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March 2025
The global oligonucleotide CDMO market size is calculated at US$ 2.55 in 2024, grew to US$ 3.11 billion in 2025, and is projected to reach around US$ 18.37 billion by 2034. The market is expanding at a CAGR of 21.83% between 2025 and 2034. The rise in next-generation sequencing for various genes-related research and study is driving the oligonucleotide CDMO market.
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Therapeutics involving oligonucleotides have completely changed the pharmaceutical sector. Short RNA or DNA strands that may be artificially altered to change the expression of several disease-causing proteins make up this class of medications. Most oligonucleotides licensed by the Food and Drug Administration (FDA) and available on the market were used to treat uncommon disorders until recently. Research, illness diagnostics, and, more recently, therapies are just a few of the applications for oligonucleotides, also known as oligos. Apart from their application as PCR primers, oligonucleotides are also employed as drug carriers, probes, in situ hybridization, microarray, and antisense analysis.
In order to close the gap between R&D and commercialization, CDMOs are essential. The process of creating oligonucleotides is being redefined by AI systems like Benchling, Labguru, and Sartorius' BioPAT. To make compliance procedures easier, CDMOs use AI-powered regulatory products like Veeva Quality One and TetraScience. These tools make it possible to automate paperwork, monitor regulatory updates in real-time, and effectively handle modifications made after approval. CDMOs position themselves as proactive partners that can navigate the intricacies of compliance regulations while guaranteeing smooth execution by giving customers a clear picture of regulatory operations.
Rise in Demand for Gene and Cell Therapies
The potential of gene and cell therapies to cure a variety of illnesses, such as cancer, genetic abnormalities, and neurological diseases, is enormous. As building blocks for targeted drug delivery systems, immunotherapies, and gene editing tools, peptides and oligonucleotides are essential to these treatments. As businesses look for specialized knowledge and infrastructure to design and produce these complicated medicines, the need for peptide and oligonucleotide CDMO services has increased due to breakthroughs in gene and cell therapies. The oligonucleotide CDMO market is anticipated to continue to expand in the upcoming years due to the growing number of clinical studies and regulatory approvals for gene and cell treatments.
Strict Regulatory Compliance
The regulatory context in which oligonucleotides function is complex and always changing. It can be difficult to meet compliance standards, particularly for novel compounds with distinctive characteristics. In addition to adding another level of complexity to the entire process, CDMOs are in charge of managing intricate legal frameworks, keeping up with evolving directives, and accounting for particular demands related to oligonucleotide research and manufacture.
Technological Advancements
Solid-phase peptide synthesis (SPPS), automated synthesis, and continuous flow techniques are examples of technological developments in oligonucleotide CDMOs that have improved efficiency. With Next-Generation Sequencing (NGS), thorough oligonucleotide characterization is guaranteed. Cell-free synthesis is used to produce flexible peptides. Developments in RNA synthesis aid in the creation of RNA-based medicines. Novel delivery methods, such as those based on nanoparticles, are designed to increase bioavailability. In the ever-changing world of CDMOs, integrated analytical platforms that combine several techniques provide comprehensive product characterization and quality control.
By service, the contract manufacturing segment led the oligonucleotide CDMO market in 2024, driven by the growing need for oligonucleotide APIs to be produced on a wide scale in a cGMP-compliant manner for use in clinical and commercial settings. To address the increasing demand for ASOs, siRNAs, and mRNA-based therapies, CDMOs with sophisticated solid-phase synthesis platforms, automated fill-finish systems, and high-throughput purification technologies are essential. The market leadership of this category is further cemented by the fact that pharmaceutical businesses rely significantly on CDMOs to provide high-purity, scalable, and internationally compatible manufacturing solutions due to strict regulatory requirements and the difficulty of expanding production.
By service, the contract development segment is estimated to achieve significant growth in the oligonucleotide CDMO market during the forecast period. This section includes essential services, including preclinical development, formulation development, process development, and analytical technique development. These contract development services are essential for enhancing production procedures and guaranteeing the safety and quality of oligonucleotides and peptides. Research and development of oligonucleotide therapies is a major area of investment for pharmaceutical and biotechnology businesses. By contracting with CDMOs to handle the development and production processes, these businesses may lower expenses and speed up product development while concentrating on their core skills.
