RNAI TECHNOLOGY MARKET ANALYSIS

Rnai Technology Market Size and Trends

Global RNAi technology market is estimated to be valued at USD 2.70 Bn in 2024 and is expected to reach USD 7.10 Bn by 2031, exhibiting a compound annual growth rate (CAGR) of 14.8% from 2024 to 2031.

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The development of improved RNAi delivery mechanisms and next generation targeting capabilities can boost demand. More pharmaceutical companies are leveraging RNAi for drug discovery and developing RNAi therapeutics for genetic disorders, oncology, and infectious diseases. Increased funding for R&D and growing clinical trial approvals are can  provide opportunities for the market growth. Continued expansion of CRISPR and other gene editing technologies hamper RNAi technology adoption in the future.

Growing demand for RNAi technology due to increased R&D efforts

Rising demand for RNAi technology due to increased research and development efforts by pharmaceutical companies and research institutions can drive the market growth. RNAi refers to the process of gene silencing through the introduction of double-stranded RNA molecules into the cell, which helps in selectively turning off specific genes. This mechanism is being actively explored by drug developers for its potential to develop powerful new therapies for various diseases. Many biotech companies and academic research labs across the globe are demonstrating the broad potential of RNAi technology through various preclinical and clinical research studies. In November 2020, Alnylam Pharmaceuticals, Inc. introduced new Value-based Agreements (VBAs) aimed at enhancing patient access to givosiran, thus, strengthening the company's position in RNAi therapeutics and bolstering its business prospects. In December 2021, Novartis AG obtained approval from the U.S. Food and Drug Administration for Leqvio, the first and only small interfering RNA (siRNA) therapy that  is designed to reduce low-density lipoprotein levels with just two doses per year: an initial dose followed by another at three months.

Market Concentration and Competitive Landscape

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Advances in Delivery Technologies Opening New Avenues

One of the major bottlenecks limiting the clinical potential of RNAi therapeutics has been the lack of efficient and safe delivery systems. The highly labile nature of nucleic acid drugs and challenges associated with their in vivo delivery to target sites requires innovative formulation and design strategies. Novel delivery technologies such as ligand-conjugated nanoparticles, exosome-mimetic vesicles and cell-penetrating peptides can enhance the cellular uptake and protection of RNAi payloads. Advancements are also being made in modulating biodistribution through tissue-targeting ligands and optimizing pharmacokinetic profiles. Recent delivery platforms enable targeting of RNAi molecules to specific organs, cell types and subcellular locations based on pathological needs. This high precision delivery promises to augment therapeutic indices while reducing adverse effects. As more biocompatible carriers successfully navigate clinical translation, these will facilitate the development of RNAi drugs for diverse pathological conditions including those traditionally considered difficult to drug.

Key Takeaways from Analyst

Global RNAi technology market growth is driven by rising development of novel RNAi drug delivery technologies that can effectively target tissues across the body. Many biopharma companies are exploring modified nanoparticles, lipid-based carriers, and other advanced delivery approaches to expand the markets that can be addressed. Successful applications in oncology, cardiovascular, metabolic and rare diseases would capture vast patient pools worldwide.

North America currently dominates the market due to extensive R&D spending and a favorable regulatory environment. However, Asia Pacific is expected to emerge as the fastest growing region as Chinese and Indian government initiatives promote biotechnology development and modernization of healthcare infrastructure. Established Asia players are eagerly partnering with global innovators to build local expertise.

RNAi therapies offer promising therapeutic benefits with fewer side effects than traditional drugs but production costs and complexity of RNAi drug development can hamper the market growth. High investment requirements limit the number of programs that can be pursued simultaneously. Uncertainty around intellectual property protection could also deter investment if patent disputes arise between major players.

Market Challenges: High costs involved

Global RNAi technology market growth can be hampered by high costs involved throughout the research and development process. Developing RNAi therapeutic products requires extensive research, testing, and clinical trials over many years. The discovery stage itself takes significant time and financial investment to identify and validate suitable gene targets. Once targets are identified, specialized and patented delivery technologies must be developed to effectively deliver RNAi triggers such as siRNAs or miRNAs to cells and tissues of interest. Designing delivery platforms that can protect the fragile RNA cargo from degradation while selectively targeting disease sites is a major technical challenge that increases costs. Due to the novel nature of the technology, regulatory agencies require extensive preclinical and clinical testing to establish safety and efficacy profiles before approval of technology. Each stage from preclinical to final Phase III trials lasts for years and costs tens to hundreds of millions of dollars. For example, Phase III trial of patisiran, an RNAi therapeutic for hereditary transthyretin-mediated amyloidosis, developed by Alnylam, involved hundreds of patients across multiple countries and cost US$ 150-200 million. The high risk of failure even in late stages means only a small fraction of RNAi candidates enter the market, spreading the development costs over fewer products.

