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MARKET INSIGHTS
The 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, exhibiting a compound annual growth rate (CAGR) of 8.9%. This growth is primarily driven by the increasing demand for nucleic acid therapeutics, including mRNA vaccines, gene therapies, and CRISPR-based gene editing applications.
Oligonucleotides are short, single-stranded DNA or RNA molecules typically consisting of 20 to 30 nucleotides. They play crucial roles in antisense therapy, gene silencing, and as primers or probes in molecular biology. The manufacturing process involves solid-phase synthesis using phosphoramidite chemistry, followed by deprotection, cleavage, purification (typically using reverse-phase HPLC), and quality control analysis to ensure high purity and correct sequence integrity.
Market growth is fueled by several key factors. The COVID-19 pandemic accelerated mRNA vaccine development, demonstrating the potential of nucleic acid therapeutics and increasing R&D investment in this sector. The U.S. FDA's approval of several oligonucleotide drugs (e.g., Inotersen, Nusinersen) created regulatory pathways and increased confidence in these therapies. Advances in cancer immunotherapy and personalized medicine also drive demand for customized oligonucleotides. Additionally, the rising prevalence of genetic disorders increases demand for gene therapies and antisense oligonucleotides.
North America currently dominates the market (42% share), followed by Europe (31%) and Asia-Pacific (22%). However, Asia-Pacific is expected to show the highest growth rate due to increasing outsourcing to CMOs in countries like China and India, government initiatives supporting biotechnology, and growing pharmaceutical R&D expenditure. Key market players include Thermo Fisher Scientific, Danaher Corporation (through its IDT subsidiary), Merck KGaA, Eurofins Scientific, and FUJIFILM Irvine Scientific, among others.
Looking ahead, the market faces both opportunities and challenges. Emerging applications in CRISPR gene editing and mRNA therapeutics continue to drive demand. However, scaling manufacturing to meet commercial demand while maintaining quality presents challenges. The high cost of oligonucleotide therapeutics (e.g., Tegsedi costs approximately $450,000 annually) also creates pricing pressure that manufacturers must address through process optimization and cost reduction.
Rising Demand for Precision Medicine
The increasing adoption of personalized medicine approaches, particularly in oncology and rare genetic disorders, is driving demand for custom oligonucleotide therapies that require sophisticated manufacturing processes.
Expansion of RNA Therapeutics
The rapid 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 investing heavily in advanced manufacturing capabilities to support the pipeline of over 500 oligonucleotide drugs in clinical development.
Advancements in solid-phase synthesis and purification technologies have enabled more efficient production of complex oligonucleotides, reducing costs and accelerating development timelines.
MARKET CHALLENGES
High Development and Manufacturing Costs
The complex synthesis and purification processes required for therapeutic-grade oligonucleotides result in significantly higher production costs compared to traditional small molecule drugs, with current costs ranging from $500 to $2,000 per gram for research-grade material.
Other Challenges
Regulatory Compliance Hurdles
Meeting evolving regulatory requirements across different regions requires extensive documentation and quality control measures that add complexity to the manufacturing process.
Supply Chain Complexity
Global supply chain disruptions continue to affect the availability of key raw materials, including phosphoramidites and other specialty chemicals essential for oligonucleotide synthesis.
High Capital Investment Requirements
Establishing a state-of-the-art oligonucleotide manufacturing facility requires investments exceeding $50 million, creating significant barriers to entry for new market entrants and limiting expansion capacity among existing players.
Emerging Markets Expansion
Growing pharmaceutical industries in Asia-Pacific countries, particularly China and India, are creating new opportunities for contract manufacturing organizations (CMOs) specializing in oligonucleotide production. The market is expected to grow at a CAGR of 15.3% through 2030.
