Oligonucleotide Synthesis Market - Global Industry Size, Share, Trends, Opportunity, and Forecast, Segmented By Product Type (Synthesized Oligonucleotide Products, Reagents, Equipment, and Services), By Application (Research, Therapeutics, and Diagnostics), By End User (Academic Research Institutes, Pharmaceutical and Biotechnology Companies, and Hospital and Diagnostic Laboratories), By Region and Competition, 2020-2030F

Market Overview

The Oligonucleotide Synthesis Market has valued at USD 4.26 billion in 2024 and is expected to reach USD 8.97 billion by 2030 with a CAGR of 13.21% during the forecast period. The oligonucleotide synthesis market stands at the forefront of the biotechnology and pharmaceutical industries, embodying the convergence of cutting-edge research and therapeutic development. In recent years, this sector has experienced remarkable growth, driven by the increasing demand for custom-designed oligonucleotides used in various applications, including gene editing, molecular diagnostics, and drug discovery. This surge can be attributed to the burgeoning fields of genomics, personalized medicine, and RNA-based therapeutics, all of which rely heavily on the precise synthesis of oligonucleotides. As businesses across the globe invest heavily in genomics research and molecular diagnostics, the oligonucleotide synthesis market has become a critical linchpin, enabling scientists to access high-quality, tailor-made genetic material with utmost precision.

Moreover, Close to 300 clinical trials have been registered across different geographical regions to evaluate various oligonucleotides. Majority (>50%) of these trials were registered in North America. Further, the maximum number of patients (19,590) have been enrolled in clinical trials conducted in Europe, which account for 26% of the overall enrollment. It is worth mentioning that Ionis Pharmaceuticals is conducting the maximum number of trials in this industry for various target indications, including atherosclerosis, Crohn’s disease, elevated triglycerides, familial chylomicronemia syndrome, hATTR amyloidosis rheumatoid arthritis, transthyretin-mediated amyloid cardiomyopathy and type 2 diabetes mellitus.

The competitive landscape within this market is characterized by a mix of established industry giants and innovative startups, fostering a dynamic ecosystem. Technological advancements, such as automated synthesis platforms and novel chemical modifications, are enhancing the efficiency and versatility of oligonucleotide production, fueling further growth. Additionally, regulatory approvals and industry standards are playing a pivotal role in ensuring the quality and safety of synthesized oligonucleotides, instilling confidence in businesses and researchers alike. As the biotechnology and pharmaceutical sectors continue to expand and diversify, the oligonucleotide synthesis market is poised for sustained growth. Companies that can offer cost-effective, high-quality oligonucleotide solutions while staying abreast of evolving technologies and regulatory requirements will undoubtedly thrive in this dynamic business environment. The strategic partnerships, research collaborations, and investments made in this field are not only reshaping the landscape of life sciences but also holding the promise of groundbreaking advancements in healthcare and biotechnology, making the oligonucleotide synthesis market a cornerstone of innovation and progress in the business world.

Key Market Drivers

RNA-Based Therapeutics

RNA-Based Therapeutics represent a transformative frontier in the pharmaceutical industry, and they have a significant impact on the oligonucleotide synthesis market. These therapeutics harness the potential of ribonucleic acid (RNA) molecules, including messenger RNA (mRNA), small interfering RNA (siRNA), and antisense oligonucleotides (ASOs), to modulate gene expression and treat a wide array of diseases. Oligonucleotide synthesis is at the heart of RNA-based therapeutics, as it involves the precise design and production of synthetic RNA molecules tailored to target specific genetic sequences or pathways involved in diseases.

One of the most notable breakthroughs in this field has been the development of mRNA vaccines, exemplified by the COVID-19 vaccines produced by Pfizer-BioNTech and Moderna. These vaccines employ synthetic mRNA to instruct cells to produce viral spike proteins, triggering an immune response without using weakened or inactivated viruses. The rapid success of mRNA vaccines has demonstrated the power and versatility of RNA-based therapeutics, creating a surge in demand for custom oligonucleotides used in their formulation. Oligonucleotide synthesis companies are now focusing on optimizing and scaling up production processes to meet this heightened demand.

Moreover, RNA-based therapeutics are gaining traction in treating genetic disorders, cancers, and rare diseases. ASOs and siRNAs, for instance, can selectively inhibit the expression of disease-causing genes, offering potential cures or symptom management. The design and synthesis of these oligonucleotides must be highly precise to ensure therapeutic efficacy and minimize off-target effects.

