Safety Syringe Market

More than 1.3 million people die each year from unsafe injection practices, according to the World Health Organization. Potential routes of transmission of bloodborne pathogens such as HIV and Hepatitis C include needlestick injuries and the reuse, sharing, or unsafe disposal of non-sterile syringes. Healthcare and pharmaceutical markets across the world are now transitioning to the mandatory use of safety syringes to help protect those at risk of infection from needlestick injuries and other unsafe injection practices.

The U.S. was the first country to adopt and actively enforce legislation requiring healthcare facilities to use safety syringes, with the passage of the Federal Needlestick Prevention Act in 2000. Other healthcare markets including Canada and the European Union are now following the U.S towards the mandatory protection of healthcare workers from needlestick injury. Despite the adoption and enforcement of laws mandating the use of needlestick prevention equipment, healthcare and pharmaceutical markets continue to struggle to identify suitable products with the safety and functionality features required to protect those at risk of harm from unsafe injection practices.

One reason for the continued risk to healthcare workers is that many types of currently available safety syringes require healthcare workers to undertake a secondary action to manually engage the safety mechanism. OSHA categorizes safety-engineered medical devices with needles by the method of activation and its level of integration within the product.

According to the Emergency Care Research Institute (ECRI), the most preferred types of safety syringe are those that allow healthcare workers to activate the safety mechanism before the needle is removed from the patient, rather than those that retract the needle after it is removed from the patievnt, which can lead to blood or medication splatter.

Prefill Market Overview

• Vaccine sales are predicted to rise to $39 billion in 2013, according to market-research firm Kalorama Information.

• Greystone Associates estimates that approximately three-quarters of vaccine doses will be administered in a prefilled syringe format by 2012, with influenza vaccines being the single largest application for the delivery of a therapeutic substance via a prefilled syringe.

• The prefill market is experiencing growth at a rate of 12% annually in the USA and 10% annually in Europe.

Almost 50 injectable drug products are currently supplied in a prefilled syringe format. Combined, these drugs achieved annual sales of around $45 billion in 2007. Prefilled syringes offer significant financial and industrial benefits to pharmaceutical companies in areas such as reduced dose wastage and improved drug marketability to healthcare workers and patients who self-administer prescribed medication at home. Due to such growth drivers, we expect that more than three billion prefilled syringes will be manufactured globally in 2011. To comply with legislation that seeks to protect healthcare workers from the risk of needlestick injury, pharmaceutical companies are increasingly seeking to market their injectable drug products with a prefilled syringe that has an attached safety device. More than 20 injectable drugs with combined annual sales of approximately $24 billion – around half of all known prefilled drug sales – are supplied with a prefilled syringe that features an ancillary safety device. Currently, pharmaceutical companies must purchase safety devices separately and attach them to a standard prefilled syringe after the company has filled it. In addition to the cost to buy these ancillary safety devices, their bulky size can also increase costs by up to 70% for a pharmaceutical company to fill, package and ship a prefilled syringe. RevMed is not aware of any other prefilled safety syringe, other than Unilife’s UnifillTM Prefilled Syringe, that has automatic, user-controlled needle retraction safety features that are fully integrated and require no ancillary safety item to be attached. The Unilife syringe uses a spring-based technology to retract the needle, unlike our simpler vacuum technology.

Use of Safety Syringes in Healthcare Facilities

The introduction and enforcement of legislation within countries mandating the use of safety syringes and other safety-engineered medical devices was intended to protect healthcare workers from the risk of needlestick injury. Research data indicate, however, that current safety syringe technologies are not providing optimal protection to healthcare workers from the risk of acquiring a bloodborne pathogen. Annually reported data from the Massachusetts Sharps Injury Surveillance System as shown in the following table suggest that since OSHA began to actively enforce the Blood borne Pathogens Standard in 2002, the number of reported syringe-related needle stick injuries has remained stable, with products incorporating some type of safety feature now causing the majority of all reported needle stick injuries.

Market Segmentation and Growing Product Opportunity

Approximately 7B safety syringes were sold worldwide last year. Over 200M auto retractable safety syringes were priced at 20% to 30% higher than RevMed’s target price. The product technology platform (compressed spring) of competitors is inherently more expensive to make and less reliable than RevMed’s vaccum technology platform. 1.3B manual safety syringes, with significantly inferior performance when compared to auto-retractable safety syringes, were sold within 10% of Revmed’s target price. As RevMed’s manufacturing cost is lowered through increases in production volume, the target price of the RevVacTM Safety Syringe will approach those of the lower priced manual safety syringes expanding the market opportunity by an additional 5.5B syringes.