Sirna 의약품 시장 보고서 : 동향, 예측 및 경쟁 분석(-2035년)

Sirna Drug Market

The future of the global sirna drug market looks promising with opportunities in the hospital, research institute, and pharmaceutical & biotechnology company markets. The global sirna drug market is expected to reach an estimated $10.7 billion by 2035 from $2.4 billion in 2027 with a CAGR of 19.4% from 2027 to 2035. The major drivers for this market are the increasing prevalence of genetic disorders, the rising demand for personalized medicine, and the growing focus on RNA-based therapies.

• Lucintel forecasts that, within the delivery method category, nanoparticles is expected to witness the highest growth over the forecast period due to better cellular delivery and stability offered by nanoparticles.
• Within the end use category, hospitals is expected to witness the highest growth over the forecast period due to increased clinical use of gene silencing therapies.
• In terms of regions, North America is expected to witness the highest growth over the forecast period due to strengthened research and well-established biotechnology and gene therapy industries.

Emerging Trends in Sirna Drug Market

The market for siRNA drugs is evolving from early-stage platforms to established drugs. During the 2025-2027 time period, we expect better delivery systems and more commercial partnerships to accelerate the development of drugs for rare diseases, cardiovascular and metabolic conditions, and infectious diseases. According to Lucintel, the maturity of drug delivery platforms determines the potential for longer-term, sustainable market growth.

• Precision Therapeutics: In 2025, several siRNA drugs targeting diseases caused by genomic abnormalities progressed to advanced stages of clinical development. Improvements in RNAi drug delivery and manufacturing, along with better understanding of the clinical endpoints, should allow drug developers to focus on less common diseases.
• Targeted Delivery: Delivery of siRNA drugs to the liver using GalNAc conjugates continues to be the primary focus of the field; however, improvements in the delivery of siRNA drugs to other (extricate) tissues could stimulate the development of drugs for new indications. Increased delivery efficiency to extricate tissues in 2025 encouraged further research in previously unexplored areas.
• Expansion Into Chronic Diseases: Companies are shifting siRNA therapy development from targeting ultra-rare diseases to more prevalent cardiometabolic disorders. While larger patient populations enhance the commercial potential of a therapy, the cost and efficacy of therapeutic approaches will impact the market potential.
• Advances in Manufacturability: Leading oligonucleotide manufacturers made process and facilities investments in 2025 to improve their capacity to produce kilogram-scale batches. Advances in synthesis and purification of oligonucleotides have improved the consistency of batches and the supply of therapeutic batches. Improved manufacturability of oligonucleotide therapies should decrease the cost of each dose.
• Alliance-based Strategies: Alliances remain the predominant method to commercially validate RNA-based technologies, particularly for companies lacking the ability to commercialize on a global scale. Shared risks and limited geographic-based rights influenced 2025 alliances. In the next five years, alliances will impact the RNA technology market by controlling access to specialized delivery systems.

Manufacturing and durability of RNA therapies will be the primary competitive differentiators in the market. Competition will intensify for allied partnerships. Companies that integrate manufacturability of RNA therapies with reliable supply and cushioning will be best positioned to achieve commercial partnerships for RNA therapies.

Recent Developments in the Sirna Drug Market

The market for siRNA drugs is anticipated to grow between the years 2025 and 2027, as more drugs come to market and medical companies build their delivery systems. According to Lucintel, more approved drugs will target the liver and induce the need for repeat medication. Investors have begun to fund siRNA drug companies, and more commercial partnerships have formed.

