Oligonucleotide Synthesis Market

Market Overview

The global oligonucleotide synthesis market was valued at USD 7.74 billion in 2023. It is estimated to reach USD 25.57 billion by 2032, growing at a CAGR of 14.2% during the forecast period (2024–2032). In recent years, owing to lifestyle changes, there has been a rapid rise in the cases of genetic disorders worldwide. This is estimated to drive the global oligonucleotide synthesis market, as oligonucleotides play an important role in developing therapeutics and diagnostics. Moreover, as the demand for novel oligonucleotides increases, there is a subsequent rise in the research and development of new synthesis methods for oligonucleotides, which is anticipated to generate opportunities for the market.

Highlights

• Synthesized oligonucleotides dominate the product type segment
• North America is the highest shareholder in the global market

Oligonucleotide synthesis is a process used to chemically produce short sequences of nucleic acids, typically DNA or RNA molecules. Oligonucleotides consist of short chains of nucleotides, the basic units of DNA and RNA. Each nucleotide comprises a sugar molecule (deoxyribose in DNA and ribose in RNA), a phosphate group, and one of four nitrogenous bases, i.e., adenine (A), cytosine (C), guanine (G), or thymine (T) in DNA, or uracil (U) in RNA.

The synthesis of oligonucleotides involves adding these nucleotide building blocks one by one in a specific order dictated by the desired sequence. This can be achieved through various chemical methods, such as solid-phase synthesis or solution-phase synthesis. Oligonucleotide synthesis is widely used in molecular biology, genetics, diagnostics, and therapeutics. It plays a primary role in several applications, including PCR (polymerase chain reaction), DNA sequencing, gene editing (such as CRISPR), and as tools for studying gene function and regulation.

Market Dynamics

Global Oligonucleotide Synthesis Market Drivers:

Growing Prevalence of Genetic Disorders

The growing prevalence of genetic disorders, encompassing conditions like cancer, rare diseases, and genetic mutations, is a significant driver of the oligonucleotide synthesis market. A World Health Organization (WHO) study found that genetic disorders have a substantial effect on millions of people worldwide. Similarly, as per the same source, cancer was the leading worldwide cause of death, resulting in around 10 million deaths in 2020.

Oligonucleotides are critical in developing targeted therapies and molecular diagnostics tailored to specific genetic variations. As the understanding of genetic mechanisms underlying diseases deepens, the demand for oligonucleotide-based interventions rises. This trend is further propelled by the quest for precision medicine, where personalized treatments address individual genetic profiles. Consequently, the market experiences a heightened demand for oligonucleotide-based therapeutics and diagnostic tools to mitigate the impact of genetic disorders.

Global Oligonucleotide Synthesis Market Restraint:

Complexity of Synthesis

The complexity of oligonucleotide synthesis represents a significant restraint in the market due to several factors. Firstly, the process requires specialized equipment, reagents, and expertise, which can be prohibitive for smaller research labs or organizations with limited resources. Further, synthesizing longer or modified sequences often involves intricate chemical reactions and purification steps, increasing the risk of errors and reducing overall efficiency.

Moreover, optimizing synthesis conditions for specific applications can be time-consuming and technically challenging. These complexities not only raise the barrier to entry for new players but also necessitate ongoing investment in research and development to improve synthesis methods, streamline processes, and expand the range of available oligonucleotide products. Overall, the intricate nature of oligonucleotide synthesis poses a formidable challenge for widespread adoption and market growth.

Global Oligonucleotide Synthesis Market Opportunities:

Rising Research and Development

In recent years, there has been a rise in the research on oligonucleotides and the development of novel processes for oligonucleotide synthesis. For instance, in April 2023, a research group from Aarhus University in Denmark, in partnership with Novo Nordisk, developed a method to streamline the creation of an entire library of therapeutic oligonucleotide-peptide conjugates. The researchers found a synthesis technique for oligonucleotide (ON) conjugates with built-in handles and a unique linker, allowing for the facile connection of ONs to a peptide marker by altering the pH. This technique avoids requiring specialized and costly ON building blocks to include peptides in the oligonucleotide sequence.

Furthermore, Sarah Lovelock and colleagues at the University of Manchester devised a biocatalytic approach for synthesizing oligonucleotides in June 2023. The process can be conducted in an aqueous solution and involves utilizing a polymerase enzyme to elongate a template strand using unshielded nucleoside triphosphate units, along with an endonuclease enzyme to free the oligonucleotide, enabling the template to be recycled. The novel technology is significant since it can potentially reduce costs and increase scalability in oligonucleotide production compared to traditional solid-phase synthesis methods that have been prevalent in the industry for over 30 years. Such developments are anticipated to create opportunities for market expansion.

Regional Analysis

North America Dominates the Global Market

Based on region, the global oligonucleotide synthesis market is bifurcated into North America, Europe, Asia-Pacific, Latin America, and the Middle East and Africa.

North America is the most significant global oligonucleotide synthesis market shareholder and is expected to expand substantially during the forecast period. The region's robust healthcare infrastructure, increasing investments in research and development, and high prevalence of genetic disorders contribute to its regional dominance. For instance, in April 2021, the CDC stated that Down syndrome affects over 6,000 infants born each year in the U.S., which is equivalent to one in every 700 newborns. Moreover, governments allocate resources to upgrade healthcare infrastructure to provide better healthcare services. In 2020, the Government of Canada invested about USD 5.6 million to facilitate the debut of genomic companies' goods in the market, as the Federal Economic Development Agency for Southern Ontario reported. The government has allocated an additional USD 400 million to support developing and implementing a Pan-Canadian Genomics Strategy. The government intends to be a leader in genetic advancements and technologies. These factors are expected to accelerate market expansion.

