The global oligonucleotide synthesis market size is expected to reach USD 5.71 Billion in 2021 and register a revenue CAGR of 16.8% during the forecast period. Growing investments by governments in pharmaceutical & biotechnology projects, rising demand for high-end customized oligos, and upgradation in purification in addition to increasing usage of synthesized oligonucleotides in molecular diagnostics and clinical applications are a few of the key factors driving the revenue growth of the market. Oligonucleotides (ONs) are gaining more importance as a potential new class of biopharmaceuticals. The provision of critical function in gene regulation enables creation of custom-made medicines (also known as N-to-1) that act on gene expression at the pre-translational stage. Growing number of Food and Drug Administration (FDA) approvals of ON-based medicines coupled with a significant need for high-quality chemically modified ONs are expected to drive revenue growth of the market.
Oligonucleotide synthesis (or gene synthesis) is used for various applications in medicine and life science research including as primers for sequencing and amplification [Polymerase Chain Reaction (PCR)], probes for detecting complementary DNA or RNA via hybridization, synthesis of artificial genes, anti-sense oligonucleotides (several siRNAs in clinical development), as well as tools for the targeted introduction of genetic mutations. Moreover, the number of oligonucleotide synthesizers for small-scale synthesis and medium to large-scale synthesis is increasingly available for commercial purposes which is one of the key factors expected to drive revenue growth of the market. On 27 September 2021, SpeeDx Pty, Ltd., which is a developer of potential molecular diagnostic solutions, announced an investment in SynGenis Pty Ltd., which is an experienced oligonucleotide producer located in Western Australia. Collaboration is expected to strengthen SpeeDx’s internal ability to accommodate large-scale increases in production while establishing and extending the sovereign capacity of critical raw materials needed in molecular diagnostics.
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Oligonucleotides are synthesized in a very precise way, which makes them highly targetable with very few side effects. Oligonucleotides can be customized to hybridize with specific pathogenic DNA or RNA, for which they are used in screening assays for tuberculosis, malaria, and HIV. Rising demand for genetic tests, caused mainly by an increase in the number of incidences of genetic illnesses such as cancer, as well as acceptance, need large oligo production capabilities and quick turnaround times. According to World Health Organization (WHO), Chronic Obstructive Pulmonary Disease (COPD) is the third greatest cause of mortality globally, accounting for 3.23 million deaths in 2022.
Allele-specific testing, aptamer design, and triplex-forming oligonucleotides for dsDNA binding are three of the most popular uses for research and therapeutics. Therapeutics based on oligonucleotides are of intermediate size, have significantly better target selectivity, and have fewer off-target effects than small molecules. Oligonucleotide Therapies (OTs), which are now being researched for their potential application in neurological illnesses, cancer, and even orphan diseases, include antisense RNAs, microRNAs (MIR), small interfering RNAs (siRNA), and aptamers. However, concerns regarding complexities associated with therapeutic oligos and issues related to the delivery of oligonucleotide drugs to specific targets are factors expected to provide some restraints to revenue growth of the market.
Market Dynamics:
Driver: Growing investments by governments in pharmaceutical & biotechnology projects
Rising number of life science research & development projects coupled with increasing governmental initiatives, high-value funds, and grants are two key factors driving revenue growth of the market. On 3 November 2021, medical technology start-up SynGenis Pty Ltd received USD 50,000 under the MTP Manufacturing Voucher Program. The Perth-based company manufactures the raw ingredients required for PCR COVID-19 testing, and the funding will allow SynGenis to offer goods that are ISO 9001:2015 and GMP certified. SynGenis established Australia’s only commercial manufacturing facility for custom synthetic oligonucleotides including DNA, RNA, and modified RNA in 2020 and has since grown rapidly.
Restraint: Concerns regarding complexities associated with therapeutic oligos
Key challenges to the effective therapeutic development of oligonucleotide drugs are insufficient pharmacokinetic characteristics and low cellular absorption. The difficulties of using molecules produced from nucleic acids therapeutically have not yet been overcome. Delivery to tissues and organs besides the liver has not been achieved adequately. Even after market approval, toxicology problems connected to chemical alterations are poorly understood and a significant source of concern. Moreover, the lack of skilled professionals with proper knowledge and funding for research in emerging countries are expected to contribute to restraining factor for the oligonucleotide synthesis market.