• The FDA's Expansion of The Use of SiRNA Drugs: In March 2025, the FDA approved Qfitlia to treat certain patients with haemophilia A and B. With this approval, the use of siRNA drugs to treat patients outside of the lipid disorders and deployments market has expanded.
• Use of SiRNA Drugs in Cardiovascular: Also in March 2025, Amvuttra received FDA approval and was expanded to treat certain patients with cardiovascular disease.
• Strategic Alliances: In 2025, Alnylam Pharmaceuticals, Inc. announced an expansion to its existing partnership with Regeneron Pharmaceuticals, Inc. to jointly discover and develop RNAi therapeutics. This alliance reduces the risk for Alnylam for the discovery and development of RNAi therapeutics.
• Manufacturing Scale-up: Alnylam projected a need for $200 million in 2025 to build out RNAi product supply. Each commercial product is expected to facilitate hundreds of thousands of doses. While Alnylam is not publicly stating specific capacity goals, Alnylam expects rival supply of conjugates to be a binding constraint for market expansion.
• Pipeline Diversification: Silence Therapeutics added to its GalNAc-siRNA pipeline in 2025 to include the cardiovascular and metabolic systems. The company's choice of delivery systems will have to address whether the platform is capable of addressing system level pathology.

Alnylam and Silence expect the dominant constraints on their markets to be the science of delivery and not the biology. Competition will be fierce for cardiovascular and metabolic labels. The first-mover advantage may be short-lived, especially if the systems can be applied to the broad array of pathologies. Manufacturing constraints and capacity will influence the labelling strategy and the pricing and reimbursement policies implemented by healthcare systems.

Strategic Growth Opportunities in the Sirna Drug Market

The commercialization of siRNA drugs is expected to increase due to several recent developments. Lowering barriers to adoption will encourage the sale of siRNA drugs. Between 2024 and 2026, expected approvals will increase and provide therapies for non-rare, or chronic, diseases. We've defined five of these developments and expect they will influence strategic alliances and investment in the coming years.

• Cardiometabolic Therapies: In March 2025, the FDA approved Fitusiran for the treatment of haemophilia. Metabolic conditions and other cardiovascular diseases are expected to benefit from siRNA therapy in the next 3 to 5 years.
• Premium Long-Acting Therapies: Alnylam said that 2 million doses of the drug ONPATTRO and AMVUTTRA had been administered as of June 2025. Premium prices can be charged for long-acting therapies.
• International Markets: In 2025, China approved the first siRNA drug, patisiran. Other countries in the Asia-Pacific region are expected to follow China's lead, as there is sufficient capacity and demand for these specialty drugs.
• Advancements in Manufacturability: Contract manufacturers are partnering with companies to produce siRNAs using higher-yield processes. An industry report predicted that there will be over 20 siRNA candidates in clinical development by 2025. Improvements in manufacturing processes will improve industry profit margins in the upcoming years.
• Alternative Delivery Systems: GalNAc is currently the dominant delivery system for targeting the liver. However, other systems are being developed for targeting other areas of the CNS and the muscle. In 2025, Alnylam announced that their drug in development for the liver, zilebesiran, met its primary endpoint in its Phase 3 clinical trial.

Delivering therapeutic siRNAs remains the biggest challenge for the siRNA companies. There is potential for significant market opportunities for siRNA-based medicines in various indications, especially if they are priced based on the evidence supporting the Medicare reimbursement. The greatest opportunity is for medicines that provide durable replacements for chronic, symptomatic conditions.

Sirna Drug Market Drivers and Challenges

Technological developments such as the simplification of siRNA production and synthesis and advancements in drug formulation and delivery systems, combined with the development of favorable regulations and reimbursement policies and the increase in investment in life sciences, create opportunities for the growth of the sirna drug market. Risks include the high costs of clinical development, access and reimbursement. The pace of development and commercial launch of siRNA drugs will be determined by the balance of these factors.

