Global siRNA Drugs Market Growth (Status and Outlook) 2025-2031
Description
According to this study, the global siRNA Drugs market size will reach US$ 16700 million by 2031.
Small interfering RNA (siRNA), sometimes known as short interfering RNA or silencing RNA, is a class of double-stranded RNA at first non-coding RNA molecules, typically 20–24 (normally 21) base pairs in length, similar to miRNA, and operating within the RNA interference (RNAi) pathway. siRNA plays a crucial role in gene silencing and regulation of gene expression. siRNA-based therapeutics have gained significant attention in recent years due to their potential to target specific genes involved in diseases such as cancer, genetic disorders, viral infections, and neurodegenerative diseases. The scope of siRNA drug products encompasses various aspects, including their design, development, testing, and regulatory approval.
Core manufacturers of siRNA Drugs include Alnylam, Novartis, Novo Nordisk, Genzyme and Arrowhead. USA is the largest consumption region, accounting for approximately 57% of the global market, followed by Europe. In terms of product type, subcutaneous injection are the largest market segment, with a share of more than 77%. In terms of product application, the largest application market is nervous system therapy, with a share of approximately 52%.
In-depth analysis of siRNA drug market driving factors
I. Technological breakthroughs: the leap from laboratory to clinic
Delivery system innovation
Lipid nanoparticle (LNP) technology optimization: Early siRNA drugs were limited to the field of rare diseases due to low delivery efficiency and insufficient targeting. In recent years, through technological breakthroughs such as ionized lipid component improvement and PEG modification, LNP can achieve liver-targeted delivery (such as Alnylam's Onpattro) or cross the blood-brain barrier (such as Denali's RVT-1201), significantly broadening the scope of indications.
Popularization of GalNAc coupling technology: This technology achieves efficient liver-targeted delivery by binding to asialoglycoprotein receptors, reducing the frequency of administration (such as Novartis' Leqvio subcutaneous injection once every six months), and promoting siRNA to penetrate into chronic diseases such as cardiovascular and metabolic diseases.
Mature chemical modification technology
Improved stability: Through 2'-O-methyl modification, thiophosphate backbone and other technologies, the half-life of siRNA is extended to several weeks, reducing the risk of immunogenicity.
Reduced off-target effects: AI-assisted sequence design (such as Sirnaomics' AI algorithm) combined with bioinformatics screening improves siRNA specificity and significantly improves clinical safety.
2. Market demand: The outbreak of unmet clinical needs
Indications expand from rare diseases to common diseases
Breakthrough in chronic diseases: Among the approximately 1 billion cardiovascular disease patients worldwide, the market potential for hypercholesterolemia is huge.
New paradigm for tumor treatment: siRNA combined with PD-1 inhibitors (such as Arrowhead's ARO-HIF2) shows synergistic effects in the treatment of renal cancer, pushing tumor immunotherapy into the era of gene regulation.
The rise of personalized medicine: siRNA therapy based on genotyping (such as Alzheimer's disease drugs for patients with APOE4 mutations) meets the needs of precision treatment and increases patients' willingness to pay.
3. Policy support: Improvement of the global regulatory framework
China's policy dividends"The 14th Five-Year Plan for the Development of the Pharmaceutical Industry": Clearly support the development of new delivery systems and nucleic acid drugs, and provide tax incentives and research and development subsidies.
Priority review channel: CDE implements fast approval for innovative siRNA drugs, such as Sirnaomics' STP705 (treatment of squamous cell skin cancer) included in the breakthrough therapy.
International regulatory coordination
FDA accelerated approval: Onpattro (2018) was approved as the first siRNA drug, turning on the regulatory green light.
EMA adaptive path: Allows conditional approval based on alternative endpoints (such as biomarker changes) to shorten the R&D cycle.
IV. Capital influx: catalytic effect of industrial ecology
Increased investment and financing activity
Global capital layout: 33 financings in the field of small nucleic acid drugs in 2022, with an amount of nearly US$6 billion (such as Sirnaomics IPO raising US$150 million).
MNC giants enter the market: Roche acquires Dicerna for US$2.8 billion, and Novartis and Alnylam reach a US$3.5 billion cooperation to accelerate pipeline development.
