According to the statistics of China Blueprint for In Vitro Diagnostic, as of 2016, the size of China’s immunodiagnostic market reached 16.2 billion RMB (2.61 billion USD), accounting for 33% of the IVD market in China, and it is expected to maintain a growth rate of around 25% in the future.
At the present, immunological diagnosis has exceeded biochemical diagnosis (accounting for 27%) and has become the mainstream of IVD market in China. However, compared with developed countries, there is still room for alternative biochemical diagnosis to continue to expand in China’s immune-diagnostic since the average ratio of biochemical over immunization in about 1:2 on average according to statistical data from a number of agencies. It is expected that as technical innovation continues to advance and high-end testing needs continue to increase, the diagnosis is expected to further consolidate its mainstream diagnostic status.
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.