The applications of oligonucleotides are vast, even beyond the life science / pharma sector; however, owing to complexities associated with the synthesis and processing of these molecules, such operations are usually outsourced to capable CMOs
The report features an extensive study of the current scenario and future potential of the custom synthesis, modification and purification services market for oligonucleotides, which are intended for research, diagnostic, and therapeutic applications. The study includes in-depth analyses, highlighting the capabilities of service providers engaged in this domain. In addition to other elements, it includes:
· A detailed review of the current status of the market with respect to oligonucleotide manufacturers focused on research and diagnostic, and therapeutic applications.
· A competitiveness analysis of prominent oligonucleotide manufacturers, featuring insightful pictorial summaries and representations.
· Elaborate profiles of key players that offer a diverse range of capabilities for custom synthesis, modification and purification of oligonucleotides.
· An analysis of the various partnerships pertaining to oligonucleotide manufacturing, which have been established in the recent past.
· An analysis of the various expansion initiatives undertaken by service providers engaged in this domain.
· A detailed analysis of completed, ongoing and planned clinical research studies of various oligonucleotide-based drug products.
· An estimate of the overall, annual capacity for manufacturing oligonucleotides based on data reported by industry stakeholders in the public domain.
· An informed estimate of the annual clinical and commercial demand for oligonucleotides.
· A discussion on affiliated trends, key drivers and challenges, under an elaborate SWOT framework.
· A survey analysis featuring inputs solicited from various experts who are directly / indirectly involved in providing custom synthesis, modification and purification services for oligonucleotides.
Chapter 1 is an executive summary of the key insights captured in our research. It offers a high-level view on the likely evolution of the oligonucleotide synthesis, modification and purification services market in the mid to long term.
Chapter 2 presents a general introduction to oligonucleotides, featuring information on the oligonucleotide-based products available in the market. Further, it features a detailed discussion on different steps involved in the custom synthesis, chemical modification and purification of oligonucleotides, along with information on the key challenges that are currently associated with this market. In addition, the chapter includes a brief discussion on the need for outsourcing within the oligonucleotides market. Further, it includes a list of commonly outsourced oligonucleotide synthesis, modification and purification operations, and highlights the key factors that need to be considered while selecting a service provider. The chapter concludes with a discussion on the key growth drivers and roadblocks related to oligonucleotide manufacturing, as well as upcoming trends in this field.
Chapter 3 provides a detailed review of the current status of the market with respect to oligonucleotide manufacturers focused on research and diagnostic applications. The chapter features information on the year of establishment, company size, scale of operation (small, medium, and large), location of headquarters, number of manufacturing facilities, along with their locations (country-wise), and regulatory accreditations and certifications received by them, type of oligonucleotide manufactured (antisense oligonucleotides, aptamers, decoys, miRNA, shRNA, siRNA, specialty amidites, and others), type of offering (custom synthesis, modification and purification), type of manufacturing service(s) offered (process development and characterization, method validation and testing, analytical development, sequencing capabilities, stability studies, quality assurance and control, scale-up, fill/finish, downstream processing, regulatory support, data analytics and reporting, and others), type of modification(s) offered (amino modifiers, backbone modifications, fluorescent probes, dyes and quenchers, modified bases, phosphorylation, thiol modifications, and others), type of purification method(s) used (desalting, cartridge purification, HPLC, ion exchange purification, PAGE, and others), and compliance to cGMP standards.
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