Small Interfering RNA (siRNA) Therapeutics Market 2025: Industry Insights, Q4 Approvals, Future Scope, Key Developments, Emerging Players

Global 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 at a CAGR of 17.4% during the forecast period 2025-2033.

For example, patisiran (Onpattro) is priced at US$10,455 for a 5 mL vial of 2 mg/mL IV solution.

Currently, Amvuttra is the leading small interfering RNA therapy, holding 38.05% market share with US$ 970.45 million in sales in 2024.

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United States: Recent Industry Developments

✅ October 2025: CRISPR Therapeutics and Sirius Therapeutics expanded their collaboration to co-develop SRSD107, a long-acting Factor XI siRNA designed for thromboembolic disorders.

✅ September 2025: The Novotech CRO reported over 150 industry-sponsored siRNA clinical trials conducted from 2020-2024, highlighting strong momentum in siRNA R&D.

✅ August 2025: Silence Therapeutics shared its corporate update, confirming progress in its siRNA pipeline and highlighting its GalNAc-ligand delivery platform optimized for liver targeting.

Japan: Recent Industry Developments

✅ October 2025: GC Corporation announced pharmacological studies for RECQL1-siRNA, a novel siRNA targeting the helicase RECQL1, aiming to develop treatment for advanced peritoneal cancers.

✅ September 2025: Japanese researchers published a new transformer-based model (siDPT) to predict siRNA efficacy more precisely, leveraging deep learning to improve siRNA sequence design.

✅ August 2025: Innovations in siRNA delivery continued with new cholic acid-based mixed micelle systems for safer and more efficient gene silencing, as reported in recent supramolecular chemistry research

Key Players:

Alnylam Pharmaceuticals, Inc., Novartis AG, and Novo Nordisk A/S

Emerging Players

The emerging players in the small interfering RNA (siRNA) therapeutics market are Arbutus Biopharma, ADARx Pharmaceuticals, Arrowhead Pharmaceuticals, Inc., and Amgen Inc

Key industry Development:

In April 2025, Alnylam Pharmaceuticals announced that the EMA's Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion recommending approval of vutrisiran for treating wild-type or hereditary transthyretin amyloidosis with cardiomyopathy (ATTR-CM) in adults.

In March 2025, the FDA approved Alnylam's seventh siRNA therapy, fitusiran (Qfitlia), for Hemophilia A and B. This marks the first siRNA treatment approved for hemophilia, working by reducing antithrombin (AT) to improve blood clotting.

M&A Activity

Novartis continues heavy investment in RNA therapeutics, recently acquiring cardiovascular disease siRNA assets for $1.4 billion, expanding their pipeline with precision RNAi therapeutics targeting disease-causing genes.​

Biogen, AstraZeneca, and GSK announced strategic collaborations and acquisitions focusing on siRNA delivery platforms and pipeline expansion for rare genetic, metabolic, and neurology indications.

Research Process:

Both primary and secondary data sources have been used in the global Small Interfering RNA (siRNA) Therapeutics Market research report. During the research process, a wide range of industry-affecting factors are examined, including governmental regulations, market conditions, competitive levels, historical data, market situation, technological advancements, upcoming developments, in related businesses, as well as market volatility, prospects, potential barriers, and challenges.

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Key Segmentation:

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

FDA Approvals

✦ Arrowhead Pharmaceuticals' REDEMPLO (plozasiran) received FDA approval in November 2025 as the first siRNA drug to treat familial chylomicronemia syndrome (FCS) by reducing triglycerides via APOC3 suppression. It is administered via once-every-three-month subcutaneous injection at home.​

✦ Other recent siRNA approvals include Sanofi's Qfitlia (fitusiran) for Hemophilia A/B and Amgen/Novartis' Leqvio (inclisiran) for hypercholesterolemia, reflecting broadening applications beyond rare diseases.

Clinical Trials

1. Multiple siRNA candidates are in late-stage trials: Ayala's AL102 for desmoid tumors, Alnylam's vutrisiran extension studies for transthyretin-mediated diseases, and multi-target hepatocyte-directed RNAi platforms advancing for liver and metabolic disorders.​

2. Trials focusing on neurological disorders like Huntington's disease, Parkinson's, and Alzheimer's via RNAi mechanisms are also progressing, enabled by novel delivery systems enhancing CNS penetration.

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FAQ's

Q1: What is the current size of the Small Interfering RNA (siRNA) Therapeutics Market?

A: The Small Interfering RNA (siRNA) Therapeutics Market stood at US$ 2.55 billion in 2024 and is set to experience remarkable growth, reaching US$ 12.38 billion by 2033

Q2: How fast is the Small Interfering RNA (siRNA) Therapeutics Market growing?

A: The Market is on an impressive growth trajectory, expected to expand at a CAGR of 17.4% from 2025 to 2032

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Drugs and Pipeline Updates

✦ FDA-approved siRNA drugs currently include 8 products such as Onpattro (patisiran), Givlaari (givosiran), Oxlumo (lumasiran), Amvuttra (vutrisiran), and Rivfloza (nedosiran), covering indications from amyloidosis, porphyria to primary hyperoxaluria.​

✦ New chemical modifications like 2′-OMe, 2′-MOE, and 2′-F are enhancing siRNA stability, specificity, and reducing immunogenicity, improving clinical outcomes.​

✦ Novel siRNA therapies target cardiovascular, metabolic, oncology, genetic, and infectious diseases with an expanding therapeutic scope.

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