Korean healthcare companies are making strides with development in microneedle-based drugs to drastically improve convenience and reliability in the delivery of life-saving therapies and vaccines.

A microneedle literally means a microscopic needle with a needle length of 1 mm or less. It is also referred to as a drug delivery system (DDS) that uses the needle to deliver medicines through the skin without pain.

The development of microneedle drugs is expected to open a new chapter in the pharmaceutical and biotech industries. It is also expected that the distribution and storage system will be greatly improved by drying and solidifying liquid medicines into microneedle drugs.

Korean companies have been researching the application of microneedle technology for functional cosmetics like Raphas established in 2006.

Last month, Raphas completed an IND application to the Ministry of Food and Drug Safety for an investigational immunotherapy drug to treat allergic rhinitis. It is the first IND in the world for microneedle-based allergy immunotherapy. Raphas received regulatory approval for Phase 1 clinical trials for its osteoporosis treatment patch. The company is also developing treatments for dementia and obesity, patch-type vaccines in cooperation with domestic pharmaceutical manufacturers.

QuadMedicine founded in 2017 is building a microneedle platform for medical use. The company has been in limelight as it was selected as a project leader for biotechnology development supervised by the government. It also built the world`s first microneedle production facility suitable for vaccine manufacturing regulations. The company plans to enter Phase 1 clinical trials for its hepatitis B vaccine, while putting efforts to develop osteoporosis and hair loss drugs.

Eubiologics and ADM Bioscience signed a memorandum of understanding early this month for joint development of a next-generation Covid-19 vaccine. Eubiologics is conducting a phase 2 clinical trial in Korea for a patch-type Covid-19 vaccine through microneedle technology.

According to the Ministry of Food and Drug Safety, the worldwide microneedle market grew from $470 million in 2015 to $621 million in 2019. The market value is estimated to reach $1.2 billion in 2030. But there is no approved microneedle-based drug in the world.

U.S. Zosano Pharma’s migraine drug M207 based on the company’s proprietary intracutaneous microneedle-array drug-delivery system is one of the closest to regulatory approval.

If microneedle technology is successfully applied to pharmaceuticals, it will be an innovative method to replace drug injection as expected by the World Health Organization (WHO) and the International Vaccine Institute (IVI), a market official said. It can also be developed as a platform for medical diagnostic devices that can measure biomarkers in body fluids without blood collection, the official added.

By Park Yoon-gyun and Minu Kim

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