The factors responsible for driving this market include:

• Increasing Demand for Personalized Medicine: With more targeted therapies becoming available for rare cancers, and with recently approved siRNA therapies to treat rare diseases such as transthyretin-related amyloidosis, the enzyme Reactive LDL Cholesterolaemia, and Lipoprotein, and Hepatocytic Porphyrius, the number of indications for siRNA therapeutics is anticipated to rapidly increase. The positive clinical outcomes of siRNA drugs will encourage demand for other lasting and precise therapies in the field of oncology, cardiology, metabolic disorders, and other field of medicine. It is anticipated that in the next five years, the personalized medicine industry will flourish.
• Advances in Delivery Technologies: Modifications to siRNA delivery technologies including the use of lipid nanoparticles and GalNAc conjugation, as well as the development of tissue-targeted delivery systems, are improving the stability and increasing the duration of action of siRNA. GalNAc-based therapies approved in 2025 allowed for dose intervals of approximately six months. In the next several years, the technologies are likely to allow for the targeting and treatment of a variety of neurological, pulmonary, and systemic diseases.
• Regulatory Updates and Clinical Advances: The favorable decisions by regulatory agencies on siRNA-based therapies and the increasing number of clinical trials positively influenced the market perception of siRNA. In 2025, there was expected to be a consistent body of evidence supporting the safety and efficacy of multiple siRNA therapies for the treatment of rare and chronic diseases. The improvement and clarification of regulatory pathways and the body of clinical evidence is expected to result in the formation of new strategic alliances to advance and support the further development of late stage siRNA therapies.
• Addressing Chronic Disease Indications: SiRNA therapies are being developed for conditions where there is benefit from reducing the level of a particular protein, including transthyretin mediated amyloidosis (TMA) and other genetic and liver diseases, as well as conditions such as hypertension and hypercholesterolemia. Therapies targeting chronic indications are being evaluated using three to twelve month dosing. Continuous improvements in siRNA technology are expected to create a market characterized by a few, high-value, rapidly repeating revenue streams.
• Manufacturing Efficiency and Platform Investment: The barriers to production of siRNA therapies have lessened due to a variety of reasons including improvements in large-scale manufacturing and automation. In June 2025, companies disclosed the use of automated platforms to manufacture siRNA at a large scale. In the next 3-5 years, further process improvements are expected to ease the supply constraints for siRNA therapies. As a result, price reductions are expected.

The challenges facing this market include:

• Delivery and Tissue Targeting: Most of the currently available siRNA therapies target the liver. The brain, muscles, and other tissues remain inaccessible. To reach previously untargeted tissues, there is ongoing research to develop new delivery systems. This affects the market because untargeted tissues equal a lack of therapies for those diseases and increases the market risk.
• Safety and Immune Response: SiRNA therapies are known to cause unwanted side effects and reduce the duration of treatment. In August 2025, studies assessed the long-term effects of siRNA therapy. Improving the duration of action of siRNA therapies and reducing side effects is essential for the market to grow.
• High Costs and Uncertain Reimbursement: Therapies may cost a lot to research and develop because they may require specialized manufacturing, long-term and continuous monitoring, and other post-marketing requirements. In 2025, the expected annual cost of some RNA therapies was estimated to be more than $100,000. The high costs of some innovative therapies will potentially result in insurers restricting coverage to only the most serious cases and requiring clinical and economic evidence to prove that the therapy will yield better outcomes than other available therapies.

Advances in the delivery of siRNA drugs, and an improving regulatory environment, should stimulate the market for siRNA drugs. Interest in the treatment of chronic and rare diseases is expected to improve the market. However, several factors, including high costs, may impact the success of drugs in the market and the pipelines of pharmaceutical companies. Improvements in the safety and affordability of therapies are likely to benefit the most the number of patients suffering from chronic and rare diseases.

List of Sirna Drug Market Companies

Companies in the market compete on the basis of product quality offered. Major players in this market focus on expanding their manufacturing facilities, R&D investments, infrastructural development, and leverage integration opportunities across the value chain. Through these strategies sirna drug market companies cater increasing demand, ensure competitive effectiveness, develop innovative products & technologies, reduce production costs, and expand their customer base. Some of the sirna drug market companies profiled in this report include-

• Alnylam Pharmaceuticals, Inc.
• Arrowhead Pharmaceuticals, Inc.
• Silence Therapeutics plc
• Dicerna Pharmaceuticals, Inc.
• Ionis Pharmaceuticals, Inc.
• Arbutus Biopharma Corporation
• Benitec Biopharma Ltd.
• Marina Biotech, Inc.
• Quark Pharmaceuticals, Inc.
• RXi Pharmaceuticals Corporation

Sirna Drug Market by Segment

The study includes a forecast for the global sirna drug market by delivery method, application, end use, and region.

