US DNA Synthesis Market 2025 – 2034

As per the US DNA Synthesis Market analysis conducted by the CMI team, the US DNA synthesis market is expected to record a CAGR of 19.57% from 2025 to 2034. In 2025, the market size was USD 3.73 Billion. By 2034, the valuation is anticipated to reach USD 18.67 Billion.

Overview

The increasing focus on infectious disease solutions and vaccines is one of the critical drivers to the US DNA synthesis market. In April 2025, technology Networks did highlight rising interest in the DNA vaccines as one of the promising alternatives to mRNA technology. The article mentioned that DNA vaccines offer numerous advantages, inclusive of improved stability, simplicity of storage, and affordability, which are important for distribution of vaccines all over the US.

The overall discussion also indicated recent advancements in the DNA vaccine platforms like IMUNON’s PlaCCine, which aim toward improvement of immune responses and widen applicability of the DNA-based vaccines way beyond the infectious diseases.

The efforts are also ON regarding the development of next-generation vaccines against the upcoming infectious diseases, and enhancements in the synthetic vaccine platforms continue driving the need for reliable and scalable DNA synthesis.

Key Trends & Drivers

• Rise in Demand for DNA Sequences and Synthetic Genes

The demand for DNA sequences and synthetic genes has been increasing at a faster rate with advancements in genetic engineering and synthetic biology. DNA sequences and synthetic genes could be used effectively for creating new proteins, enzymes, and other molecules with specified properties, which could be used in numerous applications such as drug development, gene therapy, and agricultural biotechnology. On these grounds, Evonetix does describe DNA synthesizer technology that would expedite development across various therapeutic modalities.

• Rise in Applications in Food and Agriculture Vertical

DNA synthesis is used in farming for improving crops, inclusive of the development of genetically modified organisms (GMOs), trait introgression, and gene stacking. DNA synthesis is used for engineering genetically modified (GM) crops with various desirable traits such as improved nutritional content, improved yield, and tolerance to environmental hazards. Scientists, by synthesis of specified DNA sequences and their introduction to plant genomes, do develop crops with various targeted genetic modifications.

Furthermore, several farming operations, like crop cultivation, result in alterations with respect to gene expression. DNA technology is used for detecting changes in levels, assisting in regulating crop growth and development. DNA standards have the ability of being used in verification of reliability and precision of molecular detection methods like polymerase chain reaction (PCR), detection of allergens, genetically modified organisms (GMOs), and contaminants. The US Department of Energy has invested US$178 Mn for several bioenergy projects in order to advance sustainable technology, which aids in enhancing public health.

What’s trending in the US DNA Synthesis Market?

DNA sequencing has turned out to be a vital tool in several sectors like biotechnology, molecular biology, synthetic biology, and genetic engineering. DNA synthesis technology could be accessed easily. As such, it is available to a wide spectrum of consumers, such as scientists, researchers, and the like. DNA sequencing does develop user-friendly platforms as well as software for designing DNA. Also, open source initiatives with protocols are expected to keep the cash registers ringing for the market for DNA synthesis in the US.

Key Threats

• Errors and Safety Concerns

Though DNA synthesis technology has shown improvement in the last few years, the likelihood of occurrence of errors can’t be ruled out. For instance, synthesized DNA’s quantity is determined using several methods like quantitative PCR (qPCR) or UV spectroscopy. This ascertains that the desired quantity of DNA is synthesized. The manufacturers may also go for functional tests for assessing synthesized DNA’s performance. These tests imply cloning of the DNA into a host organism and evaluating the functionality in numerous assays. This is where errors could occur, i.e. during polymerase elongation or mis-hybridization.

Also, there is a risk involved in the form of accidental release of synthetic DNA or creation of dangerous pathogens. This, in turn, could involve putting strict safety protocols into practice, which could be pricey and cumbersome.

These are a few threats to the US DNA synthesis market.

