Needle-Free Nanopatch Smaller Than A Fingernail Could This Be The Future Of Vaccines? - Frost & Sullivan Market Insight
Needle-Free Nanopatch SmallerThan A Fingernail
CouldThis BeThe Future Of Vaccines?
By Swathi Allada; Research Analyst, Medical Devices, Healthcare
Frost & Sullivan
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Vaccine Industry:A Sneak Preview
The vaccine industry has diverse profiles on the basis of three fundamental parameters—geography,
technology, and disease type. Research and development (R&D) for novel vaccine technologies is more
prominent in developed economies,particularly in the US,due to a greater number of startup companies
and better financial support. New vaccine delivery technologies such as needle-free transdermal and
intradermal systems (patches and degradable implants), edible vaccines, intranasal formulations, and
pulmonary delivery methods will be used increasingly to improve access to vaccines and the overall
efficacy of the vaccine delivery process.The development of thermostable vaccines with a long shelf life
is an area of focus for many vaccine developers, especially for those marketing to nations where
cold-chain storage is an issue.The following factors presented in exhibit 1 highlight the necessity for
needle-free (NF) delivery of vaccines.
Exhibit 1: Factors Influencing Growth in theVaccine Industry, Global, 2014
Has theTime Finally Arrived for Needle-free Delivery ofVaccines?
Drug delivery technologies are becoming an essential part of the entire drug development process.
Pharmaceutical companies are recognizing the significance of drug delivery technologies during the
primary stages of drug development. Pharmaceutical companies are also investing billions of dollars in
research to not only develop new molecules, but to understand the application of drug delivery
technologies to these molecules. As a result, drug delivery technologies are being used to enhance
pharmacodynamic and pharmacokinetic profiles, and also to increase patient comfort and compliance.
A targeted delivery of drugs is also being used to help reduce the adverse side effects of many drugs.
The needle-based approach is one of the oldest vaccine delivery techniques employed to achieve the
desired result; however, this procedure is associated with a lot of risk. It is prone to cause needle-stick
injuries to healthcare workers, can be painful, and at times also be associated with excruciating pain; it
can also be a potential agent for the spread of dangerous infections such as hepatitis and HIV.
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Immediate alternatives for NF
vaccination are auto disable and
safety syringes, which are already
in use in LMICs. Prefilled syringes
and reconstitution devices are
Due to the conservative mindset
of manufacturers and the need for
incentives and supporting clinical
data, needle-based vaccines will
drive the industry until 2020.
Significant development costs of
suitable vaccine formulations ideal
for needle-free device technology
may delay their availability until
Delivery techniques that are
incorporated in the early stages of
new vaccine development are
expected to have fast growth.
The global vaccine market was
once valued at US $24 billion in
2009 and is expected to reach
$47 billion by 2015, with emerging
markets in South America and
Asia expected to drive growth.
Emergence of novel delivery
techniques will further bolster this
Vaccine availability is expected to
increase in low and middle income
countries (LMICs) from 2015 to
2020, and become globalized by
Global health issues such as pan-
demics (for example, H1N1 –
Swine Flu) keep vaccines as a key
focus for manufacturers.
Vaccines are a major revenue
source for top-tier firms. Hence,
companies are expanding their
investments into vaccines and
vaccine delivery technologies.
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Needle-free delivery: The drug is injected without the use of any needles and is delivered into the
systemic circulatory system.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.
One of the injectable delivery types—needle-free technology—offers a substitute to needles
traditionally associated with injectable drug delivery. Currently, the size of needle-free delivery sector
makes up only a very small fraction of the total drug delivery market. Furthermore, the major factors
driving the growth of NF deliveries are estimated to be an increased awareness of such products,patient
acceptance, and the introduction of new devices.
Significant advancements have been made in needle-free injection technology, most of which have
focused on addressing patient comfort levels and increasing the adoption of self-injectable therapies.
Although the concept of needle-free drug delivery existed from the 1940s, it is only now that the
concept is becoming implemented into reality. Needle-free technology can be applied by healthcare
professionals for mass vaccinations and insulin delivery; it can also be made available for home use.The
early forms of this technology were developed to address and eliminate multi-use systems, which
increased the risk of disease transmission.Today,the goal of needle-free injection technology has changed
from merely improving patient comfort,to increasing the adoption of the self-injection at home.Exhibit
2 presents the factors influencing needle-free vaccine delivery technology.
Exhibit 2: Factors Driving Needle-FreeVaccine DeliveryTechnology, Global, 2014
Vaccine Delivery Market Is Ripe forTechnological Innovation
Vaccine technologies have garnered increased interest from pharmaceutical companies and biotech
companies in the last few years. Companies are not just working on newer vaccine types, but also on
platform technologies for delivery, production, and adjuvants. Live vaccines containing active viruses or
bacteria are extremely hard to deliver in resource-deprived areas because they must be properly and
continually refrigerated to keep them viable.The present mode of delivering vaccines into human tissue
locations using a needle and syringe has several limitations. Such limitations include administering
vaccines to candidates who are needle phobic, accidental needle-stick injuries, and the improper and
unsafe usage of needles that may lead to the rapid spread of infectious diseases.
