Verified Insights
Precision-driven research you can trust. We uphold rigorous data validation processes to ensure every report is reliable and based on credible sources.
+91 9425150513 (Asia) support@24lifesciences.com
+91 9425150513 (Asia) support@24lifesciences.com
Download Sample Pdf
MARKET INSIGHTS
The global oligonucleotide CDMO and CRDMO services market was valued at USD 1.4 billion in 2024 and is projected to reach USD 2.62 billion by 2031, growing at a CAGR of 9.2%. This growth is primarily driven by the increasing adoption of RNA-based therapeutics and growing demand for personalized medicine approaches.
Oligonucleotide CDMO (Contract Development and Manufacturing Organization) and CRDMO (Contract Research, Development, and Manufacturing Organization) services provide comprehensive solutions for biopharmaceutical companies and research institutions, covering the entire process from R&D to commercial production. These services include process development, synthesis, purification, analytical method development, quality control, GMP manufacturing, and regulatory support. While CDMO primarily focuses on production and process optimization, CRDMO extends to early-stage research and preclinical development. With the rapid advancement of gene and RNA-based therapies, the demand for high-quality, regulatory-compliant oligonucleotide synthesis and manufacturing continues to grow, driving technological innovation and industrial capabilities in CDMO and CRDMO companies.
The market's rapid expansion is attributed to several key factors. First, the increasing incidence of genetic disorders and oncological diseases is driving demand for targeted therapies. Second, regulatory agencies are providing clearer pathways for oligonucleotide-based drug approvals, with the FDA approving 12 oligonucleotide drugs by 2024. Third, advancements in manufacturing technologies are reducing production costs while improving product quality. Finally, growing investment in cell and gene therapy research is creating a robust pipeline for future demand.
Regionally, North America currently dominates with 48% market share, followed by Europe at 32%, due to established regulatory frameworks and concentration of biotech companies. However, Asia-Pacific is expected to show the highest growth rate (12.3% CAGR) due to increasing outsourcing of manufacturing to countries like China and India, where labor costs are lower and regulatory environments are becoming more favorable.
The market faces several challenges including the high cost of GMP-grade oligonucleotide production (typically $150,000-$300,000 per kilogram), complex regulatory requirements across different regions, and the need for specialized cold chain logistics. However, increasing adoption of platform technologies and growing investment in precision medicine are expected to drive continued growth through 2031.
Growing Demand for Personalized Medicine
The rapid expansion of personalized medicine and targeted therapies is driving significant demand for oligonucleotide CDMO and CRDMO services. Pharmaceutical companies are increasingly outsourcing these complex manufacturing processes to specialized contract organizations.
Expanding Therapeutic Applications
With over 200 oligonucleotide-based therapies in clinical development, the demand for CDMO services has increased by 45% over the past two years. The expansion into new therapeutic areas including oncology, rare diseases, and infectious diseases continues to drive market growth.
➤ The global market for oligonucleotide therapeutics is projected to reach $12.8 billion by 2028, creating substantial opportunities for CDMO providers with specialized expertise.
Advancements in RNA therapeutics and mRNA vaccine technologies have further accelerated the need for high-quality manufacturing partners, with contract manufacturers reporting 30-50% annual growth in this segment.
MARKET CHALLENGES
High Development and Manufacturing Costs
The complex synthesis and purification processes required for oligonucleotide manufacturing present significant cost challenges. Average development costs for a single oligonucleotide drug can exceed $15 million, creating barriers for smaller biotech companies.
Other Challenges
Regulatory Compliance Complexity
Navigating the evolving regulatory landscape across different regions adds complexity. The FDA and EMA have implemented more stringent guidelines for oligonucleotide-based therapies, requiring additional quality control measures that increase development time and costs.
Manufacturing Scalability Issues
Scaling from clinical-grade to commercial-scale manufacturing presents significant technical challenges. Many CDMOs face challenges in maintaining quality consistency when scaling from kilogram to multi-kilogram production levels.
High Barrier to Entry
The specialized nature of oligonucleotide manufacturing creates significant barriers to entry. New entrants face challenges in acquiring the necessary equipment, which can cost upwards of $50 million, and require specialized expertise that is in limited supply globally.
Emerging Markets Expansion
The Asia-Pacific region shows particularly strong growth potential, with countries like China, South Korea, and Singapore investing heavily in biomanufacturing infrastructure. Current estimates suggest the Asian market will grow at 22% CAGR through 2028, creating substantial opportunities for CDMOs with global capabilities.
