Prefilled syringes are not a new technology by any means. They debuted during World War II to accommodate the need for on-the-spot, sterile medications in battlefield hospitals. The next big push into the market came when Becton Dickinson and Company (BD, Franklin Lakes, NJ) began supplying glass prefillable syringes to support Dr. Jonas Salks' poliomyelitis vaccination program in the early 1950s. Prefilled syringes continued to be used mostly for delivering insulin or human growth hormone. In the past five years, however, they have really come into their own, becoming not just a desirable product but almost a required product for parenteral makers to offer.
"If you're going to launch a new product with an already competitive indication, it should be filled in a prefilled syringe for success on the market," says Jörg Zimmermann, head of production at Vetter Pharma-Fertigung GmbH & Co. "Most innovative new products, if they're liquid, are going to be in a syringe, when appropriate."The numbers attest to this: a study conducted by BD and IMS Health shows that the market for prefilled syringes is expected to grow by 12.8% per year. In 2006, about 1.4 billion prefilled syringes were sold, and by 2010 the quantity is expected to top 2.4 billion.
Changes drive increasing interest
The sudden and intense interest in prefilled syringes can be attributed to several changes in the industry.
Ease of use. The market has seen an increase in the number of biotechnology therapies and drug candidates that can only be administered by injection. These new treatments target a wide range of areas such as multiple sclerosis, fertility, osteoperosis, hepatitis, rheumatoid arthritis, cancer, anemia, and hemophilia.
Some biotech-based drugs require frequent injections to be administered by the patients themselves, and it's these patients, according to Michael N. Eakins, principal consultant with Eakins & Associates (West Windsor, NJ), who stand to benefit the most from the ease of use a prefilled syringe offers.
"A prefilled syringe takes out a series of operations, which makes it quicker and easier," notes Eakins. "It's a great advantage from the patient point of view in ease, safety, and training to have a dose all ready to go in a prefilled syringe."
It's patients who are the true driving force behind the demand for prefilled syringes. Measuring out a dose from a vial into a syringe may be time-consuming and pose a risk for error for those with little training. Moreover, diseases such as rheumatoid arthritis often make it difficult or even impossible for patients to hold a vial and withdraw an accurate dose. Pharmaceutical products that started out as a lyophilized formulations have been changed to liquid formulations to be packaged in prefilled syringes. Berlex's (Wayne, NJ) "Betaseron" multiple sclerosis treatment, and the human growth hormones "Norditropin" (Novo Nordisk, Princeton, NJ), and "Nutropin" (Genentech, San Francisco, CA) all have been reformulated from lyophilized to liquid and are now offered in prefilled syringes.
Ease of manufacture. Syringe component suppliers have stepped up to meet the rising demand in ready-to-use units. Stelmi's (Paris, France) ready-to-use plungers and BD's "Hypak SCF" prefillable syringes eliminate the need for washing, depyrogenation, and sterilization at the filling site. Ready-to-use components are washed, EtO or gamma sterilized, and validated for direct use.