An informed estimate of the annual commercial demand for oligonucleotide-based drug products (in grams), 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.

Roots Analysis has announced the addition of the “Oligonucleotide Synthesis, Modification and Purification Services Market: Focus on Research, Diagnostic and Therapeutic Applications, 2020-2030” report to its list of offerings.

In fact, several big pharma companies are known to outsource more than half of their clinical-stage oligonucleotide manufacturing operations. Anticipating a sharp rise in demand, oligonucleotide manufacturers are increasingly consolidating their portfolios, building new capabilities and expanding their respective capacities, mostly through acquisitions, in order to gain a competitive edge.

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Key Market Insights

Presently, there are 270+ trials evaluating a number of oligonucleotide-based interventions

Of these, around 40% are investigating the use of antisense oligonucleotides. Till date, more than 47,000 patients have been enrolled in ongoing / planned trials; majority of them being enrolled in Europe.

Over 80 companies claim to offer manufacturing services, at different scales of operation, for oligonucleotides

The market landscape is currently dominated by the presence of small firms (1-50 employees), which represent close to 50% of the total number of industry stakeholders. This is followed by the larger and more established firms (~32%) and mid-sized players (~20%). More than 40% of service providers claim to operate at all scales of operation.

More than 70% service providers focus on production of oligonucleotides for research and diagnostic applications

However, several players are shifting their focus onto manufacturing oligonucleotides for therapeutic use. It worth highlighting that close to 20% of service providers engaged in this domain claim to offer manufacturing services for research, diagnostic, and therapeutic applications.

Partnership activity has increased at a CAGR of over 60% within this domain, since 2014

Majority of the agreements (40%) were signed to offer manufacturing services to oligonucleotide-based product developers, followed by mergers / acquisitions (21%), aimed at the consolidation of existing service portfolios.

Multiple expansion initiatives were undertaken by service providers, between 2014 and 2019

Over 45% of such initiatives were reported to be focused on expanding manufacturing-related capabilities, followed by building new facilities (25%).

Demand for oligonucleotides is anticipated to grow at a CAGR of 13.3%, during 2020-2030

Given the fact that several oligonucleotide-based drug products were approved in the last 3-4 years, the commercial demand for oligonucleotides is high. Interestingly, over 65% of the estimated commercial demand was observed to have generated from products intended for treating neuromuscular disorders.

The US and EU have emerged as major oligonucleotide manufacturing hubs, both in terms of number of facilities and installed capacity

More than 55 oligonucleotide manufacturers were observed to have facilities in the US and EU. At present, the annual, installed manufacturing capacity in these regions is estimated to represent around 75% of the available global capacity. This is primarily driven by players with commercial scale expertise / capabilities.

Antisense oligonucleotides and siRNAs are anticipated to capture over 70% of the market share. by 2030

Interestingly, the manufacturing services market for miRNAs and other novel oligonucleotides is anticipated to grow at a relatively faster rate during the next decade.

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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?

The ~USD 3.0 billion financial opportunity (by 2030) within the oligonucleotide synthesis, modification and purification services market has been analyzed across the following segments:

• Application
• Research and diagnostics
• Therapeutics

• Type of oligonucleotide manufactured
• Antisense
• miRNA
• siRNA
• Other oligonucleotides

• Scale of Operation
  • Preclinical / Clinical
  • Commercial

• Company Size
• Small
• Mid-sized
• Large

• Target Therapeutic Area
• Oncological disorders
• Ophthalmic disorders
• Metabolic disorders
• Autoimmune disorders
• Other therapeutic areas

• Key geographical regions
  • North America
  • Europe
  • Asia-Pacific
  • Rest of the world

The report features inputs from the eminent industry stakeholders, according to whom the oligonucleotide manufacturing services market is primarily driven by the increasing demand for such molecules for use in diagnostic and therapeutic applications. The report includes detailed transcripts of discussions held with the following experts:

• Joachim Bertram (Chief Scientific Officer and Managing Director, IBA Lifesciences)
• Tobias Pohlmann (Founder and Managing Director, BianoScience)

The research covers detailed profiles, featuring a brief company overview, its financial information (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.

• Agilent Technologies
• Ajinomoto Bio-Pharma Services
• BioSpring
• CordenPharma
• Integrated DNA Technologies
• Kaneka Eurogentec
• LGC Biosearch Technologies
• Microsynth
• Nitto Denko Avecia
• Sigma Aldrich
• Thermo Fisher Scientific
• Trilink Biotechnologies

For additional details, please visit https://www.rootsanalysis.com/reports/view_document/oligonucleotide-synthesis/304.html  or email sales@rootsanalysis.com

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