Due to the impact of the birth control policy and the decline in birth rate after the economy growth, the population structure in China is gradually entering an aging society. After the age of 45, humans have entered the stage of high incidence of chronic diseases, and the diagnosis of many chronic diseases require in vitro diagnostic (IVD).
In 2016, the number of people over the age of 45 in China has reached 536 million, accounting for 38.22% of the total population, and this proportion is still rising. According to the UN’s forecast, the proportion of people over the year of 45 will continue to rise rapidly before 2040.
Although China’s IVD industry has achieved rapid growth in the past few years, the IVD market has grown from 10.8 billion RMB (1.75 billion USD) in 2009 to 36.9 billion RMB (5.95 billion USD) in 2016, with an average compound annual growth rate of 16.6%. However, the per capita annual consumption of IVD in China is only 3 USD, compared with the level of per capita annual consumption of 30 USD in developed countries, there is still a huge growth potential. Furthermore, as the aging of the population intensifies, China’s IVD industry is expected to maintain sustained and rapids growth in the next five years, and the market will become hundreds billion dollars “Blue Ocean”.
About China Med Device, LLC
China Med Device, LLC provides turn-key solutions for western medical device/IVD companies to enter China with regulation and commercialization services. Our CFDA regulatory services cover strategy, premarket submission, clinical evaluation, CRO, post market compliance as well as legal agent representation. Our commercial services cover market assessment research, reimbursement, partnership, distribution qualification and management. We have an office in Beijing, Suzhou and Boston. Our management team have 100+ years of combined experience in medical device and IVD and had been involved with 1,000+ CFDA certificates, 200+ western companies’ entry.