In the third installment of our Q&A series with Kelly Scientific, we’re discussing the future of the regenerative medicine market. Regenerative medicine’s main objective is to heal and replace organs/cells that have been damaged by age, trauma or disease.
There are over 700 regenerative medicine companies globally at present, with more than 500 products commercialized.
Q. What disruptive technology is advancing the overall regenerative medicine market?
At present induced pluripotent stem cells (iPSCs), 3D in vitro models, organs on chips and single cell dissection are disrupting the regenerative medicine market. Growth of 3D spherical cultures allows for numerous investigations that relate to the architecture of in vivo tissue and provide data on the functional effect of potential drugs and treatments. Once the sphere forms, a mini-organ or micro-tissue that exhibits cell to cell contact and the life span of the sphere is increased by up to ten fold compared to single cell culture.
Generation of induced pluripotent stem cells (iPSCs) over ten years ago revolutionized regenerative medicine. iPSCs are cultured with specific differentiation factors to transform them into specialized cell types, that can be used in disease models for drug screening. Interestingly, iPSCs can also be used for drug delivery of therapeutics or to correct a mutated gene. iPSC-derived models of disease are an important tool in clinical research.
Pluripotent stem cells can be generated from adult somatic cells, and so this allows for the production of cellular models with drug sensitivities and resistance. Toxicity testing can also be performed on cells derived from patients with neurological, hepatic and cardiovascular disease. A number of pharma companies have significant interest in this area. High throughput screening is also an important technology in the regenerative medicine space as it allows for more efficient early drug discovery protocols.
Q. What are the main restraints of the regenerative medicine industry as a whole?
A number of restraints are challenging the industry as it is in it’s infancy from a commercialization point of view. As these new therapies have new mechanisms of action, stakeholders in the market are potentially nervous due to lack of knowledge. This unfamiliar territory might restrict access, however increased education and access to specialist consultancy should allay fears. Positive outcomes from ongoing clinical trials should also reinforce a sense of security in the space. However, with this comes a lack of long term data with these new therapies, and so the coming years will be sensitive territory for regenerative medicine and new cellular therapies such as CAR-T and gene therapies.
More specific restraints and challenges include upscaling protocols from R&D labs to a commercial scale is a major challenge. This is complicated by the genetic instability of stem cells. Industry wide standards also need to be established and added pressures from regulators and reimbursement stakeholders also restrain the market. Pricing is also an issue, as is upfront investment due to the high requirement of funds.
FUTURE OF THE STEM CELL MARKET
Q. Where do you see the stem cell market heading in the next five years? What impact could this have on the overall regenerative medicine industry?
Looking forward, the regenerative medicine market is promising for a number of robust reasons including:
- Increasing number of potentially successful clinical trials.
- Increasing number of mergers and acquisitions.
- High unmet need in many indications.
- Global penetration, especially in Japan will boost the market.
Over the next five years, the regenerative medicine space is forecast to grow at a CAGR of over 23% to $53 billion. This will be mainly seen in North America and Europe, but high growth will be noted in Japan, South Korea and other emerging markets. Combined therapies will potentially be on the horizon as players try to maximize profits from current therapeutics.
Don’t forget to check out the first two parts of the series:
- 'Immunotherapy Will Become The Oncology Treatment Of Choice'
- How Personalized Medicine Will Transform Health Economics
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