In the 20th century, major research went into discovery of a therapeutic class with the primary purpose of interfering with the RNA expression linked to disease causing proteins, nowadays classified as oligonucleotides. These short, single-stranded DNA or RNA molecules have various applications in biopharmaceutical and biotechnology industries including, genetic testing, basic research, forensic analysis and other analytical procedures. Till date, 14 oligonucleotide-based therapies have been approved. Notable examples of recently approved therapies include (in reverse chronological order of year of approval) AMONDYS 45 (2021), Oxlumo™ (2020) and Viltepso™ (2020). Post the onset of the COVID-19 pandemic, a significant surge in the demand for oligonucleotide-based testing kits has been observed. As a result, contract service providers are expanding their existing capacities and capabilities, that is likely to result in lucrative opportunities for their services, in the foreseen future.
Recent Activity in the Oligonucleotide Domain
The current landscape consists of more than 95 players that claim to offer oligonucleotide contract manufacturing services for research, diagnostic and therapeutic applications. These contract service providers are actively entering into strategic collaborations to augment their existing portfolios. Further, a number of expansion initiatives are being undertaken by several biopharmaceutical big pharma players, in order to enhance their capabilities in this rapidly evolving domain. Majority of the partnerships inked in this domain were observed to be focused on manufacturing and supply of oligonucleotide-based therapies, followed by mergers and acquisitions. The US has emerged as a prominent region in terms of partnerships and expansion activity in this domain. It is worth highlighting that most of the initiatives were carried out for the establishment of new facilities.
Current Global Capacity for Oligonucleotide Synthesis
Of the total global oligonucleotide synthesis capacity, around 87% of the capacity is being installed in large companies owing to multiple facilities across several locations. Further, majority of the capacity is dedicated for commercial operations, followed by preclinical / clinical operations. It is worth highlighting that major share of the global oligonucleotide manufacturing capacity is installed in North America, primarily in the US. Companies based in Asia-Pacific are increasingly undertaking initiatives in order to expand their manufacturing capacities.
Evolving Demand for Oligonucleotide-based Therapies
The global manufacturing demand for oligonucleotide-based therapies is expected to grow at an annual growth rate of 10.5% by 2031. Antisense oligonucleotides are likely to capture the highest share of the overall commercial demand. Moreover, by 2031, majority of the commercial demand is anticipated to be generated by oligonucleotides intended for neuromuscular disorders. From secondary research, it has been inferred that during the forecast period, the current supply is sufficient to cater to the demand, and the trend is unlikely to differ in the future. Nevertheless, stakeholders are rapidly installing additional capacities to ensure a consistent supply of oligonucleotides.
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