Personalized Medicine Advancements
The rise of personalized cancer vaccines and gene therapies requiring custom oligonucleotides is creating specialized niches for manufacturers with advanced technological capabilities. Current estimates suggest the addressable market for personalized oligonucleotide therapies exceeds $12 billion by 2028.
| Segment Category | Sub-Segments | Key Insights |
| By Type |
|
Synthetic Oligonucleotides dominate due to their versatility in research applications and the ability to create custom sequences for specific therapeutic or diagnostic applications, while the custom synthesis segment shows strong growth driven by personalized medicine requirements. |
| By Application |
|
Therapeutic Development leads as pharmaceutical companies increasingly invest in oligonucleotide-based therapies for rare diseases and complex disorders, while research applications remain strong due to academic and institutional research into gene function and regulation mechanisms. |
| By End User |
|
Pharmaceutical & Biotech Companies lead in adoption due to their significant investments in oligonucleotide therapeutics and the need for robust manufacturing processes to support clinical trials and eventual commercialization of these advanced therapies. |
Companies Invest in Advanced Technologies to Strengthen Competitive Position
Thermo Fisher Scientific Inc. (USA) maintains a dominant position in the oligonucleotide process development and manufacturing market, leveraging its extensive portfolio of analytical instruments and purification systems. The company's strong global presence and comprehensive service offerings make it a preferred partner for pharmaceutical companies.
Danaher Corporation (USA), through its subsidiary Integrated DNA Technologies, has significantly expanded its oligonucleotide manufacturing capabilities, offering custom synthesis and large-scale production services. The company's focus on quality control and process optimization has strengthened its competitive position.
Merck KGaA (Germany) continues to invest in expanding its oligonucleotide manufacturing facilities, particularly focusing on therapeutic-grade production. The company's recent acquisitions have enhanced its capabilities in the production of modified oligonucleotides for therapeutic applications.
Eurofins Scientific (Luxembourg) has emerged as a key player through strategic acquisitions and organic growth, offering end-to-end solutions from process development to commercial manufacturing. Their global network of facilities allows for regional manufacturing capabilities.
List of Key Oligonucleotide Process Development and Manufacturing CompaniesThermo Fisher Scientific Inc. (USA)
Danaher Corporation (USA)
Merck KGaA (Germany)
Eurofins Scientific (Luxembourg)
LGC Limited (UK)
Danaher Corporation (USA)
The global oligonucleotide therapeutics market is experiencing unprecedented growth, with demand for personalized medicine approaches driving increased investment in process development and manufacturing capabilities. Pharmaceutical companies are allocating over $2.5 billion annually to expand their oligonucleotide manufacturing facilities, focusing primarily on North American and European markets where regulatory frameworks are most developed.
Other TrendsIncreased Outsourcing to CROs and CDMOs
The complexity of oligonucleotide synthesis and purification has led to 35% annual growth in outsourcing to specialized contract organizations. These partners are developing novel purification technologies that reduce manufacturing costs by up to 40% while improving product consistency and yield. Major pharmaceutical companies are establishing long-term partnerships with CDMOs possessing advanced purification and analytical capabilities.
Chromatography and purification technologies have evolved significantly, with new systems achieving 99.8% purity rates for therapeutic-grade oligonucleotides. These advancements are critical as regulatory agencies demand higher quality standards. The market has responded with investments exceeding $800 million in purification technology development over the past two years.
Continuous manufacturing approaches are reducing production times from weeks to days while improving batch consistency. Automated synthesis platforms now achieve 98.5% coupling efficiency, representing a 15% improvement over traditional methods. These advancements are particularly crucial for antisense oligonucleotides and siRNA therapeutics requiring complex modifications.
Regulatory harmonization efforts between FDA and EMA have created clearer pathways for oligonucleotide drug approval, accelerating process development timelines by approximately 40%. The market now sees 25% more investigational new drug applications involving oligonucleotides compared to five years ago, with manufacturing capacity expanding correspondingly.
Regional Analysis: Oligonucleotide Process Development and Manufacturing MarketEurope
Europe maintains a strong position in oligonucleotide process development and manufacturing, characterized by advanced regulatory frameworks and quality standards. The European Medicines Agency (EMA) provides clear guidance for advanced therapy medicinal products, facilitating market entry. Several European countries have established specialized centers for advanced therapy manufacturing, creating clusters of expertise. The region benefits from cross-border collaboration and harmonized regulations within the EU, enabling efficient technology transfer and scale-up. European companies also show strong export activity, supplying both domestic and international markets with oligonucleotide-based therapies and research compounds.
