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The U.S. Food and Drug Administration (FDA) defines human gene therapy as the administration of genetic material to modify or manipulate the expression of a gene product or to alter the biological properties of living cells for therapeutic use. The FDA approval of Kymriah for the treatment of paediatric and young adult patients with acute lymphoblastic leukaemia (ALL), Yescarta for the treatment of B-cell lymphoma and Luxturna for the treatment of children and adults with retinal dystrophy due to a mutation of the RPE65 gene in 2017 has encouraged many large life sciences companies to focus the development of gene therapy products, either through investment in research & development (R&D) or boosting their pipeline through acquisitions. For example, Novartis AG acquired AveXis, Inc. for $8.7 billion whereas Astellas Pharma Inc. acquired Quethera Ltd. in 2018.
The growth in the number of products in the advanced stages of R&D along with the focus on the treatment of rare diseases is anticipated to drive the gene therapy market size at a considerably fast rate. A study published by The Massachusetts Institute of Technology (MIT) has predicted that around 40 FDA-approved gene therapy products will be in the market by 2022.
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The factor that is expected to inhibit the growth of the market is the huge price tag associated with gene therapy products. For example, Kymriah is expected to cost patients around $475,000 for a treatment course. Regulatory and clinical hurdles might also impact the growth of the market due to delays in product approvals.
Some of the major companies that are present in the global gene therapy market research report are;
By Disease Indication
By Type of Vectors
By Type of Cells
At present, cancer accounts for the largest proportion of the market and this is not expected to change in the forecast period based on MIT study, which predicted that out of the 40 FDA-approved gene therapy products by 2022, around half are expected to be in the oncology space.
The global gene therapy market has been segmented into North America, Europe, Asia Pacific, Latin America and Middle East & Africa. North America followed by Europe are the two largest markets for gene therapy at present and they are expected to account for a large proportion of the market in the forecast period as well. The world’s first gene therapy, Glybera, was approved in Europe in 2012 and the region had ten cell and gene therapies approved in 2018. In the Asia Pacific region, Japan is expected to provide the largest market opportunity. AnGes MG, a biopharmaceutical start-up based in Japan, is expected to receive approval for a gene therapy product for the treatment of inadequate blood circulation in legs in the country in 2019.
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