Author(s):

Adrienne Ma, M.Sc.

Introduction:

Through 2014, the Japanese peripheral vascular (PV) device market will grow at a steady compound annual growth rate as a result of a rapidly aging population—more prone to peripheral vascular disease (PVD)—and new device approvals, especially in the PV stent, embolic protection device (EPD), and aortic stent graft segments. The strict regulatory environment in Japan has often impeded competitors trying to enter this market, but progress is being made toward improving the efficiency of the regulatory process, resulting in more device approvals in recent years. These new device approvals will drive adoption of minimally invasive procedures by increasing disease awareness and availability of endovascular treatments. Moreover, Japan has one of the fastest growing elderly populations in the world, which is putting a strain on the Japanese health care system. In response, the Japanese government will look toward implementing more drastic reimbursement cuts than have been seen in previous years. These reimbursement cuts will limit revenues in this market somewhat through 2014. Nevertheless, a growing number of physicians outside the interventional radiology space are adopting minimally invasive treatments for PVD, which will increase diagnosis rates and patient access to endovascular treatments. This will in turn lead to climbing procedure volumes and expanding revenues over the forecast period.

Questions Answered in This Report:

  *   In Japan, Cordis received Ministry of Health, Labour and Welfare approval of the first stents indicated for the carotid and renal arteries in 2008 and 2009, respectively. How did approval of stenting in these two indications affect the PV stent, PTA balloon catheter, and EPD markets? How did the launch of these two products affect off-label use of stents approved for other indications? How did these approvals affect competitor market shares?

  *   The first thoracic aortic stent graft was approved in Japan in 2008, and a second thoracic aortic stent graft was launched in 2009. What impact will the approval of thoracic aortic stent grafts have on the synthetic surgical graft market through 2014? Was thoracic endovascular aortic repair readily accepted by Japanese physicians? Because thoracic aortic surgery has a high-risk of mortality, will patient and physician demand for thoracic aortic stent graft procedures increase?

  *   With an increasing number of retrievable inferior vena cava filters (IVCFs) entering the Japanese market, there is a shift from permanent IVCF procedures to retrievable IVCF procedures. How will a shift from permanent IVCF procedures to retrievable IVCF procedures impact the IVCF market? Will greater accessibility to retrievable IVCFs promote prophylactic use of IVCFs?

  *   The Japanese government continues to implement biennial reimbursement cuts on medical devices to bring average selling prices (ASPs) more in line with foreign average pricing. How are reimbursement cuts affecting ASPs and overall market revenues? Is the Japanese government making more drastic cuts as a result of the struggling Japanese economy and health care system? How are reimbursement cuts affecting current market competitors and competitors looking to enter the market?

Scope:

Regions covered: Japan

Segmentation: Our analysis uses the following segmentation of the market:

• PV stents
  • By indication (carotid, renal, iliac, fem-pop, and infrapop)
  • By type (self-expandable and balloon-expandable)
• PTA balloon catheters
  • By indication (carotid, renal, iliac, fem-pop, infrapop, AV acccess)
  • By type (small, standard and other [large, high-pressure, and specialty])
• EPDs
• IVCFs
  • Retrievable
  • Permanent
• Aortic stent grafts
  • Abdominal aortic
  • Thoracic aortic
• Synthetic surgical grafts
  • By indication (abdominal aortic, thoracic aortic, aorto-iliac bypass, extra-anatomical bypass, peripheral bypass [above-the-knee and below-the-knee], and AV access)
  • By graft material (expanded polytetrafluoroethylene, Dacron, and polyurethane)
• PV accessory devices
  • PV guidewires (interventional, diagnostic, and hydrophilic)
  • PV sheaths (introducer and guiding)
  • Diagnostic catheters (standard and hydrophilic)
  • Guiding catheters

Market forecast features: Based on primary research with industry professionals and product end users, we use our proprietary forecasting model to provide an in-depth examination of current and future trends in procedure volumes, unit sales, ASPs, and market values over a 7-year period (2008–2014).

Competitive analysis: We provide a detailed analysis of the competitive landscape in the market, as well as market shares and qualitative discussions of the leading competitors in each market segment.