Like all consumers, patients and healthcare providers want products that will make their lives easier, and any product that
makes administering or taking an injection easier is bound to be popular. It's no wonder, then, that the vast majority of
pharmaceutical companies are noting the advantages of prefilled syringes and scrambling to include them in their portfolios.
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.