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The market for self-injection devices is growing at above-average rates, fueled by the continuing demand for pen systems for insulin and other cartridge-based therapies, and by the adoption of easier-to-use and more-convenient autoinjector systems for delivering monodose therapies.
While the first wave of biotechnology drugs used in pen injectors were hormone-replacement therapies such as insulin and human growth hormone, newer monodose therapies, such as those for the treatment of autoimmune diseases, are driving interest in prefilled and safety syringes, and autoinjectors.
Pens are essentially sophisticated syringes for accurate and safe dosing and multiple injections from a cartridge. Designed for use with prefilled syringes, autoinjectors automatically insert the needle and perform the injection. Fully disposable autoinjectors provide additional convenience. In these systems, the prefilled syringe is packaged into the autoinjector, requiring that the patient only remove the needle cap and inject.
Pen- and cartridge-based systems and autoinjection devices are being employed in more self-injection therapies. The multivariable dose Puregon/Follistim pen from Organon is used in home delivery of therapies such as infertility drugs. BD Medical-Pharmaceutical Systems (Franklin Lakes, NJ) makes the pen, which uses the BD Ultrafine Original Pen Needle. “We are presently doing next-generation development on the self-injection device platform,” says Michael Ratigan, worldwide business platform leader for self-injection, BD Medical.
“Traditionally, pen and cartridge systems have been used for self-injection of insulin. Their use has expanded to include follicle-stimulating hormones and the hepatitis C market,” he says.
“There seems to be an initial shift from the clinical setting to the home healthcare setting in the areas of rheumatoid arthritis, multiple sclerosis, and epogen for cancer and anemia therapies,” he adds.
Amgen (Thousand Oaks, CA) this year launched the first fully disposable autoinjector pen for a therapeutic protein. The Aranesp SureClick delivers Aranesp (darbepoetin alfa) for anemia treatment.
For improved safety in reusable autoinjector devices, Ypsomed has teamed with Safety Syringes Inc. to incorporate that firm’s Ultra Safe Passive Delivery system. “We are seeing real interest, particularly for therapy in the hospital and in the home, where patients say they don’t necessarily require a fully disposable autoinjector,” says Ian Thompson, manager of business development, Ypsomed (Burgdorf, Switzerland).
Thompson says there is a “scale of convenience” among self-injection devices. “A simple prefilled syringe can bring much greater convenience to an injection therapy, such as in Abbott’s launch of Humira, a prefilled syringe for rheumatoid arthritis treatment. However, autoinjectors in combination with the prefilled syringes bring an additional ease of use and safety, with the fully disposable autoinjector being the gold standard for infrequent injections performed at home,” he says.
For pen delivery of insulin, Sanofi-Aventis announced FDA approval of Apidra (insulin glulisine [rDNA origin] injection) cartridges for its OptiClik reusable pen.
Despite the interest in expanding pen and autoinjection pen delivery for biodrugs, insulin continues to dominate the market for self-injection devices. “The development of next-generation pens is being driven by competition in the insulin market,” says Thompson.
Advancing technology in insulin-injection systems and the imminent availability of needleless insulin delivery promise new levels of patient convenience in the treatment of diabetes. As industry waits to see how patients and physicians will accept the new treatment Pfizer is offering with Exubera, market analysts’ sales estimates for the product have varied considerably.
Says one industry source: “The forecasts for inhaled insulin are mixed. It is not going to grab a large percentage of the market right away. The efficacy of inhaled insulin is significantly lower than injected insulin. You have to take more of it to get the same effect.”