Asia-Pacific
Asia-Pacific shows exceptional growth in oligonucleotide process development and manufacturing, driven by increasing healthcare investments and growing biopharmaceutical sector. Countries like China and South Korea have made significant progress in developing domestic manufacturing capabilities, reducing dependence on imports. The region benefits from government initiatives supporting biotechnology development and increasing international collaborations. Several Asia-Pacific countries now host state-of-the-art manufacturing facilities that serve both domestic needs and export markets. The region's growing expertise in bioprocessing and competitive cost structure positions it as both a major manufacturing hub and emerging market for oligonucleotide-based therapies.
Global Collaborations
Global collaboration plays a crucial role in oligonucleotide process development and manufacturing, with North American and European companies increasingly partnering with Asian manufacturers for cost-effective production. These collaborations often involve technology transfer, joint development programs, and shared expertise in process optimization. International regulatory harmonization efforts also facilitate smoother technology transfer and market entry across regions. Collaborations extend beyond manufacturing to include joint research initiatives, clinical trial partnerships, and regulatory pathway alignment, creating a more integrated global market for oligonucleotide-based therapies and technologies.
Emerging Markets
Beyond the traditional strongholds, several emerging markets show promising growth in oligonucleotide process development and manufacturing capabilities. Countries in Latin America, particularly Brazil and Mexico, are developing their capabilities in biomanufacturing and advanced therapies. Middle Eastern countries with strong healthcare investments, particularly in the Gulf region, are beginning to develop local manufacturing capabilities for advanced therapies. These emerging markets benefit from technology transfer from established regions while adapting processes to local needs and regulations, creating new growth opportunities in the global landscape of oligonucleotide process development and manufacturing.
This market research report offers a holistic overview of global and regional markets for the forecast period 2025–2032. It presents accurate and actionable insights based on a blend of primary and secondary research.
✅ Market Overview
Global and regional market size (historical & forecast)
Growth trends and value/volume projections
✅ Segmentation Analysis
By product type or category
By application or usage area
By end-user industry
By distribution channel (if applicable)
✅ Regional Insights
North America, Europe, Asia-Pacific, Latin America, Middle East & Africa
Country-level data for key markets
✅ Competitive Landscape
Company profiles and market share analysis
Key strategies: M&A, partnerships, expansions
极彩Product portfolio and pricing strategies
✅ Technology & Innovation
Emerging technologies and R&D trends
Automation, digitalization, sustainability initiatives
Impact of AI, IoT, or other disruptors (where applicable)
✅ Market Dynamics
极彩Key drivers supporting market growth
Restraints and potential risk factors
Supply chain trends and challenges
✅ Opportunities & Recommendations
High-growth segments
Investment hotspots
Strategic suggestions for stakeholders
✅ Stakeholder Insights
This report is designed to support strategic decision-making for a wide range of stakeholders, including:
Pharmaceutical and biotech companies
Medical device and diagnostics manufacturers
Healthcare providers and hospital systems
Contract research and manufacturing organizations
Investors, consultants, and policy makers
-> Global oligonucleotide process development and manufacturing market was valued at USD 1143 million in 2024 and is projected to reach USD 2037 million by 2031.
Which key companies operate in Global Oligonucleotide Process Development and Manufacturing Market?
-> Key players include ST Pharm, EUROAPI, Danaher(IDT), Merck, Eurofins Scientific, Thermo Fisher Scientific, Agilent Technologies, Nippon Shokubai, Eurogentec, and Ajinomoto Bio-Pharma, among others.
-> Key growth drivers include increasing demand for nucleic acid therapeutics, mRNA vaccine development, and the rising prevalence of genetic disorders.
-> North America is the dominant market with a 42% share, while Asia-Pacific is expected to show the highest growth rate.
-> Emerging trends include advancements in CRISPR gene editing, mRNA therapeutics, and process optimization for cost reduction.
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