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Key Inclusions
§ A detailed review ofthe current status of the market with respect to oligonucleotide manufacturersfocused on research and diagnostic, and therapeutic applications. It featuresinformation on the year of establishment, company size, scale of operation(preclinical, clinical, and commercial), location of headquarters, number ofmanufacturing facilities, along with their locations (country-wise), andregulatory accreditations and certifications received by them, type ofoligonucleotide 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, qualityassurance and control, scale-up, fill/finish, downstream processing, regulatorysupport, data analytics and reporting, and others), type of modification(s)offered (amino modifiers, backbone modifications, fluorescent probes, dyes andquenchers, 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 companycompetitiveness analysis, highlighting prominent oligonucleotide manufacturersfor research and diagnostic, and therapeutic applications, based on supplierstrength (which was calculated by considering the size of employee base of acompany and its experience in this field) and service strength (quantified basedon scale of operation, expertise in manufacturing different types ofoligonucleotides, 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 manufacturingfacilities).
§ Elaborate profiles ofkey players that offer a diverse range of capabilities for custom synthesis,modification and purification of oligonucleotides for use in researchand diagnostic, and therapeutic applications. Each profile includes an overviewof the company, its financial performance (if available), informationrelated to its service portfolio, manufacturing facilities, details onpartnerships, recent developments (expansions), and awards received by thefirm, as well as an informed future outlook.
§ An analysis of thevarious partnerships pertaining to oligonucleotide manufacturing, which have beenestablished since 2014, based on several parameters, such as the year ofpartnership, type of partnership, type of partner, most active players (interms of number of partnerships signed), and a geographical analysis.
§ An analysis of thevarious expansion initiatives undertaken by service providers engaged in thisdomain, in order to augment their respective oligonucleotide manufacturingcapabilities, over the period 2014-2019, taking into consideration severalrelevant parameters, such as year of expansion, type of expansion (capabilityexpansion, capacity expansion, facility expansion and new facility), scale ofoperation (preclinical, clinical and commercial), application (research andmanufacturing operations), and location of manufacturing facility.
§ A detailed analysisof completed, ongoing and planned clinical research studies of variousoligonucleotide-based drug products, highlighting prevalent trends acrossseveral relevant parameters, such as trial registration year, phase ofdevelopment, type of oligonucleotide, current trial recruitment status, studyfocus area, key therapeutic areas (in terms of number of trials undertaken/ conducted), enrolled patient population and trial location, andleading industry and non-industry players (in terms of number of trialsundertaken / conducted).
§ An estimate of theoverall, annual capacity for manufacturing oligonucleotides based on datareported by industry stakeholders in the public domain; it highlights thedistribution of available oligonucleotide synthesis capacity on the basis ofcompany size (small, mid-sized, and large firms), scale of operation(preclinical, clinical and commercial), and key geographical regions (NorthAmerica, Europe, Asia-Pacific and rest of the world).
§ An informed estimateof the annual commercial demand for oligonucleotide-based drug products (inkilograms), taking into account the marketed oligonucleotide products; the analysistakes into consideration the target patient population, dosing frequency anddose strength, of the aforementioned products. The annual clinical demand foroligonucleotide-based drug products was also estimated, taking into accountongoing and planned clinical trials.
§ A discussion onaffiliated trends, key drivers and challenges, under an elaborate SWOTframework, which are likely to impact the industry’s evolution, including aHarvey ball analysis, highlighting the relative effect of each SWOT parameteron the overall industry.
§ A survey analysisfeaturing inputs solicited from various experts who are directly / indirectlyinvolved in providing custom synthesis, modification and purification servicesfor oligonucleotides.
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The report also features the likely distribution of thecurrent and forecasted opportunity across important market segments, mentionedbelow:
§ Custom Manufacturing
§ Large-scale Manufacturing
- Type of Oligonucleotides Manufactured
§ Antisense Oligonucleotides
§ miRNAs
§ shRNAs
§ siRNAs
§ Otheroligonucleotides
- 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
§ NorthAmerica
§ Europe
§ Asia-Pacificand Rest of the World
§ Transcripts ofinterviews held with the following senior level representatives of stakeholdercompanies
§ Joachim Bertram (ChiefScientific Officer and Managing Director, IBA Lifesciences)
§ TobiasPohlmann (Founder and Managing Director, BianoScience)
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KeyQuestions Answered
§ Who are the leading manufacturers of oligonucleotides foruse in research, diagnostic and therapeutic applications?
§ What are the preferred custom synthesis, modification andpurification methods used for oligonucleotides?
§ What are the key challenges faced by oligonucleotidemanufacturers?
§ What kind of partnership models are commonly adopted byindustry stakeholders?
§ What are the recent expansion initiatives undertaken byservice providers within this domain?
§ What is the annual clinical and commercial demand foroligonucleotides?
§ What is the current, installed manufacturing capacity foroligonucleotides?
§ What percentage of oligonucleotide manufacturing operationsare outsourced to service providers?
§ Whatare the opportunities in emerging markets for oligonucleotide manufacturing?
§ How is the current and future market opportunity likely tobe distributed across key market segments?
§ What are the anticipated future trends related tooligonucleotide manufacturing?
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About Roots Analysis
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