Genome engineering is a process of insertion, deletion, modification or replacement of DNA bases in an organism. There are two types of gene therapy, Ex-Vivo Gene Therapy and In-Vivo Gene Therapy. Ex-vivo gene therapy involves the transfer of genes in cultured cells and then reintroducing in patient, while in In-vivo gene therapy, genes are directly delivered in cells of a particular tissue. Key companies such as CRISPR Therapeutics AG, Editas Medicine, Inc., and Intellia Therapeutics, Inc. are focusing on developing In-Vivo and Ex-vivo gene therapy. Major techniques used in genome engineering are CRISPR, TALEN, and ZFN. CRISPR (CRISPR-Cas9). These are innovative genome editing tools that enable researchers to edit parts of the genome by adding, removing, or altering sections of the DNA sequence. CRISPR is an accurate, faster, and cheaper technique for editing DNA as compared to others methods such as TALEN and ZFN. Transcription activator-like effector nucleases (TALEN) is a technology widely used in live cell gene editing. Zinc-finger nucleases (ZFNs) is an artificial restriction enzyme, which simplifies targeted editing of genome by creating double-strand breaks in DNA at user-specified locations.
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Increasing development of novel technologies in genome engineering is expected to drive growth of the global genome engineering market in the near future
Key players in the market are focusing on developing novel technologies and launching new products for genome engineering, in order to increase their market share. For instance, in February 2018, Sangamo Therapeutics, Inc. received clinical trial authorization (CTA) from Medicines and Healthcare Products Regulatory Agency (MHRA) in the U.K. for its SB-FIX, a zinc finger nuclease (ZFN)-mediated in-vivo genome editing treatment for hemophilia B. CTA has allowed for the beginning of Europe's first in-vivo genome editing study. In 2017, Integrated DNA Technologies, Inc. launched the first Cas9 enzyme variant, which reduces off-target effects in CRISPR genome editing. The launch of latest Cas9 enzyme variant is a major step towards therapeutic use of CRISPR. In 2017, Scientists at Salk Institute for Biological Studies, modified CRISPR to epigenetically treat diabetes, kidney disease, and muscular dystrophy. They developed a latest version of CRISPR/Cas9 genome editing technology, which allows for activation of genes without creating breaks in the DNA. The development of such novel technologies is expected to be major driving factor for growth of global genome engineering market.
The global genome engineering market was valued at US$ 2,582.7 Mn in 2016 and is expected to witness a CAGR of 14.3% over the forecast period (2017–2025).
Increasing strategic collaboration for genome engineering technologies by key players is expected to drive market growth in the near future
Players in the market are focusing on strategic collaborations, in order to increase their product offerings. For instance, in February 2018, Kite Pharma, Inc.—a Gilead Sciences, Inc. company— collaborated with Sangamo Therapeutics Inc. for developing engineered cell therapies to treat cancer. As per the agreement, Kite Pharma, Inc. will use Sangamo Therapeutics’ zinc finger nuclease (ZFN) gene-editing technology for developing next-generation ex vivo cell therapies for treatment of cancer. Furthermore, in 2017, Synthego and Thermo Fisher Scientific collaborated to manufacture and distribute synthetic guide RNA products for CRISPR genome engineering. In 2016, CRISPR Therapeutics and Bayer AG collaborated and formed a joint venture Casebia Therapeutics, for developing CRISPR-based therapeutics in select disease areas. Moreover, in 2017, Casebia Therapeutics collaborated with CureVac AG. According to collaboration agreement, CureVac will develop novel Cas9 mRNA constructs with improved properties for gene editing applications. In 2015, AstraZeneca plc. announced research collaborations with The Wellcome Trust Sanger Institute, The Innovative Genomics Initiative, Thermo Fisher Scientific, and Broad Institute/Whitehead Institute to use their CRISPR technology for genome editing. Such strategic collaborations among major key players and research institutes is expected to drive market growth in the near future.
Moreover, increasing funding and investments for the development and research of new genetic engineering technologies is also expected to drive market growth. For instance, in January 2018, the U.S. National Institutes of Health (NIH) announced to grant US$ 190 million for genome editing research. This new program, Somatic Cell Genome Editing, will award funds to biomedical researchers over the following six years. The support from major research organizations such as NIH is expected to attract more researchers in this field, which may lead to advancements in technology and also aid in growth of the market.
High cost of genome engineering technologies is expected to be the major factor, restraining growth of the genome engineering market over the forecast period. For instance, according to the fees chart provided by Yale Genome Editing Center, in 2018, it charges between US$ 8,000 and US$ 15,000 for gene editing facilities. The high cost associated with genome engineering facilities is expected to hamper the market growth, especially in emerging economies such as India, Brazil, and South Africa. Moreover, genome engineering is a very complex technology and needs high skilled researchers, which limits its adoption rate.
Key players operating in the genome engineering market include Thermo Fisher Scientific Inc., CRISPR Therapeutics AG, Intellia Therapeutics, Inc., Editas Medicine, Inc., Sangamo Therapeutics, Inc., Bluebird Bio, Inc., Cellectis S.A., and Merck Group.
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