Oligonucleotide Therapy Market is expected to reach US$ 40.16 Billion by 2033 | Top key players - Novartis AG, Biogen, Wave Life Sciences.

Market Size and Forecast:

The Global Oligonucleotide Therapy Market size reached US$ 8.80 Billion in 2024 from US$ 7.51 Billion in 2023 and is expected to reach US$ 40.16 Billion by 2033, growing at a CAGR of 18.6% during the forecast period 2025-2033. The Market is driven by rising demand for targeted genetic treatments, increasing prevalence of rare and chronic diseases, and advancements in RNA-based drug technologies. According to DataM Intelligence

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The Oligonucleotide Therapy Market refers to the industry focused on developing and commercializing short DNA or RNA molecules designed to modify gene expression or protein function. These therapies target genetic and rare diseases, cancers, and viral infections by silencing, modifying, or repairing faulty genes, offering a precise and personalized approach to disease treatment and management.

Industry Recent Developments: United States

✅ October 2025: The US FDA approved DAWNZERA (donidalorsen), a groundbreaking RNA-targeted medicine designed to prevent attacks of hereditary angioedema (HAE) in patients aged 12 and older. This approval marks a significant milestone as it underscores the growing acceptance and regulatory support for oligonucleotide therapies targeting genetic disorders.​

✅ October 2025: A report highlights that the US continues to lead in oligonucleotide drug approvals, with 22 therapies approved by the FDA as of April 2025. The market growth is driven by strong regulatory backing, ongoing R&D investments, and a robust pipeline of innovative therapies addressing rare genetic diseases, neurodegenerative, and oncological conditions.​

✅ September 2025: The US market exhibits a surge in personalized oligonucleotide therapies aimed at rare and complex diseases. Companies are advancing antisense oligonucleotides to develop targeted treatments, with continuous innovation in delivery systems and conjugate technologies to improve efficacy and safety profiles.​

Industry Recent Developments: Japan

✅ October 2025: The Japanese oligonucleotide synthesis market is projected to grow at a CAGR of 11.42% from 2025 to 2033. The rising incidence of genetic diseases like Duchenne muscular dystrophy and spinal muscular atrophy is fueling demand for oligonucleotide-based therapeutics and research applications.​

✅ October 2025: Collaborations between biotech companies, research institutions, and pharmaceutical firms are strengthening in Japan, facilitating the development of region-specific oligonucleotide therapies. This synergy aims to address prevalent genetic disorders, further fueling the growth of the market.​

✅ September 2025: The expansion of bioinformatics and genomics research in Japan is positively impacting the market by generating greater demand for innovative oligonucleotides. The focus is shifting toward personalized, gene-based therapies, which are increasingly being explored for rare genetic diseases.

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Key FDA Approval (2025):

✅ Qfitlia (fitusiran) - FDA approval, 28 Mar 2025
Sanofi / Alnylam's siRNA fitusiran (Qfitlia) was approved by the FDA on March 28, 2025 for routine prophylaxis to prevent or reduce bleeding in people (≥12 yrs) with hemophilia A or B (with or without inhibitors).

Major Regulatory Designations / Approvals (2025):

✅ DYNE-101 (Dyne Therapeutics) - Fast Track (21 Jan 2025) - later Breakthrough
The FDA granted Fast Track designation to Dyne's ASO candidate DYNE-101 for myotonic dystrophy type 1 on Jan 21, 2025; the program later received an expedited designation (Breakthrough Therapy) as Dyne advanced its registrational plans.

✅ BIIB080 (Biogen) - Fast Track (2 Apr 2025)
Biogen's tau-targeting antisense oligonucleotide BIIB080 received Fast Track designation from the FDA on April 2, 2025 for Alzheimer's disease (CELIA phase-2 program ongoing).

✅ AMX0114 (Amylyx) - Fast Track (3 Jun 2025)
The FDA granted Fast Track to Amylyx's antisense candidate AMX0114 for ALS in June 2025. (Company press release / investor communications).

Notable Mergers & Acquisitions (2025):

✅ Novartis - Avidity Biosciences (Oct 2025 announcement) - large strategic buy (RNA delivery / oligo conjugate platform)

✅ In late October 2025 Novartis announced a definitive agreement to acquire Avidity Biosciences (major bet on RNA/oligonucleotide delivery technologies and neuromuscular programs). This deal is a strong signal of big-pharma appetite for oligonucleotide delivery platforms.
(Note: timing = late Oct 2025 - included because it's a major RNA/oligo M&A event in the same calendar year.)

✅ AbbVie - ADARx (collaboration + license option, 14 May 2025)
AbbVie signed a multi-area collaboration and license-option with ADARx to develop next-gen siRNA therapies across neuroscience, immunology and oncology (reported May 14, 2025; sizable upfront + milestones). This is an example of large pharmas securing access to innovative RNA discovery platforms in 2025.

✅ AlphaRose Therapeutics - acquired Alpha Anomeric SA (29 Apr 2025)
AlphaRose announced the acquisition of Alpha Anomeric (a French company with a novel oligonucleotide chemistry platform) on 29 Apr 2025 - an example of smaller strategic bolt-on M&A in the ASO chemistry space.

✅ Multiple licensing & partnership deals (May 2025 and through 2025)
2025 saw a steady flow of licensing / collaboration deals (e.g., CRISPR Therapeutics licensing siRNA programs from Sirius, multiple pharma-RNA biotech partnerships) as big players locked up discovery/delivery platforms rather than exclusively buying assets outright. Industry roundups from May 2025 summarize this trend.

Major Key Players:

Sarepta Therapeutics, Inc.
Ionis Pharmaceuticals, Inc.
Alnylam Pharmaceuticals, Inc.
Wave Life Sciences
Novartis AG
Biogen
Regeneron Pharmaceuticals Inc.
Avidity Biosciences.

Segments Covered in the Oligonucleotide Therapy Market:

By Type: Antisense Oligonucleotides, Small Interfering RNA (siRNA), MicroRNA (miRNA), Aptamers, Ribozymes, and Others.

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

By End User: Hospitals, Academic and Research Institutes, and Others.

Regional Analysis for Oligonucleotide Therapy Market:

⇥ 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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Frequently asked questions:

➠ What is the global sales value, production value, consumption value, import and export of Oligonucleotide Therapy market?

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➠ What are the Oligonucleotide Therapy market opportunities and threats faced by the vendors in the global Oligonucleotide Therapy Industry?

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