Oligonucleotide Synthesis Market Size Worth over USD 13.5 Billion in 2035 | Roots Analysis

Various challenges associated with the development process of oligonucleotides, such as complex stages of manufacturing, limitations of analytical sciences, lack of incentives and the current statutory and regulatory framework, have contributed heavily to the demand for consistent evolution of product development and manufacturing processes.

Furthermore, it is very difficult for the drug / therapy developers to keep up with the latest manufacturing trends and technologies. These difficulties faced by developers are likely to translate into lucrative business opportunities for contract service providers.

According to Roots Analysis, the oligonucleotide synthesis market is anticipated to be worth USD 4.8 billion in 2024, and this value is likely to reach over USD 13.5 billion by 2035, expanding at a CAGR of 9.9%.

Key Report Takeaways

§  Presently, over 110 synthesis providers (established as well as startups) claim to have the necessary capabilities to offer oligonucleotide synthesis services; majority of these firms are based in North America

§  Stakeholders in this domain synthesize various types of oligonucleotides, across different scales of operations; close to 90% of the players offer purification services

§  In pursuit of building a competitive edge in this field, stakeholders are actively upgrading their existing

§  capabilities and adding new competencies to enhance their respective portfolios 

§  Close to 300 clinical trials (with over 75,000 enrolled patients) have been registered to investigate oligonucleotide based-therapeutic products, across different geographies

§  Since 2017, more than 55 deals have been inked between various stakeholders engaged in this domain; acquisitions emerged as the most common type of partnership model

§  To keep pace with the growing demand for oligonucleotides, companies have made elaborate investments to expand their existing capacities and capabilities; this trend is most pronounced in the US and China

§  Several big pharma players have undertaken various initiatives, including partnerships, expansions and funding initiatives; 48% of such initiatives were focused on the development and manufacturing of RNAi oligonucleotides

§  The global, installed oligonucleotide synthesis capacity is spread across various geographies; interestingly, more than 75% of the total capacity is installed at the facilities owned by large and very large players

§  Given the growing complexity of APIs, the demand for oligonucleotides has upsurged; by 2035, it is anticipated to reach around 2,200 kilograms, across clinical and commercial scales

§  Considering the wide array of applications of oligonucleotides and continuous research efforts of stakeholders in this domain, the adoption of these modalities is poised to witness a steady growth in the foreseeable future

§  Driven by the increasing number of chronic indications (requiring novel personalized therapies), and ongoing research on oligonucleotide-based therapeutics, this market is anticipated to grow at a CAGR of 9.9%, till 2035

§  The anticipated future opportunity, in terms of annual service revenues, is expected to be well distributed across segments, such as scale of operation, therapeutic area, end-users, company size, and key geographical regions

Competitive Landscape of Oligonucleotide Synthesis Market

The oligonucleotide synthesis market landscape features 110+ very large, large, mid-sized and small oligonucleotide synthesis offering custom oligonucleotide synthesis, oligonucleotide modification and oligonucleotide purification services, which are intended for research, diagnostic and therapeutic applications. Further, the most adopted modification techniques for oligonucleotides include labeling modifications, backbone modifications and modified bases.

It is worth highlighting that modified bases are locked nucleic acids that can be incorporated into DNA or RNA at multiple sites during synthesis to enhance the therapeutic effect of the product. 

Examples of companies offering modified bases include (arranged in alphabetical order) Eurofins Genomics, Integrated DNA Technologies, LGC Biosearch Technologies and ThermoFisher Scientific. Furthermore, HPLC is the most used technique for oligonucleotides purification, followed by polyacrylamide gel electrophoresis. This can be attributed to the fact that these techniques help to obtain highly pure and premium quality oligonucleotides. In addition, various high throughput RNA/DNA synthesizers are being launched with advanced purification technology to improve yield.

Oligonucleotide Synthesis Market Regional Outlook

Based on the key geographical regions, the oligonucleotide synthesis market can be segmented into four major regions, North America, Europe, Asia Pacific and rest of the world. Majority of the oligonucleotide synthesis providers are headquartered in North America, followed by companies based in Europe. 

Currently, North America and Europe capture around 75% of the market share of the global oligonucleotide synthesis market. In recent years, demand for oligonucleotide-based products in the North America region has witnessed a significant increase owing to increasing R&D investments and number of clinical studies pertaining to the development of oligonucleotides / oligonucleotide-based products. It is worth highlighting that, in the coming years, the market in Asia-Pacific is likely to grow at a higher owing to the lower manufacturing costs, cheap and skilled labor and supportive regulatory landscapes in this region.

Oligonucleotide Synthesis Market Key Players

Examples of key companies engaged in oligonucleotide synthesis market (which have also been profiled in this market report; the complete list of companies is available in the full report) include Agilent Technologies, Ajinomoto Bio-Pharma Services, CordenPharma, Integrated DNA Technologies, Kaneka Eurogentec, LGC Biosearch Technologies, Microsynth, Nitto Avecia, Merck, Thermo Fisher Scientific, TriLink BioTechnologies.

It is interesting to note that in October 2023, Integrated DNA Technologies opened a new therapeutic oligonucleotide manufacturing facility in Iowa, US. The new 41,000 sq ft facility will support customers with new research and manufacturing capabilities and expertise. Such types of developments are expected to drive the demand for oligonucleotides across the globe, resulting in substantial market growth during the forecast period.

Oligonucleotide Synthesis Market Segments

Based on the research, Roots Analysis has segmented the Oligonucleotide Synthesis Market into Application Area, Type of Product Synthesized, Type of Oligonucleotide Synthesized, Scale of Operation, Therapeutic Area, End-users, Company Size and Key Geography Regions.

by Application Area

§  Research and Diagnostics

§  Therapeutics

by Type of Product Synthesized

§  Active Pharmaceutical Ingredients

§  Finished Dosage Forms

by Type of Oligonucleotide Synthesized

§  Antisense

§  DNA

§  siRNA

§  Other Oligonucleotides

by Scale of Operation

§  Clinical

§  Commercial

by Therapeutic Area

§  Cardiovascular Disorders

§  Genetic Disorders

§  Liver Disorders

§  Rare Diseases

§  Other Disorders

by End-users

§  Pharmaceutical / Biopharmaceutical Companies

§  Academic And Research Institutes

§  Hospitals

by Company Size

§  Small

§  Mid-sized

§  Large and Very Large

by Key Geographical Regions

§  North America

§  Europe

§  Asia-Pacific

§  Rest of the World

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