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A new value paradigm is taking shape in the drug delivery market. Nanostructured delivery techniques will shape the future of drug delivery.
Market Drivers:
Clinical Benefits of Nanotechnology in Drug Delivery
The benets of nanotech-based drug DDS will be dramatic for both doctors and patients, providing lower drug
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Opportunities:
The Creation of New DDS Companies
The global pharmaceutical industry is increasingly relying on outsourcing innovation in every business area, from clinical trials to drug discovery. The result has been a healthy market for acquisitions of companies which have a proven technology, and this has in turn stimulated more and more venture backed start ups in the bio and pharma space. The development of nano-enabled DDS has followed this pattern, and has not been restricted to the large pharmaceutical companies. Many new companies have been launched that have developed novel methods for exploiting nanotechnologies in drug delivery, and many more are in incubation. Nano DDS companies are popping up all around the world, in Europe, the US and across Asia, for example Nanocarrier (Japan) CeramiSphere Pty Ltd (Australia) Nanovindex Ltd (UK) Aquanova (Germany) Insert Therapeutics (USA) Biophan (USA) Capsulution (Germany) Flamel Technologies (France)
Market Growth
Unlike other markets in which nanotechnology is merely projected to have an impact, nano-enabled DDS already represents a $3.39 billion market. But we are just seeing the tip of the iceberg as the technology shifts from polymer therapeutics through to truly innovative approaches enabled by our control of materials on the same scale at which nature works. By 2012 the total market for nanotechnology-enabled drug delivery will rise to $26 billion, representing a compound annual growth rate of 37% over the next ve years, and after 2012 things become really interesting, the value of these nano-enabled compounds will sky rocket, reaching $220 billion by 2015. Beyond just the economics, the use of nanoparticles will transform medical treatment, allowing practitioners to use drugs to target specic areas of the body, without side effects or concerns over toxicity since lower doses could be used, concentrating the effect where needed. The utility of nanoparticles in drug delivery to improve human health and quality of life is potentially enormous. This White Paper presents four technologies that will change the paradigm of the drug delivery market, including:
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Nanoparticles (including inorganic, polymer and solid lipid nanoparticles) Nanocrystals Polymer Therapeutics (including polymer drugs, polymer drug conjugates, polymer micelles and dendrimers) Liposomes For more detailed information please see The Nanoparticle Drug Delivery Market Report
$250,000
$200,000
US$ Millions
$150,000
$100,000
$50,000
$0 2006 2007 2008 2009 2010 2011 2012 2013 2014 2015 Year
Available Applications Of Nanoparticle In Drug Delivery 1. Acromegaly 2. Age-related macular degeneration 3. Anesthetic 4. Antibodies 5. Antiemetic 6. Antiinfectives, oncologics, cardiac drugs and others 7. Atopic dermatitis 8. B-cell Chronic Lymphocytic/Non-Cancer therapy 9. Chronic kidney disease 10. Eating disorders 11. End stage renal failure Lymphoma/Intrathecal therapy of lymphomatous meningitis 12. Febrile neutropenia 13. Fungal infections 14. Glioblastoma 15. Hepatitis A, C 16. HIV/AIDS 17. Inuenza 18. Immunodeciency syndrome 19. Immunosuppressant 20. Kaposi sarcoma 21. Hodgkins Chronic fatigue immune dysfunction (myalgic encephalomyelitis; ME) 22. Lipid regulation 23. Menopausal therapy 24. Multiple sclerosis 25. Rheumatoid arthritis and Crohns disease
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Nanoparticles
What are they?