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Needle-free or painless
vaccines bring about enhanced
occupational safety for
vaccinators and other health
providers, and hence can be
easily accepted, with a
possibility of becoming
essential in the future.
Developing nations face
short supply of vaccines,
which require cold storage
and extended refrigeration.
Painless or NF vaccines
may eliminate such issues,
and thus ease and speed up
vaccine supplies for the
The need for mass inoculations
of vaccines recommended by
the World Health Organization
(WHO) is critical in developing
countries. Producing new and
safer vaccines could prevent
millions of childhood deaths
caused by the use of poorly
Demand in Developed CountriesDemand in Developing Countries
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Furthermore, 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
Forms of Needle-FreeVaccine Delivery
• Jet injectors
• Micro needles
• Transdermal patches
• Oral/nasal sprays and inhalers
• Vaccine implants
• Fast-dissolving tablets
VaxxasTechnology:A Classic Example of the Future of Needle-Free Delivery
The introduction of vaccine delivery using physical targeting methods, such as liquid jet injection, gene
guns, and micro needles is used to facilitate vaccine delivery through the skin; however, the inability to
consistently and directly deliver vaccines to these cell types and the minimal cell damage caused during
administration, renders such delivery methods incapable and inefficient.This inefficiency opens new
opportunities for vaccine developers to create and commercialize a needle-free vaccine delivery system
that is not fraught with challenges.
Enchasing on this potential market opportunity is a biotechnology start-up calledVaxxas, which had its
humble beginnings in the Australian Institute for Bioengineering and Nanotechnology (AIBN), a
multi-disciplinary research institute that is an undertaking of the University of Queensland, Brisbane
(Australia). A team of researchers under the able guidance of Professor Mark Kendall have 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.This development can effectively address the issue
of vaccine refrigeration or ‘cold-chain’ supply, which can be a challenge in remote areas of developing
and underdeveloped nations with little or no infrastructure.Overall,it will eliminate needle-stick injuries
known to cause around 1.3 million deaths per year, according to statistics from the World Health
Organization.The needle-free vaccine delivery platform will also eliminate other issues such as the
elimination of pain associated with needle pricks, risk of contamination through needle pricks with
blood-borne illnesses like HIV [human-immunodeficiency virus], and also the cost of doing away with
The Nanopatch is a class of device for needle-free delivery of vaccines.It is a micro-needle patch,which
is comprised of very small and densely packed micro-projections with a defined geometry. It is capable
of directly depositing vaccine to thousands of skin immune cells, while not causing potential damage to
the cell membrane in the process.The Nanopatch device is roughly about 5 millimeters (mm) × 5 mm
in size and is made up of 1 square centimeter of solid silicon, dry-coated with antigen, adjuvant, and/or
DNA payloads that could be used for a range of indications.The surface of the patch has around 20,000
micro-projections on its surface,invisible to the naked eye and 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.
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More importantly, the use of the Nanopatch eliminates the requirement of adjuvants to boost the
immunogenicity of vaccines, which unlike traditional inoculation methods would mean a more efficient
delivery of vaccine to produce the required immunological response and better patient compliance.
Furthermore, being smaller than a postage stamp, the Nanopatch offers a host of benefits and also
achieves precise, controlled, and consistent skin penetration along with rapid dissolution and diffusion
of the vaccine.The Nanopatch also eliminates the need for refrigeration as the vaccine is formulated in
dry form and is thermostable; this makes transportation and storage significantly cheaper as compared
to traditional needles. In addition, the Nanopatch is painless and could be used for patients who are
needle phobic; it also improves patient convenience and reduces complications.
This device elicits minimal skin response through its usage and does not cause bleeding, inflammation,
or bruises; it accommodates the accurate delivery of the drug into the underlying tissue wherein the
drug dissolves and is present for action in the blood stream. Although the technique has only been
tested on rodents, the results have been very promising. Researchers have been able to identify for the
first time, a group of cells in the skin capable of detecting the type of vaccine being injected and putting
the body’s immune system on alert. Using these specialized cells, room-temperature vaccines can be
produced to create the same level of immune response as that of traditional liquid medicine stored in
a freezer. However, with the animal model testing complete with successful results, scientists will now
have to look at scaling up their production and seeking FDA approval once the clinical trials on humans
have been completed.
Several other ways of drug and vaccine delivery would include PharmaJet Stratis Needle-Free Injection
System,SeroJet,Mhi-500,cool.click,Recojet,Intraject technology,Biovalve Mini-Ject,Antares Medi-Jector
VISION, Needle-free, auto and pen injectors, MadaJet XL Needle Free Injector, BiojectZetaJet, INJEX
30 Injex needle-free injections for infiltration anesthesia, and others. Over the next five to ten years it
is estimated that a number of vaccine products will migrate to skin delivery moving away from needles
and syringes.The vaccine industry will be fundamentally changed with these newer technologies such
as needle-free injections, fast-dissolving tablets, patches, and inhalers, which will disrupt the vaccine
industry.As more companies realize the potential benefits of needle-free drug delivery, this technology
will gain its traction, both among patients and physicians, ultimately enhancing the adoption of
needle-free injectable drugs or vaccine deliveries.
Swathi Allada is the Research Analyst for the Medical Devices Healthcare business unit at Frost & Sullivan.
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