Pharmaceutical companies have harnessed oligonucleotide active pharmaceutical ingredients (APIs) popularly in solid solutions (powdered form) and recently in solution form. The drive for the oligonucleotide API market stems from the vast utilization of oligonucleotides in treating a wide range of diseases. The product devcamelopment has paved way to new therapeutic strategies in numerous therapies, notably in ophthalmologic indications, neuromuscular diseases, and as adjuvants for vaccine development.
Some of the key oligonucleotide classes are antisense oligonucleotides, micro-RNA, small/short interfering RNA, immunostimulatory oligonucleotides, splice-switching oligonucleotides, and aptamers. Some of the factors that have boosted the trend of oligonucleotide APIs in solution are solution stability, viscosity, concentration, end-to-end manufacturing, and packaging.
Progress made in industry associations sharing of CMC (chemistry, manufacturing, and control) strategies is boosting the prospect in the oligonucleotide APIs market. Growing demand for new drug classes for COPD (Chronic Obstructive Pulmonary Disease) and asthma has unlocked new avenues in the market.
The growing percentage of oligonucleotide APIs in drug pipeline worldwide is a key factor underpinning the evolution of the market. Over the past 10 – 15 years, pharma companies have benefitted from the industry trend toward harmonization of oligonucleotide development and their commercialization. In this regard, the European Pharma Oligonucleotide Consortium (EPOC) has made concerted efforts with pharma companies around the world. A growing body of science-based recommendations has paved way to development of oligonucleotide therapeutics. Rise in research in biologic therapeutics has strengthened the drug pipeline of pharma companies in the oligonucleotide APIs market.
The market stakeholders have benefited from a comparative study on solution versus powder API. The several benefits associated with powder API produced by process of lyophilization has increased its preference. Several studies on preserving the stability of different classes of oligonucleotides have boosted the expansion of the oligonucleotide APIs market. Advances in methods aimed at concentration of the oligonucleotide API solution has led to gains to pharma companies. Further, the growing use of advanced chromatographic purification is boosting the oligonucleotide APIs market.
Antisense oligonucleotide (ASO) therapeutics have gained popularity in the expansion of the market. Key ones are Tegsedi, Waylivra, and Spinraza. In recent years, the increased focus on personalized medicine among various healthcare systems around the world has stimulated new avenues for stakeholders including industry players.
Research in utilizing oligonucleotides in infectious and genetic diseases has spurred new therapeutic strategies in the oligonucleotide APIs market. Several pharma companies over the past 10 years have rebuffed their efforts in utilizing the potential. To this end, they have been notably ramped up their investments in expanding their production capacities.
Corden Pharma GmbH, a German pharma company, has announced to make manufacturing capacity expansion in Colorado, U.S. The capacity expansion notably includes the synthesis and purification of the concentrate. The company has aimed at offering companies manufacturing services expanding their drug development programs in clinical trials.
As many as oligonucleotide programs are in development in 2019, moving from research through Phase III. This accounts for the vast investment potential for pharma companies in the oligonucleotide APIs market.
Some of the promising industry players in the oligonucleotide APIs market are Biogen, GE Healthcare Life Sciences, and Nitto Denko Avecia.
Expansion of commercially approved oligonucleotide therapeutics has attributed the rise in avenues in North America and Europe in the global APIs market. These regions have seen a few exciting paradigms in API manufacturing process taking place. Increasing focus on developing personalized medicine for cancer has also spurred product development in these geographies.
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