Advanced Technology Integration
Integration of artificial intelligence and machine learning in process optimization presents a significant opportunity. Companies that successfully implement AI-driven manufacturing processes have shown 40% reduction in development time and 30% cost reduction compared to traditional methods.
| Segment Category | Sub-Segments | Key Insights |
| By Type |
|
GMP Grade Oligonucleotides represent the premium segment due to stringent quality requirements for clinical applications and therapeutic use, where regulatory compliance and batch consistency are paramount for patient safety and regulatory approval processes. |
| By Application |
|
Therapeutic Development drives the highest value segment as pharmaceutical companies increasingly leverage oligonucleotides for novel therapeutic modalities including mRNA vaccines, CRISPR therapies, and personalized medicine approaches that require custom synthesis and stringent quality controls. |
| By End User |
|
Pharmaceutical and Biotechnology Companies dominate this segment as they drive the development of novel biologics and cell/gene therapies requiring custom oligonucleotides at scale, while also demanding comprehensive CDMO services including process development, analytical validation, and regulatory support throughout the product lifecycle. |
Companies Strengthen Their Capabilities in Oligonucleotide CDMO and CRDMO Services
Lonza Group leads the oligonucleotide CDMO and CRDMO services market with its comprehensive service offerings that span from early discovery to commercial manufacturing. The company's significant investments in expanding its oligonucleotide manufacturing capacity, particularly in the U.S. and Europe, have strengthened its position as the preferred partner for many biopharmaceutical companies.
Samsung Biologics and Thermo Fisher Scientific follow closely, offering integrated services that include process development, analytical testing, and regulatory support. Their global presence enables them to serve a diverse client base across North America, Europe, and Asia-Pacific, with Samsung Biologics particularly strong in the Asian markets.
Catalent and Charles River Laboratories have been expanding their oligonucleotide CDMO capabilities through both organic growth and strategic acquisitions. Catalent's acquisition of Delphi Genetics added significant plasmid DNA manufacturing capabilities, while Charles River's acquisition of Cognate BioServices strengthened its cell and gene therapy service offerings, including oligonucleotide-based therapies.
Emerging players like CordenPharma and Ajinomoto Bio-Pharma are focusing on niche areas within the oligonucleotide space, with CordenPharma emphasizing complex lipid nanoparticle (LNP) formulations and Ajinomoto focusing on high-potency active pharmaceutical ingredients (APIs) and their delivery systems.
List of Key Oligonucleotide CDMO and CRDMO Services CompaniesLonza Group (Switzerland)
Thermo Fisher Scientific Inc. (United States)
Samsung Biologics (South Korea)
Charles River Laboratories International, Inc. (United States)
Catalent, Inc. (United States)
Fujifilm Holdings Corporation (Japan)
CordenPharma International GmbH (Germany)
Ajinomoto Bio-Pharma Services (United States)
The global oligonucleotide CDMO and CRDMO services market is experiencing significant growth, driven by increasing demand for personalized medicine and advanced therapeutic applications. Market analysis indicates a compound annual growth rate of 18.3% over the past five years, with projections suggesting continued expansion as biopharmaceutical companies increasingly outsource their manufacturing needs to specialized service providers.
Other TrendsExpansion of CRISPR and Gene Therapy Applications
The rapid advancement of CRISPR technology and gene editing applications has created substantial demand for high-quality oligonucleotide production. CDMO providers are expanding their capabilities to support complex gene therapy projects, with particular growth in modified oligonucleotides and specialty RNA molecules that require advanced manufacturing expertise.
Pharmaceutical companies are increasingly outsourcing complex oligonucleotide manufacturing to specialized CDMOs, particularly for complex modified oligonucleotides and large-scale productions. This trend is driven by the high capital investment required for in-house manufacturing and the need for specialized technical expertise that CDMOs provide. Contract manufacturers are responding by expanding their capacity and developing more sophisticated purification and analytical technologies.
Regional Market Developments
North America continues to dominate the market with approximately 48% market share, attributed to strong biopharmaceutical sector and advanced research infrastructure. The Asia-Pacific region shows the highest growth rate at 22.1% CAGR, driven by increasing investments in biotech infrastructure and cost-effective manufacturing capabilities. Europe maintains strong presence with several leading CDMOs expanding their oligonucleotide service offerings.
Quality and Regulatory Compliance
Market leaders are prioritizing investments in quality control systems and regulatory compliance capabilities, particularly as regulatory agencies increase scrutiny on oligonucleotide-based therapeutics. Current Good Manufacturing Practice (cGMP) compliance has become a key differentiator, with CDMOs investing significantly in quality management systems and regulatory affairs departments to meet FDA and EMA requirements.
