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The oligonucleotide synthesis market size is forecast to increase by USD 3.37 billion at a CAGR of 13.54% between 2023 and 2028. The market is experiencing significant growth, driven by the increasing shift towards RNA-based therapeutics. This trend is fueled by the advancements in RNA technology and the potential of RNA therapeutics to treat various diseases, including genetic disorders and cancer. Another trend transforming the market is the integration of artificial intelligence (AI) and automation in oligonucleotide synthesis. This technology enhances efficiency, reduces errors, and lowers production costs. However, regulatory issues associated with oligonucleotide therapeutics remain a challenge. Stringent regulatory requirements and lengthy approval processes can hinder market growth. Additionally, ensuring the safety and efficacy of these therapeutics is crucial to gaining regulatory approval and market acceptance. Despite these challenges, the market is expected to continue growing, driven by the potential of oligonucleotide therapeutics to revolutionize healthcare.
Oligonucleotides are short sequences of DNA or RNA, typically ranging from 10 to 100 nucleotides in length. These molecules are essential components of genetic material, composed of nucleotides, which include the nitrogenous bases Adenine (A), Cytosine (C), Guanine (G), Thymine (T), and Uracil (U), attached to a sugar molecule, either Deoxyribose for DNA or Ribose for RNA, with a phosphate group. The market has experienced significant growth due to the increasing applications in various fields, such as genetic disorders, synthetic biology, genome projects, and therapeutic drugs. Oligonucleotides play a crucial role in gene therapy, antisense therapy, and vector technologies.
For instance, they are used to interfere with specific RNA sequences to treat diseases like cystic fibrosis. The solid-phase synthesis method is commonly used for oligonucleotide production, enabling the efficient and large-scale production of these molecules. The market for oligonucleotides is expected to continue growing as new applications and advancements in technology are discovered.
The market research report provides comprehensive data (region-wise segment analysis), with forecasts and estimates in "USD billion" for the period 2024-2028, as well as historical data from 2018-2022 for the following segments.
The PCR primers segment is estimated to witness significant growth during the forecast period. Oligonucleotides, specifically synthesized PCR primers, play a pivotal role in various molecular and genetic applications. These short sequences of DNA or RNA, composed of adenine, cytosine, guanine, thymine, and uracil, are designed to bind to specific target nucleotide chains in PCR reactions. They are indispensable for initiating the amplification process in gene expression analysis, DNA sequencing, mutation detection, and genotyping. Companies specializing in oligonucleotide synthesis provide custom design and synthesis services for PCR primers. Researchers can specify the target DNA sequence, primer length, and other parameters to obtain PCR primers tailored to their experiments. Advanced synthesis techniques ensure high-quality, pure, and accurately synthesized PCR primers.
However, these companies often offer online primer design tools or software to assist researchers in designing optimal PCR primers. Synthesized oligonucleotides find extensive applications in therapeutics and diagnostics. For instance, they are used in CRISPR technology for gene editing, cancer therapy, and rare diseases like Down syndrome and Charcot-Marie-Tooth disease caused by genetic mutations in the IGHMBP2 gene. In synthetic biology and genome projects, oligonucleotides are used as therapeutic drugs, vector technologies, gene therapy, antisense therapy, and interference RNA. The phosphate group and sugar molecule (deoxyribose for DNA and ribose for RNA) in oligonucleotides contribute to their unique properties, making them essential for genetic testing and molecular testing.
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The PCR primers segment was valued at USD 499.37 million in 2018 and showed a gradual increase during the forecast period.
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 shape the market during the forecast period.
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The market is witnessing significant growth due to the increasing demand for analytical testing, artificial gene synthesis, and gene therapies. Key players in the market, such as Agilent Technologies Inc., Thermo Fisher Scientific Inc., and QIAGEN NV, based primarily in North America, particularly in the US, are driving market expansion. These companies provide customized oligonucleotide products, fueling research, therapeutic, and diagnostic applications. Advanced technologies and methodologies, including enzymatic DNA synthesis and polyacrylamide gel electrophoresis, are being employed to meet the escalating demand for oligonucleotides. For instance, Agilent Technologies Inc. Has enhanced its per-cycle synthesis yield through process modification, reaching 99.5%, compared to the conventional 98% yield. This improvement significantly contributes to the production of high-quality oligonucleotides for RNA-induced silencing complex and protein synthesis in clinical trials and studies. Oligonucleotide modification and purification technologies, including labeling modifications, backbone modifications, and Oligonucleotide purification technology, are crucial for the successful application of oligonucleotides in various fields.
Our researchers analyzed the data with 2023 as the base year, along with the key drivers, trends, and challenges. A holistic analysis of drivers will help companies refine their marketing strategies to gain a competitive advantage.
The growing shift toward RNA-based therapeutics is the key driver of the market. Oligonucleotide synthesis holds significant importance in the realm of genetic research and therapeutics, particularly in the production of RNA-based therapeutics. These innovative treatments, which include mRNA vaccines, small interfering RNAs (siRNAs), antisense oligonucleotides (ASOs), and microRNAs, rely on custom-synthesized oligonucleotides for their fabrication. With the expanding development and commercialization of RNA-based drugs, the demand for high-quality, sequence-specific oligonucleotides is escalating. For instance, mRNA vaccines, such as those engineered by BioNTech for COVID-19, necessitate custom-designed mRNA sequences encapsulated in lipid nanoparticles. The synthesis of these mRNA sequences is crucial, thereby fueling the demand for oligonucleotide synthesis and propelling the growth of the market.
