The Market Reports

Synopsis
The global market for siRNA Drugs was estimated to be worth US$ 2443 million in 2024 and is forecast to a readjusted size of US$ 16238 million by 2031 with a CAGR of 28.9% during the forecast period 2025-2031.
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.
This report aims to provide a comprehensive presentation of the global market for siRNA Drugs, focusing on the total sales revenue, key companies market share and ranking, together with an analysis of siRNA Drugs by region & country, by Type, and by Application.
The siRNA Drugs market size, estimations, and forecasts are provided in terms of sales revenue ($ millions), considering 2024 as the base year, with history and forecast data for the period from 2020 to 2031. With both quantitative and qualitative analysis, to help readers develop business/growth strategies, assess the market competitive situation, analyze their position in the current marketplace, and make informed business decisions regarding siRNA Drugs.
Market Segmentation
By Company
Alnylam
Novartis
Novo Nordisk
Genzyme
Arrowhead
Silence
Sylentis
Avidity Biosciences
Sirnaomics
Segment by Type
Intravenous Injection
Subcutaneous Injection
Segment by Application
Nervous System Therapy
Endocrine and Metabolic Therapy
Others
By Region
North America
United States
Canada
Asia-Pacific
China
Japan
South Korea
Southeast Asia
India
Australia
Rest of Asia-Pacific
Europe
Germany
France
U.K.
Italy
Netherlands
Nordic Countries
Rest of Europe
Latin America
Mexico
Brazil
Rest of Latin America
Middle East & Africa
Turkey
Saudi Arabia
UAE
Rest of MEA
Chapter Outline
Chapter 1: Introduces the report scope of the report, global total market size. This chapter also provides the market dynamics, latest developments of the market, the driving factors and restrictive factors of the market, the challenges and risks faced by manufacturers in the industry, and the analysis of relevant policies in the industry.
Chapter 2: Detailed analysis of siRNA Drugs company competitive landscape, revenue market share, latest development plan, merger, and acquisition information, etc.
Chapter 3: Provides the analysis of various market segments by Type, covering the market size and development potential of each market segment, to help readers find the blue ocean market in different market segments.
Chapter 4: Provides the analysis of various market segments by Application, covering the market size and development potential of each market segment, to help readers find the blue ocean market in different downstream markets.
Chapter 5: Revenue of siRNA Drugs in regional level. It provides a quantitative analysis of the market size and development potential of each region and introduces the market development, future development prospects, market space, and market size of each country in the world.
Chapter 6: Revenue of siRNA Drugs in country level. It provides sigmate data by Type, and by Application for each country/region.
Chapter 7: Provides profiles of key players, introducing the basic situation of the main companies in the market in detail, including product revenue, gross margin, product introduction, recent development, etc.
Chapter 8: Analysis of industrial chain, including the upstream and downstream of the industry.
Chapter 9: Conclusion.

Index