Prefilled Syringes Market size was estimated at $5.6 billion in 2020, projected to grow at a CAGR of 8.3% during the forecast period 2021-2026. Syringes have played a crucial role in administering parenteral therapies, and in helping to guarantee that these therapies are microbially sterile and free of contaminants. As more biopharmaceutical products like vaccines are required in developing countries and more therapies are self-administered, the designing an innovative solution that satisfy the payer needs while retaining the high level of consistency, effectiveness and protection for end-user has become a key challenge. Prefilled syringes (PFS) are one of the technologies that aimed in addressing these changing demands and currently one of the fastest expanding segments of injectable drug distribution arena. Prefilled syringes are single-dose pack of vaccine that includes needle. Metal or glass has been common in the past but it’s been a trend of using plastic and disposable syringes such as needle is safe and cannot be reused (Prefilled disposable systems). It stimulated demand for compact and safe PFS over traditional glass vial for packaging of parental medications. Glass has been a material of choice for many things including prefilled syringes. However, owing to the technological advancements in polymer chemistry and biopharmaceutical industry, plastic PFS are emerging in the market.
The most common materials used in making PFS are cyclic olefin copolymer, cyclic olefin polymer, polypropylene and polycarbonate. The liquid drug formulations for prefilled syringes are usually for a shelf-life of 3 years. The two main categories of prefilled syringes that are found are Staked (pre-attached) Needle syringe where the injection cannula is pre-attached, and the Lucer Cone/ Luer Lock Syringes where the user attaches hypodermic needle during the time of injection. PFS has wide range of applications across various therapeutic sectors outside of the conventional anticoagulant and vaccine realms. The use of PHS is poised to accelerate over the coming decades. For biopharmaceutical industry, the benefits of prefilled syringe are reducing drug wastage, improving shelf-life of a product, increasing market share. For healthcare worker, PHS are known as an effective, secure and most convenient form of drug administration. The ability of PFS to deliver the benefits of improved dosing accuracy, safety and convenience over the other traditional syringe and vial formats is boosting the Prefilled Syringes market growth. Moreover, the increasing geriatric population coupled with growing prevalence of chronic diseases worldwide is the major factor attributed to growth of prefilled syringes market. However, interaction of prefilled syringe with drug and contamination caused by glass-based prefilled syringe are the factors that hinders the prefilled syringes market growth.
Prefilled Syringes Market Segment Analysis - By Material
Based on Material, Prefilled Syringes Market is segmented into Glass-based and Plastic-based. Glass-based accounted for the largest revenue market share in 2020 owing to its compatible features, higher stability, oxygen permeability and by its non-reactive nature. Plastic-based PFS are estimated to grow with the fastest CAGR of 8.9% in the forecast period 2021-2026 owing to the use of advanced polymer material like polypropylene that does not react to any drug with inner walls of the syringe. Further, these materials maintain pH level of medicine, are biocompatible, more durable with no chance of breakage, free from heavy metals with little to no siliconization are the factors attributed to its faster growth.
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Prefilled Syringes Market Segment Analysis - By Usage
Based on Usage, Prefilled Syringes Market is segmented into Disposable and Reusable. Disposable segment is accounted for the largest revenue market share in 2020 owing to its wide range of applications and reduced risk of contamination. Also, it helps to dosing errors that resulted in increased usage of disposable PFS in hospitals and other healthcare centres. Prefilled syringes are emerged as the fastest-growing choice for single dose medication as biopharmaceutical companies are minimising the drug wastage, especially when the compound is shortage or is costly. Disposable PFS are advisable as they do not require an extra step of sterilization, helps in preventing infection from patient to patient. Reusable segment is poised to grow with the fastest CAGR of 8.6% in the forecast period 2021-2026 owing to the development of innovative auto-injectors that has attributed to the growth of this segment.
Prefilled Syringes Market Segment Analysis - By Geography
Based on Geography, Europe Prefilled Syringes Market accounted for the 39.6% revenue share in 2020. This is majorly attributed to the rising demand for PFS in this region coupled with increasingly growing pharmaceutical industry that has become sophisticated. Moreover, the strong presence of key global market players in this region is further playing a significant role in fueling the region’s growth. Asia-Pacific market is poised to grow with the fastest CAGR in the forecast period 2021-2026 owing to its increasing geriatric population, upsurge in prevalence of chronic diseases, growing surgeries with various reasons, developing economies, like as China and India with untapped growth opportunities are the factors attributed to region’s growth.
