MARKET INSIGHT
Needle-Free Nanopatch SmallerThan A Fingernail
CouldThis BeThe Future Of Vaccines?
By Swathi Allada; Resear...
Frost & Sullivan | Market Insight
Frost.com
2
Vaccine Industry:A Sneak Preview
The vaccine industry has diverse profiles o...
Frost.com
3
Frost & Sullivan | Market Insight
Needle-free delivery: The drug is injected without the use of any needles an...
Frost & Sullivan | Market Insight
Frost.com
4
Furthermore, in most cases the needle does not place the vaccine doses in th...
Frost.com
5
Frost & Sullivan | Market Insight
More importantly, the use of the Nanopatch eliminates the requirement of adj...
Precious Metals Market Opportunity and
the Role of South Africa
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© 2014 Frost & Sullivan
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Needle-Free Nanopatch Smaller Than A Fingernail Could This Be The Future Of Vaccines? - Frost & Sullivan Market Insight

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Needle-Free Nanopatch Smaller Than A Fingernail Could This Be The Future Of Vaccines? - Frost & Sullivan Market Insight

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Needle-Free Nanopatch Smaller Than A Fingernail Could This Be The Future Of Vaccines? - Frost & Sullivan Market Insight

  1. 1. MARKET INSIGHT Needle-Free Nanopatch SmallerThan A Fingernail CouldThis BeThe Future Of Vaccines? By Swathi Allada; Research Analyst, Medical Devices, Healthcare Frost & Sullivan
  2. 2. Frost & Sullivan | Market Insight Frost.com 2 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. Source: Frost & Sullivan Immediate alternatives for NF vaccination are auto disable and safety syringes, which are already in use in LMICs. Prefilled syringes and reconstitution devices are emerging alternatives. 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 2020. 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 sector. Vaccine availability is expected to increase in low and middle income countries (LMICs) from 2015 to 2020, and become globalized by 2025. 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. Central Conclusion
  3. 3. Frost.com 3 Frost & Sullivan | Market Insight 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. Source: Frost & Sullivan 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 needy. 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 preserved vaccines. Demand in Developed CountriesDemand in Developing Countries
  4. 4. Frost & Sullivan | Market Insight Frost.com 4 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 responses. 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 hypodermic needles. 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.
  5. 5. Frost.com 5 Frost & Sullivan | Market Insight 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. Conclusion 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. Follow us on LinkedIn:Transform Health Twitter: @Frost_Sullivan Slidesharenet: FrostandSullivan Facebook: frostandsullivan
  6. 6. Precious Metals Market Opportunity and the Role of South Africa 6 © 2014 Frost & Sullivan Text Auckland Bahrain Bangkok Beijing Bengaluru Bogotá Buenos Aires Cape Town Chennai Colombo Delhi/NCR Detroit Frost & Sullivan, the Growth Partnership Company, works in collaboration with clients to leverage visionary innovation that addresses the global challenges and related growth opportunities that will make orbreak today’s market participants. For more than 50 years, we have been developing growth strategies for the Global 1000, emerging businesses, the public sector and the investment community. Is your organization prepared for the next profound wave of industry convergence, disruptive technologies, increasing competitive intensity, Mega Trends, breakthrough best practices, changing customer dynamics and emerging economies? Contact Us: +44 207 343 8383 • enquiries@frost.com • www.frost.com. Mumbai Moscow Oxford Paris Pune Rockville Centre San Antonio São Paulo Seoul Shanghai Shenzhen Silicon Valley Singapore Sophia Antipolis Sydney Taipei Tel Aviv Tokyo Toronto Warsaw Washington, DC Dubai Frankfurt Iskander Malaysia/Johor Bahru Istanbul Jakarta Kolkata Kuala Lumpur London Manhattan Mexico City Miami Milan

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