Oligonucleotide CDMO Market’s CAGR of 8.9%: Key Players

According to a newly published market research report by 24LifeSciences, global oligonucleotide process development and manufacturing market was valued at USD 1.14 billion in 2024 and is projected to reach USD 2.04 billion by 2031, growing at a compound annual growth rate (CAGR) of 8.9% during the forecast period 2025-2031.

Oligonucleotides, which are short, single-stranded DNA or RNA molecules typically consisting of 20 to 30 nucleotides, play crucial roles in antisense therapy, gene silencing, and as primers or probes in molecular biology. The manufacturing process involves sophisticated techniques including solid-phase synthesis using phosphoramidite chemistry, followed by deprotection, cleavage, purification (typically using reverse-phase HPLC), and rigorous quality control analysis to ensure high purity and correct sequence integrity. These precision molecules continue to underpin the advancement of nucleic acid therapeutics and personalized medicine approaches.

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Expansion of RNA Therapeutics and Personalized Medicine Fuels Market Growth

The remarkable growth of mRNA vaccines and RNA-based therapeutics following the COVID-19 pandemic has created unprecedented demand for high-quality oligonucleotide manufacturing at commercial scale. Pharmaceutical companies are increasingly investing in advanced manufacturing capabilities to support the robust pipeline of over 500 oligonucleotide drugs currently in clinical development. The success of mRNA vaccine technology has demonstrated the tremendous potential of nucleic acid therapeutics, leading to increased R&D investment across this sector.

Additionally, the rising adoption of personalized medicine approaches, particularly in oncology and rare genetic disorders, is driving demand for custom oligonucleotide therapies that require sophisticated manufacturing processes. The U.S. FDA's approval of several oligonucleotide drugs has created clearer regulatory pathways and increased confidence in these advanced therapies among healthcare providers and patients.

Technological Advancements Enhance Manufacturing Efficiency and Scalability

Significant advancements in solid-phase synthesis and purification technologies have transformed the market by enabling more efficient production of complex oligonucleotides. Modern automated synthesis platforms now achieve 98.5% coupling efficiency, representing a substantial improvement over traditional methods. These innovations have reduced production costs while accelerating development timelines, making oligonucleotide therapies more accessible.

Continuous manufacturing approaches are revolutionizing production by reducing processing times from weeks to days while simultaneously improving batch consistency. These advancements are particularly crucial for antisense oligonucleotides and siRNA therapeutics that require complex modifications and high purity standards. The evolution of chromatography and purification technologies has been equally impressive, with new systems achieving 99.8% purity rates for therapeutic-grade oligonucleotides.

Market Challenges: Cost Pressures and Regulatory Complexity

Despite the positive growth trajectory, the market faces several notable challenges that require careful navigation:

• High development and manufacturing costs associated with the complex synthesis and purification processes required for therapeutic-grade oligonucleotides
• Stringent regulatory approval pathways in major markets including the U.S. and Europe that demand extensive documentation and quality control measures
• Global supply chain complexities affecting the availability of key raw materials, including phosphoramidites and other specialty chemicals essential for synthesis
• Technical challenges in scaling manufacturing to meet commercial demand while maintaining product quality and consistency

The high cost of oligonucleotide therapeutics, with some treatments costing approximately $450,000 annually, creates significant pricing pressure that manufacturers must address through continuous process optimization and cost reduction strategies.

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North America Leads the Global Oligonucleotide Manufacturing Market

The North American region dominates the global oligonucleotide process development and manufacturing market, accounting for approximately 42% of total market share. This leadership position is driven by several key factors:

• Presence of major pharmaceutical and biotechnology companies with extensive R&D capabilities
• Advanced research infrastructure and substantial investment in bioprocessing technologies
• Favorable regulatory frameworks and established pathways for advanced therapy approval
• Strong demand for personalized medicine approaches that rely heavily on custom oligonucleotide manufacturing

Europe maintains a strong secondary position with 31% market share, characterized by advanced regulatory frameworks and quality standards, while the Asia-Pacific region shows the fastest growth rate due to increasing outsourcing to CMOs and government initiatives supporting biotechnology development.

Pharmaceutical Companies Dominate Market by End User

By end user, pharmaceutical and biotechnology companies represent the largest and most critical segment due to their significant investments in oligonucleotide therapeutics and the need for robust manufacturing processes to support clinical trials and commercialization. The complex nature of oligonucleotide drugs requires specialized expertise and infrastructure, making this segment particularly important for market growth.
By application, therapeutic development holds the dominant share owing to the increasing number of oligonucleotide-based drugs entering clinical trials and reaching commercialization, driven by advances in cancer immunotherapy and genetic disorder treatments.

Competitive Landscape: Innovation-Driven with Strategic Partnerships

Global oligonucleotide process development and manufacturing market features a competitive landscape where innovation and technological capability determine market position. The environment is shaped by factors including product quality, regulatory compliance, manufacturing scale, and research collaboration networks.

Key companies profiled in the report include:

• Thermo Fisher Scientific Inc.
• Danaher Corporation (IDT)
• Merck KGaA
• Eurofins Scientific
• LGC Limited
• ST Pharm
• EUROAPI
• and More

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Market Opportunities: Emerging Applications and Geographic Expansion

Significant growth opportunities exist in emerging markets across Asia-Pacific and Latin America, supported by improving healthcare access and rising awareness of advanced therapies. Countries like China and India are developing sophisticated manufacturing capabilities, reducing dependence on imports and creating new hubs for oligonucleotide production.

Furthermore, the development of novel oligonucleotide applications in areas such as CRISPR gene editing, personalized cancer vaccines, and targeted drug delivery systems is expected to generate new intellectual property and expand clinical adoption. The convergence of oligonucleotide technology with other advanced therapeutic modalities presents additional avenues for market expansion and innovation.

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https://www.24lifesciences.com/oligonucleotide-process-development-and-manufacturing-market-5182

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