Oligonucleotide Synthesis Market - Growth, Trends, COVID-19 Impact, and Forecasts (2022 - 2027)
The oligonucleotide synthesis market is expected to register a CAGR of 12.3% during the forecast period of 2022-2027
COVID-19 is an infectious disease caused by the most recently discovered novel coronavirus. Largely unknown before the outbreak began in Wuhan (China) in December 2019, COVID-19 has moved from a regional crisis to a global pandemic. The World Health Organization (WHO) officially declared the outbreak of COVID-19 a pandemic. A mix of established pharmaceutical and biopharmaceutical companies, along with the players in the oligonucleotide synthesis market, have stepped forward to contribute to worldwide research efforts by providing oligo products for developing test kits, treatments, and vaccines that target the infection caused by the novel Coronavirus. For instance, In April 2021, Microsynth AG (Switzerland) provided key reagents such as primer-probe sets to PCR testing labs to support molecular diagnostic companies in developing & validating accurate, cutting-edge detection methods and to provide comprehensive genomics expertise for research labs studying coronaviruses. The main contribution includes the supply of RT-qPCR primer-probe sets for SARS-CoV-2 detection and synthesis of primers for NGS-based SARS-CoV-2 high-throughput diagnostic, among others. Hence, COVID-19 has positively impacted the oligonucleotide synthesis market to a certain extent.
The growth of the oligonucleotide synthesis market is due to the increasing government investments and R&D expenditure in pharmaceutical and biotechnology companies and the use of synthesized oligonucleotides in molecular diagnostics and clinical applications. The usage of synthetic oligonucleotides has been increasing rapidly over the past decade, owing to several benefits offered by molecular diagnostics and growing clinical applications. The nucleic acid application techniques are the reference methods, and they are very useful for carrying out the molecular diagnosis in several diseases, like the detection of infectious diseases, such as hepatitis. For instance, In January 2020, the Department of Biotechnology (DBT) initiated the “Genome India Project” (GIP). The project aims to collect 10,000 genetic samples from citizens across India to build a reference genome. Some focus areas of this project are precision health, rare genetic disorders, mutation spectrum of genetic & complex diseases in the Indian population, genetic epidemiology of multifactorial lifestyle diseases, and translational research.
In addition to this, In February 2021, the Centre for Process Innovation (CPI) launched a project in the Medicines Manufacturing Innovation Centre in the United Kingdom. This project aims to revolutionize the manufacturing of oligonucleotides through a collaboration with AstraZeneca, Exactmer, Novartis, and the United Kingdom Research & Innovation. Inclisiran, a small interfering RNA used in the treatment of atherosclerotic cardiovascular disease (ASCVD), would be the first medicine produced at a commercial scale as a result of this collaboration. Synthetic oligonucleotides also have significant clinical applications, primarily for the detection of autoimmune antibodies. There have been consistent developments in synthetic biology over the past few years, where synthetic oligonucleotides were used to develop assays for the detection of anti-double-stranded DNAs. Thus, all these factors are responsible for the growth of the oligonucleotide synthesis market. However, there have been various instances in the past, wherein due to high complexities such as severe side effects, many drugs have been withdrawn or have failed in clinical trial phases. Such instances could become recurrent and may restrain market growth to a certain extent.
Key Market TrendsThe Therapeutic Application Segment is Expected to Hold Significant Market Share Over the Forecast PeriodOligonucleotide therapeutics, which include antisense oligonucleotides, small interfering RNAs, and aptamers, show promising clinical outcomes for disease indications such as Duchenne muscular dystrophy, familial amyloid neuropathies, and macular degeneration. The increasing number of Food and Drug Administration-approved drugs and a rich clinical pipeline of oligonucleotide-based drugs are factors expected to drive the growth of these therapeutics in the coming years.
The increasing applications of oligos as therapeutic agents (such as antisense oligos and siRNA) used in treating neurological, infectious, and rare genetic disorders are expected to drive market growth. Oligonucleotide therapeutics is an emerging drug modality, which consists of modified or unmodified short nucleic acid molecules, and includes antisense oligonucleotides (ASOs), small interfering RNA (siRNAs), microRNA (miRNAs), aptamers, and DNAzymes. For instance, as per the study published by the National Library of Medicine in March 2021, titled 'Recent Advances in Oligonucleotide Therapeutics in Oncology', currently, oligonucleotide therapeutics investigated in clinical trials include ASOs, siRNAs, miRNAs, aptamers, and DNAzymes. Their mechanisms of action differ, resulting in the correction of either abnormal expression or splicing patterns.
In addition to this in March 2020, viltolarsen, developed by Japanese companies, was approved as a treatment for Duchenne muscular dystrophy. Moreover, in June 2022, GSK plc presented promising interim results from the B-Clear phase IIb trial showing that bepirovirsen, an investigational antisense oligonucleotide treatment for hepatitis B, reduced levels of hepatitis B surface antigen (HBsAg) and hepatitis B virus (HBV) DNA after 24 weeks’ treatment in people with chronic hepatitis B (CHB). Such investigations are expected to boost the segment's growth in the years to come. Nucleic acid-based therapeutics that regulate gene expression have been developed for clinical use at a steady pace for several decades, but in recent years the field has been accelerating and hence have, contributed to the segment's strong growth.
North America is Expected to Occupy a Significant Share in the Oligonucleotides Synthesis Market Over the Forecast PeriodNorth America dominates the market due to the presence of better healthcare infrastructure and the increasing usage of oligonucleotides by pharmaceutical companies in the region. Furthermore, the strong foothold of North America in genomics, proteomics, oncology, diagnostic screening, and drug discovery has significantly contributed to maintaining its large share. The presence of numerous global players in this region is the leading key factor contributing to this market segment. In the region, the United States is leading the market and is expected to continue the same over the forecast period. Danaher Corporation, Thermo Fisher Scientific, Inc., Maravai Life Sciences, and many more players are pouring millions into the oligonucleotide synthesis market. For instance, in March 2021, Nitto Denko Corporation revealed its plan to invest about JPY 25 billion in its United States-based subsidiary, Nitto Denko Avecia Inc., and other businesses to increase the manufacturing capacity of its oligonucleotide therapeutic business.
Apart from these, the number of small and mid-sized players is also leveraging in this market. Moreover, there have been clinical trials conducted in the United States in recent years, which are expected to promote the growth of the oligonucleotide synthesis market. For instance, as per a press release in December 2021, researchers from the UMass Chan Medical School showed the ability to suppress mutant forms of the ALS (amyotrophic lateral sclerosis) gene known as C9ORF72 in a single-patient pilot study. C9ORF72 is the most common cause of familial ALS and familial frontotemporal dementia (FTD). North America region owing to increasing investments and rising funds dedicated to the manufacturing companies as well as academic and research institutes for the development of genes synthesis-based ends products such as precision medicine and other therapeutics. Therefore, considering the above-mentioned factors the growth of the market in the country is likely to contribute the largest share in the North American region during the forecast period.
Competitive LandscapeThe companies are seen adopting various strategies that include the acquisition of players in the emerging markets, distribution partnerships, and collaboration for the development of novel technologies. The companies operating in the oligonucleotide synthesis industry are also expanding and developing their product portfolios, which helps to drive the overall market and makes the market fairly competitive. Some of the companies which are currently dominating the market are Agilent Technologies, Thermo Fisher Scientific, Merck KGaA, Danaher Corporation, Bio-Synthesis Inc., Eurofins Scientific, Kaneka Corporation (Eurogentec), GenScript, LGC Limited (LGC Biosearch Technologies) and others.
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