Drug Delivery Technologies: Nucleic Acid Delivery

Published Date: 26/06/2009
Category: Drug Delivery & Devices

Research Report Decription

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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.

Key Questions Answered:

Unique company & technology evaluation: It is vital that management information is reliable, current and insightful. Today, product and company assessment must be seen in a wider competitive and market environment.In this report we present a précis on each of the leading delivery specialists and potential new delivery platforms and have identified their key attributes, based on a number of criteria including:

• What proprietary delivery technologies are under evaluation?
• Which delivery technologies are being applied by the pharmaceutical industry?
• Who are the leading delivery specialists within the sector?
•  What are the key competitors within the delivery technology sector?
• Which products are under development or approved utilising these novel delivery technologies?

Companies Mentioned:

AlphaRx Corporation, ALZA Corporation, Antares Pharma, Biovail Corporation, Camurus AB, Cerulean Pharma,  Cipher Pharmaceuticals, Debiopharm Group, DelSite Biotechnologies, Depomed, Durect Corporation, Elan Corporation, Elite Pharmaceuticals, Endo Pharmaceuticals, Ethypharm SA, Eurand N.V., Flamel Technologies, Glycologic, KV Pharmaceuticals, Labopharm, Lavipharm SA, Nano Interface Technology, OctoPlus N.V., Penwest Pharmaceuticals, SCOLR Pharma, Shire, Skinvisible, SkyePharma, Spherics Pharmaceuticals, Watson Pharmaceuticals

Paper Highlights:

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

Drug Delivery Technologies:Players, Products & Prospects to 2018Focusing on the sectors that are driving growth

• VOLUME I - CONTROLLED- RELEASE
• VOLUME II - NANOTECHNOLOGY
• VOLUME III-NUCLEIC ACID DELIVERY
• VOLUME IV-TARGETED DELIVERY

We have established a competitor ratio analysis based on each of the criteria mentioned above. Each criterion attracts an award of up to 10 points, with a maximum score of 50, thus enabling the establishment of an Espicom “ranking table” in each segment of the market, dependent on their relative attributes.

Multi-point evaluation and scoring assessment: Pharma drugs that utilise drug delivery systems have been evaluated based on a number of parameters, including:The technology

• Comparison of delivery platforms within each area including: activated, degradation or diffusion for controlled-release systems; nano-engineered (nanocrystals, nanoparticle, nanosuspension) or nanocarriers (carbon/ceramic, dendrimer, liposome, micelle, polymeric nanoparticles) for nano-enabled delivery; viral or non-viral platforms for nucleic acid delivery and active or passive platforms for targeted delivery systems
• The application of the technology within a number of therapy areas: Route of delivery (oral, parenteral, transdermal, implantable), delivery of small molecules/macromolecules and vaccines, additional features such as bioerodible materials etc
• The current status of the technology in clinical development or following approval: Number of approved and marketed products, clinical or preclinical development candidates, single or multiple products.
• Competition within the technology arena: Alternative drug delivery systems to technologies under evaluation, advantages and disadvantages over competitors.
• The drug delivery specialist’s expertise: Number of drug delivery systems in development, strategic alliances, financial position, marketing presence.
• The product portfolio: Drug delivery systems under evaluation, products in development, commercialisation/development partnerships.
• Potential drug sales: Based on key events such as market, competition, patent expiry, time of entry into the market.