Sirna Drug Market by Delivery Method [Value ($B) from 2019 to 2035]:

• Nanoparticles
• Lipid-based
• Polymer-based
• Others

Sirna Drug Market by Application [Value ($B) from 2019 to 2035]:

• Oncology
• Cardiovascular
• Respiratory
• Neurological
• Infectious Diseases
• Others

Sirna Drug Market by End Use [Value ($B) from 2019 to 2035]:

• Hospitals
• Research Institutes
• Pharmaceutical & Biotechnology Companies
• Others

Sirna Drug Market by Region [Value ($B) from 2019 to 2035]:

• North America
• Europe
• Asia Pacific
• The Rest of the World

Country Wise Outlook for the Sirna Drug Market

The scope of the sirna drug market has begun to evolve, focusing on cardiovascular and metabolic disorders, as well as diseases of the liver. It is expected that by 2025-2027 the market will be more widely established due to the anticipated approval of siRNA drugs, as well as on-site manufacturing and licensing. The rest of the market will be determined by the skills of market players to manufacture and distribute drugs, and their ability to negotiate insurance reimbursement. According to Lucintel, the sirna drug market is still in its early stages and evolving.

• United States: In March 2025, the FDA approved Alnylam's Qfitlia (fitusiran) for the treatment of haemophilia A and B. The approval advanced the RNA Interference ('RNAi') drug development platform and encouraged the development of drugs to treat other disorders. Other drugs in this class may be approved in the next 3-5 years.
• China: In 2025, Alnylam received approval from the NMPA to market vutrisiran for the treatment of hereditary transthyretin-related amyloidosis. China's first approval of an siRNA drug established a pathway for Alnylam to commercialize its drugs in the Chinese market and encouraged other pharmaceutical companies to pursue siRNA drug development.
• Germany: Although European approval processes enabled the local distribution of approved siRNA products, German pharmaceutical companies continued to work on RNA and sterile injectable products. Where Germany stands in the high-quality biologics market in the next few years will determine the potential supply of these products.
• India: In addition to its collaboration to provide specialty medicines, Cipla strengthened its partnerships to provide innovative medicines. Indian regulators and biopharmaceutical companies began preparing for the introduction of RNA therapies, which are expected to be available commercially from 2025. India has the potential to produce therapies at a lower cost, and if successful, meet the demand within the country and export to other regions.
• Japan: Newer RNA-based therapies for various rare diseases are expected to be approved. In addition to its programs to facilitate the approval of new rare disease therapies, Japan's national health insurance system and reimbursement policies strengthened the commercial potential of RNA therapies.

Features of the Global Sirna Drug Market

• Market Size Estimates: sirna drug market size estimation in terms of value ($B).
• Trend and Forecast Analysis: Market trends (2019 to 2026) and forecast (2027 to 2035) by various segments and regions.
• Segmentation Analysis: sirna drug market size by delivery method, application, end use, and region in terms of value ($B).
• Regional Analysis: sirna drug market breakdown by North America, Europe, Asia Pacific, and Rest of the World.
• Growth Opportunities: Analysis of growth opportunities in different delivery method, application, end use, and regions for the sirna drug market.
• Strategic Analysis: This includes M&A, new product development, and competitive landscape of the sirna drug market.

Analysis of competitive intensity of the industry based on Porter's Five Forces model.

If you are looking to expand your business in this or adjacent markets, then contact us. We have done hundreds of strategic consulting projects in market entry, opportunity screening, due diligence, supply chain analysis, M & A, and more.

