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2026 RNAi Drug Delivery Market Report: Global Revenues to Reach $3.34 Billion by 2031, Driven by siRNA Approvals and Delivery Platform Innovation

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ALNY Alnylam Pharmaceuticals is mentioned for its planned $250 million investment in siRNA manufacturing capacity in Massachusetts, reinforcing regional supply capabilities and indicating strong growth prospects in the RNAi drug delivery market. ARWR Arrowhead Pharmaceuticals is listed as a company profile in the report, suggesting its involvement in the RNAi drug delivery market. However, no specific positive or negative sentiment is detailed. ABUS Arbutus Biopharma Corporation is listed as a company profile in the report, suggesting its involvement in the RNAi drug delivery market. No specific positive or negative sentiment is detailed. PFE Pfizer Inc. is listed as a company profile in the report, suggesting its involvement in the RNAi drug delivery market. No specific positive or negative sentiment is detailed. AZN AstraZeneca plc is listed as a company profile in the report, suggesting its involvement in the RNAi drug delivery market. No specific positive or negative sentiment is detailed. IONS Ionis Pharmaceuticals, Inc. is listed as a company profile in the report, suggesting its involvement in the RNAi drug delivery market. No specific positive or negative sentiment is detailed. MRK Merck KGaA is listed as a company profile in the report, suggesting its involvement in the RNAi drug delivery market. No specific positive or negative sentiment is detailed. NVO Novo Nordisk A/S is listed as a company profile in the report, suggesting its involvement in the RNAi drug delivery market. No specific positive or negative sentiment is detailed. ROG Roche Holding AG is listed as a company profile in the report, suggesting its involvement in the RNAi drug delivery market. No specific positive or negative sentiment is detailed. SNY Sanofi is listed as a company profile in the report, suggesting its involvement in the RNAi drug delivery market. No specific positive or negative sentiment is detailed. SLN Silence Therapeutics plc is listed as a company profile in the report, suggesting its involvement in the RNAi drug delivery market. No specific positive or negative sentiment is detailed. TAK Takeda Pharmaceutical Company Limited is listed as a company profile in the report, suggesting its involvement in the RNAi drug delivery market. No specific positive or negative sentiment is detailed.

2026 RNAi Drug Delivery Market Report: Global Revenues to Reach $3.34 Billion by 2031, Driven by siRNA Approvals and Delivery Platform Innovation Dublin, Aug. 18, 2026 (GLOBE NEWSWIRE) -- The "RNAi Drug Delivery - Market Share Analysis, Industry Trends & Statistics, Growth Forecasts (2026-2031)" has been added to ResearchAndMarkets.com's offering.

The global RNAi drug delivery market is projected to expand from USD 1.21 billion in 2025 and USD 1.43 billion in 2026 to USD 3.34 billion by 2031. The market is forecast to grow at a compound annual growth rate of 18.41% from 2026 to 2031, supported by approved siRNA therapies, advances in lipid nanoparticle engineering, and rising investment in extrahepatic delivery platforms.

Approved siRNA Therapies Strengthen Market Confidence

Clinical and commercial validation from approved siRNA products is reducing development uncertainty and encouraging broader adoption of RNAi drug delivery technologies. The 2025 approval of AMVUTTRA for transthyretin-mediated amyloidosis with cardiomyopathy reinforced the commercial potential of quarterly subcutaneous dosing and expanded the regulatory precedent available to developers.

Revenue expectations for established RNAi products are also strengthening interest in licensing agreements, platform partnerships, and manufacturing investment. Each successful approval provides additional clinical, regulatory, and commercial evidence for emerging RNAi assets, supporting continued expansion across pharmaceutical and biotechnology pipelines.

Next-Generation Lipid Nanoparticle Engineering Accelerates Development

Lipid nanoparticle engineering remains central to the growth of the RNAi drug delivery market. Computational platforms, including the COMET model trained on the LANCE dataset, are enabling faster assessment of non-canonical lipid nanoparticle configurations. These capabilities can improve formulation screening and support more precise optimization of lipid tail length, linker chemistry, and head-group pKa.

