$13.5B Oligonucleotide Synthesis Market Outlook to 2035: Pharma & Biopharma Dominate
The global oligonucleotide synthesis market is poised for significant growth, expanding from USD 4.8 billion in the current year to an estimated USD 13.5 billion by 2035, reflecting a robust CAGR of 9.9% during the forecast period. Oligonucleotides, short DNA or RNA molecules, are widely used in biopharmaceutical and biotechnology fields for various applications, including genetic testing, forensic analysis, drug discovery, and research. The increasing interest in oligonucleotide-based therapeutics has fueled the rapid development of this market.
Market Drivers and Trends
Oligonucleotides are gaining prominence as a viable therapeutic option, particularly for treating rare and genetic disorders. Currently, around 300 clinical trials are registered worldwide to assess oligonucleotides for therapeutic applications. With advancements in synthesis technology, automatic oligo synthesizers have been introduced, streamlining large-scale production and improving efficiency. These synthesizers execute key steps, including molecule synthesis, purification, and lyophilization, enhancing overall output quality.
Despite advancements, several challenges persist, such as lengthy production timelines, lack of purification techniques, regulatory hurdles, and compliance-related issues. These complexities have led to an increased trend of outsourcing oligonucleotide manufacturing to specialized contract research and manufacturing organizations (CROs and CMOs). Presently, more than 110 providers offer custom oligonucleotide synthesis, modification, and purification services, catering to research, diagnostic, and therapeutic applications. Given the promising pipeline of oligonucleotide-based drugs and ongoing clinical trials, the market is expected to offer lucrative opportunities for custom service providers in the coming years.
Market Segmentation
Product Type
The oligonucleotide synthesis market is primarily divided into two categories: Active Pharmaceutical Ingredients (APIs) and Finished Dosage Forms. Among these, the Finished Dosage Form segment holds the largest market share and is projected to maintain dominance throughout the forecast period. The increasing commercialization of oligonucleotide-based therapies significantly contributes to this trend.
Oligonucleotide Type
Based on the type of oligonucleotide synthesized, the market includes antisense oligonucleotides, DNA oligonucleotides, siRNA, and others. Among these, siRNA and antisense oligonucleotides are expected to witness the highest growth rates due to the rising number of approved therapies for rare diseases, genetic disorders, and oncology indications.
Scale of Operation
The market is categorized into clinical-scale and commercial-scale operations. The commercial-scale segment is anticipated to account for a significant share due to increasing drug approvals and large-scale production of oligonucleotide-based therapeutics.
End-User Segments
The end-user landscape is composed of pharmaceutical and biopharmaceutical companies, academic and research institutes, and hospitals. Pharmaceutical and biopharmaceutical companies currently dominate the market and are projected to witness substantial revenue growth, driven by rising investments in oligonucleotide-based drug development.
Company Size
Market players are segmented into small, mid-sized, and large companies. While large and very large firms currently dominate the market, mid-sized companies are expected to grow at a higher pace due to their increasing role in research, development, and contract manufacturing.
Therapeutic Areas
Oligonucleotide-based therapeutics cater to various therapeutic areas, including cardiovascular disorders, genetic disorders, liver disorders, and rare diseases. The rare diseases segment holds the largest market share, while the cardiovascular disorders segment is expected to witness notable growth in the coming years.
Regional Insights
The market is geographically segmented into North America, Europe, Asia-Pacific, and the Rest of the World. North America currently holds the largest share due to its strong presence of key industry players and extensive research initiatives. However, the Asia-Pacific region is expected to witness the highest CAGR, driven by increased investments in biotech infrastructure and government support for research and development in countries such as China and India.
Key Insights and Industry Developments
- Over 110 oligonucleotide synthesis providers worldwide, with the majority based in North America.
- Around 90% of market players offer purification services as part of their oligonucleotide synthesis offerings.
- Several industry players are expanding their capabilities to strengthen their competitive edge and enhance their service portfolios.
- Nearly 300 clinical trials, involving over 75,000 patients, are currently evaluating oligonucleotide-based therapeutics.
- Numerous collaborations and acquisitions have taken place among stakeholders, with acquisitions being the most common partnership model.
- Large-scale investments are being made to expand manufacturing capacities, particularly in the U.S. and China.
- Big pharmaceutical companies are heavily investing in oligonucleotide research, with 48% of initiatives focused on RNAi oligonucleotides.
- The global oligonucleotide synthesis capacity is primarily concentrated in large-scale manufacturing facilities owned by major industry players.
- The demand for oligonucleotides is projected to reach approximately 2,200 kilograms by 2035, covering both clinical and commercial scales.
- The increasing prevalence of chronic diseases and advancements in personalized medicine are expected to drive steady market growth.
- The Chinese market is anticipated to be a key growth driver, with significant expansion expected in the coming years.
Industry Interviews and Stakeholder Perspectives
Insights from industry leaders, including founders, managing directors, chief scientific officers, and business executives, were incorporated into the research report. Key stakeholders interviewed include representatives from:
- BianoGMP
- Hanugen Therapeutics
- IBA Life Sciences
- Axolabs
- SBS Genetech
- Aptagen
- Invitek Diagnostics
Leading Market Players
Several major players are actively engaged in oligonucleotide synthesis, contributing to market growth and innovation. Prominent companies profiled in the report include:
- Agilent Technologies
- Ajinomoto Bio-Pharma Services
- CordenPharma
- Creative Biolabs
- Ella Biotech
- Eurofins Genomics
- Future Synthesis
- Integrated DNA Technologies
- Kaneka Eurogentec
- LGC Biosearch Technologies
- Microsynth
- Nitto Avecia
- Merck
- Ribo Biotechnology
- STA Pharmaceutical
- Sumitomo Chemical
- Thermo Fisher Scientific
- TriLink Biotechnologies
The oligonucleotide synthesis market is set to experience sustained growth, driven by advancements in genetic research, increased adoption of personalized medicine, and rising demand for RNA-based therapies. With continuous innovation, strategic partnerships, and expansion efforts, industry stakeholders are well-positioned to capitalize on emerging opportunities in this rapidly evolving market.
By 2035, the industry is expected to witness a significant transformation, with new technologies and regulatory support further accelerating market growth. The increasing focus on rare diseases and chronic conditions, coupled with rising investments in research and development, will solidify oligonucleotides as a crucial component of the pharmaceutical and biopharmaceutical landscape.
