Players in the nanomedicine market range from private companies that make small annual revenues to large medicine companies that dominate multiple industries, generating large revenues from many patents and FDA-approved drugs. Nanomedicines are a combination of nanotechnology with the drug itself, and are required to pass standard regulatory milestones. This includes proven safety and efficacy based on pre-clinical and clinical trials.

Listed below are the key regulatory trends impacting the nanotechnology industry, as identified by GlobalData.

FDA regulation of nanotechnology

Historically, nanotechnologies for medicine have followed the 510(k) FDA regulatory pathway in a manner similar to other medical devices. However, this pathway leads to complications when trying to gain approval, since there was no specific category for these types of products. In 2018, the FDA announced that it would expand the 510(k) program to take into consideration the opinion of other organisations, such as the Nanotechnology Characterization Lab and the Nano Task Force. GlobalData expects the approval of new nanomedicines in 2020 to slow down as the FDA shifts its focus to the approval of diagnostics and therapies for SARS-CoV-2.

Government & regulatory agencies

While the US had been investing money into the development of nanotechnology in medicine, GlobalData expects that government funding for new nanomedicines will slow down in 2020, as national budgets and economies have been crippled by the COVID-19 pandemic.

Patents & IP

The design of new nanomedicines sometimes involves the use of a previously existing nanotechnology or drug. This can potentially result in ambiguity when determining if a new nanomedicine is indeed novel. In some cases, licensing agreements might be required between companies in order for the approval of nanomedicines to occur. This industry is unique, as it combines the fields of medical devices and pharmaceuticals. Therefore, patent officers with expertise in these fields would be benefit to the industry and improve rates of commercialisation. GlobalData expects the number of new patents and IP for nanomedicines in 2020 to decline, while patents and IP for COVID-19-related therapies increase, as companies divert resources towards COVID-19-related R&D.

This is an edited extract from the Nanotechnology in Medicine – Thematic Research report produced by GlobalData Thematic Research.

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