Global siRNA Pharmaceuticals Market | Competitive Landscape, M&A, and Regulatory Updates

AUSTIN, TX, UNITED STATES, December 1, 2025 /EINPresswire.com/ -- Market Size and Forecast

According to DataM Intelligence, the Global Small Interfering RNA (siRNA) Therapeutics Market was valued at USD 2.55 billion in 2024 and is projected to climb to USD 12.38 billion by 2033, registering a robust CAGR of 17.4% from 2025 to 2033.

The exponential rise in precision medicine, RNA-based drug development, and gene-silencing technology is fueling demand for siRNA therapeutics targeting rare diseases, oncology, metabolic disorders, and infectious diseases. siRNA enables sequence-specific gene silencing by targeting mRNA, offering high efficacy and minimal off-target toxicity positioning it as the next major pillar of advanced therapeutics.

Breakthrough approvals like Leqvio (Novartis), Onpattro and Givlaari (Alnylam), and Amvuttra (Alnylam) and the expanding clinical pipeline across oncology, CNS, and cardiometabolic diseases are accelerating global adoption.

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Growth Drivers

• More than 985 siRNA-based clinical trials were active globally in 2024, projected to exceed 1,850 by 2032.
• RNA therapeutics funding crossed USD 18.4 billion in 2024, with siRNA receiving the highest share among RNA modalities.
• siRNA delivery nanotechnologies (LNPs, GalNAc-conjugates) have increased liver-targeting efficiency by >98%, reducing dosing frequency and toxicity.
• Cardiovascular and rare disease applications are projected to contribute USD 11.2 billion in annual revenue by 2032.
• Chronic disease prevalence (cardiovascular, diabetes, hepatic fibrosis) is expected to expand the siRNA patient base to >18 million globally by 2032.

Market Segmentation Analysis
By Molecule Type
• Chemically Modified siRNA – 68% share (USD 3.68 billion in 2024); projected to surpass USD 18.7 billion by 2032 at 21.9% CAGR.
• Unmodified Natural siRNA – 32% share (USD 1.74 billion); will reach USD 8.1 billion by 2032 driven by low-cost R&D and biosimilar-style competition.

By Therapeutic Application
• Oncology – 30% share (USD 1.63 billion in 2024); expected to exceed USD 9.2 billion by 2032 driven by KRAS, STAT3, and VEGF targets.
• Genetic & Metabolic Disorders – 26% share (USD 1.41 billion); projected to reach USD 8 billion by 2032.
• Cardiovascular Diseases – 18% share (USD 975 million); will rise to USD 4.9 billion by 2032 led by PCSK9- and Lp(a)-targeting therapeutics.
• Infectious Diseases – 16% share (USD 867 million); driven by siRNA for respiratory viruses, HIV, HPV, and hepatitis.
• Neurological Disorders & Others – 10% (USD 540 million), but fastest-growing at 24.8% CAGR.

By Route of Administration
• Intravenous – 45% share (USD 2.44 billion) due to large molecule delivery.
• Subcutaneous – 40% (USD 2.17 billion), growing fastest due to reduced dosing frequency and GalNAc targetability.
• Inhalation & Oral – 15% share; expected to reach USD 2.8 billion by 2032 due to nanocarrier advances.

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Regional Insights

United States

North America held the leading position in the small interfering RNA (siRNA) therapeutics market, accounting for the largest share of 52.2% in 2024.

The U.S. siRNA therapeutics market was valued at USD 2.75 billion in 2024 and is projected to reach USD 13.89 billion by 2032 at 22% CAGR.

• The FDA fast-track pipeline for siRNA increased by 46% between 2022 and 2024.
• NIH awarded USD 1.4 billion in RNA-focused grants in 2024, with siRNA as the leading category.
• >65% of global siRNA clinical trials involve U.S. participants.

Japan

Japan’s siRNA therapeutics market reached USD 435 million in 2024 and will grow to USD 2.14 billion by 2032 (21.5% CAGR).
• Pharmaceutical giants Takeda, Daiichi Sankyo, and Astellas are investing heavily in oncology-focused siRNA.
• Japanese health insurers are fast-tracking reimbursement for siRNA rare disease therapies.

Competitive Landscape

The market is moderately consolidated, with RNA therapeutic innovators dominating early commercialization.

Key Players

Alnylam Pharmaceuticals | Novartis | Arrowhead Pharmaceuticals | Dicerna (Novo Nordisk) | Ionis Pharma | Sirnaomics | Takeda | Silence Therapeutics | AstraZeneca | Sanofi |

Key Highlights

1. Alnylam generated USD 1.72 billion in 2024 revenue from approved siRNA therapies; its portfolio expanded 41% YoY.
2. Novartis’ Leqvio sales crossed USD 950 million in 2024, supported by 27 new country approvals.
3. Arrowhead has 14 siRNA drug candidates in clinical development, the largest pipeline globally.
4. Silence Therapeutics and AstraZeneca co-advanced SLN360, improving Lp(a) reduction by 96% in Phase II trials.

Recent Developments

1. Alnylam secured FDA approval for vutrisiran for hereditary ATTR polyneuropathy (April 2025).
2. Arrowhead announced positive Phase III results for ARO-APOC3 to treat severe hypertriglyceridemia (March 2025).
3. Takeda and Silence Therapeutics initiated siRNA partnership for hematology indications (January 2025).
4. AstraZeneca launched its first inhaled siRNA delivery platform targeting respiratory infections (December 2024).

Market Outlook & Opportunities

• Oncology and cardiometabolic disorders to contribute >55% of total revenue by 2032.
• GalNAc-based subcutaneous siRNA is expected to replace >65% of IV-based siRNA administration by 2030.
• CNS-delivery breakthroughs expected to unlock a USD 6.4 billion opportunity by 2032.
• Asia-Pacific projected as the fastest-growing region (24.6% CAGR) due to manufacturing scale and clinical research expansion.

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Conclusion

The Global Small Interfering RNA (siRNA) Therapeutics Market is rapidly transforming the landscape of precision medicine, offering targeted, durable, and safe gene suppression strategies, siRNA is advancing from rare disease therapeutics to mainstream clinical treatment across oncology, metabolic, and cardiovascular medicine.

According to DataM Intelligence, Alnylam, Novartis, Arrowhead, and Silence Therapeutics are leading clinical and commercial innovation, while strong government funding, regulatory support, and delivery breakthroughs position siRNA as a dominant gene-silencing platform by 2032.

Related Reports:

RNAi Therapeutics Market

miRNA Tools and Services Market

Sai Kiran
DataM Intelligence 4market Research LLP
+1 877-441-4866
sai.k@datamintelligence.com
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