Needle-free injections finally become a reality
Is controlled release to become obsolete?
The market demand for non-invasive drug delivery has finally been met, with the launch January 10th 2001 of Bioject's ‘cool.click' formulation of Saizen (rh somatropin). This needle-free delivery system of Ares-Serono's growth hormone is entering a market with high demand and challenge products that are injected using traditional needles. The Canadian launch follows a roll out in the US in late 2000 and cool.click Saizen is expected to be launched in further markets soon.
However, if needle-free systems prove to offer the promised advantages of reduced pain and increased patient compliance, will anyone use needle-delivered controlled release formulations?
Datamonitor's new report, Drug Delivery: A Key Company and Market Analysis, reveals:
- Cool.click Saizen marks the end of promises and the start of actual results for needle free drug delivery
- Reduce pain, increased compliance: why would anyone want to inject even a controlled release formulation?
Companies focused on injectable drug delivery have been pursuing two different development strategies: either improving bioactivity in the body or delivering a therapeutic dose without traditional needles. Bioject's cool.click system uses spring powered compression to force a high pressure liquid jet through the skin. This offers significant safety benefits compared to penetrating the skin with a needle and reduces patients' apprehension of pain, leading to increased patient compliance.
Bioject's first approved product is a formulation of Ares-Serono's growth hormone, Saizen (rh somatropin), which received US approval in June 2000 and Canadian approval on January 10 2001. Growth hormones are a friendly market for launching needle-free delivery, as the majority of indications are pediatric and need long term dosing. Parents are often deeply reluctant to commit their children to the trauma of regular injections and, with the need for long term daily dosing, this is compounded. Therefore, a needle-free formulation could prove more popular. However, although the theory has been heavily marketed, commercial success may prove trickier. Safety benefits are obvious, but the reduction in pain may be more hoped for than real, and the system is physically bulky and priced at a premium compared to more traditional injections.
Regardless of the long term outcome of needle-free delivery, for the next few years a large number of products that have previously been administered using a needle are due to move from development onto the market. For example, PowderJect's Lidocaine (lidocaine) anesthetic, a needle free injection, is in phase III trials. Such launches will drive sales of this drug delivery market and will ensure it remains a high profile arena.
Reduced pain, increased compliance: why would anyone want to inject even a controlled release formulation?
Drug delivery companies specializing in injectable formulations not only develop needle-free delivery but are also developing and marketing products with extended and controlled bioactivity but delivered using a traditional injection. By focusing on improving bioactivity in the body, companies like Takeda have developed long acting or controlled release formulations of marketed products as a means to guard against patent loss or to differentiate a product from otherwise similar competitors. For example TAP's LupronDepot (leuprolide acetate), indicated for prostate cancer, employed a formulation which requires injection on a 16 week cycle as a way of overcoming increasing competition from AstraZeneca's Zoladex (goserelin).
While such long treatment cycles represent a significant benefit for controlled release injectable delivery, the advantage of once-daily controlled release insulin, for example, compared to the standard three injections per day, is increasingly under threat from needle-free formulations. Controlled release formulations are still delivered using a traditional syringe. This exposes patients to the safety and pain issues that lead to compliance problems with injected drugs. Needle-free delivery promises a way to reduce the pain of drug administration, with far greater safety. If the common problems associated with multiple injections are removed, how are controlled release formulations going to compete in a future in which patients can avoid having an injection all together?
Datamonitor expects that, in the future, controlled release and needle-free delivery will converge as demand for long acting and depot formulations coincides with an awareness that using needles to inject drugs is not the only available option. However, as depot formulations have been developed simply to avoid frequent injections the possibility emerges that needle free delivery might render long acting formulations redundant in the future. A controlled release formulation delivered using needle-free technology really would hold a strong market position.
Datamonitor Analyst Oliver Sexton comments "Controlled release, needle-free delivery really would be a stab in the back for competing products."
For further information on this press release, please contact Elisabeth Overend-Freeman at efreeman@datamonitor.com .
Drug Delivery: A Key Company and Market Analysis
is available from Datamonitor, priced at $5,800. Datamonitor is an independent market analysis firm that publishes a wide portfolio of strategic business information. Datamonitor has expertise in the following industry sectors: Automotive & Transport; Consumer; Financial Services; Healthcare; Industrial; Medical Devices; Technology. Datamonitor can be contacted at 212-686-7400, or visit www.datamonitor.com.Source: Datamonitor
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