The global oligonucleotide synthesis market was valued at approximately USD 3.71 billion in 2023 and is expected to reach nearly USD 12.88 billion by 2033, expanding at a CAGR of 13.25% between 2024 and 2033.
The oligonucleotide synthesis market is driven by the growing demand for genetic testing, personalized medicine, and advanced therapeutics. Rising investments in RNA-based drugs, increasing applications in diagnostics such as PCR and sequencing, and expanding use in gene editing technologies like CRISPR are fueling growth. Additionally, supportive regulatory approvals and collaborations between pharmaceutical companies and research institutes are accelerating market adoption.
What is Oligonucleotide Synthesis?
Oligonucleotide synthesis is the laboratory-based chemical process of creating short sequences of DNA or RNA, usually ranging from 15 to 200 nucleotides in length. These synthetic molecules act as building blocks of genetic research and have become indispensable in modern biotechnology. Unlike natural DNA or RNA, which are extracted from biological sources, synthetic oligonucleotides can be custom-designed with precise sequences, allowing scientists to target specific genes or regions of interest.
The versatility of oligonucleotides has made them vital in several areas:
- In diagnostics, they are used as primers and probes in PCR and qPCR, helping detect genetic mutations, pathogens, or cancer biomarkers.
- In therapeutics, antisense oligonucleotides, aptamers, and siRNAs are being developed to treat rare genetic disorders, cancers, and viral infections.
- In research and drug discovery, they enable gene editing, CRISPR-based modifications, and functional genomics studies.
Oligonucleotide Synthesis Market Overview
The oligonucleotide synthesis market is gaining strong momentum as demand for advanced genetic tools, diagnostics, and therapeutic solutions continues to expand. Oligonucleotides short sequences of nucleotides are essential for research in molecular biology, diagnostics, gene editing, and increasingly in therapeutic development. Pharmaceutical and biotechnology companies are adopting oligonucleotide-based drugs for conditions ranging from cancer to rare genetic diseases, driving robust investments and innovation across the sector.
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Oligonucleotide Synthesis Market Growth
The market for oligonucleotide synthesis is experiencing rapid expansion as advancements in synthetic biology and precision medicine fuel adoption. Continuous improvements in automated synthesizers, purification technologies, and high-throughput platforms are enhancing scalability and cost-effectiveness, making oligonucleotide-based solutions more accessible to a broader range of applications.
Growing collaborations between pharma companies, contract research organizations (CROs), and academic institutes are further propelling growth. Regulatory approvals for oligonucleotide therapeutics, combined with rising investments in personalized medicine and targeted therapies, are setting the stage for sustained market acceleration.
Oligonucleotide Synthesis Market Trends
- Rising Therapeutic Adoption – The use of oligonucleotide-based drugs in treating genetic, metabolic, and rare diseases is steadily increasing. Regulatory approvals for therapies such as antisense oligonucleotides and siRNA drugs are driving demand for advanced synthesis technologies and scaling up production capabilities.
- Integration with CRISPR and Gene Editing – Oligonucleotides are essential in CRISPR research, acting as guide RNAs and repair templates. With gene editing gaining prominence in both research and therapeutic pipelines, the demand for high-precision, custom oligos continues to rise.
- Automation and High-Throughput Platforms – Modern synthesizers and automated platforms are revolutionizing oligonucleotide production. These systems reduce manual intervention, improve efficiency, and lower costs, making it feasible to produce high-quality oligos at industrial scale.
- Shift Toward Outsourcing – Pharmaceutical and biotech companies are increasingly outsourcing oligonucleotide synthesis to specialized contract manufacturing organizations (CMOs). This trend allows firms to reduce capital expenditure while ensuring access to cutting-edge synthesis capabilities and expertise.
- Expansion of RNA-based Therapeutics – With the success of RNA-based vaccines and therapeutics, there is a surge in interest in RNA oligonucleotides. This trend is opening new opportunities for synthesis providers to support drug discovery and development in infectious diseases, oncology, and neurology.
What is the Maximum Length of Oligonucleotide Synthesis?
The length of synthetic oligonucleotides is an important factor in determining their accuracy and usability. Using standard solid-phase phosphoramidite chemistry, the maximum length achievable is generally 200–300 nucleotides. Beyond this range, the error rate increases because each nucleotide addition step carries a small chance of failure, leading to incomplete or incorrect sequences.
To overcome this limitation, researchers often adopt a modular approach:
- Multiple short oligonucleotides (20–60 bases) are synthesized separately.
- These are then assembled enzymatically (using ligases or polymerases) or through cloning techniques to build longer DNA constructs, sometimes spanning thousands of bases.