Opportunities

Personalized medicine finds its base in pharmacogenomics, pharmacometabolomics, pharmacogenetics, and pharmacoproteomics information. It aids in improving early diagnosis as well as prevention of several disorders and monitoring the therapy. The scientists are utilizing gene synthesis for developing personalized medicine for the patients with specified genetic mutations and variations. DNA synthesis plays a crucial role in developing DNA-based diagnostic tests. They imply using synthetic DNA primers or probes for detecting genetic sequences linked with pathogens, diseases, or genetic variations. The rise in demand for precision diagnostics and personalized diagnostics is likely to drive growth of DNA-based diagnostics in the near future.

The researchers are also using gene synthesis for designing custom DNA chains, which are, in turn, used for designing personalized treatments for patients with exclusive mutations or variations. For instance, scientists are being able to target the cancer antigens specific to every patient by deploying gene synthesis to have personalized cancer vaccines in place. According to the National Center for biotechnology Information (NCBI), 9.4% of pediatric patients are battling genetic disorders, out of which newborns constitute 44.7%. It further states that nearly 13.17 million patients are suffering from genetic disorders all across the US

Category Wise Insights

By Service Type

• Oligonucleotide Synthesis

Oligonucleotides are important for genetics, molecular biology, and genomics, whereby they extend support to applications such as DNA sequencing, PCR, and gene expression studies. In May 2025, the Oligo factory launched low-scale oligo synthesis capabilities all across the US, thereby facilitating the production of GMP-ready, small custom nucleotides. This expansion is enhancing access to diagnostic, therapeutic, and life science applications.

• Gene Synthesis

The gene synthesis segment is driven by increasing prevalence of cancers and genetic disorders, growing investment in various advanced therapies, and rising adoption of gene editing technologies like CRISPR-Cas9. Expansion of clinical trials followed by regulatory approvals for cell-based and gene treatments has accelerated the demand for high-class DNA products further. In May 2025, the United States Pharmacopeia (USP) introduced a webinar emphasizing plasmid DNA standards, wherein it highlighted the vitality of quality control in gene therapy and the requirement for strong regulatory practices. These initiatives are aiding in strengthening industry standards and reinforcing DNA synthesis’ critical role in facilitating effective and safe gene and cell therapies.

By Application

• Research & Development

The research & development segment of the US DNA synthesis market is catalyzed by increased use of DNA synthesis for supporting ongoing research studies all across the US Oligonucleotides are required for molecular biology research, drug development, and genetic testing. Along these lines, researchers in the US, in August 2024, launched the synthetic “alien” DNA, thereby expanding therapeutic and diagnostic capabilities by improving molecular binding specificity for enhanced disease detection with targeted treatment applications. The researchers are also employing CRISPR for different applications encompassing therapeutic interventions and knockout studies.

• Diagnostics

Diagnostics make use of synthetic DNA for gene editing (like CRISPR) as well as personalized medicine that relies on exclusive DNA sequences. Diagnostics companies utilize synthetic DNA for creating probes for several diagnostic techniques, thereby facilitating proper identification of genetic mutations and pathogens. Advancements in DNA synthesis that comprise enzymatic methods are increasing precision, speed, and affordability, thereby meeting the requirements of the diagnostic field.

• Therapeutics

Nucleotide synthesis is important in extending support to the ongoing therapeutic research all over the US, thereby facilitating scalable and consistent development of genetic solutions. With precise and rapid DNA synthesis technologies available, profiling as well as targeting of a wide range of disease markers, right from designing synthetic gene circuits to screening and engineering enzymes for therapeutic applications, is possible.

By End-use

• Biopharmaceutical & Diagnostics Companies

The biopharmaceutical & diagnostic companies hold more than 40% of the market share. This dominance is credited to extensive usage of high-purity DNA products in gene therapies, drug development, and vaccine manufacturing. The pharmaceutical companies show a sizable reliance on biotechnology DNA for ascertaining safety, regulatory compliance, and efficacy in commercial and clinical applications. In January 2025, LineaRx completed construction of a GMP facility in New York with the objective of addressing the growing demand for domestic DNA synthesis of supporting mRNA therapeutics and various reshoring activities.

