AUSTIN, Texas and TOKYO, Sept. 4, 2025 /PRNewswire/ -- According to DataM Intelligence, the RNAi technology market size reached US$ 2.75 Billion in 2024 from US$ 2.51 Billion in 2023 and is expected to reach US$ 6.63 Billion by 2033, growing at a CAGR of 10.4% during the forecast period 2025-2033.
The breakthrough approval of Onpattro (patisiran) in 2018 marked the first siRNA drug to reach patients, validating gene silencing as a viable medical strategy. This success was quickly followed by other Alnylam products like Givlaari (givosiran) for acute hepatic porphyria, Oxlumo (lumasiran) for primary hyperoxaluria, and Amvuttra (vutrisiran), which established RNAi's leadership in rare genetic and hepatic disorders. A pivotal milestone came with Leqvio (inclisiran), developed with Novartis, expanding RNAi into the large cardiovascular disease market, demonstrating scalability beyond niche indications.
Advances in delivery technologies, particularly GalNAc conjugates for hepatocyte targeting and lipid nanoparticles (LNPs), have further amplified RNAi's market potential by improving safety, durability, and patient convenience. Strategic partnerships between RNAi innovators and global pharma leaders are accelerating commercialization and broadening clinical pipelines, while regulatory agencies are offering supportive pathways such as orphan drug and breakthrough designations. RNAi is no longer confined to rare disease therapies but is poised to tackle oncology, CNS disorders, and infectious diseases. By silencing disease-causing genes with precision, RNAi is amplifying not only clinical outcomes but also its market footprint, positioning it as one of the most promising frontiers in next-generation therapeutics.
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Key Highlights from the Report
- The global RNAi technology market is expected to grow from US$ 2.75 billion in 2024 to US$ 6.63 billion by 2033 at a CAGR of 10.4%.
- North America dominates with a 42.73% market share in 2024, driven by advanced biotech ecosystem and early regulatory approvals.
- The siRNA segment holds the largest share at 43.61% in 2024, supported by successful clinical validations.
- The Asia Pacific region is expected to see significant growth, fueled by the fastest CAGR of 11.7% over the forecast period.
Proven Clinical Validation with First-to-Market RNAi Therapeutics is Significantly Driving the RNAi
The proven clinical validation of first-to-market RNAi therapeutics is one of the most powerful catalysts driving the RNAi technology market's growth. For years, RNAi was viewed largely as a promising research tool, but skepticism persisted around its clinical viability due to delivery and safety challenges. This changed with the approval of Onpattro (patisiran) in 2018, the first siRNA-based drug approved for treating hereditary transthyretin-mediated amyloidosis. Its success not only validated RNAi's therapeutic potential but also demonstrated that gene silencing could translate into meaningful patient outcomes.
This milestone was quickly followed by other approvals, such as Givlaari (givosiran) for acute hepatic porphyria, Oxlumo (lumasiran) for primary hyperoxaluria, and Leqvio (inclisiran) for hypercholesterolemia, collectively establishing RNAi as a credible therapeutic modality. Each approval has progressively built trust among regulators, investors, and pharmaceutical companies, reducing uncertainties around safety, durability, and regulatory pathways.
These successes have proven RNAi's scalability beyond ultra-rare diseases, with inclisiran marking a significant step into the large cardiovascular market. The commercial performance of these drugs, combined with positive Phase III trial results from emerging candidates, has attracted major partnerships and licensing deals between RNAi-focused biotechs like Alnylam and Arrowhead and global pharma leaders. This validation loop successful approvals driving partnerships, funding, and expanded pipelines, is significantly accelerating the overall RNAi market, transforming it from a niche innovation into a mainstream therapeutic platform.
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The siRNA (small interfering RNA) Segment is Dominating the RNAi Technology Market with a 43.61% Share in 2024
The siRNA (small interfering RNA) segment is dominating the RNAi technology market because it has delivered the most successful and clinically validated products to date, establishing itself as the core therapeutic modality in RNAi. siRNAs are synthetic double-stranded oligonucleotides that precisely silence disease-causing genes, and their design flexibility, combined with advances in delivery technologies such as GalNAc conjugates and lipid nanoparticles, has made them commercially viable.