Furthermore, market participants engage in strategic initiatives such as joint ventures, product launches, mergers and acquisitions, etc. For instance, in December 2022, EnPlusOne Biosciences (EnPlusOne Bio), a startup company focused on RNA synthesis, was founded through a partnership between Northpond Labs and the Harvard University Wyss Institute for Biologically Inspired Engineering. The startup company has signed an exclusive licensing agreement with Harvard's Office of Technology Development. EnPlusOne Bio has the right to commercialize a new, controlled enzymatic RNA oligonucleotide synthesis technology called the "ezRNA" platform. This technology was developed by George Church, Ph.D., a professor at Harvard Medical School and a member of the Wyss Core Faculty. Ansa Biotechnologies, Inc., a leader in next-generation DNA synthesis, announced in March 2023 that they had created the longest DNA oligonucleotide ever reported to be made in a single synthesis. Therefore, these factors contribute to the expansion of the market.

Asia-Pacific is expected to have the fastest market growth due to its advanced healthcare infrastructure, economic development, and increased government support and investment. Moreover, an increase in genetic disorders contributes to the market's expansion. For instance, in 2020, the WHO South-East Asia Region reported around 2.2 million new cases of cancer and 1.4 million deaths related to cancer. These deaths accounted for about 10% of all deaths in the region. Approximately 23,000-29,000 children in India have Down syndrome, with a prevalence incidence of one in every 831 children annually.

Moreover, the primary players in the market are engaged in strategic endeavors to improve their market share. For instance, in May 2023, GenScript Biotech Corporation, a prominent provider of life-science research equipment and services, expanded its main manufacturing plant for oligonucleotide and peptide production in Zhenjiang, Jiangsu, China. GenScript's expansion enhances its reputation for providing top-notch oligos and peptides to scientists globally over two decades. The enhanced oligonucleotide synthesis capacity provides a variety of oligos for qPCR, NGS, RNA, and DNA to assist various applications such as molecular diagnostics, RNAi, and genome editing. These factors contribute to the regional market growth.

Segmental Analysis

The global oligonucleotide synthesis market is segmented by product type, application, and end-user.

Based on product type, the global oligonucleotide synthesis market is divided into synthesized oligonucleotide products, reagents, and equipment.

The synthesized oligonucleotides segment dominates the global market. Synthesized oligonucleotides are short sequences of nucleotides (DNA or RNA) created through chemical synthesis in a laboratory, as opposed to being obtained from a biological origin. Synthesis involves the sequential assembly of nucleotides using automated synthesizers that regulate the addition of each nucleotide in a precise order. Synthetically produced oligonucleotides have benefits compared to conventional extraction methods, such as greater flexibility in designing sequences, higher purity, and quicker processing times.

Furthermore, synthesized oligonucleotides are commonly utilized in research and clinical environments for various purposes, including genetic research, diagnostics, and therapies. PCR investigations have seen a rise in the usage of synthesizers and consumables like PCR primers, leading to an increase in synthetic products. The broad adoption of PCR technologies in research and diagnostics is driving the growth of this market because of their simplicity, high sensitivity, and cost-effectiveness.

Based on application, the global oligonucleotide synthesis market is bifurcated into research, diagnostics, and therapeutics.

Oligonucleotides are receiving considerable interest in therapeutic synthesis because of their capacity to regulate gene expression and protein synthesis. Pharmaceutical companies increasingly use oligonucleotides in medication production for many purposes, including cancer, neurological, cardiovascular, and uncommon disorders. There is an increase in the development of therapeutics, and numerous treatments are currently in the trial phase.

For instance, in January 2024, Vanda Pharmaceuticals Inc. announced that the U.S. Food and Drug Administration (FDA) approved the Investigational New Drug (IND) application to assess VCA-894A, a new antisense oligonucleotide candidate for treating a patient with Charcot-Marie-Tooth disease, axonal, type 2S (CMT2S), a rare disease caused by cryptic splice site variants within the IGHMBP2 gene. This is expected to enhance the growth of the segment.

Based on end-users, the global oligonucleotide synthesis market is divided into academic research institutes, pharmaceutical and biotechnology firms, diagnostic laboratories, and others.

The diagnostic laboratory segment is expected to experience the highest CAGR. This is due to the rising utilization of oligonucleotides in diagnostic applications. Oligonucleotide synthesis is essential in diagnostic laboratories for a variety of purposes. Oligonucleotides detect genetic mutations associated with neurological disorders such as spinocerebellar ataxia (SCA), epilepsy, and Alzheimer's disease. Oligonucleotide-based biosensors have been used to detect tiny chemicals, peptides, proteins, and genetic targets. This has broadened the range of applications for these sensors in the medical and healthcare sectors.

Recent Developments

• March 2023- A new collaboration worth £2.7 million was established among the Centre for Process Innovation (CPI), AstraZeneca, Novartis, and The University of Manchester. The collaboration's goal was to transform oligonucleotide manufacturing.
• July 2023- Analytix introduced two new instruments for organic synthesis: wavePREP, designed for oligonucleotide synthesis, and Xelsius, a multireaction synthesis workstation.