- This strategy allows for the creation of large and highly accurate genetic fragments while minimizing synthesis errors. Such methods are crucial in fields like synthetic biology, where scientists build artificial genes, metabolic pathways, and even synthetic genomes.
- Advances in next-generation synthesis platforms and enzymatic DNA synthesis technologies are pushing these boundaries even further, making it possible to produce longer, more accurate oligonucleotides for industrial-scale applications.
What are the Steps of Oligonucleotide Synthesis?
Oligonucleotide synthesis is a highly controlled chemical process that builds DNA or RNA sequences one nucleotide at a time. The most widely used technique is the phosphoramidite method, which allows for precise and automated synthesis on a solid support. Each cycle of synthesis adds one nucleotide to the growing chain until the desired sequence is complete.
Here’s a step-by-step look at the process
- De-blocking (Detritylation): The process begins with a nucleotide attached to a solid support, which is protected by a chemical “cap” called a DMT group (dimethoxytrityl group). This protective group prevents unwanted reactions. In the de-blocking step, the DMT group is removed, exposing a reactive site where the next nucleotide can attach.
- Coupling: The next nucleotide, in the form of an activated phosphoramidite, is introduced. It binds to the exposed site on the growing chain. High efficiency during this step is critical, because incomplete coupling can lead to errors in the final sequence.
- Capping: Not every nucleotide reacts perfectly in the coupling step. To prevent these unreacted strands from continuing in the synthesis cycle and creating “deletion errors,” they are chemically capped. This means inactive strands are blocked from further extension.
- Oxidation: The bond between nucleotides formed during coupling is initially unstable. In this step, the bond is oxidized, converting it into a more stable phosphate linkage.
- Repetition of the Cycle: Steps 1 through 4 (De-blocking → Coupling → Capping → Oxidation) are repeated until the entire oligonucleotide sequence is assembled. Each cycle adds one nucleotide, making the process highly precise but also time-intensive.
- Cleavage and De-protection: Once the full sequence is complete, the oligonucleotide is released from the solid support. At the same time, any remaining protective chemical groups on the bases or backbone are removed.
- Purification and Quality Control: The crude product often contains incomplete strands, chemical by-products, or other impurities. Techniques such as high-performance liquid chromatography (HPLC) or polyacrylamide gel electrophoresis (PAGE) are used to separate and purify the correct sequence. Quality control methods like mass spectrometry verify that the oligonucleotide has the right length and composition.
Oligonucleotide Synthesis Market Dynamics
Drivers
The oligonucleotide synthesis market is primarily driven by the surge in genetic and genomic research across academic, clinical, and industrial sectors. The rapid shift toward precision medicine where treatments are tailored to an individual’s genetic profile is creating strong demand for custom-designed oligonucleotides. Their growing role in diagnostics, including PCR-based tests and next-generation sequencing, further reinforces their importance in modern healthcare. Additionally, the increasing number of clinical trials evaluating antisense oligonucleotides, siRNA therapies, and aptamers reflects growing industry confidence. Successful approvals of oligonucleotide-based drugs are validating their therapeutic potential, thereby attracting investment from pharmaceutical companies and venture capitalists.
Opportunities
The market offers vast opportunities through the expansion of RNA-based therapeutics, especially after the global success of mRNA vaccines. CRISPR and other gene-editing platforms also rely heavily on synthetic oligonucleotides as guide sequences and repair templates, making this field a high-potential growth driver. Moreover, the development of chemically modified oligonucleotides with enhanced stability and delivery efficiency opens doors for novel therapies targeting cancer, neurological, and metabolic diseases. Emerging markets, particularly in Asia-Pacific and Latin America, are strengthening their biotech ecosystems with new research centers and government support. This presents an opportunity for global suppliers and contract research organizations (CROs) to expand services in these regions.
Challenges
Despite strong growth prospects, the oligonucleotide synthesis market faces several hurdles. High production costs remain a barrier, particularly for large-scale therapeutic applications, as longer sequences are prone to synthesis errors requiring extensive purification. The industry also navigates complex regulatory frameworks, since oligonucleotide-based drugs are relatively new and require rigorous safety and efficacy validation. Scaling up from laboratory-scale synthesis to commercial manufacturing continues to be technically challenging. Intellectual property (IP) disputes over sequence design, synthesis methods, and delivery technologies add another layer of complexity. Furthermore, the market faces competition from alternative modalities such as gene therapy, cell therapy, and monoclonal antibodies, which may compete for investment and adoption in certain therapeutic areas.
