Below are the regulatory trends impacting the nanotechnology theme in medicine, as identified by GlobalData.
Unlike most MedTech industries, the nanomedicine market has remained relatively unscathed by the Covid-19 pandemic, primarily due to the severity of the health problems nanomedicines are being used for. GlobalData expects the market to continue growing through at least 2026, with regulatory authorities continuing to approve the reuse of microbubbles for the delivery of therapeutic compounds.
FDA Regulation of Nanotechnology
Historically, nanotechnologies in medicine have followed the 510(k) US Food and Drug Administration (FDA) regulatory pathway in a manner similar to other medical devices. However, this route led to complications in obtaining approval, as there was no specific category for these types of products. In 2018, the FDA announced it would expand the 510(k) program to take into account the views of other organizations, such as the Nanotechnology Characterization Lab and the Nano Task Force.
While this change has the potential to streamline the approval trajectory for nanotechnologies in medicine, GlobalData expects the approval of new nanodrugs to slow in 2020 as the FDA shifts its focus to approval of diagnostics and therapies for SARS-CoV-2. virus.
Government and Regulatory Agencies
While North America dominated the market in 2020 with the largest share, GlobalData expects government funding for new nanomedicines to pick up again in 2022 as national budgets and economies recover from the Covid-19 pandemic.
Patents and Intellectual Property (IP)
When designing new nanomedicines, use is sometimes made of a previously existing nanotechnology or medicine. This could potentially lead to uncertainty in determining whether a new nanomedicine is indeed new. In some cases, inter-company licensing agreements may be required for nanomedicine approval to take place. Therefore, clear definitions are needed of what meets the requirements for a new patent. This industry is unique in that it combines the fields of medical devices and pharmaceuticals.
Therefore, patent officers with expertise in these areas would benefit the industry and improve the degree of commercialization. GlobalData expects the number of new patents and IP for nanomedicines to rise in 2021, while patents and IP for Covid-19-related therapies decline as companies divert resources away from 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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