• Academic & Research Institutes

Universities and research institutions are the major consumers of DNA synthesis, thereby using it for excessive research in areas such as genomics, genetic editing, synthetic biology, and epigenetics. Such institutions are important in educating as well as training the future researchers and scientists in utilization of DNA synthesis technologies, thereby driving market growth.

• Contract Research Organizations

The contract research organizations (CROs) is likely to witness the quickest CAGR all through the forecast period. This is due to growing demand for outsourced DNA synthesis, thereby facilitating pharmaceutical and biotechnology companies to expedite research & development timelines while conducting cost optimization. The rising complexity on the part of personalized medicine and DNA-based therapeutics catalyzes reliance on CROs, which does position them as key contributors toward market growth.

How are Regulatory Frameworks Influencing the US DNA Synthesis Market?

Regulatory frameworks do influence the US DNA synthesis market in the form of ascertaining genetic technologies’ efficacy, safety, and ethical application. The US FDA does oversee regulation of the gene therapy products, inclusive of the ones implying genome editing, under the Public Health Service Act and the Federal Food, Drug, and Cosmetic Act. The manufacturers need to adhere to stern guidelines such as Good Tissue Practice (GTP) and Good Laboratory Practice (GLP) in order to make sure that the products are quality-compliant and safe.

Report Scope

Key Developments

The US DNA synthesis market is witnessing a significant organic and inorganic expansion. Some of the key developments include –

• In May 2025, Aldevron, in collaboration with Integrated DNA Technologies (IDT), launched the world’s very first mRNA-based personalized CRISPR therapy. The objective was to treat infants battling life-threatening urea cycle disorder (UCD) with a treatment that could be delivered within six months (three times quicker than the standard timeline meant for gene editing drug products).

• In October 2024, Twist Bioscience inked a royalty purchase agreement worth US$ 15 Mn with XOMA Royalty, thereby granting the latter rights to royalties from the former’s gene therapy as well as mRNA vaccine collaborations.

The US DNA synthesis market is highly competitive, with a large number of service providers globally. Some of the key players in the market include:

• Charles River Laboratories
• VGXI Inc.
• Danaher (Aldevron)
• Thermo Fisher Scientific
• Lonza
• GenScript
• Twist Bioscience
• AGC Biologics
• Catalent
• Eurofins Genomics
• Others

These firms apply a plethora of strategies to enter the market, including innovations, mergers and acquisitions, and collaboration.

The US DNA synthesis market is shaped by the presence of diversified players that compete based on product innovation, vertical integration, and cost efficiency.

The US DNA Synthesis Market is segmented as follows:

By Service Type

• Oligonucleotide Synthesis
• Type
• Standard Oligonucleotide Synthesis
• Custom Oligonucleotide Synthesis
• Length
• Less than 50 nt
• 51-100 nt
• 101-150 nt
• More than 150 nt
• Gene Synthesis
• Type
• Custom Gene Synthesis
• Gene Library Synthesis
• Length
• Less than 500 nt
• 501-1000 nt
• 1001-1500 nt
• 1501-2000 nt
• 2001-2500 nt
• More than 2500 nt

By Application

• Research & Development
• Oligonucleotide Synthesis
• PCR
• NGS
• CRISPR
• Cloning and Mutagenesis
• Others
• Gene Synthesis
• Synthetic Biology
• Vaccine Development
• Genetic Engineering
• Others
• Diagnostics
• Therapeutics
• RNAi Therapies
• Antisense Oligonucleotide-based Therapies
• Others

By End-use

• Biopharmaceutical & Diagnostics Companies
• Academic & Research Institutes
• Contract Research Organizations

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