Key Takeaways
Product Outlook:
Based on product, the global oligonucleotide synthesis market has been segmented into synthesized oligonucleotides, oligonucleotide-based drugs, equipment, and reagents. Synthesized oligonucleotides segment is further sub-segmented into product and type. The product is segmented into primers, probes, RNA oligos, DNA oligos, and others. Type is segmented into predesigned oligos and customized oligos. Synthesized oligonucleotides segment is expected to register a significant revenue growth rate during the forecast period. One of the most prevalent applications for oligonucleotides is PCR primers. Primers are intended to have at least part of their sequence complementary to the 5′ end of the sequence being amplified. Synthetic oligonucleotides are mostly used as relatively short probes and primers (up to 30-mer) in a wide range of applications. This entails creating a nucleotide sequence that is complementary to a bigger, target DNA or RNA strand (target sequence). Oligos are generally employed as primers to start enzymatic reactions that produce millions to billions of copies of a short or long target sequence. PCR or the Sanger sequencing technique are two well-known examples. Oligo primers are used in DNA sequencing, gene expression, cloning, and molecular diagnostics.
Application Outlook:
Based on application, the global oligonucleotide synthesis market has been segmented into research, therapeutic and diagnostic. The therapeutic segment is expected to register a significant revenue growth rate over the forecast period owing to the potential of oligonucleotide drugs for treating or managing a wide range of disorders. Target selectivity of therapeutic drugs provides relevant treatments for clinical productivity. The basic structure and sequence of OT have a direct impact on their delivery and potency. Oligonucleotide medicines are commonly used to treat neurological illnesses such as amyotrophic lateral sclerosis, Huntington’s disease, and spinal muscular atrophy as well as respiratory disorders such as asthma and COPD, diabetic retinopathy, and a variety of malignancies. Specific structural alterations of the oligonucleotide therapy, such as changes in the nucleotide backbone or sugar moieties, help in incorporating desired properties into the medicine molecule, improving its safety and efficacy which is driving revenue growth of the segment.
End-User Outlook:
Based on end-user, the global oligonucleotide synthesis market has been segmented into pharmaceutical & biotechnology companies, hospitals, diagnostic laboratories, academic research institutes, and Contract Research Organizations (CROs) & Chief Medical Officers (CMOs). The pharmaceutical & biotechnology companies segment is expected to register a rapid revenue growth rate in 2021. High-value investments in various research & development projects for OTs by major biotechnology and pharmaceutical companies are one of the key factors driving revenue growth of the market. Rising number of companies are focused on curing rare diseases, with 14 oligonucleotide therapies now authorized by the FDA and European Medicines Agency (EMA). Furthermore, with around 200 clinical studies and over 600 preclinical trials for oligo-based products, pharmaceutical, and biotechnology companies are increasingly involved in developing and manufacturing new oligo-based therapies that are expected to alter patients’ lives.
Regional Outlook:
North America accounted for the largest revenue share in the global oligonucleotide synthesis market in 2021, owing to a rising number of innovations and various major pharmaceutical & biotechnology companies increasingly involved in developing processes that would be more scalable and sustainable. Growing number of clinical trials and preclinical trials for oligo-based products are further attributing to the revenue growth of the market in this region. On 28 January 2022, Maravai LifeSciences, Inc., a global provider of life science reagents and services to researchers and biotech startups, announced today that it has acquired MyChem, LLC for USD 240 million in cash at closing with the possibility of additional contingent cash consideration based on achievement of certain conditions after closing. With the medicines and vaccine application industries growing quickly, the purchase will increase Maravai’s product line of key contributions.
Oligonucleotide synthesis market in Europe is expected to register a steady growth rate over the forecast period. Major biotechnological companies and research institutes are involved in meeting rising demand for synthesized oligonucleotides in molecular diagnostics and clinical applications. High Mergers & Acquisitions (M&A) activities are another primary factor contributing to revenue growth of the market in Europe. On 20 October 2021, The Swedish life sciences firm Biotage purchased the U.K.-based oligonucleotide synthesis business ATDBio. Acquisition, which cost £45 million (USD 62 million) in cash and stock, gives Biotage access to knowledge in the creation of extremely complicated DNA and RNA and will enable quicker development of the U.K. company’s operations.
