Global Pre-Filled Syringes Market - 2025-2033

The global pre-filled syringes market reached US$ 8656.06 million in 2023 and is expected to reach US$ 30042.62 million by 2033, growing at a CAGR of 15.5% during the forecast period 2025-2033.

Pre-filled syringes are ready-to-use medical devices containing a pre-measured medication or vaccine dose. These syringes come pre-loaded with a specific amount of a drug, making them convenient for healthcare professionals and patients. The pre-filled syringe typically consists of a syringe barrel, a plunger, and a needle or a needle shield. Some pre-filled syringes come with safety features, such as needle shields or retractable needles, to enhance safety during use and disposal. Pre-filled syringes often have a longer shelf life compared to some traditional forms of medication packaging, as they can protect the drug from environmental factors.

The rise of self-care interventions has played a significant role in driving the demand for pre-filled syringes in the healthcare market. Self-administration of medications is becoming increasingly common as people take a more active role in managing their health. For instance, according to the Study conducted by the National Institute of Health (NIH), in total, 234 patients completed the questionnaire. Half (50%) of the patients were willing to self-administer medication. However, only 37% of patients preferred self-administration of medication over nurse-led medication administration. Pre-filled syringes offer a user-friendly solution, eliminating the need for complex dosage measurements and making it easier for individuals to self-administer their medications. Additionally, according to Harvard University, 7 billion prefilled syringes are used annually around the world.

Market Dynamics: Drivers & Restraints

Rising popularity of self-administration

The rising popularity of self-administration is significantly driving the growth of the pre-filled syringes market and is expected to drive the market over the forecast period. Self-administration allows patients to inject medications in the comfort of their homes, which is particularly important for chronic conditions such as diabetes, rheumatoid arthritis and multiple sclerosis. This convenience reduces the need for frequent hospital visits, thus saving time and costs for both patients and healthcare providers.

For instance, according to the study conducted by the National Institute of Health (NIH), the majority (62%) of the diabetes study patients had a favorable attitude toward insulin self-administration. Although the majority of 177(72.2%) of the study patients have administered insulin themselves, only 120(49.0%) of the patients injected insulin appropriately at 45 degrees.

According to the International Diabetes Federation estimated that diabetes reach 592 million in the year 2035. Similarly, there were more than 1.8 million diabetes patients in Ethiopia with a national prevalence of 4.36% among the adult population. This rising diabetes increases the demand for insulin self-administration, which in turn increases the demand for prefilled syringes.

The growth of home healthcare services is closely tied to the self-care trend. Pre-filled syringes fit well within the home healthcare model, allowing patients to receive necessary treatments without the need for frequent hospital or clinic visits. The increasing use of telemedicine and remote monitoring technologies supports self-care interventions. Pre-filled syringes can be prescribed during virtual consultations, and healthcare providers can remotely monitor patients' progress, offering guidance and adjustments to treatment plans as needed.

Additionally, according to WHO, estimated that 1 in 5 of the world's population are now living in humanitarian crises, in which health systems are challenged to deliver essential services. Self-care interventions are tools that support the ability of individuals, families and communities to promote health, prevent disease, maintain health, and cope with illness and disability with or without the support of a health worker.

Limited drug capacity

The limited drug capacity of pre-filled syringes is expected to hamper the growth of the market due to several challenges that restrict their utility, especially for complex and large-volume drugs. Pre-filled syringes typically have a smaller drug capacity compared to vials and other packaging formats. This restricts their use of medications with specific dosage requirements. Many pre-filled syringes are designed for single-dose applications, often limiting the total volume to 1 to 2 mL.

For instance, according to the Diabetes Journals Organization, insulin syringes come in different sizes, including 0.3, 0.5 and 1.0 mL sizes that hold up to 30, 50, and 100 units of insulin, respectively. Insulin pre-filled syringes are limited to a maximum dose of around 1.0 mL due to syringe capacity constraints. This may not be sufficient for medications requiring larger doses.

