Oligonucleotide Synthesis Market Analysis North America, Europe, Asia, Rest of World (ROW) - US, Canada, Germany, China, Japan - Size and Forecast 2024-2028

Oligonucleotide Synthesis Market Size 2024-2028

The global oligonucleotide synthesis market size is estimated to grow by USD 3.37 billion at a CAGR of 13.54% between 2023 and 2028.

The expanding field of RNA-based therapeutics, encompassing mRNA vaccines, siRNAs, ASOs, and microRNAs, relies heavily on custom-designed oligonucleotides produced through oligonucleotide synthesis. The commercialization of RNA-based drugs, exemplified by mRNA vaccines like those for COVID-19 from BioNTech, underscores the significance of the market. RNAi therapies, employing siRNAs or shRNAs to silence specific genes, represent another promising avenue, necessitating custom synthesis. For instance, Sarepta Therapeutics Inc. utilizes PMO chemistries to develop DMD therapies, with their PPMOs designed for enhanced tissue penetration. This paradigm shift toward RNA-based therapeutics is poised to drive substantial growth in the market.

What will be the size of the Market During the Forecast Period?

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Segmentation by Application, End-user, and Geography Analysis

In the market, advancements in synthetic biology drive innovation, with genome projects fueling therapeutic developments targeting genetic disorders. Solid-phase synthesis techniques enable precise construction of nucleotide chains containing adenine, cytosine, guanine, thymine, and uracil. Phosphate group and sugar molecule are fundamental components, alongside nitrogenous base, forming the building blocks for next-generation therapeutic drugs. This market thrives on breakthroughs in therapeutic drugs and nucleotides, enhancing treatment options for various genetic conditions.

Application Analysis

The market share growth by the PCR primers segment will be significant during the forecast period. PCR primers are short oligonucleotide sequences that are designed to bind to specific target DNA sequences and initiate the amplification process in PCR reactions. They serve as essential components in PCR-based applications, including gene expression analysis, DNA sequencing, mutation detection, and genotyping. 

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The PCR primers segment was valued at USD 499.37 million in 2018. The demand for PCR primers is particularly high in high-throughput applications, such as large-scale genotyping or DNA sequencing projects. Oligonucleotide synthesis companies are equipped to handle the synthesis of a large number of PCR primers simultaneously to support these high-throughput applications. The growth of the PCR primers segment in the market is projected to benefit from these factors over the forecast period.

End-user Analysis

Oligonucleotide synthesis finds significant applications in pharmaceutical and biotechnology companies, particularly in the development of oligonucleotide therapeutics. These companies are actively researching various oligonucleotide-based treatments, including siRNA therapy, antisense oligonucleotide therapy, miRNA therapy, aptamer therapy, and CpG oligonucleotide therapy. Regulatory approvals from agencies like the FDA and EMA have spurred the focus on oligonucleotide therapies, making pharmaceutical and biotech companies major users of oligonucleotide synthesis products and services. The rising number of drug-related research and clinical trials globally is expected to drive market growth in the coming years.

Increased demand for oligonucleotide synthesis stems from its expanding applications in research and academic institutes, driven by advancements in molecular biology. The rise in clinical developments, with around 80 oligonucleotide therapies in progress in 2022, intensifies demand from research institutes. Market players like Alnylam Pharmaceuticals Inc. are collaborating with academic institutions to enhance genomic studies, fostering oligonucleotide-based research. Additionally, rising investments in synthetic biology for advanced therapeutics by both private and governmental entities further propel oligonucleotide research, stimulating market growth.

Regional Analysis

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North America is estimated to contribute 40% to the growth of the global market during the forecast period. Technavio’s analysts have elaborately explained the regional trends and drivers that will shape the market during the forecast period. North America dominates the regional market, with the US leading the regional market.  The adoption of synthetic nucleic acids for research, therapeutic applications, and diagnosis is driven by the presence of a leading market. Market players in the US are using advanced technologies and methodologies to meet the growing demand for oligonucleotides. 

Additionally, the growing approval of oligonucleotide therapies by the US FDA has eased the commercial availability of these treatments in North America. Most oligonucleotide therapies are focused on the treatment of rare diseases such as Homozygous Familial Hypercholesterolemia and DMD. In other countries of North America, including Canada, oligonucleotide therapies such as Exondys 51 for DMD are under clinical trials. The growing prevalence of rare diseases has increased the demand for oligonucleotide therapies in the region during the forecast period. 

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Key Market Players 

Companies are implementing various strategies, such as strategic alliances, partnerships, mergers and acquisitions, geographical expansion, and product/service launches, to enhance their presence in the market. The report also includes detailed analyses of the competitive landscape of the market and information about 20 market companies, including:

• Agilent Technologies Inc.: The company offers oligonucleotide synthesis products such as SurePrint HiFi for the production of completely custom oligo pools in rapid turnaround times.