Market Opportunities: Partnership with contract manufacturing organizations

Partnering with contract manufacturing organizations could provide companies in the global RNAi technology market an significant opportunities for growth. Contract manufacturers allow firms to focus on their core competencies of research and development while reducing capital expenditure requirements for manufacturing infrastructure and equipment. This allows smaller biotech companies working with limited capital to harness the scale and expertise of specialized CMOs. CMOs offer flexible, high-quality manufacturing capabilities tailored to the complex needs of RNAi production. RNAi therapeutics often utilize multi-step synthesis and purification methods that demand stringent quality control protocols to ensure product safety and efficacy. Established CMOs have deep experience adhering to current good manufacturing practices and can more easily meet regulatory expectations compared to in-house manufacturing facilities of smaller biotechs. Partnering with CMOs experienced in mRNA, siRNA or other RNA production techniques allows firms to rely on optimized manufacturing know-how and capacity instead of building these capabilities from scratch internally.

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Insights, By Application: Versatile applications drive growth of drug discovery and development segment

 By application, drug discovery and development segment is estimated to contribute the highest market share of 40.21% in 2024 due to the versatility of RNAi technologies. RNA interference allows researchers to efficiently study gene function and validate drug targets. This process of discovering the roles of specific genes in health and disease is profoundly accelerated using RNAi techniques as compared to other molecular biology methods. RNAi technologies have become a mainstream approach for high-throughput screening of potential drug targets. By knocking down gene expression, scientists can evaluate a gene's involvement in various disease mechanisms. This enables the selection and prioritization of promising drug targets early in the drug development pipeline. RNAi technologies are also being utilized to identify new biomarkers and develop personalized medicines. The ability to control gene expression with RNAi can offer new therapeutic strategies for previously undruggable targets. As biopharmaceutical companies work to overcome challenges in drug discovery like high attrition rates, the flexibility and throughput provided by RNAi technologies makes them an indispensable asset. RNAi allows the high-volume evaluation of novel targets and rapid validation of therapeutic hypotheses. Customized siRNA and shRNA libraries created for specific disease pathways further enhance the drug discovery potential.

Insights, By End User: Pharmaceutical leadership stems from therapeutic applications

By end user, pharmaceutical and biotechnology companies’ segment is estimated to contribute the highest market share of 50.10% in 2024 due to the expanding therapeutic applications of RNAi. RNAi-based drugs offer promising new treatments for various inherited disorders and cancers by selectively silencing disease-causing genes. A major driver is the approval and commercialization of the first-ever RNAi therapeutic, Patisiran, to treat hereditary transthyretin-mediated amyloidosis. More RNAi drugs are progressing through clinical trials for conditions like alpha-1 antitrypsin deficiency, transthyretin amyloidosis, primary hyperoxaluria type 1, and others. The arrival of new RNAi therapeutics will strengthen pharmaceutical leadership as these innovative medicines reach the market. Growing interest in RNAi as a platform technology paves the way for various new modalities such as nucleotide prodrugs, GalNAc-siRNA conjugates, lipid nanoparticles, and more. These advancements enhance delivery capabilities while maintaining potency and safety.

Regional Insights

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The Asia Pacific region is increasingly becoming a dominant force in the global RNAi technology market, with high share of 38.2% in 2024, primarily driven by soaring investments in research and development related to RNAi therapeutics and a growing focus on personalized medicine. Robust government initiatives and funding, strategic collaborations among biotech and pharmaceutical companies, and the rising prevalence of chronic diseases like cancer and hepatitis B, which require novel therapeutic approaches, further bolster this growth. Countries such as Japan, China, and South Korea are making significant advancements in RNAi research, harnessing the potential of these technologies for developing innovative treatments. Additionally, the Asia Pacific region benefits from cost-effective labor and manufacturing processes, increasing international partnerships, and a thriving academic and clinical research environment, which are pivotal to the growth of the RNAi technology market.