Advancements in Genomic Research

Advancements in Genomic Research have catalyzed a remarkable growth trajectory for the oligonucleotide synthesis market. Genomic research, which focuses on decoding the entirety of an organism's genetic material, has evolved rapidly, powered by technologies like Next-Generation Sequencing (NGS) and CRISPR-Cas9 gene editing. These innovations have led to a substantial increase in the demand for custom-designed oligonucleotides – short DNA or RNA sequences – that serve as the fundamental building blocks for genetic analysis, manipulation, and sequencing.

The oligonucleotide synthesis market plays a pivotal role in this genomics revolution by supplying researchers with tailor-made genetic material. Scientists require these oligonucleotides for a myriad of applications, including whole-genome sequencing, gene expression profiling, epigenetic studies, and functional genomics. As researchers aim to decipher the genetic basis of diseases, identify biomarkers, and develop targeted therapies, the need for high-quality, precise oligonucleotides continues to escalate.

Moreover, the emergence of single-cell genomics, which allows for the analysis of individual cells within heterogeneous tissues, has introduced additional complexity and demand for specialized oligonucleotides. Researchers in this field rely heavily on unique oligonucleotide probes and primers to explore the intricacies of gene expression and cellular diversity at the single-cell level.

Download free Sample Report

Key Market Challenges

Efficiency and Scalability

Efficiency and scalability are critical challenges in the oligonucleotide synthesis market, driven by the escalating demand for custom oligonucleotides in various applications. Efficiency is crucial in ensuring that the synthesis processes are not only fast but also precise and error-free. Researchers and manufacturers alike require reliable and consistent results, and any inefficiencies can lead to delays, increased costs, and compromised research outcomes. Scalability, on the other hand, revolves around the industry's ability to meet the growing demand for oligonucleotides, especially with the expanding applications of genomics, gene therapy, and molecular diagnostics. Scaling up production while maintaining quality standards is a complex endeavor, often requiring significant investments in infrastructure, automation, and process optimization.

The challenge lies in striking a balance between efficiency and scalability. While automation and high-throughput technologies have improved efficiency, ensuring they are scalable to meet the surge in demand is a constant struggle. Additionally, the synthesis of long or highly modified oligonucleotides can be particularly challenging, as it may require specialized equipment and processes. Furthermore, regulatory constraints in some regions necessitate rigorous quality control and documentation, which can impact efficiency and scalability efforts.

Cost Constraints

Cost constraints in the oligonucleotide synthesis market represent a multifaceted challenge that impacts both research and commercial applications. Oligonucleotides are essential components in a wide range of genetic research, diagnostics, and therapeutic development endeavors. However, their synthesis, especially when dealing with long or chemically modified sequences, can be cost-prohibitive. Researchers operating on limited budgets often grapple with the high expenses associated with procuring custom oligonucleotides, potentially limiting the scope of their experiments. Moreover, in the context of RNA-based therapeutics, the production of large quantities of high-quality synthetic RNA molecules, such as mRNA for vaccines or gene therapies, can involve significant costs. Balancing the need for cost-effective oligonucleotides with the requirement for precision and purity is a constant challenge for the industry.

Companies in the oligonucleotide synthesis market also face cost-related pressures. While advancements in automation and synthesis technologies have improved efficiency and reduced costs to some extent, competition within the market necessitates competitive pricing. This can be challenging for companies looking to maintain profit margins while investing in research and development to stay at the forefront of the field. Additionally, the incorporation of chemical modifications or specialized sequences can significantly increase production costs, further complicating the cost-effectiveness equation.

Key Market Trends

Therapeutic Advancements

Therapeutic advancements represent a pivotal trend in the oligonucleotide synthesis market, ushering in a new era of precision medicine and targeted therapies. This trend is characterized by the development and commercialization of RNA-based therapeutics, including messenger RNA (mRNA) vaccines and gene therapies, which rely heavily on custom oligonucleotide synthesis. mRNA vaccines, exemplified by the COVID-19 vaccines from Pfizer-BioNTech and Moderna, have demonstrated the transformative potential of synthetic RNA molecules in eliciting immune responses without using weakened or inactivated viruses. Oligonucleotide synthesis is at the core of these vaccines, producing precisely designed mRNA sequences encoding viral antigens. Beyond vaccines, oligonucleotides play a crucial role in gene therapies, where they are used to modify, repair, or replace defective genes responsible for genetic disorders.

