Demand for Prefilled Syringes Continues to Grow, Given the Numerous Benefits they Offer Over Conventional Injectable Drug Delivery Systems
The first successful use of prefilled syringes can be traced back to early 1980s when Sanofi and Rhone Poulenc-Rorer (Sanofi-Aventis) introduced syringes as drug delivery devices for heparins, in Europe. In the initial years, prefilled syringes were niche market products and their applications were limited to some vaccines and antic prefilled syringes
oagulant products. Now they have been around for more than three decades and are used as injectable formulations for all major therapeutic drug classes. Owing to their numerous benefits over conventional delivery systems, such as vials or ampoules, prefilled syringes, have become indispensable in the medical field.
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The prefilled syringes market has witnessed impressive growth post their introduction. They are now a primary container of choice for parenteral mode of drug administration. The driving factors behind the increasing demand for prefilled syringes are listed below:
- Quick administration of drugs, which is especially beneficial in emergency situations.
- Increase patient compliance because of ease of self-administering; patients can thus save time and money instead of going to a doctor’s office or infusion center.
- Increase accuracy and reduce dosing errors because of pre-measured doses.
- Relatively higher assurance of sterility.
- Easy to store and dispose.
- Removal of preservatives (such as thimerosal which is potentially neurotoxic) from prefilled vaccine formulations.
- Better and efficient use of controlled drugs, such as narcotics.
- Reduced injection cost due to less manual preparation of dosage.
Prefilled syringes market size – One of the key objectives of the report was to evaluate the current market size and the future opportunity within the prefilled syringes market.
Additionally, key benefits of prefilled syringes to the manufacturers are listed below:
- Reduced cost of manufacturing; it is worth highlighting that plastic prefilled syringes are more affordable. Moreover, these syringes are less prone to damage (cracking or breakage) compared to their glass counterparts.
- Reduced time for fill / finish due to availability of ready to fill, pre-sterilized containers.
- Reduced drug overfills, helping manufacturers further optimize on overall expenditure (by preventing product loss during fill / finish). For a 0.5 ml vial, the United States Pharmacopeia (USP) recommends 20%-25% overfill, whereas the required overfill is < 2% for a 0.5 ml prefilled syringe.
- Higher filling line efficiency, compared to vials, with use of modern automated filling technology, such as barrier isolation systems.
- More robust and versatile drug delivery device (compared to vials), with the potential to be marketed at premium prices. This is likely to directly impact the revenue generation potential of developer companies.
Owing to the benefits listed above, applications of prefilled syringes have extended to new indications, such as rheumatoid arthritis and multiple sclerosis. Prefilled syringes market is one of the fastest growing markets in drug delivery and pharmaceutical packaging industry. Despite the large number of benefits offered by them, limitations with the use of prefilled syringes still exist, leaving room for further technological improvements. Manufacturers of prefilled syringes are continuously looking for innovations in technologies and materials to enhance the benefits and applications of prefilled syringes. Incorporation of new design features and technical improvements to meet the needs of healthcare industry promises to maintain dominance of prefilled syringes in drug delivery market.
During our research, we identified 100 prefilled syringes that are available / under development for delivery of different types of drug molecules. Majority (~70%) of such syringes have glass barrels, while the remaining have plastic barrels. A large proportion (84%) of prefilled syringes have a single chamber and very few companies manufacture dual chamber prefilled syringes. Examples of dual chamber prefilled syringes include (in alphabetical order, no selection criteria) Companion Dual Chamber Reconstitution Syringe, Dual Chamber PrefillableTM Syringe, FULJECT Passive Type Syringe, Lyo-DCPS and PC-Lyo.
