The global prefilled syringes (PFS) market was valued at USD 4.72 billion in 2019 and is expected to grow at a CAGR of 9.8% during the forecast period. The significant factors propelling prefilled syringes market growth include increase in the prevalence of chronic and infectious diseases, consumer preference towards self administration, its benefits over the conventional syringes, and increasing usage in the non-medical settings. Most of the pharmaceutical companies are shifting their focus from traditional devices to PFS owing to their financial, economic, and logistic benefits. With a strong interest in the healthcare industry for PFS, owing to its convenience by the patients. Many of the latest and upcoming biotech and liquid stable formulation drugs cannot be self-administered with ease using traditional syringes.
Pharmaceutical industry undergoing a transformation from small-molecules chemical drugs to large molecules, including biologics. The long-term treatment advances for many serious diseases such as oncology and immunology are made possible with biologics. Hence, many pharmaceutical companies are investing more of their resources and research efforts for the development of biologics. Currently, six out of 10 drugs in development are biologics which requires parenteral administration. PFS is an important option for packaging and delivering the biological products due to its advantages such as material and cost savings, accuracy and ease of administration. Nine out of 10 drugs available in PFS are biologics and most of these are used for the treatment of chronic diseases such as diabetes, multiple sclerosis and rheumatoid arthritis. According to PhRMA, currently, about 900 biological drugs and vaccines for more than 100 diseases are in clinical trials and most of the will use PFS as preferred delivery systems and primary containers.
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PFS has been associated with many limitations and drawbacks. The quality of the drug being compromised when stored in PFS due to the direct contact of drug with the primary packaging (piston, nozzle cap etc.) of the syringe for long durations. The silicone oil that is used to lubricate PFS to ensure optimal functionality can itself be a source of extractable or leachable in the device. Many of the drugs that are being manufactured have protein and peptide based content in them that can interact with glass surface of the PFS. The tungsten residuals in the PFS can also degrade biotech drugs. There are many instances where pharmaceutical companies offering drugs in PFS recalled their products due to adverse interactions.
The market is primarily segmented on the basis of material, by design, by type, by application, and geographic region.
· North America (U.S., Canada)
· Europe (France, Germany, UK, Italy, Spain, Netherlands, Austria)
· Asia Pacific (Japan, China, India, Malaysia, Indonesia. South Korea)
· Latin America (Brazil, Mexico, Argentina)
· MEA (Saudi Arabia, UAE, Israel, South Africa)
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Based upon the material, the global prefilled syringe market is categorized into glass and plastic syringes. In 2019, the glass PFS accounted for the largest share in the global market, however, this dominance is challenged by the plastic PFSs, owing to its comparative better offerings and growing adoption among the physicians.
Plastic has the added advantage of better design flexibility and dimensional precision which is vital for PFS when they are combined with devices like auto-injectors or needle safety systems. Manufacturers can also design and integrate plastic PFS with luer locks which is superior than the luer lock adapters that are used in glass PFS. The number of biopharmaceuticals are increasing at significant rate. These are highly viscous and requires more pressure on the syringe flange for the delivery. Glass PFS are more prone to break when more pressure is exercised, while plastic PFS are robust and facilitates the delivery of biologics by applying high forces.
On the basis of application, the global market is categorized into insulin, vaccine, anti-coagulant, and others. In 2019, the insulin segment accounted for the largest share, followed by vaccine and anticoagulants segments. The rising incidence of diabetes in both developed and developing countries, increasing patient's preference for home healthcare, and increasing physician's preference for PFS due to accurate insulin delivery and increasing adherence to treatment regimens are driving the segment’s growth.
Geographically, the global prefilled syringes market is bifurcated into North America, Europe, Asia Pacific, Latin America, and Middle East & Africa (MEA). North America region is the largest revenue contributor followed by Europe and the Asia Pacific region. In 2019, the North America region accounted for more than 42% of the global market.
Increased prevalence of chronic diseases such as diabetes and vaccine preventable infectious diseases are driving the growth of prefilled syringe market in this region. Nearly, 133 million Americans or every second person in the U.S. lives with at least one chronic disease. In 2015, nearly 44.3 million people had diabetes in North America & Caribbean island nations, and this number is expected to reach to 60.5 million by 2040. Technological advancements in PFS devices and recommendations by CDC are the other factors that are influencing the growth of PFS market in the Americas. Healthcare reforms in the US are focused on reducing healthcare expenditure for end-users. These reforms have increased the use of self-injection devices in non-medical settings. The above mentioned factors are responsible for the concerned market growth.
APAC is the fastest growing region in the global market, with China being the major revenue contributor. Rising aging population, increased prevalence of chronic diseases and vaccines preventable diseases and technological advancements are driving the growth of the market. It is estimated that nearly 50% of the diabetics of the world live in China, India, US, Brazil and Indonesia, which provides huge opportunity for the market penetration. Many countries of these region are currently relying on imports for PFS from developed countries. For instance, more than 85% of the demand for PFS in India is met via imports from the countries such as US, Germany and France. However, many PFS manufacturers are seeking to expand their operations to emerging countries such as India and China to increase their business. Many players in APAC are increasing their production capacity to meet the demand for PFS.
There is an oligopoly in global prefilled syringes market where only few players are holding majority of market share. The prominent players operating in the market are Becton Dickinson (BD), Medpro, Haselmeier AG, Stevanato Group, Owen Mumford, SCHOTT, Unilife Corporation, OMPI, Fresenius Kabi, Catalent, Vetter Pharma International GmbH, Gerresheimer, Weigao Corporation, West Pharmaceutical Services, Inc., and Nipro Medical Corporation.
The intense rivalry is resulting in shifting the bargaining power from sellers to the buyers. Companies are focusing on acquisitions, partnerships, and technological advancements to expand in the market. The demand and supply gap in the market enabling the suppliers to revamp up production capabilities, while the existing players are focusing on expanding their production, new entrants are focusing on development of new and improved designs by using advanced materials such as COP-based plastic and advanced and innovative drug filling technologies.