The Global Oligonucleotide API Industry is on track for significant expansion, driven by the increasing demand for new drug classes, according to a recent market analysis. Valued at US$2.81 billion in 2024, the market is expected to rise at a robust Compound Annual Growth Rate (CAGR) of 5.60% over the next decade, reaching a projected US$4.84 billion by 2034.
Based on an analysis by FMI, the current landscape reveals that over 100 oligonucleotide APIs are advancing through clinical trial phases with regulatory approval on the horizon. Post-approval, there is an anticipated surge in the demand for production capacity, thereby propelling the Global Oligonucleotide API Industry’s growth trajectory through 2030.
Oligonucleotides are emerging as a prominent class of therapeutics, following in the footsteps of biologics and small molecules. This shift is attributed to their potential to develop drugs at reduced costs, making them a promising avenue for the pharmaceutical industry.
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Apart from immune therapy, microbial and cardiovascular infections, and cancer, oligonucleotide APIs are being tried out to treat neurological disorders like Alzheimer’s as well. However, factors like regulatory complexities and timely delivery of oligonucleotides (amidst COVID-19) are acting as restraints.
Key Takeaways from Global Oligonucleotide API Industry Study
- Antisense oligonucleotide APIs are anticipated to reach US$ 4.84 Bn by 2034.
- 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 the use of antisense oligonucleotide APIs (especially post-approval from the 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 Global Oligonucleotide API Industry,” says Sabyasachi Ghosh (Associate Vice President at Future Market Insights, Inc.).
New Product Launches: Key Indicators to Global Oligonucleotide API Industry
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 entered into a collaboration with Clover Biopharmaceuticals to develop 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.
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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 to sell the API for “lurbinectedin”, one of the late-phase treatments for SCLC (small cell lung cancer) so that the latter could commercialize it.
Key Segments of Oligonucleotide API Industry Survey:
Global Oligonucleotide API Industry 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.)
Global Oligonucleotide API Industry by Marketing Status:
- Marketed
- Clinical Trials (Clinical Phases)
Global Oligonucleotide API Industry by End User:
- Contract Manufacturing Organizations (CMOs)
- Pharmaceutical Companies
- Biopharmaceutical Companies
- Contract Development & Manufacturing Organizations (CDMOs)
Global Oligonucleotide API Industry by Region:
- North America Oligonucleotide API Market
- Latin America Oligonucleotide API Market
- Europe Oligonucleotide API Market
- East Asia Oligonucleotide API Market
- South Asia & Pacific Oligonucleotide API Market
- Middle East & Africa (MEA) Oligonucleotide API Market
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Global Oligonucleotide API Industry Key Companies Profiled:
- Jazz Pharmaceuticals, Inc.
- Sarepta Therapeutics
- Biogen
- Dynavax Technologies
- Akcea Therapeutics.
- Alnylam Pharmaceuticals, Inc.
Author
Sabyasachi Ghosh (Associate Vice President at Future Market Insights, Inc.) holds over 12 years of experience in the Healthcare, Medical Devices, and Pharmaceutical industries. His curious and analytical nature helped him shape his career as a researcher.
Identifying key challenges faced by clients and devising robust, hypothesis-based solutions to empower them with strategic decision-making capabilities come naturally to him. His primary expertise lies in Market Entry and Expansion Strategy, Feasibility Studies, Competitive Intelligence, and Strategic Transformation.
Holding a degree in Microbiology, Sabyasachi has authored numerous publications and has been cited in journals, including The Journal of mHealth, ITN Online, and Spinal Surgery News.
About Future Market Insights (FMI)
Future Market Insights, Inc. (ESOMAR certified, recipient of the Stevie Award, and a member of the Greater New York Chamber of Commerce) offers profound insights into the driving factors that are boosting demand in the market. FMI stands as the leading global provider of market intelligence, advisory services, consulting, and events for the Packaging, Food and Beverage, Consumer Technology, Healthcare, Industrial, and Chemicals markets. With a vast team of over 400 analysts worldwide, FMI provides global, regional, and local expertise on diverse domains and industry trends across more than 110 countries.
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