An analytical article has examined the strengths and challenges of domestic companies in Japan's stem cell therapy market and compared them with overseas players. It covers the leading stem cell therapy companies, the supply system and the market outlook.
The article organises the strengths and challenges of domestic companies in Japan's stem cell therapy market and explains the market structure from the perspective of comparison with overseas players. It distinguishes between companies focused on stem cell therapies and companies with strengths as suppliers when explaining the competitive strengths of domestic companies by area.
The major companies in the stem cell therapy market are said to include Osiris Therapeutics, NuVasive, Chiesi Pharmaceuticals, JCR Pharmaceutical, Pharmicell, Medi-post, Anterogen, Molmed and Takeda (TiGenix), with JCR Pharmaceutical and Takeda Pharmaceutical Company being the only companies currently classified as Japanese. JCR's strengths are said to be that its main products use allogeneic mesenchymal stem cells and that it maintains consistent quality control under Japanese regulations. Through its acquisition of TiGenix, Takeda Pharmaceutical is advancing the development and commercialisation of allogeneic stem cell therapies and has a global clinical development network and manufacturing expertise.
Japanese contract manufacturing companies are said to have strengths in areas including cell-culture equipment, aseptic filling technology and quality-control systems that minimise lot-to-lot variation, enabling a stable supply. Expectations from purchasers include the submission of quality data, information sharing when processes are changed, a stable supply from multiple sites, and thorough root-cause investigations and prevention of recurrence. The importance of flexible customisation to meet clinical needs and long-term partnerships is also emphasised.
Challenges cited include intensifying cost competition and price pressure for the expensive reagents and equipment used in cell culture and gene editing, the importance of development speed in bringing therapies into practical use, higher costs associated with scaling up production as international demand expands, and new burdens from establishing overseas sites and managing multinational supply chains. Automation and standardisation are expected to advance, increasing the importance of CDMOs, while more suppliers of culture media, cytokines, cell-culture equipment and quality-management systems are expected to enter the market.