Prefillable Syringes

# Executive Summary * The prefillable syringes market is experiencing a surge in demand, primarily driven by the rapid expansion of biologic and GLP-1 therapies for chronic conditions like diabetes and obesity. * Stricter sterile manufacturing regulations, particularly EU GMP Annex 1, are accelerating the industry's shift towards higher-value, Ready-to-Use (RTU) products, creating a competitive advantage for compliant manufacturers. * Technological innovation is focused on patient-centric solutions, with significant investment in user-friendly auto-injectors and connected devices to support the trend of self-administration at home. * Leading companies are differentiating through proprietary materials and integrated systems, moving from being component suppliers to end-to-end solution partners for pharmaceutical clients. * Financial performance is diverging, with companies directly exposed to high-growth biologics showing mid-to-high single-digit growth, while niche players can achieve even faster expansion. * Significant capital is being allocated towards capacity expansion and building resilient, localized supply chains to meet future demand and mitigate geopolitical risks. ## Key Trends & Outlook The primary growth catalyst for the prefillable syringes industry is the unprecedented demand for biologic drugs, particularly GLP-1 therapies for diabetes and obesity. These complex, often self-administered drugs require high-quality, sterile, and precise delivery systems, moving the market away from traditional vials. This directly boosts revenue and margins, as companies can sell higher-value systems. For instance, West Pharmaceutical Services (WST) reports that GLP-1 elastomers already represent 9% of its total sales. This demand is happening in parallel with a major regulatory shift, as the EU GMP Annex 1, fully effective in August 2023, is forcing manufacturers to upgrade facilities and adopt sterile, "Ready-to-Use" (RTU) solutions to minimize contamination risk. This regulation creates a significant barrier to entry and benefits companies like Stevanato Group (STVN) and WST, which have invested heavily in compliant manufacturing and can command higher prices for these advanced products. To meet the needs of patients self-administering biologics, the industry is rapidly innovating beyond the basic syringe. Major investment is flowing into the development of auto-injectors, pen injectors, and wearable devices that improve ease of use, safety, and dose accuracy. Companies like Becton, Dickinson and Company (BDX) are developing wearable injectors such as BD Libertas and BD Evolve for next-generation biologics. Similarly, West Pharmaceutical Services (WST) is developing an integrated system for human-use prefilled syringes, targeting a late 2025 or early 2026 launch to capture this trend. The largest opportunity lies in becoming an integrated partner for pharmaceutical companies, providing a complete system of containment (syringe/cartridge) and delivery (auto-injector/wearable device), particularly for the growing pipeline of biologic and biosimilar drugs. The primary risk is execution on capacity expansion and supply chain resilience; failure to build out localized manufacturing, as Stevanato Group (STVN) is doing with its new facilities in the U.S. and Italy, could lead to an inability to meet the surging demand and a loss of market share to better-prepared competitors. ## Competitive Landscape The global drug containment solution market is projected to grow at an 8% Compound Annual Growth Rate (CAGR) through 2030. While specific market share data is limited, the industry consists of large, diversified leaders and smaller, highly specialized players. This competitive structure fosters distinct strategic approaches among participants. One prevalent strategy is Proprietary Component and Material Science Leadership, where companies focus on developing and manufacturing highly engineered, proprietary components that offer superior performance for sensitive biologic drugs. This approach creates a deep competitive moat through intellectual property, allowing for strong pricing power and high margins, as these companies become deeply integrated into the customer's drug development and regulatory process. West Pharmaceutical Services (WST) exemplifies this model, with its competitive advantage built on proprietary elastomers and Crystal Zenith polymer solutions, which are critical for containing sensitive GLP-1 and biologic drugs. In contrast, other players adopt an Integrated End-to-End Containment and Delivery Systems strategy, offering a complete solution from primary drug containment (glass vials, syringes) through to drug delivery devices (auto-injectors, pens), supported by engineering and manufacturing services. This provides a "one-stop-shop" for pharma clients, simplifying their supply chain and accelerating time-to-market, with a global manufacturing footprint enabling supply chain security. Stevanato Group (STVN) emphasizes its integrated value proposition, from its core expertise in glass-forming technology (Nexa syringes, EZ-fill cartridges) to its expanding device manufacturing operations in Fishers, Indiana. A third distinct approach is Niche Application and Delivery Specialization, where companies dominate a specific, high-need segment of the drug delivery market with a purpose-built system. This allows for rapid growth and high margins by addressing an underserved market, often fostering strong patient and physician loyalty. KORU Medical Systems (KRMD) focuses exclusively on large-volume subcutaneous drug delivery with its Freedom infusion system, which is designed for direct compatibility with prefilled syringes, a key advantage for users. Ultimately, the key competitive battleground is the ability to provide reliable, high-quality, and innovative solutions for the demanding biologics and GLP-1 drug classes. This imperative is forcing all players to invest heavily in technology and manufacturing capacity to maintain or gain market share. ## Financial Performance Revenue growth across the industry is not uniform, diverging based on how effectively companies are capturing the biologics boom and managing internal operations. While most large players are in the mid-to-high single-digit growth range, the spectrum extends from KORU Medical Systems (KRMD) reporting a robust +20.9% year-over-year revenue growth in Q2-25, reflecting deep penetration in its specialized niche. In contrast, Lifecore Biomedical (LFCR) reported a -4% year-over-year revenue decline in Q4-25, highlighting that industry tailwinds do not guarantee success, as company-specific challenges can create significant headwinds. {{chart_0}} Profitability in the sector is a clear indicator of competitive advantage, with a wide gap between specialized technology leaders and more diversified manufacturers. Gross margins range significantly, with KORU Medical Systems (KRMD) achieving an industry-leading 63.5% gross margin in Q2-25. This high margin is a direct result of its specialized focus on the subcutaneous infusion niche, allowing it to command premium pricing. Meanwhile, larger players like West Pharmaceutical Services (WST) sustain strong margins, reporting 36.6% in Q3-25, through their proprietary high-value components and integrated ecosystems. {{chart_1}} Capital allocation strategies reflect a dual priority: funding the capacity expansions needed to capture the biologics opportunity while also returning cash to shareholders. Companies are aggressively allocating capital to fund future growth, with Stevanato Group (STVN) securing €200 million in financing for major CAPEX investments in its U.S. and Italian facilities to expand capacity for high-value solutions. Simultaneously, mature, cash-generative leaders are returning significant capital, with Becton, Dickinson and Company (BDX) planning to deploy $1 billion for share repurchases by the end of the calendar year. {{chart_2}} The industry's strong demand drivers and focus on high-value products translate into healthy cash generation, supporting strong balance sheets. This financial strength enables both the significant capital investments in new facilities and the shareholder return programs. West Pharmaceutical Services (WST) demonstrates robust liquidity, with $628.5 million in cash and equivalents as of Q3 2025, and a 54% surge in free cash flow to $294 million for the nine months ended September 30, 2025.