The oligonucleotide synthesis market is integral to therapeutic advancements as it provides the essential raw materials - custom-designed oligonucleotides - with high precision and purity. This allows researchers and pharmaceutical companies to develop RNA-based therapeutics with unprecedented accuracy and efficacy. As research in RNA-based treatments expands to address various diseases, including cancer, rare genetic disorders, and autoimmune conditions, the oligonucleotide synthesis market is poised to grow exponentially. It will continue to serve as a cornerstone of innovation and progress in healthcare, offering the means to manufacture these transformative therapeutics on a scale required to meet global healthcare needs. Consequently, staying at the forefront of oligonucleotide synthesis technologies is critical for companies aiming to contribute to this dynamic and rapidly evolving field.

Gene Editing and CRISPR-Cas9

Gene editing, particularly through the revolutionary CRISPR-Cas9 technology, has emerged as a major driving force in the oligonucleotide synthesis market. CRISPR-Cas9, a versatile genome-editing tool, relies on the precise design and synthesis of oligonucleotides to target and modify specific DNA sequences within an organism's genome. Oligonucleotides, known as guide RNAs (gRNAs), are synthetically engineered to complement the target DNA, guiding the Cas9 enzyme to the desired genomic location for editing. This technology has unlocked new possibilities in genetic research, enabling researchers to manipulate genes with unprecedented precision for applications ranging from fundamental research to therapeutic interventions.

The oligonucleotide synthesis market plays a pivotal role in supporting CRISPR-Cas9 applications by providing custom-designed gRNAs and donor DNA templates for gene editing. Researchers and biotechnology companies require these oligonucleotides to facilitate precise modifications, such as gene knockouts, gene insertions, or base pair substitutions. The ability to rapidly produce high-quality oligonucleotides tailored to specific gene-editing experiments is crucial for advancing the field of CRISPR-based genome engineering.

As gene editing continues to expand in areas like agriculture, medicine, and biotechnology, the oligonucleotide synthesis market is poised for substantial growth. Companies that can offer cost-effective, reliable, and customizable oligonucleotide solutions tailored to the unique requirements of CRISPR-Cas9 applications will remain essential players in this dynamic and transformative field, driving innovation and progress in genetics and biotechnology.

Segmental Insights

Product Type Insights 

Based on Product Type, ​The synthesized oligonucleotide products segment holds a significant position in the oligonucleotide synthesis market. This prominence is largely due to the widespread use of synthesized oligonucleotides in various research applications, including gene expression analysis, genetic testing, and the development of biochips (DNA chips) for analyzing multiple clinical samples simultaneously. Additionally, the increasing utilization of antisense oligonucleotides in clinical trials targeting conditions such as cancer, cardiac disorders, and ocular dysfunctions further contributes to the segment's substantial market share. In January 2023, QIAGEN acquired Verogen, specializing in NGS technologies, in a transaction worth USD 150 million. QIAGEN plans to integrate Verogen's technologies and talent into its existing operations.

Download free Sample Report

Regional Insights

Based on Region, the North America region has established itself as the leader in the Oligonucleotide Synthesis Market. North America has emerged as the frontrunner in the oligonucleotide synthesis market for several compelling reasons. Firstly, the region boasts a well-developed and highly innovative pharmaceutical and biotechnology industry. The United States, in particular, is home to numerous leading biotech companies and research institutions that drive the demand for custom oligonucleotides in various applications, from genomics research to therapeutic development. The robust presence of these industry leaders has created a thriving ecosystem that fosters innovation, research collaborations, and market growth. Secondly, North America benefits from a substantial investment in healthcare and life sciences research. Government funding, private investments, and venture capital have poured into the region to support cutting-edge genomic studies, gene therapies, and RNA-based therapeutics.  For instance, in April 2021, DNAScript collaborated with Moderna along with a USD 5 million grant from the U.S. Defense Advanced Research Projects Agency. This collaboration was intended to develop a prototype for robust manufacturing of therapeutics and vaccines as part of the global nucleic acids on-demand program.

