siRNA Drugs Industry Research: Reach USD 16.2 Billion by 2031 with 28.9% CAGR

According to the recent report from QYResearch, RNAi therapeutics are moving rapidly from promise to practice. Anchored by breakthroughs in cardiovascular disease and transthyretin amyloidosis, small interfering RNA (siRNA) drugs are reshaping global treatment strategies. Recent clinical trial readouts, regulatory approvals, and commercial performance in 2024-2025 have positioned the sector for strong growth, with global revenues projected to reach US$16.2 billion by 2031 at a 28.9% CAGR.

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Latest Data

· Forecasted market size (2031): US$ 16,238 million

· CAGR (2025-2031): 28.9%

· Regional split: USA ≈57% of global consumption, Europe second

· By product type: Subcutaneous injection >77% share, intravenous remainder

· By application: Nervous system therapy ≈52% share, followed by endocrine & metabolic, and others

Leading Companies

Alnylam
Novartis
Novo Nordisk
Genzyme
Arrowhead
Silence
Sylentis
Avidity Biosciences
Sirnaomics

Classification

· Intravenous Injection

· Subcutaneous Injection

Applications

· Nervous System Therapy

· Endocrine and Metabolic Therapy

· Others

2024-2025 Highlights

Alnylam - AMVUTTRA (vutrisiran): In 2025, Alnylam expanded vutrisiran into ATTR-CM with approvals in Europe, UK, Japan, and Brazil. Long-term data showed a 36% reduction in all-cause mortality and 33% reduction in cardiovascular mortality through 42 months, reinforcing the drug's role beyond biomarkers. Quarterly dosing supports adoption and sales in Q2 2025 reached $492 million, with around 1,400 ATTR-CM patients treated.

Novartis - LEQVIO (inclisiran): In July 2025, the FDA approved inclisiran as a first-line monotherapy for LDL-C reduction, broadening its use beyond add-on therapy. Inclisiran sales in 2024 reached $754 million (up 112% year-on-year). The twice-yearly subcutaneous dosing model has gained traction across the US and Europe, including NHS-supported rollout in England.

Arrowhead - plozasiran (ARO-APOC3): Phase 3 PALISADE results in 2024 demonstrated up to 80% median triglyceride reductions and significant decreases in acute pancreatitis incidence. This program targets familial chylomicronemia syndrome and severe hypertriglyceridemia, creating a foundation for expansion into larger dyslipidemia populations.

Silence Therapeutics - zerlasiran (SLN360): Mid-stage trial results in 2024 showed ~80-90% reductions in Lp(a) sustained up to 60 weeks with dosing intervals as long as 16-24 weeks. This positions zerlasiran among leading siRNA approaches in lipoprotein(a) lowering, addressing a major unmet cardiovascular risk factor.

Avidity Biosciences - del-desiran (AOC 1001): First-in-class muscle-targeted siRNA showed durable improvements in strength, myotonia, and daily functioning in myotonic dystrophy type 1 patients. The FDA lifted a partial clinical hold in late 2024, clearing the path for Phase 3 studies in 2025. This represents one of the first successful extrahepatic delivery programs for siRNA.

Product Snapshots

Alnylam - AMVUTTRA (vutrisiran)

· Target: TTR silencing

· Dosing: 25 mg subcutaneous every 3 months

· 42-month outcomes: 36% fewer deaths, 33% lower cardiovascular mortality

· Sales Q2 2025: $492M; ~1,400 ATTR-CM patients treated globally

Novartis - LEQVIO (inclisiran)

· Target: PCSK9 silencing

· Dosing: Initial, 3 months, then every 6 months

· LDL-C reduction: ~50% sustained long term (>6 years data)

· 2024 sales: $754M (+112% YoY); FDA first-line approval July 2025

Arrowhead - plozasiran (ARO-APOC3)

· Target: APOC3 silencing

· Phase 3: ~80% triglyceride reduction; reduced pancreatitis incidence

· Dosing: infrequent subcutaneous injections under study

Silence Therapeutics - zerlasiran (SLN360)

· Target: LPA silencing

· Phase 2: ~80-90% Lp(a) reduction; effect maintained up to 60 weeks

· Dosing: q16-24 weeks

Avidity Biosciences - del-desiran (AOC 1001)

· Target: DMPK silencing in muscle

· Data: Strength, myotonia, daily living improvements sustained long term

· Regulatory: FDA hold lifted 2024; Phase 3 initiated 2025

Market Trend

Subcutaneous Delivery Becomes Dominant

With more than 77% of global siRNA drug sales tied to subcutaneous formats, quarterly or semi-annual dosing has become standard. Inclisiran and vutrisiran prove that low-frequency injections significantly improve adherence and long-term outcomes, accelerating payer acceptance.

Cardiometabolic Expansion

Cardiovascular and metabolic diseases are set to become the largest drivers of siRNA adoption. Inclisiran's broad LDL-C lowering, plozasiran's impact on triglycerides, and zerlasiran's durable Lp(a) reductions signal that siRNA will expand far beyond rare diseases into large-scale public health markets.

Extrahepatic Delivery Breakthroughs

Historically restricted to the liver, siRNA is now successfully reaching muscle tissue with Avidity's AOC platform. This unlocks therapeutic opportunities in neuromuscular disorders and points toward possible future applications in the brain and other organs.

Hard Outcomes Strengthen Value

HELIOS-B results with vutrisiran delivered mortality and cardiovascular event reductions, elevating siRNA beyond surrogate biomarker evidence. Similar outcomes trials are underway in LDL-C and Lp(a) lowering, potentially cementing siRNA's role in guideline-directed care.

Policy and Regulatory Acceleration

The FDA's first-line approval for inclisiran in 2025 and NHS England's nationwide rollout provide strong regulatory tailwinds. These moves embed siRNA into primary care settings, ensuring earlier adoption across broader patient populations.

Manufacturing Scale and CDMO Growth

Global contract manufacturers have scaled siRNA output from grams to kilograms annually. Agilent, WuXi STA, and ST Pharm have all expanded capacity in 2024-2025 to support surging demand, driving down cost per dose and ensuring supply stability.

Next-Generation Delivery Chemistry

Advances in GalNAc design and chemical modifications now allow longer intervals between doses-16 to 24 weeks or more-while improving safety and reducing off-target effects. This trend underpins payer confidence and expands use in chronic disease management.

Downstream Customers

Cleveland Clinic
Mayo Clinic
Mass General Brigham
Kaiser Permanente
Mount Sinai Health System
UCLA Health
NYU Langone Health
Stanford Health Care
UCSF Health
Houston Methodist
Intermountain Health
Geisinger
Ochsner Health
Cedars-Sinai
HCA Healthcare

Conclusion

The siRNA drugs sector has entered a new era in 2025, driven by landmark regulatory wins, strong commercial momentum, and robust clinical outcomes. With subcutaneous formats dominating, cardiometabolic expansion accelerating, and extrahepatic delivery maturing, siRNA therapies are on track to become the third great drug class after small molecules and antibodies. Industry leaders such as Alnylam, Novartis, Arrowhead, Silence, and Avidity are defining the competitive landscape, while hospitals and health systems worldwide prepare to integrate these therapies into standard care.

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