The market for prefilled syringes is projected to grow, owing to factors, such as increasing adoption of self-care devices, benefits associated with prefilled syringes, and high demand for improved safety in injectables.
The prefilled syringes make injections easy, accurate, and safe for, both, patients and doctors. Pre-filled syringes have emerged as one of the fastest-growing choices for unit dose medication, as the pharmaceutical industry seeks new and more convenient drug delivery methods.
In addition, pharmaceutical companies can get benefit by saving the cost of vials. The prefilled syringes work well with safety devices and auto-injection systems. Pharmaceutical companies are able to minimize drug waste and increase product life span, while patients are able to self-administer injectable drugs at their home instead of the hospital. Pre-filled syringes have also been utilized across a wide range of therapeutic sectors, such as vaccines, blood stimulants, and therapeutic proteins.
Eliminating dosing errors and ease of use are two of the greatest advantages of pre-filled syringes. Consequently, the differential advantages provided by prefilled syringes over traditional syringes are leading to the increased adoption and contributing to the global market growth.
Key Market Trends
Glass Prefilled Syringes are Projected to Experience Highest Growth Over the Forecast Period
The pharmaceutical industry uses glass syringes manufactured from Type 1 borosilicate glass, which consists primarily of silicon dioxide, along with oxides of boron, aluminum, sodium, and potassium. Metal ions, specifically sodium dioxide, are included in the mixture to alter the physical properties of the glass.
Glass syringes are manufactured from tubing glass. The glass tubing is created by heating the glass mixture to approximately 1500°C and continuously pulling the molten glass along a hollow spindle. Processing conditions, such as speed and airflow, are tightly controlled to prevent failures, such as airlines in the glass, from occurring. While glasses are generally unreactive, they are not necessarily inert. Alkali metals can leach out of glass, resulting in pH shifts in the solution. Some drug molecules are also labile for adsorption to the charged surface of the glass, resulting in decreased potency of the drug solution.
There have been reported instances when tungsten residues in the glass syringe Luer cone left behind during manufacturing have led to aggregation and particle formation in protein solutions. Apart from the above-mentioned challenges of drug interaction, glass prefilled syringes are also prone to breakage.
The market for glass prefilled syringes will grow regardless, albeit very sluggishly in the forecast period, primarily due to increased adoption of prefilled syringes in the developing regions, where glass syringes provide reusability and lower cost.
North America Dominates the Market
On January 22, 2013, the US FDA published the long-anticipated Final Rule: “Current Good Manufacturing Practice Requirements for Combination Products”, with the purpose of clarifying regulatory requirements for quality systems used to design, develop, and manufacture combination products, and to help ensure consistent and appropriate application and enforcement of these requirements.
Prefilled drug delivery systems, including prefilled syringes, are combination products subject to the Final Rule. From a manufactures perspective, the Final Rule, as provided by the US FDA, tightens the regulations for syringe manufacturers and has made the manufacturing operation more stringent than before. This has acted as a deterrent to global players based in the United States and prevents them from expanding their regional operations, in other regions.
Overall, there is a large concentration of vendors supplying both end products and original components in the prefilled syringe market. The use of prefilled syringes in the United States is consequently ensured by the presence of appropriate vendors. Lifestyle associated illnesses and growing demand for easy-to-administer injectables in patients of chronic disease are helping the US prefilled syringe market flourish.
The market for prefilled syringes is moderately competitive and there is high price competition in the market. The market is comprised of, both, global and local players. Most of the developing countries are having local players that provide prefilled syringes at a lower price. However, the market is majorly dominated by global companies. Few companies are expected to penetrate the market in the near future and they are expected to account for a substantial share of the prefilled syringes market.
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