The global oligonucleotide active pharmaceutical ingredients (API) market is poised for significant growth, with demand expected to increase at a CAGR of 5.60% from 2024 to 2034. The market, valued at USD 2.81 billion in 2024, is projected to reach USD 4.84 billion by the end of the forecast period. This growth is largely driven by the increasing need for new drug classes, particularly in the fields of genetic disorders, cancer therapies, and personalized medicine.
Oligonucleotide-based drugs, which are designed to target specific genetic sequences, are gaining momentum as a promising treatment option for conditions that have been difficult to address with traditional therapies. The growing understanding of diseases at the molecular level and the ability to develop highly targeted treatments are leading to a surge in demand for oligonucleotide APIs. These advancements are facilitating the development of antisense oligonucleotides (ASOs), small interfering RNA (siRNA), and mRNA-based therapies, which are transforming the landscape of modern medicine.
The continued progress in gene therapy and the rise of biologics and RNA-based drugs have further fueled the demand for oligonucleotide APIs. As the global healthcare industry continues to shift towards more targeted, individualized treatments, the oligonucleotide API market is well-positioned for long-term growth. Regulatory agencies’ increasing support for these cutting-edge therapies also bolsters market prospects.
Key Takeaways:
- The oligonucleotide API market is projected to grow from USD 2.81 billion in 2024 to USD 4.84 billion by 2034, at a CAGR of 5.60%.
- Rising demand for targeted therapies, especially in genetic disorders and cancer, is driving the market’s expansion.
- Advances in genetic medicine, including gene therapies and mRNA-based treatments, are fueling the need for oligonucleotide APIs.
- Ongoing regulatory support and innovation in biologics are expected to sustain market growth throughout the forecast period.
Key Market Drivers
The increasing number of oligonucleotide-active pharmaceutical ingredients in medication pipelines around the world is a major driver of market growth. Pharma businesses have benefited from the ongoing trend toward harmonization of oligonucleotide development and marketing over the last 10-15 years. Several other reasons are also leading to the growth of the oligonucleotide API market:
- Expansion of synthetic biology applications due to the demand for custom oligonucleotide synthesis, enabling precise control over gene expression and metabolic pathway
- Emergence of CRISPR-Cas gene editing technology fuelling demand for oligonucleotides as tools for genetic manipulation, facilitating targeted genome modifications with high efficiency
- Rising adoption of RNA-based therapeutics, such as mRNA vaccines and RNA interference therapies, leveraging oligonucleotides for precise modulation of gene expression and protein synthesis
- Growing use of oligonucleotides in molecular diagnostics for detecting genetic mutations and infectious diseases, offering rapid and accurate detection with high specificity
- Increasing research focus on antisense oligonucleotides for treating neurological disorders and cancer, exploiting their ability to target disease-causing genes and protein
- Advancements in oligonucleotide synthesis techniques, enhancing scalability and cost-effectiveness, enabling the production of high-quality oligonucleotides at larger scales
- Demand for oligonucleotide APIs in agricultural biotechnology for crop improvement and pest management, harnessing their potential for enhancing plant traits and controlling agricultural pests
- Expansion of contract manufacturing organizations (CMOs) offering oligonucleotide synthesis services, and providing outsourcing solutions for pharmaceutical companies and research institutions
- Collaborations between academia, pharmaceutical companies, and government institutions to advance oligonucleotide-based therapies, fostering interdisciplinary research and development efforts.
- Heightened interest in oligonucleotide-based therapies targeting rare diseases and oncology indications, addressing unmet medical needs and offering potential breakthrough treatments.
Competitive Landscape
The global oligonucleotide active pharmaceutical ingredient (API) market is still in its early stages and is dominated by a few key players. These include Jazz Pharmaceuticals, Inc., Sarepta Therapeutics, Biogen, Dynavax Technologies, Akcea Therapeutics, and Alnylam Pharmaceuticals, Inc.
However, the market is expected to grow with strategic partnerships and the introduction of new products by industry leaders. To stay competitive in this market, companies need to have a strong creative and innovative capacity.
Recent Developments
- In September 2023, ST Pharm broke ground on its second oligonucleotide manufacturing plant in Ansan, Gyeonggi Province. The USD830.9 million investment aimed to establish the world’s largest oligonucleotide API manufacturer, with projected production capabilities of 14 mol.
- In May 2022, Bachem and Eli Lilly & Co. initiated a strategic collaboration to develop and manufacture oligonucleotide-based active pharmaceutical ingredients. Bachem provided engineering infrastructure and personnel at its Switzerland facilities, with Lilly committing to placing manufacturing projects worth around CHF 100 million over seven years.
- In November 2021, Korea’s ST Pharm announced a USD126 million investment to construct its second oligonucleotide manufacturing plant, doubling its capacity to 14 moles per year by 2025, positioning it as the world’s largest oligonucleotide CDMO.
Key Companies in the Market
- Jazz Pharmaceuticals, Inc.
- Sarepta Therapeutics
- Biogen
- Dynavax Technologies
- Akcea Therapeutics.
- Alnylam Pharmaceuticals, Inc.
Full Report Revealed
Oligonucleotide API Market Segmentation
By API:
- Antisense Oligonucleotides APIs
- Short Interfering RNA (siRNA) APIs
- Phosphorodiamidate Morpholino Oligonucleotides (PMO) APIs
- MiRNA APIs
- Aptamers APIs
- CpG Oligonucleotides APIs
- Others (ON Conjugates (NP), ShRNA, etc.)
By Marketing Status:
- Marketed
- Clinical Trials (Clinical Phases)
By End User:
- Contract Manufacturing Organizations (CMOs)
- Pharmaceutical Companies
- Biopharmaceutical Companies
- Contract Development & Manufacturing Organizations (CDMOs)
By Region:
- North America
- Latin America
- Asia Pacific
- Middle East and Africa (MEA)
- Europe
Author By:
Sabyasachi Ghosh (Associate Vice President at Future Market Insights, Inc.) holds over 12 years of experience in the Healthcare, Medical Devices, and Pharmaceutical industries. His curious and analytical nature helped him shape his career as a researcher.
Identifying key challenges faced by clients and devising robust, hypothesis-based solutions to empower them with strategic decision-making capabilities come naturally to him. His primary expertise lies in areas such as Market Entry and Expansion Strategy, Feasibility Studies, Competitive Intelligence, and Strategic Transformation.
Holding a degree in Microbiology, Sabyasachi has authored numerous publications and has been cited in journals, including The Journal of mHealth, ITN Online, and Spinal Surgery News.
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