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Review
. 2019 Jan;14(1):93-126.
doi: 10.2217/nnm-2018-0120. Epub 2018 Nov 19.

Nanopharmaceuticals and nanomedicines currently on the market: challenges and opportunities

Fatemeh Farjadian  1 , Amir Ghasemi  2   3 , Omid Gohari  2 , Amir Roointan  4 , Mahdi Karimi  5   6   7 , Michael R Hamblin  7   8   9
Affiliations
Review

Nanopharmaceuticals and nanomedicines currently on the market: challenges and opportunities

Fatemeh Farjadian et al. Nanomedicine (Lond). 2019 Jan.

Abstract

There has been a revolution in nanotechnology and nanomedicine. Since 1980, there has been a remarkable increase in approved nano-based pharmaceutical products. These novel nano-based systems can either be therapeutic agents themselves, or else act as vehicles to carry different active pharmaceutical agents into specific parts of the body. Currently marketed nanostructures include nanocrystals, liposomes and lipid nanoparticles, PEGylated polymeric nanodrugs, other polymers, protein-based nanoparticles and metal-based nanoparticles. A range of issues must be addressed in the development of these nanostructures. Ethics, market size, possibility of market failure, costs and commercial development, are some topics which are on the table to be discussed. After passing all the ethical and biological assessments, and satisfying the investors as to future profitability, only a handful of these nanoformulations, successfully obtained marketing approval. We survey the range of nanomedicines that have received regulatory approval and are marketed. We discuss ethics, costs, commercial development and possible market failure. We estimate the global nanomedicine market size and future growth. Our goal is to summarize the different approved nanoformulations on the market, and briefly cover the challenges and future outlook.

Keywords: nanopharmaceuticals; drug delivery; market size; nanocrystal; nanodrug; nanoliposome; nanomedicine; nanopolymer; nanotechnology; regulatory approval.

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Conflict of interest statement

Financial & competing interests disclosure

MR Hamblin was supported by US NIH grants R01AI050875 and R21AI121700. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.

No writing assistance was utilized in the production of this manuscript.

Figures

<b>Figure 1.</b>
Figure 1.. Schematic illustration of three types of nanopharmaceuticals available in the market.
<b>Figure 2.</b>
Figure 2.. Chemical structures of approved nanopharmaceuticals within the nanocrystals category.
<b>Figure 3.</b>
Figure 3.. Ostim is a nanocrystalline paste of calcium hydroxyapatite.
(A) Transmission electron microscopy image of Ostim® nanocrystal (150,000×) reproduced with permission from [132] © BMC (2006) licensed with CC BY 2.0. (B) Macromorphology of Ostim, arrows showing a very little number of macrophage cells near to the particles (hydroxyapatite paste particles). Reproduced with permission from [132] © BMC (2006) licensed with CC BY 2.0.
<b>Figure 4.</b>
Figure 4.. Approved nanopharmaceuticals with liposomal formulations.
<b>Figure 5.</b>
Figure 5.. Proposed mechanism of action of AmB.
Free and liposome-bound AmB circulate in the bloodstream after injection of AmBisome. After attachment of the liposomes to the cell wall of the fungal cells, active AmB molecules are released and then bind to the cell membrane and by pore formation eventually leads to ionic leakage and cell death. Taken with permission from [187] © Springer Nature (2016).
<b>Figure 6.</b>
Figure 6.. Schematic illustration of Abelcet® lipid nanoformulation.
<b>Figure 7.</b>
Figure 7.. Structures of PEGylated nanopharmaceuticals; linking agent is in purple and conjugation site is in red.
<b>Figure 8.</b>
Figure 8.. Schematic illustration of other types of polymeric nanopharmaceuticals.
<b>Figure 9.</b>
Figure 9.. Structure of albumin-bound paclitaxel known as Abraxane®.
<b>Figure 10.</b>
Figure 10.. Cellular uptake of albumin-bound nanopartcles containing paclitaxel.
Endothelial transcytosis pathways via gp60 followed by binding to that are present at the tumor site [274]. Taken with permission from [274] © Elsevier (2012). SPARC: Cysteine-rich secreted proteins.
See this image and copyright information in PMC

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