November 1, 2009 (Vol. 29, No. 19)
Bruce Carlson Publisher Kalorama Information
Patients and Healthcare Providers Should Benefit from Proliferation of Needle-Free Systems
Three-quarters of biologic drugs cannot be delivered orally, and this has forced makers of most novel drugs to think about delivery. If a protein or peptide must be injected, makers then are seeking the most patient-friendly methods, including needle-free systems. This trend has helped fuel a $2.7 billon market for pharmaceutical products combined with needle-free technology.
In its “Drug Delivery Markets: Implantable, Injectable, and Needle-Free Systems” report, Kalorama Information stated that the demand for better delivery and a recent convergence of materials and design software will propel the market for such products to nearly 10% annual growth over the next five years.
Standard needle injection creates some issues. Injuries are common, and needles must be disposed of. Also, patients don’t like being pricked by a needle. Marketers fear that this patient resistance will translate to negative feelings for their products. Using needle-free injection has been shown to mitigate all of these problems—reduce needlestick injuries, increase compliance, and eliminate the need for disposal—all advantages that will help sales.
Needle-free injection devices operate by using metal springs, compressed air, or CO2 to accelerate a small jet of liquid or powder at high speed, causing it to penetrate the skin for subcutaneous, intradermal, or intramuscular administration. Although used for mass vaccination for a number of years, these devices are currently being promoted as devices for the self-administration of parenteral drugs. The development of disposable prefilled systems should be instrumental toward achieving this.
Needle-free device makers are coming up with a number of designs for different niches in the overall needle-free injector market. There are a number of ways in which devices are classified. Some are powered by springs, others by compressed gas. Nozzle openings vary in size from less than 0.1 mm to almost 0.4 mm. Devices are also distinguished by how they are filled. Some are refilled automatically from a multidose vial, others use single doses prefilled by vaccine manufacturers.
While up-front costs on some of these systems are higher, makers are hopeful that customers will see the long-term benefits. Over time, savings can be seen from needle-free systems. An analysis showed the cost of conventional needles and syringes to be $1 million per million injections. In comparison, the cost per million of needle-free systems which used disposable cartridge jet injectors, was between $100,000 and $200,000, and disposable nozzle injectors was $42,000.
Needle-free manufacturers are hopeful that the healthcare industry will begin to recognize the cost benefits of safer devices and find ways to finance their purchase. When one looks at vaccine delivery, where a large number of inoculations are needed, per shot savings is expected to be a big selling point.
In the United States, more than a dozen needle-free jet injectors have been licensed by the FDA and are on the market. One of the more popular needle-free jet injectors is the Biojector 2000. This device is being used by over 120 office-based physicians in the U.S., according to Bioject. Currently, each manufacturer makes its own type of cartridge that holds the vaccine and is attached to the device before injection. None of these cartridges is interchangeable, which is a major limitation to their widespread use.
Vitajet, also from Bioject, is a nozzle-type delivery system, currently used to deliver subcutaneous injections of insulin. The device has three components: the reusable injection device, disposable nozzle, and disposable vial holder. The nozzle is replaced once a week. It may be used in the home for self-administration. The Vitajet 3 is powered by an internal spring, and more than 3,000 injections may be delivered from a single device.
Merck Serono’s SeroJet is a needle-free injection system for delivering Serostim recombinant human growth hormone for treatment of HIV-associated wasting in adults. PowderMed, which was acquired by Pfizer, delivers DNA-coated microscopic gold particles into the skin using pressurized helium gas. The particles penetrate the skin, activating cells that, in turn, trigger an immune response.
The Intraject system by Zogenix, a prefilled, disposable, needle-free injector, is suitable for a wide range of liquid drugs, including pharmaceuticals, therapeutic proteins, and vaccines, according to the company.
Glide Pharma’s Glide SDI, which is intended for the injection of solid doses, is composed of a pen-like actuator and cassette containing the medicine in the form of a tiny, rod-shaped solid dosage form.
Antares Pharma’s Medi-Jector Vision is a small, handheld device that uses pressure to create a microthin stream of insulin that penetrates the skin and is deposited into the subcutaneous tissue in a fraction of a second. This seventh-generation device reportedly offers the comfort of needle-free injection without compromising on convenience or ease of use. In June, the FDA approved the Tev-Tropin Tjet injector system, on which Teva and Antares collaborated.
Crossject from Crossject Medical Technology is a single-use prefilled needle-free injection targeted for subcutaneous, intramuscular, or intradermal use. There is no pressurized gas present while the injector is kept in storage, thus avoiding the difficulties of gas leakage.
The needle-free market is expanding to include a greater number of pharmaceutical and biotechnology drugs. Developers of needle-free devices understand the drawbacks and weaknesses of their technologies and seek to improve their products in order to expand the market. As more drugs are developed to be delivered by needle-free devices, the market size is expected to grow.
The price of needle-free devices is expected to erode in the coming years, which, in turn, is expected to increase sales volume, spurring revenues for the manufacturers. Increased awareness and patient acceptance is expected to play a crucial role in the market penetration of the needle-free technology.
The efficacy and safety of new devices being developed and anticipated to be launched in the coming years will determine the market acceptance. Some of the applications expected to be key to the success of needle-free technologies include vaccines, protein and peptide drugs, gene delivery, and insulin. Needle-free devices have come a long way to the present state and are playing an increasingly important role in the novel drug delivery technologies markets.
Bruce Carlson ([email protected]) is publisher at Kalorama Information. More information on this report is available at www.kaloramainformation.com.