Regional Analysis: Oligonucleotide CDMO and CRDMO Services MarketEurope
Europe maintains a strong position in the oligonucleotide CDMO and CRDMO services market, with several established players offering comprehensive services from early development to commercial manufacturing. The region benefits from strong intellectual property protection, advanced research infrastructure, and a skilled workforce specializing in complex therapeutics. European CDMOs demonstrate particular strength in personalized medicine applications and rare disease treatments, supported by favorable regulatory frameworks and significant public funding for advanced therapy research. Collaboration between academic institutions and contract manufacturers remains particularly strong, contributing to Europe's continued prominence.
Asia-Pacific
Asia-Pacific represents both a substantial manufacturing base and rapidly growing market for oligonucleotide services. The region benefits from lower production costs compared to Western markets while maintaining high quality standards through adoption of international regulations. Countries including China, South Korea, and India have made significant investments in biopharmaceutical infrastructure, creating substantial capacity for both domestic and international clients. The region shows particular strength in process development and scale-up activities, with several CDMOs offering integrated services from early-stage development through commercial manufacturing for global markets.
South America
South America demonstrates emerging capabilities in oligonucleotide CDMO services, with Brazil and Argentina showing the most significant development. The region benefits from growing biotech sectors, academic research partnerships, and increasing investment in life sciences. While smaller in scale than other regions, South America demonstrates particular strengths in specific therapeutic areas and regional collaboration. The market shows steady growth with potential for increased regional collaboration and specialization.
Middle East & Africa
The Middle East and Africa represent developing markets for oligonucleotide CDMO and CRDMO services, with most activities concentrated in a few key countries. The region shows growing interest and investment in biopharmaceutical manufacturing, though it remains in early stages for complex oligonucleotide services. Several countries have established biotechnology parks and special economic zones to attract foreign investment and technology transfer. The region shows potential for future growth through strategic partnerships and infrastructure development.
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
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
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
-> The global oligonucleotide CDMO and CRDMO services market was valued at US$ 1.40 billion in 2024 and is expected to reach US$ 2.61 billion by 2031.
Which key companies operate in Global Oligonucleotide CDMO and CRDMO Services Market?
-> Key players include ST Pharm, EUROAPI, Danaher (IDT), Merck, Eurofins Scientific, Thermo Fisher Scientific, Agilent Technologies, Nippon Shokubai, and Eurogentec, among others.
-> Key growth drivers include increasing demand for personalized medicine, growth in RNA-based therapeutics, and expansion of gene therapy applications.
-> North America is the largest market, while Asia-Pacific is the fastest-growing region.
-> Emerging trends include increased outsourcing of complex manufacturing, adoption of continuous manufacturing technologies, and focus on personalized medicine CDMO services.
Our Clients
“The data provided by 24LifeScience was clear, well-organized, and useful for internal strategy planning. It helped us understand the competitive landscape more effectively.”
“We used one of their market overview reports for early-stage feasibility work. It gave us a helpful snapshot of current trends and key players in our therapeutic area.”
“I appreciated the team’s responsiveness and willingness to adjust the scope based on our feedback. The final report was aligned with our expectations and timelines.”
“Their custom report on clinical trial trends was a helpful reference as we explored new indications."
“As someone working on early product planning, I found their therapeutic area briefs quite useful. The information was presented in a way that made it easy to extract key takeaways.”
“We didn’t need anything overly complex—just solid, dependable data. 24LifeScience delivered exactly that, without unnecessary fluff.”
“Their reports gave us a good foundation to start our own market assessment. While we supplemented it with other data, this was a great starting point.”
“I’ve used a few of their reports for academic and grant writing purposes. They’re generally well-cited and reliable for understanding market scope.”
At 24LifeScience, we combine domain expertise with dependable research delivery. What truly differentiates us isn't just what we do — it's how we do it. Our clients trust us because we offer consistency, security, value, and most importantly, insight that drives action.
Precision-driven research you can trust. We uphold rigorous data validation processes to ensure every report is reliable and based on credible sources.
We uphold rigorous data validation processes to ensure every report is reliable, up-to-date, and based on credible sources.
24LifeScience powers research for top firms in 20+ nations.Chosen by leading life sciences companies worldwide.
We offer competitive pricing models that align with your project scope — no hidden charges, no lock-in. Tailored pricing for every scale and need.
8–10+ years of life sciences expertise turned into strategic insights.We don’t just summarize data we contextualize it.
Whether it's a ready-made report or a custom project, we deliver within the promised timeline With real-time updates