Small Interfering RNA (siRNA) Therapeutics Market to Reach US$ 12.38 Billion by 2033, Growing at 17.4% CAGR

The global small interfering RNA (siRNA) therapeutics market was valued at US$ 2.55 billion in 2024 and is projected to reach US$ 12.38 billion by 2033, registering a CAGR of 17.4% between 2025-2033, according to DataM Intelligence. The surge is fueled by increasing research into precision medicines, new regulatory approvals, and the growing demand for alternatives to traditional treatments for life-threatening chronic and rare genetic diseases.

siRNA drugs operate by silencing disease-causing genes at the post-transcriptional level, preventing harmful protein production. Since the FDA's 2018 approval of patisiran (Onpattro), the market has seen a steady stream of breakthroughs. The most recent milestone occurred in March 2025, with the U.S. FDA approving fitusiran (Qfitlia) for hemophilia A and B, marking the first siRNA therapy in the hemophilia treatment landscape.

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Key Highlights from the Report

➤ Global siRNA market expected to grow at 17.4% CAGR, reaching US$ 12.38 billion by 2033
➤ Vutrisiran (Amvuttra) leads with 38.05% market share and US$ 970.45 million sales in 2024
➤ North America holds 52.2% market share, driven by U.S. dominance in approvals and sales
➤ Seven siRNA therapies approved globally; more expected during forecast period
➤ Emerging pipeline therapies target wider range of genetic and rare diseases
➤ March 2025 FDA approval of Fitusiran marks breakthrough for hemophilia treatment

Market Segmentation

The siRNA therapeutics market is segmented by drug, indication, route of administration, and region.

By drug, Vutrisiran (Amvuttra) dominates, approved for hereditary transthyretin-mediated amyloidosis (hATTR) and cardiomyopathy. Developed by Alnylam Pharmaceuticals, it has shown transformative impact in reducing cardiovascular mortality and hospitalizations. In 2024, it achieved US$ 970.45 million in total sales, with nearly 65% revenue from the U.S. market.

By indication, siRNA treatments address conditions with high unmet needs, including amyloidosis, hemophilia, and hypercholesterolemia. New therapy development focuses on expanding into broader chronic illnesses with genetic roots, offering potential to scale commercial adoption.

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Regional Insights

North America leads the global market, accounting for 52.2% share in 2024, reflecting both high disease prevalence and strong regulatory and commercial activity. All approved siRNA drugs are available in the U.S., and revenues from the region are substantial:

Europe is also expanding rapidly, driven by EMA approvals and health system uptake. In April 2025, the European Medicines Agency (CHMP) granted a positive opinion recommending Vutrisiran for ATTR-CM cardiomyopathy treatment.

Asia-Pacific shows significant potential, with improving regulatory frameworks and biopharma collaboration driving faster introduction of advanced RNA therapies into regional markets.

Market Dynamics

Market Drivers

Rising global incidence of rare genetic diseases and demand for precision therapies underpin growth. Increasing funding for biopharma R&D and expansion of approved siRNA indications amplify opportunities.

Market Restraints

High treatment costs remain a barrier, as drugs like Onpattro cost over US$ 10,000 per infusion, posing affordability challenges in low- and middle-income countries.

Market Opportunities

Next-generation delivery systems, subcutaneous formulations, and expanding therapeutic applications into chronic lifestyle diseases present lucrative growth avenues for industry players.

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Reasons to Buy the Report

✔ Detailed insight into current approved siRNA therapies and clinical pipeline developments
✔ Analysis of pricing models, reimbursement trends, and market access challenges
✔ Breakdown of market share by drug, region, and indication for strategic planning
✔ Competitive benchmarking of leading and emerging siRNA developers
✔ Identification of innovation opportunities in delivery platforms and patient outreach

Frequently Asked Questions (FAQs)

◆ How big is the global siRNA therapeutics market in 2024?
◆ Who are the leading companies in the RNA-based drug development sector?
◆ What CAGR is projected for the siRNA market from 2025-2033?
◆ Which siRNA therapy currently holds the largest market share?
◆ Which region will dominate the global siRNA therapeutics market by 2033?

Company Insights

Alnylam Pharmaceuticals, Inc.

Novartis AG

Novo Nordisk A/S

Emerging Players:

Arbutus Biopharma

ADARx Pharmaceuticals

Arrowhead Pharmaceuticals, Inc.

Amgen Inc.

Recent Developments:

April 2025 - CHMP (EMA) adopts positive opinion recommending Vutrisiran for ATTR-CM cardiomyopathy treatment.

March 2025 - FDA approves Fitusiran (Qfitlia) for hemophilia A and B, marking first siRNA therapy in hemophilia treatment landscape.

Conclusion

The global siRNA therapeutics market is entering an era of accelerated growth as breakthrough drugs expand beyond rare diseases into broader care segments. North America's leadership combined with Europe's regulatory momentum and Asia-Pacific's fast-developing biotech ecosystem sets the stage for robust market performance. With rapid innovation in delivery technologies and new approvals anticipated, siRNA drugs are poised to redefine the landscape of genetic and chronic disease management through 2033.

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This release was published on openPR.