Because of the increased demand for novel drug classes, the Oligonucleotide APIs Market Demand is predicted to rise at a high CAGR of 10.2% between 2022 and 2030. As a result, the global oligonucleotide API market is predicted to rise from US$ 2.46 billion in 2022 to US$ 5.36 billion by 2030.
According to FMI’s analysis, more than 100 oligonucleotide APIs are currently in clinical studies, with regulatory approval imminent. Following approval, the demand for production capacity will skyrocket, propelling the oligonucleotide API market through 2030.
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Following biologics and molecules, oligonucleotides are viewed as the next significant type of medicines. This could be related to their assurance to develop drugs at a lesser cost.
Apart from immunological therapy, microbial and cardiovascular infections, and cancer, oligonucleotide APIs are also being investigated for the treatment of neurological illnesses such as Alzheimer’s. However, regulatory complications and timely supply of oligonucleotides (amidst Covid-19) are limiting issues.
Key Takeaways from Oligonucleotide API Market Study
- Antisense Oligonucleotide APIs are expected to be worth $4 billion by 2030.
- North America and Europe accounted for more than 47% of total revenue in 2019, with Asia Pacific predicted to expand at the quickest rate over the projection period.
- Increased use of antisense oligonucleotide APIs (particularly after FDA approval in 2016) will drive the market during the projected period.
“Inorganic mode of growth coupled with broad therapeutic applications in gene therapy is expected to bolster the oligonucleotide API market” says the FMI analyst.
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New Product Launches: Key Indicators to Oligonucleotide APIs Market
FMI has analyzed players such as Akcea Therapeutics, Biogen, Sarepta Therapeutics, Jazz Pharmaceuticals, Inc., Alnylam Pharmaceuticals, Inc., and Dynavax Technologies in this report. According to the analysis, these players are consolidating their positions through new product launches.
For instance –
- Dynavax announced a collaboration with Clover Biopharmaceuticals in March 2020 to develop a vaccine candidate to combat Covid-19. Clover is in the advanced stages of testing its Covid-19 S-Trimer, protein-based coronavirus vaccine candidate, and Dynavax has the technical knowledge as well as its patented toll-like receptor 9 (TLR9) agonist adjuvant, CpG 1018, to execute this.
- Givlaari and Onpattro were commercialised in 2018 by Alnylam Pharmaceuticals, Inc.
Gene Therapy and Oligonucleotide APIs
Synthetic oligonucleotides are being used in gene therapy for inactivating genes that help in propagating the disease. Antisense oligonucleotide APIs are used for disrupting the faulty gene’s transcription.
Also, siRNA could be used for signaling the cell to disrupt faulty mRNA’s translation. Along these lines, Pharmamar, in Jan 2020, signed an agreement with Jazz Pharmaceuticals for selling the API for “lurbinectedin”, one of the late-phase treatments for SCLC (small cell lung cancer) so that the latter could commercialize it.
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Key Segments of Oligonucleotide API Industry Survey
Oligonucleotide API Market by API:
- Antisense Oligonucleotides APIs
- Short Interfering RNA (siRNA) APIs
- Phosphorodiamidate Morpholino Oligonucleotides (PMO) APIs
- MiRNA APIs
- Aptamers APIs
- CpG Oligonucleotides APIs
- Others (ON Conjugates (NP), ShRNA, etc.)
Oligonucleotide API Market by Marketing Status:
- Marketed
- Clinical Trials (Clinical Phases)
Oligonucleotide API Market by End User:
- Contract Manufacturing Organizations (CMOs)
- Pharmaceutical Companies
- Biopharmaceutical Companies
- Contract Development & Manufacturing Organizations (CDMOs)
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Future Market Insights, Inc. (ESOMAR certified, Stevie Award – recipient market research organization and a member of Greater New York Chamber of Commerce) provides in-depth insights into governing factors elevating the demand in the market. It discloses opportunities that will favor the market growth in various segments on the basis of Source, Application, Sales Channel and End Use over the next 10-years.
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