These financial backing fuels the demand for oligonucleotide synthesis services, as researchers seek reliable and specialized partners for their projects. Additionally, the regulatory environment in North America is conducive to oligonucleotide-based therapeutics. Regulatory agencies like the U.S. Food and Drug Administration (FDA) have developed clear pathways and guidelines for the approval of oligonucleotide drugs and therapies, instilling confidence in the market and facilitating the commercialization of novel products. Moreover, the region's strong emphasis on precision medicine and personalized healthcare has propelled the growth of the oligonucleotide synthesis market. Tailored therapies that utilize custom-designed oligonucleotides to target specific genetic markers or mutations align with North America's healthcare priorities, contributing to market expansion. Lastly, North America's well-established infrastructure and logistics networks ensure efficient supply chains and timely delivery of oligonucleotides, further enhancing its competitive advantage.

Recent Developments

• In June 2024, GSK finalized the acquisition of Elsie Biotechnologies for $50 million, aiming to enhance its capabilities in oligonucleotide research and development.
• In April 2024, Asahi Kasei Bioprocess signed an agreement with Axolabs to establish a 59,000-square-foot cGMP oligonucleotide manufacturing facility in Germany.
• In March 2024, Merck announced the launch of its first cGMP-compliant oligonucleotide manufacturing facility in the United States.
• In October 2023, Integrated DNA Technologies (IDT) opened a new therapeutic manufacturing facility to address the growing demand in genomic medicine. This state-of-the-art facility is designed to support the production of therapeutic oligonucleotides, meeting the expanding requirements of genomics and personalized medicine.
• In September 2023, Danaher Corporation (through IDT) launched a suite of xGen NGS products optimized for the Ultima Genomics UG 100™ platform. The product range includes adapters, primers, and universal blockers, supporting a variety of sequencing applications such as DNA, RNA, and methylation workflows. These are enhanced by IDT’s trusted hybridization capture chemistry, offering greater flexibility for researchers.
• In July 2022, WuXi STA, a subsidiary of WuXi AppTec, launched a new large-scale oligonucleotide and peptide manufacturing facility at its Changzhou campus. This new launch enhances its capacity and capability to meet the fast-growing customer needs for oligonucleotide and peptide therapeutics development and manufacturing worldwide.
• In April 2022, Bachem entered a strategic collaboration with Eli Lilly & Company to develop and manufacture active pharmaceutical ingredients based on oligonucleotides, a rising new class of complex molecules. Under the agreement, Bachem provides the appropriate engineering infrastructure and expertise to implement Lilly’s novel oligonucleotide manufacturing technology.

Key Market Players

• Thermo Fisher Scientific Inc
• Agilent Technologies, Inc.
• Merck KGaA
• BIO-Synthesis Inc
• Eurofins Scientific SE
• Danaher Corporation
• Ajinomoto Bio-Pharma Services
• Biogen Inc.
• Ionis Pharmaceuticals, Inc.
• Sarepta Therapeutics, Inc.

Report Scope:

In this report, the Oligonucleotide Synthesis Market has been segmented into the following categories, in addition to the industry trends which have also been detailed below:

• Oligonucleotide Synthesis Market, Product Type:
• Synthesized Oligonucleotide Products
• Reagents
• Equipment
• Services
• Oligonucleotide Synthesis Market, Application:
• Research
• Therapeutics
• Diagnostics
• Oligonucleotide Synthesis Market, End User:
• Academic Research Institutes
• Pharmaceutical & Biotechnology Companies
• Hospital & Diagnostic Laboratories
• Oligonucleotide Synthesis Market, By Region:
• North America

§  United States

§  Mexico

§  Canada

o   Europe

§  France

§  Germany

§  United Kingdom

§  Italy

§  Spain

o   Asia-Pacific

§  China

§  India

§  South Korea

§  Japan

§  Australia

o   South America

§  Brazil

§  Argentina

§  Colombia

o   Middle East and Africa

§  South Africa

§  Saudi Arabia

§  UAE

Competitive Landscape

Company Profiles: Detailed analysis of the major companies present in the Oligonucleotide Synthesis Market.

Available Customizations:

Oligonucleotide Synthesis Market report with the given market data, TechSci Research offers customizations according to a company's specific needs. The following customization options are available for the report:

Company Information

• Detailed analysis and profiling of additional market players (up to five).

Oligonucleotide Synthesis Market is an upcoming report to be released soon. If you wish an early delivery of this report or want to confirm the date of release, please contact us at sales@techsciresearch.com