RNAi 약물전달 시장 : 점유율 분석, 업계 동향 및 통계, 성장 예측(2026-2031년)

According to Mordor Intelligence, the rNAi drug delivery market size is projected to be USD 1.21 billion in 2025, USD 1.43 billion in 2026, and reach USD 3.34 billion by 2031, growing at a CAGR of 18.41% from 2026 to 2031.

This report is Segmented by Technology (siRNA, Mirna, and More), Delivery System (Lipid Nanoparticles, Polymeric Nanoparticles, and More), Route of Administration (Intravenous and More), Target Disease (Cancer, Genetic Disorders, and More), Target Tissue (Liver, Lungs, and More), End-User (Pharmaceutical Companies and More), and Geography (North America and More). Forecasts are Provided in Terms of Value (USD).

Global RNAi Drug Delivery Market Trends and Insights

Clinical Pull From Approved siRNA Therapies

The RNAi drug delivery market is benefiting from a stronger regulatory base because approved siRNA products have reduced the uncertainty that once limited platform adoption. AMVUTTRA's 2025 approval in ATTR amyloidosis with cardiomyopathy validated a quarterly subcutaneous dosing model that is easier to scale commercially than hospital-centered infusion models. That approval also changed how large drug makers evaluate delivery risk, because proven commercial products now offer a better reference point than early laboratory promise alone. Revenue guidance from Alnylam for 2026 further strengthens that view, since it suggests that approved products can support sustained expansion rather than a one-time launch spike. This is making counterparties more willing to sign large licensing agreements around delivery platforms with clearer commercial precedent. The result is a reinforcing cycle in the RNAi drug delivery market where every new approval improves confidence in the next wave of assets and the systems that carry them.

Next-Generation Lipid Nanoparticle Engineering

The RNAi drug delivery market is also advancing because lipid nanoparticle design is becoming more predictable and more deliberate than earlier formulation work. The COMET model, trained on the LANCE dataset, showed that non-canonical LNP configurations can be evaluated with much greater speed, which reduces the time needed to screen potential delivery compositions. This matters because changing lipid tail length, linker chemistry, and head-group pKa can materially shift where an LNP distributes after administration. German translational programs such as BASE-Lipid and NanoGen also show that formulation research is moving closer to regulatory and manufacturing settings instead of remaining only in academic proof-of-concept work. That shift improves the likelihood that successful laboratory candidates can move into reproducible, compliant production processes. As these methods mature, the RNAi drug delivery market is likely to broaden from liver-biased performance toward a more diverse tissue delivery profile.

Extrahepatic Delivery Efficiency Limits

The biggest technical ceiling in the RNAi drug delivery market is still the difficulty of reaching non-hepatic tissues with enough active material to create durable therapeutic benefit. The blood-brain barrier, dense cardiac tissue structure, and endosomal trapping all reduce the fraction of delivered material that reaches the cytosol in a productive form. Reviews published in 2025 also noted that many nanocarriers intended for the brain are still cleared by the liver before they can reach central nervous system targets in useful quantities. Even when early animal data looks promising, repeat dosing and protein corona effects can alter biodistribution in ways that are hard to predict at later stages. This creates a scientific problem and a financing problem at the same time because uncertain translation raises the attrition risk of expensive extrahepatic programs. That is especially relevant for brain-directed programs, which represent one of the fastest-moving parts of the RNAi drug delivery market but still lack broad human validation.

Other drivers and restraints analyzed in the detailed report include:

1. Expanding Hepatic Delivery Validation
2. Under-Served Extrahepatic Targets
3. High Formulation and CMC Complexity

For complete list of drivers and restraints, kindly check the Table Of Contents.