Ajinomoto Bio Pharma. , Alnylam Pharmaceuticals Inc., Amgen Inc., Ansa Biotechnologies, Bio Synthesis Inc, Biogen Inc., Biotage AB, Danaher Corp., Eurofins Scientific SE, General Electric Co., Ionis Pharmaceuticals Inc., Kaneka Corp., LGC Science Group Holdings Ltd., Merck KGaA, Mettler Toledo International Inc., QIAGEN NV, Sarepta Therapeutics Inc., Synbio Technologies, Syngene International Ltd., and Thermo Fisher Scientific Inc.

Qualitative and quantitative analysis of companies has been conducted to help clients understand the wider business environment as well as the strengths and weaknesses of key market players. Data is qualitatively analyzed to categorize companies as pure play, category-focused, industry-focused, and diversified; it is quantitatively analyzed to categorize companies as dominant, leading, strong, tentative, and weak.

Market Dynamics and Customer Landscape

The market is propelled by advancements in synthetic biology and genome projects, enabling targeted therapies for genetic disorders. RNA plays a pivotal role, with nucleotides like adenine, cytosine, guanine, thymine, and uracil forming the building blocks. Solid-phase synthesis techniques facilitate the creation of precise nucleotide chains, crucial for gene therapy and antisense therapy. Therapeutic breakthroughs target conditions such as Duchenne Muscular Dystrophy (DMD), cystic fibrosis, and thrombotic thrombocytopenic purpura. Vector technologies aid in delivery, while interference RNA offers novel treatment avenues. The market thrives on innovation, harnessing phosphate groups and sugar molecules like deoxyribose and ribose to develop next-generation therapeutic drugs. Our researchers analyzed the market research and growth data with 2023  as the base year, along with the key market growth analysis, trends, and challenges. A holistic analysis of drivers, trends, and challenges will help companies refine their marketing strategies to gain a competitive advantage. 

Key Market Drivers

Increasing use as therapeutic and diagnostic tools is the key factor driving the market. Genetic diagnosis of targets, peptides, small molecules, and proteins are some applications where oligonucleotide biosensors are considerably used. This has broadened the applications of oligonucleotides in the healthcare and medical sectors, specifically for in vitro diagnosis of infectious diseases such as respiratory tract infections (including tuberculosis and influenza), hepatitis, and encephalitis, using PCR amplification and microarray-based methodologies.

Additionally, the high prevalence of infectious diseases has surged the demand for performing DNA microarray, transcription-mediated amplification (TMA), and nucleic acid sequence-based amplification, which is used in in vitro diagnosis of these diseases. This has surged the demand for oligonucleotide synthesis in diagnostic laboratories. Further, the market is observing a rising demand from the pharmaceutical and biotechnology sectors owing to the increasing commercial approval of oligonucleotide therapies by authorities such as the US FDA and EMA. Thus, the growing commercial availability of oligonucleotide therapies is expected to drive market growth during the forecast period.

Significant Market Trends

The rise in demand for low-cost and high-throughput oligonucleotide synthesis is a primary trend in the market. The large-scale production of desired gene sequences at a lower cost could contribute to rapid progress in both fundamental and applied biological research.  The costs of gene synthesis are directly proportional to the cost since genetic material is made from oligonucleotides. The reduction of the process costs makes it possible to generate a more efficient set of gene data. Hence, there is an increasing demand for techniques and technologies that allow the synthesis of oligonucleotides and their assembly into larger DNA constructs with increased sequence fidelity at a reduced cost.

Additionally, automated methods have become more common, such as the synthesis of oligonucleotides with Computer Controlled Instruments for Solid Phase Support. The major costs of gene synthesis are also associated with reagents that are applied. Hence, there is an increasing demand for approaches and tools that reduce reagent consumption, enhance the robustness and accuracy of the gene assembly process, and increase throughput in oligonucleotide synthesis. Such factors are expected to drive the growth of the market during the forecast period.

Major Market Challenges

The diversity in oligonucleotide molecules is a major challenge that impedes market growth. Oligonucleotides are larger molecules than traditional small molecules used in therapeutics. Effective uptake of oligonucleotides in a targeted location decides the success of drug candidates. However, the diversity within the classes of therapeutics in terms of the size of the molecule and range of chemical modification necessitates careful consideration before nucleic acid synthesis.

Furthermore, compared to complex molecules, fewer target sites allow small molecules to be modified in a restricted manner. For this reason, to address the different mechanisms of action and features of these molecules, all oligonucleotide types must be considered carefully. The complexity and diversity in oligonucleotide molecules increase the propensity for performance failure of drug candidates due to undetected impurity and toxicity. Thus, non-compliance with regulatory requirements can negatively impact drug manufacturers. This trend is expected to hinder the growth of the market during the forecast period.