Nanoparticles can be divided into three groups: Inorganic nanoparticles Solid lipid nanoparticles Polymer nanoparticles Inorganic nanoparticles is the generic term for several nanoparticles including for example metal oxide- and non-oxide ceramics, metals, calcium phosphate, gold, silicate and magnetic nanoparticles. So called nanoshells combine various inorganic elements or materials. They typically have a silicon core, which is sealed in an outer metallic cover. Polymer nanoparticles involve various natural or biocompatible synthetic polymers. They include rationally designed macromolecular drugs, polymerdrug and polymer-protein conjugates, polymeric micelles containing covalently bounded drugs, and polyplexes for DNA delivery. Polymer nanoparticles can be divided into nanospheres, which build a continuous polymer matrix
and can be referred as drug sponges and nanocapsules, which consist of a polymer layer enclosing a uid-lled cavity and are mimicking liposomes. Solid lipid nanoparticles combine the advantages but avoiding the disadvantages of other colloidal carriers have attracted increasing attention in recent years, and are regarded as an alternative carrier system to traditional colloidal systems, such as emulsions, liposomes and polymeric microparticles and nanoparticles.
How are they applied to drug delivery?
Nanoparticles are widely used in drug delivery where they can increase drug solubility and, additionally, can lead to controlled release and/or drug targeting. They are used in anti-cancer treatment, genedelivery, asthma inhalers, hormone delivery through the skin, drug delivery through the eye and in oral and vaccine delivery systems. A lot of companies employ nanoparticles in anti-cancer treatment.
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Nanocrystals
What are they?
Increasing the active surface area is the key to many applications of nanotechnologies, from improving automotive and industrial catalysts to improving the uptake of poorly soluble drugs in the human body. Nanocrystals are ground in special mills and the resulting drugs can be applied intravenously as nanosuspensions or bronchially through an inhaler. This small size enhances the surface/volume-ratio and bioavailability of almost insoluble pharmaceuticals. drug substance using a proprietary, wet-milling technique. The resulting particles of the drug are stabilized against agglomeration by surface adsorption of selected GRAS (Generally Regarded As Safe) stabilizers. The result is an aqueous dispersion of the drug substance that behaves like a solution, which can be processed into nished dosage forms for all routes of administration. The size of the particles allows for safe and effective passage through capillaries. NanoCrystal technology represents both an enabling technology for evaluating new chemical entities that exhibit poor water solubility and also a valuable tool for optimizing the performance of established drugs. NanoCrystal technology is of particular benet for drugs with poor solubility in water. The process is also useful for moderately soluble drugs when a high concentration of drug in a low volume of uid is desired.
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Polymer Therapeutics
What is it?
Polymer therapeutics differ from particle shaped drug delivery systems in their dimensions. They are molecular units with diameters of a few nanometres and can be subdivided into four groups: Polymer drugs Polymer drug conjugates Polymer micelles Dendrimers Early designs for a polymer therapeutic system involved attaching a water-soluble polymer to a drug through a selected linker molecule. Trapping low molecular weight drugs as polymer conjugates not only temporarily inactivates the drug, but also restricts their uptake by cells to endocytosis (the process whereby cells absorb material such as proteins from the outside by engulng it with their cell membrane). As high molecular weight macromolecules of the drugs are unable to diffuse passively into cells, they are 'engulfed' as membrane-encircled sacs called vesicles, in which intracellular enzymes then set to work to release the drug. This means that the polymer-drug conjugate should be able to circulate longer in the body, potentially without the toxic side-effects associated with many drugs. With the appropriate biodegradable linker, and/or a cell-specic targeting group, it should be possible to deliver the drug direct to the target site.
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Liposomes
What are they?
Liposomes are small spheres that have a lipid layer that surrounds an active pharmaceutical ingredient. Their basic components are amphiphilic molecules, which spontaneously form liposomes in aqueous ambiance. Hydrophilic ends of the globular bilayers point to the waterside, hydrophobic ends are oriented bilateral to the centre of the layer.
the membrane) they can be (indiscriminately) delivered past the lipid bilayer. Liposomes can also be designed to deliver drugs in other ways. Liposomes that contain low (or high) pH can be constructed such that dissolved aqueous drugs will be charged in solution. As the pH naturally neutralizes within the liposome the drug will also be neutralized, allowing it to freely pass through a membrane. Another strategy for liposome drug delivery is to target endocytosis events. Liposomes can be made in a particular size range that makes them viable targets for natural macrophage phagocytosis. These liposomes may be digested while in the magrophage's phagosome, thus releasing its drug. Liposomes can also be decorated with opsonins and ligands to activate endocytosis in other cell types.