Segment Analysis

siRNA held 65.31% of the RNAi drug delivery market size in 2025, making it the clear commercial anchor across approved products and partner interest. Its lead comes from a much deeper clinical history, better understood conjugate and LNP delivery routes, and a stronger set of regulatory precedents than other RNA interference formats. Large licensing transactions have followed that pattern because platform buyers still prefer molecule classes with visible clinical and commercial proof. In the RNAi drug delivery industry, that preference keeps siRNA at the center of both marketed revenue and platform valuation discussions. miRNA remains smaller today, but investor interest increased in 2026 when Thalia Therapeutics acquired Sanmirna Therapeutics for its clinical-stage anti-miRNA-126 program in acute myeloid leukemia.

shRNA is forecast to grow at a 22.38% CAGR from 2026 to 2031, which makes it the fastest-moving technology segment in the RNAi drug delivery market. That expansion is linked to viral vector-based central nervous system programs where long-duration gene silencing can support neurodegenerative disease strategies. Alnylam's ALN-HTT02 for Huntington's disease is expected to deliver Phase 1 data in the second half of 2026, and that readout could shape how investors view shRNA-based delivery over the next few years. Even so, shRNA carries more compliance pressure because viral vector manufacturing, cargo limits, and immunogenicity remain active review points under current gene therapy expectations. Other technologies such as aptamer-mediated delivery are present, but the available evidence suggests they will remain niche positions rather than near-term volume drivers in the RNAi drug delivery industry.

Lipid nanoparticles accounted for 60.24% share in 2025 and therefore represented the largest delivery platform in the RNAi drug delivery market. Their position rests on validated manufacturing infrastructure, established intellectual property, and the credibility built through global RNA vaccine production systems. The commercial importance of that lead is clear because patisiran established an early clinical benchmark for LNP-enabled hepatic transthyretin knockdown and shaped later development standards. LNPs also remain the easiest platform for many developers to explain to regulators and partners because there is a more mature evidence base around quality control and clinical behavior. Exosomes and viral vectors still play useful roles in specialized settings, especially where biological barrier crossing or lower innate immunogenicity matters more than standardized scale.

Polymeric nanoparticles are projected to grow at a 20.52% CAGR from 2026 to 2031, which gives them the highest growth pace among delivery systems in the RNAi drug delivery market. Their appeal comes from tunable degradability, easier surface functionalization for active targeting, and better flexibility for pairing siRNA with other therapeutic payloads. German research programs are already exploring tyrosine-modified polyamine systems for inhaled siRNA delivery in lung tumor models, which shows that polymeric systems are being positioned for routes and tissues that are harder for standard LNPs to serve. These materials still need stronger late-stage validation, but their design range gives them a clear role in the next expansion phase of the RNAi drug delivery market. Regulatory expectations around biodegradable excipients and biocompatibility are becoming easier to manage as RNA-focused CMC frameworks mature, which lowers one barrier to future adoption.

Complete Report Scope:

• By Technology
  • siRNA
  • miRNA
  • shRNA
  • Other Technologies
• By Delivery System
  • Lipid Nanoparticles
  • Polymeric Nanoparticles
  • Exosomes
  • Viral Vectors
  • Other Delivery Systems
• By Route of Administration
  • Intravenous
  • Subcutaneous
  • Intranasal
  • Other Routes of Administration
• By Target Disease
  • Cancer
  • Genetic Disorders
  • Viral Infections
  • Metabolic Diseases
  • Other Target Diseases
• By Target Tissue
  • Liver
  • Lungs
  • Brain
  • Heart
  • Other Target Tissues
• By End-User
  • Pharmaceutical Companies
  • Biotechnology Companies
  • Academic and Research Institutions
  • Hospitals and Clinics
  • Other End-Users
• By Geography
  • North America
    • United States
    • Canada
    • Mexico
  • Europe
    • Germany
    • United Kingdom
    • France
    • Italy
    • Spain
    • Rest of Europe
  • Asia-Pacific
    • China
    • Japan
    • India
    • Australia
    • South Korea
    • Rest of Asia-Pacific
  • Middle East and Africa
    • GCC
    • South Africa
    • Rest of Middle East and Africa
  • South America
    • Brazil
    • Argentina
    • Rest of South America

