United States Lead Small Interfering RNA (siRNA) Therapeutics Market at 17.4% CAGR on Regulatory Approvals & RNA Innovation

Leander, Texas and Tokyo, Japan - Jan.08.2026
As per DataM Intelligence research report "Small Interfering RNA (siRNA) Therapeutics Market reached US$ 2.55 billion in 2024 and is expected to reach US$ 12.38 billion by 2033, growing with a CAGR of 17.4% from 2025 to 2033." Rising research and development activities, regulatory approvals, demand for targeted therapies against chronic and rare diseases, and advancements in delivery technologies are fueling growth in the small interfering RNA (siRNA) therapeutics market.

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Japan: Recent Industry Developments
✅ In October 2025, GC Corporation announced pharmacological studies for RECQL1-siRNA, a novel siRNA targeting the helicase RECQL1, aiming to develop treatments for advanced peritoneal cancers.
✅ In 2025, Investments in biotech and genomic medicine grew, with partnerships between local firms and international players advancing siRNA research for metabolic and genetic disorders.
✅ In 2025, Government-supported RNA research initiatives in Japan accelerated siRNA pipeline development for oncology and rare diseases.

United States: Recent Industry Developments
✅ In March 2025, The U.S. FDA approved fitusiran (Qfitlia) by Alnylam Pharmaceuticals as the seventh siRNA therapy, marking the first for hemophilia A or B.
✅ In October 2025, CRISPR Therapeutics and Sirius Therapeutics expanded collaboration to co-develop SRSD107, a long-acting Factor XI siRNA for thromboembolic disorders.
✅ In September 2025, Novotech CRO reported strong momentum with over 150 industry-sponsored siRNA clinical trials from 2020-2024.

Small Interfering RNA (siRNA) Therapeutics Market: Drivers
The small interfering RNA (siRNA) therapeutics market is driven by rising R&D for novel therapies, increasing regulatory approvals, and demand for precise alternatives to traditional drugs for life-threatening chronic and rare diseases. Technological advancements in delivery methods like GalNAc conjugates and lipid nanoparticles improve efficacy and targeting. Expanding applications in oncology, genetic disorders, cardiovascular, and metabolic conditions, along with supportive investments and precision medicine trends, further accelerate market growth.

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Small Interfering RNA (siRNA) Therapeutics Market: Major Players
Alnylam Pharmaceuticals, Inc., Novartis AG, Novo Nordisk A/S, Arbutus Biopharma, ADARx Pharmaceuticals, Arrowhead Pharmaceuticals, Inc., Amgen Inc.

Segment Covered in the Small Interfering RNA (siRNA) Therapeutics Market:
By Drug
Patisiran, Givosiran, Lumasiran, Inclisiran, Nedosiran, Vutrisiran, Others.
By Indication
Transthyretin Amyloidosis, Acute Hepatic Porphyria, Primary Hyperoxaluria Type 1, Primary Hyperlipidemia, Others.
By Route of Administration
Intravenous, Subcutaneous.

Regional Analysis
North America - Dominant Share
North America leads with 52.2% share in 2024, driven by biopharmaceutical innovations, all approved siRNA therapies available, high sales, advanced infrastructure, and strong R&D in the United States.
Asia Pacific - Fastest-Growing
Asia Pacific expands rapidly due to rising biotech investments, healthcare infrastructure growth, government funding for RNA research, and increasing prevalence of target diseases.
Europe - Significant Share
Europe grows with regulatory support for novel therapeutics and focus on rare genetic disorders.
South America - Gradual Growth
South America shows steady progress amid improving access to advanced treatments and rising disease awareness.
Middle East & Africa - Emerging Growth
Middle East & Africa rises with investments in biotechnology and growing demand for precision therapies.

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