The global stem cell therapy market is estimated to reach USD 145.8 million by 2021, growing at a CAGR of 11.0% during the forecast period
Supportive regulations across developing countries
Emerging countries (such as South Korea, India, and China) are supporting their respective domestic stem cell industry through various regulatory reforms that support commercialization and research activities related to stem cell therapy.
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Due to flexible policies regarding stem cell research, South Korea has made significant advancement in this industry. The less stringent and relatively fast approval process of clinical trials has enabled South Korean manufacturers to commercialize their stem cell therapy products. Researchers in the country have successfully developed stem cells that are a perfect genetic match to patients of all races, genders, and so forth. Due to progress in therapeutic cloning, they can efficiently produce stem cells tailored to the individual and with a low risk of immunological rejection.
The medical tourism industry in Mexico is growing rapidly. The country has been a popular destination for stem cell treatments. A significant number of Americans and Canadians travel to Mexico to avail lower-priced treatments that are unavailable in their countries due to regulatory policies. Many private companies in Mexico offer stem cell treatments. However, these treatments are not approved by the Federal Commission for the Protection against Sanitary Risk (COFEPRIS – Mexican government regulatory authority for the manufacture and commercialization of drugs and medical products); they are also not considered as registered clinical trials. Yet, many of these treatments are offered as proven and effective therapies. COFEPRIS does not have standards or guidelines for evaluating, authorizing, and monitoring research and therapeutic activities involving human tissues and cells.
Many other developing countries have allowed the use of ESCs for R&D purpose.
n In March 2005, the Brazilian government passed a legislation that allows the use of in vitro fertilized embryos that have been frozen for more than three years.
n In India, it is permissible to establish new human ESC lines from spare embryos by obtaining approval from regulatory authorities.
n In China, regulatory guidelines (established in 2013) permit the use of embryos for stem cell research only if the embryos are obtained from in vitro fertilization (IVF); fetal cells from abortions; somatic cell nuclear transfer (SCNT); or voluntarily donated germ line cells.
Such supportive regulations across developing countries will provide significant growth opportunities for local as well as international players in the stem cell therapy market.
Technical limitations related to production scale-up
Due to technical difficulties faced at various manufacturing stages such as stem cell identification, isolation, storage, and preservation, it becomes difficult for a manufacturer to scale-up the production. Limited manufacturing capability for production scale-up is expected to hinder the large-scale manufacturing of stem cells. The scaling-up process is also affected due to the development process adopted during the research phase. Typically, less attention is paid to the scalability of production and the cost associated with it. Different stem cells require different environments for proliferation and differentiation, potentially including mechanical stimuli or flow conditions, variable gas tensions, chemical gradients, 3D frameworks, and supporting-cell paracrine signaling. These factors depend on the source and type of stem cell.
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There is a requirement for a basic stem-cell manufacturing solution which supports the production of a variety of stem cells and provides optimal environment. With current technological advancements, it is possible that a manufacturing solution can be programmed to control some factors; however, it is very difficult to provide a production system that fits all solutions. There are also concerns regarding the possibility of cells to adapt to different, more large-scale culture conditions while retaining safety and therapeutic efficacy. These limitations form a key challenge in the stem cell therapy market.
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