Oligonucleotide Synthesis Market

Oligonucleotide Synthesis Market Overview

The oligonucleotide synthesis market is estimated to be worth $2.2 billion and is expected to grow at CAGR of 17.8% during the forecast period. Post the marketing of Vitravene®, the first antisense oligonucleotide-based therapy to receive approval (in 1998), various stakeholders have undertaken multiple research initiatives to verify the potential of oligonucleotides as therapeutic agents. The known applications of oligonucleotides in research and diagnostics, in addition to their therapeutic use, have significantly increased. It is worth mentioning that these molecules play a crucial role in genetic testing, molecular testing protocols and various analytical testing procedures, such as artificial gene synthesis and polymerase chain reaction. In fact, several preclinical and clinical studies have demonstrated the potential of oligonucleotides as a safe and effective treatment modality, owing to their unique characteristics, such as high target specificity and superior pharmacokinetic profile. , As a result, over 14 oligonucleotide-based therapies have been approved till date. Notable examples of recently approved products include (in reverse chronological order of year of approval) AMONDYS 45 (2021), Oxlumo™ (2020) and Viltepso™ (2020). Further, over 350 oligonucleotide-based therapies are currently being evaluated across different development stages.

Oligonucleotides are usually manufactured using chemical synthesis approaches, such as phosphoramidite synthesis and solid-phase synthesis (used for manufacturing small molecules). Given to the intricacy of the aforementioned synthesis procedures, production of synthetic oligonucleotides is often associated with several challenges, such as lack of purification and analytical expertise among the stakeholders. Presently, a significant portion of the existing manufacturing capabilities and expertise in oligonucleotide synthesis market belong to contract service providers. Therefore, several researchers and therapy / diagnostic developers engaged in oligonucleotide synthesis market prefer to outsource their oligonucleotide manufacturing operations. Moreover, with the rise in global disease burden, there has been an increase in the demand for effective targeted therapies. Specifically, post the onset of the COVID-19 pandemic, there has been a significant rise in the demand for oligonucleotides, given their use in COVID-19 testing kits. Consequently, contract service providers are expanding their existing capacities and capabilities in order to cater to the growing demand. In addition, we believe that encouraging clinical trial results and extensive research activity related to oligonucleotides, coupled to their growing demand, is likely to result in lucrative market growth opportunities for custom / contract service providers, during the forecast period.

Key Oligonucleotide Manufacturers in Oligonucleotide Synthesis Market 

Examples of key oligo synthesis companies engaged in synthesis, modification and purification of oligonucleotides (which have also been profiled in this market report; the complete list of oligo synthesis companies is available in the full report) include Ajinomoto Bio-Pharma Services, Integrated DNA Technologies, Sigma Aldrich, Thermo Fisher Scientific, Kaneka Eurogentec, Microsynth, Sumitomo Chemical, Agilent Technologies, Nitto Denko Avecia, TriLink Biotechnologies, CordenPharma, LGC, Biosearch Technologies, Lonza and STA Pharmaceutical. This oligonucleotide synthesis market report includes an easily searchable excel database of all the oligonucleotide manufacturers, worldwide.

Recent Developments in Oligonucleotide Synthesis Market:

Several recent developments have taken place in the field of oligonucleotide synthesis. We have outlined some of these recent initiatives below. These developments, even if they took place post the release of our market report, substantiate the overall market trends that have been outlined in our analysis.

• In March 2023, Centre for Process Innovation, AstraZeneca, Novartis, and The University of Manchester entered into a collaboration in order to facilitate large-scale manufacturing of oligonucleotides for the total amount of EUR 2.77 million. 
• In March 2023, Ansa Biotechnologies announced the successful de novo synthesis of the world’s longest DNA oligonucleotide at 1,005 bases in a single synthesis. 
• In January 2023, Aurisco entered into a collaboration with Cytiva with an aim to build its first Oligo FlexFactory platform for commercial production of nucleotides.