Many biologics and high-concentration drugs require larger volumes for effective treatment, but pre-filled syringes are not always suitable due to limited capacity. The challenge is particularly pronounced with drugs used in oncology, where high concentrations and volumes are needed to maintain efficacy. For instance, the majority of pre-filled syringes on the market can hold up to 2 mL, which might not be sufficient for drugs like monoclonal antibodies and high-concentration biologics.

Segment Analysis

The global pre-filled syringes market is segmented based on product, material, design, application, end-user and region.

Product Type:

The needled prefilled syringes segment is expected to dominate the pre-filled syringes market share

Needled pre-filled syringes are widely used for a range of applications, including insulin administration, vaccines and biologic therapies. Insulin and diabetes management are prime examples, where pre-filled syringes equipped with needles provide a reliable and convenient method for daily self-administration. Needled pre-filled syringes are preferred for their ability to deliver drugs directly into the bloodstream, ensuring effective therapeutic outcomes. The presence of a needle allows for precise dosing, which is crucial for biologics and therapies requiring targeted delivery.

For instance, in September 2024, BD (Becton, Dickinson and Company) released the BD Neopak XtraFlow Glass Prefillable Syringe and the latest capacity expansion of the BD Neopak Glass Prefillable Syringe platform to serve the growing market for biologic therapies. This solution features an 8-millimeter needle length and thinner wall cannula to optimize subcutaneous delivery of higher viscosity drug profiles by reducing the injection force and time required for a fixed solution viscosity. The BD Neopak Glass Prefillable Syringe platform is designed to address key development needs for biologic drugs.

Advanced safety mechanisms integrated into needled pre-filled syringes improve their safety profile. These features have become essential in healthcare settings, especially for hospital administrations, and for patient safety. For instance, in August 2024, Schreiner MediPharm introduced Needle-Trap Secu, a protection label with a newly integrated seal function that enhances sustainability and cost efficiency in the storage, transportation and disposal of prefilled syringes. Its compact design technology effectively protects against needlestick injuries while saving space and resources.

Geographical Analysis

North America is expected to hold a significant position in the pre-filled syringes market share

There is a growing trend towards self-administration in North America especially in the United States, driven by the convenience it offers to patients and caregivers. Self-injection pens and needled pre-filled syringes are widely used for managing chronic conditions like diabetes, rheumatoid arthritis, and multiple sclerosis. For instance, the National Institute of Health reports indicate that in the United States, approximately 40% of the population self-medicates, this further boosts the demand for prefilled syringes in the region.

North America is a major market for biologics and biosimilars, which are primarily delivered using pre-filled syringes. The growing prevalence of chronic diseases and the increasing adoption of biologics for treatment have driven the demand for pre-filled syringes in the region. For instance, according to the Pharmaceutical Research and Manufacturers of America, as of the end of 2022, 40 biosimilars have been approved and there are 27 biosimilars on the market in the U.S. competing against ten brand biologics with several more scheduled to launch throughout 2023.

Asia-Pacific is growing at the fastest pace in the Pre-Filled Syringes market

Rapidly improving healthcare infrastructure across countries like China, India, Japan, South Korea, and others in the APAC region is driving the adoption of advanced medical devices like pre-filled syringes. Investments in healthcare facilities, government initiatives to improve access to quality healthcare, and the establishment of specialized hospitals and clinics are boosting the demand for pre-filled syringes. For instance, in China, the government's healthcare reforms have led to increased spending on healthcare infrastructure, which is accelerating the adoption of advanced drug delivery systems such as pre-filled syringes.

For instance, in June 2022, WuXi Biologics launched the GMP operation of its new drug product facility DP5 located in Wuxi, China. The DP5 is the ninth operational drug product facility in the global network of WuXi Biologics. The DP5 facility features an isolator filling line for continuous and steady filling services, which offers multiple volume delivery options for pre-filled syringes (PFS), including 1 mL Long, 1 mL, 2.25 mL and 3 mL, notes WuXi. The maximum filling speed reportedly can reach 400 PFS/min to support 17 million syringes of drug products manufacturing every year.

