Oligonucleotide API Market Trends

Growth Drivers

• Globally Rising Prevalence of Cancer and Neurodegenerative Diseases - Based on data from the National Cancer Institute, as of 2020, there were 1,806,590 new cancer diagnoses in the United States and 606,520 cancer deaths. The rising number of cancer cases is propelling the demand for advanced testing procedures. Moreover, the treatment of neurodegenerative diseases requires a personalized approach as well. In terms of neurodegenerative conditions, Alzheimer's disease is one of the most common. There are several limitations associated with conventional medicine in this area, so oligonucleotide APIs are being studied extensively. This factor is expected to expand the global oligonucleotide API market size during the forecast period.
• Growth in Percentage of API Manufacturing Facilities - According to the US Food & Drug Administration (FDA), there were more than 28% of API manufacturing facilities based in the United States in 2019 catering to the market in the U.S. Rest of were located in other regions, including 13% in China.
• An Upsurge in Medical Approval Programs for Oligonucleotides - It was observed that as of 2019, around 605 oligonucleotide approval programs were in development throughout the world, compared with only 200 in 2010.
• Growing Expenditures on Healthcare Throughout the World - Global healthcare expenditure accounted for 9.83 billion in 2019 according to data provided by the World Bank, an increase from 9.7 billion in 2018.
• Rising per Capita Income Worldwide - The World Bank reported that worldwide annual per capita income increased by 4.8% in 2021, up from 1.5% in 2019.

Challenges

• High Production of Waste Associated with Oligonucleotide - The current state of the art in oligonucleotide synthesis provides a waste and expense burden to firms, with just 12 oligonucleotide pharmaceuticals having reached the market to date and hundreds more being developed in medical studies and preclinical research. So, the waste from the reversed-phase purification process comprises the hazardous waste disposal. For instance, solvent recovery is economically and environmentally advantageous at high production volumes, but around 50% of the waste volume still needs to be disposed of as aqueous-rich hazardous waste.
• Complex Procedure of Manufacturing
• Mandatory GMP Guidelines and Product Licensing