Demand for oligonucleotide APIs is expected to develop at a high CAGR of 10.2% between 2022 and 2030, owing to the growing need for novel 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 the end of 2030.
According to FMI’s analysis, as of now, 100+ oligonucleotide APIs are in the clinical trials’ phase, and regulatory approval is on the cards. Post-approval, the demand for production capacity will witness an exponentiation, thereby driving the oligonucleotide API market through 2030.
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Oligonucleotides are being looked upon as the subsequent large group of therapeutics following biologics and molecules. This could be attributed to the assurance on their part to develop drugs at lower costs.
Apart from immune therapy, microbial and cardiovascular infections, and cancer, oligonucleotide APIs are being tried out to treat neurological disorders like Alzheimer’s as well. However, factors like regulatory complexities and timely delivery of oligonucleotides (amidst Covid-19) are acting as restraints.
Key Takeaways from Oligonucleotide API Market Study
- Antisense Oligonucleotides APIs are anticipated to reach US$ 4 Billion by 2030.
- North America and Europe collectively accounted for more than 47% of revenue share in 2019 while Asia Pacific is expected to grow at the fastest rate in the forecast period.
- Increase in use of antisense oligonucleotide APIs (especially post approval from US FDA in 2016) to boost the market in the forecast 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 –
- In Mar 2020, Dynavax entered into collaboration with Clover Biopharmaceuticals for developing a vaccine candidate to combat Covid-19. Clover is into advanced evaluation of its Covid-19 S-Trimer, protein-based coronavirus vaccine candidate and Dynavax has its technical expertise along with proprietary toll-like receptor 9 (TLR9) agonist adjuvant, CpG 1018 for executing this.
- Alnylam Pharmaceuticals, Inc., in 2018, launched Givlaari and Onpattro at the commercial level.
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)
About FMI:
Future Market Insights (ESOMAR certified 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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