This report answers following 11 key questions:

• Q.1. What are some of the most promising, high-growth opportunities for the sirna drug market by delivery method (nanoparticles, lipid-based, polymer-based, and others), application (oncology, cardiovascular, respiratory, neurological, infectious diseases, and others), end use (hospitals, research institutes, pharmaceutical & biotechnology companies, and others), and region (North America, Europe, Asia Pacific, and the Rest of the World)?
• Q.2. Which segments will grow at a faster pace and why?
• Q.3. Which region will grow at a faster pace and why?
• Q.4. What are the key factors affecting market dynamics? What are the key challenges and business risks in this market?
• Q.5. What are the business risks and competitive threats in this market?
• Q.6. What are the emerging trends in this market and the reasons behind them?
• Q.7. What are some of the changing demands of customers in the market?
• Q.8. What are the new developments in the market? Which companies are leading these developments?
• Q.9. Who are the major players in this market? What strategic initiatives are key players pursuing for business growth?
• Q.10. What are some of the competing products in this market and how big of a threat do they pose for loss of market share by material or product substitution?
• Q.11. What M&A activity has occurred in the last 8 years and what has its impact been on the industry?

Table of Contents

1. Executive Summary

2. Market Overview

• 2.1 Background and Classifications
• 2.2 Supply Chain

3. Market Trends & Forecast Analysis

• 3.1 Macroeconomic Trends and Forecasts
• 3.2 Industry Drivers and Challenges
• 3.3 PESTLE Analysis
• 3.4 Patent Analysis
• 3.5 Regulatory Environment

4. Global siRNA Drug Market by Delivery Method

• 4.1 Overview
• 4.2 Attractiveness Analysis by Delivery Method
• 4.3 Nanoparticles : Trends and Forecast 2019 to 2035
• 4.4 Lipid-based : Trends and Forecast 2019 to 2035
• 4.5 Polymer-based : Trends and Forecast 2019 to 2035
• 4.6 Others : Trends and Forecast 2019 to 2035

5. Global siRNA Drug Market by Application

• 5.1 Overview
• 5.2 Attractiveness Analysis by Application
• 5.3 Oncology : Trends and Forecast 2019 to 2035
• 5.4 Cardiovascular : Trends and Forecast 2019 to 2035
• 5.5 Respiratory : Trends and Forecast 2019 to 2035
• 5.6 Neurological : Trends and Forecast 2019 to 2035
• 5.7 Infectious Diseases : Trends and Forecast 2019 to 2035
• 5.8 Others : Trends and Forecast 2019 to 2035

6. Global siRNA Drug Market by End Use

• 6.1 Overview
• 6.2 Attractiveness Analysis by End Use
• 6.3 Hospitals : Trends and Forecast 2019 to 2035
• 6.4 Research Institutes : Trends and Forecast 2019 to 2035
• 6.5 Pharmaceutical & Biotechnology Companies : Trends and Forecast 2019 to 2035
• 6.6 Others : Trends and Forecast 2019 to 2035

7. Regional Analysis

• 7.1 Overview
• 7.2 Global siRNA Drug Market by Region

8. North American siRNA Drug Market

• 8.1 Overview
• 8.2 North American siRNA Drug Market by Delivery Method
• 8.3 North American siRNA Drug Market by End Use
• 8.4 The United States siRNA Drug Market
• 8.5 Canadian siRNA Drug Market
• 8.6 Mexican siRNA Drug Market

9. European siRNA Drug Market

• 9.1 Overview
• 9.2 European siRNA Drug Market by Delivery Method
• 9.3 European siRNA Drug Market by End Use
• 9.4 German siRNA Drug Market
• 9.5 French siRNA Drug Market
• 9.6 Italian siRNA Drug Market
• 9.7 Spanish siRNA Drug Market
• 9.8 The United Kingdom siRNA Drug Market

10. APAC siRNA Drug Market

• 10.1 Overview
• 10.2 APAC siRNA Drug Market by Delivery Method
• 10.3 APAC siRNA Drug Market by End Use
• 10.4 Chinese siRNA Drug Market
• 10.5 Indian siRNA Drug Market
• 10.6 Japanese siRNA Drug Market
• 10.7 South Korean siRNA Drug Market
• 10.8 Indonesian siRNA Drug Market