Moreover, it is a well-known fact that unsafe needle practices result in an increased incidence of infections due to transmission of blood-borne pathogens. Re-use of needles and syringes without sterilization has contributed significantly to this problem. To address such safety issues, there has been an increasing demand for ready-to-use, single dose, disposable syringe systems with safety features. Healthcare facilities are opting for safety devices to protect their staff from occupational hazards and to comply with strict standards and regulations set by governments around the world for mandatory use of safety-engineered devices. In such a scenario, prefilled syringes are becoming increasingly popular. They are ready-to-use, easily disposable and reduce risk of cross contamination. They can be easily combined with safety devices, such as needle retraction systems to prevent needlestick injuries. Moreover, prefilled syringes with integrated safety features have also been developed. Use of prefilled syringes considerably reduces the risk of blood-borne pathogens transmission.
As a result, many pharmaceutical companies have already initiated the shift from conventional parenteral packaging to prefilled syringes, for both drug formulations and vaccines. Currently, more than 100 parenteral drug products are available in prefilled syringes and a large number of pipeline drugs are also under consideration for delivery via such devices. Further, biologics are growing to be the future of the drug development market and the injectable drug pipeline continues to move from small molecules to complex biologics, such as mAbs. This trend is likely to contribute to the demand for prefilled syringes, in the coming years. In fact, nine of the top-10 drugs available in prefilled syringes are biologics with majority of these being used for treating chronic diseases, such as diabetes, rheumatoid arthritis, and multiple sclerosis. Additionally, growth in the biosimilars market is likely to increase opportunities for prefilled syringe market.
Currently, the prefilled syringes are more commonly used in developed markets of the US and Europe but are slowly gaining popularity in Asian and other markets. The US and Europe have traditionally been most receptive to adoption of any new drugs, devices, and delivery technologies. Introduction of favorable reimbursement policies and decrease in price of prefilled syringes is likely to increase the demand for prefilled syringes in emerging markets in the coming years. Although, the short-term growth prospects in the developing economies are small, the growing pharmaceutical markets of countries, such as India and China, will provide huge opportunities for prefilled syringe manufacturers in the long term.
In fact, in an interview with the chief technical officer of a mid-sized company, he stated that “In India, there will be a gradual uptake for prefilled syringes because of several reasons. The primary reason is the cost associated with prefilled syringes. People are unaware of the fact that if we add the indirect cost involved in the use of vials and ampoules, it comes out to be almost equivalent to the prefilled syringe. Therefore, there is an ardent need to create awareness among the people regarding this. Additionally, unlike the US and EU markets, reimbursement is also a key challenge in India.”
Despite various technical and manufacturing-related challenges, this field is expected to grow owing to an ever-increasing demand for self-injecting devices for the treatment of several chronic conditions. Over the years, new developments in prefilled syringes have resulted in innovative designs capable of catering to a wide range of patients’ needs. Manufacturers are developing patient centric solutions for drug delivery. Introduction of advanced features and emergence of efficient technologies are further anticipated to provide an additional impetus to the growth of this market.
In fact, according to the base scenario of our forecast model, the market for prefilled syringes is expected to grow to around USD 3.6 billion by 2030. Further, our estimates suggest that, even though, glass barrel prefilled syringes presently hold the dominant share (86%) in the overall market, the market for plastic prefilled syringes is likely to grow at a CAGR of 6%. Further, the combined market share of prefilled syringes containing small molecules and protein is expected to be around 60%. Further, the market for prefilled syringes containing peptides is likely to grow at a CAGR of 12%.
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The market is featured by the presence of across 30 companies that are presently manufacturing different types of prefilled syringes. The industry is dominated by a handful of large and well-established players; the Asia-Pacific region is one of the key hubs for prefilled syringe manufacturers. Moreover, majority of the companies (56%) have manufacturing facilities in Asia-Pacific; among these, five companies have facilities in Japan followed by four companies with facilities in China.
Prefilled syringes market growth – We are seeing an increased demand in the emerging markets, particularly within the BRICS nations, namely Brazil, Russia, India, China and South Africa. North Africa and the Middle East also present a similar scenario, characterized by a growth rate of 10-18% for prefilled syringes
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