By type, the ASO segment held a significant share of the oligonucleotide CDMO market in 2024. The biotechnology and pharmaceutical industries have created a number of new and creative approaches to target significant disease-related proteins throughout the past century. Over the past few decades, RNA therapeutics—particularly antisense oligonucleotide (ASO) technology—have advanced significantly. Several ASO-based medications are already on the market following FDA clearance, and many ASOs are being tested in various clinical stages.
By type, the siRNA segment is expected to grow significantly in the oligonucleotide CDMO market during the forecast period. Improved methods for ranking targets and medication candidates are required. To meet this demand, siRNA technologies provide remarkable speed and specificity. Certain preclinical drug development obstacles can be addressed with siRNA technology. These technologies are now being utilized to assist in determining which pharmacological targets are most appropriate for a certain illness indication. These technologies are currently being investigated for a new and possibly potent use in aiding in the prioritization of drug candidates.
By application, the therapeutic segment held the largest share of the oligonucleotide CDMO market in 2024. Numerous methods have been created to enhance the pharmacokinetics and pharmacodynamics of oligonucleotides. Large patient populations can now benefit from oligonucleotides, which were once developed to target uncommon illnesses and niche markets. Despite its ups and downs, the area of therapeutic oligonucleotides is now expanding quickly. There are now 44 businesses with compounds either in late clinical development (beyond phase II) or on the market. These include Big Pharma firms like Johnson & Johnson, Roche, Novartis, and AstraZeneca, as well as biotech firms that specialize in oligonucleotides, such as Ionis Pharmaceuticals and Alnylam Pharmaceuticals. There has been significant activity in the field of oligonucleotide patents and applications concurrent with the rise of medicinal oligonucleotides.
By application, the research segment is anticipated to grow at a significant rate in the oligonucleotide CDMO market during the forecast period. Research institutions' contributions to early-stage research, cutting-edge technology, and scientific breakthroughs have a big impact on market share. Research organizations are crucial in identifying the therapeutic potential of oligonucleotides, which opens doors for partnerships with CDMOs and pharmaceutical firms and has a direct impact on their market share. The market expands as a result of research institution advancements that improve distribution systems, analytical procedures, and synthesis processes. Since these entities' published findings influence medication development and manufacturing tactics, industry players are interested in these advances.
By end-use, the pharma segment held a major share of the oligonucleotide CDMO market in 2024. The use of oligonucleotide therapies has transformed medicine. Products of oligonucleotide drugs that have received commercial approval in the US and the EU are examined. A mixture of single-stranded and double-stranded polydeoxyribonucleotides, six small interfering ribonucleic acids (siRNAs), twelve antisense oligonucleotides (ASOs), and one aptamer are among the twenty products that have been found. Since 2016, approvals have been granted annually, demonstrating the treatment modality's increasing effectiveness and, consequently, the pharmaceutical industry's interest.
By end-use, the biotech segment is anticipated to achieve a significant share of the oligonucleotide CDMO market during the forecast period. A vast array of biotechnology breakthroughs are made possible by the functionalization of proteins with DNA via the creation of covalent connections. Biotechnologically generated molecules with therapeutic value for illnesses like AIDS and cancer may be created from oligonucleotides in the future.
North America dominated the oligonucleotide CDMO market in 2024. due to well-established research facilities, significant R&D expenditures for therapies based on peptides and oligonucleotides, and the rising prevalence of chronic illnesses. Biopharmaceuticals, such as oligonucleotides and peptides, have been in greater demand. By providing specialized services in the development and production of these complex compounds, CDMOs in North America are well-positioned to meet this demand. The market for peptides and oligonucleotides CDMO is growing as a result of pharmaceutical and biotech businesses' ongoing expenditures in R&D. In order to get specialized infrastructure and experience; these investments frequently entail partnerships with CDMOs.