The rising prevalence of chronic diseases such as diabetes, cardiovascular diseases and cancer in the APAC region is a major driver. These diseases often require long-term treatment regimens, making pre-filled syringes a convenient and preferred method of drug delivery. For instance, China has one of the highest numbers of diabetes patients, currently having 140.9 million people with diabetes, which is set to increase to 174.4 million by 2045., driving the demand for insulin-pre-filled syringes

Competitive Landscape

The major global players in the pre-filled syringes market include Becton, Dickinson, and Company, Gerresheimer AG, Schott AG, Stevanato Group S.p.A., Terumo Corporation, Sanofi S.A., Hikma Pharmaceuticals PLC, MedXL Inc., West Pharmaceutical Services, Inc., Cardinal Health and among others.

Key Developments

• In September 2024, BD (Becton, Dickinson and Company) announced the commercial release of the BD Neopak XtraFlow Glass Prefillable Syringe and the latest capacity expansion of the BD Neopak Glass Prefillable Syringe platform to serve the growing market for biologic therapies.
• In March 2024, Biocon Biologics, a subsidiary of Biocon, on Monday officially announced a settlement with Bayer and Regeneron Pharmaceuticals. This agreement allows Biocon Biologics to launch Yesafili, a proposed biosimilar to EYLEA (aflibercept) Injection, in the Canadian market. Under the terms of the company agreement, Biocon Biologics has secured a launch date for Yesafili 2 mg New Drug Submission (NDS) for vials and prefilled syringes, with the launch set up to July 1, 2025.
• In January 2023, Schreiner MediPharm presented a security label for syringes at Pharmapack Paris in early February. Met with ample interest among eventgoers, the company's Syringe-Closure-Wrap is a multifunctional label for pre-filled syringes that provides a clear first-opening indication, enabling the detection of previous use, tampering or counterfeiting attempts.

Why Purchase the Report?

• Pipeline & Innovations: Reviews ongoing clinical trials, product pipelines, and forecasts upcoming advancements in medical devices and pharmaceuticals.
• Product Performance & Market Positioning: Analyzes product performance, market positioning, and growth potential to optimize strategies.
• Real-World Evidence: Integrates patient feedback and data into product development for improved outcomes.
• Physician Preferences & Health System Impact: Examines healthcare provider behaviors and the impact of health system mergers on adoption strategies.
• Market Updates & Industry Changes: Covers recent regulatory changes, new policies, and emerging technologies.
• Competitive Strategies: Analyzes competitor strategies, market share, and emerging players.
• Pricing & Market Access: Reviews pricing models, reimbursement trends, and market access strategies.
• Market Entry & Expansion: Identifies optimal strategies for entering new markets and partnerships.
• Regional Growth & Investment: Highlights high-growth regions and investment opportunities.
• Supply Chain Optimization: Assesses supply chain risks and distribution strategies for efficient product delivery.
• Sustainability & Regulatory Impact: Focuses on eco-friendly practices and evolving regulations in healthcare.
• Post-market Surveillance: Uses post-market data to enhance product safety and access.
• Pharmacoeconomics & Value-Based Pricing: Analyzes the shift to value-based pricing and data-driven decision-making in R&D.

The global pre-filled syringes market report delivers a detailed analysis with 78 key tables, more than 71 visually impactful figures, and 179 pages of expert insights, providing a complete view of the market landscape.

Target Audience 2024

• Manufacturers: Pharmaceutical, Medical Device, Biotech Companies, Contract Manufacturers, Distributors, Hospitals.
• Regulatory & Policy: Compliance Officers, Government, Health Economists, Market Access Specialists.
• Technology & Innovation: AI/Robotics Providers, R&D Professionals, Clinical Trial Managers, Pharmacovigilance Experts.
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