11. ROW siRNA Drug Market

• 11.1 Overview
• 11.2 ROW siRNA Drug Market by Delivery Method
• 11.3 ROW siRNA Drug Market by End Use
• 11.4 Middle Eastern siRNA Drug Market
• 11.5 South American siRNA Drug Market
• 11.6 African siRNA Drug Market

12. Competitor Analysis

• 12.1 Product Portfolio Analysis
• 12.2 Operational Integration
• 12.3 Porter's Five Forces Analysis
  • Competitive Rivalry
  • Bargaining Power of Buyers
  • Bargaining Power of Suppliers
  • Threat of Substitutes
  • Threat of New Entrants
• 12.4 Market Share Analysis

13. Opportunities & Strategic Analysis

• 13.1 Value Chain Analysis
• 13.2 Growth Opportunity Analysis
  • 13.2.1 Growth Opportunity by Delivery Method
  • 13.2.2 Growth Opportunity by Application
  • 13.2.3 Growth Opportunity by End Use
• 13.3 Emerging Trends in the Global siRNA Drug Market
• 13.4 Strategic Analysis
  • 13.4.1 New Product Development
  • 13.4.2 Certification and Licensing
  • 13.4.3 Mergers, Acquisitions, Agreements, Collaborations, and Joint Ventures

14. Company Profiles of the Leading Players Across the Value Chain

• 14.1 Competitive Analysis Overview
• 14.2 Alnylam Pharmaceuticals, Inc.
  • Company Overview
  • siRNA Drug Market Business Overview
  • New Product Development
  • Merger, Acquisition, and Collaboration
  • Certification and Licensing
• 14.3 Arrowhead Pharmaceuticals, Inc.
  • Company Overview
  • siRNA Drug Market Business Overview
  • New Product Development
  • Merger, Acquisition, and Collaboration
  • Certification and Licensing
• 14.4 Silence Therapeutics plc
  • Company Overview
  • siRNA Drug Market Business Overview
  • New Product Development
  • Merger, Acquisition, and Collaboration
  • Certification and Licensing
• 14.5 Dicerna Pharmaceuticals, Inc.
  • Company Overview
  • siRNA Drug Market Business Overview
  • New Product Development
  • Merger, Acquisition, and Collaboration
  • Certification and Licensing
• 14.6 Ionis Pharmaceuticals, Inc.
  • Company Overview
  • siRNA Drug Market Business Overview
  • New Product Development
  • Merger, Acquisition, and Collaboration
  • Certification and Licensing
• 14.7 Arbutus Biopharma Corporation
  • Company Overview
  • siRNA Drug Market Business Overview
  • New Product Development
  • Merger, Acquisition, and Collaboration
  • Certification and Licensing
• 14.8 Benitec Biopharma Ltd.
  • Company Overview
  • siRNA Drug Market Business Overview
  • New Product Development
  • Merger, Acquisition, and Collaboration
  • Certification and Licensing
• 14.9 Marina Biotech, Inc.
  • Company Overview
  • siRNA Drug Market Business Overview
  • New Product Development
  • Merger, Acquisition, and Collaboration
  • Certification and Licensing
• 14.10 Quark Pharmaceuticals, Inc.
  • Company Overview
  • siRNA Drug Market Business Overview
  • New Product Development
  • Merger, Acquisition, and Collaboration
  • Certification and Licensing
• 14.11 RXi Pharmaceuticals Corporation
  • Company Overview
  • siRNA Drug Market Business Overview
  • New Product Development
  • Merger, Acquisition, and Collaboration
  • Certification and Licensing

15. Appendix

• 15.1 List of Figures
• 15.2 List of Tables
• 15.3 Research Methodology
• 15.4 Disclaimer
• 15.5 Copyright
• 15.6 Abbreviations and Technical Units
• 15.7 About Us
• 15.8 Contact Us