Abstract
The nucleic acid delivery market is maturing with over 1,450 clinical trials
underway worldwide. The majority of these are in early clinical development
(approximately 60%) with just over 3% in Phase III trials. Our analysis
indicates that up to 35 novel nucleic acid products could reach the market
within our forecasting period (2008-2018). However the harsh economic
environment may force companies to place promising drugs on hold as they focus
on lead projects rather than multiple programmes. To date, only a handful of
nucleic acid-based products have been approved for human prescription and
these products rely on delivery technologies in one shape or form. We
estimate the nucleic acid market was worth just over US$80 million globally in
2008.
By 2018 we anticipate the nucleic acid technology market will have matured as
many of the late-stage clinical programmes come to fruition and drug delivery
companies continue to overcome issues surrounding its safety and efficiency.
The development of nucleic acid delivery systems will help to improve
specificity whilst the development of novel polymers and lipopolymer complexes
will help to carry larger DNA payloads in order to target cells and make
multigene targeting a reality. We forecast that nucleic acid products in
development from 11 key companies could generate additional sales of nearly
US$2.3 billion by 2018. These products utilise a range of delivery platforms
including viral to non-viral delivery systems, and cover gene therapies, gene
agents and DNA vaccines for a variety of targets including cancer,
cardiovascular and infectious diseases.
Catalysts for change
Improvements in our understanding into the underlying genetic causes of
disease as well as the uptake of new mechanisms of modulating DNA such as RNA
interference which will help to fuel market growth. The development of a new
generation of DNA vaccines that will provoke strong immunogenic responses and
will help to determine whether this has been a sound investment for the pharma
industry. Launch of the first siRNA-based therapeutics (although progress has
been dampened following the recent termination of Opko Health' s leading eye
treatment at the Phase III development stage). We anticipate companies will
pursue other conditions such as infectious diseases and cancer where robust
preclinical studies have already been performed and where drug delivery
platforms have been adopted rather than the use of naked siRNAs.
This report is part of a major new 4-volume strategic analysis
- VOLUME I CONTROLLED- RELEASE
- VOLUME II NANOTECHNOLOGY
- VOLUME III NUCLEIC ACID DELIVERY
- VOLUME IV TARGETED DELIVERY
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