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Delivery Mechanisms for Large Molecule Drugs: Successes and Failures of Leading Technologies and Key Drivers for Market Success
Business Insights, Jan 2009, Pages: 138
Emerging drug delivery technologies aim to improve measures of safety, efficacy, convenience and compliance in both new and existing drug candidates and products. For currently marketed products, reformulations with new delivery technologies will extend the period of patent protection. New formulas will be key to boosting sales volume of large molecule products in chronic diseases where patient compliance surrounding dosing strategies and ease of administration are limitations on market growth. In R&D pipelines, novel applications of delivery technologies will expose new methods to reformulate failed or discontinued drugs and mask their unfavourable effects, expanding the market of potential drug candidates.
‘Delivery Mechanisms for Large Molecule Drugs’ is a report published by Business Insights that examines the future of the drug delivery technologies market, and the short, mid, and long-term growth dynamics which will underpin investment decisions. This report will measure the performance of leading drug delivery technologies applied within clinical R&D pipelines and identify when specific therapy area populations are set to benefit from emerging innovations. The market success of new technologies is forecast by their ability to fulfil unmet medical need, the maturity of the technology in clinical application, and the level of commercial interest and investment landscape.
Key Findings
Nanotechnology will have the greatest impact on the drug delivery market. However, the immaturity of the technology is likely to delay marketed presence over the next 7-10 years.
Antibody fragmentation and PEGylation technologies are the leading targeted large molecule particle engineering formulas with marketed drug product presence. However, antibody fragments have suffered 33 candidate failures compared with 12 PEGylated products.
Active transdermal technologies have generated the greatest number of technologies and devices amongst large molecule delivery innovations, with 16 clinical and 8 preclinical drug/device combination products and 49 stand-alone devices.
Electronic delivery is set to have the greatest impact upon the device industry. Electronic device control is more advanced within the field of pulmonary delivery than transdermal delivery, with the average pulmonary-based product in early clinical phase I compared to late-stage preclinical investigation for transdermal. There are, however, 25 transmembrane electroporation technologies currently being developed, in comparison to 12 for electronic active pulmonary delivery.
Use this report to...
- Understand the drivers of new delivery platform developments with this report’s analysis of therapy area growth drivers, clinical development spend and unmet clinical need.
- Identify the risks and opportunities associated with emerging delivery technologies by measuring the risk potential and maturity of innovative platforms.
- Evaluate the latest developments in systemic targeting technologies by using this report’s analysis of innovations and pipeline progress for the latest active and passive targeting techniques.
- Discover which technologies have the greatest potential within large molecule product markets in the future with this report’s comparative analysis of growth metrics for leading platforms and an evaluation of their established clinical drug application.
- Assess recent innovations in pulmonary delivery technologies and needle-free transdermal delivery with this report’s analysis of clinical and preclinical developments and commercial potential.
Explore issues including...
-High failure rates for new technologies. The high failure rates of drugs to which pioneering delivery techniques have been applied have made investors cautious. Unknown clinical safety and efficacy profiles have made it harder to determine appropriate parameters for success in clinical application.
-Immaturity of technologies. Many of the technology platforms profiled in this report are in the early stages of application to clinical drug candidates. Those that have achieved success in marketed drug candidates already have ‘next generation’ alternatives in technology pipelines.
-Unknown clinical pharmacokinetics. Many of these platforms remain in such an immature stage that they have yet to be applied to drug candidates. In vivo experimental use in drug candidates can never accurately predict success once a technology has reached maturity. Even for those technologies with established use in R&D pipelines, long-term clinical efficacy remains unknown.
-Regulation of the new technologies. While the clinical performance of new particle engineered drug molecules or active delivery devices remain unknown, regulatory bodies only have existing data-measure demands on which to benchmark their expectations. This framework will be shifted in line with emerging clinical performance datasets.
Discover...
- Which delivery technologies will have the greatest impact on the large molecule market in the short, mid, and long-term?
- How mature are the different delivery technologies and what is their pipeline presence in terms of application to R&D drugs?
- Will particle engineering technologies drive injectable formulas to dominate the market?
- Which therapy areas will benefit most from growth in the different technologies?
- How can the risk-profiles associated with clinical use be most effectively minimized?
- What are the leading novel platforms?
- Who are the targets for out-licensing and co-development of platforms for clinical use?
- What are the leading technology platforms within different classifications and how have they achieved their growth?
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