem-pop) stent segment in particular has seen significant activity in the past year. Prior to the approval of the first product in March 2012, procedures using fem-pop stents were only performed off-label; since then, three fem-pop stents have received approval. Cook Medical's Zilver PTX stent was the first to enter the market, and this product also represents the first drug-eluting stent (DES) approved for peripheral indications in Japan. Because this product enjoys a first-to-market advantage, many Japanese physicians continue to prefer it to other fem-pop stents that received later approval.
The aortic stent graft market has also seen a number of recent product approvals, and most new products address previous limitations of aortic stent grafts and will allow a greater number of patients to be treated with these minimally invasive devices. For example, Medtronic's Endurant abdominal aortic stent graft is a low-profile device, providing physicians with a better treatment option for patients with difficult anatomies.
"The availability of these novel devices and the entry of new competitors will help raise the profile of aortic stent graft treatment," said MRG Analyst Tonya Martin. "These developments will encourage more physicians to learn the procedures, and this market will begin to see penetration comparable to Europe."
The Japanese PV device market will, however, be limited by the Ministry of Health, Labour and Welfare (MHLW)'s biennial reimbursement cuts, which will place substantial pressure of PV device prices. MHLW cuts will have the most significant impact on the percutaneous transluminal angioplasty (PTA) balloon catheter market, which will ultimately decline as a result.
Millennium Research Group's Japanese Markets for Peripheral Vascular Devices 2013 report includes unit, procedure, average selling price and revenue information, along with market drivers and limiters and a competitive landscape for PV stents, PTA balloon catheters, chronic total occlusion crossing devices, embolic protection devices, inferior vena cava filters, aortic stent grafts, synthetic surgical grafts and PV accessory devices in Japan.