Highly prized, due to their therapeutic potential, stem cell therapies are believed to treat a wide variety of diseases. Stem cell research progresses at a fast pace; however, both adult and embryonic stem cells have their own unique challenges that must be overcome before therapies make it to the market.
New analysis from Frost & Sullivan (pharmaceuticals.frost.com), U.S. Stem Cell Market - Current Developments, provides insights and analysis on stem cell therapeutic development in the U.S., including the clinical trial pipeline, key market drivers and challenges, and the market potential for stem cell therapy in selected disease indications. In this research, Frost & Sullivan's expert analysts thoroughly examine this cutting-edge healthcare technology market.
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“New research into stem cell therapies has resulted in several technological innovations that have improved the manufacturing and design of these products,” notes Frost & Sullivan Research Analyst Katheryn Symank. “For example, improvements in cell sorting and cell culture have allowed for improved survival and growth of adult stem cells. This allows for the rapid production of a high-quality adult stem cell product with increased bio-availability that may be produced on a large scale.”
Adult stem cell therapies were traditionally thought to have poor therapeutic potential because they could only be produced in limited quantities or as needed. Now adult stem cells have the potential to become standardized pre-made therapies that can be mass produced.
However, both stem cell types have challenges and technical difficulties that impede product development. Embryonic stem cells, while hailed for their promise as potential therapies, are immersed in both political and ethical controversy. In addition, some researchers have questioned the safety of embryonic stem cells in humans, while adult stem cells require a high degree of technical expertise because they are difficult to culture and lose potency over time.
”Both embryonic stem cells and adult stem cells have their own challenges that must be overcome,” explains Symank. “The controversy surrounding embryonic stem cells has resulted in severe limitations in federal funding for their research, while adult stem cells are often viewed as having less therapeutic potential because they can differentiate into a limited number of cells.”
New evidence suggests that adult stem cells may actually have more plasticity than once thought, and may actually derive more tissue types. In addition, new technical innovations allow for adult stem cells to be cultured in large quantities without the loss of potency. In regards to embryonic stem cells, despite the severe limitations in federal funding, support from private sources and individual states have allowed research to progress at a fast pace. However, there have been concerns over the safety of the use of embryonic stem cells in humans because of potential adverse consequences from undifferentiated cells.
”In order to ensure the safety of embryonic stem cell products in humans, strict manufacturing regulations may need to be imposed by the FDA,” advises Symank. “In addition, there could be strict product safety testing in place to guarantee their safety.”
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