According to analyses from Evaluate and Boston Consulting Group (BCG), the global Oligonucleotide drugs market value is expected to register $15 billion (approximately 106.7 billion RMB) by 2026. Compared to the global market, China currently lags in the development of oligonucleotide drugs, especially in terms of the number of approved drugs, the indication range, and clinical stages. However, many Chinese pharmaceutical enterprises such as Visirna Drugs, Ribo, and Sirnaomics have been advancing their research and development efforts and working to gain market access.
Status of Approved Oligonucleotide Drugs
Oligonucleotides as therapeutic drugs are in a variety of forms including antisense oligonucleotides (ASOs), small interfering RNAs (siRNAs), small hairpin RNAs (shRNAs), anti-micro RNAs (anti-miRs), Aptamer, etc.
Up until August 2024, 19 oligonucleotide drugs have successfully been launched globally, among which ASO is the most commonly approved form. The global market of approved oligonucleotide drugs is mainly held by Ionis, Sarepta, and Alnylam. Notably, Ionis and Sarepta lead the ASO sector, with seven and three ASO drugs available, respectively. Alnylam has developed five siRNA drugs, almost holding a monopoly on the siRNA market.
In China, only two oligonucleotide drugs received approval in 2019 and 2023, respectively: Nusinersen for treating spinal muscular atrophy, developed by Ionis and Biogen, and Inclisiran targeting hypercholesterolemia, developed by Alnylam and Novartis. Both drugs were developed by overseas companies, which means currently no approved oligonucleotide drugs from domestic companies in China.
Clinical Stages of Oligonucleotide Drugs
In China, 44 oligonucleotide drugs are under research and development, while the figure is 580 globally. In terms of clinical trial stages, 34.9% of global oligonucleotide drugs are in Phase II and Phase III, whereas in China, this figure stands at 25.0%.
Data Source: DRUGDATAEXPY
Data Source: DRUGDATAEXPY
Among the 44 drugs in China, six are ASO drugs under research and development, with four currently in Phase II clinical trials. SiRNA represents the most researched type of oligonucleotide drug, but most are still in the preclinical stage, with only two reaching Phase III clinical trials.
Range of Oligonucleotide Drugs Indications
Data from Yaozh indicates that the indication range of oligonucleotide drug under research in China is narrower than that of drugs already on the market or in development globally. While global oligonucleotide drug indications primarily focus on rare diseases, tumors, inflammatory diseases, metabolic disorders etc., the indications in China mainly include metabolic disorders, tumors, gastrointestinal diseases, and cardiovascular diseases.
Data Source: DRUGDATAEXPY
Data Source: DRUGDATAEXPY