 Conversely, North America exhibits the fastest growth rate in the RNAi technology market. This trend can be attributed to several factors, including the presence of a sophisticated healthcare infrastructure, substantial biotechnology and pharmaceutical industries, and a strong focus on research and innovation. The region's regulatory landscape is conducive to the development and approval of advanced therapeutics, and with substantial investments in genomics and proteomics, there is an accelerated uptake of RNAi technologies in drug development processes. North America’s advanced clinical trial ecosystem, significant intellectual property rights provisions, and presence of key industry players contribute to its rapid progress in the RNAi technology sector. Injecting substantial resources into tackling genetic disorders and life-threatening diseases, North America continues to pave the way for advancements in RNAi therapeutics and diagnostics, setting a precedent for market growth globally.

Market Report Scope

Rnai Technology Industry News

• In April 2024, Phio Pharmaceuticals, a clinical-stage biotechnology company, revealed that its INTASYL siRNA gene silencing technology, aimed at enhancing immune cells' ability to combat tumor cells, will be featured in "Viewpoint," a national program hosted by Mr. Dennis Quaid
• In January 2024, Shanghai Argo Biopharmaceutical Co., Ltd. announced two exclusive license and collaboration agreements with Novartis Pharma AG. The first agreement grants Novartis an global exclusive licenses for a Phase 1 program, including a research collaboration.The second agreement provides Novartis with an exclusive ex-Greater China license for a Phase 1/2a clinical-stage program in cardiovascular disease. These assets, developed using Argo's RNAi platform technology, promise leading efficacy and durability in therapies.
• In August 2023, Sirnaomics Ltd., a prominent biopharmaceutical company specializing in RNAi therapeutics, completed all dosing regimens for its Phase I study of STP707. This therapy targets multiple solid tumors in patients with late-stage cancers resistant to previous treatments. Results showed that approximately 74% of evaluable patients achieved stable disease (SD), with some demonstrating reduced tumor burden according to RECIST criteria.

*Definition: Global RNAi technology market involves the development and use of RNA interference techniques and platforms for various research and therapeutic applications. RNA interference utilizes small interfering RNA molecules to silence or alter targeted gene expression, showing promise for treating genetic disorders, infectious diseases, and various types of cancer. This market covers products and services focused on RNAi delivery mechanisms, libraries, design tools, and microarray systems for applications such as drug discovery, therapeutics development, agricultural research, and studying gene function. Key players are developing novel RNAi technologies to drive continued growth in this innovative space.

Market Segmentation

•  Application Insights (Revenue, USD Bn, 2019 - 2031)
  • Drug Discovery and Development
  • Therapeutics
    • Neurology
    • Oncology
    • Infectious Diseases
    • Metabolic Diseases
    • Others
  • Functional Genomics
  • Others
•  End User Insights (Revenue, USD Bn, 2019 - 2031)
  • Pharmaceutical & Biotechnology Companies
  • Academic & Research Institutes
  • CROs & CMOs
  • Others
• Regional Insights (Revenue, USD Bn, 2019 - 2031)
  • North America
    • U.S.
    • Canada
  • Latin America
    • Brazil
    • Argentina
    • Mexico
    • Rest of Latin America
  • Europe
    • Germany
    • U.K.
    • Spain
    • France
    • Italy
    • Russia
    • Rest of Europe
  • Asia Pacific
    • China
    • India
    • Japan
    • Australia
    • South Korea
    • ASEAN
    • Rest of Asia Pacific
  • Middle East
    • GCC Countries
    • Israel
    • Rest of Middle East
  • Africa
    • South Africa
    • North Africa
    • Central Africa
• Key Players Insights
  • Alnylam Pharmaceuticals
  • OriGene Technologies, Inc.
  • Arrowhead Pharmaceuticals
  • Dicerna Pharmaceuticals
  • Silence Therapeutics
  • Ionis Pharmaceuticals
  • Merck & Co.
  • Qiagen N.V.
  • Thermo Fisher Scientific
  • Synlogic
  • Benitec Biopharma
  • Gradalis
  • Sirnaomics, Inc.
  • Marina Biotech
  • Quark Pharmaceuticals
  • Regulus Therapeutics
  • GeneCare Research Institute Co., Ltd.
  • ASC Therapeutics