CDMO service ecosystem matures
RiboBio, WuXi AppTec: Provide "one-stop" services from sequence design to cGMP production, reducing R&D costs by more than 50%.
Breakthrough in large-scale production: Through continuous flow synthesis technology, the annual production capacity of siRNA has been increased from grams to kilograms, and the cost per dose has been reduced to less than $100.
V. Competitive landscape: From technical barriers to ecological barriers
Strengthening of patent layout
Core patents for delivery systems: Alnylam owns key technology patent clusters such as LNP and GalNAc, forming a technological monopoly.
Chemical modification patent network: Ionis' 2'-MOE modification and Sirnaomics' GalNAc-siRNA coupling technology build a patent moat.
Cross-border cooperation is accelerating
Pharmaceutical company-biotechnology company alliance: For example, AstraZeneca and Silence Therapeutics cooperate to develop cardiovascular siRNA drugs, sharing R&D risks and benefits.
Collaborative innovation between industry, academia and research: Harvard University and Moderna cooperate to develop RNA editing technology to promote the transformation of basic research to clinical practice.
VI. Challenges and coping strategies
Breakthrough in technical bottlenecks
Improved tissue penetration: Through cell penetrating peptide (CPP) modification or exosome delivery, the problem of siRNA delivery in organs such as the lungs and brain is solved.
Long-term safety assessment: Establish real-time quantitative PCR to monitor off-target effects, and optimize sequence design in combination with single-cell sequencing technology.
Balance between cost and accessibility
Tiered pricing strategy: Adopt the "patent pool" model (such as MPP) in low-income countries to improve drug accessibility.
In the future, siRNA drugs are expected to become the third largest drug type after small molecules and antibodies, reshaping the biopharmaceutical industry landscape. Companies need to focus on core technology breakthroughs, differentiated indication layout and global cooperation to seize market opportunities.
LPI (LP Information)' newest research report, the “siRNA Drugs Industry Forecast” looks at past sales and reviews total world siRNA Drugs sales in 2024, providing a comprehensive analysis by region and market sector of projected siRNA Drugs sales for 2025 through 2031. With siRNA Drugs sales broken down by region, market sector and sub-sector, this report provides a detailed analysis in US$ millions of the world siRNA Drugs industry.
This Insight Report provides a comprehensive analysis of the global siRNA Drugs landscape and highlights key trends related to product segmentation, company formation, revenue, and market share, latest development, and M&A activity. This report also analyses the strategies of leading global companies with a focus on siRNA Drugs portfolios and capabilities, market entry strategies, market positions, and geographic footprints, to better understand these firms’ unique position in an accelerating global siRNA Drugs market.
This Insight Report evaluates the key market trends, drivers, and affecting factors shaping the global outlook for siRNA Drugs and breaks down the forecast by Type, by Application, geography, and market size to highlight emerging pockets of opportunity. With a transparent methodology based on hundreds of bottom-up qualitative and quantitative market inputs, this study forecast offers a highly nuanced view of the current state and future trajectory in the global siRNA Drugs.
This report presents a comprehensive overview, market shares, and growth opportunities of siRNA Drugs market by product type, application, key players and key regions and countries.
Segmentation by Type:
Intravenous Injection
Subcutaneous Injection
Segmentation by Application:
Nervous System Therapy
Endocrine and Metabolic Therapy
Others
This report also splits the market by region:
Americas
United States
Canada
Mexico
Brazil
APAC
China
Japan
Korea
Southeast Asia
India
Australia
Europe
Germany
France
UK
Italy
Russia
Middle East & Africa
Egypt
South Africa
Israel
Turkey
GCC Countries
The below companies that are profiled have been selected based on inputs gathered from primary experts and analyzing the company's coverage, product portfolio, its market penetration.
Alnylam
Novartis
Novo Nordisk
Genzyme
Arrowhead
Silence
Sylentis
Avidity Biosciences
Sirnaomics
Please note: The report will take approximately 2 business days to prepare and deliver.
