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DDS Market Trends
Shift Towards Large-Volume Subcutaneous Administration in Drug Delivery Systems
Chapter of the 2025 Global Drug Delivery System Trends Report
4 minute read
Drug delivery is transforming as the industry shifts from traditional intravenous (IV) administration to subcutaneous (SC) and, increasingly, large-volume subcutaneous (LVSC) delivery. While IV administration remains standard for many therapies, advances in formulation science and wearable injection technologies now allow higher-volume, more viscous biologics to be administered safely and comfortably beyond clinical settings. LVSC delivery is becoming a cornerstone of next-generation therapeutic administration—combining clinical efficacy, patient centricity, and economic efficiency.
This article explores the industry’s transition from intravenous to SC and LVSC delivery, highlighting how advances in biologics and wearable injectors are enabling safer, more convenient, and cost-efficient treatment outside clinical settings.
Key Drivers: Growth of High-Volume Biologics and Home-Based Care Models
IVs, while remaining standard for many biopharmaceuticals, often require administration in acute care settings due to safety concerns and long infusion times. This creates significant logistical, time, and resource burdens on both healthcare systems and patients. SC administration is emerging as a viable alternative to address these challenges, offering shorter administration times, lower costs, and greater flexibility in care delivery. SC delivery models can shift care away from hospitals by enabling treatment in outpatient or home settings, reducing strain on healthcare systems while offering patients greater convenience and autonomy.
The scope of SC administration is building on these advantages, expanding as both drug formulations and patient expectations evolve. Many therapies, such as apomorphine, still rely on daily, time-consuming pump infusions that burden patients and healthcare providers and can cause skin reactions. New wearable autoinjectors, by contrast, can deliver large volumes subcutaneously without wiring or tubing, improving comfort, mobility, and convenience. These innovations, combined with advances in biologics that enable higher injection volumes and more viscous formulations, are driving demand for less frequent, high-volume doses outside clinical settings. Together, these trends underpin the rise of LVSC delivery as a practical and patient-centric alternative to traditional infusion.
The market used to believe you couldn’t go beyond 1 mL. Now, we’re seeing 2.25 and even 3 mL becoming the norm. The market’s shifting fast, and even mid-trial programs are rethinking delivery because patients and payers want it simpler.
Strategic Decision: the Transition to SC and LVSC
This evolution reflects an industry shift, with pharmaceutical companies strategically adopting delivery systems that combine higher-volume capacity with ease of use. Companies aim to improve convenience, strengthen adherence, and enhance overall treatment efficiency by moving away from multiple smaller doses toward LVSC, especially as biologic therapies grow more complex and patient-friendly administration becomes a priority.
In 2024, about 15% of all approved or clinical-stage IV and SC biopharmaceuticals were LVSC agents, primarily monoclonal or bispecific antibodies. These target predominantly cancer (41%) and autoimmune conditions (27%). Most therapies fall within the 2–20 mL range, with nearly half (44%) concentrated in the lower 2–5 mL tier.
Sources: Green, P., Schneider, A., & Lange, J. (2024). Navigating large-volume subcutaneous injections of biopharmaceuticals: a systematic review of clinical pipelines and approved products. mAbs, 16(1); Alira Health analysis.
Non-cancer LVSCs, such as those for asthma, inflammatory bowel disease, and migraine, are generally within the 2–5 mL range, aligning with handheld autoinjector capabilities for at-home use. In contrast, most cancer LVSCs fall within the 5–20 mL range and often still require administration in hospitals by healthcare professionals. The push toward home-based cancer care, however, is accelerating demand for user-friendly LVSC delivery solutions that can ensure safety and precision outside clinical settings.
As the LVSC pipeline advances, it’s reshaping the landscape of drug delivery—bringing new complexities that demand innovative, patient-centric solutions. We believe this evolution calls for close collaboration across the industry, combining translational and usability insights to support successful, scalable commercialization.
Several challenges still limit LVSC delivery’s broad adoption, despite it gaining traction. Companies are responding with a mix of formulation innovation and device design strategies, including:
- Limited evidence on safe dosing: Evidence on patient tolerability thresholds for injection volume and frequency remains limited, making it difficult to define best practices. Market players are conducting clinical studies and collecting real-world data to establish safe dosing ranges and support integration into routine care.
- Extended dosing intervals: Larger SC doses are required as some therapies move toward longer intervals (e.g., every four to six weeks), increasing device design complexity. Companies are developing large capacity autoinjectors and wearable injectors that can reliably handle higher volumes to address this issue.
- High-viscosity formulations: Increasing drug concentration reduces injection volume but raises viscosity, making delivery more challenging and potentially uncomfortable. Companies are advancing modular platforms to overcome this, with configurable needles, shorter and wider designs to lower injection force, and high-force autoinjectors capable of delivering viscous formulations without compromising patient comfort.
- Oncology care complexity: Cancer patients often undergo combination therapy with IV chemotherapy or radiotherapy, requiring infusion-center visits that diminish the value of at-home SC options. Companies are exploring the feasibility of at-home administration for selected anticancer agents, supported by new delivery technologies designed for safe self-injection.