Oligonucleotides are short chain RNA or DNA which are usually manufactured by utilizing automated synthesizers. Purification of the oligonucleotide is done by anion exchange chromatography which is followed by desalting and freezing technique. For the synthesis of siRNA duplex oligonucleotide, an annealing step is carried out where two purified oligonucleotide strands are brought together in an equimolar ratio.
Oligonucleotide therapeutics are different from conventional medicine as they can inhibit the expression of certain genes. This has given rise to innovative new oligonucleotides that can target specific genes and treat chronic diseases. The development of oligonucleotide therapeutics is done through chemically modified artificial nucleic acids. The artificial oligonucleotides are being developed which has improved in vivo stability and enhanced affinity to target mRNA.
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The demand for oligonucleotides is expected to upsurge as there are very few approved molecules. This has offered oligonucleotide market players a wide scope to discover new molecular entities. Moreover, the technology upgrades of chemically synthesized oligonucleotides have led to the development of more stable and extended half-life molecules. There are around 135 oligonucleotide therapeutics currently in different stages of drug development, which may further add to the limited three approved drugs currently available in the oligonucleotide therapeutics market.
The area of treatment with oligonucleotides is wide and offers promising results. Oligonucleotides have a distinguishing feature as compared to small molecule and protein therapeutics in that it can directly affect the protein targets. Specific RNA interference at the cellular level and targeting malfunctioning gene to suppress, manipulate or silence can all be done via oligonucleotides therapeutics.
The number of oligonucleotides in the clinical pipeline is small compared to other therapeutic classes, but still, the clinical movement of these molecules is increasing. From 2012 to 2015, the biggest increase in oligonucleotides clinical phase was from Phase 1 to Phase 2. By mid-2015, the number of oligonucleotides in Phase 2 almost doubled than that in Phase 1, indicating that the pipeline is maturing.
The presence of the main market leaders, market consolidation and commercialization of new molecules are all contributing towards the dominating position of North America in the oligonucleotides therapeutic market. Miragen Therapeutics, Inc. agreed to merge with Signal Genetics, Inc for an initial investment of USD 40 million. Through this merger both the companies expect to develop micro RNA-targeted oligonucleotide clinical products. New molecule application is also another strategy the market players are using to mark their presence in the oligonucleotide therapeutic market. Biogen recently received FDA approval for a new drug application for nusinersen. If approved, the antisense oligonucleotides molecule would be the first of its kind to be used for treating spinal muscular atrophy.
Asia-Pacific is the fastest growing region as several oligonucleotide therapeutics manufacturers are looking forward to establishing manufacturing facilities in this region. Moreover, research undertaking and funding in the synthesis of oligonucleotides are expected to add on to the increasing demand. Recently, Daiichi Sankyo Co., Ltd. announced its intention to open up a new company named Orphan Disease Treatment Institute Co., Ltd. to treat Duchenne muscular dystrophy through its active ingredient ENA oligonucleotide. The company is a collaboration between Daiichi, Mitsubishi UFJ Capital Co., Ltd. and Innovation Network Corporation of Japan and looks forward to entering the oligonucleotide therapeutics market.
One of the major trends driving the oligonucleotides therapeutic market is the increasing licensing and collaboration activities. Moreover, the demand for advanced technologies in oligonucleotide therapeutics such as gene silencing through RNAi is gaining importance due to its high efficiency, thereby propelling the oligonucleotide therapeutics market.
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Some of the key contributors to the oligonucleotide therapeutics market are PCI Biotech, SomaGenics, ContraVir, Alnylam, Regulus Therapeutics, Ionis Pharmaceuticals, Gilead, Santaris, InteRNA, miRage, Biogen, Merck and Pfizer, among others.
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