Nanomedicine
Nanomedicine is a rapidly growing field of medical research involving the development of nanoparticles (NPs) for prophylactic, diagnostic, and therapeutic purposes. The unique properties of nanomedicines offer potential solutions for many of the current challenges in treating cancer, cardiovascular, and neurodegenerative diseases, as well as other illnesses. Many nanomedicines and nanodiagnostics are already FDA-approved and on the market, and many more are in clinical trials. Currently, the most active areas of nanomedical research and product development are cancer treatments, imaging contrast agents, and biomarker detection although many nanotherapeutics and nanodiagnostics are already in use, many barriers prevent bringing nanomedical products to market.
Nanomedicines function on the same scale as many biological processes, cellular mechanisms, and organic molecules, so they are thought to provide an especially promising approach. There has been significant progress in synthesis, functionalization, and use of NPs, presenting new strategies for molecular targeting, personalized therapies, and minimally invasive diagnostic techniques.
Although many nanomedicines are already in use or are being studied in clinical trials, many barriers impede bringing these drugs to market. Multiple challenges and risks make converting nanomedical research into commercially available medical products extremely complicated.
One challenge is the FDA approval process This complex and demanding process, as well as other FDA regulations, makes bringing nanomedicine products to market much more difficult than introducing other types of nanotechnology products that are not as strictly regulated. Administrative burdens can delay the initiation of a clinical trial for an average of 800 days. Patient enrollment can also be challenging, with as few as 3% of eligible patients participating in cancer clinical trials. Compared with conventional medicines, relatively few clinical trials are investigating NPs so the potential of many nanomedicines is yet to be determined. Because of these and other factors, nanomedical products currently occupy only a tiny niche of the total drug, biotech, and device market
Attracting investment for nanomedicine research is also particularly challenging. Investment in nanomedical research is currently driven by small and medium-sized companies and venture capitalists who invest in startups. Universities are also pushing for funding to adapt basic nanomedical research into real products. However, investors are extremely cautious about making large investments in nanomedicine, because positive returns occur only over the long term, if at all. Most, if not all, of these companies and university groups, will eventually partner with large biotech or drug companies to make their enterprises a business success. However, the fact that there have been relatively few commercially viable nanomedical products to date makes finding such a partner difficult. Nanomedicines are currently regulated like conventional drugs, so investors are also concerned if the FDA will be even stricter in regulating these products in the future. Multiple NP patent applications have also been filed at the U.S. Patent and Trademark Office, which has granted surprisingly broad patents This has created confusion because competing interests are unsure of the validity and enforceability of the patents.
The process of bringing a medicine, device, or diagnostic to market is so complicated and expensive that pharma and biotech companies also tend to want to focus on drugs that are expected to be blockbusters. However, potential blockbusters are difficult to identify, because of a scarcity of data. It has therefore been suggested that stakeholders, including research scientists, clinical investigators, health care providers, patient associations, and investors, develop a shared communication platform to facilitate communication and collaboration. The creation of an international, central nanoparticle database could characterize NPs and summarize findings from animal studies and clinical trials. Ultimately, this database could be beneficial for patients, health care providers, and investors by helping to bring innovative and profitable medical products to market
Despite these problems, investments in nanomedicine are expected to increase. Pharma and biotech companies are still expected to embrace nanotherapeutics and other nanomedical products, especially if they have novel properties, fulfill unmet medical needs, and offer an attractive cost-benefit ratio The success of nanomedicines like Doxil and Abraxane, and an expanding market for nanotherapeutics, has made the risk-reward ratio for these agents more appealing. At the moment, nanomedicine dominates venture capital investment in the healthcare market, predicting a bright future for this promising area of research. Nanomedicine is also expected to create additional revenue streams for pharmaceutical companies by creating new patentable formulations of off-patent proprietary drugs, extending the life of these products. It is even expected that novel or reformulated nanotherapeutics will disrupt the generic drug market.
Nanomedicines have unique properties that can potentially provide novel solutions in the treatment of many diseases. Several FDA-approved therapeutics, medical devices, imaging agents, and diagnostic devices containing nanomaterials have already become available, advancing medicine and improving healthcare. Despite considerable barriers that impede the development and availability of nanomedical products, it is expected that research and investment in this area will continue at a rapid pace, enabling these products to become an integral part of mainstream medicine in the future.
