Oligonucleotide Synthesis, Modification and Purification Services Market

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Key Inclusions

• A detailed review of the current status of the market with respect to oligonucleotide manufacturers focused on research and diagnostic, and therapeutic applications. It features information on the year of establishment, company size, scale of operation (preclinical, clinical, and commercial), 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.
• A company competitiveness analysis, highlighting prominent oligonucleotide manufacturers for research and diagnostic, and therapeutic applications, based on supplier strength (which was calculated by considering the size of employee base of a company and its experience in this field) and service strength (quantified based on scale of operation, expertise in manufacturing different types of oligonucleotides, type of offering, type of manufacturing service(s) offered, type of modification(s) offered, type of purification method(s) used, compliance to cGMP standards, as well as number and location of manufacturing facilities).
• Elaborate profiles of key players that offer a diverse range of capabilities for custom synthesis, modification and purification of oligonucleotides for use in research and diagnostic, and therapeutic applications. Each profile includes an overview of the company, its financial performance (if available), information related to its service portfolio, manufacturing facilities, details on partnerships, recent developments (expansions), and awards received by the firm, as well as an informed future outlook.
• An analysis of the various partnerships pertaining to oligonucleotide manufacturing, which have been established since 2014, based on several parameters, such as the year of partnership, type of partnership, type of partner, most active players (in terms of number of partnerships signed), and a geographical analysis.
• An analysis of the various expansion initiatives undertaken by service providers engaged in this domain, in order to augment their respective oligonucleotide manufacturing capabilities, over the period 2014-2019, taking into consideration several relevant parameters, such as year of expansion, type of expansion (capability expansion, capacity expansion, facility expansion and new facility), scale of operation (preclinical, clinical and commercial), application (research and manufacturing operations), and location of manufacturing facility.
• A detailed analysis of completed, ongoing and planned clinical research studies of various oligonucleotide-based drug products, highlighting prevalent trends across several relevant parameters, such as trial registration year, phase of development, type of oligonucleotide, current trial recruitment status, study focus area, key therapeutic areas (in terms of number of trials undertaken / conducted), enrolled patient population and trial location, and leading industry and non-industry players (in terms of number of trials undertaken / conducted).
• An estimate of the overall, annual capacity for manufacturing oligonucleotides based on data reported by industry stakeholders in the public domain; it highlights the distribution of available oligonucleotide synthesis capacity on the basis of company size (small, mid-sized, and large firms), scale of operation (preclinical, clinical and commercial), and key geographical regions (North America, Europe, Asia-Pacific and rest of the world).
• An informed estimate of the annual commercial demand for oligonucleotide-based drug products (in kilograms), taking into account the marketed oligonucleotide products; the analysis takes into consideration the target patient population, dosing frequency and dose strength, of the aforementioned products. The annual clinical demand for oligonucleotide-based drug products was also estimated, taking into account ongoing and planned clinical trials.
• A discussion on affiliated trends, key drivers and challenges, under an elaborate SWOT framework, which are likely to impact the industry’s evolution, including a Harvey ball analysis, highlighting the relative effect of each SWOT parameter on the overall industry.
• A survey analysis featuring inputs solicited from various experts who are directly / indirectly involved in providing custom synthesis, modification and purification services for oligonucleotides.

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The report also features the likely distribution of the current and forecasted opportunity across important market segments, mentioned below:

• Type of Manufacturing 
• Custom Manufacturing
• Large-scale Manufacturing 
• Type of Oligonucleotides Manufactured
• Antisense Oligonucleotides
• miRNAs
• shRNAs
• siRNAs
• Other oligonucleotides
• Scale of Operation
• Clinical
• Commercial
• Purpose of Production
• In-house
• Outsourced
• Target Therapeutic Area
• Autoimmune Disorders 
• Cardiovascular Disorders
• Genetic Disorders
• Infectious Diseases
• Metabolic Disorders
• Neuromuscular Disorders
• Oncological Disorders
• Ophthalmic Disorders
• Other Therapeutic Areas
• Size of manufacturer
• Small
• Mid-sized
• Large
• Key Geographical Region 
• North America
• Europe
• Asia-Pacific and Rest of the World

• Transcripts of interviews held with the following senior level representatives of stakeholder companies

• Joachim Bertram (Chief Scientific Officer and Managing Director, IBA Lifesciences)

• Tobias Pohlmann (Founder and Managing Director, BianoScience)

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Key Questions Answered

• Who are the leading manufacturers of oligonucleotides for use in research, diagnostic and therapeutic applications?
• What are the preferred custom synthesis, modification and purification methods used for oligonucleotides?
• What are the key challenges faced by oligonucleotide manufacturers?
• What kind of partnership models are commonly adopted by industry stakeholders?
• What are the recent expansion initiatives undertaken by service providers within this domain?
• What is the annual clinical and commercial demand for oligonucleotides?
• What is the current, installed manufacturing capacity for oligonucleotides?
• What percentage of oligonucleotide manufacturing operations are outsourced to service providers?
• What are the opportunities in emerging markets for oligonucleotide manufacturing?
• How is the current and future market opportunity likely to be distributed across key market segments?
• What are the anticipated future trends related to oligonucleotide manufacturing?

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