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Applications in the Market
Oligonucleotide synthesis has become a cornerstone across diagnostics, therapeutics, and research in the life sciences. In diagnostics, oligonucleotides are used as primers and probes in PCR, qPCR, and next-generation sequencing (NGS) to accurately detect infectious diseases, genetic disorders, and cancers. In therapeutics, synthetic oligonucleotides such as antisense oligonucleotides (ASOs), small interfering RNAs (siRNAs), and aptamers are being developed as direct treatment agents, offering targeted approaches for rare genetic conditions and neurodegenerative diseases. Beyond healthcare, they play a vital role in research and biotechnology, serving as indispensable tools in cloning, mutagenesis, CRISPR-based gene editing, and synthetic biology. Their ability to be custom-designed makes them invaluable for studying gene functions, protein interactions, and for driving innovation in genomics and personalized medicine.
Case Study: Spinraza – A Breakthrough in Rare Disease Therapy
One of the most notable breakthroughs in oligonucleotide therapeutics is Spinraza (Nusinersen), developed for treating spinal muscular atrophy (SMA), a rare and often fatal genetic disorder. Approved by the FDA in 2016, Spinraza became the first commercially available antisense oligonucleotide drug.
Its success demonstrated the real-world therapeutic potential of oligonucleotides, not only validating decades of research but also encouraging pharmaceutical companies and biotech startups to invest heavily in RNA-based drug pipelines. Today, inspired by Spinraza’s impact, multiple oligonucleotide therapies are being developed for oncology, neurology, and rare genetic conditions.
Read More: https://www.heathcareinsights.com/us-non-alcoholic-steatohepatitis-biomarkers-market/
Oligonucleotide Synthesis Market Key Players
Thermo Fisher Scientific, Inc.
Merck KGaA
Danaher Corporation
Dharmacon Inc.
Agilent Technologies
Bio-synthesis
Kaneka Eurogentec S.A
LGC Biosearch Technologies
Biolegio
Twist Bioscience
Oligonucleotide Synthesis Market Segmentation
By Product & Service
- Oligonucleotides
- DNA
- Column-based
- Array-based
- DNA
- RNA
- By Technology
- Column-based
- Array-based
- By Type
- Short RNA Oligos (<65 nt)
- Long RNA Oligos (>65 nt)
- CRISPR (sgRNA)
- By Technology
- Equipment/Synthesizer
- Reagents
- Services
- DNA
- Custom Oligo Synthesis Services
- 25 nmol
- 50 nmol
- 200 nmol
- 1000 nmol
- 10000 nmol
- Modification Services
- Purification Services
- Custom Oligo Synthesis Services
- RNA
- Custom Oligo Synthesis Services
- 25 nmol
- 100 nmol
- 1000 nmol
- 10000 nmol
- Custom Oligo Synthesis Services
- DNA
- Modification Services
- Purification Services
By Application
- PCR Primers
- Academic Research Institutes
- Diagnostic Laboratories
- Pharmaceutical – Biotechnology Companies
- PCR Assays & Panels
- Academic Research Institutes
- Diagnostic Laboratories
- Pharmaceutical – Biotechnology Companies
- Sequencing
- Academic Research Institutes
- Diagnostic Laboratories
- Pharmaceutical – Biotechnology Companies
- DNA Microarrays
- Academic Research Institutes
- Diagnostic Laboratories
- Pharmaceutical – Biotechnology Companies
- Fluorescence In Situ Hybridization (FISH)
- Academic Research Institutes
- Diagnostic Laboratories
- Pharmaceutical – Biotechnology Companies
- Antisense Oligonucleotides
- Academic Research Institutes
- Diagnostic Laboratories
- Pharmaceutical – Biotechnology Companies
- Other Applications
By Region
- North America
- Europe
- Asia Pacific
- Latin America
- Middle East and Africa (MEA)
Future Outlook
The future of the oligonucleotide synthesis market looks highly promising, driven by rapid advancements in medicine, technology, and global biotech investments. The success of mRNA vaccines and RNA-targeted therapies has placed RNA oligonucleotides at the center of pharmaceutical innovation, with upcoming treatments expected to address cancers, viral infections, and metabolic disorders. At the same time, the ability to design oligonucleotides tailored to a patient’s genetic profile is paving the way for personalized and precision medicine, offering new hope for rare disease management and complex conditions.
Continuous improvements in synthesis technologies, including automation, high-throughput platforms, and enzymatic DNA/RNA synthesis, are expected to reduce costs while enhancing accuracy, making these products more widely accessible. Furthermore, strong investments in genomics and biotech infrastructure across Asia-Pacific and Latin America, combined with collaborations between global pharma companies and regional biotech firms, will support significant market expansion worldwide.
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