Oligonucleotide Drugs Pipeline Escalates Manufacturing Demand

As therapeutic agents, oligonucleotide drugs are known to be associated with several unique features, such as high selectivity and potency (similar to biologics), and differentiated pharmacology, which further augment their drug-like properties. At present, eight oligonucleotide drugs are available in the market, namely (in reverse chronological order of year of approval) GIVLAARI™ (2019), ONPATTRO® (2018), TEGSEDI™ (2018), SPINRAZA® (2016), EXONDYS 51® (2016), DEFITELIO® (2016), KYNAMRO™ (2013), and MACUGEN® (2004). As the market for such therapeutic interventions continues to evolve, it is likely to induce a steadily growing demand for oligonucleotide drugs.

Recent Clinical Activity in the Oligonucleotide Drugs Domain

More than 200 unique oligonucleotide drugs candidates are currently being evaluated in various preclinical / clinical phases of development. In fact, we came across more than 270 registered clinical trials focused on oligonucleotides, till 2019; it is worth noting that the maximum (34) number of trials were registered in 2019.

Further, these trials recruited more than 47,400 patients, across the globe. It is important to highlight that most of the trials being conducted within this domain are / were evaluating antisense oligonucleotides (110), followed by those involving the use of siRNAs (101).

Oligonucleotide - contributing directly to growing manufacturing demand in the industry
Oligonucleotides – clinical research landscape

Current Annual Demand for Oligonucleotide Drugs Manufacturing

By 2030, it is expected that siRNAs are likely to capture the highest share of the overall clinical demand for oligonucleotides. In addition, in 2030, majority of the clinical demand is likely to be generated by oligonucleotides being investigated for the treatment of oncological disorders, followed by those intended for ophthalmic disorders and metabolic disorders. Further, majority of the current as well as future demand for oligonucleotide based drugs is likely to be generated in developed regions, such as North America and Europe.

Oligonucleotides - manufacturing demand pattern suggests growing demand as per Roots Analysis
Oligonucleotides – manufacturing demand analysis

Recent Activity in the Oligonucleotide Domain

The current oligonucleotide drugs manufacturing landscape comprises of more than 80 players that claim to have the capability to manufacture oligonucleotides, at varying scales, for various pharmacological interventions. Further, in order to keep pace with the growing demand within the oligonucleotide synthesis market, these service providers are increasingly investing in or entering into collaborations to expand their existing capabilities. Majority of the partnership instances were reported to be manufacturing and supply agreements, followed by mergers / acquisitions.

Oligonucleotides - recent expansions suggest investment is coming in manufacturing space as per Roots Analysis
Oligonucleotides – recent expansions

For more details, you can also download the SAMPLE REPORT on oligonucleotides by Roots Analysis.