Geography Analysis

North America held 44.61% of the RNAi drug delivery market share in 2025, which kept it as the largest regional base for commercial revenue and clinical execution. The United States remains the center of this position because it combines approved siRNA product revenue, established FDA review precedent, and a dense network of platform developers working on next-generation delivery approaches. Alnylam's plan to invest USD 250 million in dedicated siRNA manufacturing capacity in Massachusetts adds an industrial layer to that regional advantage and reinforces local supply depth. Canada is also contributing through targeted public support for lipid nanoparticle work tied to active endosomal escape, which signals that North American capacity building is extending beyond product commercialization into platform design. This combination keeps North America at the center of the RNAi drug delivery market even as other regions accelerate research and regulatory activity.

Europe remained the second-largest region in 2025, supported by a strong translational research base, active collaboration networks, and a structured regulatory setting for advanced therapeutic products. Programs such as BASE-Lipid and NanoGen show that Europe is building delivery science around both preclinical evidence and scalable manufacturing methods. Asia-Pacific is the fastest-growing regional segment, with the RNAi drug delivery market size in that region projected to advance at a 20.65% CAGR through 2031. China is a major driver because approval pathways for oligonucleotide drugs have been improving, while domestic developers are moving further into liver-targeted and extrahepatic siRNA programs. Japan and South Korea also support the regional story through platform innovation, as shown by PeptiDream's extrahepatic delivery work with Alnylam and the OliX collaboration with Vect-Horus on central nervous system delivery.

Middle East and Africa, together with South America, accounted for a minor share of 2025 revenue in the RNAi drug delivery market. Their current role is still early stage, but interest is increasing as governments place more attention on local biopharmaceutical capability and advanced therapeutics readiness. Gulf countries are building broader biopharma manufacturing agendas, while South Africa remains the strongest Sub-Saharan base for clinical trial execution and research partnerships. In South America, regulatory attention to advanced therapy products is improving, which should support gradual expansion as pricing models become more workable for highly specialized RNA therapies.

1. Alnylam Pharmaceuticals
2. Arbutus Biopharma Corporation
3. Arcturus Therapeutics Holdings Inc.
4. Arrowhead Pharmaceuticals
5. AstraZeneca
6. Genentech
7. Ionis Pharmaceuticals
8. Merck
9. Novartis
10. Novo Nordisk
11. Pfizer
12. Roche
13. Sanofi
14. Silence Therapeutics plc
15. Sirnaomics Ltd.
16. Takeda Pharmaceuticals

Additional Benefits:

• The market estimate (ME) sheet in Excel format
• 3 months of analyst support

TABLE OF CONTENTS

1 Introduction

• 1.1 Study Assumptions & Market Definition
• 1.2 Scope of the Study

2 Research Methodology

3 Executive Summary

4 Market Landscape

• 4.1 Market Overview
• 4.2 Market Drivers
  • 4.2.1 Expanding Hepatic Delivery Validation
  • 4.2.2 Clinical Pull From Approved siRNA Therapies
  • 4.2.3 Next-Generation Lipid Nanoparticle Engineering
  • 4.2.4 Rising Need for Precision Gene Silencing
  • 4.2.5 Under-Served Extrahepatic Targets
  • 4.2.6 Platform Convergence With Oligonucleotide and Gene Editing Pipelines
• 4.3 Market Restraints
  • 4.3.1 Extrahepatic Delivery Efficiency Limits
  • 4.3.2 High Formulation and CMC Complexity
  • 4.3.3 Immunogenicity and Off-Target Risk
  • 4.3.4 Limited Reimbursement for Ultra-Specialty Therapies
• 4.4 Regulatory Landscape
• 4.5 Technological Outlook
• 4.6 Porter's Five Forces Analysis
  • 4.6.1 Bargaining Power of Suppliers
  • 4.6.2 Bargaining Power of Buyers
  • 4.6.3 Threat of New Entrants
  • 4.6.4 Threat of Substitutes
  • 4.6.5 Intensity of Competitive Rivalry