European translational initiatives such as BASE-Lipid and NanoGen are helping move nanoparticle research toward scalable manufacturing and regulatory compliance. Continued advances are expected to broaden delivery beyond established liver-targeted applications and create opportunities in the lungs, brain, heart, and other tissues.

Extrahepatic Delivery Remains a Major Technical Constraint

Efficient delivery to non-hepatic tissues continues to be one of the RNAi drug delivery market's most significant challenges. The blood-brain barrier, cardiac tissue architecture, endosomal trapping, protein corona formation, and rapid hepatic clearance can reduce productive cytosolic delivery.

Translation from animal studies to human trials also remains difficult, particularly for repeat-dose and central nervous system programs. These limitations increase clinical attrition and financing risk for extrahepatic assets. Additional market considerations include expanding hepatic delivery validation, demand for underserved extrahepatic targets, and high formulation and chemistry, manufacturing, and controls complexity.

RNAi Drug Delivery Market Segment Insights

siRNA accounted for 65.31% of the RNAi drug delivery market in 2025, making it the leading technology segment. Its position reflects an established clinical history, validated conjugate and lipid nanoparticle platforms, and stronger regulatory precedent than other RNA interference technologies. The segment continues to attract licensing activity and strategic investment from major pharmaceutical companies.

miRNA remains a smaller segment, although transaction activity has increased. In 2026, Thalia Therapeutics acquired Sanmirna Therapeutics and its clinical-stage anti-miRNA-126 program for acute myeloid leukemia, highlighting continued interest in emerging RNA-targeted oncology assets.

shRNA is forecast to record a CAGR of 22.38% from 2026 to 2031, making it the fastest-growing technology segment. Growth is associated with long-duration gene-silencing strategies and viral vector-based central nervous system programs. However, manufacturing requirements, immunogenicity, cargo limitations, and regulatory scrutiny remain important development considerations.

Lipid nanoparticles represented 60.24% of the market in 2025 and remained the largest delivery system segment. Their leadership is supported by validated manufacturing infrastructure, established intellectual property, and an expanding body of regulatory and clinical evidence. Patisiran provided an early commercial benchmark for lipid nanoparticle-enabled hepatic transthyretin knockdown and helped establish subsequent development standards.

Polymeric nanoparticles are projected to grow at a CAGR of 20.52% from 2026 to 2031, the highest rate among delivery systems. Tunable degradability, surface functionalization, active targeting capabilities, and compatibility with combination payloads support their development potential. Research into inhaled siRNA delivery for lung tumors also demonstrates their relevance for tissues and administration routes that remain challenging for conventional lipid nanoparticle systems.

Regional RNAi Drug Delivery Market Outlook

North America held 44.61% of the global RNAi drug delivery market in 2025. The United States leads the region through approved siRNA product sales, established FDA review pathways, extensive clinical development activity, and a strong concentration of RNA delivery companies. Alnylam Pharmaceuticals' planned USD 250 million investment in dedicated siRNA manufacturing capacity in Massachusetts is expected to reinforce regional supply capabilities.

Europe ranked as the second-largest regional market in 2025, supported by translational research, collaborative development networks, and an established regulatory environment for advanced therapies. Germany is contributing through lipid nanoparticle and polymeric delivery research designed to connect preclinical innovation with scalable manufacturing.

Asia-Pacific is forecast to be the fastest-growing regional market, advancing at a CAGR of 20.65% through 2031. China is strengthening its position through evolving oligonucleotide drug approval pathways and expanding domestic pipelines. Japan and South Korea are also supporting extrahepatic delivery innovation through strategic collaborations, including PeptiDream's work with Alnylam and OliX Pharmaceuticals' central nervous system delivery collaboration with Vect-Horus.

The Middle East, Africa, and South America currently account for smaller revenue shares. Nevertheless, investment in biopharmaceutical manufacturing, clinical research infrastructure, advanced therapy regulation, and regional partnerships is expected to support gradual long-term market development.

Key Topics Covered

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

For more information about this report visit https://www.researchandmarkets.com/r/rri3xg

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