GlobalData has identified the main trends in the nanotechnology industry over the next 12 to 24 months and classified them into three categories: technology/scientific trends, macroeconomic trends, and regulatory trends, as listed below.
Nanotechnology in medicine – Leading technology/scientific trends
Improving the ability of nanotechnologies to target specific cells or tissues is of great interest to companies producing nanomedicines. This area of research involves attaching nanoparticles onto drugs or liposomes to increase specific localisation. Since different cell types have unique properties, nanotechnology can be used to “recognise” cells of interest. This allows associated drugs and therapeutics to reach diseased tissue while avoiding healthy cells. While this is a promising area of research, very few nanomedicines exist that successfully utilise nanotechnology in this manner. This is due to ill-defined parameters associated with pairing the correct ratio or combination of nanoparticles with the drug of interest.
Controlled Drug Release
The ability to control the release of a drug or therapeutic compound from its associated nanotechnology is gaining a lot of interest from industry. This “triggered” release, in theory, could be achieved from within the body or from outside the body. Internal mechanisms include changes in the environment of tumours compared to surrounding tissue, while external stimuli include temperature changes, light, or ultrasound. Currently, research efforts are focused on trying to understand how to release diagnostic molecules and drugs from liposomes with heat, and microbubbles using ultrasound.
Understanding Different Patient Populations
In general, there is a lack of understanding about what makes patients different from each other in terms of why drugs lack ubiquitous efficacy. This extends to why nanotechnologies are not always able to improve the therapeutic output of drugs for every patient. It will be important to understand how nanomedicines behave when encountering different physiological characteristics of patients and their disease states.
Nanotechnology in medicine – Leading macroeconomic trends
There are many registered clinical trials in progress that involve nanotechnology for medicine. Many of these studies are related to oncology; however, other therapy areas include autoimmune diseases, anti-fungal agents and rare diseases. As such, GlobalData predicts that the market for nanomedicines will be on the rise.
Lack of Nanomaterial Experts
The absence of nanotechnology experts in both academia and industry will prevent rapid discovery of new nanotechnologies for medicine. Lack of expertise will also delay promising technologies from obtaining regulatory approval and commercialisation across geographic regions.
Mergers and Acquisitions
Mergers and acquisitions (M&As) are a significant part of the nanomedicine industry overall. In an industry that is typically slowed by extended timelines of product development, clinical testing, and federal regulation, M&As allow for growth and innovation to happen at a more rapid pace. In nanomedicine, M&As happen in all arenas, from large leading companies acquiring start-ups with novel technologies, to smaller companies acquiring their direct competitors, to start-up companies acquiring companies with complementary technology. M&As will continue into the foreseeable future since they are a good way to drive growth within companies and the industry overall.
Nanomedicines are often more complicated to synthesise and produce compared to standard drug compounds. In some cases, this might limit the ability of drug manufacturers or pharmaceutical companies to produce large quantities of nanomedicines. If issues related to production are not addressed, companies will not be so eager to invest resources into this industry. In the case of liposomes, there has been much success with producing simple structures for molecule compartmentalisation. However, more innovative designs have been met with synthesis challenges.
Nanotechnology in medicine – Leading regulatory trends
FDA Regulation of Nano-technology
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 they would expand the 510(k) programme to take into consideration the opinion of other organisations, such as the Nanotechnology Characterization Lab and the Nano Task Force. This change has the potential to streamline the approval pathway for nanotechnologies in medicine and will have a positive effect on the nanomedicine market.
Government & Regulatory Agencies
While the US is investing money into medical devices utilising nanotechnology, regulatory approval is still difficult for nanomedicines. This is partly due to a lack of understanding regarding how nanotechnologies interact with cells and tissues in the human body. This complexity has the potential to limit the approval of nanomedicines due to stringent regulations. Standard regulatory pathways for nanotechnologies in medicine need to be established to prevent a stifling of innovation and an increase in the costs of receiving approval.
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. As such, clear definitions on what satisfies the requirements for a new patent is required. This industry is unique, as it combines the fields of medical devices and pharmaceuticals. Therefore, patent officers with expertise in these fields would benefit the industry and improve rates of commercialisation.
This is an edited extract from Nanotechnology in Medicine report produced by GlolbalData Thematic Research.