What is the supporting industry for regenerative medicine products, and which companies should enter it?
One business attracting new entrants in recent years is the industry that supports the manufacturing and quality control of regenerative medicine products (here, the “regenerative medicine supporting industry”). This column looks at what that industry is, and which companies are well suited to enter it.
What are regenerative medicine products?
Under Japan’s Act on Pharmaceuticals and Medical Devices, regenerative medicine products are products made by processing human or animal cells, plus gene therapy products. Human cells include somatic cells, somatic stem cells (such as hematopoietic, neural and mesenchymal stem cells), embryonic stem (ES) cells and induced pluripotent stem (iPS) cells.
Examples of the supporting business
The supporting industry provides what is needed to manufacture and control the quality of processed cells (human cell-processed products). That includes the equipment, instruments, media, reagents and contract services used in life science R&D. Typical cell analysis products include:
- Cell sorters and flow cytometers
- Automated cell culture systems
- Cell culture reagents
- Cell counters and viability analyzers
- Cell culture scaffolds
- Bio 3D printers
- Mass spectrometers
- Cell imaging and single-cell analysis systems
- Next-generation DNA sequencers (NGS)
- Digital PCR
- Liquid handling systems
Challenges in manufacturing and quality control
Regenerative medicine products must be of assured quality and safety, but there are many challenges, including:
- Stability and cost of large-scale cell culture
- Reliability of differentiation induction
- Precision of cell processing
- Precision of cell quality control
- Maintaining stability in cell storage
A range of enabling life science technologies (research instruments and reagents) is being developed to meet these challenges, and is expected to accelerate the regenerative medicine business.
Which companies suit this industry?
The supporting industry is a high-tech field that combines measurement science and precision engineering. The market is taking shape largely around US life science companies, but because it rewards Japanese manufacturing strengths, there are opportunities for manufacturers with applicable core technology, such as chemical, materials and machinery companies.
Evaluating core technology for the life science business
When entering the life science industry with your core technology, we recommend a demand study with BioSurvey, our market research service with front-line life science researchers in Japan. Because we never reveal the client’s name, it suits confidential new-entry projects and the evaluation of new product prototypes.
Summary
The regenerative medicine supporting industry draws on measurement science, precision engineering and manufacturing strength, and offers opportunities for manufacturers with applicable core technology. Overseas suppliers looking at Japan’s regenerative medicine market will meet both demanding customers and capable local competitors, so understanding researchers’ needs early pays off.