USA Prefilled Syringes Market Size, Share, Growth, Trends, and Global Industry Analysis: Size, Share, Growth, Trends, and Industry Analysis By Type (Disposable, Reusable), By Material (Glass, Plastic), By Design (Single-chamber, Dual-chamber, Customized, Others), By Application (Anaphylaxis, Rheumatoid Arthritis, Diabetes, Cancer, Others) and Country Forecast 2020-2031

USA Prefilled Syringes Market size was valued at US$ 2,900 million in 2024 and is expected to reach US$ 4,700 million by 2031, growing at a significant CAGR of 7.0% from 2025-2031. The market is moving into a new era of drug delivery, one featuring precision, safety, and patient control. As more people are self-injecting for such chronic conditions as diabetes, rheumatoid arthritis, and multiple sclerosis, prefilled syringes offer convenience and compliance never before possible with vial-and-syringe technology. From biosimilars to biologics, pharma firms are increasingly looking to prefilled formats to improve dosing accuracy and reduce contamination risk. The US healthcare system with its focus on value-based care and home treatment options is ready for mass adoption. Regulatory support, combined with the necessity of safer injectable platforms, positions this segment as a corner pillar in modern injectable delivery therapy.

Facts & Figures

• More than 80% of biologic drugs approved for use in the U.S. in the last five years have been marketed in prefilled syringe formats or will come with them for convenience of self-administration by patients.
• Large healthcare settings in the U.S. reported saving 30–40% of time spent preparing drugs after they transitioned from the conventional vial-and-syringe system to prefilled syringe systems.
• Prefilled syringes are becoming the delivery vehicle of choice for monoclonal antibody therapies due to increasing applications of subcutaneous formulation in oncology, immunology, and rare disease.
• Some U.S.-based med tech firms are venturing capital into human-factor design to fine-tune grip design, one-handed use, and visible-to-the-naked-eye dose confirmation, to make self-injecting safer and easier across all ages.       

Key Developments:

• In June 2025, Pharmaceutics International, Inc. (Pii) enhanced prefilled syringe (PFS) fill/finish capacity through a $3.6 million investment in state-of-the-art fill/finish equipment, automated visual inspection, and precision labeling. The investment enhances the CDMO's capacity to accommodate U.S.-based pharma and biotech customers' needs for scalable, end-to-end injectable solutions.
• In April 2025, The FDA approved a new prefilled syringe formulation of subcutaneous efgartigimod (Vyvgart; Argenx) for the treatment of generalized myasthenia gravis (gMG) and CIDP. This represents a significant shift from IV-based treatments to home-based PFS administration, promoting convenience and patient adherence.
• In November 2025, Pii solidified its position as a top CDMO contender by announcing the same $3.6 million investment with a focus on expanding prefilled syringe capacity. This reassertion indicates sustained demand for outsourced syringe manufacture in the U.S. injectable drug delivery market.

USA Prefilled Syringes Market Segmentation:

Based on the type:

• Disposable
• Reusable

Disposable prefilled syringes represent the largest segment of the U.S. market, as they present enhanced convenience, infection control advantages, and good compatibility with single-use healthcare procedures. Hospital and home care prefer the use of disposables as a precaution to prevent the risk of cross-contamination and provide sterile delivery, especially for immunocompromised or post-op patients. These syringes also eliminate nurses' and caregivers' workload by precluding the drawing by hand, thereby cutting down on prep time and enhancing dosing accuracy. Also, in response to regulatory constraints to avoid needle-stick injury, disposable formats often carry in-built safety caps or retractable components. With self-administration becoming mainstream in chronic disease management, there is greater demand for safe, pre-filled disposable syringes driven by clinical efficiency as well as patient confidence.

Based on the material:

• Glass
• Plastic

Glass is still the material of choice for prefilled syringes in the US market, particularly for biologics and high-stability drug products. Its good barrier properties ensure much better integrity maintenance of the drug under extended shelf life and reduce leaching or contact with sensitive preparations. Glass syringes are commonly used in injectable oncology drugs, vaccines, and specialty pharmaceuticals where long-term storage without loss of potency is critical. While plastic syringes offer the benefits of cost and shatter resistance, there is still confidence in glass when purity and chemical resistance are not a trade-off. Certain pharmaceutical firms collaborate with packagers to achieve added safety of glass syringes in the form of coatings and shatter-resistant design. Glass, despite increasing polymer advances, has the confidence of the regulators and formulators for high-end drug delivery.

Based on the design:

• Single- Chamber
• Dual- Chamber
• Customized
• Others

Single-chamber systems are the backbone of the U.S. prefilled syringe industry, popular for ease, consistency, and widespread compatibility in all therapeutic categories. Single-dose drug syringes, pre-filled and pre-measured, ready for administration, simplifying preparation steps, dosing mistakes, and risk of contamination. Single-chamber syringes are best for high-speed therapeutics such as epinephrine, vaccines, and analgesics where speed is critical and convenience is a prime concern. Their low construction further allows mass production, packaging, and hospital and retail automation. With more emphasis on rapid delivery of medications in emergency medicine and outpatient treatment, single-chamber prefilled syringes provide a reliable combination of speed, sterility, and affordability.

Based on the application:

• Anaphylaxis
• Rheumatoid Arthritis
• Diabetes
• Cancer
• Others

Rheumatoid arthritis (RA) is one of the most significant use cases for prefilled syringes in the U.S., fuelled by growing use of biologics like adalimumab and etanercept. They are normally self-administered subcutaneously, so user-friendliness and accuracy of prefilled syringes are crucial to management of chronic disease. RA patients with limited hand mobility appreciate ergonomic designs minimizing injection effort and improving grip. Manufacturers have, in response, created single-handed-use syringes with larger finger flanges to improve control. With biologics now accounting for a greater percentage of RA treatment regimens and payors covering home-injection devices with greater frequency, prefilled syringes are now essential devices to optimize adherence and clinical outcomes.