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

1 Scope of the Report
    1.1 Market Introduction
    1.2 Years Considered
    1.3 Research Objectives
    1.4 Market Research Methodology
    1.5 Research Process and Data Source
    1.6 Economic Indicators
    1.7 Currency Considered

2 Executive Summary
    2.1 World Market Overview
        2.1.1 Global siRNA Drugs Market Size 2025-2031
        2.1.2 siRNA Drugs Market Size CAGR by Region
    2.2 siRNA Drugs Segment by Type
        2.2.1 Intravenous Injection
        2.2.2 Subcutaneous Injection
    2.3 siRNA Drugs Market Size by Type
        2.3.1 Global siRNA Drugs Market Size Market Share by Type (2025-2031)
        2.3.2 Global siRNA Drugs Market Size Growth Rate by Type (2025-2031)
    2.4 siRNA Drugs Segment by Application
        2.4.1 Nervous System Therapy
        2.4.2 Endocrine and Metabolic Therapy
        2.4.3 Others
    2.5 siRNA Drugs Market Size by Application (2025-2031)
        2.5.1 Global siRNA Drugs Market Size Market Share by Application (2025-2031)
        2.5.2 Global siRNA Drugs Market Size Growth Rate by Application (2025-2031)

3 siRNA Drugs Key Players
    3.1 Date of Key Players Enter into siRNA Drugs
    3.2 Key Players siRNA Drugs Product Offered
    3.3 Key Players siRNA Drugs Funding/Investment Analysis
    3.4 Funding/Investment
        3.4.1 Funding/Investment by Regions
        3.4.2 Funding/Investment by End-Industry
    3.5 Key Players siRNA Drugs Valuation & Market Capitalization
    3.6 Key Players Mergers & Acquisitions, Expansion Plans
    3.7 Market Ranking
    3.8 New Product/Technology Launches
    3.9 Partnerships, Agreements, and Collaborations
    3.10 Mergers and Acquisitions

4 siRNA Drugs by Regions
    4.1 siRNA Drugs Market Size by Regions (2025-2031)
    4.2 United States siRNA Drugs Market Size Growth (2025-2031)
    4.3 China siRNA Drugs Market Size Growth (2025-2031)
    4.4 Europe siRNA Drugs Market Size Growth (2025-2031)
    4.5 Rest of World siRNA Drugs Market Size Growth (2025-2031)

5 United States
    5.1 United States siRNA Drugs Market Size by Type (2025-2031)
    5.2 United States siRNA Drugs Market Size by Application (2025-2031)

6 Europe
    6.1 Europe siRNA Drugs Market Size by Type (2025-2031)
    6.2 Europe siRNA Drugs Market Size by Application (2025-2031)

7 China
    7.1 China siRNA Drugs Market Size by Type (2025-2031)
    7.2 China siRNA Drugs Market Size by Application (2025-2031)

8 Rest of World
    8.1 Rest of World siRNA Drugs Market Size by Type (2025-2031)
    8.2 Rest of World siRNA Drugs Market Size by Application (2025-2031)
    8.3 Japan
    8.4 South Korea
    8.5 Southeast Asia

9 Market Drivers, Challenges and Trends
    9.1 Market Drivers & Growth Opportunities
    9.2 Market Challenges & Risks
    9.3 Industry Trends

10 Key Investors in siRNA Drugs
    10.1 Company A
        10.1.1 Company A Company Details
        10.1.2 Company Description
        10.1.3 Companies Invested by Company A
        10.1.4 Company A Key Development and Market Layout
    10.2 Company B
        10.2.1 Company B Company Details
        10.2.2 Company Description
        10.2.3 Companies Invested by Company B
        10.2.4 Company B Key Development and Market Layout
    10.3 Company C
        10.3.1 Company C Company Details
        10.3.2 Company Description
        10.3.3 Companies Invested by Company C
        10.3.4 Company C Key Development and Market Layout
    10.4 Company D
    10.5 ……

11 Key Players Analysis
    11.1 Alnylam
        11.1.1 Alnylam Company Details
        11.1.2 Alnylam siRNA Drugs Product Offered
        11.1.3 Alnylam siRNA Drugs Market Size (2024 VS 2030)
        11.1.4 Alnylam Main Business Overview
        11.1.5 Alnylam News
    11.2 Novartis
        11.2.1 Novartis Company Details
        11.2.2 Novartis siRNA Drugs Product Offered
        11.2.3 Novartis siRNA Drugs Market Size (2024 VS 2030)
        11.2.4 Novartis Main Business Overview
        11.2.5 Novartis News
    11.3 Novo Nordisk
        11.3.1 Novo Nordisk Company Details
        11.3.2 Novo Nordisk siRNA Drugs Product Offered
        11.3.3 Novo Nordisk siRNA Drugs Market Size (2024 VS 2030)
        11.3.4 Novo Nordisk Main Business Overview
        11.3.5 Novo Nordisk News
    11.4 Genzyme
        11.4.1 Genzyme Company Details
        11.4.2 Genzyme siRNA Drugs Product Offered
        11.4.3 Genzyme siRNA Drugs Market Size (2024 VS 2030)
        11.4.4 Genzyme Main Business Overview
        11.4.5 Genzyme News
    11.5 Arrowhead
        11.5.1 Arrowhead Company Details
        11.5.2 Arrowhead siRNA Drugs Product Offered
        11.5.3 Arrowhead siRNA Drugs Market Size (2024 VS 2030)
        11.5.4 Arrowhead Main Business Overview
        11.5.5 Arrowhead News
    11.6 Silence
        11.6.1 Silence Company Details
        11.6.2 Silence siRNA Drugs Product Offered
        11.6.3 Silence siRNA Drugs Market Size (2024 VS 2030)
        11.6.4 Silence Main Business Overview
        11.6.5 Silence News
    11.7 Sylentis
        11.7.1 Sylentis Company Details
        11.7.2 Sylentis siRNA Drugs Product Offered
        11.7.3 Sylentis siRNA Drugs Market Size (2024 VS 2030)
        11.7.4 Sylentis Main Business Overview
        11.7.5 Sylentis News
    11.8 Avidity Biosciences
        11.8.1 Avidity Biosciences Company Details
        11.8.2 Avidity Biosciences siRNA Drugs Product Offered
        11.8.3 Avidity Biosciences siRNA Drugs Market Size (2024 VS 2030)
        11.8.4 Avidity Biosciences Main Business Overview
        11.8.5 Avidity Biosciences News
    11.9 Sirnaomics
        11.9.1 Sirnaomics Company Details
        11.9.2 Sirnaomics siRNA Drugs Product Offered
        11.9.3 Sirnaomics siRNA Drugs Market Size (2024 VS 2030)
        11.9.4 Sirnaomics Main Business Overview
        11.9.5 Sirnaomics News

12 Research Findings and Conclusion