Because a liposome can encapsulate an aqueous solution with a hydrophobic outer membrane, hydrophilic solutes cannot pass through the lipids. So, lipsomes can carry both hydrophobic molecules (its outer membrane) and hydrophilic molecules (the inner aqueous core). The liposome delivers its contents to the appropriate site by having its lipid bilayer fuse with bilayers of the cell membrane. By making liposomes in a solution of DNA or drugs (which would normally be unable to diffuse through
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EXPANDING GOVERNMENTAL FUNDING DRIVES THE NANOBIOTECHNOLOGY MARKET. 59 HOW DRUG COMPANIES ARE REACTING TO THIS EXPANSION. 60 FUTURE BARRIERS AND CHALLENGES...................... 62 BIG PHARMACEUTICAL COMPANIES RELUCTANT TO INVEST IN UNTRIED TECHNOLOGIES. 62 LACK OF REGULATORY CASE LAW. 62 LONG ADMISSION PROCEDURES INCLUDING FOR EXAMPLE SEVERAL CLINICAL TRIALS. 63 A NEED FOR RAPID SCREENING METHODS. 63 SCALABILITY OF NANOPARTICLE PRODUCTION. 63 AN URGENT NEED FOR ANALYTICAL METHODS. 63 A NEED FOR THE INVESTIGATION OF FURTHER NANOPARTICLES.63 THE POTENTIAL TOXICITY OF ENGINEERED NANOPARTICLES IS AN UNSOLVED ISSUE AND STILL NEEDS TO BE DEALT WITH. 64 THE FUTURE OF NANO AND BIO COLLABORATIONS IS PROMISING. 67 NANOPARTICLE ADDED VALUE IN DRUG DELIVERY.......................................................................................... 69 CASE STUDY -- UNIVERSITY OF MICHIGANS NANOPARTICLE-BASED PAIN RELIEF STUDY FOR MILITARY BATTLEFIELD USE. 69 CASE STUDY -- ACUSPHERES HYDROPHOBIC DRUG DELIVERY SYSTEM (HDDS) FOR REFORMULATION OF HYDROPHOBIC DRUGS. 70 CASE STUDY -- IMARXS HYDROPLEX PLATFORM FOR DELIVERING HYDROPHOBIC DRUGS. 72 CASE STUDY ALPHARXS NANOPARTICLE DRUG DELIVERY PLATFORM FOR ANTIBIOTIC DRUGS. 75 CASE STUDY CYTRXS RNAI NANOPARTICLE DELIVERY TECHNOLOGY FOR RNAI THERAPEUTICS. 76 INVESTING IN NANOPARTCLE-ENABLED DRUG DELIVERY INDUSTRY........................................................ 78 CASE STUDY NANOTHERAPEUTICS COMMERCIALISATION STRATEGY. 78 Business Summary.78 Technology Core Competency. 78 Commercialisation Strategy.78 Available Market.79 CASE STUDY HOW CAN NANOVINDEXS NANOPARTICLE HYDROGEL COMPOSITES ADD VALUE FOR DRUG DELIVERY INVESTORS. 79 Business Summary.79 Technology Core Competency. 79 How Nanoparticles Add Value For Investors In Drug Delivery Company.79 Comercialization Strategy. 80 Available Market.80 CASE STUDY -- KEYSTONE NANOS MOLECULAR DOTS (MDS) COMMERCIALISATION STRATEGY. 80 Business Summary.80 Technology Core Competency. 80 How Nanoparticles Add Value For Investors In Drug Delivery Company.80 Commercialisation Strategy.81 Available Market.81
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Ordering Information
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Nanotech Revolution in Drug Delivery This new white paper analyses the impact of nanoparticles on the drug delivery market by focusing on ve groups of nanoparticles that are projected to capture a majority of the market. www.cientica.com
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