Last year, we published our 2018 China medical device market outlook. It is time for us to give our 2019 outlook in this post.
Continuing with its growth momentum, China’s 2018 health expenditure reached $777 billion USD, or 5.7% of China’s total GDP. At this percentage, China’s health expenditure remains lower than that of the U.S. (17% GDP). However, China’s annual health expenditure is expected to increase to between 6.5-7.0% of the national GDP by 2020.
In China, the medical device market now accounts for 14% of the pharmaceuticals market. In contrast, this number goes up to 42% globally. As the world’s second largest economy, we therefore believe there is a significant growth potential of the medical device sector in China.
As evidenced by the following table, we estimated that China will enjoy the continued medical device market growth in market size, domestic production, export and import.
|China Medical |
|2016||2017||2018||2019 (est.)||2018-2019 |
Data in this table was compiled from https://www.export.gov/ and other sources.
China’s demand for medical devices has grown at a fast pace and we predicate that both production and demand will continue to grow in years to come. The key factors fueling this growth trend in china include
It is no doubt that domestic manufacturers dominate the Chinese medical device market. However, they mainly saturate low-range devices, recently become more competitive in mid-range devices. This still leaves the high-end device sectors more open to overseas device manufactures. Moreover, healthcare providers and hospitals in China prefer imported devices when selecting products from innovative and high-tech categories.
China’s regulatory and market-entry system has been under significant reform. But when compared to other markets such as US, EU, and Japan, China continues to present a significant challenge for those overseas manufacturers who want to enter its domestic market. As its device market grows rapidly, Chinese regulatory system keeps updating itself in a fast pace as well. Overseas device manufacturers are required to keep pace with the regulatory changes and requirements in order to enter the Chinese market. However, despite these obstacles, China remains to be one of the most important medical device markets in 2019 and beyond.
ChinaMed Device, LLC (www.ChinaMedDevice.com) provides regulatory and commercialization turnkey solutions for medical device, IVD, CDx and combination products in China. As a qualified NMPA (CFDA) legal agent with offices in Boston and Beijing, we can represent manufacturers for the complete product life cycle without their need to create a local entity in China. Our NMPA (CFDA) regulatory services include strategy, registration, local type testing, product technical requirement (PTR), clinical evaluation report (CER), clinical trial, GMP and post-market surveillance (AE, recall, inspection, etc.). Our commercialization services include market research, reimbursement, partnership strategy and distribution qualification.