Small interfering RNA (siRNA), sometimes known as short interfering RNA or silencing RNA, is a class of double-stranded RNA at first non-coding RNA molecules, typically 20–24 (normally 21) base pairs in length, similar to miRNA, and operating within the RNA interference (RNAi) pathway. siRNA plays a crucial role in gene silencing and regulation of gene expression. siRNA-based therapeutics have gained significant attention in recent years due to their potential to target specific genes involved in diseases such as cancer, genetic disorders, viral infections, and neurodegenerative diseases. The scope of siRNA drug products encompasses various aspects, including their design, development, testing, and regulatory approval.
Core manufacturers of siRNA Drugs include Alnylam, Novartis, Novo Nordisk, Genzyme and Arrowhead. USA is the largest consumption region, accounting for approximately 57% of the global market, followed by Europe. In terms of product type, subcutaneous injection are the largest market segment, with a share of more than 77%. In terms of product application, the largest application market is nervous system therapy, with a share of approximately 52%.
In-depth analysis of siRNA drug market driving factors
I. Technological breakthroughs: the leap from laboratory to clinic
Delivery system innovation
Lipid nanoparticle (LNP) technology optimization: Early siRNA drugs were limited to the field of rare diseases due to low delivery efficiency and insufficient targeting. In recent years, through technological breakthroughs such as ionized lipid component improvement and PEG modification, LNP can achieve liver-targeted delivery (such as Alnylam's Onpattro) or cross the blood-brain barrier (such as Denali's RVT-1201), significantly broadening the scope of indications.
Popularization of GalNAc coupling technology: This technology achieves efficient liver-targeted delivery by binding to asialoglycoprotein receptors, reducing the frequency of administration (such as Novartis' Leqvio subcutaneous injection once every six months), and promoting siRNA to penetrate into chronic diseases such as cardiovascular and metabolic diseases.
Mature chemical modification technology
Improved stability: Through 2'-O-methyl modification, thiophosphate backbone and other technologies, the half-life of siRNA is extended to several weeks, reducing the risk of immunogenicity.
Reduced off-target effects: AI-assisted sequence design (such as Sirnaomics' AI algorithm) combined with bioinformatics screening improves siRNA specificity and significantly improves clinical safety.
2. Market demand: The outbreak of unmet clinical needs
Indications expand from rare diseases to common diseases
Breakthrough in chronic diseases: Among the approximately 1 billion cardiovascular disease patients worldwide, the market potential for hypercholesterolemia is huge.
New paradigm for tumor treatment: siRNA combined with PD-1 inhibitors (such as Arrowhead's ARO-HIF2) shows synergistic effects in the treatment of renal cancer, pushing tumor immunotherapy into the era of gene regulation.
The rise of personalized medicine: siRNA therapy based on genotyping (such as Alzheimer's disease drugs for patients with APOE4 mutations) meets the needs of precision treatment and increases patients' willingness to pay.
3. Policy support: Improvement of the global regulatory framework
China's policy dividends"The 14th Five-Year Plan for the Development of the Pharmaceutical Industry": Clearly support the development of new delivery systems and nucleic acid drugs, and provide tax incentives and research and development subsidies.
Priority review channel: CDE implements fast approval for innovative siRNA drugs, such as Sirnaomics' STP705 (treatment of squamous cell skin cancer) included in the breakthrough therapy.
International regulatory coordination
FDA accelerated approval: Onpattro (2018) was approved as the first siRNA drug, turning on the regulatory green light.
EMA adaptive path: Allows conditional approval based on alternative endpoints (such as biomarker changes) to shorten the R&D cycle.
IV. Capital influx: catalytic effect of industrial ecology
Increased investment and financing activity
Global capital layout: 33 financings in the field of small nucleic acid drugs in 2022, with an amount of nearly US$6 billion (such as Sirnaomics IPO raising US$150 million).
MNC giants enter the market: Roche acquires Dicerna for US$2.8 billion, and Novartis and Alnylam reach a US$3.5 billion cooperation to accelerate pipeline development.
CDMO service ecosystem matures
RiboBio, WuXi AppTec: Provide "one-stop" services from sequence design to cGMP production, reducing R&D costs by more than 50%.
Breakthrough in large-scale production: Through continuous flow synthesis technology, the annual production capacity of siRNA has been increased from grams to kilograms, and the cost per dose has been reduced to less than $100.