Scope of the Report

The “Oligonucleotide Synthesis Market: Focus on Research, Diagnostic and Therapeutic Applications (2nd Edition), Distribution by Type of Manufacturing (Custom Manufacturing and Contract Manufacturing), Type of Oligonucleotide Manufactured (Antisense, siRNA, shRNA, miRNA and Others), Scale of Operation (Clinical and Commercial), Purpose of Production (In-house Operations and Outsourced Operations), Type of Operation (API and FDF), Size of Manufacturer (Small, Mid-sized and Large), Key Therapeutic Areas (Autoimmune Disorders, Cardiovascular Disorders, Genetic Disorders, Infectious Diseases, Metabolic Disorders, Neuromuscular Disorders, Oncological Disorders, Ophthalmic Disorders, And Other Therapeutic Areas) and Key Geographical Regions  (North America, Europe, Asia-Pacific and Rest of the World): Industry Trends and Global Forecasts, 2021-2035” market report features a detailed study of the current market landscape, market size, market share, market forecast, market outlook and future opportunities for the oligonucleotide synthesis market. Further, the market research report underlines an in-depth analysis, highlighting the capabilities of service providers engaged in oligonucleotide synthesis market. In addition to other elements, the market research report covers:

• A detailed overview of the current market landscape of oligonucleotide manufacturers focused on research and diagnostic and therapeutic applications, based on several relevant parameters, such as year of establishment, company size, scale of operation (preclinical, clinical, and commercial), location of headquarters, number of manufacturing facilities, along with information on the location of facility (country-wise), regulatory accreditations and certifications received, type of oligonucleotide manufactured (antisense oligonucleotides, aptamers, decoys, miRNA, shRNA, siRNA, specialty amidites and others), type of offering (custom oligonucleotide 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, fill / finish, 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) and type of purification method(s) used (desalting, cartridge purification, HPLC, ion exchange purification, PAGE and others).
• An insightful company competitiveness analysis, highlighting the key oligonucleotide manufacturers focused on research and diagnostic, and therapeutic applications, based on supplier strength (on the basis of size of employee base and its experience) and service strength (on the basis of scale of operation, type of oligonucleotide manufactured, type of offering, type of manufacturing service(s) offered, type of modification(s) offered, type of purification method(s) used, and number and location of manufacturing facilities).
• Elaborate profiles of key players engaged in offering custom oligonucleotide synthesis, modification and purification of oligonucleotides for 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 inked, recent developments and an informed future outlook.
• A qualitative analysis highlighting the various factors that need to be considered by players engaged in oligonucleotide synthesis market, while deciding whether to manufacture their respective products in-house or engage the services of a service provider.
• A detailed review of the various oligonucleotide-based manufacturing initiatives undertaken by big pharma players (on the basis of revenues generated by top 5 pharmaceutical companies in 2020), highlighting trends across parameters, such as year of initiative, type of initiative and type of oligonucleotide.
• An analysis of recent partnerships inked between players engaged in oligonucleotide manufacturing, during the period 2014-2021, based on several parameters, such as year of partnership, type of partnership, type of partner, most active players (in terms of number of partnerships signed), and region.
• An analysis of the various expansion initiatives undertaken by service providers engaged in oligonucleotide synthesis market, during the period 2016-2021, along with information on 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), type of application (research and manufacturing operations), and location of manufacturing facility. 
• An in-depth analysis of over 90 oligonucleotide-based therapy developers that are likely to partner with contract service providers engaged in oligonucleotide synthesis market, based on several relevant parameters, such as developer strength (on the basis of company size and its experience), pipeline strength and maturity (on the basis of number of drugs in pipeline and their stage of development) and other manufacturing capabilities.
• A detailed analysis of completed and ongoing clinical research studies of various oligonucleotide-based drugs, based on 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 global, installed capacity for the manufacturing of oligonucleotides, based on information provided by various industry stakeholders in the public domain. It also features 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 drugs (in kilograms), based on several relevant parameters, such as target patient population, dosing frequency and dose strength. The annual clinical demand for oligonucleotide-based drug products was also estimated, taking into account ongoing clinical trials.
• An elaborate discussion on how the recent COVID-19 pandemic is likely to impact the oligonucleotide synthesis market, along with information on the key initiatives undertaken by players engaged in oligonucleotide synthesis market to overcome the challenges faced due to the pandemic.
• 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 oligonucleotide synthesis, modification and purification services for oligonucleotides.

