The questions you send us often relate to market size, market forces and future predictions. To answer these questions specific to Japan, we went to Toshihito Seto, Consultant, Medical Device Strategic and Regulatory Affairs for CMIC Group, a Japanese regulatory and manufacturing consulting company.
1) What is the size of the Japanese orthopaedic market and subsegments?
Mr. Seto divides the orthopaedic market into the categories of joint replacement, trauma, spine and artificial bone. Those markets combined yield more than $1.9 billion in revenue.
- Joint Replacement - $951 million
- Trauma - $487 million
- Spine - $426 million
- Artificial Bone (bone void fillers) - $74 million
2) What market forces should companies consider in 2019?
The Regenerative Medicine Promotion Act passed by the Ministry of Health, Labour and Welfare in 2014 remains a market force that orthopaedic companies should be aware of, says Mr. Seto. The regulatory change established a pathway for regenerative medicine (e.g. stem cell and autologous products) for the first time, providing a faster and easier pathway to market. The regenerative medicine market is significant due to Japan’s aging population.
3) What buzzwords are you hearing about orthopaedic technology?
More companies worldwide are engaged in artificial intelligence (AI), says Mr. Seto. Japan doesn’t have established AI guidelines for medical devices, but he expects that more conversations about the technology will take place.