Prefilled Syringes Market Drivers
Advantage Over Traditional Process
The usage of PFS is increased owing to various disadvantages of traditional process. PHS makes it easier and safer for both doctors and patients as it ensures the patients always get the right amount of dose. Prefilled polypropylene syringes or plastic syringes has improved quality and safety of care, these are ready to use type syringes that helps in minimizing the risk of drug administration errors. Advantages that PFS has over traditional packaging is it is user convenience, reduces risk of contamination, compatibility with safety devices and auto-injectors and makes injection safe, and convenient. It eliminates dosing errors as they come with exact dose and reduction on overfill requirements, less wastage of sample, that is most advantageous character particularly when the drug is shortage or is costly. There is some degree of variability while removing drug from vial with a conventional disposable needle and syringe. Prefilled syringe system eliminates the withdrawal step and delivers the drug directly to the patient that results in more accurate dose of drug with less exposure of the needles. Moreover, when compared to vials, PHS reduces the overfill of samples that are costly in biopharmaceuticals, also, the customized delivery systems and PFS are helping pharmaceutical companies in biotech industry to deliver personalized drugs formulated for smaller patient populations. The pre-attached needle brings additional advantages that boosts the prefilled syringes market growth.
Increasing Prevalence of Chronic Diseases
Prefilled syringes are mostly used in treatment of chronic diseases, like as diabetes, heart diseases, auto immune diseases that require self-administration of medications. The increase in prevalence of chronic diseases owing to the change in lifestyle and urbanization, people are adopting to sedentary life style generating the increased product demand. Chronic diseases are among the most prevalent health condition in United States. In 2018, around 133 million population of America had at least one chronic disease and this number is continuously growing every year. Further, growing geriatric population is another major factor attributing to the growth of Prefilled Syringes Market. In 2019, global population 703 million were aged 65 and above and this number is estimated to double by 2050.
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Prefilled Syringes Market Challenges
Interaction of PHS with Drug
The interaction of PFS with drug is the major challenge associated with the prefilled syringes market. This interaction is mostly concerned owing to the stability issues. Pharmaceutical companies need to ensure patient safety as extractables and leachables (E&L) interfere with drug and compromise the effectiveness of the drug. As PFS are in contact with not only drug but also other materials and compounds resulting in creating additional opportunities for interactions of E&L.
Contamination with Glass Material:
The major challenge faced by prefilled syringes market is by the use of glass material. As glass is more susceptible to breakage, the chemical reaction with glass and sample leads to delamination where glass corrodes or flakes. In addition, the manufacturing process and material of construction, glass syringes sometimes contaminate the biopharmaceutical sample with sodium, heavy metals or tungsten. This can be a major concern if the sample contains demetallated proteins. Moreover, contamination is caused by the adhesives, silicon oil and elastomer components that are mostly added in the glass syringes which effects while working with sensitive biological samples and protein. For an instance, glass syringes that are lubricated with silicon oil were found to increase the protein loss in biological samples by forming insoluble aggregates.
Prefilled Syringes Market Landscape
Product launches, mergers and acquisitions, joint ventures and geographical expansions are key strategies adopted by players in the Prefilled Syringes Market. Prefilled Syringes Market top 10 companies are Stevanto Group, Baxter International, Gerresheimer, Catalent Inc., Becton Dickinson (BD), SCHOTT AG, Fresenius Kabi, West Pharmaceutical Services, Inc., Ompi, Oval Medical Technologies, SHL Medical AG, Terumo.
Acquisitions/Product Launches:
In December 2020, Becton, Dickinson and Company (BD) has invested USD 1.2 billion in order to expand its manufacturing technology and capacity of Prefilled Syringes.
In March 2019, SCHOTT has announced to launch syriQ BioPure, which is the world’s first lubricant free prefilled glass syringe.
Key Takeaways
Geographically, Europe Prefilled Syringes Market held the largest revenue share of 39.6% in 2020 owing to the highest disposable income and growing geriatric population in this region.
Increased demand for R&D made by the key players in different region of the world are driving the market.
Detailed analysis on the Strength, Weakness and Opportunities of the prominent players operating in the market is provided in the Prefilled Syringes Market.
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