Global DNA Manufacturing Market Poised to Quadruple by 2032, Driven by Gene Therapy and mRNA Vaccine Innovations

Rapid Expansion of the Global DNA Manufacturing Market

The DNA manufacturing market, valued at USD 5.18 billion in 2024, is forecasted to reach USD 20.28 billion by 2032, registering a robust CAGR of 18.65% during 2025–2032. Growth is primarily propelled by the surging applications of DNA in cell and gene therapy, vaccine development, and synthetic biology. High demand for plasmid and synthetic DNA in pharmaceutical, biotechnology, and research sectors is prompting investments in advanced automation, gene synthesis technologies, and GMP-grade production, driving global scalability and faster turnaround times.

The U.S. remains the dominant player in North America, with its market estimated at USD 1.73 billion in 2024 and projected to grow to USD 6.63 billion by 2032 at a CAGR of 18.33%. The country benefits from a well-established biotech ecosystem, extensive academic and industrial research, and federal support for genomics and gene therapy. Key industry leaders such as Thermo Fisher Scientific, Integrated DNA Technologies, and Twist Bioscience further reinforce the U.S.’s position as a global DNA manufacturing hub.

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Vaccine Development Accelerates Market Growth

The expansion of mRNA and DNA vaccine platforms is a key driver of market growth. The COVID-19 pandemic underscored the importance of rapid vaccine development, increasing the need for high-quality plasmid DNA, which serves as the template for RNA synthesis in mRNA vaccines. DNA vaccines, delivering genetic material directly to cells to elicit an immune response, are gaining traction in both human and veterinary medicine. Investments from pharmaceutical companies and governments in scalable and rapid vaccine production technologies have further boosted the demand for GMP-grade DNA.

Notable developments include IMUNON’s promising Phase 1 results for its DNA plasmid vaccine (IMNN-101) against COVID-19, demonstrating six-month durability and manufacturing advantages over mRNA vaccines. Similarly, CEPI’s USD 4.7 million grant to DNA Script for enzymatic DNA template synthesis highlights efforts to accelerate vaccine readiness, particularly in under-served regions.

Technological Advancements Revolutionize DNA Manufacturing

Innovations in synthetic biology and automation are reshaping DNA manufacturing. Enzymatic DNA synthesis, high-throughput gene assembly, and benchtop automated platforms, such as BioXp systems, enable faster, more accurate, and cost-effective DNA production. Automation minimizes errors, increases reproducibility, and scales production to meet rising demand across therapeutics, diagnostics, and agricultural applications.

For instance, Telesis Bio introduced the Gibson SOLA enzymatic synthesis platform in May 2025, offering high-fidelity, automated DNA synthesis integrated with liquid-handling systems. Earlier, DNA Script launched its SYNTAX benchtop platform for on-demand production of up to 96 oligos, streamlining research workflows and accelerating adoption in academic and commercial labs.

Market Challenges: High Costs of GMP-Grade DNA

Despite robust growth, high production costs of GMP-grade DNA remain a restraint. Manufacturing DNA under GMP standards involves stringent quality control, cleanroom facilities, and regulatory compliance, significantly raising costs compared to R&D-grade DNA. Small biotech firms, academic institutions, and early-stage researchers often find these costs prohibitive, limiting market penetration and innovation in certain segments.

Segmentation Insights: Type, Grade, Application, and End-Use

Synthetic DNA dominated the market in 2024 with a 71.25% share due to its broad applications in genetic engineering, diagnostics, and pharmaceutical research. Its customizable nature, rapid production, and scalability make it essential for vaccine development, CRISPR gene editing, and molecular diagnostics.

Plasmid DNA, on the other hand, is projected to grow fastest, driven by applications in cell and gene therapy, DNA vaccines, and mRNA production. With increasing clinical applications and regulatory focus on GMP-quality plasmid DNA, pharmaceutical and biotech adoption continues to expand.

By grade, GMP-grade DNA accounted for 68.50% of the market in 2024, reflecting its critical role in regulated therapeutic applications, while R&D-grade DNA is expected to experience rapid growth due to its affordability and suitability for early-stage research, synthetic biology, and personalized medicine.

Among applications, cell and gene therapy dominated with a 46.20% market share in 2024, fueled by the surge in gene therapy trials and commercial demands for high-quality DNA constructs. Oligonucleotide-based drugs are anticipated to be the fastest-growing application, driven by precision medicine, RNA-targeted therapies, and technological advancements in DNA synthesis.

Pharmaceutical and biotechnology companies accounted for 60.3% of the market in 2024, leveraging DNA manufacturing for gene therapies, vaccines, and personalized medicines. Contract research organizations (CROs) are expected to witness the fastest growth as companies increasingly outsource DNA production for specialized and cost-efficient services, especially under GMP conditions.

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Regional Analysis: North America Leads, Asia Pacific Surges

North America led the global DNA manufacturing market in 2024, holding a 45.05% share, due to strong biotech infrastructure, high investment in genomics, and the presence of key market players. Government support, high clinical trial activity, and well-established regulatory frameworks further strengthen the region’s position.

Asia Pacific is forecasted to be the fastest-growing region, with a CAGR of 19.58% through 2032. Investment in life sciences, growing biopharmaceutical industries, and government-backed initiatives in countries like China, India, and South Korea are driving growth. Increasing local DNA production and clinical research expansion are catalyzing adoption in academic and commercial sectors.

Europe is also witnessing significant growth, driven by strong pharmaceutical sectors in Germany, the UK, and France, alongside academic-commercial collaborations such as Catalent’s plasmid DNA facility in Belgium and Imperial College London’s advanced DNA synthesis platforms. Latin America and the Middle East & Africa are experiencing moderate growth due to emerging research infrastructure and partnerships with global biotech firms.

Key Players and Recent Developments

Prominent players shaping the DNA manufacturing landscape include Thermo Fisher Scientific, Integrated DNA Technologies, GenScript Biotech Corporation, Eurofins Scientific, Twist Bioscience, Bioneer Corporation, LGC Biosearch Technologies, Quintara Biosciences, Eton Bioscience, and Codex DNA (Telesis Bio Inc.).

Recent developments underscore the market’s rapid evolution. In June 2024, GenScript launched its FLASH Gene service for accelerated sequence-to-plasmid delivery. Thermo Fisher introduced the KingFisher PlasmidPro Maxi Processor, automating large-scale plasmid purification. IDT completed a new Therapeutic Oligonucleotide Manufacturing plant in Iowa to meet rising global demand.

Future Outlook

The global DNA manufacturing market is poised for continued expansion, driven by the convergence of gene therapy, synthetic biology, and mRNA vaccine innovation. Technological advancements in automated DNA synthesis, coupled with increasing GMP-grade production, will improve accessibility, efficiency, and cost-effectiveness. Rising demand from pharmaceutical, biotechnology, and research sectors worldwide will sustain market momentum through 2032, while emerging regions in Asia Pacific and Europe will play pivotal roles in shaping global production capabilities.

Conclusion

As the DNA manufacturing industry scales new heights, driven by scientific innovation and regulatory adoption, it is transforming the way therapies, vaccines, and diagnostics are developed. With GMP-grade DNA production at the forefront of clinical and commercial applications, and R&D-grade DNA fueling research innovation, the market is well-positioned to support the global life sciences ecosystem in the coming decade.