Regenerative medicine is a branch of medical research related to tissue engineering and molecular biology to restore the regular functioning of an organ or tissue by replacing or regenerating identical cells. This technique of medicine encompasses the possibilities of tissue culture and organ culture in laboratories to implant them in individuals. It also encompasses the use and techniques of treatment with stem cells.
The new region selective pluripotent stem cells offer easy scaling up for commercial purposes, easier laboratory growth and better gene-editing capability. Regeneration addresses one of the most complicated challenges in tissue grafting, which is transplant rejection. The process has the ability to repair damaged tissue and organs. Human tissue of various kinds can be grown in-vitro and used whenever necessary.
Cell banking or biobanking forms a supplementary system to this market as they are the source for tissue. This new branch of medicine has the potential to reduce chronic illnesses such as diabetes as regular functioning tissue can be regenerated with complete function. Failing organs such as liver and kidneys can also be replaced with in-vitro grown identical cells and tissue which can become a boon for the aging population.
Current approved regenerative medicine that is in clinical practice is the use of heparan sulfate analogs used in procedures such as inguinal hernia repair. Intense clinical research is also being carried out to induce pancreatic cells to produce normal quantities of insulin so as to help diabetic patients reduce the number of injections they take. In 2015, a program for the treatment of retinitis pigmentosa received the approval of US$ 4.9 million. The grant was provided by the California Institute of Regenerative Medicine.
Neural diseases were theoretically possible to cure, but RM and biotechnology have provided analytical tools that will enable this on-paper data to be practically performed.
With core pharmaceutical companies such as Cephalon investing in a company like Mesoblast for its global rights to their mesenchymal precursor stem cell platform, it is evident that pharma understands the capability of sustenance through future biotechnology. The investment opportunities have been growing tremendously past few years and investors have a keen eye on this segment of medical care.
Private Investor sources such as Proteus Ventures suggest the presence of around 400 products that are currently available today and more than 500 still in the pipeline. The key players covered in this study include Aastrom Biosciences, Cytori Therapeutics, Cerco Medical, Cook Biotech, Genzyme Corporation, HemaStem Therapeutics, HepaLife Technologies, LifeCell, Cellerix, NeuralStem, Osiris Therapeutics, OrthoVita and BrainStorm Cell Therapeutics.
There are several challenges in commercialization related to the scaling up of production in this field. The process for manufacturing these products is unique in several ways and primarily requires highly skilled professionals who are very low in number.
Another aspect of this area is the immaturity of understanding immunology related to regenerative treatment. Yet, NIH and FDA along with other regulatory authorities have been extending supporting the growth of this market by issuing guidelines and focusing on cutting-edge technologies in the field of biomedical engineering.
North America leads the global regenerative medicine market with a share of more than 40%, followed by Europe which due to the current economic situation is observed to have low key activity. Even Asia-Pacific countries along with Japan and China, in particular, have invested significant amounts in these technologies. New regulations accelerating the approval of regenerative therapies began in November 2014 in Japan. The country has been at the forefront of stem cell research.
With increasing importance given to the commercialization and upscaling of stem cells along with other regenerative techniques, Asia-Pacific is expected to grow along with North America and Europe as compared to the conventional status of being a follower.
Medical tourism will further boost this market in Asia. Besides these regions, middle-east and Brazil are also expected to add their unique contribution to RM in terms of innovative products and clinical data and would certainly open new market opportunities for players in the coming years.
The below mentioned quantitative and qualitative analysis is subject to enhancement and refinement during the course of research.
The report analyses and estimates the market by:
- Product Segment/Sub-segment Types
- Market Share Analysis – segments, players, geographies
- Geographic Analysis