The Oligonucleotide APIs Market Demand need is expected to rise at a high CAGR of 10.2% between 2022 and 2030 due to increased need for innovative medication classes. As a result, the global Oligonucleotide API market is expected to grow from US$ 2.46 billion in 2022 to US$ 5.36 billion by 2030.
According to FMI’s research, over 100 Oligonucleotide APIs are currently in clinical trials, with regulatory approval on the horizon. Following approval, there will be a surge in demand for production capacity, boosting the Oligonucleotide API market through 2030.
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Following biologics and molecules, Oligonucleotides are thought to be the most important type of medicine. This could be related to their assurance that pharmaceuticals will be developed at a lower cost.
Aside from immunotherapy, microbial and cardiovascular infections, and cancer, Oligonucleotide APIs are being studied for the treatment of neurological diseases like as Alzheimer’s. However, regulatory concerns and the timely availability of Oligonucleotides (in the midst of Covid-19) are limiting factors.
Key Takeaways from Oligonucleotide API Market Study
- By 2030, antisense Oligonucleotide APIs are estimated to be valued $4 billion.
- North America and Europe accounted for more than 47% of total revenue in 2019, with Asia Pacific expected to grow the fastest during the forecast period.
- During the forecast period, the market will be driven by increased usage of antisense Oligonucleotide APIs (especially after FDA approval in 2016).
“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 –
- In March 2020, Dynavax announced a collaboration with Clover Biopharmaceuticals to develop a vaccine candidate to combat Covid-19. Clover is in the advanced phases of testing its protein-based coronavirus vaccine candidate, Covid-19 S-Trimer, and Dynavax has the technical know-how as well as its proprietary toll-like receptor 9 (TLR9) agonist adjuvant, CpG 1018, to carry this out.
- Alnylam Pharmaceuticals, Inc. launched Givlaari and Onpattro in 2018.
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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