Global synergies among diverse entities are broadening applications and helping to create growth opportunities and common standards, finds Frost & Sullivan
Regenerative medicine is redefining medical technology by combining stem cell technology with tissue engineering. Advanced biomaterials are joining up with small molecules and biologics to replace or regenerate and restore functions of human tissues and organs.
But the scope of application has extended far beyond acute injuries, chronic diseases and congenital malformations into therapeutics, research and difficult-to-treat diseases.
New analysis from Frost & Sullivan, Regenerative Medicine – The Future of Therapy, finds that medical device and drug manufacturing companies have been forming partnerships to combine their tissue engineering platforms with the most advanced stem cell therapeutics to lower operational costs and time. There have been numerous local, regional and international initiatives to build first-in-class biomanufacturing facilities, while developing expertise in managing progenitor cells, and creating repositories of research and clinical grade stem cells. Some of the countries involved in these initiatives are the UK, Canada, the US and Japan.
'Companies are steadily streaming into the regenerative medicine space by developing culture medium and reagents before advancing to the cell-based medicines market,' said Frost & Sullivan's TechVision Industry Analyst Cecilia Van Cauwenberghe.
'Their main goal is the development of cell-based medicines using induced pluripotent stem cells (iPSCs). In the long-term, iPSCs will drive the market and advance stem cell therapeutics worldwide.'
Companies are steadily streaming into the regenerative medicine space by developing culture medium and reagents before advancing to the cell-based medicines market
The growing popularity of regenerative medicine research is attracting substantial funding from both public and private sources, the analysis finds. Investments have been particularly high in cell therapies, gene therapies, tissue engineering, biomaterials, and small and biologic molecules in other advanced therapies.
As well as trying to resolve financial and technology constraints, stakeholders also need to address the issues related to process development, manufacturing, logistics and intellectual property protection, the report suggests. Most important, the involvement of various countries in regenerative medicine research has stoked a need for new standards and common regulations.
'Domestic and international standardisation is crucial for devices, packaging, transportation, equipment, consumable supplies, culture media and reagents and services in the regenerative medicine space,' said Cauwenberghe.
'Stakeholders have already started consolidating strategic advisory boards to provide advice on clinical, logistical and regulatory issues, intellectual property strategy, technology transfer and licensing deals.'
One of the prominent players in the regenerative medicine is Japan, which in 2014 created the Forum for Innovative Regenerative Medicine (FIRM), comprising 185 firms as well as organisations from the across the world. The health reform in the country in 2015 adapted policies, which encourage collaborations among multiple organisations and contract manufacturing organisations.
Indeed, the regenerative medicine has grown exponentially in recent years despite being nascent in terms of technology readiness for some applications. The escalating synergies among nanotechnology, biotechnology and biomedical engineering will accelerate the introduction of products and technologies that can take regenerative medicine to the next level, says Frost & Sullivan.