5 Market Size & Growth Forecasts (Value, USD)

• 5.1 By Technology
  • 5.1.1 siRNA
  • 5.1.2 miRNA
  • 5.1.3 shRNA
  • 5.1.4 Other Technologies
• 5.2 By Delivery System
  • 5.2.1 Lipid Nanoparticles
  • 5.2.2 Polymeric Nanoparticles
  • 5.2.3 Exosomes
  • 5.2.4 Viral Vectors
  • 5.2.5 Other Delivery Systems
• 5.3 By Route of Administration
  • 5.3.1 Intravenous
  • 5.3.2 Subcutaneous
  • 5.3.3 Intranasal
  • 5.3.4 Other Routes of Administration
• 5.4 By Target Disease
  • 5.4.1 Cancer
  • 5.4.2 Genetic Disorders
  • 5.4.3 Viral Infections
  • 5.4.4 Metabolic Diseases
  • 5.4.5 Other Target Diseases
• 5.5 By Target Tissue
  • 5.5.1 Liver
  • 5.5.2 Lungs
  • 5.5.3 Brain
  • 5.5.4 Heart
  • 5.5.5 Other Target Tissues
• 5.6 By End-User
  • 5.6.1 Pharmaceutical Companies
  • 5.6.2 Biotechnology Companies
  • 5.6.3 Academic and Research Institutions
  • 5.6.4 Hospitals and Clinics
  • 5.6.5 Other End-Users
• 5.7 By Geography
  • 5.7.1 North America
    • 5.7.1.1 United States
    • 5.7.1.2 Canada
    • 5.7.1.3 Mexico
  • 5.7.2 Europe
    • 5.7.2.1 Germany
    • 5.7.2.2 United Kingdom
    • 5.7.2.3 France
    • 5.7.2.4 Italy
    • 5.7.2.5 Spain
    • 5.7.2.6 Rest of Europe
  • 5.7.3 Asia-Pacific
    • 5.7.3.1 China
    • 5.7.3.2 Japan
    • 5.7.3.3 India
    • 5.7.3.4 Australia
    • 5.7.3.5 South Korea
    • 5.7.3.6 Rest of Asia-Pacific
  • 5.7.4 Middle East and Africa
    • 5.7.4.1 GCC
    • 5.7.4.2 South Africa
    • 5.7.4.3 Rest of Middle East and Africa
  • 5.7.5 South America
    • 5.7.5.1 Brazil
    • 5.7.5.2 Argentina
    • 5.7.5.3 Rest of South America

6 Competitive Landscape

• 6.1 Market Concentration
• 6.2 Market Share Analysis
• 6.3 Company Profiles (includes Global Level Overview, Market Level Overview, Core Segments, Financials as available, Strategic Information, Market Rank/Share, Products and Services, Recent Developments)
  • 6.3.1 Alnylam Pharmaceuticals, Inc.
  • 6.3.2 Arbutus Biopharma Corporation
  • 6.3.3 Arcturus Therapeutics Holdings Inc.
  • 6.3.4 Arrowhead Pharmaceuticals, Inc.
  • 6.3.5 AstraZeneca plc
  • 6.3.6 Genentech, Inc.
  • 6.3.7 Ionis Pharmaceuticals, Inc.
  • 6.3.8 Merck KGaA
  • 6.3.9 Novartis AG
  • 6.3.10 Novo Nordisk A/S
  • 6.3.11 Pfizer Inc.
  • 6.3.12 Roche Holding AG
  • 6.3.13 Sanofi
  • 6.3.14 Silence Therapeutics plc
  • 6.3.15 Sirnaomics Ltd.
  • 6.3.16 Takeda Pharmaceutical Company Limited

7 Market Opportunities and Future Outlook

• 7.1 White-Space and Unmet-Need Assessment