The U.S. Food and Drug Administration is investing in clinical research for uncommon disorders, which necessitates the analysis of genetic data. Because of this, CDMOs in the United States can meet the demand for oligonucleotides. For example, the FDA announced in 2024 that seven new clinical trials funded under the Orphan Products Funding Program will be given in fiscal year (FY) 2024 for clinical trials that would address the important and frequently unmet needs of individuals with rare illnesses. Over the following four years, $17.2 million will be allocated to clinical researchers overall. During FY 2024, the FDA announced more than $5.4 million in funding for clinical research under the Rare Neurodegenerative Disease (RNDD) Grants Program.
The Canadian government is dedicated to promoting the creation of novel therapies and instruments that might save lives, enhance health outcomes, and fortify Canada's ability to innovate in the future. The Canadian government is spending over $43 million to fund 14 new clinical studies aimed at developing the nation's life sciences industry and equipping Canada to handle future medical catastrophes. With this additional support, 36 clinical trial programs have received more than $103.1M since 2022.
Asia Pacific is estimated to host the fastest-growing oligonucleotide CDMO market during the forecast period. Asia Pacific has emerged as a dynamic and rapidly growing region in the world market. Due to a number of circumstances, including their sizable populations, concentration on biopharmaceutical developments, and encouraging healthcare investments, countries like China, Japan, India, and South Korea are leading the way in this development. Over the past several years, Asia Pacific's market share has increased significantly. The region's economic growth and affluence are partly responsible for this feature, which makes it a desirable location for outsourcing the manufacturing of pharmaceuticals. Additionally, this growing trend in the region's market share has been strengthened by increased investments in R&D along with advancements in healthcare infrastructure.
China is increasingly turning its attention to neighboring areas as tech competition enters the biotech industry in an effort to relieve supply chain concerns brought on by the United States. Southeast Asia has become a popular travel destination as a result of this shift. The biopharmaceutical industry is a critical rising sector that is related to national economic growth, public welfare, and national security, according to Chinese President Xi Jinping. China has been further encouraged to increase its geopolitical influence by the region's increasing need for easily accessible and reasonably priced biopharmaceutical goods, especially in response to chronic illnesses and infectious diseases.
With around 4% of the global biotech industry and significant capabilities in vaccines and biopharmaceuticals, India's biotechnology sector is quickly becoming a key engine of both economic and technical progress. From a $10 billion business in 2014 to over $130 billion in 2024 and expected to reach $300 billion by 2030, India's biotechnology sector has seen remarkable expansion. The Indian government has already approved 1000 crores in 2024 to further spur biotechnology innovation.
Europe is expected to be significantly growing in the oligonucleotide CDMO market during the forecast period propelled by its robust pharmaceutical and biotechnology sectors, as well as the existence of important market participants. The adoption of peptide and oligonucleotide CDMO services for the creation and production of cutting-edge medicines and diagnostics is facilitated by the region's strong regulatory environment and high standards of quality.
With more than 650 biotech businesses, Germany's biopharmaceutical sector ranks fourth in the world. It is fueled by bioregions and robust industry-research-government partnerships. Due to an aging population and an increase in chronic illnesses, the industry sees an 8% annual prescription growth, with firms like Calidi Biotherapeutics, Eleva Biologics, and Roche profiting from Germany's strategic advantages. These trends will be addressed by #BMG2025, which is committed to advancing bioprocessing innovation and market expansion.
A world-class talent base and a long-term strategy and cooperation with the government underpin the UK's thriving, global biopharmaceutical sector. With a $1.5 trillion worldwide market, the biopharmaceutical industry is one with rapid development. Growth and prospects in drug discovery, advanced treatments, R&D services, data and empirical evidence, bioprocessing and bioengineering, and AI applications in R&D and healthcare have been the main drivers of this. In Q1 and Q2 of 2024, the UK's cutting-edge biotech and life sciences industry has already raised £1.98 billion in investment, up from £1.80 billion the previous year.
In September 2024, Jingui Yong, general manager of Ribobay Pharma, stated: With Cytiva's help, we will quickly grow our oligo CRDMO business by producing unique, high-quality medications and a new vaccine adjuvant (CpG-ODNs) for clients throughout the world. With our partners, we are eager to expand on existing synergies and provide further value. Cytiva and Ribobay Pharma's partnership is a flexible reaction to market demands and developmental roadblocks.
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