It may not match the proportions of the burgeoning market for oral products, but a new study by Frost & Sullivan (http://www.pharma.frost.com) pegs the growth rate in the European advanced injectable product market at between 10 per cent and 15 per cent in 2001, making it the fastest growing segment of the total drug delivery market.
The international marketing consulting company values the global market for advanced injectable products at around $3.8 million, poised to speed past the $7 billion mark in 2006.
The growing incidence of cancer and other chronic disorders has shifted attention to the compassionate use of medication and the improvement of patients'' quality-of-life issues. Patients should be made as comfortable as possible by relieving pain and other distressing symptoms through the applica-tion of gentle and safe treatment methods.
"Despite consistent inroads into alternative delivery routes, patients still have to deal with the pain and inconvenience of intramuscular injections of drugs which are not administered in any other form. Traditional injectables are often associated with poor compliance, short-term efficacy, a higher degree of adverse side effects and significant costs due to frequent dosing," reports Stephanie Maclean, Research Analyst at Frost & Sullivan.
"A glut of drug companies'' anti-cancer agents and biotechnology drugs can only be given through the needle-based channel. Market participants have seized the opportunity to use advanced delivery techniques in order to augment these drugs'' patient-friendliness. Moreover, pegylated technology is a particularly effective method of providing proteins. This delivery technique is being applied to a number of compounds, particularly in the area of oncology," Ms Maclean continues.
There are at least 400 genetically engineered drugs in development, which can only be delivered via injection at present. In an effort to improve the delivery of their existing products or new chemical entities, Frost & Sullivan believes that a rising number of biotechnology and pharmaceutical companies will embark on collaborative projects with drug delivery companies.
Several impending patent expiries will prompt the big pharma and biotech companies to forge strategic alliance with drug delivery companies to clinch a bigger slice of the overall injectable drug delivery market.
Concentrated research into the development of novel technologies in the injectable drug delivery domain has ushered in a new generation of systems, especially in the liposomal/lipid based and sustained release sector. "Until now, the application of delivery systems has been restricted to a limited number of therapeutic compounds. The initial burst release associated with many of the older depots has been avoided or significantly reduced following the development of advanced technologies," the author remarks.
Profitability in the injectable drug delivery industry is being vigorously sustained by limited competition from alternative delivery routes. "Physicians are familiar with using injectables and are likely to be sceptical of the efficacy of certain drugs if given orally or by inhalation. Oral and inhaleable delivery of proteins, such as insulin, have encountered a number of set-backs, including concerns over safety. It is unlikely that oral insulin will appear on the European marketplace during this decade," the study cautions.
Some injectable products incorporating advanced delivery systems are not maximising their full sales potential due to rising healthcare costs and limited clinical data. Consequently, the study adds, many physicians still favour conventional therapies.
The high cost of many advanced injectables is slowing uptake of the technology. Products utilising second generation injectable delivery systems tend to be more expensive due to the costs associated with the manufacturing processes, R&D expenses, improved efficacy and safety profiles over competing products, marketing costs, as well as milestone and royalty payments. Furthermore, physicians are becoming increasingly aware of the need to adhere to their budgets and are often reluctant to prescribe expensive medicines.
There are approximately 14 drug delivery companies operating in this market. The majority of these companies are involved in sustained release injectable delivery and tend to offer multiple technology platforms, such as Atrix Laboratories. However, a new wave of drug delivery companies focused on sustained injectable delivery of proteins and poorly soluble drugs, including MacroMed and Infimed Therapeutics, have become more prominent.
Sustained Release injectable technologies are the most established form of injectable drug delivery and consequently boast the most bustling marketplace with key players such as Alkermes and Atrix Laboratories.
Most of the companies are US-based, with the exception of Debio Research Pharma and Ethypharm. Competition in the area of sustained injectable delivery is set to intensify due to an influx of new companies such as MacroMed, which specialise in emerging sustained release delivery systems. This is expected to give rise to a stream of new business partnerships with the major pharma and biotech giants.