However, Oligonucleotides are essential building blocks of DNA and RNA, consisting of nucleotides, a sugar molecule (deoxyribose for DNA or ribose for RNA), and a phosphate group. These nucleotides include adenine (A), cytosine (C), guanine (G), thymine (T), and uracil (U). In genetic disorders like Down syndrome, Charcot-Marie-Tooth disease, and genetic mutations linked to cancer and rare diseases, genetic testing and molecular testing increasingly rely on oligonucleotide synthesis for diagnostic purposes. Synthetic biology and genome projects further expand the application spectrum of oligonucleotides, with therapeutic drugs such as gene therapy and antisense therapy also benefiting from interference RNA and nucleotide chains.
The integration of AI and automation in oligonucleotide synthesis is the upcoming trend in the market. Oligonucleotides, which are synthetic nucleotide chains consisting of deoxyribose or ribose, adenine, cytosine, guanine, thymine, or uracil, play a crucial role in various applications, including genetic testing, molecular diagnostics, and therapeutics. With advancements in genetic research, the demand for oligonucleotides is surging, particularly in the field of CRISPR gene editing and the diagnosis and treatment of genetic disorders such as Down syndrome, Charcot-Marie-Tooth disease, and cystic fibrosis. AI-driven algorithms are revolutionizing oligonucleotide design by optimizing sequences based on factors such as specificity, secondary structure formation, and target binding affinity. These platforms analyze vast datasets to predict the most effective sequences for a given application, thereby accelerating the design process and improving success rates.
Additionally, AI-driven automation platforms enable high-throughput production of custom oligonucleotides, allowing for the parallel synthesis of multiple sequences in a single run. This increases the throughput and scalability of oligonucleotide synthesis, making it possible to produce large quantities rapidly for various applications. Synthetic biology, genome projects, and vector technologies are also driving the demand for oligonucleotides in gene therapy, antisense therapy, and interference RNA. The phosphate group and sugar molecule in oligonucleotides play a vital role in their functionality, and the nitrogenous bases determine their specificity. Diagnostic laboratories and research institutions are major consumers of oligonucleotides, and the market for these molecules is expected to continue growing as research in genetic disorders, rare diseases, and genetic mutations progresses.
The regulatory issues associated with oligonucleotide therapeutics is a key challenge affecting the market growth. Oligonucleotides, which are short chains of DNA or RNA nucleotides, play a crucial role in genetic research and therapeutics. These nucleotides, composed of adenine, cytosine, guanine, thymine, and uracil, are essential in genetic testing and molecular diagnostics for identifying genetic disorders such as Down syndrome, Charcot-Marie-Tooth disease, and cystic fibrosis. In therapeutics, oligonucleotides are used for various applications, including CRISPR gene editing, antisense therapy, interference RNA, and gene therapy. Manufacturers of oligonucleotides face unique regulatory challenges due to the complex nature of these molecules. Oligonucleotide therapeutics are a blend of small and large molecular biologics, exhibiting a more typical interaction with biological systems in vivo.
However, this interaction creates difficulties in implementing regulatory guidelines for both manufacturers and regulatory authorities. The US Food and Drug Administration (FDA) classifies oligonucleotide drugs as small molecules, falling under the Center for Drug Evaluation and Research (CDER) jurisdiction. However, the lack of specificity in regulations poses challenges for manufacturers in complying with the varying guidelines from different regulatory bodies, such as the European Medicines Agency (EMA). Synthesized oligonucleotides are used in various applications, including PCR primers, diagnostic laboratories, synthetic biology, genome projects, and therapeutic drugs. The phosphate group and sugar molecule (deoxyribose or ribose) in oligonucleotides play a vital role in their stability, accuracy, and potency. Oligonucleotide therapeutics hold immense potential in addressing genetic mutations and rare diseases, making them a significant area of research and development in the biotechnology industry.
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 report also includes key purchase criteria and drivers of price sensitivity to help companies evaluate and develop their market growth analysis strategies.
Customer Landscape
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.
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.
The market research and growth report includes detailed analyses of the competitive landscape of the market and information about key companies, including:
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.
Oligonucleotides are short sequences of nucleotides, the building blocks of DNA and RNA. These synthetic molecules play a crucial role in various applications, including genetic testing, diagnostics, and therapeutics. The market for oligonucleotides has experienced significant growth due to the increasing prevalence of genetic disorders such as Down syndrome, Charcot-Marie-Tooth disease, and Cystic fibrosis, among others. These disorders are often caused by genetic mutations in specific genes, leading to a demand for synthesized oligonucleotides for use as PCR primers, CRISPR tools, and therapeutic agents. Oligonucleotides are composed of nitrogenous bases, including Adenine, Cytosine, Guanine, Thymine, and Uracil, attached to a sugar molecule, either Deoxyribose (for DNA) or Ribose (for RNA), and a phosphate group.
In conclusion, synthetic biology and genome projects have further fueled the demand for oligonucleotides in the production of therapeutic drugs and vector technologies, such as gene therapy and antisense therapy. Diagnostic laboratories also utilize oligonucleotides for molecular testing in the diagnosis and monitoring of various diseases. Other key players in the market are continuously innovating to meet the growing demand for oligonucleotides in various applications.
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, market forecast, fast-growing and slow-growing segment analysis, COVID-19 impact and recovery analysis and future consumer dynamics, market condition analysis for the forecast period |
Customization purview |
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1 Executive Summary
2 Market Landscape
3 Market Sizing
4 Historic Market Size
5 Five Forces Analysis
6 Market Segmentation by Application
7 Market Segmentation by End-user
8 Customer Landscape
9 Geographic Landscape
10 Drivers, Challenges, and Trends
11 Vendor Landscape
12 Vendor Analysis
13 Appendix
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