United States Oligonucleotide Synthesis Market: Government Initiatives and Strategic Developments by Leading Players to Drive Growth

The United States oligonucleotide synthesis market is poised for substantial growth, driven by increasing demand for therapeutic and diagnostic applications, rising investment in life sciences research, and the continued emphasis on precision and personalized medicine. According to new industry insights, the global oligonucleotide synthesis market, valued at US$8.9 billion in 2024, expanded to US$10.5 billion in 2025 and is expected to advance at a robust CAGR of 18.6% from 2025 to 2030, ultimately reaching US$24.7 billion by the end of the period.

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Oligonucleotide synthesis – the chemical process of creating short DNA or RNA fragments – is a critical component of modern biotechnology, enabling breakthroughs in drug development, diagnostics, and genetic research. The U.S. market, home to many leading biotechnology and pharmaceutical innovators, plays a central role in driving global growth.

Key Market Drivers: Therapeutics and Diagnostics Fuel Demand

A primary growth driver is the increasing use of synthesized oligonucleotides in therapeutics and diagnostics. Oligonucleotide-based drugs have demonstrated significant potential in treating neurological disorders, genetic diseases, and rare orphan conditions. The U.S. Food and Drug Administration (FDA) has accelerated approvals for therapies built on antisense oligonucleotides (ASOs) and small interfering RNA (siRNA), underscoring both their effectiveness and safety.

Beyond drug development, oligonucleotides are indispensable in molecular diagnostics, genetic testing, and research applications. Their versatility and ability to deliver precise detection of genetic sequences make them crucial in identifying infectious and hereditary diseases. Modified oligonucleotides with fluorescent probes enhance diagnostic sensitivity, supporting advances in precision medicine and clinical research.

Market Restraints: Complexity and Waste Management

Despite its rapid growth, the oligonucleotide synthesis industry faces notable challenges. One major barrier is the complexity of manufacturing therapeutic oligonucleotides. The synthesis process demands high accuracy in sequence length and structural uniformity, with strict quality control required to meet regulatory standards. As oligonucleotide structures increase in size and intricacy, production becomes more difficult, reducing yields and increasing costs.

Another pressing issue is the environmental impact of synthesis. Large volumes of chemical waste are generated, much of it from unused nucleotides, which adds both cost and compliance challenges. Safe disposal in adherence with environmental regulations further complicates production and reduces overall efficiency.

Opportunities: Emerging Economies and Personalized Medicine

Emerging markets such as China, India, Japan, Brazil, and Argentina present lucrative opportunities for global and U.S.-based players. These regions are witnessing accelerated investments in biotechnology, healthcare infrastructure, and R&D. For example, in 2023, Merck KGaA announced a USD 76 million investment to expand manufacturing in Nantong, China, strengthening local production and facilitating innovation.

Additionally, the global shift toward personalized medicine continues to fuel demand for oligonucleotide-based therapies. These therapies, designed to target specific genetic markers, align with the rising prevalence of precision medicine initiatives across the U.S. healthcare system. Hospitals, diagnostic laboratories, and biotech firms are at the forefront of adopting these technologies, creating a favorable environment for long-term market growth.

Challenges: Delivery Mechanisms for Oligonucleotide Drugs

One of the most pressing challenges remains drug delivery. Traditional intravenous (IV) delivery is often inefficient, limiting the quantity of oligonucleotide-based drugs reaching the intended tissues. This is particularly problematic for treating neurological diseases, where the blood-brain barrier (BBB) poses a formidable obstacle. The negative charge and large molecular size of oligonucleotides further hinder cellular penetration.

Addressing these delivery challenges is critical for unlocking the full therapeutic potential of oligonucleotides. Research into nanoparticle carriers, lipid-based delivery systems, and advanced targeting technologies is underway, offering promising avenues for improved efficacy.

Market Segmentation

By Product:

Oligonucleotide-based drugs are expected to dominate during the forecast period, reflecting the increasing approvals of ASO and siRNA-based therapeutics.

Additional segments include synthesized oligonucleotides, reagents & consumables, and synthesis equipment.

By Application:

Therapeutic applications will continue to account for the largest market share, followed by research and diagnostic applications. Growing acceptance of oligonucleotide-based treatments for both rare and more common conditions, such as cardiovascular diseases, is a key factor driving this trend.

By Region:

North America leads the global market, followed by Europe and Asia Pacific. The United States remains the single largest contributor, supported by a strong research ecosystem, favorable regulatory environment, and presence of major market players.

Key Market Players

The United States remains home to several leading companies shaping the oligonucleotide synthesis landscape, including:

Danaher Corporation (US)

Thermo Fisher Scientific Inc. (US)

Agilent Technologies, Inc. (US)

Maravai LifeSciences (US)

Ionis Pharmaceuticals, Inc. (US)

Alnylam Pharmaceuticals, Inc. (US)

Biogen (US)

Sarepta Therapeutics, Inc. (US)

Creative Biogene (US)

Azenta US Inc. (US)

These companies, alongside international leaders such as Merck KGaA (Germany), AstraZeneca (UK), Nippon Shinyaku (Japan), Novartis AG (Switzerland), and Eurofins Scientific (Luxembourg), are investing heavily in research, manufacturing, and commercialization.

Outlook: A Strong Growth Trajectory

The U.S. oligonucleotide synthesis market is on track to play a defining role in shaping the future of therapeutics, diagnostics, and research. With strong demand for precision medicine, increasing FDA approvals, and robust investments in biotechnology infrastructure, the sector is positioned for sustained expansion.

While challenges around production efficiency, waste management, and drug delivery remain, advances in synthetic biology and innovative delivery systems are expected to mitigate these barriers. As a result, the market is well-positioned to reach US$24.7 billion globally by 2030, with the United States continuing to be a pivotal driver of growth.