Introductory Chapter: Overview on Nanomedicine Market

*Islam Ahmed Hamed Khalil, Islam A. Arida and Mohamed Ahmed*

## **1. Introduction**

Nanomedicine is an emerging field that has caught the interest of many medical scientists and chemists due to its unique characteristics that open the door wide for several unique applications that might lead to solving many problems that were found difficult to tackle in medicine. Nanomedicine has opened a new category of medicines called nanomedicines where the medicine is reduced to the nanoscale size, hoping to enhance its physicochemical properties. The chapter summarizes the nanomedicines that have been approved by the Food and Drug Administration (FDA) or European Medicines Agency (EMA) and the nanomedicines whose clinical trials based on previously published review articles by Anselmo and Mitragotri are ongoing [1, 2].

To gain insight to current trends in nanomedicine research and the most successful types of nanomedicines in the market, the approved nanomedicines are presented in **Figure 1**. The number of approved nanomedicine products is 29 till 2019 [1]. Liposomes represented 44.8% (13 products). Inorganic nanoparticles ranked second with 41.4% (12 products). Other nanoparticles (polymeric and protein) have only 4 products (13.8%). These findings are very interesting as liposomes are one of the oldest nanomedicines. This opens an argument about the challenges in nanomedicine translation as a new platform requires further investigations to prove its activity and safety. On the other hand, cancer nanotherapeutics is ranked first with 10 products in the market, followed by iron-replacement therapies with 8 products. Also, it is worth to mention that imaging agents (six marketed products) are ranked in third place, especially the inorganic nanoparticles (three products).

Moreover, nanomedicines, currently undergoing clinical trials, are presented in **Figure 2**. The number of products under clinical trials is 47 till 2019 [1], where liposomes represented 61.7% (29 products) and micelles ranked second with 19.15% (9 products). Other nanoparticles have only nine products (19.15%). Also, these findings are similar to approved nanomedicine, where liposomes are the most used nanomedicine. On the other hand, 39 products are dedicated for cancer treatment. It is worth to mention that 10 products out of the 39 products are loaded with gene therapy and not chemotherapeutic agents.

Generally, the total number of nanomedicines in the market or in clinical trial are 76 products, where liposome formulations were the most used delivery system with 55.26% (42 products), followed by inorganic nanoparticles with 21% (16 products) as presented in **Figure 3**. According to the World Health Organization in 2015, the first leading cause of death in around 50% of countries is cancer [3]. According to the International Agency for Research on Cancer report that published in 2018 on the global burden of cancer, there are 18.1 million cancer cases and 9.6 million cancer deaths in 2018 [3]. These reports inspired the

#### **Figure 1.**

*Clinically approved nanomedicine for therapy and diagnostic.*

**5**

**Figure 4.**

*nanoparticles.*

*Introductory Chapter: Overview on Nanomedicine Market*

pharmaceutical industry to invest in this market. As mentioned previously, there are only 10 nanomedicine products out of 29 products available in the market to treat cancer, while there are 39 products out of 47 products for cancer treatment. This number of clinical trials for cancer is mainly derived by the 15 years of support by the US National Cancer Institute through the Centers of Cancer Nanotechnology

Nanomedicines are mainly classified into two classes, either inorganic nanoparticles such as gold, silica, and iron oxide or organic nanoparticles such as polymeric,

Liposome-based nanomedicine is a type of drug formulation where a drug is encapsulated inside the phospholipid bilayer structure to enhance its bioavailability and therapeutic activity. Liposome formulations are one of the oldest nanomedicines with a well-established technique. Many research efforts were focused on using liposomes to encapsulate several cargos like small molecules such as doxorubicin, nucleic acid such as RNAs, and biological molecules such as vaccines for hepatitis A virus. Furthermore, administration of the liposomes without an encapsulated drug is also a possibility if the liposome subunits have a certain therapeutic effect such as sphingomyelin and cholesterol. PEGylation is an option to consider while using liposomes due to its importance in adding stealth to the delivery system. Most of the approved liposome-based nanomedicines are used for the treatment of cancer diseases. They take a large place in research as 10 out of the 29 approved

liposomes, and micelles (**Figure 4**). These nanoparticles are mostly used for therapeutic and diagnostic nanoparticles. Inorganic nanoparticles have been used for a variety of applications including lymph node imaging, hyperthermia, and anemia treatment. Some of them have successfully gone through preclinical studies and clinic trials. Along with inorganic nanoparticles, organic-based nanoparticles have successfully reached the clinical phase and currently reached the market for

different applications like vaccination, microbial infection, and cancer.

*Clinically approved and investigated nanomedicines including organic nanoparticles and inorganic* 

*DOI: http://dx.doi.org/10.5772/intechopen.91890*

Excellence (CCNEs) [4].

**2. Types of nanomedicines**

**2.1 Liposome-based nanomedicines**

nanomedicines are liposome-based.

*Introductory Chapter: Overview on Nanomedicine Market DOI: http://dx.doi.org/10.5772/intechopen.91890*

pharmaceutical industry to invest in this market. As mentioned previously, there are only 10 nanomedicine products out of 29 products available in the market to treat cancer, while there are 39 products out of 47 products for cancer treatment. This number of clinical trials for cancer is mainly derived by the 15 years of support by the US National Cancer Institute through the Centers of Cancer Nanotechnology Excellence (CCNEs) [4].
