For purposes of analysis (in Report #M510), the Asia-Pacific region encompasses Japan, Australia and Korea. Australia is a well-established market in many respects. Japan is a difficult market to penetrate, due to its stringent device review laws, its culture and the fact that in some ways the Japanese physiology is said to differ from that of the Westerner. For example, research is indicating that the Japanese population experiences more spinal stenosis than is seen in the West, possibly because the foramen is smaller in the Japanese anatomy and therefore more susceptible to stenosis.
In Japan, the Ministry of Health, Labor and Welfare, or MHLW must approve of all medical devices classed as â€œhighly controlledâ€™, before these devices may be imported and sold in the country. Foreign medical device manufacturers which do not operate through a Japanese entity are required to appoint a contractually bound in-country caretaker who holds a license to market the relevant medical devices to directly submit an application for device approval to the MHLW. The MHLW evaluates each device for safety and efficacy and may require that the product be tested in Japanese laboratories. After a device is approved for importation and commercial sale in Japan, the MHLW continues to monitor sales of approved products for compliance. The process from application to product launch can easily take five years. It tends to be more of a market for the larger multinationals, who have the deeper pockets and can more easily absorb the costs and the delay before seeing any return on their investment.
The total spine surgery market in this region is estimated to be growing rapidly, at a compound annual growth rate of 18%. Â The market is expected to more than quadruple in size by the end of the forecast period.
The Asia Pacific market is a strong one for Synthes, which is just behind Medtronic. Medtronic leads the market, primarily due to its strength in Australia. Synthes has leveraged its strength in Europe to penetrate the Australian and Japanese markets, and may well match Medtronicâ€™s market share soon.
Excerpt from “Worldwide Spine Surgery 2008-2017,” Report #M510, Published by MedMarket Diligence.