Nanotechnology Trends in Medicine

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anomedicines 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.

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.

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 from microbubbles using ultrasound.

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.

Unlike most MedTech industries, the nanomedicine market remained relatively unscathed by the Covid-19 pandemic, primarily due to the severity of health conditions for which nanomedicines are used. GlobalData expects the market to continue to grow until at least 2026, with regulatory bodies continuing to approve any repurposing of microbubbles for the delivery of therapeutic compounds adding to the momentum.

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 pathway led 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) programme to take into consideration the opinion of other organisations, such as the Nanotechnology Characterisation Lab and the Nano Task Force.

While this change has the potential to streamline the approval pathway for nanotechnologies in medicine, 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 the SARS-CoV-2 virus.

While North America dominated the market in 2020, accounting for the largest share, GlobalData expects that government funding for new nanomedicines will increase again in 2022, as national budgets and economies recover from the Covid-19 pandemic

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 for the approval of nanomedicines to occur. As such, clear definitions on what satisfies the requirements for a new patent are required. This industry is unique, as it combines the fields of medical devices and pharmaceuticals.

Therefore, patent officers with expertise in these fields would be a benefit to the industry and improve rates of commercialisation. GlobalData expects the number of new patents and IP for nanomedicines in 2021 to rise, while patents and IP for Covid-19-related therapies decrease, as companies divert resources away from Covid-19-related R&D.

Players in the nanomedicine market range from private companies that make small annual revenues to large companies that dominate multiple industries, generating large revenues from many patents and the US Food and Drug Administration (FDA)-approved drugs.

There are many registered clinical trials in progress that involve nanotechnology for medicine. Many of these studies are related to oncology; other therapy areas include autoimmune diseases, anti-fungal agents, and rare diseases. However, many of these studies as well as clinical trials for new nanomedicines were put on hold during the global Covid-19 pandemic to protect participants and investigators.

The lack of nanotechnology experts in both academia and industry will prevent the rapid discovery of new nanotechnologies for medicine. Lack of expertise will also delay promising technologies from obtaining regulatory approval and commercialisation across geographic regions. Due to the pandemic, company resources will be focused on hiring and developing expertise related to Covid-19, to maintain a competitive edge. Others will stop hiring altogether. Even after the pandemic, the resulting lack of expertise will delay promising technologies from obtaining regulatory approval and commercialisation across geographic regions.

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 between companies producing nanomedicines are expected to slow down as companies shift their attention away from developing non-Covid-19 related products.

Nanomedicines are often more complicated to synthesise and produce than 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. Patients depending on these medications will still require a constant supply. However, the production of novel therapies will likely be negatively impacted by the Covid-19 pandemic.

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