Oligonucleotide API Market Poised for Robust Expansion at USD 5.1 Billion Through 2035: Established Giants and Emerging Innovators Redefining the Landscape

The global oligonucleotide API market is entering a transformative growth phase. Valued at USD 3.0 billion in 2025 and projected to reach USD 5.1 billion by 2035, the market is set to expand at a compound annual growth rate (CAGR) of 5.6%. Driven by the increasing adoption of nucleic acid–based therapeutics, soaring investments in genetic research, and the rapid expansion of clinical applications, the sector is becoming a cornerstone in the evolution of genetic medicine.

Across the globe, both established pharmaceutical manufacturers and emerging biotech innovators are intensifying their efforts to expand production capacities, establish strategic partnerships, and integrate cutting‑edge synthesis technologies. This wave of collaboration is reshaping the oligonucleotide API supply chain and paving the way for a new generation of precision therapies.

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Market Dynamics: From Gene Targeting to Global Commercialization

The growing pipeline of oligonucleotide‑based drugs—including antisense therapies, siRNA platforms, and mRNA vaccines—has attracted strong regulatory support, fostering faster approval cycles and commercial confidence. Advanced synthesis technologies have further improved purity, scalability, and yield, directly translating into higher manufacturing efficiency and broader clinical reach.

The antisense oligonucleotide segment remains the market’s dominant category, representing 28.6% of overall API production in 2025. Its established role in modulating gene expression and correcting genetic mutations continues to make it a vital component of next‑generation therapeutics targeting rare diseases, cancer, and neurodegenerative conditions.

On the commercialization front, marketed oligonucleotide APIs account for over 61% of the market share, reflecting the growing number of approved therapies that have entered worldwide distribution. The pharmaceutical sector leads end‑user demand with 46.7% share, owing to its production scale, regulatory compliance, and extensive global networks.

Established Leaders and Rising Pioneers

Among the leading players shaping this market are Biogen, Jazz Pharmaceuticals, Sarepta Therapeutics, Dynavax Technologies, Akcea Therapeutics, and Alnylam Pharmaceuticals. These companies continue to strengthen their competitive positioning through advanced R&D programs, strategic acquisitions, and manufacturing expansion.

At the same time, newer entrants and regional manufacturers across Asia and Europe are contributing significantly to capacity growth. Firms in India, Thailand, Malaysia, and Indonesia are investing heavily in modern production sites to supply the surging global demand for oligonucleotide APIs. India, with a projected CAGR of 7.8% through 2035, is emerging as a cost‑competitive production hub, offering high‑quality, regulatory‑compliant oligonucleotides to global partners. Meanwhile, Thailand’s incentive‑driven pharmaceutical policies and Malaysia’s expanding biotech infrastructure are fostering a fertile environment for both domestic and foreign players.

Recent investments underscore this collaboration trend. In September 2025, South Korea’s ST Pharm launched construction of a second oligonucleotide manufacturing facility in Ansan, Gyeonggi Province. With an investment of USD 830.9 million, this site is set to become the world’s largest oligonucleotide API manufacturing complex with a 14‑mole annual production capacity. Likewise, in May 2025, Bachem AG and Eli Lilly & Co. began a strategic partnership aimed at developing oligonucleotide‑based APIs—a seven‑year collaboration valued at approximately CHF 100 million.

Key Growth Drivers and Opportunities

The market is experiencing strong momentum due to multiple converging drivers:

• Expansion of synthetic biology applications enabling custom oligonucleotide synthesis.
• Accelerated adoption of CRISPR‑Cas and RNA‑based therapies, including mRNA vaccines and RNA interference technologies.
• Rapid integration of oligonucleotides into molecular diagnostics for genetic and infectious disease detection.
• Broadening R&D pipelines in antisense and miRNA therapeutics addressing rare and oncology‑related indications.
• Growth of contract manufacturing and development organizations (CMOs/CDMOs) offering specialized oligonucleotide synthesis services.

These drivers are supported by an expanding ecosystem of partnerships among academia, government institutions, and private enterprises, all aiming to advance the scientific and commercial maturity of oligonucleotide‑based medicines.

Regional Outlook: Asia Leads, Europe Steadies

The Asia‑Pacific region continues to deliver the strongest growth rates, driven by cost efficiency, talent availability, and supportive government policies. India, Malaysia, and Thailand are particularly well‑positioned to serve as regional powerhouses in oligonucleotide API manufacturing. Indonesia also exhibits strong potential, with multinational collaborations accelerating local technological adoption.

Europe maintains a robust foothold, with France benefitting from well‑established regulatory systems and government‑sponsored research programs through entities such as the French National Research Agency (ANR). This infrastructure provides a secure framework for biopharmaceutical innovation and commercialization.

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Challenges and Future Outlook

Despite encouraging growth forecasts, the oligonucleotide API industry continues to face challenges. Complex production processes, high R&D costs, and stringent regulatory requirements can slow market entry for new therapies. Moreover, competition from alternative modalities—biologics, gene therapies, and small molecules—remains a constant consideration.

However, as interest in personalized medicine expands and oligonucleotide manufacturing technologies mature, the market’s long‑term trajectory remains overwhelmingly positive. Manufacturers investing today in automation, regulatory compliance, and innovative delivery systems will secure a competitive advantage as oligonucleotide drugs transition from niche applications to mainstream therapeutics.

The next decade promises to be a defining period for the oligonucleotide API market—one in which collaboration, innovation, and scientific rigor will determine who leads the next era of genetic medicine.

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