RNAI TECHNOLOGY MARKET ANALYSIS

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.