Induced pluripotent stem cells (iPSC) are artificially derived from adult stem cells by manipulating gene expression. This avoids using embryos – a method that’s garnered a lot of controversy – as is done with embryonic stem cells. It’s been over ten years since iPSC technology was discovered, and the market has steadily become an immutable part of the life sciences. Methods for commercializing this cell type are expanding every year, and clinical studies investigating iPSCs are swelling in number.
The benefits of iPSCs are catching on, which is setting the market on a course of continued expansion. BCC Research predicts the global market for induced pluripotent stem cells to grow from $2.8 billion in 2021 to $4.4 billion by 2026, at a CAGR (compound annual growth rate) of 9.3%.
Induced pluripotent stem cells appear to be a great alternative to embryonic stem cells, but what are the benefits and disadvantages? BCC Research is diving into some of the factors for and against these innovative stem cells.
Advantage: Elimination of ethical issues
The use of ESCs in research is full of ethical issues concerning personhood, justice toward humankind, and human dignity associated with the use of human life in its earliest form, the embryo. Additional concerns surrounding the use of ESCs are improper incentives, informed consent, and safety and health concerns of the women providing eggs for the generation of embryos by in-vitro fertilization (IVF). Induced pluripotent stem cells have solved the controversy over the destruction of embryos associated with the use of ESCs in research.
Compared to ESCs, the production of iPSCs does not require the destruction of human embryos, which avoids the ethical concern in this field. Without the bioethical issues, researchers are more likely to obtain more federal funding and support.
Advantage: Reduced chances of immunorejection
iPS cells are generated from the somatic cells of one's own body, which effectively means the new cells are genetically tailored to a patient. This helps eliminate immune system rejection, which can sometimes occur when the body’s immune system identifies implanted cells or tissues as unknown bodies and attacks them.
Advantage: Overall reduced cost and risk of clinical trials
For every new drug to reach the market, about 5000-10,000 compounds need to be tested during preclinical trials. As a result, any strategy which standardizes the prediction of toxicity would affect the cost. Many drugs fail after Phase III, with a big example being BMS-094, a hepatitis C drug, that failed after the death of a patient. The costs of clinical trials could be reduced by using iPS cells to provide the toxicity aspects of the drug by different cytotoxicity assays. Most of the expense for preclinical testing is due to the requirement of animal models for the estimation of bioavailability of the new drug. As animal models do not imitate the microenvironment of the human cells fully, the use of iPSCs for these tests might cut the cost associated with providing animal models, which ultimately decreases the overall costs of the clinical trials.
Disadvantages
There are strict quality controls for clinical-grade iPSCs. The agreement on critical quality attributes need to be established, which may include the cell identity, microbiological sterility, endotoxin, genetic fidelity and stability, viability, characterization and potency, and so on. Although there are some initiatives here, such as those done by Global Alliance for iPSC Therapies (GAiT), further work for developing an international standard, building global consensus and having community engagement is needed for the global application of iPSCs and iPSC-derived cellular therapeutics.
In addition, the risk of the overgrowth of the transplanted cells, or, in other words, cancer, continues to be a major hurdle. Recently, some in vitro and in vivo tumorigenicity assays have been described to verify the safety of human iPSC-derived cardiomyocytes for cell transplantation therapy. However, probably it is necessary to elucidate the biological mechanisms underlying iPSCs' tumorigenicity, particularly the difference between iPSCs’ teratoma formation and cancer initiation, which should help for an effective solution to this critical issue for iPSCs clinical applications.
The good news for the industry is that some of the key disadvantages of iPSC technology have recently been overcome. Any new technology has its initial drawbacks – but progression in this area is encouraging for the future of iPSC.
Low reprogramming efficiency can now be changed by down-regulating the nucleosome remodeling and deacetylation (NuRD). Genomic integration of the transcription factors may cause the risk of mutations being inserted into the target cell’s genome, causing tumorigenesis. Different vectors such as plasmids, adenoviruses and transposon vectors have been used to avoid genomic insertion.
Discover more about the induced pluripotent stem cell industry
Detailed industry and market analysis for iPSCs is needed – and BCC Research’s latest report meets this demand. Great opportunities coexist alongside huge risks, but our detailed analysis and forecasts of the iPSCs market can answer the questions you need to thrive in this industry.
Download your complimentary report overview of Induced Pluripotent Stem Cells: Global Markets now.
Consider becoming a member of the BCC Research library and gain access to the full catalog of reports within your chosen category. Get in touch with a helpful member of the team today to find out more.