United States Oligonucleotide Therapy Market Set for Breakthrough Growth with Rising Demand for Precision Medicine 2025 | Top key players - Kastle Therapeutics, Sarepta Therapeutics, Pfizer Inc.

Market Size and Growth:

The Oligonucleotide Therapy Market was valued at USD 6,533.09 million in 2024 and is projected to reach USD 24,462.21 million by 2033, growing at a CAGR of 15.8% during the forecast period (2025-2033).

The Oligonucleotide Therapy Market report, published by DataM Intelligence, provides in-depth insights and analysis on key market trends, growth opportunities, and emerging challenges. Committed to delivering actionable intelligence, DataM Intelligence empowers businesses to make informed decisions and stay ahead of the competition. Through a combination of qualitative and quantitative research methods, it offers comprehensive reports that help clients navigate complex market landscapes, drive strategic growth, and seize new opportunities in an ever-evolving global market.

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The Oligonucleotide Therapy Market refers to the industry focused on developing and commercializing short DNA or RNA molecules designed to modulate gene expression or protein synthesis. These therapies target genetic disorders, cancers, and rare diseases by silencing, repairing, or regulating faulty genes. The market encompasses research, drug development, clinical applications, and commercialization of innovative oligonucleotide-based treatments.

Recent Key Developments of United States (U.S):

FDA Approval of Dawnzera (August 21, 2025): The FDA approved Ionis Pharmaceuticals' Dawnzera (donidalorsen) as the first and only RNA-targeted prophylactic treatment for hereditary angioedema (HAE) in patients 12 years of age and older.

FDA Expanded Approval for a Gene Therapy (July 2025): Atsena Therapeutics announced that the FDA agreed to an expansion of the company's ongoing Phase 1/2 clinical trial for a gene therapy aimed at reversing or preventing blindness. While not exclusively an oligonucleotide, this highlights the broader trend of targeted genetic therapies.

Launch of a New Oligonucleotide CDMO Company (April 2025): Sumitomo Chemical launched Sumitomo Chemical Advanced Medical Solutions America LLC in Massachusetts. The new company is part of its oligonucleotide CDMO (Contract Development and Manufacturing Organization) business, indicating an increase in manufacturing and development capabilities in the U.S. market.

TIDES USA 2025 Conference: The TIDES USA conference took place, bringing together experts to discuss advancements in oligonucleotide and peptide therapeutics. Key topics included innovation in therapeutic modalities, clinical strategy, and manufacturing and process development for oligonucleotides.

Biogen/Stoke Therapeutics Partnership (February 2025): Biogen partnered with Stoke Therapeutics to develop and commercialize an investigational antisense oligonucleotide (ASO) for Dravet syndrome, a form of genetic epilepsy. This collaboration demonstrates continued investment in ASO technology for novel disease-modifying approaches.

List of the Key Players in the Oligonucleotide Therapy Market:

Kastle Therapeutics
Sarepta Therapeutics
Pfizer Inc.
InteRNA Technologies B.V.
Santaris
Akcea Therapeutics
Miragen Therapeuutics Inc.
Alnylam Pharmaceuticals Inc.
Biogen Inc.
Ionis Pharmaceuticals Inc.

This Report Covers:

✔ Go-to-market Strategy.

✔ Neutral perspective on the market performance.

✔Development trends, competitive landscape analysis, supply side analysis, demand side analysis, year-on-year growth, competitive benchmarking, vendor identification, and other significant analysis, as well as development status.

✔Customized regional/country reports as per request and country level analysis.

✔ Potential & niche segments and regions exhibiting promising growth covered.

✔ Analysis of Market Size (historical and forecast), Total Addressable Market (TAM), Serviceable Available Market (SAM), Serviceable Obtainable Market (SOM), Market Growth, Technological Trends, Market Share, Market Dynamics, Competitive Landscape and Major Players (Innovators, Start-ups, Laggard, and Pioneer).

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Segments Covered in the Oligonucleotide Therapy Market:

By Type: Antisense Oligonucleotide, Aptamer, Other.

By Application: Infectious Diseases, Oncology, Neurodegenerative Disorders, Cardiovascular Diseases, Kidney Diseases, Others.

By End User: Hospitals, Research Institutes.

Regional Analysis:

⇥ North America (U.S., Canada, Mexico)

⇥ Europe (U.K., Italy, Germany, Russia, France, Spain, The Netherlands and Rest of Europe)

⇥ Asia-Pacific (India, Japan, China, South Korea, Australia, Indonesia Rest of Asia Pacific)

⇥ South America (Colombia, Brazil, Argentina, Rest of South America)

⇥ Middle East & Africa (Saudi Arabia, U.A.E., South Africa, Rest of Middle East & Africa)

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Chapter Outline

⏩ Market Overview: It contains five chapters, as well as information about the research scope, major manufacturers covered, market segments, Oligonucleotide Therapy market segments, study objectives, and years considered.

⏩ Market Landscape: The competition in the Global Oligonucleotide Therapy Market is evaluated here in terms of value, turnover, revenues, and market share by organization, as well as market rate, competitive landscape, and recent developments, transaction, growth, sale, and market shares of top companies.

⏩ Companies Profiles: The Global Oligonucleotide Therapy market's leading players are studied based on sales, main products, gross profit margin, revenue, price, and growth production.

⏩ Market Outlook by Region: The report goes through gross margin, sales, income, supply, market share, CAGR, and market size by region in this segment. North America, Europe, Asia Pacific, Middle East & Africa, and South America are among the regions and countries studied in depth in this study.

⏩ Market Segments: It contains the deep research study which interprets how different end-user/application/type segments contribute to the Oligonucleotide Therapy Market.

⏩ Market Forecast: Production Side: In this part of the report, the authors have focused on production and production value forecast, key producers forecast, and production and production value forecast by type.

⏩ Research Findings: This section of the report showcases the findings and analysis of the report.

⏩ Conclusion: This portion of the report is the last section of the report where the conclusion of the research study is provided.

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