Many pharmaceutical and biotech companies are having to deal with increasingly more potent, selective and complex molecules than they have in the past. For example, it has been estimated that around 38 of the top 100 products are peptide and protein-based (1). This situation is likely to continue in the future as advances in biotechnology along with the application of new discovery technologies, have led to a large increase in the number of macromolecule drugs over the last several years. Due to their large size and complex biopharmaceutical properties, macromolecules have typically been administered by painful injections, which are unpopular with patients; therefore a number of alternative routes of administration are being developed by drug delivery companies to avoid these problems. The novelty of these molecules being developed by biotech and pharmaceutical companies, as a result of new discovery platform technologies, is likely to be a driver of the use of drug delivery systems over the next ten years.
A number of different technologies fall within the scope of drug delivery and consequently this has led to different estimates of the global market size. A widely quoted estimate states that around 13% of the global pharmaceutical market is accounted for by sales of products incorporating a drug delivery system (2, 3). Novel technologies
A typical problem facing companies when developing drugs is that active substances have poor membrane partitioning and are subject to extensive first-pass metabolism. A number of technologies are being developed to circumvent these problems, often by dedicated technology companies, but their overall success has been limited (2). Until a range of efficient and acceptable alternatives to oral delivery can be offered, the outlook for active substances exhibiting poor oral bioavailability during the R&D process will be bleak and such projects will be superceded by those involving compounds with a greater certainty of getting to market.
An area where impressive advances have been made is in the field of pulmonary delivery technology (2). Furthermore, there appears to be good market acceptance of such inhalation technologies, particularly in the treatment of pulmonary diseases. However, most of the success in this area has been with locally acting drugs. The inhalation route is still in its infancy regarding the delivery of drugs that will have a systemic effect, although research is being carried out using inhalation technology to deliver insulin. The outcome of this work will have an important impact on the future development of similar technologies aimed at providing systemic efficacy.
Although various alternatives are in development, oral delivery is still considered more preferable than other routes of drug administration. This is apparent from looking at the relative distribution of sales of the different routes of drug delivery being utilised in the marketplace. Compared with the major market share due to products delivered by the oral route, technologies using implants, or employing transdermal and topical routes, account for a minority of sales. This clearly indicates that not all technologies can be given the same weight during the R&D process, as the likely market penetration of any subsequent product must be considered.
Oral administration clearly remains the preferred option of the consumer, and hence the pharmaceutical industry. If the market preference for oral delivery does not change, major advances will need to be made to address the currently limitations in oral bioavailability. Life cycle management and pricing
There has been a growing trend to use drug delivery technologies to extend the life-cycles of existing products rather than incorporating them into the development of novel compounds. A survey of large pharmaceutical companies carried out in 2000 revealed that only 40% of the surveyed projects incorporating drug delivery systems were specifically focused on novel compounds (2). A major reason cited by the participants for this trend was the desire to minimise risk during the R&D process. It was considered a safer option is to apply the drug delivery system to a molecule that is already on the market, and thus has already negotiated the major hurdles of the drug development process.
Although new formulations of existing drugs often present opportunities to produce second generation drugs with improved adverse event profiles (as well as other benefits), it is often difficult to conclusively demonstrate these improvements to consumers and thus justify high prices. Indeed, a first generation product is extremely unlikely to show major adverse effects as this would limit its success in the market.
Cost-benefit improvements over an existing product may also need to be attached to the second generation product in order to encourage patients to pay a premium for a new product. Convenience alone is unlikely to be enough to convince people that a high price is justified. Furthermore, many governments are implementing cost containment strategies to slow healthcare spending, and targeting drug expenditure is one means to achieve this. Outlook
For the moment, drug delivery technologies will continue to be preferentially applied to the sustained development of existing products. However, even applying the delivery technology to products already on the market will create problems when it comes to pricing. Companies will need to factor in these concerns when attempting to recoup their original R&D expenses.
An immense amount of technology is available for the delivery of drugs, but as yet its impact on the global market has been limited. There is no doubt that drug delivery technologies are playing an increasingly important role in medicine, but the rapidity of their uptake in R&D will be decided by those who have the confidence to let them play a leading role in new drug development rather than a supporting role. References
- Greener M. (2000). A Tour Round Drug Delivery. Pharmalicencing.com.
- Kermani F and Findlay G (2000). The Application of Drug Delivery Systems: Current Practices and Future Strategies. CMR International.
- K. Jain (2000). Drug Delivery Technology & Markets. Urch Publishing.
Dr Faiz Kermani has several years experience in both academia and the pharmaceutical industry. He has worked in pharmaceutical R&D, pricing and reimbursement, marketing and medical communications. He holds a PhD in Immunopharmacology from St. Thomas’ Hospital, London and a First Class Honours degree in Pharmacology with Toxicology from King’s College, London. He has written extensively on international healthcare issues, and is on the editorial board of a number of publications. In March 2006, he was a delegate on the UK Government’s Trade and Investment Biotech Scoping Mission to China and was a speaker at the subsequent presentation.
You can contact Dr Kermani via firstname.lastname@example.org