V. Competitive landscape: From technical barriers to ecological barriers
Strengthening of patent layout
Core patents for delivery systems: Alnylam owns key technology patent clusters such as LNP and GalNAc, forming a technological monopoly.
Chemical modification patent network: Ionis' 2'-MOE modification and Sirnaomics' GalNAc-siRNA coupling technology build a patent moat.
Cross-border cooperation is accelerating
Pharmaceutical company-biotechnology company alliance: For example, AstraZeneca and Silence Therapeutics cooperate to develop cardiovascular siRNA drugs, sharing R&D risks and benefits.
Collaborative innovation between industry, academia and research: Harvard University and Moderna cooperate to develop RNA editing technology to promote the transformation of basic research to clinical practice.
VI. Challenges and coping strategies
Breakthrough in technical bottlenecks
Improved tissue penetration: Through cell penetrating peptide (CPP) modification or exosome delivery, the problem of siRNA delivery in organs such as the lungs and brain is solved.
Long-term safety assessment: Establish real-time quantitative PCR to monitor off-target effects, and optimize sequence design in combination with single-cell sequencing technology.
Balance between cost and accessibility
Tiered pricing strategy: Adopt the "patent pool" model (such as MPP) in low-income countries to improve drug accessibility.
In the future, siRNA drugs are expected to become the third largest drug type after small molecules and antibodies, reshaping the biopharmaceutical industry landscape. Companies need to focus on core technology breakthroughs, differentiated indication layout and global cooperation to seize market opportunities.
LPI (LP Information)' newest research report, the “siRNA Drugs Industry Forecast” looks at past sales and reviews total world siRNA Drugs sales in 2024, providing a comprehensive analysis by region and market sector of projected siRNA Drugs sales for 2025 through 2031. With siRNA Drugs sales broken down by region, market sector and sub-sector, this report provides a detailed analysis in US$ millions of the world siRNA Drugs industry.
This Insight Report provides a comprehensive analysis of the global siRNA Drugs landscape and highlights key trends related to product segmentation, company formation, revenue, and market share, latest development, and M&A activity. This report also analyses the strategies of leading global companies with a focus on siRNA Drugs portfolios and capabilities, market entry strategies, market positions, and geographic footprints, to better understand these firms’ unique position in an accelerating global siRNA Drugs market.
This Insight Report evaluates the key market trends, drivers, and affecting factors shaping the global outlook for siRNA Drugs and breaks down the forecast by Type, by Application, geography, and market size to highlight emerging pockets of opportunity. With a transparent methodology based on hundreds of bottom-up qualitative and quantitative market inputs, this study forecast offers a highly nuanced view of the current state and future trajectory in the global siRNA Drugs.
This report presents a comprehensive overview, market shares, and growth opportunities of siRNA Drugs market by product type, application, key players and key regions and countries.
Segmentation by Type:
Intravenous Injection
Subcutaneous Injection
Segmentation by Application:
Nervous System Therapy
Endocrine and Metabolic Therapy
Others
This report also splits the market by region:
Americas
United States
Canada
Mexico
Brazil
APAC
China
Japan
Korea
Southeast Asia
India
Australia
Europe
Germany
France
UK
Italy
Russia
Middle East & Africa
Egypt
South Africa
Israel
Turkey
GCC Countries
The below companies that are profiled have been selected based on inputs gathered from primary experts and analyzing the company's coverage, product portfolio, its market penetration.
Alnylam
Novartis
Novo Nordisk
Genzyme
Arrowhead
Silence
Sylentis
Avidity Biosciences
Sirnaomics
Please note: The report will take approximately 2 business days to prepare and deliver.
Table of Contents
92 Pages
- *This is a tentative TOC and the final deliverable is subject to change.*
- 1 Scope of the Report
- 2 Executive Summary
- 3 siRNA Drugs Key Players
- 4 siRNA Drugs by Regions
- 5 United States
- 6 Europe
- 7 China
- 8 Rest of World
- 9 Market Drivers, Challenges and Trends
- 10 Key Investors in siRNA Drugs
- 11 Key Players Analysis
- 12 Research Findings and Conclusion
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