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Key Market Customer Landscape

The market forecasting report includes the adoption lifecycle of the market, covering from the innovator’s stage to the laggard’s stage. It focuses on adoption rates in different regions based on penetration. Furthermore, the market growth and forecasting report also includes key purchase criteria and drivers of price sensitivity to help companies evaluate and develop their growth strategies.

 Customer Landscape

Segment Overview

The market report forecasts market growth by revenue at global, regional & country levels and provides an analysis of the latest trends and growth opportunities from 2018 to 2028. 

• Application Outlook
  • PCR primers
  • PCR assays and panels
  • DNA microarrays
  • Fluorescence in situ hybridization
  • Sequencing and others

• End-user Outlook
  • Pharmaceutical and biotechnology companies
  • Research and academic institutes
  • Diagnostic laboratories
  • Hospitals

• Region Outlook
  • North America
    • The U.S.
    • Canada
  • Europe
    • U.K.
    • Germany
    • France
    • Rest of Europe
  • Asia
    • China
    • India
  • Rest of World (ROW)
    • Argentina
    • Australia
    • Brazil

Market Analyst Overview:

The market is witnessing remarkable growth, driven by advancements in solution-phase synthesis and polymerase chain reaction (PCR) techniques. Technologies like CRISPR have revolutionized genetic testing and gene therapies, particularly in addressing diseases such as cancer and Charcot-Marie-Tooth disease caused by genetic mutations. Companies like EnPlusOne Biosciences and Ajinomoto Bio-Pharma Services are at the forefront, offering synthesized oligonucleotides and contract services for oligonucleotide-based drugs and therapies. Antisense oligonucleotide drugs like Vitravene are gaining traction in clinical studies, showcasing the potential of oligonucleotide-based therapies. Providers offer services such as oligonucleotide modification, purification, and labeling to meet the demands of molecular testing and analytical testing. The market is propelled by artificial gene synthesis and enzymatic DNA synthesis, paving the way for innovative gene therapies and protein synthesis.

Further, the market is witnessing substantial growth with advancements in diagnostics and genetic research. Technologies like polymerase chain reactions (PCR) play a crucial role in amplifying DNA sequences for various applications, including diagnosing genetic disorders such as Down syndrome. Targeted therapies using antisense oligonucleotide drug are gaining momentum, particularly for conditions linked to specific genes like the IGHMBP2 gene. Contract service providers like Creative Biolabs are instrumental in offering oligonucleotide synthesis providers and purification services, including labeling modifications and backbone modifications, to meet diverse research needs. Cutting-edge techniques such as polyacrylamide gel electrophoresis and RNA-induced silencing complex are enhancing oligonucleotide purification technology, driving innovation in molecular biology and therapeutics.

Market Scope
Report Coverage	Details
Page number	183
Base year	2023
Historic period	2018-2022
Forecast period	2024-2028
Growth momentum & CAGR	Accelerate at a CAGR of 13.54%
Market Growth 2024-2028	USD 3.37 billion
Market structure	Fragmented
YoY growth 2023-2024(%)	13.32
Regional analysis	North America, Europe, Asia, and Rest of World (ROW)
Performing market contribution	North America at 40%
Key countries	US, Canada, Germany, China, and Japan
Competitive landscape	Leading Companies, Market Positioning of Companies, Competitive Strategies, and Industry Risks
Key companies profiled	Agilent Technologies Inc., Ajinomoto Bio Pharma. , Alnylam Pharmaceuticals Inc., Amgen Inc., Ansa Biotechnologies, Bio Synthesis Inc, Biogen Inc., Biotage AB, Danaher Corp., Eurofins Scientific SE, General Electric Co., Ionis Pharmaceuticals Inc., Kaneka Corp., LGC Science Group Holdings Ltd., Merck KGaA, Mettler Toledo International Inc., QIAGEN NV, Sarepta Therapeutics Inc., Synbio Technologies, Syngene International Ltd., and Thermo Fisher Scientific Inc.
Market dynamics	Parent market analysis, Market growth inducers and obstacles, Fast-growing and slow-growing segment analysis, COVID-19 impact and recovery analysis and future consumer dynamics, Market condition analysis for forecast period.
Customization purview	If our report has not included the data that you are looking for, you can reach out to our analysts and get segments customized.

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What are the Key Data Covered in this Market Research Report?

• CAGR of the market during the forecast period
• Detailed information on factors that will drive the growth of the between 2024 and 2028
• Precise estimation of the size of the size and its contribution of the market in focus to the parent market
• Detailed analysis of customer landscape covering Diver of price sensitivity, Adoption of the lifecycle, and key purchase criteria 
• Companies landscape comparing criticality of inputs and factors of differentiation
• Exclusive Matrix on companies position and classification
• Accurate predictions about upcoming trends and changes in consumer behavior
• Growth of the market industry across North America, Europe, Asia, and Rest of World (ROW)
• Thorough analysis of the market’s competitive landscape and detailed information about companies
• Comprehensive analysis of factors that will challenge the growth of companies

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