Market in Asia Pacific is expected to register significant revenue growth during the forecast period. Some of the major factors driving revenue growth of the market in Asia Pacific are rising demand for diagnostic tools, growing awareness of the oligonucleotide synthesis technique, as well as rising Research and Development (R&D) activities by various major research and biopharmaceutical companies. On 7 July 2022, New large-scale oligonucleotide and peptide synthesis capabilities have been disclosed by WuXi STA, a division of WuXi AppTec, at its Changzhou production location. In addition to more than 20 small- to mid-sized production lines, the 30,570-square-foot oligonucleotide facility has four large-scale oligonucleotide manufacturing lines. Three additional manufacturing lines with reactors that can hold up to 1,000 liters are installed in the 22,260-square-foot peptide facility.
Competitive Landscape:
Competitive landscape of the global oligonucleotide synthesis market is fragmented with many key companies operating at global and regional levels. Major companies are engaged in research and development initiatives and testing and entering into alliances to develop and introduce more novel and innovative products and services.
Some major companies in the global market report include Danaher, Thermo Fisher Scientific, Merck KGaA, Eurofins Scientific, KANEKA CORPORATION, Agilent Technologies, Biolytic Lab Performance Inc., Generi Biotech, Biogen and Ionis Pharmaceuticals, Inc.
- On 20 October 2021, Biotage AB agreed to acquire all outstanding shares in the privately held company ATDBio Limited which is based in Oxford and Southampton, U.K., for a total purchase price of approximately 45 MGBP on a debt-free and cash-free basis (around USD 53.57 million), financed through a combination of a share issue of new ordinary Biotage shares, cash on hand, and a revolving credit facility. The transaction was completed in conjunction with the execution of the share purchase agreement. The addition of ATDBio extends Biotage’s platform solutions for DNA and RNA oligonucleotide synthesis and purification. This technique is utilized in drug development, molecular diagnostics (such as PCR testing), nucleic acid-based therapies, and next-generation DNA and RNA sequencing technologies. The acquisition is expected to considerably enhance and improve Biotage’s position as a leading provider of life science tools and impact technology services.
- On 19 October 2022, Telesis Bio which is a leader in automated multi-omic and synthetic biology solutions, and Cellibre which is a leading manufacturing technology company, are collaborating to optimize the development and validation of Telesis Bio’s BioXp Digital-to-Biological Converter (DBC) instrument for fully automated manufacturing of on-demand CRISPR-Cas9 guide RNA (gRNA) for genome editing. BioXp DBC instrument integrates Telesis Bio’s Short Oligonucleotide Ligation Assembly (SOLA) Enzymatic DNA Synthesis (EDS) technology directly onto its BioXp 9600 system, offering scientists same-day design and build capabilities for their guide RNAs without the need to order custom reagents. gRNA synthesis kit is the first of several BioXp DBC kits planned by the business.
Segments Covered in the report
This report offers historical data and forecasts revenue growth at a global, regional, and country level, and provides analysis of market trends in each of the sub-segments from 2022 to 2030. For the purpose of this report, Reports and Data has segmented the global oligonucleotide synthesis market based on product, application, end-user, and region:
Product Outlook (Revenue, USD Billion; 2022-2030)
- Synthesized oligonucleotides
- Oligonucleotide-based drugs
- Equipment
- Reagents
Application (Revenue, USD Billion; 2022-2030)
- Research
- Therapeutic
- Diagnostic
End-User Outlook (Revenue, USD Billion; 2022-2030)
- Pharmaceutical & biotechnology companies
- Hospitals
- Diagnostic laboratories
- Academic research institutes
- Contract Research Organizations (CROs) & Chief Medical Officers (CMOs) treatment
Regional Outlook (Revenue, USD Billion; 2022-2030)
- North America
- U.S.
- Canada
- Mexico
- Europe
- Germany
- U.K.
- France
- Italy
- Spain
- Sweden
- BENELUX
- Rest of Europe
- Asia-Pacific
- China
- India
- Japan
- South Korea
- Rest of APAC
- Latin America
- Brazil
- Rest of LATAM
- Middle East & Africa
- Saudi Arabia
- UAE
- South Africa
- Israel
- Rest of MEA
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