Cell and gene therapy plays a major role in modern healthcare, as they provide concepts and techniques that can be used in gene regulation, cell-cell interactions, regenerative capacity, and remodeling.
The global cell and gene therapy market size was valued at US$ 6,020.0 million in 2017 and is expected to exhibit a CAGR of 21.9% over the forecast period (2018 – 2026).
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Gene therapy aims at influencing the course of various genetic and acquired disorders at the genetic level whereas cell therapy targets various diseases at the cellular level i.e. by restoration of a certain cell population or using cells as carriers of therapeutic carrier. High prevalence of cardiovascular disease is expected to propel demand for cell and gene therapy, which in turn is expected to drive the market growth. According to the World Health Organization (WHO), May 2017, around 17.9 million people died due to cardiovascular disease in 2016 globally, which accounts for 31% of all worldwide deaths. According to WHO, in 2012, cancer was the second leading cause of morbidity and mortality globally, with around 14 million new cases registered in 2012 and in 2015, cancer was responsible for 8.8 million deaths, worldwide. Moreover, WHO stated that the number of new cases is expected to rise by around 70% by 2030.
Furthermore, introduction of effective guidelines is expected to propel growth of the global cell and gene therapy market over the forecast period. For instance, the U.S. Food and Drug Administration (FDA) included around 28 guidelines documents from 1998 to 2018 regarding various cell and gene therapies.
However, several development challenges such as safety and efficacy issues, lengthy procedures for conducting clinical studies, stringent regulatory framework, and high costs are expected to limit the adoption of cell and gene therapy, thereby hindering the market growth.
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North America holds dominant position in the global cell and gene therapy market, owing to high prevalence of genetic disorders. According to the U.S. Pharmacist Journal, January 2018, annually, around 1.2 million adults are diagnosed with early symptoms of brain disorders, of which 21% are due to Alzheimer’s disease, and the total number of new cases of Parkinson’s disease and traumatic brain injuries is around 135 million in U.S.
Moreover, increasing research and development activities is expected to increase demand for cell and gene therapy. According to the Catalyst report, in December 2018, around 289 novel cell and gene therapies were in development for a variety of diseases, of which around 111 medicines were for cancer and around 28 medicines were for cardiovascular disease. These medicines in development are either in clinical trials or awaiting for approval from the U.S. Food and Drug Administration (FDA).
Major players operating in the global cell and gene therapy market include Amgen, Biogen, BioMarin Pharmaceuticals, Bristol-Myers Squibb Company, GlaxoSmithKline, Novartis, Pfizer, Regeneron Pharmaceuticals and Sanofi, Spark Therapeutics, Agilis Biotherapeutics, Angionetics AVROBIO, Freeline Therapeutics, Horama, MeiraGTx, Myonexus Therapeutics, Nightstar Therapeutics, Kolon TissueGene, Inc., JCR Pharmaceuticals Co., Ltd., and MEDIPOST.
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