The clot management device market in Japan is unique in terms of the factors that favor or restrict this market as compared to the US and European markets. Demographic factors, regulatory systems, and product availability cause this market to follow a much different pattern compared to other countries. Here are a few factors affecting the clot management device market specifically.
- Aging population: Japan has rapidly growing elderly demographic, which continues to grow in the face of an overall declining population. This factor has at least a minor positive influence on most medical device markets.
- Acute ischemic stroke: The market for acute ischemic stroke (AIS) treatments in Japan is very different from the US and Europe both for pharmaceutical and device interventions. One of the major differences between Japan and the rest of the developed world is the high drug-treated rate. At 75% drug-treated, Japan really jumps out as a unique market. The difference here is due to the availability of edaravone only in Japan, which is used often because it’s a neuroprotection agent (believed to protect cells from the damage associated with oxidative stress). Neuroprotection is really important for stroke treatment because the longer the patient is unprotected, the fewer therapy options there are. Thus edaravone can be used on its own or in conjunction with other therapies to widen the treatment window. The presence of edaravone therefore should help increase the adoption of new thrombectomy devices.
- Mechanical thrombectomy devices: Ever the tinkerers of small mechanisms, some Japanese physicians use homemade mechanical thrombectomy devices. American and European physicians see this as as incredibly strange and risky. However, in Japan, usage of homemade thrombectomy devices somewhat limits the usage of commercially available mechanical thrombectomy devices.
- Reimbursement: The reimbursement system is also very unique and complex in Japan as compared to other developed geographies. Medical device reimbursement prices are regulated every two years to create a balance with the foreign average prices. The percentage of the reimbursement cut is not same for all device segments. Clot management device segments like embolectomy balloons and catheter-directed thrombectomy devices will witness heavy price declines whereas newer segments like neurovascular thrombectomy devices will remain minimally affected because the average market prices for these devices are already in line with the foreign average prices.
- Device approvals: Japan has a cumbersome approval system with stringent requirements, which leads to delayed approvals of many devices in Japan. Thus, Japan has been far behind the US and Europe in terms of availability of many devices. An example from a related field, transcatheter embolization and occlusion devices, would be the introduction of the first flow-diverter (Medtronic’s Pipeline Flex) in Japan in late 2015, whereas the first flow-diverter (Covidien’s Pipeline Embolization Device) was approved in the US in 2011. However, availability of supporting Japanese clinical evidence does aid in approval chances and better adoption of the devices in Japan.
These are some of the factors that will be responsible in shaping up the overall market clot management device market in Japan. Whether these unique factors will be helpful in making the Japanese clot management device market lucrative is something to be analyzed in depth.