The landmark approval of Onpattro (patisiran) in 2018 for hereditary transthyretin-mediated amyloidosis was the first breakthrough, proving siRNA's potential in rare genetic diseases. This was followed by other Alnylam products like Givlaari (givosiran) for acute hepatic porphyria, Oxlumo (lumasiran) for primary hyperoxaluria, and Amvuttra (vutrisiran), which further validated siRNA's role in treating liver-related disorders. Additionally, Leqvio (inclisiran), co-developed by Novartis and Alnylam, marked a major expansion of siRNA into the cardiovascular market, addressing high cholesterol in a much larger patient population. These successes demonstrate siRNA's scalability beyond ultra-rare diseases, making it the most commercially advanced RNAi segment.
North America Is Expected to Dominate the Global RNAi Technology Market with a 44.13% in 2024
North America holds dominance in the RNAi technology market due to its advanced biotech ecosystem, strong funding landscape, and early regulatory approvals of pioneering RNAi drugs. The US, in particular, is home to industry leaders such as Alnylam Pharmaceuticals, which has successfully commercialized multiple siRNA therapies, including Onpattro (patisiran), Givlaari (givosiran), and Oxlumo (lumasiran), setting global benchmarks for RNAi therapeutics. The region also spearheaded the launch of Leqvio (inclisiran) in collaboration with Novartis, marking a major expansion into the high-prevalence cardiovascular disease space.
North America benefits from supportive regulatory frameworks, with the FDA granting designations like orphan drug and breakthrough therapy that have accelerated development timelines for RNAi assets. Additionally, strong academic institutions and research centers in the US and Canada drive innovation in RNAi delivery systems and preclinical research. The presence of established pharmaceutical companies actively partnering with RNAi-focused biotechs further strengthens commercialization pathways. These factors, combined with a high prevalence of genetic and metabolic disorders, robust reimbursement infrastructure, and significant venture capital interest, ensure that North America continues to lead in both revenue share and pipeline advancement in the global RNAi technology market.
Key Market Companies:
Major companies working towards the market's growth include Alnylam Pharmaceuticals, Inc., Thermo Fisher Scientific Inc., Merck KGaA, Creative Biolabs, GenScript, Revvity, Promega Corporation, OriGene Technologies, Inc. and Altogen Biosystems, among others.
Recent Developments in the Market
- In March 2025, Alnylam Pharmaceuticals, Inc., the leading RNAi therapeutics company, highlighted the significance of the US Food and Drug Administration's (FDA) approval of Qfitlia (fitusiran), the sixth Alnylam-discovered RNAi therapeutic approved in the U.S., and the first and only therapeutic to lower antithrombin (AT), a protein that inhibits blood clotting, to promote thrombin generation to rebalance hemostasis and prevent bleeds. Qfitlia is indicated in the U.S. for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adult and pediatric patients 12 years of age and older with hemophilia A or B, with or without factor VIII or IX inhibitors (neutralizing antibodies).
- In March 2025, Alnylam Pharmaceuticals, Inc. announced the U.S. Food and Drug Administration (FDA) approval of the supplemental New Drug Application (sNDA) for its RNAi therapeutic, AMVUTTRA (vutrisiran), for the treatment of the cardiomyopathy of wild-type or hereditary transthyretin-mediated amyloidosis (ATTR-CM) in adults to reduce cardiovascular mortality, cardiovascular hospitalizations and urgent heart failure visits. The approval expands the indication for AMVUTTRA, which now becomes the first and only therapeutic approved by the FDA for the treatment of ATTR-CM and the polyneuropathy of hereditary transthyretin-mediated amyloidosis (hATTR-PN) in adults.
Related Reports:
- Small Interfering RNA (siRNA) Therapeutics Market Size, Share Analysis, Growth Trends and Forecast Report 2025-2033
- miRNA Tools and Services Market Size, Share, Industry, Forecast and outlook (2024-2031)
- RNAi Therapeutics Market Size, Share, Industry, Forecast and outlook (2024-2031)
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