Currently, the needle-free sector makes up only a small fraction of the total drug delivery market, though types of new delivery systems are expected to expand and vary from patches and degradable implants to fast-dissolving tablet vaccines, inhalers, and pulmonary delivery methods.
“While certain forms of needle-free vaccines, such as liquid jet injection, gene guns and micro-needles are already in use, the cell damage caused during administration and the inability to consistently and directly deliver vaccines renders such delivery methods inefficient,” study author Swathi Allada says.
Allada told us the penetration of new needle-free vaccine "is likely depend on time of commercialization. In the next 10 years, we anticipate at least 40-50% penetration in five years of commercialization."
The major factors driving the growth of needle-free delivery systems are estimated by Frost & Sullivan to be an increased awareness of such products, patient acceptance, and the introduction of new devices.
The delivery of drugs through needle-free devices is gaining acceptance because of technology upgrades as well as availability of more formulations for needle-free deliveries.
The US FDA last month approved its first needle-free vaccine delivery system for the flu vaccine Afluria. But the system is not without its kinks as the agency noted that injection-related side effects were reported more frequently with the needle-free system than with a needle injection.
But the Frost & Sullivan report notes that “in most cases the needle does not place the vaccine doses in the body sites that are known to elicit optimal immune response. Clinical data evolved over the years show that both the needle and syringe place the vaccine dose in muscles wherein immunologically sensitive cells are present at a much lower density. However, clinicians theorize that the thinner and viable upper skin layers contain a greater population of antigen-presenting cells (APCs) than what is required for potential immune responses.”
The report notes the potential market opportunity in biotech start-up Vaxxas, which has found a delivery method to administer a dried live vaccine directly to the skin in a needle-free manner, which would also remain effective at room temperatures.
Vaxxas’ Nanopatch device, which is roughly 5 mm × 5 mm and made up of one square centimeter of solid silicon, dry-coated with antigen, adjuvant, and/or DNA payloads that could be used for a range of indications. The patch’s surface has about 20,000 micro-projections invisible to the naked eye and arranged in an ultra-high density array. Early stage tests conducted on mouse models have shown that the Nanopatch-delivered flu vaccine is effective with just 1/150th of the dose as compared to the traditional syringe.
The Nanopatch also can eliminate the requirement of adjuvants to boost the immunogenicity of vaccines, which unlike traditional inoculation methods would mean a more efficient delivery of vaccine.
The development of thermostable vaccines with a long shelf life is an area of focus for vaccine developers because of the difficulty of delivering vaccines to nations where cold-chain storage and vaccination rates are issues.
“As more companies realize the potential benefits of needle-free drug delivery, this technology will gain traction, both among patients and physicians, ultimately enhancing the adoption of needle-free injectable drugs or vaccine deliveries,” the report says.