Developing new ways of delivering drugs has become big business with companies now investing many millions of pounds in seeking the next big breakthrough.
Indeed, market analysts Mordor Intelligence estimates in a new report that the European New Drug Delivery Systems (NDDS) market alone is estimated to have reached USD 46.78 billion in 2016 and will grow at 8.15% a year until 2021. That makes the European market for NDDS the second largest in the world, accounting for almost 30 % of the global market share.
According to Mordor, the drug delivery system market in the United States represents the highest share globally and is also expected to grow at a good pace until 2021. Mordor Intelligence says that the growth is being driven by unprecedented developments in genomics and molecular biology, supported by a growing acknowledgement that the method by which a drug is delivered can have a significant impact on its efficacy. According to the report: “The industries have diverted their research focus from the conventional dosage forms to novel drug delivery technologies that have significantly improved market requirements.
“In recent years, the pharmaceutical companies have been struggling to maintain a balance between the pressure to drop prices and the high innovation costs. It is always advantageous for companies to develop their own innovative delivery devices to maintain a lead in the market.
“The high cost associated with … reducing healthcare budgets is leaving no alternative, but to use pharmaceutical drugs effectively in order to cut costs.
“Novel drug delivery systems can help in using drugs more effectively. Targeted delivery systems, which can specifically target the diseased part of body, can be very helpful in treating some disease with low amounts of drug being consumed.
“In addition, it can also eliminate side-effects associated with excessive drug use or drugs accumulated at the wrong site, thus decreasing the overall cost associated with the procedure.”
among areas witnessing rapid developments is cardiovascular disease, which accounts for more than 17 million deaths worldwide and is the primary cause of death globally.
Cancer is another area seeing advances in the delivery of drugs. According to the American Cancer Society, there were 1.6 million new cases and approximately 600,000 deaths due to cancer in the United States in 2015 alone.
Mordor says: “1.6 million new cases is a really high number; each of these is expected to have the potential of developing some form of side-effects during cancer treatment. This is expected to again lead to the rise in demand for novel drug delivery systems, which, in turn, are expected to drive the growth of the market.”
Among the technologies driving forward the advances is bioengineering, as illustrated by five studies presented to the recently-held 58th American Society of Hematology (ASH) Annual Meeting and Exposition in San Diego. They showed how researchers are applying advanced biomedical engineering methods to improve the delivery of life-saving treatments to sites in the body where they are needed most.
Armand Keating, professor of medicine and biomedical engineering and director of the Cell Therapy Program at the University Health Network in Toronto, Canada, said: “I believe each of these has the potential to change practice. All of these studies represent substantial advances resulting from biomedical engineering. They build upon established science with bioengineering strategies that could make therapies significantly more effective if they are pursued and refined.”
Among them, researchers have developed the first artificial red blood cells designed to emulate vital functions of natural red blood cells. If confirmed safe for use in humans, the nanotechnology-based product could represent an innovative alternative to blood transfusions that would be especially valuable on the battlefield and in other situations where donated blood is difficult to obtain or store. The artificial cells, called ErythroMer, are designed to be freeze-dried, stored at ambient temperatures, and simply reconstituted with water when needed.
Lead study author Allan Doctor, MD, of Washington University in Saint Louis, said: “One key goal is to advance field resuscitation of civilian trauma victims in remote settings and soldiers who are wounded in austere environments without access to timely evacuation.
“ErythroMer would be a blood substitute that a medic can carry in his or her pack and literally take it out, add water, and inject it. There are currently no simple, practical means to bring transfusion to most trauma victims outside of hospitals. Delays in resuscitation significantly impact outcomes; it is our goal to push timely, effective care to field settings.”
Proof-of-concept studies in mice, conducted in partnership with Greg Hare MD, PhD, at the University of Toronto, demonstrated that the artificial cells capture oxygen in the lungs and release it to tissues — the main functions of red blood cells — in a pattern that is indistinguishable from that seen in a control group of mice injected with their own blood. In rats, ErythroMer effectively resuscitated animals in shock following acute loss of 40 percent of their blood volume.
The donut-shaped artificial cells are formulated with nanotechnology in partnership with Dipanjan Pan, PhD, at the University of Illinois at Urbana-Champaign, and are about one-fiftieth the size of human red blood cells. A special lining encodes a control system that links ErythroMer oxygen binding to changes in blood pH, thus enhancing oxygen acquisition in the lungs and then dispensing oxygen in tissues with the greatest need.
Tests show ErythroMer matches this vital oxygen binding feature of human red blood cells within 10%, a level the researchers say should be sufficient to stabilise a bleeding patient until a blood transfusion can be obtained.
If further testing goes well, the researchers estimate that ErythroMer could be ready for use by field medics and emergency responders within 10-12 years.
Development work has been supported by the Children’s Discovery Institute at Washington University and St. Louis Children’s Hospital, the Skandalaris Center at Washington University and the BioSTL Fundamentals Program.