Published Date: 12/09/2011
Category: Drug Delivery & Devices
Lipid-based delivery technologies: Many new chemical entities are poorly water soluble which may affect a drug’s bioavailability and efficacy. Advanced drug delivery systems using biocompatible lipid-based technologies can be used to improve solubility, increase bioavailability (enhance absorption) and efficacy, helping to reduce the level of drug dosage and decrease the incidence and severity of adverse effects.
To date more than a dozen products have been approved that utilise some of the first generation lipid-based technologies, pioneered by Elan Pharmaceuticals, Enzon, Gilead Pharmaceuticals, ALZA (acquired by Johnson & Johnson), Skye Pharma, and The Liposome Company (acquired by Elan Pharmaceuticals). These products encompass anaesthetics, antiinfectives and oncology agents and together generate over US$1.85 billion in sales annually.
Research activity is intensive and the top 20 drug delivery specialists are currently investigating more than 75 products in preclinical and clinical development; over half of these products (c.46 products) are likely to reach the market by 2020 to generate global sales in excess of US$2.6 billion by 2020.Polymer-based delivery technologies: The pharmaceutical industry has been utilising advanced polymer-based delivery technologies to improve the pharmacokinetics and targeted delivery of small and large molecule drugs. To date more than two dozen products have been approved that utilise PEGylation technologies developed by some of the industry pioneers, such as ALZA, Endo Pharmaceuticals and Nektar Therapeutics. In addition, several specialists have developed controlled-release polymer matrix to prolong the release of active pharmaceutical ingredients in situ with technologies developed by Debiopharm Group and Durect.
By 2020 we forecast that nearly 60 novel polymer-based products could reach the market to generate global sales in excess of US$5 billion through improved pharmacokinetics of approved and new compounds, as well as the emergence of novel biologics, nucleic acid based medicines and small molecule agents.Biovectors: During the last twenty years there have been significant advances in the manufacture, development and delivery of gene therapies, RNA therapies and vaccines. No single biovector stands out for each field and many different development strategies have been adopted to optimise delivery. Gene-related medicines have achieved limited success to date - no gene therapies have been approved and only a few antisense drugs have carved out a therapeutic niche in ocular diseases (Vitravene; CMV, Macugen; wet AMD). However, R&D investment for gene related products continues to grow at a fast rate and this highlights the challenges and opportunities which face developers, delivery technologists and regulators in this field.
In contrast, interest in the vaccine market has rocketed fuelled by biodefence programmes and the outbreak of avian influenza as well as advances in vaccine production technologies which has lowered the barrier to entry for the smaller players. Whilst infectious diseases, particularly influenza and HIV, remain a major area of interest, therapeutic vaccines are emerging to gain a share of the marketplace.
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AlphaRx Corporation, Access Pharmaceuticals, Alkermes, Alnylam Pharmaceuticals, Aphios Corporation, Aradigm Corporation, Ark Therapeutics, Axentis Pharma AG, Azaya Therapeutics, BioDelivery Sciences International, Bio-Path Holdings, BTG International, Calando Pharmaceuticals, Camurus AB, Celsion Corporation, Ceregene, Clavis Pharma ASA, Cornerstone Pharmaceuticals, Crucell N.V, CureVac GmbH, Debiopharm Group, Durect Corporation, Endo Pharmaceuticals, Enzon Pharmaceuticals, Expression Genetics, GlobeImmune, Ichor Medical Systems, Inovio Pharmaceuticals, Insys Therapeutics, Juvaris BioTherapeutics, Labopharm, Latitude Pharmaceuticals, Lipocine, Lipotek Pty, Marina Biotech, Merrimack Pharmaceuticals, Mersana Therapeutics, Mountain View Pharmaceuticals, NanoBio Corporation, Nanocarrier, Nektar Therapeutics, Neurologix, Novagali Pharma SA, OctoPlus N.V., Oxford BioMedica, Samyang Pharmaceuticals, Santaris Pharma A/S, Silence Therapeutics, Supratek Pharma, SurModics, Taiwan Liposome Company, Talon Therapeutics, Teikoku Pharma USA, Tekmira Pharmaceutical Corporation, Vica, VIRxSys