Pharma cos turn to pre-filled syringes for safer drug delivery

Pharmaceutical and biotech companies such as Dr Reddy?s Laboratories, Aurobindo Pharma, Biocon and Bharat Biotech, among others, are increasingly looking at new drug delivery systems for better patient compliance. One such solution is the pre-filled syringes (PFS) segment. PFS are single use, disposable syringes filled with a prescribed unit dose of medication, which are replacing the traditional vial and syringe format to deliver protein-based drugs, sustained release formulations and other medications.

Globally, there are six companies manufacturing PFS ? BD (Becton, Dickinson & Co), Schott, Stevanato Group, Weigao, Gerresheimer and Nipro.

?With more than 100 years of drug delivery expertise and innovation in patented drug delivery systems, BD possesses unparalleled market knowledge and experience in developing drug delivery systems. We have an established customer base with global quality assurance systems and necessary regulatory assistance in local markets worldwide. Such capabilities, along with our continual investment programmes help us meet current and evolving production demands in the markets,?? Murli Sundrani, business director, BD Medical, Pharmaceutical Systems, India, told FE.

?There is an increasing segment of the Indian market demanding for better drug delivery solutions that will increase patient compliance and will have a reduced risk of dosage error and contamination. At BD we believe in providing innovative solutions to reduce the spread of infection, enhance treatment and advance drug delivery,?? he added.

In fact, Roselabs Bioscience, which is planning to raise R100 crore by the end of Q3 to expand the PFS range, is in talks with pharma companies for contract manufacturing as well. It has also entered into a loan-licence agreement with Bharat Biotech for PFS. Accordingly, Bharat Biotech would use the PFS manufacturing facility of Roselabs to manufacture PFS for its vaccines.

Nearly 95% of PFS are imported into the country, Roselabs Bioscience director Zameer Agarwal said. Earlier, most injectable drugs were mainly supplied to end users in sterile vials and syringes.

According to few analysts, the ease-of-use factor that these syringes offer to patients and healthcare professionals, is helping the segment grow.

The usages of PFS provides multiple advantages, which are crucial for any patient as it remains sterilised for longer time than standard syringes with no chances of discrepancy in drug strength. ?It is pre-measured and ready-to-use with assured sterility guarantees along with safety to patients,?? said Agrawal. PFS reduces the likelihood of contamination during the injection process. ?In case of vials and ampoules, there is overfilling of 15-25% while in case of PFS, it is only 2-3%. It also ensures medical waste is brought down by 50%,?? he said. It is estimated that every year, there are around 3 million accidents due to needle stick injuries. PFS can cut down this risk.

Besides, it can also help drug manufacturers with brand differentiation and life cycle management for their products. In 2009, the total revenues in the Indian PFS market were an estimated $0.028 billion, 1.2% share of the world market.

Currently, the Indian and Chinese PFS market is one of the world?s most rapidly growing. This high-growth trend will continue through 2010-2025, with the market achieving a CAGR of 6.4% during that period, a report from Visiongain said.

Companies are developing innovative technology for improving the compatibility profile of PFS with biologic drugs, including development of lubrication technology for silicone-free syringes. According to few reports, there is an increase in the number of self-injecting patients and development of biologic drugs will be the primary drivers for market growth. While the market is still relatively small, capturing just 25.4% of total injectable drug delivery systems market, it is forecasted to grow strongly over the period 2012-2017.

As per few available statistics, the global PFS market is likely to achieve sales of $6.9 billion by 2018, growing at a CAGR of 13.8% from 2012 to 2018. Plastic syringes accounted for just 0.5% of total PFS market in 2012. Their share is expected to increase with the development of improved polymers that offer better leachables and extractables profile compared to glass syringes. Besides, there is increasing number of suppliers now provide ready to fill/sterile PFS, which make up more than 80.0% of the PFS market in 2012. Developed markets of the US and Europe together accounted for 80.0% of the PFS market in 2012.