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Pre-filled Syringes: Revolution in Dosage Delivery Trend
- Zameer Agarwal, Roselabs Bioscience Ltd
95 per cent of India's pre-filled syringes demand is met through imports and their use is likely to increase considerably. Studies suggest that more than 50 drugs, including antithrombotic agents, vaccines, blood stimulants, interferons, and rheumatoid arthritis treatments, are now available in pre-filled syringe formats.

Pre-filled syringes (PFS) are pre-measured single-dose ready-touse injectables for parenteral drug delivery. PFS are a simple, efficient and convenient way for dosage delivery. Tracing its history back to the early 80s, PFS currently are the preferred drug delivery device and there are over 50 types of drug pre-filled syringes available in the market and many more are in pipelines.

Till recently, most injectable drugs were mainly supplied to end users in sterile vials and syringes. However, the growing use of biologics and biotechnology drugs, coupled with a staggering increase in the number of patients who self-administer drugs to treat chronic diseases, has forced drug manufacturers to reconsider the vial-and-syringe format, which is prone to dosing errors and low patient-compliance. Because of this, pre-filled syringes — single use, disposable syringes filled with a prescribed unit dose of medication — are rapidly replacing the traditional vial and syringe format to deliver protein-based drugs, sustained release formulations, and other parenteral medications.

There are two types of PFS available in the market, glass based PFS and plastic based PFS.

Typically, pre-filled syringes are made of glass and use a conventional plungerbarrel delivery mechanism. These syringes come in a variety of sizes starting with the 0.5 ml to 10ml. Glass PFS has been the preferred as it is strong, chemically inert, dimensionally stable, and easy to sterilise.

Further, it is transparent, which allows visible inspection of a dosage form before it is injected. In recent years, syringe manufacturers have introduced plastic pre-filled syringes, mainly in response to the possibility of breakage and plunger failures associated with glass PFS.

Using syringe/vial for injection involves 10-12 steps whereas pre-fill involves two to three steps. So it minimises response time during emergency and increases patient compliance and reduces chances of administration errors.

This revolutionary dosage delivery enhances safety of patients as well as healthcare professionals and reduces risks of bacteriological contamination, misidentification and improper dosage delivery. PFS also offer assured sterility, reduce risk of injury and exposure to drug in addition to considerable reduction of medical waste. Because of such benefits, use of PFS is likely to increase considerably. Over 2.5 billion PFS were used in 2011 which is expected to cross 3.5 billion by 2015 and 6.83 billion by 2025.

PFS are useful in emergency situations and busy hospitals as the process of transferring a drug from vials & ampoules is eliminated. Most healthcare professionals also prefer PFS to conventional syringes as it reduces the needle struck injuries drastically. As per WHO estimates, every year 3 million accidents occur because of needle stick. Such injuries can involve needles or other sharps contaminated with blood borne pathogens, such as HIV, HBV or HCV. All such accidents can be reduced drastically by using PFS as they are meant for single use and are immediately discarded after injecting the medication.

Healthcare reform, cost containment, and changing medical practices are also driving the uptake of pre-filled syringes. While pre-filled syringes offer many advantages to end users, they also offer a variety of benefits to drug makers. Along with other benefits it helps drug manufacturers with brand differentiation. Further, pre-filled syringes usually offer drug makers lower overall cost-perdosage- unit as compared with syringe and vial formats. This is because prefilled syringes require just 2-3 per cent overfilling of drug to be delivered as compared to vials which need to be overfilled by 10 to 25 per cent. From a logistical and supply chain management perspective, pre-filled syringes are easier to handle, store, and ship than vials. Prefilled syringes weigh less and take up less space than vials, so they cost less to ship. PFS occupy less shelf space at distributors and pharmacies, which makes them easier to store than vials, which can also help to reduce costs.

Pharma IQ Report "Demand will also gain upward momentum as hospitals, outpatient facilities and other health care establishments adopt stricter safeguards to meet infection prevention standards," said the report.

Market experts estimate that growth of PFS has been over 50 per cent in last 5 years and the segment is expected to grow at over 10 per cent in years to come. With the increased use of biologics and the rise in number of injectable biotherapeutics, growth of PFS as effective dosage delivery system will surge. Further, as demand for pre-filled syringes is increasing it also offers contract manufacturers are taking advantage of this opportunity.

According to a recent iRAP report, PH-1 Nano-Enabled Packaging for the Pharmaceutical Industry—“Global demand for prefillable inhalers and pre-filled syringes will generate the fastest growth opportunities among all pharmaceutical packaging products, based on performance advantages in drug delivery and the introduction of new bioengineered medicines.”

While glass remains the industry standard for pre-filled syringes, industry also seen the emergence of plastic pre-filled syringes. Development of this cyclic olefin polymers and copolymers (eg, COC, COP, and CZ) are “glasslike” in appearance; have low extractable, leachable, and protein surface adsorption properties; and are stable over wide pH ranges.

Market for PFS
According to Global Industry Analysts Inc, pre-filled syringes are finding increased use due to their ability to eliminate risk of cross-contamination, and other risks, such as that of drug counterfeiting and dosing error, that may occur with ampoules or vials.

With its pre-dominant use in the US, Europe and Japan, pre-filled syringes with their numerous benefits, are expanding its base in developing countries such as India and China.

Reports indicate that, PFS command market size of over USD 50 billion – approximately 23 per cent of total injectables market. Notable players in the pre-filled syringe market (Surgical part only) include Becton, Dickinson and Co (BD), Vetter Pharma, SCHOTT, Abbott Laboratories, Ypsomed, Gerresheimer and McGlass.

London-based business information company, Visiongain predicts world pre-filled syringe technology revenues will reach USD 3.9 billion in 2015, up from USD 2.7 billion in 2010 in its report ‘ Pre-Filled Syringes: World Market Outlook 2011-2021’.

Experts feel that further development of the pre-filled syringe market will be dependent upon developments in syringe technologies and materials. Improvements to performance, product stability, convenience of use, and cost-effectiveness will stimulate increasing use of pre-filled syringes and related devices this decade.

The Indian pre-filled syringe market, at present, is less than 1 per cent of world syringe market and 95 per cent of demand is imported. Hence it has huge potential for growth. Rapidly-expanding economy, increasing size of the Indian middle class and the aging population are growth triggers for PFS in Indian market. India also has the potential to become a hub for supply of injectable products.

New Trends and Innovation in Pre-Filled Syringes
Innovation in pre-filled syringes and injection devices has been spurred by a demand for disposable medical supplies on a global scale. Visiongain expects total syringe market (disposable and reusable) could reach USD 11.8 billion by 2017, with much of that being stimulated by the pre-filled syringe.

In recent years, there has been a shift from glass to plastic syringes, due to advances in materials construction and manufacturing processes.

Despite the commercial availability of a plethora of pre-filled syringe design options, many syringe manufacturers and drug delivery experts believe there is still plenty of room for innovation in the pre-filled syringe market. Microneedle transdermal patches and needleless auto injectors may represent promising areas of innovation.

However, for the foreseeable future, it appears that conventional pre-filled syringe formats will remain the method of choice for self-administering biologics and other parenteral drugs.