The key objective of oligonucleotide synthesis market report is to provide a detailed market analysis in order to estimate the existing market size, market value, statistics and future opportunity for oligonucleotide synthesis market during the forecast period. Based on multiple parameters, such as anticipated growth in number of oligonucleotide-focused projects, cost of goods sold, and direct manufacturing costs, we have developed informed estimates of the likely evolution of the market over the forecast period. Additionally, the market report features the likely distribution of the current and forecasted opportunity across [A] type of manufacturing (custom manufacturing, and contract manufacturing), [B] type of oligonucleotide manufactured (antisense oligonucleotides, miRNA, shRNA, siRNA, and others), [C] scale of operation (clinical and commercial), [D] purpose of production (in-house operations and outsourced operations), [E] type of operation (active pharmaceutical ingredient (API) and finished dosage form (FDF)) [F] size of manufacturer (small, mid-sized, and large companies), [G] key therapeutic areas (autoimmune disorders, cardiovascular disorders, genetic disorders, infectious diseases, metabolic disorders, neuromuscular disorders, oncological disorders, ophthalmic disorders, and other therapeutic areas), and [H] key geographical regions (North America, Europe, and Asia-Pacific and rest of the world). In order to account for the uncertainties associated with the growth of the oligonucleotide synthesis, modification and purification services market and to add robustness to our model, we have provided three market forecast scenarios, portraying the conservative, base and optimistic tracks of the market’s evolution.

The opinions presented in this market report were influenced by inputs (through an industry-wide survey) of several key players in oligonucleotide synthesis market. In addition, the market research report features detailed transcripts of interviews held with the following individuals:

• Arun Shastry (Co-Founder and Managing Director, Hanugen Therapeutics)
• Hans-Peter Vornlocher (Managing Director, Axolabs)
• Joachim Bertram (Chief Scientific Officer and Managing Director, IBA Life Sciences)
• Tobias Pohlmann (Founder and Managing Director, BianoScience)

All actual figures have been sourced and analyzed from publicly available information forums and primary research discussions. Financial figures mentioned in this market research report are in USD, unless otherwise specified.

Frequently Asked Questions

Question 1: What is oligonucleotide synthesis?

Answer: Oligonucleotide synthesis refers to the chemically driven synthesis of short fragments of nucleic acid molecules with defined chemical structures for gene therapy or gene cloning applications.

Question 2: How oligonucleotide synthesis market size?

Answer: The oligonucleotide synthesis market size is estimated to be worth $2.2 billion in 2021.

Question 3: What is the projected market growth of the oligonucleotide synthesis market?

Answer: The oligonucleotide synthesis market is expected to grow at compounded annual growth rate (CAGR) of over 17.8% during the forecast period.

Question 4: Who are the leading oligonucleotide manufacturers in the oligonucleotide synthesis market?

Answer: Examples of key companies engaged in oligonucleotide synthesis (which have also been profiled in this market report; the complete list of companies is available in the full report) include Ajinomoto Bio-Pharma Services, Integrated DNA Technologies, Sigma Aldrich, Thermo Fisher Scientific, Kaneka Eurogentec, Microsynth, Sumitomo Chemical, Agilent Technologies, Nitto Denko Avecia, TriLink Biotechnologies, CordenPharma, LGC, Biosearch Technologies, Lonza and STA Pharmaceutical.

Question 5: How many companies are currently engaged in the oligonucleotide synthesis market?

Answer: Over 90 oligonucleotide manufacturers are currently engaged in the oligonucleotide synthesis market.

Question 6: How many companies are engaged in developing oligonucleotide therapeutics?

Answer: More than 95 companies are currently engaged in developing oligonucleotide based therapeutics.

Question 7: How many oligonucleotide therapeutics have been approved till date?

Answer: Till date, over 14 oligonucleotide therapeutics have been approved, including AMONDYS 45, Oxlumo™ and Viltepso™.