Oligonucleotides Market Intelligence

Industry Outlook & Drivers

Global Market Overview on Oligonucleotides

More than 100 Oligonucleotides are currently under clinical trials and are moving towards regulatory approval. As they reach the market, demand for manufacturing capacity will increase forcing CMOs to expand .Global oligonucleotide CMO market is expected to grow at about 25 percent and reach a value of $550 million by  2020.

Supply Demand

Antisense oligonucleotides account for the major type of oligonucleotide currently in clinical trials. 83 out of the 142 ongoing clinical trials are antisense oligonucleotides.Currently there are 4-5 major CMOs in the market and they may not be able to support the growing demand once all drugs lined up for regulatory approval get market authorization

More than 100 Oligonucleotides are currently under clinical trials and are moving towards regulatory approval. As they reach the market, demand for manufacturing capacity will increase forcing CMOs to expand

• Oligonucleotides are regarded as the next big group of  therapeutics after small molecule and biologics. This is mainly due to their promise of low drug development cost and ability to reach targets that conventional small molecule drugs cannot achieve
• Antisense oligonucleotide therapeutics  are currently the most promising class of oligonucleotides that have seen more success within the category
• Challenges currently faced by oligonucleotide therapeutics include regulatory complexity, effective delivery of oligonucleotides, etc.
• Although the number of oligo drugs in pipeline may be small as compared to small molecule and biologics, they still offer huge market potential

Market Overview – Supply Demand

Oligonucleotide API market has seen the demand accelerate and the market is growing at about 20-30% a year and this could expand further when these drugs are commercialized

Supply

• Supply market is very small at present since there are only four drugs in the market
• Currently there are 4-5 major CMOs in the market and they may not be able to support the growing demand, once all drugs lined up for regulatory approval get market authorisation
• All oligo API manufacturing CMOs have planned expansion of their existing facility or entered into joint ventures to construct a new manufacturing facility

Demand

• Demand is expected to increase many folds in the near future
• With more drugs entering the market, there will be increased reliance on CMOs for their manufacturing expertise and experience
• Well known CMOs with many years of experience in this space many be more sought after
• Due to lack of capacity CMOs who are next in line with a good track record may also be considered

Market Trends – Oligonucleotide API

• In November 2017, RiboBio and GE Healthcare entered into a Strategic Partnership to build an Oligonucleotide CRO/CMO facility
• ST Pharm announced the construction of its new oligo manufacturing unit in Korea. This plant is said to be operational by 2019
• Similarly, GeneDesign a subsidiary of Ajinomoto announced that it will establish a new plant for Oligo API manufacturing in Japan, expected to be operational by 2019
• Nitto Denko Avecia in July 2017 expanded their Oligonucleotide API manufacturing facility in Massachusetts by 2000 square feet. The facility is capable of producing oligonucleotide API capacity up to 1.8 molecular weight (mol)
• In July 2017, CordenPharma International and GE Healthcare's Dharmacon business have entered a strategic collaboration to create end-to-end solution for oligonucleotide-based drug discovery